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Comment & Controversy

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Drospirenone vs norethindrone progestin-only pills. Is there a clear winner?

ROBERT L. BARBIERI, MD (FEBRUARY 2022)

Contraception queries

Dr. Barbieri, addressing your editorial on drospirenone and norethindrone pills, can you tell me why there are 4 placebo pills in Slynd? In addition, why did Exeltis choose a 24/4 regimen instead of a continuous regimen? And are there data on bleeding patterns with continuous drospirenone versus 24/4?

Meredith S. Cassidy, MD

Colorado Springs, Colorado

Dr. Barbieri responds

I thank Dr. Cassidy for the excellent question! The purpose of the 4 placebo pills in the Slynd (drospirenone 4 mg) 24/4 progestin-only contraceptive is to induce scheduled bleeding and reduce the number of days of unscheduled uterine bleeding. In a study of 858 patients, compared with a continuous progestin-only desogestrel contraceptive, Slynd with 4 placebo pills, was associated with significantly fewer days of unscheduled bleeding, 22 days versus 35 days (P<.0003) over 8 months of contraceptive use.1

The norethindrone progestin-only pill (POP) , which is available in the United States has very weak anti-ovulatory properties. If there were 4 placebo pills in the norethindrone POP, ovulation rates would increase, leading to reduced contraceptive efficacy. In contrast, Slynd with 4 placebo pills has excellent anti-ovulatory efficacy.

Reference

1. Palacios S, Colli E, Regidor PA. Bleeding profile of women using a drospirenone-ony 4 mg over nine cycles in comparison with desogestrel 0.075 mg. PLoS ONE. 2020;15:e0231856.

Should every scheduled cesarean birth use an Enhanced Recovery After Surgery (ERAS) pathway?

ROBERT L. BARBIERI, MD (NOVEMBER 2022)

ERAS for all cesarean deliveries

In Dr. Barbieri’s editorial “Should every scheduled cesarean birth use an Enhanced Recovery After Surgery (ERAS) pathway?”, he and Dr. Schantz-Dunn outline several reasons why the answer is a resounding, “Yes!”

I would suggest that ERAS principles should be used for all cesarean deliveries (CDs), not only scheduled ones. Many components of CD ERAS pathways are equally applicable to scheduled and unscheduled CDs, specifically those components that apply to intraoperative care (antibiotic prophylaxis, skin preparation, surgical technique, uterotonic administration, normothermia, and multimodal anesthesia) and postoperative care (VTE prophylaxis, gum chewing, early oral intake, early ambulation, early removal of bladder catheter, predischarge patient education, scheduled analgesic prophylaxis with acetaminophen, and NSAIDS). Although scheduled CDs have the additional advantage of the pre-hospital components (breastfeeding education, shortened fasting interval, carbohydrate loading, anemia prevention, and physiologic optimization), most of the benefit of ERAS for CD is likely attributable to the intraoperative and postoperative components.

For example, in our CD ERAS program, the median postoperative opioid consumption was reduced from a baseline of more than 100 morphine mg equivalents (MME) in both scheduled CDs (23 MME, interquartile range [IQR], 0-70) and unscheduled CDs (23 MME, IQR, 0-75).1 Remarkably, 29% of patients in the ERAS pathway used no postoperative opioids at all, a testament to the efficacy of neuraxial morphine and postoperative acetaminophen and NSAIDS. In another program, ERAS was associated with decreased postpartum length of stay and reduced direct costs in both scheduled and unscheduled CDs.2

References

  1. Combs CA, Robinson T, Mekis C, et al. Enhanced recovery after cesarean: impact on postoperative opioid use and length of stay. Am J Obstet Gynecol. 2021;224:237-239.
  2. Fay EE, Hitti JE, Delgado CM, et al. An enhanced recovery after surgery pathway for cesarean delivery decreases hospital stay and cost. Am J Obstet Gynecol. 2019;221:349.e1-e9.

C. Andrew Combs, MD, PhD

Sunrise, Florida

Dr. Barbieri responds

I am grateful to Dr. Combs’ advocacy for applying ERAS principles to all CD births, including scheduled and unscheduled operations. Dr. Combs notes that the intraoperative and postoperative components of ERAS can be used for both scheduled and unscheduled CD births. Of particular note is the marked reduction in opioid medication use achieved among Dr. Combs’ patients who were on an ERAS pathway. Hopefully, due to Dr. Combs clinical and research leadership many more patients will benefit from the use of an ERAS pathway.

ObGyns united in a divided post-Dobbs America

ERIN TRACY BRADLEY, MD, MPH, AND MEGAN L. EVANS,MD, MPH (DECEMBER 2022)

ObGyns are not united on this issue

I just finished reading the article by Drs. Bradley and Evans in the December edition of OBG Management. I am an older ObGyn, and I remember when the American College of Obstetricians and Gynecologists and other organizations within our specialty were more circumspect when discussing abortion. They recognized that there were many practitioners who held sincere opinions regarding abortion, feeling that it was ending a sacred life. I am one of those practitioners. I have always felt that we, of all practitioners, should be aware of the reality of early fetal life. We scan patients every day. To see the unborn fetus in all its glory should indelibly impress on each of us that this is life.

The unborn seem not to have advocates like Drs. Bradley and Evans. In fact, those who hold pro-life opinions are regularly silenced in publications and on social media. The Facebooks and Twitters of the world tend to hold us in derision when they are not silencing us. There used to be a detente in our field where we each respected the viewpoint of the other, but now it is nonstop advocacy for abortion. Some authors want to accelerate and intensify that advocacy. I suspect that the pro-life views like mine will continue to be silenced. I just want the authors to know that we are not united in this post-Dobbs world. Many of us want appropriate limits on termination. We are not in favor of the unlimited right to abort a fetus up to the moment of delivery.

Steven G. Nelson

Phoenix, Arizona

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Drospirenone vs norethindrone progestin-only pills. Is there a clear winner?

ROBERT L. BARBIERI, MD (FEBRUARY 2022)

Contraception queries

Dr. Barbieri, addressing your editorial on drospirenone and norethindrone pills, can you tell me why there are 4 placebo pills in Slynd? In addition, why did Exeltis choose a 24/4 regimen instead of a continuous regimen? And are there data on bleeding patterns with continuous drospirenone versus 24/4?

Meredith S. Cassidy, MD

Colorado Springs, Colorado

Dr. Barbieri responds

I thank Dr. Cassidy for the excellent question! The purpose of the 4 placebo pills in the Slynd (drospirenone 4 mg) 24/4 progestin-only contraceptive is to induce scheduled bleeding and reduce the number of days of unscheduled uterine bleeding. In a study of 858 patients, compared with a continuous progestin-only desogestrel contraceptive, Slynd with 4 placebo pills, was associated with significantly fewer days of unscheduled bleeding, 22 days versus 35 days (P<.0003) over 8 months of contraceptive use.1

The norethindrone progestin-only pill (POP) , which is available in the United States has very weak anti-ovulatory properties. If there were 4 placebo pills in the norethindrone POP, ovulation rates would increase, leading to reduced contraceptive efficacy. In contrast, Slynd with 4 placebo pills has excellent anti-ovulatory efficacy.

Reference

1. Palacios S, Colli E, Regidor PA. Bleeding profile of women using a drospirenone-ony 4 mg over nine cycles in comparison with desogestrel 0.075 mg. PLoS ONE. 2020;15:e0231856.

Should every scheduled cesarean birth use an Enhanced Recovery After Surgery (ERAS) pathway?

ROBERT L. BARBIERI, MD (NOVEMBER 2022)

ERAS for all cesarean deliveries

In Dr. Barbieri’s editorial “Should every scheduled cesarean birth use an Enhanced Recovery After Surgery (ERAS) pathway?”, he and Dr. Schantz-Dunn outline several reasons why the answer is a resounding, “Yes!”

I would suggest that ERAS principles should be used for all cesarean deliveries (CDs), not only scheduled ones. Many components of CD ERAS pathways are equally applicable to scheduled and unscheduled CDs, specifically those components that apply to intraoperative care (antibiotic prophylaxis, skin preparation, surgical technique, uterotonic administration, normothermia, and multimodal anesthesia) and postoperative care (VTE prophylaxis, gum chewing, early oral intake, early ambulation, early removal of bladder catheter, predischarge patient education, scheduled analgesic prophylaxis with acetaminophen, and NSAIDS). Although scheduled CDs have the additional advantage of the pre-hospital components (breastfeeding education, shortened fasting interval, carbohydrate loading, anemia prevention, and physiologic optimization), most of the benefit of ERAS for CD is likely attributable to the intraoperative and postoperative components.

For example, in our CD ERAS program, the median postoperative opioid consumption was reduced from a baseline of more than 100 morphine mg equivalents (MME) in both scheduled CDs (23 MME, interquartile range [IQR], 0-70) and unscheduled CDs (23 MME, IQR, 0-75).1 Remarkably, 29% of patients in the ERAS pathway used no postoperative opioids at all, a testament to the efficacy of neuraxial morphine and postoperative acetaminophen and NSAIDS. In another program, ERAS was associated with decreased postpartum length of stay and reduced direct costs in both scheduled and unscheduled CDs.2

References

  1. Combs CA, Robinson T, Mekis C, et al. Enhanced recovery after cesarean: impact on postoperative opioid use and length of stay. Am J Obstet Gynecol. 2021;224:237-239.
  2. Fay EE, Hitti JE, Delgado CM, et al. An enhanced recovery after surgery pathway for cesarean delivery decreases hospital stay and cost. Am J Obstet Gynecol. 2019;221:349.e1-e9.

C. Andrew Combs, MD, PhD

Sunrise, Florida

Dr. Barbieri responds

I am grateful to Dr. Combs’ advocacy for applying ERAS principles to all CD births, including scheduled and unscheduled operations. Dr. Combs notes that the intraoperative and postoperative components of ERAS can be used for both scheduled and unscheduled CD births. Of particular note is the marked reduction in opioid medication use achieved among Dr. Combs’ patients who were on an ERAS pathway. Hopefully, due to Dr. Combs clinical and research leadership many more patients will benefit from the use of an ERAS pathway.

ObGyns united in a divided post-Dobbs America

ERIN TRACY BRADLEY, MD, MPH, AND MEGAN L. EVANS,MD, MPH (DECEMBER 2022)

ObGyns are not united on this issue

I just finished reading the article by Drs. Bradley and Evans in the December edition of OBG Management. I am an older ObGyn, and I remember when the American College of Obstetricians and Gynecologists and other organizations within our specialty were more circumspect when discussing abortion. They recognized that there were many practitioners who held sincere opinions regarding abortion, feeling that it was ending a sacred life. I am one of those practitioners. I have always felt that we, of all practitioners, should be aware of the reality of early fetal life. We scan patients every day. To see the unborn fetus in all its glory should indelibly impress on each of us that this is life.

The unborn seem not to have advocates like Drs. Bradley and Evans. In fact, those who hold pro-life opinions are regularly silenced in publications and on social media. The Facebooks and Twitters of the world tend to hold us in derision when they are not silencing us. There used to be a detente in our field where we each respected the viewpoint of the other, but now it is nonstop advocacy for abortion. Some authors want to accelerate and intensify that advocacy. I suspect that the pro-life views like mine will continue to be silenced. I just want the authors to know that we are not united in this post-Dobbs world. Many of us want appropriate limits on termination. We are not in favor of the unlimited right to abort a fetus up to the moment of delivery.

Steven G. Nelson

Phoenix, Arizona

 

Drospirenone vs norethindrone progestin-only pills. Is there a clear winner?

ROBERT L. BARBIERI, MD (FEBRUARY 2022)

Contraception queries

Dr. Barbieri, addressing your editorial on drospirenone and norethindrone pills, can you tell me why there are 4 placebo pills in Slynd? In addition, why did Exeltis choose a 24/4 regimen instead of a continuous regimen? And are there data on bleeding patterns with continuous drospirenone versus 24/4?

Meredith S. Cassidy, MD

Colorado Springs, Colorado

Dr. Barbieri responds

I thank Dr. Cassidy for the excellent question! The purpose of the 4 placebo pills in the Slynd (drospirenone 4 mg) 24/4 progestin-only contraceptive is to induce scheduled bleeding and reduce the number of days of unscheduled uterine bleeding. In a study of 858 patients, compared with a continuous progestin-only desogestrel contraceptive, Slynd with 4 placebo pills, was associated with significantly fewer days of unscheduled bleeding, 22 days versus 35 days (P<.0003) over 8 months of contraceptive use.1

The norethindrone progestin-only pill (POP) , which is available in the United States has very weak anti-ovulatory properties. If there were 4 placebo pills in the norethindrone POP, ovulation rates would increase, leading to reduced contraceptive efficacy. In contrast, Slynd with 4 placebo pills has excellent anti-ovulatory efficacy.

Reference

1. Palacios S, Colli E, Regidor PA. Bleeding profile of women using a drospirenone-ony 4 mg over nine cycles in comparison with desogestrel 0.075 mg. PLoS ONE. 2020;15:e0231856.

Should every scheduled cesarean birth use an Enhanced Recovery After Surgery (ERAS) pathway?

ROBERT L. BARBIERI, MD (NOVEMBER 2022)

ERAS for all cesarean deliveries

In Dr. Barbieri’s editorial “Should every scheduled cesarean birth use an Enhanced Recovery After Surgery (ERAS) pathway?”, he and Dr. Schantz-Dunn outline several reasons why the answer is a resounding, “Yes!”

I would suggest that ERAS principles should be used for all cesarean deliveries (CDs), not only scheduled ones. Many components of CD ERAS pathways are equally applicable to scheduled and unscheduled CDs, specifically those components that apply to intraoperative care (antibiotic prophylaxis, skin preparation, surgical technique, uterotonic administration, normothermia, and multimodal anesthesia) and postoperative care (VTE prophylaxis, gum chewing, early oral intake, early ambulation, early removal of bladder catheter, predischarge patient education, scheduled analgesic prophylaxis with acetaminophen, and NSAIDS). Although scheduled CDs have the additional advantage of the pre-hospital components (breastfeeding education, shortened fasting interval, carbohydrate loading, anemia prevention, and physiologic optimization), most of the benefit of ERAS for CD is likely attributable to the intraoperative and postoperative components.

For example, in our CD ERAS program, the median postoperative opioid consumption was reduced from a baseline of more than 100 morphine mg equivalents (MME) in both scheduled CDs (23 MME, interquartile range [IQR], 0-70) and unscheduled CDs (23 MME, IQR, 0-75).1 Remarkably, 29% of patients in the ERAS pathway used no postoperative opioids at all, a testament to the efficacy of neuraxial morphine and postoperative acetaminophen and NSAIDS. In another program, ERAS was associated with decreased postpartum length of stay and reduced direct costs in both scheduled and unscheduled CDs.2

References

  1. Combs CA, Robinson T, Mekis C, et al. Enhanced recovery after cesarean: impact on postoperative opioid use and length of stay. Am J Obstet Gynecol. 2021;224:237-239.
  2. Fay EE, Hitti JE, Delgado CM, et al. An enhanced recovery after surgery pathway for cesarean delivery decreases hospital stay and cost. Am J Obstet Gynecol. 2019;221:349.e1-e9.

C. Andrew Combs, MD, PhD

Sunrise, Florida

Dr. Barbieri responds

I am grateful to Dr. Combs’ advocacy for applying ERAS principles to all CD births, including scheduled and unscheduled operations. Dr. Combs notes that the intraoperative and postoperative components of ERAS can be used for both scheduled and unscheduled CD births. Of particular note is the marked reduction in opioid medication use achieved among Dr. Combs’ patients who were on an ERAS pathway. Hopefully, due to Dr. Combs clinical and research leadership many more patients will benefit from the use of an ERAS pathway.

ObGyns united in a divided post-Dobbs America

ERIN TRACY BRADLEY, MD, MPH, AND MEGAN L. EVANS,MD, MPH (DECEMBER 2022)

ObGyns are not united on this issue

I just finished reading the article by Drs. Bradley and Evans in the December edition of OBG Management. I am an older ObGyn, and I remember when the American College of Obstetricians and Gynecologists and other organizations within our specialty were more circumspect when discussing abortion. They recognized that there were many practitioners who held sincere opinions regarding abortion, feeling that it was ending a sacred life. I am one of those practitioners. I have always felt that we, of all practitioners, should be aware of the reality of early fetal life. We scan patients every day. To see the unborn fetus in all its glory should indelibly impress on each of us that this is life.

The unborn seem not to have advocates like Drs. Bradley and Evans. In fact, those who hold pro-life opinions are regularly silenced in publications and on social media. The Facebooks and Twitters of the world tend to hold us in derision when they are not silencing us. There used to be a detente in our field where we each respected the viewpoint of the other, but now it is nonstop advocacy for abortion. Some authors want to accelerate and intensify that advocacy. I suspect that the pro-life views like mine will continue to be silenced. I just want the authors to know that we are not united in this post-Dobbs world. Many of us want appropriate limits on termination. We are not in favor of the unlimited right to abort a fetus up to the moment of delivery.

Steven G. Nelson

Phoenix, Arizona

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Ninety-four women allege a Utah doctor sexually assaulted them. Here’s why a judge threw out their case

Article Type
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Wed, 03/01/2023 - 13:35

This article was produced for ProPublica’s Local Reporting Network in partnership with The Salt Lake Tribune.

At 19 years old and about to be married, Stephanie Mateer went to an ob.gyn. within walking distance of her student housing near Brigham Young University in Provo, Utah.

She wanted to start using birth control, and she was looking for guidance about having sex for the first time on her 2008 wedding night.

Ms. Mateer was shocked, she said, when David Broadbent, MD, reached under her gown to grab and squeeze her breasts, started a vaginal exam without warning, then followed it with an extremely painful examination of her rectum.

She felt disgusted and violated, but doubt also crept in. She told herself she must have misinterpreted his actions, or that she should have known that he would do a rectal exam. Raised as a member of The Church of Jesus Christ of Latter-day Saints, she said she was taught to defer to men in leadership.

“I viewed him as being a man in authority,” Ms. Mateer said. “He’s a doctor.”

It was years, she said, before she learned that her experience was in a sharp contrast to the conduct called for in professional standards, including that doctors use only their fingertips during a breast exam and communicate clearly what they are doing in advance, to gain the consent of their patients. Eventually, she gave her experience another name: sexual assault.

Utah judges, however, have called it health care.

And that legal distinction means Utahns like Ms. Mateer who decide to sue a health care provider for alleged sexual abuse are treated more harshly by the court system than plaintiffs who say they were harmed in other settings.

The chance to go to civil court for damages is an important option for survivors, experts say. While a criminal conviction can provide a sense of justice, winning a lawsuit can help victims pay for the therapy and additional support they need to heal after trauma.

Ms. Mateer laid out her allegations in a lawsuit that she and 93 other women filed against Dr. Broadbent last year. But they quickly learned they would be treated differently than other sexual assault survivors.

Filing their case, which alleged the Utah County doctor sexually assaulted them over the span of his 47-year career, was an empowering moment, Ms. Mateer said. But a judge threw out the lawsuit without even considering the merits, determining that because their alleged assailant is a doctor, the case must be governed by medical malpractice rules rather than those that apply to cases of sexual assault.

Under Utah’s rules of medical malpractice, claims made by victims who allege a health care worker sexually assaulted them are literally worth less than lawsuits brought by someone who was assaulted in other settings – even if a jury rules in their favor, a judge is required to limit how much money they receive. And they must meet a shorter filing deadline.

“It’s just crazy that a doctor can sexually assault women and then be protected by the white coat,” Ms. Mateer said. “It’s just a really scary precedent to be calling sexual assault ‘health care.’ ”

Because of the judge’s ruling that leaves them with a shorter window in which to file, some of Dr. Broadbent’s accusers stand to lose their chance to sue. Others were already past that deadline but had hoped to take advantage of an exception that allows plaintiffs to sue if they can prove that the person who harmed them had covered up the wrongdoing and if they discovered they had been hurt within the previous year.

As a group, the women are appealing the ruling to the Utah Supreme Court, which has agreed to hear the case. This decision will set a precedent for future sexual assault victims in Utah.

Dr. Broadbent’s attorney, Chris Nelson, declined an interview request but wrote in an email: “We believe that the allegations against Dr. Broadbent are without merit and will present our case in court. Given that this is an active legal matter, we will not be sharing any details outside the courtroom.”

States have varying legal definitions of medical malpractice, but it’s generally described as treatment that falls short of accepted standards of care. That includes mistakes, such as a surgeon leaving a piece of gauze inside a patient.

Utah is among the states with the broadest definition of medical malpractice, covering any acts “arising” out of health care. The Utah Supreme Court has ruled that a teenage boy was receiving health care when he was allowed to climb a steep, snow-dusted rock outcrop as part of wilderness therapy. When he broke his leg, he could only sue for medical malpractice, so the case faced shorter filing deadlines and lower monetary caps. Similarly, the court has ruled that a boy harmed by another child while in foster care was also bound by medical malpractice law.

Despite these state Supreme Court rulings, Utah legislators have so far not moved to narrow the wording of the malpractice act.

The lawsuit against Dr. Broadbent – and the questions it raises about the broadness of Utah’s medical malpractice laws – comes during a national reckoning with how sexual assault survivors are treated by the law. Legislators in several states have been rewriting laws to give sexual assault victims more time to sue their attackers, in response to the growing cultural understanding of the impact of trauma and the barriers to reporting. Even in Utah, those who were sexually abused as children now have no deadline to file suits against their abusers.

That isn’t true for sexual abuse in a medical setting, where cases must be filed within 2 years of the assault.

These higher hurdles should not exist in Utah, said state Sen. Mike K. McKell, a Utah County Republican who works as a personal injury attorney. He is trying to change state law to ensure that sexual assault lawsuits do not fall under Utah’s Health Care Malpractice Act, a law designed to cover negligence and poor care, not necessarily deliberate actions like an assault.

“Sexual assault, to me, is not medical care. Period,” he said. “It’s sad that we need to clarify that sexual assault is not medical care. But trying to tie sexual assault to a medical malpractice [filing deadline] – it’s just wrong.”
 

 

 

‘Your husband is a lucky man’

Ms. Mateer had gone to Dr. Broadbent in 2008 for a premarital exam, a uniquely Utah visit often scheduled by young women who are members of The Church of Jesus Christ of Latter-day Saints.

Leaders of the faith, which is predominant in Utah, focus on chastity when speaking to young, unmarried people about sex, and public schools have typically focused on abstinence-based sex education. So for some, these visits are the first place they learn about sexual health.

Young women who get premarital exams are typically given a birth control prescription, but the appointments can include care that’s less common for healthy women in other states – such as doctors giving them vaginal dilators to stretch their tissues before their wedding nights.

That’s what Ms. Mateer was expecting when she visited Dr. Broadbent’s office. The ob.gyn. had been practicing for decades in his Provo clinic nestled between student housing apartments across the street from Brigham Young University, which is owned by The Church of Jesus Christ of Latter-day Saints.

So Ms. Mateer was “just totally taken aback,” she said, by the painful examination and by Dr. Broadbent snapping off his gloves after the exam and saying, “Your husband is a lucky man.”

She repeated that remark in her legal filing, along with the doctor’s advice for her: If she bled during intercourse, “just do what the Boy Scouts do and apply pressure.”

“The whole thing was like I’m some object for my husband to enjoy and let him do whatever he wants,” Ms. Mateer said. “It was just very violating and not a great way to start my sexual relationship with my new husband, with these ideas in mind.”

Ms. Mateer thought back to that visit over the years, particularly when she went to other ob.gyns. for health care. Her subsequent doctors, she said, never performed a rectal exam and always explained to her what they were doing and how it would feel, and asked for her consent.

She thought about Dr. Broadbent again in 2017, as the #MeToo movement gained momentum, and looked him up online. Ms. Mateer found reviews from other women who described Dr. Broadbent doing rough examinations without warning that left them feeling the same way she had years before.

Then in December 2021, she spoke out on “Mormon Stories,” a podcast where people who have left or have questioned their Latter-day Saint faith share their life stories. In the episode, she described the painful way he examined her, how it left her feeling traumatized, and her discovery of the reviews that echoed her experience.

“He’s on University Avenue, in Provo, giving these exams to who knows how many naive Mormon 18-year-old, 19-year-old girls who are getting married. … They are naive and they don’t know what to expect,” she said on the podcast. “His name is Dr. David Broadbent.”

After the podcast aired, Ms. Mateer was flooded with messages from women who heard the episode and reached out to tell her that Dr. Broadbent had harmed them, too.

Ms. Mateer and three other women decided to sue the ob.gyn., and in the following weeks and months, 90 additional women joined the lawsuit they filed in Provo. Many of the women allege Dr. Broadbent inappropriately touched their breasts, vaginas and rectums, hurting them, without warning or explanation. Some said he used his bare hand – instead of using a speculum or gloves – during exams. One alleged that she saw he had an erection while he was touching her.

Dr. Broadbent’s actions were not medically necessary, the women allege, and were instead “performed for no other reason than his own sexual gratification.”

The lawsuit also named as defendants two hospitals where Dr. Broadbent had delivered babies and where some of the women allege they were assaulted. The suit accused hospital administrators of knowing about Dr. Broadbent’s inappropriate behavior and doing nothing about it.

After he was sued, the ob.gyn. quickly lost his privileges at the hospitals where he worked. Dr. Broadbent, now 75, has also voluntarily put his medical license in Utah on hold while police investigate 29 reports of sexual assault made against him.

Prosecutors are still considering whether to criminally prosecute Dr. Broadbent. Provo police forwarded more than a dozen reports to the Utah County attorney’s office in November, which are still being reviewed by a local prosecutor.

A spokesperson for Intermountain Health, the nonprofit health system that owns Utah Valley Hospital, where some of the women in the suit were treated, did not respond to specific questions. The spokesperson emphasized in an email that Dr. Broadbent was an “independent physician” who was not employed by Utah Valley Hospital, adding that most of the alleged incidents took place at Dr. Broadbent’s medical office.

A representative for MountainStar Healthcare, another hospital chain named as a defendant, denied knowledge of any allegations of inappropriate conduct reported to its hospital and also emphasized that Dr. Broadbent worked independently, not as an employee.

“Our position since this lawsuit was filed has been that we were inappropriately named in this suit,” said Brittany Glas, the communications director for MountainStar.
 

 

 

Debating whether sexual abuse is health care

For the women who sued Dr. Broadbent, their case boiled down to a key question: Were the sexual assaults they say they experienced part of their health care? There was a lot hanging on the answer.

If their case was considered medical malpractice, they would be limited in how much money they could receive in damages for their pain and suffering. If a jury awarded them millions of dollars, a judge would be required by law to cut that down to $450,000. There’s no cap on these monetary awards for victims sexually assaulted in other settings.

They would also be required to go before a panel, which includes a doctor, a lawyer and a community member, that decides whether their claims have merit. This step, aimed at resolving disputes out of court, does not block anyone from suing afterward. But it does add cost and delay, and for sexual assault victims who’ve gone through this step, it has been another time they were required to describe their experiences and hope they were believed.

The shorter, 2-year filing deadline for medical malpractice cases can also be a particular challenge for those who have been sexually abused because research shows that it’s common to delay reporting such assaults.

Nationwide, these kinds of malpractice reforms were adopted in the 1970s amid concerns – largely driven by insurance companies – that the cost of health care was rising because of frivolous lawsuits and “runaway juries” doling out multimillion-dollar payouts.

Restricting the size of malpractice awards and imposing other limits, many argued, were effective ways to balance compensating injured patients with protecting everyone’s access to health care.

State laws are generally silent on whether sexual assault lawsuits should be covered by malpractice laws, leaving courts to grapple with that question and leading to different conclusions across the country. The Tribune and ProPublica identified at least six cases in which state appellate judges sharply distinguished between assault and health care in considering whether malpractice laws should apply to sexual assault–related cases.

An appellate court in Wisconsin, for example, ruled in 1993 that a physician having an erection and groping a patient was a purposeful harm, not medical malpractice.

Florida’s law is similar to Utah’s, defining allegations “arising” out of medical care as malpractice. While an earlier ruling did treat sexual assault in a health care setting as medical malpractice, appellate rulings in the last decade have moved away from that interpretation. In 2005, an appellate court affirmed a lower-court ruling that when a dentist “stopped providing dental treatment to the victim and began sexually assaulting her, his professional services ended.”

Similarly, a federal judge in Iowa in 1995 weighed in on the meaning of “arising” out of health care: “Rape is not patient care activity,” he wrote.

But Utah’s malpractice law is so broad that judges have been interpreting it as covering any act performed by a health care provider during medical care. The law was passed in 1976 and is popular with doctors and other health care providers, who have lobbied to keep it in place – and who use it to get lawsuits dismissed.

One precedent-setting case in Utah shows the law’s power to safeguard health care providers and was an important test of how Utah defines medical malpractice. Jacob Scott sued WinGate Wilderness Therapy after the teen broke his leg in 2015 when a hiking guide from the center allowed him to climb up and down a steep outcrop in Utah’s red rock desert.

His parents are both lawyers, and after they found that Utah had a 4-year deadline for filing a personal injury lawsuit, court records said, they decided to prioritize “getting Jacob better” for the first 2 years after the accident. But when Mr. Scott’s suit was filed, WinGate argued it was too late – based on the shorter, 2-year deadline for medical malpractice claims.

Mr. Scott’s attorneys scoffed. “Interacting with nature,” his attorneys argued, “is not health care even under the broadest interpretation of … the Utah Health Care Malpractice Act.”

A judge disagreed and threw out Mr. Scott’s case. The Utah Supreme Court unanimously upheld that ruling in 2021.

“We agree with WinGate,” the justices wrote, “that it was acting as a ‘health care provider’ and providing ‘health care’ when Jacob was hiking and rock climbing.”

Last summer, the women who had sued Dr. Broadbent and the two hospitals watched online as lawyers debated whether the abuse they allegedly suffered was health care.

At the hearing, attorneys for Dr. Broadbent and the hospitals argued that the women should have pursued a medical malpractice case, which required them to first notify Dr. Broadbent and the hospitals that they wanted to sue. They also argued to Judge Robert Lunnen that the case couldn’t move forward because the women hadn’t gone before a prelitigation panel.

Attorneys for Dr. Broadbent and the hospitals argued, one after the other, that the painful and traumatic exams the women described arose out of health care treatments.

“Accepting the allegations of the complaint as true – as we must for purposes of this proceeding – we have to assume that [Broadbent] did something that was medically unnecessary, medically inappropriate,” argued David Jordan, a lawyer for Intermountain Health.

“But it doesn’t change the fact that it’s an act performed to a patient, during the patient’s treatment,” he said. “Because that’s what the patient is doing in the doctor’s office. They’re there for treatment.”

The attorney team for the women pushed back. Terry Rooney argued that if Dr. Broadbent’s actions fell under medical malpractice laws, many women would be knocked out of the case because of the age of their claims, and those who remained would be limited in the amount of money in damages they could receive.

“That’s really what this is about,” he argued. “And so it’s troubling – quite frankly it’s shocking to me – that we’re debating heavily the question of whether sexual abuse is health care.”

The judge mulled the issue for months. Judge Lunnen wrote in a September ruling that if the allegations were true, Dr. Broadbent’s treatment of his patients was “insensitive, disrespectful and degrading.”

But Utah law is clear, he said. Malpractice law covers any act or treatment performed by any health care provider during the patient’s medical care. The women had all been seeking health care, Judge Lunnen wrote, and Dr. Broadbent was providing that when the alleged assaults happened.

Their lawsuit was dismissed.
 

 

 

‘I felt defeated’

Brooke, another plaintiff who alleges Dr. Broadbent groped her, remembers feeling sick on the June day she watched the attorneys arguing. She asked to be identified by only her first name for this story.

She alleges Dr. Broadbent violated her in December 2008 while she was hospitalized after experiencing complications with her first pregnancy.

The nearest hospital to her rural town didn’t have a special unit to take care of premature babies, and her doctors feared she might need to deliver her son 6 weeks early. So Brooke had been rushed by ambulance over a mountain pass in a snowstorm to Utah Valley Hospital.

Brooke and her husband were terrified, she said, when they arrived at the Provo hospital. Dr. Broadbent happened to be the doctor on call. With Brooke’s husband and brother-in-law in the room, Dr. Broadbent examined her late that evening, she said, listening to her chest with a stethoscope.

The doctor then suddenly grabbed her breasts, she recalled – his movements causing her hospital gown to fall to expose her chest. She recounted this experience in her lawsuit, saying it was nothing like the breast exams she has had since.

“It was really traumatizing,” she said. “I was mortified. My husband and brother-in-law – we just didn’t say anything about it because it was so uncomfortable.”

Brooke voiced concerns to the nurse manager, and she was assigned a new doctor.

She gave birth to a healthy baby a little more than a month later, at the hospital near her home.

Hearing the judge’s ruling 14 years later, Brooke felt the decision revealed how Utah’s laws are broken.

“I was frustrated,” she said, “and I felt defeated. … I thought justice is not on our side with this.”

If the Utah Supreme Court rules that these alleged sexual assaults should legally be considered health care, the women will likely refile their claims as a medical malpractice lawsuit, said their attorney, Adam Sorensen. But it would be a challenge to keep all 94 women in the case, he said, due to the shorter filing window. Only two women in the lawsuit allege that they were harmed within the last 2 years.

The legal team for the women would have to convince a judge that their claims should still be allowed because they only recently discovered they were harmed. But based on previous rulings, Mr. Sorensen believes the women will have a better chance to win that argument if the civil suit remained a sexual assault case.

Regardless of what happens in their legal case, the decision by Brooke and the other women to come forward could help change state law for victims who come after them.

Recently, Mr. McKell, the state senator, introduced legislation to clarify that civil lawsuits alleging sexual assault by a health care worker do not fall under Utah’s Health Care Malpractice Act.

“I don’t think it’s a close call. Sexual assault is not medical care,” he said. “I know we’ve got some bizarre rulings that have come down through our courts in Utah.”

Both an association of Utah trial lawyers and the Utah Medical Association, which lobbies on behalf of the state’s physicians, support this reform.

“We support the fact that sexual assault should not be part of health care medical malpractice,” said Michelle McOmber, the CEO for the Utah Medical Association. “Sexual assault should be sexual assault, regardless of where it happens or who’s doing it. Sexual assault should be in that category, which is separate from actual health care. Because it’s not health care.”

MountainStar doesn’t have a position on the bill, Ms. Glas said. “If the laws were to change via new legislation and/or interpretation by the courts, we would abide by and comply with those new laws.”

But lawmakers are running out of time. With only a short time left in Utah’s legislative session, state senate and house leaders have so far prioritized passing new laws banning gender-affirming health care for transgender youths and creating a controversial school voucher program that will provide taxpayer funds for students to attend private school.

Utah lawmakers were also expected to consider a dramatic change for other sexual assault victims: a bill that would remove filing deadlines for civil lawsuits brought by people abused as adults. But that bill stalled before it could be debated.

Brooke had been eager to share her story, she said, in hopes it would help the first four women who’d come forward bolster their lawsuit against Dr. Broadbent. She later joined the case as a plaintiff. She read in their lawsuit about one woman who complained about him to the same hospital 7 years before she did, and about another woman who said Dr. Broadbent similarly molested her 2 days after Brooke had expressed her own concern.

“That bothered me so much,” she said. “It didn’t have to happen to all these women.”

Brooke doubts she’ll get vindication in a courtroom. Justice for her, she suspects, won’t come in the form of a legal ruling or a settlement against the doctor she says hurt her years ago.

Instead, she said, “maybe justice looks like changing the laws for future women.”
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive the biggest stories as soon as they’re published.

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This article was produced for ProPublica’s Local Reporting Network in partnership with The Salt Lake Tribune.

At 19 years old and about to be married, Stephanie Mateer went to an ob.gyn. within walking distance of her student housing near Brigham Young University in Provo, Utah.

She wanted to start using birth control, and she was looking for guidance about having sex for the first time on her 2008 wedding night.

Ms. Mateer was shocked, she said, when David Broadbent, MD, reached under her gown to grab and squeeze her breasts, started a vaginal exam without warning, then followed it with an extremely painful examination of her rectum.

She felt disgusted and violated, but doubt also crept in. She told herself she must have misinterpreted his actions, or that she should have known that he would do a rectal exam. Raised as a member of The Church of Jesus Christ of Latter-day Saints, she said she was taught to defer to men in leadership.

“I viewed him as being a man in authority,” Ms. Mateer said. “He’s a doctor.”

It was years, she said, before she learned that her experience was in a sharp contrast to the conduct called for in professional standards, including that doctors use only their fingertips during a breast exam and communicate clearly what they are doing in advance, to gain the consent of their patients. Eventually, she gave her experience another name: sexual assault.

Utah judges, however, have called it health care.

And that legal distinction means Utahns like Ms. Mateer who decide to sue a health care provider for alleged sexual abuse are treated more harshly by the court system than plaintiffs who say they were harmed in other settings.

The chance to go to civil court for damages is an important option for survivors, experts say. While a criminal conviction can provide a sense of justice, winning a lawsuit can help victims pay for the therapy and additional support they need to heal after trauma.

Ms. Mateer laid out her allegations in a lawsuit that she and 93 other women filed against Dr. Broadbent last year. But they quickly learned they would be treated differently than other sexual assault survivors.

Filing their case, which alleged the Utah County doctor sexually assaulted them over the span of his 47-year career, was an empowering moment, Ms. Mateer said. But a judge threw out the lawsuit without even considering the merits, determining that because their alleged assailant is a doctor, the case must be governed by medical malpractice rules rather than those that apply to cases of sexual assault.

Under Utah’s rules of medical malpractice, claims made by victims who allege a health care worker sexually assaulted them are literally worth less than lawsuits brought by someone who was assaulted in other settings – even if a jury rules in their favor, a judge is required to limit how much money they receive. And they must meet a shorter filing deadline.

“It’s just crazy that a doctor can sexually assault women and then be protected by the white coat,” Ms. Mateer said. “It’s just a really scary precedent to be calling sexual assault ‘health care.’ ”

Because of the judge’s ruling that leaves them with a shorter window in which to file, some of Dr. Broadbent’s accusers stand to lose their chance to sue. Others were already past that deadline but had hoped to take advantage of an exception that allows plaintiffs to sue if they can prove that the person who harmed them had covered up the wrongdoing and if they discovered they had been hurt within the previous year.

As a group, the women are appealing the ruling to the Utah Supreme Court, which has agreed to hear the case. This decision will set a precedent for future sexual assault victims in Utah.

Dr. Broadbent’s attorney, Chris Nelson, declined an interview request but wrote in an email: “We believe that the allegations against Dr. Broadbent are without merit and will present our case in court. Given that this is an active legal matter, we will not be sharing any details outside the courtroom.”

States have varying legal definitions of medical malpractice, but it’s generally described as treatment that falls short of accepted standards of care. That includes mistakes, such as a surgeon leaving a piece of gauze inside a patient.

Utah is among the states with the broadest definition of medical malpractice, covering any acts “arising” out of health care. The Utah Supreme Court has ruled that a teenage boy was receiving health care when he was allowed to climb a steep, snow-dusted rock outcrop as part of wilderness therapy. When he broke his leg, he could only sue for medical malpractice, so the case faced shorter filing deadlines and lower monetary caps. Similarly, the court has ruled that a boy harmed by another child while in foster care was also bound by medical malpractice law.

Despite these state Supreme Court rulings, Utah legislators have so far not moved to narrow the wording of the malpractice act.

The lawsuit against Dr. Broadbent – and the questions it raises about the broadness of Utah’s medical malpractice laws – comes during a national reckoning with how sexual assault survivors are treated by the law. Legislators in several states have been rewriting laws to give sexual assault victims more time to sue their attackers, in response to the growing cultural understanding of the impact of trauma and the barriers to reporting. Even in Utah, those who were sexually abused as children now have no deadline to file suits against their abusers.

That isn’t true for sexual abuse in a medical setting, where cases must be filed within 2 years of the assault.

These higher hurdles should not exist in Utah, said state Sen. Mike K. McKell, a Utah County Republican who works as a personal injury attorney. He is trying to change state law to ensure that sexual assault lawsuits do not fall under Utah’s Health Care Malpractice Act, a law designed to cover negligence and poor care, not necessarily deliberate actions like an assault.

“Sexual assault, to me, is not medical care. Period,” he said. “It’s sad that we need to clarify that sexual assault is not medical care. But trying to tie sexual assault to a medical malpractice [filing deadline] – it’s just wrong.”
 

 

 

‘Your husband is a lucky man’

Ms. Mateer had gone to Dr. Broadbent in 2008 for a premarital exam, a uniquely Utah visit often scheduled by young women who are members of The Church of Jesus Christ of Latter-day Saints.

Leaders of the faith, which is predominant in Utah, focus on chastity when speaking to young, unmarried people about sex, and public schools have typically focused on abstinence-based sex education. So for some, these visits are the first place they learn about sexual health.

Young women who get premarital exams are typically given a birth control prescription, but the appointments can include care that’s less common for healthy women in other states – such as doctors giving them vaginal dilators to stretch their tissues before their wedding nights.

That’s what Ms. Mateer was expecting when she visited Dr. Broadbent’s office. The ob.gyn. had been practicing for decades in his Provo clinic nestled between student housing apartments across the street from Brigham Young University, which is owned by The Church of Jesus Christ of Latter-day Saints.

So Ms. Mateer was “just totally taken aback,” she said, by the painful examination and by Dr. Broadbent snapping off his gloves after the exam and saying, “Your husband is a lucky man.”

She repeated that remark in her legal filing, along with the doctor’s advice for her: If she bled during intercourse, “just do what the Boy Scouts do and apply pressure.”

“The whole thing was like I’m some object for my husband to enjoy and let him do whatever he wants,” Ms. Mateer said. “It was just very violating and not a great way to start my sexual relationship with my new husband, with these ideas in mind.”

Ms. Mateer thought back to that visit over the years, particularly when she went to other ob.gyns. for health care. Her subsequent doctors, she said, never performed a rectal exam and always explained to her what they were doing and how it would feel, and asked for her consent.

She thought about Dr. Broadbent again in 2017, as the #MeToo movement gained momentum, and looked him up online. Ms. Mateer found reviews from other women who described Dr. Broadbent doing rough examinations without warning that left them feeling the same way she had years before.

Then in December 2021, she spoke out on “Mormon Stories,” a podcast where people who have left or have questioned their Latter-day Saint faith share their life stories. In the episode, she described the painful way he examined her, how it left her feeling traumatized, and her discovery of the reviews that echoed her experience.

“He’s on University Avenue, in Provo, giving these exams to who knows how many naive Mormon 18-year-old, 19-year-old girls who are getting married. … They are naive and they don’t know what to expect,” she said on the podcast. “His name is Dr. David Broadbent.”

After the podcast aired, Ms. Mateer was flooded with messages from women who heard the episode and reached out to tell her that Dr. Broadbent had harmed them, too.

Ms. Mateer and three other women decided to sue the ob.gyn., and in the following weeks and months, 90 additional women joined the lawsuit they filed in Provo. Many of the women allege Dr. Broadbent inappropriately touched their breasts, vaginas and rectums, hurting them, without warning or explanation. Some said he used his bare hand – instead of using a speculum or gloves – during exams. One alleged that she saw he had an erection while he was touching her.

Dr. Broadbent’s actions were not medically necessary, the women allege, and were instead “performed for no other reason than his own sexual gratification.”

The lawsuit also named as defendants two hospitals where Dr. Broadbent had delivered babies and where some of the women allege they were assaulted. The suit accused hospital administrators of knowing about Dr. Broadbent’s inappropriate behavior and doing nothing about it.

After he was sued, the ob.gyn. quickly lost his privileges at the hospitals where he worked. Dr. Broadbent, now 75, has also voluntarily put his medical license in Utah on hold while police investigate 29 reports of sexual assault made against him.

Prosecutors are still considering whether to criminally prosecute Dr. Broadbent. Provo police forwarded more than a dozen reports to the Utah County attorney’s office in November, which are still being reviewed by a local prosecutor.

A spokesperson for Intermountain Health, the nonprofit health system that owns Utah Valley Hospital, where some of the women in the suit were treated, did not respond to specific questions. The spokesperson emphasized in an email that Dr. Broadbent was an “independent physician” who was not employed by Utah Valley Hospital, adding that most of the alleged incidents took place at Dr. Broadbent’s medical office.

A representative for MountainStar Healthcare, another hospital chain named as a defendant, denied knowledge of any allegations of inappropriate conduct reported to its hospital and also emphasized that Dr. Broadbent worked independently, not as an employee.

“Our position since this lawsuit was filed has been that we were inappropriately named in this suit,” said Brittany Glas, the communications director for MountainStar.
 

 

 

Debating whether sexual abuse is health care

For the women who sued Dr. Broadbent, their case boiled down to a key question: Were the sexual assaults they say they experienced part of their health care? There was a lot hanging on the answer.

If their case was considered medical malpractice, they would be limited in how much money they could receive in damages for their pain and suffering. If a jury awarded them millions of dollars, a judge would be required by law to cut that down to $450,000. There’s no cap on these monetary awards for victims sexually assaulted in other settings.

They would also be required to go before a panel, which includes a doctor, a lawyer and a community member, that decides whether their claims have merit. This step, aimed at resolving disputes out of court, does not block anyone from suing afterward. But it does add cost and delay, and for sexual assault victims who’ve gone through this step, it has been another time they were required to describe their experiences and hope they were believed.

The shorter, 2-year filing deadline for medical malpractice cases can also be a particular challenge for those who have been sexually abused because research shows that it’s common to delay reporting such assaults.

Nationwide, these kinds of malpractice reforms were adopted in the 1970s amid concerns – largely driven by insurance companies – that the cost of health care was rising because of frivolous lawsuits and “runaway juries” doling out multimillion-dollar payouts.

Restricting the size of malpractice awards and imposing other limits, many argued, were effective ways to balance compensating injured patients with protecting everyone’s access to health care.

State laws are generally silent on whether sexual assault lawsuits should be covered by malpractice laws, leaving courts to grapple with that question and leading to different conclusions across the country. The Tribune and ProPublica identified at least six cases in which state appellate judges sharply distinguished between assault and health care in considering whether malpractice laws should apply to sexual assault–related cases.

An appellate court in Wisconsin, for example, ruled in 1993 that a physician having an erection and groping a patient was a purposeful harm, not medical malpractice.

Florida’s law is similar to Utah’s, defining allegations “arising” out of medical care as malpractice. While an earlier ruling did treat sexual assault in a health care setting as medical malpractice, appellate rulings in the last decade have moved away from that interpretation. In 2005, an appellate court affirmed a lower-court ruling that when a dentist “stopped providing dental treatment to the victim and began sexually assaulting her, his professional services ended.”

Similarly, a federal judge in Iowa in 1995 weighed in on the meaning of “arising” out of health care: “Rape is not patient care activity,” he wrote.

But Utah’s malpractice law is so broad that judges have been interpreting it as covering any act performed by a health care provider during medical care. The law was passed in 1976 and is popular with doctors and other health care providers, who have lobbied to keep it in place – and who use it to get lawsuits dismissed.

One precedent-setting case in Utah shows the law’s power to safeguard health care providers and was an important test of how Utah defines medical malpractice. Jacob Scott sued WinGate Wilderness Therapy after the teen broke his leg in 2015 when a hiking guide from the center allowed him to climb up and down a steep outcrop in Utah’s red rock desert.

His parents are both lawyers, and after they found that Utah had a 4-year deadline for filing a personal injury lawsuit, court records said, they decided to prioritize “getting Jacob better” for the first 2 years after the accident. But when Mr. Scott’s suit was filed, WinGate argued it was too late – based on the shorter, 2-year deadline for medical malpractice claims.

Mr. Scott’s attorneys scoffed. “Interacting with nature,” his attorneys argued, “is not health care even under the broadest interpretation of … the Utah Health Care Malpractice Act.”

A judge disagreed and threw out Mr. Scott’s case. The Utah Supreme Court unanimously upheld that ruling in 2021.

“We agree with WinGate,” the justices wrote, “that it was acting as a ‘health care provider’ and providing ‘health care’ when Jacob was hiking and rock climbing.”

Last summer, the women who had sued Dr. Broadbent and the two hospitals watched online as lawyers debated whether the abuse they allegedly suffered was health care.

At the hearing, attorneys for Dr. Broadbent and the hospitals argued that the women should have pursued a medical malpractice case, which required them to first notify Dr. Broadbent and the hospitals that they wanted to sue. They also argued to Judge Robert Lunnen that the case couldn’t move forward because the women hadn’t gone before a prelitigation panel.

Attorneys for Dr. Broadbent and the hospitals argued, one after the other, that the painful and traumatic exams the women described arose out of health care treatments.

“Accepting the allegations of the complaint as true – as we must for purposes of this proceeding – we have to assume that [Broadbent] did something that was medically unnecessary, medically inappropriate,” argued David Jordan, a lawyer for Intermountain Health.

“But it doesn’t change the fact that it’s an act performed to a patient, during the patient’s treatment,” he said. “Because that’s what the patient is doing in the doctor’s office. They’re there for treatment.”

The attorney team for the women pushed back. Terry Rooney argued that if Dr. Broadbent’s actions fell under medical malpractice laws, many women would be knocked out of the case because of the age of their claims, and those who remained would be limited in the amount of money in damages they could receive.

“That’s really what this is about,” he argued. “And so it’s troubling – quite frankly it’s shocking to me – that we’re debating heavily the question of whether sexual abuse is health care.”

The judge mulled the issue for months. Judge Lunnen wrote in a September ruling that if the allegations were true, Dr. Broadbent’s treatment of his patients was “insensitive, disrespectful and degrading.”

But Utah law is clear, he said. Malpractice law covers any act or treatment performed by any health care provider during the patient’s medical care. The women had all been seeking health care, Judge Lunnen wrote, and Dr. Broadbent was providing that when the alleged assaults happened.

Their lawsuit was dismissed.
 

 

 

‘I felt defeated’

Brooke, another plaintiff who alleges Dr. Broadbent groped her, remembers feeling sick on the June day she watched the attorneys arguing. She asked to be identified by only her first name for this story.

She alleges Dr. Broadbent violated her in December 2008 while she was hospitalized after experiencing complications with her first pregnancy.

The nearest hospital to her rural town didn’t have a special unit to take care of premature babies, and her doctors feared she might need to deliver her son 6 weeks early. So Brooke had been rushed by ambulance over a mountain pass in a snowstorm to Utah Valley Hospital.

Brooke and her husband were terrified, she said, when they arrived at the Provo hospital. Dr. Broadbent happened to be the doctor on call. With Brooke’s husband and brother-in-law in the room, Dr. Broadbent examined her late that evening, she said, listening to her chest with a stethoscope.

The doctor then suddenly grabbed her breasts, she recalled – his movements causing her hospital gown to fall to expose her chest. She recounted this experience in her lawsuit, saying it was nothing like the breast exams she has had since.

“It was really traumatizing,” she said. “I was mortified. My husband and brother-in-law – we just didn’t say anything about it because it was so uncomfortable.”

Brooke voiced concerns to the nurse manager, and she was assigned a new doctor.

She gave birth to a healthy baby a little more than a month later, at the hospital near her home.

Hearing the judge’s ruling 14 years later, Brooke felt the decision revealed how Utah’s laws are broken.

“I was frustrated,” she said, “and I felt defeated. … I thought justice is not on our side with this.”

If the Utah Supreme Court rules that these alleged sexual assaults should legally be considered health care, the women will likely refile their claims as a medical malpractice lawsuit, said their attorney, Adam Sorensen. But it would be a challenge to keep all 94 women in the case, he said, due to the shorter filing window. Only two women in the lawsuit allege that they were harmed within the last 2 years.

The legal team for the women would have to convince a judge that their claims should still be allowed because they only recently discovered they were harmed. But based on previous rulings, Mr. Sorensen believes the women will have a better chance to win that argument if the civil suit remained a sexual assault case.

Regardless of what happens in their legal case, the decision by Brooke and the other women to come forward could help change state law for victims who come after them.

Recently, Mr. McKell, the state senator, introduced legislation to clarify that civil lawsuits alleging sexual assault by a health care worker do not fall under Utah’s Health Care Malpractice Act.

“I don’t think it’s a close call. Sexual assault is not medical care,” he said. “I know we’ve got some bizarre rulings that have come down through our courts in Utah.”

Both an association of Utah trial lawyers and the Utah Medical Association, which lobbies on behalf of the state’s physicians, support this reform.

“We support the fact that sexual assault should not be part of health care medical malpractice,” said Michelle McOmber, the CEO for the Utah Medical Association. “Sexual assault should be sexual assault, regardless of where it happens or who’s doing it. Sexual assault should be in that category, which is separate from actual health care. Because it’s not health care.”

MountainStar doesn’t have a position on the bill, Ms. Glas said. “If the laws were to change via new legislation and/or interpretation by the courts, we would abide by and comply with those new laws.”

But lawmakers are running out of time. With only a short time left in Utah’s legislative session, state senate and house leaders have so far prioritized passing new laws banning gender-affirming health care for transgender youths and creating a controversial school voucher program that will provide taxpayer funds for students to attend private school.

Utah lawmakers were also expected to consider a dramatic change for other sexual assault victims: a bill that would remove filing deadlines for civil lawsuits brought by people abused as adults. But that bill stalled before it could be debated.

Brooke had been eager to share her story, she said, in hopes it would help the first four women who’d come forward bolster their lawsuit against Dr. Broadbent. She later joined the case as a plaintiff. She read in their lawsuit about one woman who complained about him to the same hospital 7 years before she did, and about another woman who said Dr. Broadbent similarly molested her 2 days after Brooke had expressed her own concern.

“That bothered me so much,” she said. “It didn’t have to happen to all these women.”

Brooke doubts she’ll get vindication in a courtroom. Justice for her, she suspects, won’t come in the form of a legal ruling or a settlement against the doctor she says hurt her years ago.

Instead, she said, “maybe justice looks like changing the laws for future women.”
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive the biggest stories as soon as they’re published.

This article was produced for ProPublica’s Local Reporting Network in partnership with The Salt Lake Tribune.

At 19 years old and about to be married, Stephanie Mateer went to an ob.gyn. within walking distance of her student housing near Brigham Young University in Provo, Utah.

She wanted to start using birth control, and she was looking for guidance about having sex for the first time on her 2008 wedding night.

Ms. Mateer was shocked, she said, when David Broadbent, MD, reached under her gown to grab and squeeze her breasts, started a vaginal exam without warning, then followed it with an extremely painful examination of her rectum.

She felt disgusted and violated, but doubt also crept in. She told herself she must have misinterpreted his actions, or that she should have known that he would do a rectal exam. Raised as a member of The Church of Jesus Christ of Latter-day Saints, she said she was taught to defer to men in leadership.

“I viewed him as being a man in authority,” Ms. Mateer said. “He’s a doctor.”

It was years, she said, before she learned that her experience was in a sharp contrast to the conduct called for in professional standards, including that doctors use only their fingertips during a breast exam and communicate clearly what they are doing in advance, to gain the consent of their patients. Eventually, she gave her experience another name: sexual assault.

Utah judges, however, have called it health care.

And that legal distinction means Utahns like Ms. Mateer who decide to sue a health care provider for alleged sexual abuse are treated more harshly by the court system than plaintiffs who say they were harmed in other settings.

The chance to go to civil court for damages is an important option for survivors, experts say. While a criminal conviction can provide a sense of justice, winning a lawsuit can help victims pay for the therapy and additional support they need to heal after trauma.

Ms. Mateer laid out her allegations in a lawsuit that she and 93 other women filed against Dr. Broadbent last year. But they quickly learned they would be treated differently than other sexual assault survivors.

Filing their case, which alleged the Utah County doctor sexually assaulted them over the span of his 47-year career, was an empowering moment, Ms. Mateer said. But a judge threw out the lawsuit without even considering the merits, determining that because their alleged assailant is a doctor, the case must be governed by medical malpractice rules rather than those that apply to cases of sexual assault.

Under Utah’s rules of medical malpractice, claims made by victims who allege a health care worker sexually assaulted them are literally worth less than lawsuits brought by someone who was assaulted in other settings – even if a jury rules in their favor, a judge is required to limit how much money they receive. And they must meet a shorter filing deadline.

“It’s just crazy that a doctor can sexually assault women and then be protected by the white coat,” Ms. Mateer said. “It’s just a really scary precedent to be calling sexual assault ‘health care.’ ”

Because of the judge’s ruling that leaves them with a shorter window in which to file, some of Dr. Broadbent’s accusers stand to lose their chance to sue. Others were already past that deadline but had hoped to take advantage of an exception that allows plaintiffs to sue if they can prove that the person who harmed them had covered up the wrongdoing and if they discovered they had been hurt within the previous year.

As a group, the women are appealing the ruling to the Utah Supreme Court, which has agreed to hear the case. This decision will set a precedent for future sexual assault victims in Utah.

Dr. Broadbent’s attorney, Chris Nelson, declined an interview request but wrote in an email: “We believe that the allegations against Dr. Broadbent are without merit and will present our case in court. Given that this is an active legal matter, we will not be sharing any details outside the courtroom.”

States have varying legal definitions of medical malpractice, but it’s generally described as treatment that falls short of accepted standards of care. That includes mistakes, such as a surgeon leaving a piece of gauze inside a patient.

Utah is among the states with the broadest definition of medical malpractice, covering any acts “arising” out of health care. The Utah Supreme Court has ruled that a teenage boy was receiving health care when he was allowed to climb a steep, snow-dusted rock outcrop as part of wilderness therapy. When he broke his leg, he could only sue for medical malpractice, so the case faced shorter filing deadlines and lower monetary caps. Similarly, the court has ruled that a boy harmed by another child while in foster care was also bound by medical malpractice law.

Despite these state Supreme Court rulings, Utah legislators have so far not moved to narrow the wording of the malpractice act.

The lawsuit against Dr. Broadbent – and the questions it raises about the broadness of Utah’s medical malpractice laws – comes during a national reckoning with how sexual assault survivors are treated by the law. Legislators in several states have been rewriting laws to give sexual assault victims more time to sue their attackers, in response to the growing cultural understanding of the impact of trauma and the barriers to reporting. Even in Utah, those who were sexually abused as children now have no deadline to file suits against their abusers.

That isn’t true for sexual abuse in a medical setting, where cases must be filed within 2 years of the assault.

These higher hurdles should not exist in Utah, said state Sen. Mike K. McKell, a Utah County Republican who works as a personal injury attorney. He is trying to change state law to ensure that sexual assault lawsuits do not fall under Utah’s Health Care Malpractice Act, a law designed to cover negligence and poor care, not necessarily deliberate actions like an assault.

“Sexual assault, to me, is not medical care. Period,” he said. “It’s sad that we need to clarify that sexual assault is not medical care. But trying to tie sexual assault to a medical malpractice [filing deadline] – it’s just wrong.”
 

 

 

‘Your husband is a lucky man’

Ms. Mateer had gone to Dr. Broadbent in 2008 for a premarital exam, a uniquely Utah visit often scheduled by young women who are members of The Church of Jesus Christ of Latter-day Saints.

Leaders of the faith, which is predominant in Utah, focus on chastity when speaking to young, unmarried people about sex, and public schools have typically focused on abstinence-based sex education. So for some, these visits are the first place they learn about sexual health.

Young women who get premarital exams are typically given a birth control prescription, but the appointments can include care that’s less common for healthy women in other states – such as doctors giving them vaginal dilators to stretch their tissues before their wedding nights.

That’s what Ms. Mateer was expecting when she visited Dr. Broadbent’s office. The ob.gyn. had been practicing for decades in his Provo clinic nestled between student housing apartments across the street from Brigham Young University, which is owned by The Church of Jesus Christ of Latter-day Saints.

So Ms. Mateer was “just totally taken aback,” she said, by the painful examination and by Dr. Broadbent snapping off his gloves after the exam and saying, “Your husband is a lucky man.”

She repeated that remark in her legal filing, along with the doctor’s advice for her: If she bled during intercourse, “just do what the Boy Scouts do and apply pressure.”

“The whole thing was like I’m some object for my husband to enjoy and let him do whatever he wants,” Ms. Mateer said. “It was just very violating and not a great way to start my sexual relationship with my new husband, with these ideas in mind.”

Ms. Mateer thought back to that visit over the years, particularly when she went to other ob.gyns. for health care. Her subsequent doctors, she said, never performed a rectal exam and always explained to her what they were doing and how it would feel, and asked for her consent.

She thought about Dr. Broadbent again in 2017, as the #MeToo movement gained momentum, and looked him up online. Ms. Mateer found reviews from other women who described Dr. Broadbent doing rough examinations without warning that left them feeling the same way she had years before.

Then in December 2021, she spoke out on “Mormon Stories,” a podcast where people who have left or have questioned their Latter-day Saint faith share their life stories. In the episode, she described the painful way he examined her, how it left her feeling traumatized, and her discovery of the reviews that echoed her experience.

“He’s on University Avenue, in Provo, giving these exams to who knows how many naive Mormon 18-year-old, 19-year-old girls who are getting married. … They are naive and they don’t know what to expect,” she said on the podcast. “His name is Dr. David Broadbent.”

After the podcast aired, Ms. Mateer was flooded with messages from women who heard the episode and reached out to tell her that Dr. Broadbent had harmed them, too.

Ms. Mateer and three other women decided to sue the ob.gyn., and in the following weeks and months, 90 additional women joined the lawsuit they filed in Provo. Many of the women allege Dr. Broadbent inappropriately touched their breasts, vaginas and rectums, hurting them, without warning or explanation. Some said he used his bare hand – instead of using a speculum or gloves – during exams. One alleged that she saw he had an erection while he was touching her.

Dr. Broadbent’s actions were not medically necessary, the women allege, and were instead “performed for no other reason than his own sexual gratification.”

The lawsuit also named as defendants two hospitals where Dr. Broadbent had delivered babies and where some of the women allege they were assaulted. The suit accused hospital administrators of knowing about Dr. Broadbent’s inappropriate behavior and doing nothing about it.

After he was sued, the ob.gyn. quickly lost his privileges at the hospitals where he worked. Dr. Broadbent, now 75, has also voluntarily put his medical license in Utah on hold while police investigate 29 reports of sexual assault made against him.

Prosecutors are still considering whether to criminally prosecute Dr. Broadbent. Provo police forwarded more than a dozen reports to the Utah County attorney’s office in November, which are still being reviewed by a local prosecutor.

A spokesperson for Intermountain Health, the nonprofit health system that owns Utah Valley Hospital, where some of the women in the suit were treated, did not respond to specific questions. The spokesperson emphasized in an email that Dr. Broadbent was an “independent physician” who was not employed by Utah Valley Hospital, adding that most of the alleged incidents took place at Dr. Broadbent’s medical office.

A representative for MountainStar Healthcare, another hospital chain named as a defendant, denied knowledge of any allegations of inappropriate conduct reported to its hospital and also emphasized that Dr. Broadbent worked independently, not as an employee.

“Our position since this lawsuit was filed has been that we were inappropriately named in this suit,” said Brittany Glas, the communications director for MountainStar.
 

 

 

Debating whether sexual abuse is health care

For the women who sued Dr. Broadbent, their case boiled down to a key question: Were the sexual assaults they say they experienced part of their health care? There was a lot hanging on the answer.

If their case was considered medical malpractice, they would be limited in how much money they could receive in damages for their pain and suffering. If a jury awarded them millions of dollars, a judge would be required by law to cut that down to $450,000. There’s no cap on these monetary awards for victims sexually assaulted in other settings.

They would also be required to go before a panel, which includes a doctor, a lawyer and a community member, that decides whether their claims have merit. This step, aimed at resolving disputes out of court, does not block anyone from suing afterward. But it does add cost and delay, and for sexual assault victims who’ve gone through this step, it has been another time they were required to describe their experiences and hope they were believed.

The shorter, 2-year filing deadline for medical malpractice cases can also be a particular challenge for those who have been sexually abused because research shows that it’s common to delay reporting such assaults.

Nationwide, these kinds of malpractice reforms were adopted in the 1970s amid concerns – largely driven by insurance companies – that the cost of health care was rising because of frivolous lawsuits and “runaway juries” doling out multimillion-dollar payouts.

Restricting the size of malpractice awards and imposing other limits, many argued, were effective ways to balance compensating injured patients with protecting everyone’s access to health care.

State laws are generally silent on whether sexual assault lawsuits should be covered by malpractice laws, leaving courts to grapple with that question and leading to different conclusions across the country. The Tribune and ProPublica identified at least six cases in which state appellate judges sharply distinguished between assault and health care in considering whether malpractice laws should apply to sexual assault–related cases.

An appellate court in Wisconsin, for example, ruled in 1993 that a physician having an erection and groping a patient was a purposeful harm, not medical malpractice.

Florida’s law is similar to Utah’s, defining allegations “arising” out of medical care as malpractice. While an earlier ruling did treat sexual assault in a health care setting as medical malpractice, appellate rulings in the last decade have moved away from that interpretation. In 2005, an appellate court affirmed a lower-court ruling that when a dentist “stopped providing dental treatment to the victim and began sexually assaulting her, his professional services ended.”

Similarly, a federal judge in Iowa in 1995 weighed in on the meaning of “arising” out of health care: “Rape is not patient care activity,” he wrote.

But Utah’s malpractice law is so broad that judges have been interpreting it as covering any act performed by a health care provider during medical care. The law was passed in 1976 and is popular with doctors and other health care providers, who have lobbied to keep it in place – and who use it to get lawsuits dismissed.

One precedent-setting case in Utah shows the law’s power to safeguard health care providers and was an important test of how Utah defines medical malpractice. Jacob Scott sued WinGate Wilderness Therapy after the teen broke his leg in 2015 when a hiking guide from the center allowed him to climb up and down a steep outcrop in Utah’s red rock desert.

His parents are both lawyers, and after they found that Utah had a 4-year deadline for filing a personal injury lawsuit, court records said, they decided to prioritize “getting Jacob better” for the first 2 years after the accident. But when Mr. Scott’s suit was filed, WinGate argued it was too late – based on the shorter, 2-year deadline for medical malpractice claims.

Mr. Scott’s attorneys scoffed. “Interacting with nature,” his attorneys argued, “is not health care even under the broadest interpretation of … the Utah Health Care Malpractice Act.”

A judge disagreed and threw out Mr. Scott’s case. The Utah Supreme Court unanimously upheld that ruling in 2021.

“We agree with WinGate,” the justices wrote, “that it was acting as a ‘health care provider’ and providing ‘health care’ when Jacob was hiking and rock climbing.”

Last summer, the women who had sued Dr. Broadbent and the two hospitals watched online as lawyers debated whether the abuse they allegedly suffered was health care.

At the hearing, attorneys for Dr. Broadbent and the hospitals argued that the women should have pursued a medical malpractice case, which required them to first notify Dr. Broadbent and the hospitals that they wanted to sue. They also argued to Judge Robert Lunnen that the case couldn’t move forward because the women hadn’t gone before a prelitigation panel.

Attorneys for Dr. Broadbent and the hospitals argued, one after the other, that the painful and traumatic exams the women described arose out of health care treatments.

“Accepting the allegations of the complaint as true – as we must for purposes of this proceeding – we have to assume that [Broadbent] did something that was medically unnecessary, medically inappropriate,” argued David Jordan, a lawyer for Intermountain Health.

“But it doesn’t change the fact that it’s an act performed to a patient, during the patient’s treatment,” he said. “Because that’s what the patient is doing in the doctor’s office. They’re there for treatment.”

The attorney team for the women pushed back. Terry Rooney argued that if Dr. Broadbent’s actions fell under medical malpractice laws, many women would be knocked out of the case because of the age of their claims, and those who remained would be limited in the amount of money in damages they could receive.

“That’s really what this is about,” he argued. “And so it’s troubling – quite frankly it’s shocking to me – that we’re debating heavily the question of whether sexual abuse is health care.”

The judge mulled the issue for months. Judge Lunnen wrote in a September ruling that if the allegations were true, Dr. Broadbent’s treatment of his patients was “insensitive, disrespectful and degrading.”

But Utah law is clear, he said. Malpractice law covers any act or treatment performed by any health care provider during the patient’s medical care. The women had all been seeking health care, Judge Lunnen wrote, and Dr. Broadbent was providing that when the alleged assaults happened.

Their lawsuit was dismissed.
 

 

 

‘I felt defeated’

Brooke, another plaintiff who alleges Dr. Broadbent groped her, remembers feeling sick on the June day she watched the attorneys arguing. She asked to be identified by only her first name for this story.

She alleges Dr. Broadbent violated her in December 2008 while she was hospitalized after experiencing complications with her first pregnancy.

The nearest hospital to her rural town didn’t have a special unit to take care of premature babies, and her doctors feared she might need to deliver her son 6 weeks early. So Brooke had been rushed by ambulance over a mountain pass in a snowstorm to Utah Valley Hospital.

Brooke and her husband were terrified, she said, when they arrived at the Provo hospital. Dr. Broadbent happened to be the doctor on call. With Brooke’s husband and brother-in-law in the room, Dr. Broadbent examined her late that evening, she said, listening to her chest with a stethoscope.

The doctor then suddenly grabbed her breasts, she recalled – his movements causing her hospital gown to fall to expose her chest. She recounted this experience in her lawsuit, saying it was nothing like the breast exams she has had since.

“It was really traumatizing,” she said. “I was mortified. My husband and brother-in-law – we just didn’t say anything about it because it was so uncomfortable.”

Brooke voiced concerns to the nurse manager, and she was assigned a new doctor.

She gave birth to a healthy baby a little more than a month later, at the hospital near her home.

Hearing the judge’s ruling 14 years later, Brooke felt the decision revealed how Utah’s laws are broken.

“I was frustrated,” she said, “and I felt defeated. … I thought justice is not on our side with this.”

If the Utah Supreme Court rules that these alleged sexual assaults should legally be considered health care, the women will likely refile their claims as a medical malpractice lawsuit, said their attorney, Adam Sorensen. But it would be a challenge to keep all 94 women in the case, he said, due to the shorter filing window. Only two women in the lawsuit allege that they were harmed within the last 2 years.

The legal team for the women would have to convince a judge that their claims should still be allowed because they only recently discovered they were harmed. But based on previous rulings, Mr. Sorensen believes the women will have a better chance to win that argument if the civil suit remained a sexual assault case.

Regardless of what happens in their legal case, the decision by Brooke and the other women to come forward could help change state law for victims who come after them.

Recently, Mr. McKell, the state senator, introduced legislation to clarify that civil lawsuits alleging sexual assault by a health care worker do not fall under Utah’s Health Care Malpractice Act.

“I don’t think it’s a close call. Sexual assault is not medical care,” he said. “I know we’ve got some bizarre rulings that have come down through our courts in Utah.”

Both an association of Utah trial lawyers and the Utah Medical Association, which lobbies on behalf of the state’s physicians, support this reform.

“We support the fact that sexual assault should not be part of health care medical malpractice,” said Michelle McOmber, the CEO for the Utah Medical Association. “Sexual assault should be sexual assault, regardless of where it happens or who’s doing it. Sexual assault should be in that category, which is separate from actual health care. Because it’s not health care.”

MountainStar doesn’t have a position on the bill, Ms. Glas said. “If the laws were to change via new legislation and/or interpretation by the courts, we would abide by and comply with those new laws.”

But lawmakers are running out of time. With only a short time left in Utah’s legislative session, state senate and house leaders have so far prioritized passing new laws banning gender-affirming health care for transgender youths and creating a controversial school voucher program that will provide taxpayer funds for students to attend private school.

Utah lawmakers were also expected to consider a dramatic change for other sexual assault victims: a bill that would remove filing deadlines for civil lawsuits brought by people abused as adults. But that bill stalled before it could be debated.

Brooke had been eager to share her story, she said, in hopes it would help the first four women who’d come forward bolster their lawsuit against Dr. Broadbent. She later joined the case as a plaintiff. She read in their lawsuit about one woman who complained about him to the same hospital 7 years before she did, and about another woman who said Dr. Broadbent similarly molested her 2 days after Brooke had expressed her own concern.

“That bothered me so much,” she said. “It didn’t have to happen to all these women.”

Brooke doubts she’ll get vindication in a courtroom. Justice for her, she suspects, won’t come in the form of a legal ruling or a settlement against the doctor she says hurt her years ago.

Instead, she said, “maybe justice looks like changing the laws for future women.”
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive the biggest stories as soon as they’re published.

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How to place an IUD with minimal patient discomfort

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Tue, 02/28/2023 - 11:59

Photo: Shutterstock

CASE Nulliparous young woman desires contraception

An 18-year-old nulliparous patient presents to your office inquiring about contraception before she leaves for college. She not only wants to prevent pregnancy but she also would like a method that can help with her dysmenorrhea. After receiving nondirective counseling about all of the methods available, she selects a levonorgestrel intrauterine device (LNG-IUD). However, she discloses that she is very nervous about placement. She has heard from friends that it can be painful to get an IUD. What are these patient’s risk factors for painful placement? How would you mitigate her experience of pain during the insertion process?
 

IUDs are highly effective and safe methods of preventing unwanted pregnancy. IUDs have become increasingly more common; they were the method of choice for 14% of contraception users in 2016, a rise from 12% in 2014.1 The Contraceptive CHOICE project demonstrated that IUDs were most likely to be chosen as a reversible method of contraception when unbiased counseling is provided and barriers such as cost are removed. Additionally, rates of continuation were found to be high, thus reducing the number of unwanted pregnancies.2 However, pain during IUD insertion as well as the fear and anxiety surrounding the procedure are some of the major limitations to IUD uptake and use. Specifically, fear of pain during IUD insertion is a substantial barrier; this fear is thought to also exacerbate the experience of pain during the insertion process.3

This article aims to identify risk factors for painful IUD placement and to review both nonpharmacologic and pharmacologic methods that may decrease discomfort and anxiety during IUD insertion.

 

What factors contribute to the experience of pain with IUD placement?

While some women do not report experiencing pain during IUD insertion, approximately 17% describe the pain as severe.4 The perception of pain during IUD placement is multifactorial; physiologic, psychological, emotional, cultural, and circumstantial factors all can play a role (TABLE 1). The biologic perception of pain results from the manipulation of the cervix and uterus; noxious stimuli activate both the sympathetic and parasympathetic nervous systems. The sympathetic system at T10-L2 mediates the fundus, the ovarian plexus at the cornua, and the uterosacral ligaments, while the parasympathetic fibers from S2-S4 enter the cervix at 3 o’clock and 9 o’clock and innervate the upper vagina, cervix, and lower uterine segment.4,5 Nulliparity, history of cesarean delivery, increased size of the IUD inserter, length of the uterine cavity, breastfeeding status, relation to timing of menstruation, and length of time since last vaginal delivery all may be triggers for pain. Other sociocultural influences on a patient’s experience of pain include young age (adolescence), Black race, and history of sexual trauma, as well as existing anxiety and beliefs about expected pain.3,5,6-8

It also is important to consider all aspects of the procedure that could be painful. Steps during IUD insertion that have been found to invoke average to severe pain include use of tenaculum on the cervix, uterine stabilization, uterine sounding, placement of the insertion tube, and deployment of the actual IUD.4-7

A secondary analysis of the Contraceptive CHOICE project confirmed that women with higher levels of anticipated pain were more likely to experience increased discomfort during placement.3 Providers tend to underestimate the anxiety and pain experienced by their patients undergoing IUD insertion. In a study about anticipated pain during IUD insertion, clinicians were asked if patients were “pleasant and appropriately engaging” or “anxious.” Only 10% of those patients were noted to be anxious by their provider; however, patients with a positive screen on the PHQ-4 depression and anxiety screen did anticipate more pain than those who did not.6 In another study, patients estimated their pain scores at 30 mm higher than their providers on a visual analog scale.7 Given these discrepancies, it is imperative to address anxiety and pain anticipation, risk factors for pain, and offerings for pain management during IUD placement to ensure a more holistic experience.

Continue to: What are nonpharmacologic interventions that can reduce anxiety and pain?...

 

 

What are nonpharmacologic interventions that can reduce anxiety and pain?

There are few formal studies on nonpharmacologic options for pain reduction at IUD insertion, with varying outcomes.4,8,10 However, many of them suggest that establishing a trusting clinician-patient relationship, a relaxing and inviting environment, and emotional support during the procedure may help make the procedure more comfortable overall (TABLE 2).4,5,10

Education and counseling

Patients should be thoroughly informed about the different IUD options, and they should be reassured regarding their contraceptive effectiveness and low risk for insertion difficulties in order to mitigate anxiety about complications and future fertility.11 This counseling session can offer the patient opportunities for relationship building with the provider and for the clinician to assess for anxiety and address concerns about the insertion and removal process. Patients who are adequately informed regarding expectations and procedural steps are more likely to have better pain management.5 Another purpose of this counseling session may be to identify any risk factors that may increase pain and tailor nonpharmacologic and pharmacologic options to the individual patient.

Environment

Examination rooms should be comfortable, private, and professional appearing. Patients prefer a more informal, unhurried, and less sterile atmosphere for procedures. Clinicians should strive to engender trust prior to the procedure by sharing information in a straightforward manner, and ensuring that staff of medical assistants, nurses, and clinicians are a “well-oiled machine” to inspire confidence in the competence of the team.4 Ultrasonography guidance also may be helpful in reducing pain during IUD placement, but this may not be available in all outpatient settings.8

Distraction techniques

Various distraction methods have been employed during gynecologic procedures, and more specifically IUD placement, with some effect. During and after the procedure, heat and ice have been found to be helpful adjuncts for uterine cramping and should be offered as first-line pain management options on the examination table. This can be in the form of reusable heating pads or chemical heat or ice packs.4 A small study demonstrated that inhaled lavender may help with lowering anxiety prior to and during the procedure; however, it had limited effects on pain.10

Clinicians and support staff should engage in conversation with the patient throughout the procedure (ie, “verbacaine”). This can be conducted via a casual chat about unrelated topics or gentle and positive coaching through the procedure with the intent to remove negative imagery associated with elements of the insertion process.5 Finally, studies have been conducted using music as a distraction for colposcopy and hysteroscopy, and results have indicated that it is beneficial, reducing both pain and anxiety during these similar types of procedures.4 While these options may not fully remove pain and anxiety, many are low investment interventions that many patients will appreciate.

What are pharmacologic interventions that can decrease pain during IUD insertion?

The literature is more robust with studies examining the benefits of pharmacologic methods for reducing pain during IUD insertion; strategies include agents that lessen uterine cramping, numb the cervix, and soften and open the cervical os. Despite the plethora of studies, there is no one standard of care for pain management during IUD insertion (TABLE 3).

Lidocaine injection

Lidocaine is an amine anesthetic that can block the nociceptive response of nerves upon administration; it has the advantages of rapid onset and low risk in appropriate doses. Multiple randomized controlled trials (RCTs) have examined the use of paracervical and intracervical block with lidocaine.9,12-15 Lopez and colleagues conducted a review in 2015, including 3 studies about injectable lidocaine and demonstrated some effect of injectable lidocaine on reduction in pain at tenaculum placement.9

Mody and colleagues conducted a pilot RCT of 50 patients comparing a 10 mL lidocaine 1% paracervical block to no block, which was routine procedure at the time.12 The authors demonstrated a reduction in pain at the tenaculum site but no decrease in pain with insertion. They also measured pain during the block administration itself and found that the block increased the overall pain of the procedure. In 2018, Mody et al13 performed another RCT, but with a higher dose of 20 mL of buffered lidocaine 1% in 64 nulliparous patients. They found that paracervical block improved pain during uterine sounding, IUD insertion, and 5 minutes following insertion, as well as the pain of the overall procedure.

De Nadai andcolleagues evaluated if a larger dose of lidocaine (3.6 mL of lidocaine 2%) administered intracervically at the anterior lip was beneficial.14 They randomly assigned 302 women total: 99 to intracervical block, 101 to intracervical sham block with dry needling at the anterior lip, and 102 to no intervention. Fewer patients reported extreme pain with tenaculum placement and with IUD (levonorgestrel-releasing system) insertion. Given that this option requires less lidocaine overall and fewer injection points, it has the potential to be an easier and more reproducible technique.14

Finally, Akers and colleagues aimed to evaluate IUD insertion in nulliparous adolescents. They compared a 1% paracervical block of 10 mL with 1 mL at the anterior lip and 4.5 mL at 4 o’clock and 8 o’clock in the cervicovaginal junction versus depression of the wood end of a cotton swab at the same sites. They found that the paracervical block improved pain substantially during all steps of the procedure compared with the sham block in this young population.16

 

Nonsteroidal anti-inflammatory drugs

Nonsteroidal anti-inflammatory drugs (NSAIDs) show promise in reducing pain during IUD placement, as they inhibit the production of prostaglandins, which can in turn reduce uterine cramping and inflammation during IUD placement.

Lopez and colleagues evaluated the use of NSAIDs in 7 RCTs including oral naproxen, oral ibuprofen, and intramuscular ketorolac.9 While it had no effect on pain at the time of placement, naproxen administered at least 90 minutes before the procedure decreased uterine cramping for 2 hours after insertion. Women receiving naproxen also were less likely to describe the insertion as “unpleasant.” Ibuprofen was found to have limited effects during insertion and after the procedure. Intramuscular ketorolac studies were conflicting. Results of one study demonstrated a lower median pain score at 5 minutes but no differences during tenaculum placement or IUD insertion, whereas another demonstrated reduction in pain during and after the procedure.8,9

Another RCT showed potential benefit of tramadol over the use of naproxen when they were compared; however, tramadol is an opioid, and there are barriers to universal use in the outpatient setting.9

Continue to: Topical anesthetics...

 

 

Topical anesthetics

Topical anesthetics offer promise of pain relief without the pain of injection and with the advantage of self-administration for some formulations.

Several RCTs evaluated whether lidocaine gel 2% applied to the cervix or injected via flexible catheter into the cervical os improved pain, but there were no substantial differences in pain perception between topical gel and placebo groups in the insertion of IUDs.9

Rapkin and colleagues15 studied whether self-administered intravaginal lidocaine gel 2% five minutes before insertion was helpful;15 they found that tenaculum placement was less painful, but IUD placement was not. Conti et al expanded upon the Rapkin study by extending the amount of time of exposure to self-administered intravaginal lidocaine gel 2% to 15 minutes; they found no difference in perception of pain during tenaculum placement, but they did see a substantial difference in discomfort during speculum placement.17 This finding may be helpful for patients with a history of sexual trauma or anxiety about gynecologic examinations. Based on surveys conducted during their study, they found that patients were willing to wait 15 minutes for this benefit.

In Gemzell-Danielsson and colleagues’ updated review, they identified that different lidocaine formulations, such as a controlled-release lidocaine and a lidocaine-prilocaine compound, resulted in slight reduction in pain scores at multiple points during the IUD insertion process compared with controls.8 Two RCTs demonstrated substantial reduction in pain with administration of lidocaine spray 10% during tenaculum placement, sounding, and immediately after IUD placement compared with a placebo group.18,19 This may be an appealing option for patients who do not want to undergo an injection for local anesthesia.

 

Nitrous oxide

Nitrous oxide is an odorless colorless gas with anxiolytic, analgesic, and amnestic effects. It has several advantages for outpatient administration including rapid onset, rapid recovery, high safety profile, and no residual incapacitation, enabling a patient to safely leave the office shortly after a procedure.20

Nitrous oxide was studied in an RCT of 74 young (12-20 years of age) nulliparous patients and found to be effective for decreasing pain during IUD insertion and increasing satisfaction with the procedure.20 However, another study of 80 nulliparous patients (aged 13-45 years) did not find any reduction in pain during the insertion procedure.21

Prostaglandin analogues

Misoprostol is a synthetic prostaglandin E1 analog that causes cervical softening, uterine contractions, and cervical dilation. Dinoprostone is a synthetic prostaglandin E2 analog that has similar effects on the cervix and uterus. These properties have made it a useful tool in minor gynecologic procedures, such as first trimester uterine aspiration and hysteroscopy. However, both have the disadvantage of causing adverse effects on gastric smooth muscle, leading to nausea, vomiting, diarrhea, and uncomfortable gastric cramping.

Several RCTs have examined the use of misoprostol administration approximately 2 to 4 hours before IUD placement. No studies found any improvement in pain during IUD insertion, but this likely is due to the discomfort caused by the use of misoprostol itself.9 A meta-analysis and systematic review of 14 studies found no effect on reducing the pain associated with IUD placement but did find that providers had an easier time with cervical dilation in patients who received it. The meta-analysis also demonstrated that patients receiving vaginal misoprostol were less likely to have gastric side effects.22 In another review of 5 RCTs using 400 µg to 600 µg of misoprostol for cervical preparation, Gemzell-Danielsson et al found reductions in mean pain scores with placement specifically among patients with previous cesarean delivery and/or nulliparous patients.8

In an RCT, Ashour and colleagues looked at the use of dinoprostone 3 mg compared with placebo in 160 patients and found that those in the dinoprostone group had less pain during and 15 minutes after the procedure, as well as ease of insertion and overall higher satisfaction with the IUD placement. Dinoprostone traditionally is used for labor induction in the United States and tends to be much more expensive than misoprostol, but it shows the most promise of the prostaglandins in making IUD placement more comfortable.

Conclusion: Integrating evidence and experience

Providers tend to underestimate the pain and anxiety experienced by their patients undergoing IUD insertion. Patients’ concerns about pain and anxiety increase their risk for experiencing pain during IUD insertion. Patient anxieties, and thus, pain may be allayed by offering support and education prior to placement, offering tailored pharmacologic strategies to mitigate pain, and offering supportive and distraction measures during the insertion process. ●

Key recommendations
  • Patients should be counseled regarding the benefits and risks of the IUD, expectations for placement and removal, and offered the opportunity to ask questions and express their concerns.
  • Providers should use this opportunity to assess for risk factors for increased pain during IUD placement.
  • All patients should be offered premedication with naproxen 220 mg approximately 90 minutes prior to the procedure, as well as heat therapy and the opportunity to listen to music during the procedure.
  • Patients with risk factors for pain should have pharmacologic strategies offered based on the available evidence, and providers should reassure patients that there are multiple strategies available that have been shown to reduce pain during IUD placement.

—Nulliparous patients and patients with a history of a cesarean delivery may be offered the option of cervical ripening with misoprostol 400 µg vaginally 2 to 4 hours prior to the procedure.

—Patients with a history of sexual trauma should be offered self-administered lidocaine 1% or lidocaine-prilocaine formulations to increase comfort during examinations and speculum placement.

—All other patients can be offered the option of a paracervical or intracervical block, with the caveat that administration of the block itself also may cause some pain during the procedure.

—For those patients who desire some sort of local anesthetic but do not want to undergo a lidocaine injection, patients should be offered the option of lidocaine spray 10%.

—Finally, for those patients who are undergoing a difficult IUD placement, ultrasound guidance should be readily available.

References
  1. Kavanaugh ML, Pliskin E. Use of contraception among reproductive-aged women in the United States, 2014 and 2016. F S Rep. 2020;1:83-93.
  2. Piepert JF, Zhao Q, Allsworth JE, et al. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011;117:1105‐1113.
  3. Dina B, Peipert LJ, Zhao Q, et al. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018;218:236.e1-236.e9. doi:10.1016 /j.ajog.2017.10.017.
  4. McCarthy C. Intrauterine contraception insertion pain: nursing interventions to improve patient experience. J Clin Nurs. 2018;27:9-21. doi:10.1111/jocn.13751.
  5. Ireland LD, Allen RH. Pain management for gynecologic procedures in the office. Obstet Gynecol Surv. 2016;71:89-98. doi:10.1097/OGX.0000000000000272.
  6. Hunter TA, Sonalkar S, Schreiber CA, et al. Anticipated pain during intrauterine device insertion. J Pediatr Adolesc Gynecol. 2020;33:27-32. doi:10.1016/j.jpag.2019.09.007
  7. Maguire K, Morrell K, Westhoff C, Davis A. Accuracy of providers’ assessment of pain during intrauterine device insertion. Contraception. 2014;89:22-24. doi: 10.1016/j.contraception.2013.09.008.
  8. Gemzell-Danielsson K, Jensen JT, Monteiro I. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: an updated review. Acta Obstet Gyncol Scand. 2019;98:1500-1513.
  9. Lopez LM, Bernholc A, Zeng Y, et al. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015;2015:CD007373. doi:10.1002/14651858.CD007 373.pub3.
  10. Nguyen L, Lamarche L, Lennox R, et al. Strategies to mitigate anxiety and pain in intrauterine device insertion: a systematic review. J Obstet Gynaecol Can. 2020;42:1138-1146.e2. doi:10.1016/j.jogc.2019.09.014.
  11. Akdemir Y, Karadeniz M. The relationship between pain at IUD insertion and negative perceptions, anxiety and previous mode of delivery. Eur J Contracept Reprod Health Care. 2019;24:240-245. doi:10.1080/13625187.2019.1610872.
  12. Mody SK, Kiley J, Rademaker A, et al. Pain control for intrauterine device insertion: a randomized trial of 1% lidocaine paracervical block. Contraception. 2012;86:704-709. doi:10.1016/j.contraception.2012.06.004.
  13. Mody SK, Farala JP, Jimenez B, et al. Paracervical block for intrauterine device placement among nulliparous women: a randomized controlled trial. Obstet Gynecol. 2018;132:575582. doi:10.1097/AOG.0000000000002790.
  14. De Nadai MN, Poli-Neto OB, Franceschini SA, et al. Intracervical block for levonorgestrel-releasing intrauterine system placement among nulligravid women: a randomized double-blind controlled trial. Am J Obstet Gynecol. 2020;222:245.e1-245.e10. doi:10.1016/j.ajog.2019.09.013.
  15. Rapkin RB, Achilles SL, Schwarz EB, et al. Self-administered lidocaine gel for intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2016;128:621-628. doi:10.1097/AOG.0000000000001596.
  16. Akers A, Steinway C, Sonalkar S, et al. Reducing pain during intrauterine device insertion. A randomized controlled trial in adolescents and young women. Obstet Gynecol. 2017;130:795802. doi: 10.1097/AOG.0000000000002242.
  17. Conti JA, Lerma K, Schneyer RJ, et al. Self-administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial. Am J Obstet Gynecol. 2019;220:177.e1-177.e7. doi:10.1016 /j.ajog.2018.11.1085.
  18. Panichyawat N, Mongkornthong T, Wongwananuruk T, et al. 10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebocontrolled trial. BMJ Sex Reprod Health. 2021;47:159-165. doi:10.1136/bmjsrh-2020-200670.
  19. Karasu Y, Cömert DK, Karadağ B, et al. Lidocaine for pain control during intrauterine device insertion. J Obstet Gynaecol Res. 2017;43:1061-1066. doi:10.1111/jog.13308.
  20. Fowler KG, Byraiah G, Burt C, et al. Nitrous oxide use for intrauterine system placement in adolescents.  J Pediatr Adolesc Gynecol. 2022;35:159-164. doi:10.1016 /j.jpag.2021.10.019.
  21. Singh RH, Thaxton L, Carr S, et al. A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women. Int J Gynaecol Obstet. 2016;135:145-148. doi:10.1016/j.ijgo.2016.04.014.
  22. Ashour AS, Nabil H, Yosif MF, et al. Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial. Fertil Steril. 2020;114:861-868. doi: 10.1016/j. fertnstert.2020.05.004.
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CASE Nulliparous young woman desires contraception

An 18-year-old nulliparous patient presents to your office inquiring about contraception before she leaves for college. She not only wants to prevent pregnancy but she also would like a method that can help with her dysmenorrhea. After receiving nondirective counseling about all of the methods available, she selects a levonorgestrel intrauterine device (LNG-IUD). However, she discloses that she is very nervous about placement. She has heard from friends that it can be painful to get an IUD. What are these patient’s risk factors for painful placement? How would you mitigate her experience of pain during the insertion process?
 

IUDs are highly effective and safe methods of preventing unwanted pregnancy. IUDs have become increasingly more common; they were the method of choice for 14% of contraception users in 2016, a rise from 12% in 2014.1 The Contraceptive CHOICE project demonstrated that IUDs were most likely to be chosen as a reversible method of contraception when unbiased counseling is provided and barriers such as cost are removed. Additionally, rates of continuation were found to be high, thus reducing the number of unwanted pregnancies.2 However, pain during IUD insertion as well as the fear and anxiety surrounding the procedure are some of the major limitations to IUD uptake and use. Specifically, fear of pain during IUD insertion is a substantial barrier; this fear is thought to also exacerbate the experience of pain during the insertion process.3

This article aims to identify risk factors for painful IUD placement and to review both nonpharmacologic and pharmacologic methods that may decrease discomfort and anxiety during IUD insertion.

 

What factors contribute to the experience of pain with IUD placement?

While some women do not report experiencing pain during IUD insertion, approximately 17% describe the pain as severe.4 The perception of pain during IUD placement is multifactorial; physiologic, psychological, emotional, cultural, and circumstantial factors all can play a role (TABLE 1). The biologic perception of pain results from the manipulation of the cervix and uterus; noxious stimuli activate both the sympathetic and parasympathetic nervous systems. The sympathetic system at T10-L2 mediates the fundus, the ovarian plexus at the cornua, and the uterosacral ligaments, while the parasympathetic fibers from S2-S4 enter the cervix at 3 o’clock and 9 o’clock and innervate the upper vagina, cervix, and lower uterine segment.4,5 Nulliparity, history of cesarean delivery, increased size of the IUD inserter, length of the uterine cavity, breastfeeding status, relation to timing of menstruation, and length of time since last vaginal delivery all may be triggers for pain. Other sociocultural influences on a patient’s experience of pain include young age (adolescence), Black race, and history of sexual trauma, as well as existing anxiety and beliefs about expected pain.3,5,6-8

It also is important to consider all aspects of the procedure that could be painful. Steps during IUD insertion that have been found to invoke average to severe pain include use of tenaculum on the cervix, uterine stabilization, uterine sounding, placement of the insertion tube, and deployment of the actual IUD.4-7

A secondary analysis of the Contraceptive CHOICE project confirmed that women with higher levels of anticipated pain were more likely to experience increased discomfort during placement.3 Providers tend to underestimate the anxiety and pain experienced by their patients undergoing IUD insertion. In a study about anticipated pain during IUD insertion, clinicians were asked if patients were “pleasant and appropriately engaging” or “anxious.” Only 10% of those patients were noted to be anxious by their provider; however, patients with a positive screen on the PHQ-4 depression and anxiety screen did anticipate more pain than those who did not.6 In another study, patients estimated their pain scores at 30 mm higher than their providers on a visual analog scale.7 Given these discrepancies, it is imperative to address anxiety and pain anticipation, risk factors for pain, and offerings for pain management during IUD placement to ensure a more holistic experience.

Continue to: What are nonpharmacologic interventions that can reduce anxiety and pain?...

 

 

What are nonpharmacologic interventions that can reduce anxiety and pain?

There are few formal studies on nonpharmacologic options for pain reduction at IUD insertion, with varying outcomes.4,8,10 However, many of them suggest that establishing a trusting clinician-patient relationship, a relaxing and inviting environment, and emotional support during the procedure may help make the procedure more comfortable overall (TABLE 2).4,5,10

Education and counseling

Patients should be thoroughly informed about the different IUD options, and they should be reassured regarding their contraceptive effectiveness and low risk for insertion difficulties in order to mitigate anxiety about complications and future fertility.11 This counseling session can offer the patient opportunities for relationship building with the provider and for the clinician to assess for anxiety and address concerns about the insertion and removal process. Patients who are adequately informed regarding expectations and procedural steps are more likely to have better pain management.5 Another purpose of this counseling session may be to identify any risk factors that may increase pain and tailor nonpharmacologic and pharmacologic options to the individual patient.

Environment

Examination rooms should be comfortable, private, and professional appearing. Patients prefer a more informal, unhurried, and less sterile atmosphere for procedures. Clinicians should strive to engender trust prior to the procedure by sharing information in a straightforward manner, and ensuring that staff of medical assistants, nurses, and clinicians are a “well-oiled machine” to inspire confidence in the competence of the team.4 Ultrasonography guidance also may be helpful in reducing pain during IUD placement, but this may not be available in all outpatient settings.8

Distraction techniques

Various distraction methods have been employed during gynecologic procedures, and more specifically IUD placement, with some effect. During and after the procedure, heat and ice have been found to be helpful adjuncts for uterine cramping and should be offered as first-line pain management options on the examination table. This can be in the form of reusable heating pads or chemical heat or ice packs.4 A small study demonstrated that inhaled lavender may help with lowering anxiety prior to and during the procedure; however, it had limited effects on pain.10

Clinicians and support staff should engage in conversation with the patient throughout the procedure (ie, “verbacaine”). This can be conducted via a casual chat about unrelated topics or gentle and positive coaching through the procedure with the intent to remove negative imagery associated with elements of the insertion process.5 Finally, studies have been conducted using music as a distraction for colposcopy and hysteroscopy, and results have indicated that it is beneficial, reducing both pain and anxiety during these similar types of procedures.4 While these options may not fully remove pain and anxiety, many are low investment interventions that many patients will appreciate.

What are pharmacologic interventions that can decrease pain during IUD insertion?

The literature is more robust with studies examining the benefits of pharmacologic methods for reducing pain during IUD insertion; strategies include agents that lessen uterine cramping, numb the cervix, and soften and open the cervical os. Despite the plethora of studies, there is no one standard of care for pain management during IUD insertion (TABLE 3).

Lidocaine injection

Lidocaine is an amine anesthetic that can block the nociceptive response of nerves upon administration; it has the advantages of rapid onset and low risk in appropriate doses. Multiple randomized controlled trials (RCTs) have examined the use of paracervical and intracervical block with lidocaine.9,12-15 Lopez and colleagues conducted a review in 2015, including 3 studies about injectable lidocaine and demonstrated some effect of injectable lidocaine on reduction in pain at tenaculum placement.9

Mody and colleagues conducted a pilot RCT of 50 patients comparing a 10 mL lidocaine 1% paracervical block to no block, which was routine procedure at the time.12 The authors demonstrated a reduction in pain at the tenaculum site but no decrease in pain with insertion. They also measured pain during the block administration itself and found that the block increased the overall pain of the procedure. In 2018, Mody et al13 performed another RCT, but with a higher dose of 20 mL of buffered lidocaine 1% in 64 nulliparous patients. They found that paracervical block improved pain during uterine sounding, IUD insertion, and 5 minutes following insertion, as well as the pain of the overall procedure.

De Nadai andcolleagues evaluated if a larger dose of lidocaine (3.6 mL of lidocaine 2%) administered intracervically at the anterior lip was beneficial.14 They randomly assigned 302 women total: 99 to intracervical block, 101 to intracervical sham block with dry needling at the anterior lip, and 102 to no intervention. Fewer patients reported extreme pain with tenaculum placement and with IUD (levonorgestrel-releasing system) insertion. Given that this option requires less lidocaine overall and fewer injection points, it has the potential to be an easier and more reproducible technique.14

Finally, Akers and colleagues aimed to evaluate IUD insertion in nulliparous adolescents. They compared a 1% paracervical block of 10 mL with 1 mL at the anterior lip and 4.5 mL at 4 o’clock and 8 o’clock in the cervicovaginal junction versus depression of the wood end of a cotton swab at the same sites. They found that the paracervical block improved pain substantially during all steps of the procedure compared with the sham block in this young population.16

 

Nonsteroidal anti-inflammatory drugs

Nonsteroidal anti-inflammatory drugs (NSAIDs) show promise in reducing pain during IUD placement, as they inhibit the production of prostaglandins, which can in turn reduce uterine cramping and inflammation during IUD placement.

Lopez and colleagues evaluated the use of NSAIDs in 7 RCTs including oral naproxen, oral ibuprofen, and intramuscular ketorolac.9 While it had no effect on pain at the time of placement, naproxen administered at least 90 minutes before the procedure decreased uterine cramping for 2 hours after insertion. Women receiving naproxen also were less likely to describe the insertion as “unpleasant.” Ibuprofen was found to have limited effects during insertion and after the procedure. Intramuscular ketorolac studies were conflicting. Results of one study demonstrated a lower median pain score at 5 minutes but no differences during tenaculum placement or IUD insertion, whereas another demonstrated reduction in pain during and after the procedure.8,9

Another RCT showed potential benefit of tramadol over the use of naproxen when they were compared; however, tramadol is an opioid, and there are barriers to universal use in the outpatient setting.9

Continue to: Topical anesthetics...

 

 

Topical anesthetics

Topical anesthetics offer promise of pain relief without the pain of injection and with the advantage of self-administration for some formulations.

Several RCTs evaluated whether lidocaine gel 2% applied to the cervix or injected via flexible catheter into the cervical os improved pain, but there were no substantial differences in pain perception between topical gel and placebo groups in the insertion of IUDs.9

Rapkin and colleagues15 studied whether self-administered intravaginal lidocaine gel 2% five minutes before insertion was helpful;15 they found that tenaculum placement was less painful, but IUD placement was not. Conti et al expanded upon the Rapkin study by extending the amount of time of exposure to self-administered intravaginal lidocaine gel 2% to 15 minutes; they found no difference in perception of pain during tenaculum placement, but they did see a substantial difference in discomfort during speculum placement.17 This finding may be helpful for patients with a history of sexual trauma or anxiety about gynecologic examinations. Based on surveys conducted during their study, they found that patients were willing to wait 15 minutes for this benefit.

In Gemzell-Danielsson and colleagues’ updated review, they identified that different lidocaine formulations, such as a controlled-release lidocaine and a lidocaine-prilocaine compound, resulted in slight reduction in pain scores at multiple points during the IUD insertion process compared with controls.8 Two RCTs demonstrated substantial reduction in pain with administration of lidocaine spray 10% during tenaculum placement, sounding, and immediately after IUD placement compared with a placebo group.18,19 This may be an appealing option for patients who do not want to undergo an injection for local anesthesia.

 

Nitrous oxide

Nitrous oxide is an odorless colorless gas with anxiolytic, analgesic, and amnestic effects. It has several advantages for outpatient administration including rapid onset, rapid recovery, high safety profile, and no residual incapacitation, enabling a patient to safely leave the office shortly after a procedure.20

Nitrous oxide was studied in an RCT of 74 young (12-20 years of age) nulliparous patients and found to be effective for decreasing pain during IUD insertion and increasing satisfaction with the procedure.20 However, another study of 80 nulliparous patients (aged 13-45 years) did not find any reduction in pain during the insertion procedure.21

Prostaglandin analogues

Misoprostol is a synthetic prostaglandin E1 analog that causes cervical softening, uterine contractions, and cervical dilation. Dinoprostone is a synthetic prostaglandin E2 analog that has similar effects on the cervix and uterus. These properties have made it a useful tool in minor gynecologic procedures, such as first trimester uterine aspiration and hysteroscopy. However, both have the disadvantage of causing adverse effects on gastric smooth muscle, leading to nausea, vomiting, diarrhea, and uncomfortable gastric cramping.

Several RCTs have examined the use of misoprostol administration approximately 2 to 4 hours before IUD placement. No studies found any improvement in pain during IUD insertion, but this likely is due to the discomfort caused by the use of misoprostol itself.9 A meta-analysis and systematic review of 14 studies found no effect on reducing the pain associated with IUD placement but did find that providers had an easier time with cervical dilation in patients who received it. The meta-analysis also demonstrated that patients receiving vaginal misoprostol were less likely to have gastric side effects.22 In another review of 5 RCTs using 400 µg to 600 µg of misoprostol for cervical preparation, Gemzell-Danielsson et al found reductions in mean pain scores with placement specifically among patients with previous cesarean delivery and/or nulliparous patients.8

In an RCT, Ashour and colleagues looked at the use of dinoprostone 3 mg compared with placebo in 160 patients and found that those in the dinoprostone group had less pain during and 15 minutes after the procedure, as well as ease of insertion and overall higher satisfaction with the IUD placement. Dinoprostone traditionally is used for labor induction in the United States and tends to be much more expensive than misoprostol, but it shows the most promise of the prostaglandins in making IUD placement more comfortable.

Conclusion: Integrating evidence and experience

Providers tend to underestimate the pain and anxiety experienced by their patients undergoing IUD insertion. Patients’ concerns about pain and anxiety increase their risk for experiencing pain during IUD insertion. Patient anxieties, and thus, pain may be allayed by offering support and education prior to placement, offering tailored pharmacologic strategies to mitigate pain, and offering supportive and distraction measures during the insertion process. ●

Key recommendations
  • Patients should be counseled regarding the benefits and risks of the IUD, expectations for placement and removal, and offered the opportunity to ask questions and express their concerns.
  • Providers should use this opportunity to assess for risk factors for increased pain during IUD placement.
  • All patients should be offered premedication with naproxen 220 mg approximately 90 minutes prior to the procedure, as well as heat therapy and the opportunity to listen to music during the procedure.
  • Patients with risk factors for pain should have pharmacologic strategies offered based on the available evidence, and providers should reassure patients that there are multiple strategies available that have been shown to reduce pain during IUD placement.

—Nulliparous patients and patients with a history of a cesarean delivery may be offered the option of cervical ripening with misoprostol 400 µg vaginally 2 to 4 hours prior to the procedure.

—Patients with a history of sexual trauma should be offered self-administered lidocaine 1% or lidocaine-prilocaine formulations to increase comfort during examinations and speculum placement.

—All other patients can be offered the option of a paracervical or intracervical block, with the caveat that administration of the block itself also may cause some pain during the procedure.

—For those patients who desire some sort of local anesthetic but do not want to undergo a lidocaine injection, patients should be offered the option of lidocaine spray 10%.

—Finally, for those patients who are undergoing a difficult IUD placement, ultrasound guidance should be readily available.

Photo: Shutterstock

CASE Nulliparous young woman desires contraception

An 18-year-old nulliparous patient presents to your office inquiring about contraception before she leaves for college. She not only wants to prevent pregnancy but she also would like a method that can help with her dysmenorrhea. After receiving nondirective counseling about all of the methods available, she selects a levonorgestrel intrauterine device (LNG-IUD). However, she discloses that she is very nervous about placement. She has heard from friends that it can be painful to get an IUD. What are these patient’s risk factors for painful placement? How would you mitigate her experience of pain during the insertion process?
 

IUDs are highly effective and safe methods of preventing unwanted pregnancy. IUDs have become increasingly more common; they were the method of choice for 14% of contraception users in 2016, a rise from 12% in 2014.1 The Contraceptive CHOICE project demonstrated that IUDs were most likely to be chosen as a reversible method of contraception when unbiased counseling is provided and barriers such as cost are removed. Additionally, rates of continuation were found to be high, thus reducing the number of unwanted pregnancies.2 However, pain during IUD insertion as well as the fear and anxiety surrounding the procedure are some of the major limitations to IUD uptake and use. Specifically, fear of pain during IUD insertion is a substantial barrier; this fear is thought to also exacerbate the experience of pain during the insertion process.3

This article aims to identify risk factors for painful IUD placement and to review both nonpharmacologic and pharmacologic methods that may decrease discomfort and anxiety during IUD insertion.

 

What factors contribute to the experience of pain with IUD placement?

While some women do not report experiencing pain during IUD insertion, approximately 17% describe the pain as severe.4 The perception of pain during IUD placement is multifactorial; physiologic, psychological, emotional, cultural, and circumstantial factors all can play a role (TABLE 1). The biologic perception of pain results from the manipulation of the cervix and uterus; noxious stimuli activate both the sympathetic and parasympathetic nervous systems. The sympathetic system at T10-L2 mediates the fundus, the ovarian plexus at the cornua, and the uterosacral ligaments, while the parasympathetic fibers from S2-S4 enter the cervix at 3 o’clock and 9 o’clock and innervate the upper vagina, cervix, and lower uterine segment.4,5 Nulliparity, history of cesarean delivery, increased size of the IUD inserter, length of the uterine cavity, breastfeeding status, relation to timing of menstruation, and length of time since last vaginal delivery all may be triggers for pain. Other sociocultural influences on a patient’s experience of pain include young age (adolescence), Black race, and history of sexual trauma, as well as existing anxiety and beliefs about expected pain.3,5,6-8

It also is important to consider all aspects of the procedure that could be painful. Steps during IUD insertion that have been found to invoke average to severe pain include use of tenaculum on the cervix, uterine stabilization, uterine sounding, placement of the insertion tube, and deployment of the actual IUD.4-7

A secondary analysis of the Contraceptive CHOICE project confirmed that women with higher levels of anticipated pain were more likely to experience increased discomfort during placement.3 Providers tend to underestimate the anxiety and pain experienced by their patients undergoing IUD insertion. In a study about anticipated pain during IUD insertion, clinicians were asked if patients were “pleasant and appropriately engaging” or “anxious.” Only 10% of those patients were noted to be anxious by their provider; however, patients with a positive screen on the PHQ-4 depression and anxiety screen did anticipate more pain than those who did not.6 In another study, patients estimated their pain scores at 30 mm higher than their providers on a visual analog scale.7 Given these discrepancies, it is imperative to address anxiety and pain anticipation, risk factors for pain, and offerings for pain management during IUD placement to ensure a more holistic experience.

Continue to: What are nonpharmacologic interventions that can reduce anxiety and pain?...

 

 

What are nonpharmacologic interventions that can reduce anxiety and pain?

There are few formal studies on nonpharmacologic options for pain reduction at IUD insertion, with varying outcomes.4,8,10 However, many of them suggest that establishing a trusting clinician-patient relationship, a relaxing and inviting environment, and emotional support during the procedure may help make the procedure more comfortable overall (TABLE 2).4,5,10

Education and counseling

Patients should be thoroughly informed about the different IUD options, and they should be reassured regarding their contraceptive effectiveness and low risk for insertion difficulties in order to mitigate anxiety about complications and future fertility.11 This counseling session can offer the patient opportunities for relationship building with the provider and for the clinician to assess for anxiety and address concerns about the insertion and removal process. Patients who are adequately informed regarding expectations and procedural steps are more likely to have better pain management.5 Another purpose of this counseling session may be to identify any risk factors that may increase pain and tailor nonpharmacologic and pharmacologic options to the individual patient.

Environment

Examination rooms should be comfortable, private, and professional appearing. Patients prefer a more informal, unhurried, and less sterile atmosphere for procedures. Clinicians should strive to engender trust prior to the procedure by sharing information in a straightforward manner, and ensuring that staff of medical assistants, nurses, and clinicians are a “well-oiled machine” to inspire confidence in the competence of the team.4 Ultrasonography guidance also may be helpful in reducing pain during IUD placement, but this may not be available in all outpatient settings.8

Distraction techniques

Various distraction methods have been employed during gynecologic procedures, and more specifically IUD placement, with some effect. During and after the procedure, heat and ice have been found to be helpful adjuncts for uterine cramping and should be offered as first-line pain management options on the examination table. This can be in the form of reusable heating pads or chemical heat or ice packs.4 A small study demonstrated that inhaled lavender may help with lowering anxiety prior to and during the procedure; however, it had limited effects on pain.10

Clinicians and support staff should engage in conversation with the patient throughout the procedure (ie, “verbacaine”). This can be conducted via a casual chat about unrelated topics or gentle and positive coaching through the procedure with the intent to remove negative imagery associated with elements of the insertion process.5 Finally, studies have been conducted using music as a distraction for colposcopy and hysteroscopy, and results have indicated that it is beneficial, reducing both pain and anxiety during these similar types of procedures.4 While these options may not fully remove pain and anxiety, many are low investment interventions that many patients will appreciate.

What are pharmacologic interventions that can decrease pain during IUD insertion?

The literature is more robust with studies examining the benefits of pharmacologic methods for reducing pain during IUD insertion; strategies include agents that lessen uterine cramping, numb the cervix, and soften and open the cervical os. Despite the plethora of studies, there is no one standard of care for pain management during IUD insertion (TABLE 3).

Lidocaine injection

Lidocaine is an amine anesthetic that can block the nociceptive response of nerves upon administration; it has the advantages of rapid onset and low risk in appropriate doses. Multiple randomized controlled trials (RCTs) have examined the use of paracervical and intracervical block with lidocaine.9,12-15 Lopez and colleagues conducted a review in 2015, including 3 studies about injectable lidocaine and demonstrated some effect of injectable lidocaine on reduction in pain at tenaculum placement.9

Mody and colleagues conducted a pilot RCT of 50 patients comparing a 10 mL lidocaine 1% paracervical block to no block, which was routine procedure at the time.12 The authors demonstrated a reduction in pain at the tenaculum site but no decrease in pain with insertion. They also measured pain during the block administration itself and found that the block increased the overall pain of the procedure. In 2018, Mody et al13 performed another RCT, but with a higher dose of 20 mL of buffered lidocaine 1% in 64 nulliparous patients. They found that paracervical block improved pain during uterine sounding, IUD insertion, and 5 minutes following insertion, as well as the pain of the overall procedure.

De Nadai andcolleagues evaluated if a larger dose of lidocaine (3.6 mL of lidocaine 2%) administered intracervically at the anterior lip was beneficial.14 They randomly assigned 302 women total: 99 to intracervical block, 101 to intracervical sham block with dry needling at the anterior lip, and 102 to no intervention. Fewer patients reported extreme pain with tenaculum placement and with IUD (levonorgestrel-releasing system) insertion. Given that this option requires less lidocaine overall and fewer injection points, it has the potential to be an easier and more reproducible technique.14

Finally, Akers and colleagues aimed to evaluate IUD insertion in nulliparous adolescents. They compared a 1% paracervical block of 10 mL with 1 mL at the anterior lip and 4.5 mL at 4 o’clock and 8 o’clock in the cervicovaginal junction versus depression of the wood end of a cotton swab at the same sites. They found that the paracervical block improved pain substantially during all steps of the procedure compared with the sham block in this young population.16

 

Nonsteroidal anti-inflammatory drugs

Nonsteroidal anti-inflammatory drugs (NSAIDs) show promise in reducing pain during IUD placement, as they inhibit the production of prostaglandins, which can in turn reduce uterine cramping and inflammation during IUD placement.

Lopez and colleagues evaluated the use of NSAIDs in 7 RCTs including oral naproxen, oral ibuprofen, and intramuscular ketorolac.9 While it had no effect on pain at the time of placement, naproxen administered at least 90 minutes before the procedure decreased uterine cramping for 2 hours after insertion. Women receiving naproxen also were less likely to describe the insertion as “unpleasant.” Ibuprofen was found to have limited effects during insertion and after the procedure. Intramuscular ketorolac studies were conflicting. Results of one study demonstrated a lower median pain score at 5 minutes but no differences during tenaculum placement or IUD insertion, whereas another demonstrated reduction in pain during and after the procedure.8,9

Another RCT showed potential benefit of tramadol over the use of naproxen when they were compared; however, tramadol is an opioid, and there are barriers to universal use in the outpatient setting.9

Continue to: Topical anesthetics...

 

 

Topical anesthetics

Topical anesthetics offer promise of pain relief without the pain of injection and with the advantage of self-administration for some formulations.

Several RCTs evaluated whether lidocaine gel 2% applied to the cervix or injected via flexible catheter into the cervical os improved pain, but there were no substantial differences in pain perception between topical gel and placebo groups in the insertion of IUDs.9

Rapkin and colleagues15 studied whether self-administered intravaginal lidocaine gel 2% five minutes before insertion was helpful;15 they found that tenaculum placement was less painful, but IUD placement was not. Conti et al expanded upon the Rapkin study by extending the amount of time of exposure to self-administered intravaginal lidocaine gel 2% to 15 minutes; they found no difference in perception of pain during tenaculum placement, but they did see a substantial difference in discomfort during speculum placement.17 This finding may be helpful for patients with a history of sexual trauma or anxiety about gynecologic examinations. Based on surveys conducted during their study, they found that patients were willing to wait 15 minutes for this benefit.

In Gemzell-Danielsson and colleagues’ updated review, they identified that different lidocaine formulations, such as a controlled-release lidocaine and a lidocaine-prilocaine compound, resulted in slight reduction in pain scores at multiple points during the IUD insertion process compared with controls.8 Two RCTs demonstrated substantial reduction in pain with administration of lidocaine spray 10% during tenaculum placement, sounding, and immediately after IUD placement compared with a placebo group.18,19 This may be an appealing option for patients who do not want to undergo an injection for local anesthesia.

 

Nitrous oxide

Nitrous oxide is an odorless colorless gas with anxiolytic, analgesic, and amnestic effects. It has several advantages for outpatient administration including rapid onset, rapid recovery, high safety profile, and no residual incapacitation, enabling a patient to safely leave the office shortly after a procedure.20

Nitrous oxide was studied in an RCT of 74 young (12-20 years of age) nulliparous patients and found to be effective for decreasing pain during IUD insertion and increasing satisfaction with the procedure.20 However, another study of 80 nulliparous patients (aged 13-45 years) did not find any reduction in pain during the insertion procedure.21

Prostaglandin analogues

Misoprostol is a synthetic prostaglandin E1 analog that causes cervical softening, uterine contractions, and cervical dilation. Dinoprostone is a synthetic prostaglandin E2 analog that has similar effects on the cervix and uterus. These properties have made it a useful tool in minor gynecologic procedures, such as first trimester uterine aspiration and hysteroscopy. However, both have the disadvantage of causing adverse effects on gastric smooth muscle, leading to nausea, vomiting, diarrhea, and uncomfortable gastric cramping.

Several RCTs have examined the use of misoprostol administration approximately 2 to 4 hours before IUD placement. No studies found any improvement in pain during IUD insertion, but this likely is due to the discomfort caused by the use of misoprostol itself.9 A meta-analysis and systematic review of 14 studies found no effect on reducing the pain associated with IUD placement but did find that providers had an easier time with cervical dilation in patients who received it. The meta-analysis also demonstrated that patients receiving vaginal misoprostol were less likely to have gastric side effects.22 In another review of 5 RCTs using 400 µg to 600 µg of misoprostol for cervical preparation, Gemzell-Danielsson et al found reductions in mean pain scores with placement specifically among patients with previous cesarean delivery and/or nulliparous patients.8

In an RCT, Ashour and colleagues looked at the use of dinoprostone 3 mg compared with placebo in 160 patients and found that those in the dinoprostone group had less pain during and 15 minutes after the procedure, as well as ease of insertion and overall higher satisfaction with the IUD placement. Dinoprostone traditionally is used for labor induction in the United States and tends to be much more expensive than misoprostol, but it shows the most promise of the prostaglandins in making IUD placement more comfortable.

Conclusion: Integrating evidence and experience

Providers tend to underestimate the pain and anxiety experienced by their patients undergoing IUD insertion. Patients’ concerns about pain and anxiety increase their risk for experiencing pain during IUD insertion. Patient anxieties, and thus, pain may be allayed by offering support and education prior to placement, offering tailored pharmacologic strategies to mitigate pain, and offering supportive and distraction measures during the insertion process. ●

Key recommendations
  • Patients should be counseled regarding the benefits and risks of the IUD, expectations for placement and removal, and offered the opportunity to ask questions and express their concerns.
  • Providers should use this opportunity to assess for risk factors for increased pain during IUD placement.
  • All patients should be offered premedication with naproxen 220 mg approximately 90 minutes prior to the procedure, as well as heat therapy and the opportunity to listen to music during the procedure.
  • Patients with risk factors for pain should have pharmacologic strategies offered based on the available evidence, and providers should reassure patients that there are multiple strategies available that have been shown to reduce pain during IUD placement.

—Nulliparous patients and patients with a history of a cesarean delivery may be offered the option of cervical ripening with misoprostol 400 µg vaginally 2 to 4 hours prior to the procedure.

—Patients with a history of sexual trauma should be offered self-administered lidocaine 1% or lidocaine-prilocaine formulations to increase comfort during examinations and speculum placement.

—All other patients can be offered the option of a paracervical or intracervical block, with the caveat that administration of the block itself also may cause some pain during the procedure.

—For those patients who desire some sort of local anesthetic but do not want to undergo a lidocaine injection, patients should be offered the option of lidocaine spray 10%.

—Finally, for those patients who are undergoing a difficult IUD placement, ultrasound guidance should be readily available.

References
  1. Kavanaugh ML, Pliskin E. Use of contraception among reproductive-aged women in the United States, 2014 and 2016. F S Rep. 2020;1:83-93.
  2. Piepert JF, Zhao Q, Allsworth JE, et al. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011;117:1105‐1113.
  3. Dina B, Peipert LJ, Zhao Q, et al. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018;218:236.e1-236.e9. doi:10.1016 /j.ajog.2017.10.017.
  4. McCarthy C. Intrauterine contraception insertion pain: nursing interventions to improve patient experience. J Clin Nurs. 2018;27:9-21. doi:10.1111/jocn.13751.
  5. Ireland LD, Allen RH. Pain management for gynecologic procedures in the office. Obstet Gynecol Surv. 2016;71:89-98. doi:10.1097/OGX.0000000000000272.
  6. Hunter TA, Sonalkar S, Schreiber CA, et al. Anticipated pain during intrauterine device insertion. J Pediatr Adolesc Gynecol. 2020;33:27-32. doi:10.1016/j.jpag.2019.09.007
  7. Maguire K, Morrell K, Westhoff C, Davis A. Accuracy of providers’ assessment of pain during intrauterine device insertion. Contraception. 2014;89:22-24. doi: 10.1016/j.contraception.2013.09.008.
  8. Gemzell-Danielsson K, Jensen JT, Monteiro I. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: an updated review. Acta Obstet Gyncol Scand. 2019;98:1500-1513.
  9. Lopez LM, Bernholc A, Zeng Y, et al. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015;2015:CD007373. doi:10.1002/14651858.CD007 373.pub3.
  10. Nguyen L, Lamarche L, Lennox R, et al. Strategies to mitigate anxiety and pain in intrauterine device insertion: a systematic review. J Obstet Gynaecol Can. 2020;42:1138-1146.e2. doi:10.1016/j.jogc.2019.09.014.
  11. Akdemir Y, Karadeniz M. The relationship between pain at IUD insertion and negative perceptions, anxiety and previous mode of delivery. Eur J Contracept Reprod Health Care. 2019;24:240-245. doi:10.1080/13625187.2019.1610872.
  12. Mody SK, Kiley J, Rademaker A, et al. Pain control for intrauterine device insertion: a randomized trial of 1% lidocaine paracervical block. Contraception. 2012;86:704-709. doi:10.1016/j.contraception.2012.06.004.
  13. Mody SK, Farala JP, Jimenez B, et al. Paracervical block for intrauterine device placement among nulliparous women: a randomized controlled trial. Obstet Gynecol. 2018;132:575582. doi:10.1097/AOG.0000000000002790.
  14. De Nadai MN, Poli-Neto OB, Franceschini SA, et al. Intracervical block for levonorgestrel-releasing intrauterine system placement among nulligravid women: a randomized double-blind controlled trial. Am J Obstet Gynecol. 2020;222:245.e1-245.e10. doi:10.1016/j.ajog.2019.09.013.
  15. Rapkin RB, Achilles SL, Schwarz EB, et al. Self-administered lidocaine gel for intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2016;128:621-628. doi:10.1097/AOG.0000000000001596.
  16. Akers A, Steinway C, Sonalkar S, et al. Reducing pain during intrauterine device insertion. A randomized controlled trial in adolescents and young women. Obstet Gynecol. 2017;130:795802. doi: 10.1097/AOG.0000000000002242.
  17. Conti JA, Lerma K, Schneyer RJ, et al. Self-administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial. Am J Obstet Gynecol. 2019;220:177.e1-177.e7. doi:10.1016 /j.ajog.2018.11.1085.
  18. Panichyawat N, Mongkornthong T, Wongwananuruk T, et al. 10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebocontrolled trial. BMJ Sex Reprod Health. 2021;47:159-165. doi:10.1136/bmjsrh-2020-200670.
  19. Karasu Y, Cömert DK, Karadağ B, et al. Lidocaine for pain control during intrauterine device insertion. J Obstet Gynaecol Res. 2017;43:1061-1066. doi:10.1111/jog.13308.
  20. Fowler KG, Byraiah G, Burt C, et al. Nitrous oxide use for intrauterine system placement in adolescents.  J Pediatr Adolesc Gynecol. 2022;35:159-164. doi:10.1016 /j.jpag.2021.10.019.
  21. Singh RH, Thaxton L, Carr S, et al. A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women. Int J Gynaecol Obstet. 2016;135:145-148. doi:10.1016/j.ijgo.2016.04.014.
  22. Ashour AS, Nabil H, Yosif MF, et al. Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial. Fertil Steril. 2020;114:861-868. doi: 10.1016/j. fertnstert.2020.05.004.
References
  1. Kavanaugh ML, Pliskin E. Use of contraception among reproductive-aged women in the United States, 2014 and 2016. F S Rep. 2020;1:83-93.
  2. Piepert JF, Zhao Q, Allsworth JE, et al. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011;117:1105‐1113.
  3. Dina B, Peipert LJ, Zhao Q, et al. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018;218:236.e1-236.e9. doi:10.1016 /j.ajog.2017.10.017.
  4. McCarthy C. Intrauterine contraception insertion pain: nursing interventions to improve patient experience. J Clin Nurs. 2018;27:9-21. doi:10.1111/jocn.13751.
  5. Ireland LD, Allen RH. Pain management for gynecologic procedures in the office. Obstet Gynecol Surv. 2016;71:89-98. doi:10.1097/OGX.0000000000000272.
  6. Hunter TA, Sonalkar S, Schreiber CA, et al. Anticipated pain during intrauterine device insertion. J Pediatr Adolesc Gynecol. 2020;33:27-32. doi:10.1016/j.jpag.2019.09.007
  7. Maguire K, Morrell K, Westhoff C, Davis A. Accuracy of providers’ assessment of pain during intrauterine device insertion. Contraception. 2014;89:22-24. doi: 10.1016/j.contraception.2013.09.008.
  8. Gemzell-Danielsson K, Jensen JT, Monteiro I. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: an updated review. Acta Obstet Gyncol Scand. 2019;98:1500-1513.
  9. Lopez LM, Bernholc A, Zeng Y, et al. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015;2015:CD007373. doi:10.1002/14651858.CD007 373.pub3.
  10. Nguyen L, Lamarche L, Lennox R, et al. Strategies to mitigate anxiety and pain in intrauterine device insertion: a systematic review. J Obstet Gynaecol Can. 2020;42:1138-1146.e2. doi:10.1016/j.jogc.2019.09.014.
  11. Akdemir Y, Karadeniz M. The relationship between pain at IUD insertion and negative perceptions, anxiety and previous mode of delivery. Eur J Contracept Reprod Health Care. 2019;24:240-245. doi:10.1080/13625187.2019.1610872.
  12. Mody SK, Kiley J, Rademaker A, et al. Pain control for intrauterine device insertion: a randomized trial of 1% lidocaine paracervical block. Contraception. 2012;86:704-709. doi:10.1016/j.contraception.2012.06.004.
  13. Mody SK, Farala JP, Jimenez B, et al. Paracervical block for intrauterine device placement among nulliparous women: a randomized controlled trial. Obstet Gynecol. 2018;132:575582. doi:10.1097/AOG.0000000000002790.
  14. De Nadai MN, Poli-Neto OB, Franceschini SA, et al. Intracervical block for levonorgestrel-releasing intrauterine system placement among nulligravid women: a randomized double-blind controlled trial. Am J Obstet Gynecol. 2020;222:245.e1-245.e10. doi:10.1016/j.ajog.2019.09.013.
  15. Rapkin RB, Achilles SL, Schwarz EB, et al. Self-administered lidocaine gel for intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2016;128:621-628. doi:10.1097/AOG.0000000000001596.
  16. Akers A, Steinway C, Sonalkar S, et al. Reducing pain during intrauterine device insertion. A randomized controlled trial in adolescents and young women. Obstet Gynecol. 2017;130:795802. doi: 10.1097/AOG.0000000000002242.
  17. Conti JA, Lerma K, Schneyer RJ, et al. Self-administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial. Am J Obstet Gynecol. 2019;220:177.e1-177.e7. doi:10.1016 /j.ajog.2018.11.1085.
  18. Panichyawat N, Mongkornthong T, Wongwananuruk T, et al. 10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebocontrolled trial. BMJ Sex Reprod Health. 2021;47:159-165. doi:10.1136/bmjsrh-2020-200670.
  19. Karasu Y, Cömert DK, Karadağ B, et al. Lidocaine for pain control during intrauterine device insertion. J Obstet Gynaecol Res. 2017;43:1061-1066. doi:10.1111/jog.13308.
  20. Fowler KG, Byraiah G, Burt C, et al. Nitrous oxide use for intrauterine system placement in adolescents.  J Pediatr Adolesc Gynecol. 2022;35:159-164. doi:10.1016 /j.jpag.2021.10.019.
  21. Singh RH, Thaxton L, Carr S, et al. A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women. Int J Gynaecol Obstet. 2016;135:145-148. doi:10.1016/j.ijgo.2016.04.014.
  22. Ashour AS, Nabil H, Yosif MF, et al. Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial. Fertil Steril. 2020;114:861-868. doi: 10.1016/j. fertnstert.2020.05.004.
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Embattled iPLEDGE program: Changes ahead?

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Tue, 02/14/2023 - 07:27

In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.

The FDA has scheduled a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee for March 28-29 to discuss proposed changes to the iPLEDGE risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”

Ocskay Bence/Fotolia.com

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.

Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.

However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.

(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)



Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.

In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.

The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.

Dr. Andrea L. Zaenglein

“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.

As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.


The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.

A version of this article first appeared on Medscape.com.

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In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.

The FDA has scheduled a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee for March 28-29 to discuss proposed changes to the iPLEDGE risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”

Ocskay Bence/Fotolia.com

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.

Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.

However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.

(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)



Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.

In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.

The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.

Dr. Andrea L. Zaenglein

“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.

As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.


The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.

A version of this article first appeared on Medscape.com.

In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.

The FDA has scheduled a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee for March 28-29 to discuss proposed changes to the iPLEDGE risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”

Ocskay Bence/Fotolia.com

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.

Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.

However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.

(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)



Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.

In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.

The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.

Dr. Andrea L. Zaenglein

“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.

As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.


The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.

A version of this article first appeared on Medscape.com.

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Now trending on social media: Bad birth control info

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Tue, 02/07/2023 - 12:43

Add this to the list of social media’s potential health risks: unintended pregnancy.

That’s for women who take birth control advice from influencers, particularly on YouTube, where many talk about stopping hormonal contraception and may give incomplete or inaccurate sexual health information. 

In an analysis of 50 YouTube videos, University of Delaware researchers found that nearly three-quarters of influencers talked about discontinuing birth control pills or other forms hormonal birth control. And 40% were using or had used a “natural family planning” method – when women track their cycle, sometimes using an app, to identify days they might get pregnant. 

“We know from previous research that these nonhormonal options, such as fertility tracking apps, are not always as accurate as hormonal birth control,” said lead study author Emily Pfender, who reported the findings in Health Communication. “They rely on so many different factors, like body temperature and cervical fluid, that vary widely.” 

In fact, this “natural” approach only works when women meticulously follow guidelines like measuring basal body temperature and tracking cervical fluid daily. But many influencers left that part out. Using fertility-tracking methods without the right education and tools could raise the risk of unplanned pregnancy, as failure rates using these methods vary from 2% to 23%, according to the CDC. 

Even more alarming: Of the influencers who stopped hormonal birth control, only one-third mentioned replacing it with something else, Ms. Pfender said. 

“The message that some of these videos are sending is that discontinuing [hormonal birth control] is good for if you want to improve your mental health and be more natural, but it’s not important to start another form of birth control,” she said. “This places those women at an increased risk of unplanned pregnancy, and possibly sexually transmitted diseases.” 
 

Rise of the health influencer

Taking health advice from influencers is nothing new and appears to be getting more popular.

“People have been sharing health information for decades, even before the internet, but now it is much more prevalent and easier,” said Erin Willis, PhD, an associate professor at the University of Colorado, Boulder, who studies digital media and health communication.

Peer-to-peer health information is very influential, Dr. Willis said. It makes people feel understood, especially if they have the same health condition or share similar experiences or emotions. “The social support is there,” she said. “It is almost like crowdsourcing.”

In her study, Ms. Pfender and another researcher watched 50 YouTube videos posted between December 2019 and December 2021 by influencers with between 20,000 and 2.2 million followers. The top reasons influencers gave for discontinuing birth control included the desire to be more natural and to improve mental health. 

Although hormonal birth control, namely the pill, has been used for decades and is considered safe, it has been linked to side effects like depression. And people sharing their experiences with hormonal birth control online may create controversy over whether it’s safe to use. 

But Ms. Pfender found that influencers didn’t always share accurate or complete information. For example, some of the influencers talked about using the cycle tracking app Daysy, touting it as highly accurate, but none mentioned that the study backing up how well it worked was retracted in 2019 due to flaws in its research methods. 

Not all health influencers give bad information, Dr. Willis said. Many go through ethics and advocacy training and understand the sensitive position and influence they have. Still, people have different levels of “health literacy” – some may understand health information better than others. It’s crucial to analyze the info and sort the good from the bad. 

Look for information that is not linked to a particular product, the National Institutes of Health recommends. And cross-check it against reliable websites, such as those ending in “.gov” or “.org.”

A version of this article first appeared on WebMD.com.

  

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Add this to the list of social media’s potential health risks: unintended pregnancy.

That’s for women who take birth control advice from influencers, particularly on YouTube, where many talk about stopping hormonal contraception and may give incomplete or inaccurate sexual health information. 

In an analysis of 50 YouTube videos, University of Delaware researchers found that nearly three-quarters of influencers talked about discontinuing birth control pills or other forms hormonal birth control. And 40% were using or had used a “natural family planning” method – when women track their cycle, sometimes using an app, to identify days they might get pregnant. 

“We know from previous research that these nonhormonal options, such as fertility tracking apps, are not always as accurate as hormonal birth control,” said lead study author Emily Pfender, who reported the findings in Health Communication. “They rely on so many different factors, like body temperature and cervical fluid, that vary widely.” 

In fact, this “natural” approach only works when women meticulously follow guidelines like measuring basal body temperature and tracking cervical fluid daily. But many influencers left that part out. Using fertility-tracking methods without the right education and tools could raise the risk of unplanned pregnancy, as failure rates using these methods vary from 2% to 23%, according to the CDC. 

Even more alarming: Of the influencers who stopped hormonal birth control, only one-third mentioned replacing it with something else, Ms. Pfender said. 

“The message that some of these videos are sending is that discontinuing [hormonal birth control] is good for if you want to improve your mental health and be more natural, but it’s not important to start another form of birth control,” she said. “This places those women at an increased risk of unplanned pregnancy, and possibly sexually transmitted diseases.” 
 

Rise of the health influencer

Taking health advice from influencers is nothing new and appears to be getting more popular.

“People have been sharing health information for decades, even before the internet, but now it is much more prevalent and easier,” said Erin Willis, PhD, an associate professor at the University of Colorado, Boulder, who studies digital media and health communication.

Peer-to-peer health information is very influential, Dr. Willis said. It makes people feel understood, especially if they have the same health condition or share similar experiences or emotions. “The social support is there,” she said. “It is almost like crowdsourcing.”

In her study, Ms. Pfender and another researcher watched 50 YouTube videos posted between December 2019 and December 2021 by influencers with between 20,000 and 2.2 million followers. The top reasons influencers gave for discontinuing birth control included the desire to be more natural and to improve mental health. 

Although hormonal birth control, namely the pill, has been used for decades and is considered safe, it has been linked to side effects like depression. And people sharing their experiences with hormonal birth control online may create controversy over whether it’s safe to use. 

But Ms. Pfender found that influencers didn’t always share accurate or complete information. For example, some of the influencers talked about using the cycle tracking app Daysy, touting it as highly accurate, but none mentioned that the study backing up how well it worked was retracted in 2019 due to flaws in its research methods. 

Not all health influencers give bad information, Dr. Willis said. Many go through ethics and advocacy training and understand the sensitive position and influence they have. Still, people have different levels of “health literacy” – some may understand health information better than others. It’s crucial to analyze the info and sort the good from the bad. 

Look for information that is not linked to a particular product, the National Institutes of Health recommends. And cross-check it against reliable websites, such as those ending in “.gov” or “.org.”

A version of this article first appeared on WebMD.com.

  

Add this to the list of social media’s potential health risks: unintended pregnancy.

That’s for women who take birth control advice from influencers, particularly on YouTube, where many talk about stopping hormonal contraception and may give incomplete or inaccurate sexual health information. 

In an analysis of 50 YouTube videos, University of Delaware researchers found that nearly three-quarters of influencers talked about discontinuing birth control pills or other forms hormonal birth control. And 40% were using or had used a “natural family planning” method – when women track their cycle, sometimes using an app, to identify days they might get pregnant. 

“We know from previous research that these nonhormonal options, such as fertility tracking apps, are not always as accurate as hormonal birth control,” said lead study author Emily Pfender, who reported the findings in Health Communication. “They rely on so many different factors, like body temperature and cervical fluid, that vary widely.” 

In fact, this “natural” approach only works when women meticulously follow guidelines like measuring basal body temperature and tracking cervical fluid daily. But many influencers left that part out. Using fertility-tracking methods without the right education and tools could raise the risk of unplanned pregnancy, as failure rates using these methods vary from 2% to 23%, according to the CDC. 

Even more alarming: Of the influencers who stopped hormonal birth control, only one-third mentioned replacing it with something else, Ms. Pfender said. 

“The message that some of these videos are sending is that discontinuing [hormonal birth control] is good for if you want to improve your mental health and be more natural, but it’s not important to start another form of birth control,” she said. “This places those women at an increased risk of unplanned pregnancy, and possibly sexually transmitted diseases.” 
 

Rise of the health influencer

Taking health advice from influencers is nothing new and appears to be getting more popular.

“People have been sharing health information for decades, even before the internet, but now it is much more prevalent and easier,” said Erin Willis, PhD, an associate professor at the University of Colorado, Boulder, who studies digital media and health communication.

Peer-to-peer health information is very influential, Dr. Willis said. It makes people feel understood, especially if they have the same health condition or share similar experiences or emotions. “The social support is there,” she said. “It is almost like crowdsourcing.”

In her study, Ms. Pfender and another researcher watched 50 YouTube videos posted between December 2019 and December 2021 by influencers with between 20,000 and 2.2 million followers. The top reasons influencers gave for discontinuing birth control included the desire to be more natural and to improve mental health. 

Although hormonal birth control, namely the pill, has been used for decades and is considered safe, it has been linked to side effects like depression. And people sharing their experiences with hormonal birth control online may create controversy over whether it’s safe to use. 

But Ms. Pfender found that influencers didn’t always share accurate or complete information. For example, some of the influencers talked about using the cycle tracking app Daysy, touting it as highly accurate, but none mentioned that the study backing up how well it worked was retracted in 2019 due to flaws in its research methods. 

Not all health influencers give bad information, Dr. Willis said. Many go through ethics and advocacy training and understand the sensitive position and influence they have. Still, people have different levels of “health literacy” – some may understand health information better than others. It’s crucial to analyze the info and sort the good from the bad. 

Look for information that is not linked to a particular product, the National Institutes of Health recommends. And cross-check it against reliable websites, such as those ending in “.gov” or “.org.”

A version of this article first appeared on WebMD.com.

  

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Post ‘Roe,’ contraceptive failures carry bigger stakes

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Birth control options have improved over the decades. Oral contraceptives are now safer, with fewer side effects. Intrauterine devices can prevent pregnancy 99.6% of the time. But no prescription drug or medical device works flawlessly, and people’s use of contraception is inexact.

“No one walks into my office and says, ‘I plan on missing a pill,’ ” said obstetrician-gynecologist Mitchell Creinin, MD.

“There is no such thing as perfect use; we are all real-life users,” said Dr. Creinin, a professor at the University of California, Davis, who wrote a widely used textbook that details contraceptive failure rates.

Even when the odds of contraception failure are small, the number of incidents can add up quickly. More than 47 million women of reproductive age in the United States use contraception, and, depending on the birth control method, hundreds of thousands of unplanned pregnancies can occur each year. With most abortions outlawed in at least 13 states and legal battles underway in others, contraceptive failures now carry bigger stakes for tens of millions of Americans.

Researchers distinguish between the perfect use of birth control, when a method is used consistently and correctly every time, and typical use, when a method is used in real-life circumstances. No birth control, short of a complete female sterilization, has a 0.00% failure rate.

The failure rate for typical use of birth control pills is 7%. For every million women taking pills, 70,000 unplanned pregnancies could occur in a year. According to the most recent data available, more than 6.5 million women ages 15 to 49 use oral contraceptives, leading to about 460,000 unplanned pregnancies.

Even seemingly minuscule failure rates of IUDs and birth control implants can lead to surprises.

An intrauterine device releases a hormone that thickens the mucus on the cervix. Sperm hit the brick wall of mucus and are unable to pass through the barrier. Implants are matchstick-sized plastic rods placed under the skin, which send a steady, low dose of hormone into the body that also thickens the cervical mucus and prevents the ovaries from releasing an egg. But not always. The hormonal IUD and implants fail to prevent pregnancy 0.1%-0.4% of the time.

Some 4.8 million women use IUDs or implants in the U.S., leading to as many as 5,000 to 20,000 unplanned pregnancies a year.

“We’ve had women come through here for abortions who had an IUD, and they were the one in a thousand,” said Gordon Low, a nurse practitioner at the Planned Parenthood in Little Rock.

Abortion has been outlawed in Arkansas since the Supreme Court’s ruling on Dobbs v. Jackson Women’s Health Organization in late June. The only exception is when a patient’s death is considered imminent.

Those stakes are the new backdrop for couples making decisions about which form of contraception to choose or calculating the chances of pregnancy.

Another complication is the belief among many that contraceptives should work all the time, every time.

“In medicine, there is never anything that is 100%,” said Régine Sitruk-Ware, MD, a reproductive endocrinologist at the Population Council, a nonprofit research organization.

All sorts of factors interfere with contraceptive efficacy, said Dr. Sitruk-Ware. Certain medications for HIV and tuberculosis and the herbal supplement St. John’s wort can disrupt the liver’s processing of birth control pills. A medical provider might insert an IUD imprecisely into the uterus. Emergency contraception, including Plan B, is less effective in women weighing more than 165 pounds because the hormone in the medication is weight-dependent.

And life is hectic.

“You may have a delay in taking your next pill,” said Dr. Sitruk-Ware, or getting to the doctor to insert “your next vaginal ring.”

Using contraception consistently and correctly lessens the chance for a failure but Alina Salganicoff, KFF’s director of women’s health policy, said that for many people access to birth control is anything but dependable. Birth control pills are needed month after month, year after year, but “the vast majority of women can only get a one- to two-month supply,” she said.

Even vasectomies can fail.

During a vasectomy, the surgeon cuts the tube that carries sperm to the semen.

The procedure is one of the most effective methods of birth control – the failure rate is 0.15% – and avoids the side effects of hormonal birth control. But even after the vas deferens is cut, cells in the body can heal themselves, including after a vasectomy.

“If you get a cut on your finger, the skin covers it back up,” said Dr. Creinin. “Depending on how big the gap is and how the procedure is done, that tube may grow back together, and that’s one of the ways in which it fails.”

Researchers are testing reversible birth control methods for men, including a hormonal gel applied to the shoulders that suppresses sperm production. Among the 350 participants in the trial and their partners, so far zero pregnancies have occurred. It’s expected to take years for the new methods to reach the market and be available to consumers. Meanwhile, vasectomies and condoms remain the only contraception available for men, who remain fertile for much of their lives.

At 13%, the typical-use failure rate of condoms is among the highest of birth control methods. Condoms play a vital role in stopping the spread of HIV and other sexually transmitted infections, but they are often misused or tear. The typical-use failure rate means that for 1 million couples using condoms, 130,000 unplanned pregnancies could occur in one year.

Navigating the failure rates of birth control medicines and medical devices is just one aspect of preventing pregnancy. Ensuring a male sexual partner uses a condom can require negotiation or persuasion skills that can be difficult to navigate, said Jennifer Evans, an assistant teaching professor and health education specialist at Northeastern University.

Historically, women have had little to no say in whether to engage in sexual intercourse and limited autonomy over their bodies, complicating sexual-negotiation skills today, said Ms. Evans.

Part of Ms. Evans’ research focuses on men who coerce women into sex without a condom. One tactic, known as “stealthing,” is when a man puts on a condom but then removes it either before or during sexual intercourse without the other person’s knowledge or consent.

“In a lot of these stealthing cases women don’t necessarily know the condom has been used improperly,” said Ms. Evans. “It means they can’t engage in any kind of preventative behaviors like taking a Plan B or even going and getting an abortion in a timely manner.”

Ms. Evans has found that heterosexual men who engage in stealthing often have hostile attitudes toward women. They report that sex without a condom feels better or say they do it “for the thrill of engaging in a behavior they know is not OK,” she said. Ms. Evans cautions women who suspect a sexual partner will not use a condom correctly to not have sex with that person.

“The consequences were already severe before,” said Ms. Evans, “but now that Roe v. Wade has been overturned, they’re even more right now.”

This story is a collaboration between KHN and Science Friday. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Birth control options have improved over the decades. Oral contraceptives are now safer, with fewer side effects. Intrauterine devices can prevent pregnancy 99.6% of the time. But no prescription drug or medical device works flawlessly, and people’s use of contraception is inexact.

“No one walks into my office and says, ‘I plan on missing a pill,’ ” said obstetrician-gynecologist Mitchell Creinin, MD.

“There is no such thing as perfect use; we are all real-life users,” said Dr. Creinin, a professor at the University of California, Davis, who wrote a widely used textbook that details contraceptive failure rates.

Even when the odds of contraception failure are small, the number of incidents can add up quickly. More than 47 million women of reproductive age in the United States use contraception, and, depending on the birth control method, hundreds of thousands of unplanned pregnancies can occur each year. With most abortions outlawed in at least 13 states and legal battles underway in others, contraceptive failures now carry bigger stakes for tens of millions of Americans.

Researchers distinguish between the perfect use of birth control, when a method is used consistently and correctly every time, and typical use, when a method is used in real-life circumstances. No birth control, short of a complete female sterilization, has a 0.00% failure rate.

The failure rate for typical use of birth control pills is 7%. For every million women taking pills, 70,000 unplanned pregnancies could occur in a year. According to the most recent data available, more than 6.5 million women ages 15 to 49 use oral contraceptives, leading to about 460,000 unplanned pregnancies.

Even seemingly minuscule failure rates of IUDs and birth control implants can lead to surprises.

An intrauterine device releases a hormone that thickens the mucus on the cervix. Sperm hit the brick wall of mucus and are unable to pass through the barrier. Implants are matchstick-sized plastic rods placed under the skin, which send a steady, low dose of hormone into the body that also thickens the cervical mucus and prevents the ovaries from releasing an egg. But not always. The hormonal IUD and implants fail to prevent pregnancy 0.1%-0.4% of the time.

Some 4.8 million women use IUDs or implants in the U.S., leading to as many as 5,000 to 20,000 unplanned pregnancies a year.

“We’ve had women come through here for abortions who had an IUD, and they were the one in a thousand,” said Gordon Low, a nurse practitioner at the Planned Parenthood in Little Rock.

Abortion has been outlawed in Arkansas since the Supreme Court’s ruling on Dobbs v. Jackson Women’s Health Organization in late June. The only exception is when a patient’s death is considered imminent.

Those stakes are the new backdrop for couples making decisions about which form of contraception to choose or calculating the chances of pregnancy.

Another complication is the belief among many that contraceptives should work all the time, every time.

“In medicine, there is never anything that is 100%,” said Régine Sitruk-Ware, MD, a reproductive endocrinologist at the Population Council, a nonprofit research organization.

All sorts of factors interfere with contraceptive efficacy, said Dr. Sitruk-Ware. Certain medications for HIV and tuberculosis and the herbal supplement St. John’s wort can disrupt the liver’s processing of birth control pills. A medical provider might insert an IUD imprecisely into the uterus. Emergency contraception, including Plan B, is less effective in women weighing more than 165 pounds because the hormone in the medication is weight-dependent.

And life is hectic.

“You may have a delay in taking your next pill,” said Dr. Sitruk-Ware, or getting to the doctor to insert “your next vaginal ring.”

Using contraception consistently and correctly lessens the chance for a failure but Alina Salganicoff, KFF’s director of women’s health policy, said that for many people access to birth control is anything but dependable. Birth control pills are needed month after month, year after year, but “the vast majority of women can only get a one- to two-month supply,” she said.

Even vasectomies can fail.

During a vasectomy, the surgeon cuts the tube that carries sperm to the semen.

The procedure is one of the most effective methods of birth control – the failure rate is 0.15% – and avoids the side effects of hormonal birth control. But even after the vas deferens is cut, cells in the body can heal themselves, including after a vasectomy.

“If you get a cut on your finger, the skin covers it back up,” said Dr. Creinin. “Depending on how big the gap is and how the procedure is done, that tube may grow back together, and that’s one of the ways in which it fails.”

Researchers are testing reversible birth control methods for men, including a hormonal gel applied to the shoulders that suppresses sperm production. Among the 350 participants in the trial and their partners, so far zero pregnancies have occurred. It’s expected to take years for the new methods to reach the market and be available to consumers. Meanwhile, vasectomies and condoms remain the only contraception available for men, who remain fertile for much of their lives.

At 13%, the typical-use failure rate of condoms is among the highest of birth control methods. Condoms play a vital role in stopping the spread of HIV and other sexually transmitted infections, but they are often misused or tear. The typical-use failure rate means that for 1 million couples using condoms, 130,000 unplanned pregnancies could occur in one year.

Navigating the failure rates of birth control medicines and medical devices is just one aspect of preventing pregnancy. Ensuring a male sexual partner uses a condom can require negotiation or persuasion skills that can be difficult to navigate, said Jennifer Evans, an assistant teaching professor and health education specialist at Northeastern University.

Historically, women have had little to no say in whether to engage in sexual intercourse and limited autonomy over their bodies, complicating sexual-negotiation skills today, said Ms. Evans.

Part of Ms. Evans’ research focuses on men who coerce women into sex without a condom. One tactic, known as “stealthing,” is when a man puts on a condom but then removes it either before or during sexual intercourse without the other person’s knowledge or consent.

“In a lot of these stealthing cases women don’t necessarily know the condom has been used improperly,” said Ms. Evans. “It means they can’t engage in any kind of preventative behaviors like taking a Plan B or even going and getting an abortion in a timely manner.”

Ms. Evans has found that heterosexual men who engage in stealthing often have hostile attitudes toward women. They report that sex without a condom feels better or say they do it “for the thrill of engaging in a behavior they know is not OK,” she said. Ms. Evans cautions women who suspect a sexual partner will not use a condom correctly to not have sex with that person.

“The consequences were already severe before,” said Ms. Evans, “but now that Roe v. Wade has been overturned, they’re even more right now.”

This story is a collaboration between KHN and Science Friday. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Birth control options have improved over the decades. Oral contraceptives are now safer, with fewer side effects. Intrauterine devices can prevent pregnancy 99.6% of the time. But no prescription drug or medical device works flawlessly, and people’s use of contraception is inexact.

“No one walks into my office and says, ‘I plan on missing a pill,’ ” said obstetrician-gynecologist Mitchell Creinin, MD.

“There is no such thing as perfect use; we are all real-life users,” said Dr. Creinin, a professor at the University of California, Davis, who wrote a widely used textbook that details contraceptive failure rates.

Even when the odds of contraception failure are small, the number of incidents can add up quickly. More than 47 million women of reproductive age in the United States use contraception, and, depending on the birth control method, hundreds of thousands of unplanned pregnancies can occur each year. With most abortions outlawed in at least 13 states and legal battles underway in others, contraceptive failures now carry bigger stakes for tens of millions of Americans.

Researchers distinguish between the perfect use of birth control, when a method is used consistently and correctly every time, and typical use, when a method is used in real-life circumstances. No birth control, short of a complete female sterilization, has a 0.00% failure rate.

The failure rate for typical use of birth control pills is 7%. For every million women taking pills, 70,000 unplanned pregnancies could occur in a year. According to the most recent data available, more than 6.5 million women ages 15 to 49 use oral contraceptives, leading to about 460,000 unplanned pregnancies.

Even seemingly minuscule failure rates of IUDs and birth control implants can lead to surprises.

An intrauterine device releases a hormone that thickens the mucus on the cervix. Sperm hit the brick wall of mucus and are unable to pass through the barrier. Implants are matchstick-sized plastic rods placed under the skin, which send a steady, low dose of hormone into the body that also thickens the cervical mucus and prevents the ovaries from releasing an egg. But not always. The hormonal IUD and implants fail to prevent pregnancy 0.1%-0.4% of the time.

Some 4.8 million women use IUDs or implants in the U.S., leading to as many as 5,000 to 20,000 unplanned pregnancies a year.

“We’ve had women come through here for abortions who had an IUD, and they were the one in a thousand,” said Gordon Low, a nurse practitioner at the Planned Parenthood in Little Rock.

Abortion has been outlawed in Arkansas since the Supreme Court’s ruling on Dobbs v. Jackson Women’s Health Organization in late June. The only exception is when a patient’s death is considered imminent.

Those stakes are the new backdrop for couples making decisions about which form of contraception to choose or calculating the chances of pregnancy.

Another complication is the belief among many that contraceptives should work all the time, every time.

“In medicine, there is never anything that is 100%,” said Régine Sitruk-Ware, MD, a reproductive endocrinologist at the Population Council, a nonprofit research organization.

All sorts of factors interfere with contraceptive efficacy, said Dr. Sitruk-Ware. Certain medications for HIV and tuberculosis and the herbal supplement St. John’s wort can disrupt the liver’s processing of birth control pills. A medical provider might insert an IUD imprecisely into the uterus. Emergency contraception, including Plan B, is less effective in women weighing more than 165 pounds because the hormone in the medication is weight-dependent.

And life is hectic.

“You may have a delay in taking your next pill,” said Dr. Sitruk-Ware, or getting to the doctor to insert “your next vaginal ring.”

Using contraception consistently and correctly lessens the chance for a failure but Alina Salganicoff, KFF’s director of women’s health policy, said that for many people access to birth control is anything but dependable. Birth control pills are needed month after month, year after year, but “the vast majority of women can only get a one- to two-month supply,” she said.

Even vasectomies can fail.

During a vasectomy, the surgeon cuts the tube that carries sperm to the semen.

The procedure is one of the most effective methods of birth control – the failure rate is 0.15% – and avoids the side effects of hormonal birth control. But even after the vas deferens is cut, cells in the body can heal themselves, including after a vasectomy.

“If you get a cut on your finger, the skin covers it back up,” said Dr. Creinin. “Depending on how big the gap is and how the procedure is done, that tube may grow back together, and that’s one of the ways in which it fails.”

Researchers are testing reversible birth control methods for men, including a hormonal gel applied to the shoulders that suppresses sperm production. Among the 350 participants in the trial and their partners, so far zero pregnancies have occurred. It’s expected to take years for the new methods to reach the market and be available to consumers. Meanwhile, vasectomies and condoms remain the only contraception available for men, who remain fertile for much of their lives.

At 13%, the typical-use failure rate of condoms is among the highest of birth control methods. Condoms play a vital role in stopping the spread of HIV and other sexually transmitted infections, but they are often misused or tear. The typical-use failure rate means that for 1 million couples using condoms, 130,000 unplanned pregnancies could occur in one year.

Navigating the failure rates of birth control medicines and medical devices is just one aspect of preventing pregnancy. Ensuring a male sexual partner uses a condom can require negotiation or persuasion skills that can be difficult to navigate, said Jennifer Evans, an assistant teaching professor and health education specialist at Northeastern University.

Historically, women have had little to no say in whether to engage in sexual intercourse and limited autonomy over their bodies, complicating sexual-negotiation skills today, said Ms. Evans.

Part of Ms. Evans’ research focuses on men who coerce women into sex without a condom. One tactic, known as “stealthing,” is when a man puts on a condom but then removes it either before or during sexual intercourse without the other person’s knowledge or consent.

“In a lot of these stealthing cases women don’t necessarily know the condom has been used improperly,” said Ms. Evans. “It means they can’t engage in any kind of preventative behaviors like taking a Plan B or even going and getting an abortion in a timely manner.”

Ms. Evans has found that heterosexual men who engage in stealthing often have hostile attitudes toward women. They report that sex without a condom feels better or say they do it “for the thrill of engaging in a behavior they know is not OK,” she said. Ms. Evans cautions women who suspect a sexual partner will not use a condom correctly to not have sex with that person.

“The consequences were already severe before,” said Ms. Evans, “but now that Roe v. Wade has been overturned, they’re even more right now.”

This story is a collaboration between KHN and Science Friday. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Sexual health care for disabled youth: Tough and getting tougher

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Tue, 10/25/2022 - 15:53

The developmentally disabled girl was just 10 years old when Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee, helped care for her. Providing that care was not emotionally easy. “Her brother’s friend sexually assaulted her and impregnated her,” Dr. Thew said.

The girl was able to obtain an abortion, a decision her parents supported. The alternative could have been deadly. “She was a tiny little person and would not have been able to carry a fetus,” Dr. Thew, a nurse practitioner, said.

Dr. Thew said she’s thankful that tragic case occurred before 2022. After the United States Supreme Court overturned Roe v. Wade in June, Wisconsin reverted to an 1849 law banning abortion. Although the law is currently being challenged, Dr. Thew wonders how the situation would have played out now. (Weeks after the Supreme Court’s decision, a similar case occurred in Ohio. In that case, a 10-year-old girl had to travel out of the state to obtain an abortion after having been raped.)

Talking to adolescents and young adults about reproductive health, whether regarding an unexpected pregnancy, the need for contraception, or to provide information about sexual activity, can be a challenge even for experienced health care providers.

The talks, decisions, and care are particularly complex when patients have developmental and intellectual disabilities. Among the many factors, Dr. Thew said, are dealing with menstruation, finding the right contraceptives, and counseling parents who might not want to acknowledge their children’s emerging sexuality.
 

Statistics: How many?

Because the definitions of disabilities vary and they represent a spectrum, estimates for how many youth have intellectual or developmental disabilities range widely.

In 2019, the National Survey of Children’s Health found that 1 in 4 children and adolescents aged 12-17 years have special health care needs because of disability. The American Community Survey estimates more than 1.3 million people aged 16-20 have a disability.

Intellectual disabilities can occur when a person’s IQ is below 70, significantly impeding the ability to perform activities of daily living, such as eating, dressing, and communicating. Developmental disabilities are impairments in physical, learning, language, and behavior, according to the United States Centers for Disease Control and Prevention. Among the conditions are attention-deficit/hyperactivity disorder, autism spectrum disorders, fragile X syndrome, learning and language problems, spina bifida, and other conditions.
 

Addressing common issues, concerns

April Kayser is a health educator for the Multnomah County Health Department, Portland, Ore. In 2016, Ms. Kayser and other experts conducted interviews with 11 youth with developmental and intellectual disabilities and 34 support people, either parents or professionals who provide services. The survey was part of the SHEIDD Project – short for Sexual Health Equity for Individuals with Intellectual/Developmental Disabilities – at Oregon Health and Science University (OHSU).

From their findings, the researchers compiled guidelines. They provided scenarios that health care providers need to be aware of and that they need to be ready to address:

  • A boy, 14, who is unclear about what to do when he feels sexually excited and wants to masturbate but isn’t at home. He has been told that masturbation is appropriate in private.
  • A 20-year-old woman who lives in a group home is pregnant. She confesses to her parents during a visit that another resident is her boyfriend and that he is the father of the child she is expecting.
  • A 17-year-old boy wants to ask out another student, who is 15.
 

 

Some developmentally and intellectually disabled youth can’t turn to their parents for help. One person in the survey said his father told him, “You don’t need to worry about any of that stuff. You’re too young.” Another said the job of a health care provider was to offer reproductive and sex education “to make sure you don’t screw up in some bad way.”

One finding stood out: Health care providers were at the top of the list of those whom young people trusted for information about reproductive and sexual health, Ms. Kayser said. Yet in her experience, she said, health care professionals are hesitant to bring up the issues with all youth, “especially those with intellectual and developmental disabilities.”

Health care providers often talk both to the patient and to the parents. Those conversations can be critical when a child is developmentally or intellectually disabled.

Women with disabilities have been shown to have a higher risk for adverse outcomes of pregnancy, said Willi Horner-Johnson, PhD, associate professor at OHSU–Portland State University School of Public Health.

In a recent study, she and her colleagues analyzed data from the CDC’s National Survey of Family Growth that included self-reported disability status. They found that the number of women with disabilities who give birth is far higher than was previously thought.

The researchers found that 19.5% of respondents who gave birth reported at least one sensory, cognitive, or mobility-related disability, a rate that is much greater than the less than 1%-6.6% estimates that are based on hospital discharge data.

Her group reported other troubling findings: Women with disabilities are twice as likely to have smoked during their pregnancy (19% vs. 8.9%) and are more likely to have preterm and low-birthweight babies.
 

Clinicians play an important role

Dr. Horner-Johnson agreed with the finding from the Multnomah County survey that health care providers play an important role in providing those with intellectual and developmental disabilities reproductive health care that meets their needs. “Clinicians need to be asking people with disabilities about their reproductive plans,” she said.

In the Multnomah County report, the researchers advised health care providers to recognize that people with disabilities are social and sexual beings; to learn about their goals, including those regarding sex and reproductive health; and to help youth build skills for healthy relationships and sexual activity.

Dr. Horner-Johnson pointed out that the American College of Obstetricians and Gynecologists “recommends that clinicians discuss reproductive plans at every visit, for example, by asking one key question – ‘Would you like to become pregnant in the next year?’ – of every woman of reproductive age.”

Some women will not be able to answer that question, and health care providers at times must rely on a caregiver for input. But many women, even those with disabilities, could answer if given a chance. She estimated that only about 5% of disabled people are unable to communicate. “Clinicians defer to the caregiver more than they need to,” she said.

Clinicians are becoming better at providing care to those with disabilities, Dr. Horner-Johnson said, yet they have a way to go. Clinician biases may prevent some from asking all women, including those with disabilities, about their reproductive plans. “Women with disabilities have described clinicians treating them as nonsexual, assuming or implying that they would not or should not get pregnant,” she writes in her report.

Such biases, she said, could be reduced by increased education of providers. A 2018 study in Health Equity found that only 19.3% of ob.gyns. said they felt equipped to manage the pregnancy of a woman with disabilities.

Managing sexuality and sexual health for youth with disabilities can be highly complex, according to Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee. Challenges include the following:

  • Parents often can’t deal with the reality that their teen or young adult is sexually active or may become so. Parents she helps often prefer to use the term “hormones,” not contraceptives, when talking about pregnancy prevention.
  • Menstruation is a frequent concern, especially for youth with severe disabilities. Some react strongly to seeing a sanitary pad with blood, for example, by throwing it. Parents worry that caregivers will balk at changing pads regularly. As a result, some parents want complete menstrual suppression, Dr. Thew said. The American Academy of Pediatrics outlines how to approach menstrual suppression through methods such as the use of estrogen-progestin, progesterone, a ring, or a patch. In late August, the American College of Obstetricians and Gynecologists released its clinical consensus on medical management of menstrual suppression.
  • Some parents want to know how to obtain a complete hysterectomy for the patient – an option Dr. Thew and the AAP discourage. “We will tell them that’s not the best and safest approach, as you want to have the estrogen for bone health,” she said.
  • After a discussion of all the options, an intrauterine device proves best for many. “That gives 7-8 years of protection,” she said, which is the approved effective duration for such devices. “They are less apt to have heavy monthly menstrual bleeding.”
  • Parents of boys with disabilities, especially those with Down syndrome, often ask for sex education and guidance when sexual desires develop.
  • Many parents want effective birth control for their children because of fear that their teen or young adult will be assaulted, a fear that isn’t groundless. Such cases are common, and caregivers frequently are the perpetrators.

Ms. Kayser, Dr. Horner-Johnson, and Dr. Thew have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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The developmentally disabled girl was just 10 years old when Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee, helped care for her. Providing that care was not emotionally easy. “Her brother’s friend sexually assaulted her and impregnated her,” Dr. Thew said.

The girl was able to obtain an abortion, a decision her parents supported. The alternative could have been deadly. “She was a tiny little person and would not have been able to carry a fetus,” Dr. Thew, a nurse practitioner, said.

Dr. Thew said she’s thankful that tragic case occurred before 2022. After the United States Supreme Court overturned Roe v. Wade in June, Wisconsin reverted to an 1849 law banning abortion. Although the law is currently being challenged, Dr. Thew wonders how the situation would have played out now. (Weeks after the Supreme Court’s decision, a similar case occurred in Ohio. In that case, a 10-year-old girl had to travel out of the state to obtain an abortion after having been raped.)

Talking to adolescents and young adults about reproductive health, whether regarding an unexpected pregnancy, the need for contraception, or to provide information about sexual activity, can be a challenge even for experienced health care providers.

The talks, decisions, and care are particularly complex when patients have developmental and intellectual disabilities. Among the many factors, Dr. Thew said, are dealing with menstruation, finding the right contraceptives, and counseling parents who might not want to acknowledge their children’s emerging sexuality.
 

Statistics: How many?

Because the definitions of disabilities vary and they represent a spectrum, estimates for how many youth have intellectual or developmental disabilities range widely.

In 2019, the National Survey of Children’s Health found that 1 in 4 children and adolescents aged 12-17 years have special health care needs because of disability. The American Community Survey estimates more than 1.3 million people aged 16-20 have a disability.

Intellectual disabilities can occur when a person’s IQ is below 70, significantly impeding the ability to perform activities of daily living, such as eating, dressing, and communicating. Developmental disabilities are impairments in physical, learning, language, and behavior, according to the United States Centers for Disease Control and Prevention. Among the conditions are attention-deficit/hyperactivity disorder, autism spectrum disorders, fragile X syndrome, learning and language problems, spina bifida, and other conditions.
 

Addressing common issues, concerns

April Kayser is a health educator for the Multnomah County Health Department, Portland, Ore. In 2016, Ms. Kayser and other experts conducted interviews with 11 youth with developmental and intellectual disabilities and 34 support people, either parents or professionals who provide services. The survey was part of the SHEIDD Project – short for Sexual Health Equity for Individuals with Intellectual/Developmental Disabilities – at Oregon Health and Science University (OHSU).

From their findings, the researchers compiled guidelines. They provided scenarios that health care providers need to be aware of and that they need to be ready to address:

  • A boy, 14, who is unclear about what to do when he feels sexually excited and wants to masturbate but isn’t at home. He has been told that masturbation is appropriate in private.
  • A 20-year-old woman who lives in a group home is pregnant. She confesses to her parents during a visit that another resident is her boyfriend and that he is the father of the child she is expecting.
  • A 17-year-old boy wants to ask out another student, who is 15.
 

 

Some developmentally and intellectually disabled youth can’t turn to their parents for help. One person in the survey said his father told him, “You don’t need to worry about any of that stuff. You’re too young.” Another said the job of a health care provider was to offer reproductive and sex education “to make sure you don’t screw up in some bad way.”

One finding stood out: Health care providers were at the top of the list of those whom young people trusted for information about reproductive and sexual health, Ms. Kayser said. Yet in her experience, she said, health care professionals are hesitant to bring up the issues with all youth, “especially those with intellectual and developmental disabilities.”

Health care providers often talk both to the patient and to the parents. Those conversations can be critical when a child is developmentally or intellectually disabled.

Women with disabilities have been shown to have a higher risk for adverse outcomes of pregnancy, said Willi Horner-Johnson, PhD, associate professor at OHSU–Portland State University School of Public Health.

In a recent study, she and her colleagues analyzed data from the CDC’s National Survey of Family Growth that included self-reported disability status. They found that the number of women with disabilities who give birth is far higher than was previously thought.

The researchers found that 19.5% of respondents who gave birth reported at least one sensory, cognitive, or mobility-related disability, a rate that is much greater than the less than 1%-6.6% estimates that are based on hospital discharge data.

Her group reported other troubling findings: Women with disabilities are twice as likely to have smoked during their pregnancy (19% vs. 8.9%) and are more likely to have preterm and low-birthweight babies.
 

Clinicians play an important role

Dr. Horner-Johnson agreed with the finding from the Multnomah County survey that health care providers play an important role in providing those with intellectual and developmental disabilities reproductive health care that meets their needs. “Clinicians need to be asking people with disabilities about their reproductive plans,” she said.

In the Multnomah County report, the researchers advised health care providers to recognize that people with disabilities are social and sexual beings; to learn about their goals, including those regarding sex and reproductive health; and to help youth build skills for healthy relationships and sexual activity.

Dr. Horner-Johnson pointed out that the American College of Obstetricians and Gynecologists “recommends that clinicians discuss reproductive plans at every visit, for example, by asking one key question – ‘Would you like to become pregnant in the next year?’ – of every woman of reproductive age.”

Some women will not be able to answer that question, and health care providers at times must rely on a caregiver for input. But many women, even those with disabilities, could answer if given a chance. She estimated that only about 5% of disabled people are unable to communicate. “Clinicians defer to the caregiver more than they need to,” she said.

Clinicians are becoming better at providing care to those with disabilities, Dr. Horner-Johnson said, yet they have a way to go. Clinician biases may prevent some from asking all women, including those with disabilities, about their reproductive plans. “Women with disabilities have described clinicians treating them as nonsexual, assuming or implying that they would not or should not get pregnant,” she writes in her report.

Such biases, she said, could be reduced by increased education of providers. A 2018 study in Health Equity found that only 19.3% of ob.gyns. said they felt equipped to manage the pregnancy of a woman with disabilities.

Managing sexuality and sexual health for youth with disabilities can be highly complex, according to Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee. Challenges include the following:

  • Parents often can’t deal with the reality that their teen or young adult is sexually active or may become so. Parents she helps often prefer to use the term “hormones,” not contraceptives, when talking about pregnancy prevention.
  • Menstruation is a frequent concern, especially for youth with severe disabilities. Some react strongly to seeing a sanitary pad with blood, for example, by throwing it. Parents worry that caregivers will balk at changing pads regularly. As a result, some parents want complete menstrual suppression, Dr. Thew said. The American Academy of Pediatrics outlines how to approach menstrual suppression through methods such as the use of estrogen-progestin, progesterone, a ring, or a patch. In late August, the American College of Obstetricians and Gynecologists released its clinical consensus on medical management of menstrual suppression.
  • Some parents want to know how to obtain a complete hysterectomy for the patient – an option Dr. Thew and the AAP discourage. “We will tell them that’s not the best and safest approach, as you want to have the estrogen for bone health,” she said.
  • After a discussion of all the options, an intrauterine device proves best for many. “That gives 7-8 years of protection,” she said, which is the approved effective duration for such devices. “They are less apt to have heavy monthly menstrual bleeding.”
  • Parents of boys with disabilities, especially those with Down syndrome, often ask for sex education and guidance when sexual desires develop.
  • Many parents want effective birth control for their children because of fear that their teen or young adult will be assaulted, a fear that isn’t groundless. Such cases are common, and caregivers frequently are the perpetrators.

Ms. Kayser, Dr. Horner-Johnson, and Dr. Thew have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The developmentally disabled girl was just 10 years old when Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee, helped care for her. Providing that care was not emotionally easy. “Her brother’s friend sexually assaulted her and impregnated her,” Dr. Thew said.

The girl was able to obtain an abortion, a decision her parents supported. The alternative could have been deadly. “She was a tiny little person and would not have been able to carry a fetus,” Dr. Thew, a nurse practitioner, said.

Dr. Thew said she’s thankful that tragic case occurred before 2022. After the United States Supreme Court overturned Roe v. Wade in June, Wisconsin reverted to an 1849 law banning abortion. Although the law is currently being challenged, Dr. Thew wonders how the situation would have played out now. (Weeks after the Supreme Court’s decision, a similar case occurred in Ohio. In that case, a 10-year-old girl had to travel out of the state to obtain an abortion after having been raped.)

Talking to adolescents and young adults about reproductive health, whether regarding an unexpected pregnancy, the need for contraception, or to provide information about sexual activity, can be a challenge even for experienced health care providers.

The talks, decisions, and care are particularly complex when patients have developmental and intellectual disabilities. Among the many factors, Dr. Thew said, are dealing with menstruation, finding the right contraceptives, and counseling parents who might not want to acknowledge their children’s emerging sexuality.
 

Statistics: How many?

Because the definitions of disabilities vary and they represent a spectrum, estimates for how many youth have intellectual or developmental disabilities range widely.

In 2019, the National Survey of Children’s Health found that 1 in 4 children and adolescents aged 12-17 years have special health care needs because of disability. The American Community Survey estimates more than 1.3 million people aged 16-20 have a disability.

Intellectual disabilities can occur when a person’s IQ is below 70, significantly impeding the ability to perform activities of daily living, such as eating, dressing, and communicating. Developmental disabilities are impairments in physical, learning, language, and behavior, according to the United States Centers for Disease Control and Prevention. Among the conditions are attention-deficit/hyperactivity disorder, autism spectrum disorders, fragile X syndrome, learning and language problems, spina bifida, and other conditions.
 

Addressing common issues, concerns

April Kayser is a health educator for the Multnomah County Health Department, Portland, Ore. In 2016, Ms. Kayser and other experts conducted interviews with 11 youth with developmental and intellectual disabilities and 34 support people, either parents or professionals who provide services. The survey was part of the SHEIDD Project – short for Sexual Health Equity for Individuals with Intellectual/Developmental Disabilities – at Oregon Health and Science University (OHSU).

From their findings, the researchers compiled guidelines. They provided scenarios that health care providers need to be aware of and that they need to be ready to address:

  • A boy, 14, who is unclear about what to do when he feels sexually excited and wants to masturbate but isn’t at home. He has been told that masturbation is appropriate in private.
  • A 20-year-old woman who lives in a group home is pregnant. She confesses to her parents during a visit that another resident is her boyfriend and that he is the father of the child she is expecting.
  • A 17-year-old boy wants to ask out another student, who is 15.
 

 

Some developmentally and intellectually disabled youth can’t turn to their parents for help. One person in the survey said his father told him, “You don’t need to worry about any of that stuff. You’re too young.” Another said the job of a health care provider was to offer reproductive and sex education “to make sure you don’t screw up in some bad way.”

One finding stood out: Health care providers were at the top of the list of those whom young people trusted for information about reproductive and sexual health, Ms. Kayser said. Yet in her experience, she said, health care professionals are hesitant to bring up the issues with all youth, “especially those with intellectual and developmental disabilities.”

Health care providers often talk both to the patient and to the parents. Those conversations can be critical when a child is developmentally or intellectually disabled.

Women with disabilities have been shown to have a higher risk for adverse outcomes of pregnancy, said Willi Horner-Johnson, PhD, associate professor at OHSU–Portland State University School of Public Health.

In a recent study, she and her colleagues analyzed data from the CDC’s National Survey of Family Growth that included self-reported disability status. They found that the number of women with disabilities who give birth is far higher than was previously thought.

The researchers found that 19.5% of respondents who gave birth reported at least one sensory, cognitive, or mobility-related disability, a rate that is much greater than the less than 1%-6.6% estimates that are based on hospital discharge data.

Her group reported other troubling findings: Women with disabilities are twice as likely to have smoked during their pregnancy (19% vs. 8.9%) and are more likely to have preterm and low-birthweight babies.
 

Clinicians play an important role

Dr. Horner-Johnson agreed with the finding from the Multnomah County survey that health care providers play an important role in providing those with intellectual and developmental disabilities reproductive health care that meets their needs. “Clinicians need to be asking people with disabilities about their reproductive plans,” she said.

In the Multnomah County report, the researchers advised health care providers to recognize that people with disabilities are social and sexual beings; to learn about their goals, including those regarding sex and reproductive health; and to help youth build skills for healthy relationships and sexual activity.

Dr. Horner-Johnson pointed out that the American College of Obstetricians and Gynecologists “recommends that clinicians discuss reproductive plans at every visit, for example, by asking one key question – ‘Would you like to become pregnant in the next year?’ – of every woman of reproductive age.”

Some women will not be able to answer that question, and health care providers at times must rely on a caregiver for input. But many women, even those with disabilities, could answer if given a chance. She estimated that only about 5% of disabled people are unable to communicate. “Clinicians defer to the caregiver more than they need to,” she said.

Clinicians are becoming better at providing care to those with disabilities, Dr. Horner-Johnson said, yet they have a way to go. Clinician biases may prevent some from asking all women, including those with disabilities, about their reproductive plans. “Women with disabilities have described clinicians treating them as nonsexual, assuming or implying that they would not or should not get pregnant,” she writes in her report.

Such biases, she said, could be reduced by increased education of providers. A 2018 study in Health Equity found that only 19.3% of ob.gyns. said they felt equipped to manage the pregnancy of a woman with disabilities.

Managing sexuality and sexual health for youth with disabilities can be highly complex, according to Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee. Challenges include the following:

  • Parents often can’t deal with the reality that their teen or young adult is sexually active or may become so. Parents she helps often prefer to use the term “hormones,” not contraceptives, when talking about pregnancy prevention.
  • Menstruation is a frequent concern, especially for youth with severe disabilities. Some react strongly to seeing a sanitary pad with blood, for example, by throwing it. Parents worry that caregivers will balk at changing pads regularly. As a result, some parents want complete menstrual suppression, Dr. Thew said. The American Academy of Pediatrics outlines how to approach menstrual suppression through methods such as the use of estrogen-progestin, progesterone, a ring, or a patch. In late August, the American College of Obstetricians and Gynecologists released its clinical consensus on medical management of menstrual suppression.
  • Some parents want to know how to obtain a complete hysterectomy for the patient – an option Dr. Thew and the AAP discourage. “We will tell them that’s not the best and safest approach, as you want to have the estrogen for bone health,” she said.
  • After a discussion of all the options, an intrauterine device proves best for many. “That gives 7-8 years of protection,” she said, which is the approved effective duration for such devices. “They are less apt to have heavy monthly menstrual bleeding.”
  • Parents of boys with disabilities, especially those with Down syndrome, often ask for sex education and guidance when sexual desires develop.
  • Many parents want effective birth control for their children because of fear that their teen or young adult will be assaulted, a fear that isn’t groundless. Such cases are common, and caregivers frequently are the perpetrators.

Ms. Kayser, Dr. Horner-Johnson, and Dr. Thew have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Dermatologists fear effects of Dobbs decision for patients on isotretinoin, methotrexate

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Mon, 10/17/2022 - 08:02

More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, dermatologists who prescribe isotretinoin, a teratogenic drug used to treat severe nodular acne, say they worry even more than in the past about their patients and the risk of accidental pregnancies. Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.

The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.

As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.

Dr. Ilona J. Frieden

“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.

The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.

Dr. Marc Kaufmann

But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”

The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
 

Methotrexate prescriptions

Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.

The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”



“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”

The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.

Perspective: A Georgia dermatologist

Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.

Dr. Howa Yeung

That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.

In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.

Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”

Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
 

Perspective: An Arizona dermatologist

Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.

And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.

Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
 

Perspective: A Connecticut dermatologist

The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.

Dr. Jane Grant-Kels

Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”

For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.

Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”

Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
 

Need for EC education

In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.

The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.

Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, dermatologists who prescribe isotretinoin, a teratogenic drug used to treat severe nodular acne, say they worry even more than in the past about their patients and the risk of accidental pregnancies. Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.

The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.

As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.

Dr. Ilona J. Frieden

“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.

The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.

Dr. Marc Kaufmann

But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”

The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
 

Methotrexate prescriptions

Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.

The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”



“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”

The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.

Perspective: A Georgia dermatologist

Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.

Dr. Howa Yeung

That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.

In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.

Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”

Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
 

Perspective: An Arizona dermatologist

Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.

And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.

Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
 

Perspective: A Connecticut dermatologist

The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.

Dr. Jane Grant-Kels

Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”

For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.

Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”

Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
 

Need for EC education

In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.

The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.

Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, dermatologists who prescribe isotretinoin, a teratogenic drug used to treat severe nodular acne, say they worry even more than in the past about their patients and the risk of accidental pregnancies. Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.

The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.

As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.

Dr. Ilona J. Frieden

“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.

The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.

Dr. Marc Kaufmann

But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”

The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
 

Methotrexate prescriptions

Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.

The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”



“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”

The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.

Perspective: A Georgia dermatologist

Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.

Dr. Howa Yeung

That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.

In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.

Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”

Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
 

Perspective: An Arizona dermatologist

Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.

And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.

Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
 

Perspective: A Connecticut dermatologist

The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.

Dr. Jane Grant-Kels

Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”

For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.

Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”

Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
 

Need for EC education

In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.

The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.

Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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2022 Update on contraception

Article Type
Changed
Tue, 10/25/2022 - 19:42

 

On June 24, 2022, the US Supreme Court ruled in Dobbs v Jackson to overturn the landmark Roe v Wade decision, deeming that abortion is not protected by statutes that provide the right to privacy, liberty, or autonomy. With this historic ruling, other rights founded on the same principles, including the freedom to use contraception, may be called into question in the future. Clinics that provide abortion care typically play a vital role in providing contraception services. Due to abortion restriction across the country, many of these clinics are predicted to close and many have already closed. Within one month of the Dobbs decision, 43 clinics in 11 states had shut their doors to patients, reducing access to basic contraception services.1 It is more important now than ever that clinicians address barriers and lead the effort to improve and ensure that patients have access to contraceptive services.

In this Update, we review recent evidence that may help aid patients in obtaining contraception more easily and for longer periods of time. We review strategies demonstrated to improve contraceptive access, including how to increase prescribing rates of 1-year contraceptive supplies and pharmacist-prescribed contraception. We also review new data on extended use of the levonorgestrel 52 mg intrauterine device (LNG 52 mg IUD).

 

One-year prescribing of  hormonal contraception  decreases an access barrier

Uhm S, Chen MJ, Cutler ED, et al. Twelve-month prescribing of contraceptive pill, patch, and ring before and after a standardized electronic medical record order change. Contraception. 2021;103:60-63.

Providing a 1-year supply of self-administered contraception can lead to higher likelihood of continued use and is associated with reduced cost, unintended pregnancy, and abortion rates.2-4 Although some patients may not use a full year’s supply of pills, rings, or patches under such programs, the lower rates of unintended pregnancy result in significant cost savings as compared with the unused contraceptives.2,3 Accordingly, the Centers for Disease Control and Prevention (CDC) advises dispensing a 1-year supply of self-administered hormonal contraception.5 Insurance coverage and providers’ prescribing practices can be barriers to patients obtaining a year’s supply of hormonal contraception. Currently, 18 states and the District of Columbia legally require insurers to cover a 12-month supply of prescription contraceptives (FIGURE 1). Despite these laws and the CDC recommendation, studies show that most people continue to receive only a 1- to 3-month supply.6-8 One strategy to increase the number of 1-year supplies of self-administered contraception is institutional changes to default prescription orders.

Study design

In California, legislation enacted in January 2017 required commercial and medical assistance health plans to cover up to  12 months of US Food and Drug Administration (FDA)-approved self-administered hormonal contraceptives dispensed at 1 time as prescribed or requested. To better serve patients, a multidisciplinary team from the University of California Davis Health worked with the institution’s pharmacy to institute an electronic medical record (EMR) default order change from dispensing 1-month with refills to dispensing 12-month quantities for all combined and progestin-only pills, patches, and rings on formulary.

After this EMR order change in December 2019, Uhm and colleagues conducted a retrospective pre-post study using outpatient prescription data that included nearly  5,000 contraceptive pill, patch, and ring prescriptions over an 8-month period. They compared the frequency of 12-month prescriptions for each of these methods 4 months before and 4 months after the default order change. They compared the proportion of 12-month prescriptions by prescriber department affiliation and by clinic location. Department affiliation was categorized as obstetrics-gynecology or non–obstetrics-gynecology. Clinic location was categorized as medical center campus or community clinics.

Increase in 12-month prescriptions

The authors found an overall increase in 12-month prescriptions, from 11% to 27%, after the EMR order change. Prescribers at the medical center campus clinics more frequently ordered a 12-month supply compared with prescribers at community clinics both before (33% vs 4%, respectively) and after (53% vs 19%, respectively) the EMR change. The only group of providers without a significant increase in 12-month prescriptions was among obstetrics-gynecology providers at community clinics (4% before  vs 6% after).

The system EMR change modified only the standard facility order settings and did not affect individual favorite orders, which may help explain the differences in prescribing practices. While this study found an increase in 12-month prescriptions, there were no data on the actual number of supplies a patient received or  on reimbursement.

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
The study by Uhm and colleagues showed that making a relatively simple change to default EMR orders can increase 12-month contraception prescribing and lead to greater patient-centered care. Evidence shows that providers and pharmacists are not necessarily aware of laws that require 12-month supply coverage and routinely prescribe smaller supplies.6,7,9 For clinicians in states that have these laws (FIGURE 1), we urge you to provide as full a supply of contraceptives as possible as this approach is both evidence based and patient centered. Although this study shows the benefit of universal system change to the EMR, individual clinicians also must be sure to modify personal order preferences. In addition, pharmacists can play an important role by updating policies that comply with these laws and by increasing pharmacy stocks of contraception supplies.7 For those living in states that do not currently have these laws, we encourage you to reach out to your legislators to advocate for similar laws as the data show clear medical and cost benefits for patients and society.

 Continue to: Pharmacist prescription of  hormonal contraception is safe and promotes continuation...

 

 

Pharmacist prescription of  hormonal contraception is safe and promotes continuation

Rodriguez MI, Skye M, Edelman AB, et al. Association of pharmacist prescription and 12-month contraceptive continuation rates. Am J Obstet Gynecol. 2021;225:647.e1-647.e9.

Patients often face difficulty obtaining both new and timely refills of self-administered contraception.10,11 To expand contraception access, Oregon became the first state (in 2016) to enact legislation to authorize direct pharmacist prescribing of hormonal contraceptives.12 Currently, 17 states and the District of Columbia have protocols for pharmacist prescribing privileges (FIGURE 2), and proposed legislation is pending in another  14 states.10,12 These protocols vary, but basic processes include screening, documentation, monitoring, and referrals when necessary. Typically, protocols require a pharmacist to review a patient’s medical history, pregnancy status, medication use, and blood pressure, followed by contraceptive counseling.10 Pharmacies are generally located in the community they serve, have extended hours, and usually do not require an appointment.8,13,14

Pharmacist prescribing increases the number of new contraceptive users, and pharmacists are more likely to prescribe a 6-month or longer supply of contraceptives compared with clinicians.8,13,15 Also, pharmacist prescribing is safe, with adherence rates to the CDC’s US Medical Eligibility Criteria for Contraceptive Use similar to those of prescriptions provided by a clinician.13

Authors of a recent multi-state study further assessed the impact of pharmacist prescribing by evaluating 12-month continuation and perfect use rates.

Study design

Rodriguez and colleagues evaluated the results of a 1-year prospective cohort study conducted in 2019 that included 388 participants who sought contraception in California, Colorado, Hawaii, and Oregon. All these states had laws permitting pharmacist prescribing and 12-month supply of hormonal contraception. Participants received prescriptions directly from a pharmacist at 1 of 139 pharmacies (n = 149) or filled a prescription provided by a clinician (n = 239). The primary outcomes were continuation of an effective method and perfect use of contraception across 12 months.

Participant demographics were similar between the 2 groups except for education and insurance status. Participants who received a prescription from a clinician reported higher levels of education. A greater proportion of uninsured participants received a prescription from a pharmacist (11%) compared with from a clinician (3%).

Contraceptive continuation rates

Participants were surveyed 3 times during the 12-month study about their current contraceptive method, if they had switched methods, or if they had any missed days  of contraception. 

Overall, 340 participants (88%) completed a full 12 months of follow-up. Continuation rates were similar between the 2 groups: 89% in the clinician-prescribed and 90% in the pharmacist-prescribed group (P=.86). Participants in the 2 groups also reported similar rates of perfect use (no missed days: 54% and 47%, respectively [P=.69]).  Additionally, the authors reported that  29 participants changed from a tier 2 (pill, patch, ring, injection) to a tier 1 (intrauterine device or implant) method during follow-up, with no difference in switch rates for participants who received care from a clinician (10%) or a pharmacist (7%).

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Patients have difficulties in obtaining both an initial contraceptive prescription and refills in time to avoid breaks in coverage.16 Pharmacist prescription of contraception is a proven strategy to increase access to contraception for new users or to promote continuation among current users. This practice is evidence based, decreases unintended pregnancy rates, and is safe.8,13,15,17

Promoting universal pharmacist prescribing is even more important given the overruling of Roe v Wade. With abortion restrictions, many family planning clinics that also play a vital role in providing contraception will close. Most states that are limiting abortion care (FIGURE 3) are the same states without pharmacist-prescribing provisions (FIGURE 2). As patient advocates, we need to continue to support this evidence-based practice in states where it is available and push legislators in states where it is not. Pharmacists should receive support to complete the training and certification needed to not only provide this service but also to receive appropriate reimbursements. Restrictions, such as requiring patients to be 18 years or older or to have prior consultation with a physician, should be limited as these are not necessary to provide self-administered contraception safely. Clinicians and pharmacists should inform patients, in states where this is available, that they can access initial or refill prescriptions at their local pharmacy if that is more convenient or their preference. Clinicians who live in states without these laws can advocate for their community by encouraging their legislators to pass laws that allow this evidence-based practice.

Continue to: LNG 52 mg IUD demonstrates  efficacy and safety through 8 years of use... 

 

 

LNG 52 mg IUD demonstrates  efficacy and safety through 8 years of use 

Creinin MD, Schreiber CA, Turok DK, et al. Levonorgestrel 52 mg intrauterine system efficacy and safety through 8 years of use. Am J Obstet Gynecol. 2022;S00029378(22)00366-0.

Given the potential difficulty accessing contraceptive and abortion services due to state restrictions, patients may be more motivated to maintain long-acting reversible contraceptives for maximum periods of time. The LNG 52 mg IUD was first marketed as a 5-year product, but multiple studies suggested that it had potential longer duration of efficacy and safety.18,19 The most recent clinical trial report shows that the LNG 52 mg IUD has at least 8 years of efficacy  and safety.

Evidence supports 8 years’ use

The ACCESS IUS (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) phase 3 trial was designed to assess the safety and efficacy of a LNG 52 mg IUD (Liletta) for up to 10 years of use. The recent publication by Creinin and colleagues extends the available data from this study from 6 to 8 years.

Five-hundred and sixty-nine participants started year 7; 478 completed year 7 and 343 completed year 8 by the time the study was discontinued. Two pregnancies occurred in year 7 and no pregnancies occurred in year 8. One of the pregnancies in year 7 was determined by ultrasound examination to have implantation on day 4 after LNG IUD removal. According to the FDA, any pregnancy that occurs within 7 days of discontinuation is included as on-treatment, whereas the European Medicines Agency (EMA) has a 2-day cutoff. Over 8 years,  11 pregnancies occurred. The cumulative life-table pregnancy rate in the primary efficacy population through year 8 was 1.32% (95% confidence interval [CI],  0.69–2.51) under FDA rules and 1.09% (95% CI,  0.56–2.13) according to EMA guidance.

Absence of bleeding/spotting rates and adverse events

Rates of absence of bleeding/spotting remained relatively stable in years 7 and 8 at around 40%, similar to the rates during years 3 to 8 (FIGURE 4). Overall, only 2.6% of participants discontinued LNG IUD use because of bleeding problems, with a total of 4 participants discontinuing for this reason in years 7 and 8. Expulsion rates remained low at a rate of approximately 0.5% in years 7 and 8. Vulvovaginal infections were the most common adverse effect during year 7–8 of use. These findings are consistent with those found at  6 years.20

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
As abortion and contraception services become more difficult to access, patients may be more motivated to initiate or maintain an intrauterine device for longer. The ACCESS IUS trial provides contemporary data that are generalizable across the US population. Clinicians should educate patients about the efficacy, low incidence of new adverse events, and the steady rate at which patients experience absence of bleeding/spotting. The most recent data analysis supports continued use of LNG 52 mg IUD products for up to 8 years with an excellent extended safety profile. While some providers may express concern that patients may experience more bleeding with prolonged use, this study demonstrated low discontinuation rates due to bleeding in years 7 and 8. Perforations were diagnosed only during the first year, meaning that they most likely are related to the insertion process. Additionally, in this long-term study, expulsions occurred most frequently in the first year after placement. This study, which shows that the LNG IUD can continue to be used for longer than before, is important because it means that many patients will need fewer removals and reinsertions over their lifetime, reducing a patient’s risks and discomfort associated with these procedures. Sharing these data is important, as longer LNG IUD retention may reduce burdens faced by patients who desire long-acting reversible contraception.
References
  1. Kirstein M, Jones RK, Philbin J. One month post-Roe: at least 43 abortion clinics across 11 states have stopped offering abortion care. Guttmacher Institute. July 28, 2022. Accessed September 14, 2022. https://www.guttmacher.org /article/2022/07/one-month-post-roe-least-43-abortion-clinics-across -11-states-have-stopped-offering
  2. Foster DG, Hulett D, Bradsberry M, et al. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol. 2011;117:566-572.
  3. Foster DG, Parvataneni R, de Bocanegra HT, et al. Number of oral contraceptive pill packages dispensed, method continuation, and costs. Obstet Gynecol. 2006;108:1107-114.
  4. Niu F, Cornelius J, Aboubechara N, et al. Real world outcomes related to providing an annual supply of short-acting hormonal contraceptives. Contraception. 2022;107:58-61.
  5. Curtis KM, Jatlaoui TC, Tepper NK, et al. US selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep. 2016;65:1-66.
  6. Women’s sexual and reproductive health services: key findings from the 2017 Kaiser Women’s Health Survey. KFF: Kaiser Family Foundation. March 13, 2018. Accessed September 14, 2022. https://www.kff.org/womens-health-policy /issue-brief/womens-sexual-and-reproductive-health-services-key-findings -from-the-2017-kaiser-womens-health-survey/
  7. Nikpour G, Allen A, Rafie S, et al. Pharmacy implementation of a new law allowing year-long hormonal contraception supplies. Pharmacy (Basel). 2020;8:E165.
  8. Rodriguez MI, Edelman AB, Skye M, et al. Association of pharmacist prescription with dispensed duration of hormonal contraception. JAMA Netw Open. 2020;3:e205252.
  9. Insurance coverage of contraceptives. Guttmacher Institute. Updated August 1, 2022. Accessed September 14, 2022. https://www.guttmacher.org/state-policy /explore/insurance-coverage-contraceptives
  10. Chim C, Sharma P. Pharmacists prescribing hormonal contraceptives: a status update. US Pharm. 2021;46:45-49.
  11. Rodriguez MI, Hersh A, Anderson LB, et al. Association of pharmacist prescription of hormonal contraception with unintended pregnancies and Medicaid costs. Obstet Gynecol. 2019;133:1238-1246.
  12. Pharmacist-prescribed contraceptives. Guttmacher Institute. Updated August 1, 2022. Accessed September 14, 2022. https://www.guttmacher.org/state -policy/explore/pharmacist-prescribed-contraceptives
  13. Anderson L, Hartung DM, Middleton L, et al. Pharmacist provision of hormonal contraception in the Oregon Medicaid population. Obstet Gynecol. 2019;133:1231-1237.
  14. Rodriguez MI, Edelman AB, Skye M, et al. Reasons for and experience in obtaining pharmacist prescribed contraception. Contraception. 2020;102:259-261.
  15. Rodriguez MI, Manibusan B, Kaufman M, et al. Association of pharmacist prescription of contraception with breaks in coverage. Obstet Gynecol. 2022;139:781-787.
  16. Pittman ME, Secura GM, Allsworth JE, et al. Understanding prescription adherence: pharmacy claims data from the Contraceptive CHOICE Project. Contraception. 2011;83:340-345.
  17. Rodriguez MI, Skye M, Edelman AB, et al. Association of pharmacist prescription and 12-month contraceptive continuation rates. Am J Obstet Gynecol. 2021;225:647.e1-647.e9.
  18. Secura GM, Allsworth JE, Madden T, et al. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010;203:115.e1-7.
  19. Rowe P, Farley T, Peregoudov A, et al. Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A. Contraception. 2016;93:498-506.
  20. Westhoff CL, Keder LM, Gangestad A, et al. Six-year contraceptive efficacy and continued safety of a levonorgestrel 52 mg intrauterine system. Contraception. 2020;101:159-161.
Article PDF
Author and Disclosure Information

Jewel Brown, MD

Dr. Brown is a Complex Family Planning Fellow, Department of Obstetrics and Gynecology, University of California, Davis, Sacramento.

Mitchell D. Creinin, MD

Dr. Creinin is Professor and Director of the Complex Family Planning Fellowship, Department of Obstetrics and Gynecology, University of California, Davis, Sacramento.

Dr. Creinin reports that he has received speaking honorarium from Mayne and Organon, serves on an Advisory Board for Gedeon Richter, GlaxoSmithKline, OLIC, and Organon, and is a consultant for Estetra SPRL, FHI 360, Mayne, and Medicines360. Dr. Brown reports no financial relationships relevant to this article.

The Department of Obstetrics and Gynecology, University of California, Davis, receives contraceptive research funding for Dr. Creinin from Chemo Research SL, Evofem, Medicines360, Merck, Sebela, NIH/NICHD, and the Society of Family Planning.

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Jewel Brown, MD

Dr. Brown is a Complex Family Planning Fellow, Department of Obstetrics and Gynecology, University of California, Davis, Sacramento.

Mitchell D. Creinin, MD

Dr. Creinin is Professor and Director of the Complex Family Planning Fellowship, Department of Obstetrics and Gynecology, University of California, Davis, Sacramento.

Dr. Creinin reports that he has received speaking honorarium from Mayne and Organon, serves on an Advisory Board for Gedeon Richter, GlaxoSmithKline, OLIC, and Organon, and is a consultant for Estetra SPRL, FHI 360, Mayne, and Medicines360. Dr. Brown reports no financial relationships relevant to this article.

The Department of Obstetrics and Gynecology, University of California, Davis, receives contraceptive research funding for Dr. Creinin from Chemo Research SL, Evofem, Medicines360, Merck, Sebela, NIH/NICHD, and the Society of Family Planning.

Author and Disclosure Information

Jewel Brown, MD

Dr. Brown is a Complex Family Planning Fellow, Department of Obstetrics and Gynecology, University of California, Davis, Sacramento.

Mitchell D. Creinin, MD

Dr. Creinin is Professor and Director of the Complex Family Planning Fellowship, Department of Obstetrics and Gynecology, University of California, Davis, Sacramento.

Dr. Creinin reports that he has received speaking honorarium from Mayne and Organon, serves on an Advisory Board for Gedeon Richter, GlaxoSmithKline, OLIC, and Organon, and is a consultant for Estetra SPRL, FHI 360, Mayne, and Medicines360. Dr. Brown reports no financial relationships relevant to this article.

The Department of Obstetrics and Gynecology, University of California, Davis, receives contraceptive research funding for Dr. Creinin from Chemo Research SL, Evofem, Medicines360, Merck, Sebela, NIH/NICHD, and the Society of Family Planning.

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On June 24, 2022, the US Supreme Court ruled in Dobbs v Jackson to overturn the landmark Roe v Wade decision, deeming that abortion is not protected by statutes that provide the right to privacy, liberty, or autonomy. With this historic ruling, other rights founded on the same principles, including the freedom to use contraception, may be called into question in the future. Clinics that provide abortion care typically play a vital role in providing contraception services. Due to abortion restriction across the country, many of these clinics are predicted to close and many have already closed. Within one month of the Dobbs decision, 43 clinics in 11 states had shut their doors to patients, reducing access to basic contraception services.1 It is more important now than ever that clinicians address barriers and lead the effort to improve and ensure that patients have access to contraceptive services.

In this Update, we review recent evidence that may help aid patients in obtaining contraception more easily and for longer periods of time. We review strategies demonstrated to improve contraceptive access, including how to increase prescribing rates of 1-year contraceptive supplies and pharmacist-prescribed contraception. We also review new data on extended use of the levonorgestrel 52 mg intrauterine device (LNG 52 mg IUD).

 

One-year prescribing of  hormonal contraception  decreases an access barrier

Uhm S, Chen MJ, Cutler ED, et al. Twelve-month prescribing of contraceptive pill, patch, and ring before and after a standardized electronic medical record order change. Contraception. 2021;103:60-63.

Providing a 1-year supply of self-administered contraception can lead to higher likelihood of continued use and is associated with reduced cost, unintended pregnancy, and abortion rates.2-4 Although some patients may not use a full year’s supply of pills, rings, or patches under such programs, the lower rates of unintended pregnancy result in significant cost savings as compared with the unused contraceptives.2,3 Accordingly, the Centers for Disease Control and Prevention (CDC) advises dispensing a 1-year supply of self-administered hormonal contraception.5 Insurance coverage and providers’ prescribing practices can be barriers to patients obtaining a year’s supply of hormonal contraception. Currently, 18 states and the District of Columbia legally require insurers to cover a 12-month supply of prescription contraceptives (FIGURE 1). Despite these laws and the CDC recommendation, studies show that most people continue to receive only a 1- to 3-month supply.6-8 One strategy to increase the number of 1-year supplies of self-administered contraception is institutional changes to default prescription orders.

Study design

In California, legislation enacted in January 2017 required commercial and medical assistance health plans to cover up to  12 months of US Food and Drug Administration (FDA)-approved self-administered hormonal contraceptives dispensed at 1 time as prescribed or requested. To better serve patients, a multidisciplinary team from the University of California Davis Health worked with the institution’s pharmacy to institute an electronic medical record (EMR) default order change from dispensing 1-month with refills to dispensing 12-month quantities for all combined and progestin-only pills, patches, and rings on formulary.

After this EMR order change in December 2019, Uhm and colleagues conducted a retrospective pre-post study using outpatient prescription data that included nearly  5,000 contraceptive pill, patch, and ring prescriptions over an 8-month period. They compared the frequency of 12-month prescriptions for each of these methods 4 months before and 4 months after the default order change. They compared the proportion of 12-month prescriptions by prescriber department affiliation and by clinic location. Department affiliation was categorized as obstetrics-gynecology or non–obstetrics-gynecology. Clinic location was categorized as medical center campus or community clinics.

Increase in 12-month prescriptions

The authors found an overall increase in 12-month prescriptions, from 11% to 27%, after the EMR order change. Prescribers at the medical center campus clinics more frequently ordered a 12-month supply compared with prescribers at community clinics both before (33% vs 4%, respectively) and after (53% vs 19%, respectively) the EMR change. The only group of providers without a significant increase in 12-month prescriptions was among obstetrics-gynecology providers at community clinics (4% before  vs 6% after).

The system EMR change modified only the standard facility order settings and did not affect individual favorite orders, which may help explain the differences in prescribing practices. While this study found an increase in 12-month prescriptions, there were no data on the actual number of supplies a patient received or  on reimbursement.

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
The study by Uhm and colleagues showed that making a relatively simple change to default EMR orders can increase 12-month contraception prescribing and lead to greater patient-centered care. Evidence shows that providers and pharmacists are not necessarily aware of laws that require 12-month supply coverage and routinely prescribe smaller supplies.6,7,9 For clinicians in states that have these laws (FIGURE 1), we urge you to provide as full a supply of contraceptives as possible as this approach is both evidence based and patient centered. Although this study shows the benefit of universal system change to the EMR, individual clinicians also must be sure to modify personal order preferences. In addition, pharmacists can play an important role by updating policies that comply with these laws and by increasing pharmacy stocks of contraception supplies.7 For those living in states that do not currently have these laws, we encourage you to reach out to your legislators to advocate for similar laws as the data show clear medical and cost benefits for patients and society.

 Continue to: Pharmacist prescription of  hormonal contraception is safe and promotes continuation...

 

 

Pharmacist prescription of  hormonal contraception is safe and promotes continuation

Rodriguez MI, Skye M, Edelman AB, et al. Association of pharmacist prescription and 12-month contraceptive continuation rates. Am J Obstet Gynecol. 2021;225:647.e1-647.e9.

Patients often face difficulty obtaining both new and timely refills of self-administered contraception.10,11 To expand contraception access, Oregon became the first state (in 2016) to enact legislation to authorize direct pharmacist prescribing of hormonal contraceptives.12 Currently, 17 states and the District of Columbia have protocols for pharmacist prescribing privileges (FIGURE 2), and proposed legislation is pending in another  14 states.10,12 These protocols vary, but basic processes include screening, documentation, monitoring, and referrals when necessary. Typically, protocols require a pharmacist to review a patient’s medical history, pregnancy status, medication use, and blood pressure, followed by contraceptive counseling.10 Pharmacies are generally located in the community they serve, have extended hours, and usually do not require an appointment.8,13,14

Pharmacist prescribing increases the number of new contraceptive users, and pharmacists are more likely to prescribe a 6-month or longer supply of contraceptives compared with clinicians.8,13,15 Also, pharmacist prescribing is safe, with adherence rates to the CDC’s US Medical Eligibility Criteria for Contraceptive Use similar to those of prescriptions provided by a clinician.13

Authors of a recent multi-state study further assessed the impact of pharmacist prescribing by evaluating 12-month continuation and perfect use rates.

Study design

Rodriguez and colleagues evaluated the results of a 1-year prospective cohort study conducted in 2019 that included 388 participants who sought contraception in California, Colorado, Hawaii, and Oregon. All these states had laws permitting pharmacist prescribing and 12-month supply of hormonal contraception. Participants received prescriptions directly from a pharmacist at 1 of 139 pharmacies (n = 149) or filled a prescription provided by a clinician (n = 239). The primary outcomes were continuation of an effective method and perfect use of contraception across 12 months.

Participant demographics were similar between the 2 groups except for education and insurance status. Participants who received a prescription from a clinician reported higher levels of education. A greater proportion of uninsured participants received a prescription from a pharmacist (11%) compared with from a clinician (3%).

Contraceptive continuation rates

Participants were surveyed 3 times during the 12-month study about their current contraceptive method, if they had switched methods, or if they had any missed days  of contraception. 

Overall, 340 participants (88%) completed a full 12 months of follow-up. Continuation rates were similar between the 2 groups: 89% in the clinician-prescribed and 90% in the pharmacist-prescribed group (P=.86). Participants in the 2 groups also reported similar rates of perfect use (no missed days: 54% and 47%, respectively [P=.69]).  Additionally, the authors reported that  29 participants changed from a tier 2 (pill, patch, ring, injection) to a tier 1 (intrauterine device or implant) method during follow-up, with no difference in switch rates for participants who received care from a clinician (10%) or a pharmacist (7%).

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Patients have difficulties in obtaining both an initial contraceptive prescription and refills in time to avoid breaks in coverage.16 Pharmacist prescription of contraception is a proven strategy to increase access to contraception for new users or to promote continuation among current users. This practice is evidence based, decreases unintended pregnancy rates, and is safe.8,13,15,17

Promoting universal pharmacist prescribing is even more important given the overruling of Roe v Wade. With abortion restrictions, many family planning clinics that also play a vital role in providing contraception will close. Most states that are limiting abortion care (FIGURE 3) are the same states without pharmacist-prescribing provisions (FIGURE 2). As patient advocates, we need to continue to support this evidence-based practice in states where it is available and push legislators in states where it is not. Pharmacists should receive support to complete the training and certification needed to not only provide this service but also to receive appropriate reimbursements. Restrictions, such as requiring patients to be 18 years or older or to have prior consultation with a physician, should be limited as these are not necessary to provide self-administered contraception safely. Clinicians and pharmacists should inform patients, in states where this is available, that they can access initial or refill prescriptions at their local pharmacy if that is more convenient or their preference. Clinicians who live in states without these laws can advocate for their community by encouraging their legislators to pass laws that allow this evidence-based practice.

Continue to: LNG 52 mg IUD demonstrates  efficacy and safety through 8 years of use... 

 

 

LNG 52 mg IUD demonstrates  efficacy and safety through 8 years of use 

Creinin MD, Schreiber CA, Turok DK, et al. Levonorgestrel 52 mg intrauterine system efficacy and safety through 8 years of use. Am J Obstet Gynecol. 2022;S00029378(22)00366-0.

Given the potential difficulty accessing contraceptive and abortion services due to state restrictions, patients may be more motivated to maintain long-acting reversible contraceptives for maximum periods of time. The LNG 52 mg IUD was first marketed as a 5-year product, but multiple studies suggested that it had potential longer duration of efficacy and safety.18,19 The most recent clinical trial report shows that the LNG 52 mg IUD has at least 8 years of efficacy  and safety.

Evidence supports 8 years’ use

The ACCESS IUS (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) phase 3 trial was designed to assess the safety and efficacy of a LNG 52 mg IUD (Liletta) for up to 10 years of use. The recent publication by Creinin and colleagues extends the available data from this study from 6 to 8 years.

Five-hundred and sixty-nine participants started year 7; 478 completed year 7 and 343 completed year 8 by the time the study was discontinued. Two pregnancies occurred in year 7 and no pregnancies occurred in year 8. One of the pregnancies in year 7 was determined by ultrasound examination to have implantation on day 4 after LNG IUD removal. According to the FDA, any pregnancy that occurs within 7 days of discontinuation is included as on-treatment, whereas the European Medicines Agency (EMA) has a 2-day cutoff. Over 8 years,  11 pregnancies occurred. The cumulative life-table pregnancy rate in the primary efficacy population through year 8 was 1.32% (95% confidence interval [CI],  0.69–2.51) under FDA rules and 1.09% (95% CI,  0.56–2.13) according to EMA guidance.

Absence of bleeding/spotting rates and adverse events

Rates of absence of bleeding/spotting remained relatively stable in years 7 and 8 at around 40%, similar to the rates during years 3 to 8 (FIGURE 4). Overall, only 2.6% of participants discontinued LNG IUD use because of bleeding problems, with a total of 4 participants discontinuing for this reason in years 7 and 8. Expulsion rates remained low at a rate of approximately 0.5% in years 7 and 8. Vulvovaginal infections were the most common adverse effect during year 7–8 of use. These findings are consistent with those found at  6 years.20

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
As abortion and contraception services become more difficult to access, patients may be more motivated to initiate or maintain an intrauterine device for longer. The ACCESS IUS trial provides contemporary data that are generalizable across the US population. Clinicians should educate patients about the efficacy, low incidence of new adverse events, and the steady rate at which patients experience absence of bleeding/spotting. The most recent data analysis supports continued use of LNG 52 mg IUD products for up to 8 years with an excellent extended safety profile. While some providers may express concern that patients may experience more bleeding with prolonged use, this study demonstrated low discontinuation rates due to bleeding in years 7 and 8. Perforations were diagnosed only during the first year, meaning that they most likely are related to the insertion process. Additionally, in this long-term study, expulsions occurred most frequently in the first year after placement. This study, which shows that the LNG IUD can continue to be used for longer than before, is important because it means that many patients will need fewer removals and reinsertions over their lifetime, reducing a patient’s risks and discomfort associated with these procedures. Sharing these data is important, as longer LNG IUD retention may reduce burdens faced by patients who desire long-acting reversible contraception.

 

On June 24, 2022, the US Supreme Court ruled in Dobbs v Jackson to overturn the landmark Roe v Wade decision, deeming that abortion is not protected by statutes that provide the right to privacy, liberty, or autonomy. With this historic ruling, other rights founded on the same principles, including the freedom to use contraception, may be called into question in the future. Clinics that provide abortion care typically play a vital role in providing contraception services. Due to abortion restriction across the country, many of these clinics are predicted to close and many have already closed. Within one month of the Dobbs decision, 43 clinics in 11 states had shut their doors to patients, reducing access to basic contraception services.1 It is more important now than ever that clinicians address barriers and lead the effort to improve and ensure that patients have access to contraceptive services.

In this Update, we review recent evidence that may help aid patients in obtaining contraception more easily and for longer periods of time. We review strategies demonstrated to improve contraceptive access, including how to increase prescribing rates of 1-year contraceptive supplies and pharmacist-prescribed contraception. We also review new data on extended use of the levonorgestrel 52 mg intrauterine device (LNG 52 mg IUD).

 

One-year prescribing of  hormonal contraception  decreases an access barrier

Uhm S, Chen MJ, Cutler ED, et al. Twelve-month prescribing of contraceptive pill, patch, and ring before and after a standardized electronic medical record order change. Contraception. 2021;103:60-63.

Providing a 1-year supply of self-administered contraception can lead to higher likelihood of continued use and is associated with reduced cost, unintended pregnancy, and abortion rates.2-4 Although some patients may not use a full year’s supply of pills, rings, or patches under such programs, the lower rates of unintended pregnancy result in significant cost savings as compared with the unused contraceptives.2,3 Accordingly, the Centers for Disease Control and Prevention (CDC) advises dispensing a 1-year supply of self-administered hormonal contraception.5 Insurance coverage and providers’ prescribing practices can be barriers to patients obtaining a year’s supply of hormonal contraception. Currently, 18 states and the District of Columbia legally require insurers to cover a 12-month supply of prescription contraceptives (FIGURE 1). Despite these laws and the CDC recommendation, studies show that most people continue to receive only a 1- to 3-month supply.6-8 One strategy to increase the number of 1-year supplies of self-administered contraception is institutional changes to default prescription orders.

Study design

In California, legislation enacted in January 2017 required commercial and medical assistance health plans to cover up to  12 months of US Food and Drug Administration (FDA)-approved self-administered hormonal contraceptives dispensed at 1 time as prescribed or requested. To better serve patients, a multidisciplinary team from the University of California Davis Health worked with the institution’s pharmacy to institute an electronic medical record (EMR) default order change from dispensing 1-month with refills to dispensing 12-month quantities for all combined and progestin-only pills, patches, and rings on formulary.

After this EMR order change in December 2019, Uhm and colleagues conducted a retrospective pre-post study using outpatient prescription data that included nearly  5,000 contraceptive pill, patch, and ring prescriptions over an 8-month period. They compared the frequency of 12-month prescriptions for each of these methods 4 months before and 4 months after the default order change. They compared the proportion of 12-month prescriptions by prescriber department affiliation and by clinic location. Department affiliation was categorized as obstetrics-gynecology or non–obstetrics-gynecology. Clinic location was categorized as medical center campus or community clinics.

Increase in 12-month prescriptions

The authors found an overall increase in 12-month prescriptions, from 11% to 27%, after the EMR order change. Prescribers at the medical center campus clinics more frequently ordered a 12-month supply compared with prescribers at community clinics both before (33% vs 4%, respectively) and after (53% vs 19%, respectively) the EMR change. The only group of providers without a significant increase in 12-month prescriptions was among obstetrics-gynecology providers at community clinics (4% before  vs 6% after).

The system EMR change modified only the standard facility order settings and did not affect individual favorite orders, which may help explain the differences in prescribing practices. While this study found an increase in 12-month prescriptions, there were no data on the actual number of supplies a patient received or  on reimbursement.

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
The study by Uhm and colleagues showed that making a relatively simple change to default EMR orders can increase 12-month contraception prescribing and lead to greater patient-centered care. Evidence shows that providers and pharmacists are not necessarily aware of laws that require 12-month supply coverage and routinely prescribe smaller supplies.6,7,9 For clinicians in states that have these laws (FIGURE 1), we urge you to provide as full a supply of contraceptives as possible as this approach is both evidence based and patient centered. Although this study shows the benefit of universal system change to the EMR, individual clinicians also must be sure to modify personal order preferences. In addition, pharmacists can play an important role by updating policies that comply with these laws and by increasing pharmacy stocks of contraception supplies.7 For those living in states that do not currently have these laws, we encourage you to reach out to your legislators to advocate for similar laws as the data show clear medical and cost benefits for patients and society.

 Continue to: Pharmacist prescription of  hormonal contraception is safe and promotes continuation...

 

 

Pharmacist prescription of  hormonal contraception is safe and promotes continuation

Rodriguez MI, Skye M, Edelman AB, et al. Association of pharmacist prescription and 12-month contraceptive continuation rates. Am J Obstet Gynecol. 2021;225:647.e1-647.e9.

Patients often face difficulty obtaining both new and timely refills of self-administered contraception.10,11 To expand contraception access, Oregon became the first state (in 2016) to enact legislation to authorize direct pharmacist prescribing of hormonal contraceptives.12 Currently, 17 states and the District of Columbia have protocols for pharmacist prescribing privileges (FIGURE 2), and proposed legislation is pending in another  14 states.10,12 These protocols vary, but basic processes include screening, documentation, monitoring, and referrals when necessary. Typically, protocols require a pharmacist to review a patient’s medical history, pregnancy status, medication use, and blood pressure, followed by contraceptive counseling.10 Pharmacies are generally located in the community they serve, have extended hours, and usually do not require an appointment.8,13,14

Pharmacist prescribing increases the number of new contraceptive users, and pharmacists are more likely to prescribe a 6-month or longer supply of contraceptives compared with clinicians.8,13,15 Also, pharmacist prescribing is safe, with adherence rates to the CDC’s US Medical Eligibility Criteria for Contraceptive Use similar to those of prescriptions provided by a clinician.13

Authors of a recent multi-state study further assessed the impact of pharmacist prescribing by evaluating 12-month continuation and perfect use rates.

Study design

Rodriguez and colleagues evaluated the results of a 1-year prospective cohort study conducted in 2019 that included 388 participants who sought contraception in California, Colorado, Hawaii, and Oregon. All these states had laws permitting pharmacist prescribing and 12-month supply of hormonal contraception. Participants received prescriptions directly from a pharmacist at 1 of 139 pharmacies (n = 149) or filled a prescription provided by a clinician (n = 239). The primary outcomes were continuation of an effective method and perfect use of contraception across 12 months.

Participant demographics were similar between the 2 groups except for education and insurance status. Participants who received a prescription from a clinician reported higher levels of education. A greater proportion of uninsured participants received a prescription from a pharmacist (11%) compared with from a clinician (3%).

Contraceptive continuation rates

Participants were surveyed 3 times during the 12-month study about their current contraceptive method, if they had switched methods, or if they had any missed days  of contraception. 

Overall, 340 participants (88%) completed a full 12 months of follow-up. Continuation rates were similar between the 2 groups: 89% in the clinician-prescribed and 90% in the pharmacist-prescribed group (P=.86). Participants in the 2 groups also reported similar rates of perfect use (no missed days: 54% and 47%, respectively [P=.69]).  Additionally, the authors reported that  29 participants changed from a tier 2 (pill, patch, ring, injection) to a tier 1 (intrauterine device or implant) method during follow-up, with no difference in switch rates for participants who received care from a clinician (10%) or a pharmacist (7%).

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Patients have difficulties in obtaining both an initial contraceptive prescription and refills in time to avoid breaks in coverage.16 Pharmacist prescription of contraception is a proven strategy to increase access to contraception for new users or to promote continuation among current users. This practice is evidence based, decreases unintended pregnancy rates, and is safe.8,13,15,17

Promoting universal pharmacist prescribing is even more important given the overruling of Roe v Wade. With abortion restrictions, many family planning clinics that also play a vital role in providing contraception will close. Most states that are limiting abortion care (FIGURE 3) are the same states without pharmacist-prescribing provisions (FIGURE 2). As patient advocates, we need to continue to support this evidence-based practice in states where it is available and push legislators in states where it is not. Pharmacists should receive support to complete the training and certification needed to not only provide this service but also to receive appropriate reimbursements. Restrictions, such as requiring patients to be 18 years or older or to have prior consultation with a physician, should be limited as these are not necessary to provide self-administered contraception safely. Clinicians and pharmacists should inform patients, in states where this is available, that they can access initial or refill prescriptions at their local pharmacy if that is more convenient or their preference. Clinicians who live in states without these laws can advocate for their community by encouraging their legislators to pass laws that allow this evidence-based practice.

Continue to: LNG 52 mg IUD demonstrates  efficacy and safety through 8 years of use... 

 

 

LNG 52 mg IUD demonstrates  efficacy and safety through 8 years of use 

Creinin MD, Schreiber CA, Turok DK, et al. Levonorgestrel 52 mg intrauterine system efficacy and safety through 8 years of use. Am J Obstet Gynecol. 2022;S00029378(22)00366-0.

Given the potential difficulty accessing contraceptive and abortion services due to state restrictions, patients may be more motivated to maintain long-acting reversible contraceptives for maximum periods of time. The LNG 52 mg IUD was first marketed as a 5-year product, but multiple studies suggested that it had potential longer duration of efficacy and safety.18,19 The most recent clinical trial report shows that the LNG 52 mg IUD has at least 8 years of efficacy  and safety.

Evidence supports 8 years’ use

The ACCESS IUS (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) phase 3 trial was designed to assess the safety and efficacy of a LNG 52 mg IUD (Liletta) for up to 10 years of use. The recent publication by Creinin and colleagues extends the available data from this study from 6 to 8 years.

Five-hundred and sixty-nine participants started year 7; 478 completed year 7 and 343 completed year 8 by the time the study was discontinued. Two pregnancies occurred in year 7 and no pregnancies occurred in year 8. One of the pregnancies in year 7 was determined by ultrasound examination to have implantation on day 4 after LNG IUD removal. According to the FDA, any pregnancy that occurs within 7 days of discontinuation is included as on-treatment, whereas the European Medicines Agency (EMA) has a 2-day cutoff. Over 8 years,  11 pregnancies occurred. The cumulative life-table pregnancy rate in the primary efficacy population through year 8 was 1.32% (95% confidence interval [CI],  0.69–2.51) under FDA rules and 1.09% (95% CI,  0.56–2.13) according to EMA guidance.

Absence of bleeding/spotting rates and adverse events

Rates of absence of bleeding/spotting remained relatively stable in years 7 and 8 at around 40%, similar to the rates during years 3 to 8 (FIGURE 4). Overall, only 2.6% of participants discontinued LNG IUD use because of bleeding problems, with a total of 4 participants discontinuing for this reason in years 7 and 8. Expulsion rates remained low at a rate of approximately 0.5% in years 7 and 8. Vulvovaginal infections were the most common adverse effect during year 7–8 of use. These findings are consistent with those found at  6 years.20

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
As abortion and contraception services become more difficult to access, patients may be more motivated to initiate or maintain an intrauterine device for longer. The ACCESS IUS trial provides contemporary data that are generalizable across the US population. Clinicians should educate patients about the efficacy, low incidence of new adverse events, and the steady rate at which patients experience absence of bleeding/spotting. The most recent data analysis supports continued use of LNG 52 mg IUD products for up to 8 years with an excellent extended safety profile. While some providers may express concern that patients may experience more bleeding with prolonged use, this study demonstrated low discontinuation rates due to bleeding in years 7 and 8. Perforations were diagnosed only during the first year, meaning that they most likely are related to the insertion process. Additionally, in this long-term study, expulsions occurred most frequently in the first year after placement. This study, which shows that the LNG IUD can continue to be used for longer than before, is important because it means that many patients will need fewer removals and reinsertions over their lifetime, reducing a patient’s risks and discomfort associated with these procedures. Sharing these data is important, as longer LNG IUD retention may reduce burdens faced by patients who desire long-acting reversible contraception.
References
  1. Kirstein M, Jones RK, Philbin J. One month post-Roe: at least 43 abortion clinics across 11 states have stopped offering abortion care. Guttmacher Institute. July 28, 2022. Accessed September 14, 2022. https://www.guttmacher.org /article/2022/07/one-month-post-roe-least-43-abortion-clinics-across -11-states-have-stopped-offering
  2. Foster DG, Hulett D, Bradsberry M, et al. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol. 2011;117:566-572.
  3. Foster DG, Parvataneni R, de Bocanegra HT, et al. Number of oral contraceptive pill packages dispensed, method continuation, and costs. Obstet Gynecol. 2006;108:1107-114.
  4. Niu F, Cornelius J, Aboubechara N, et al. Real world outcomes related to providing an annual supply of short-acting hormonal contraceptives. Contraception. 2022;107:58-61.
  5. Curtis KM, Jatlaoui TC, Tepper NK, et al. US selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep. 2016;65:1-66.
  6. Women’s sexual and reproductive health services: key findings from the 2017 Kaiser Women’s Health Survey. KFF: Kaiser Family Foundation. March 13, 2018. Accessed September 14, 2022. https://www.kff.org/womens-health-policy /issue-brief/womens-sexual-and-reproductive-health-services-key-findings -from-the-2017-kaiser-womens-health-survey/
  7. Nikpour G, Allen A, Rafie S, et al. Pharmacy implementation of a new law allowing year-long hormonal contraception supplies. Pharmacy (Basel). 2020;8:E165.
  8. Rodriguez MI, Edelman AB, Skye M, et al. Association of pharmacist prescription with dispensed duration of hormonal contraception. JAMA Netw Open. 2020;3:e205252.
  9. Insurance coverage of contraceptives. Guttmacher Institute. Updated August 1, 2022. Accessed September 14, 2022. https://www.guttmacher.org/state-policy /explore/insurance-coverage-contraceptives
  10. Chim C, Sharma P. Pharmacists prescribing hormonal contraceptives: a status update. US Pharm. 2021;46:45-49.
  11. Rodriguez MI, Hersh A, Anderson LB, et al. Association of pharmacist prescription of hormonal contraception with unintended pregnancies and Medicaid costs. Obstet Gynecol. 2019;133:1238-1246.
  12. Pharmacist-prescribed contraceptives. Guttmacher Institute. Updated August 1, 2022. Accessed September 14, 2022. https://www.guttmacher.org/state -policy/explore/pharmacist-prescribed-contraceptives
  13. Anderson L, Hartung DM, Middleton L, et al. Pharmacist provision of hormonal contraception in the Oregon Medicaid population. Obstet Gynecol. 2019;133:1231-1237.
  14. Rodriguez MI, Edelman AB, Skye M, et al. Reasons for and experience in obtaining pharmacist prescribed contraception. Contraception. 2020;102:259-261.
  15. Rodriguez MI, Manibusan B, Kaufman M, et al. Association of pharmacist prescription of contraception with breaks in coverage. Obstet Gynecol. 2022;139:781-787.
  16. Pittman ME, Secura GM, Allsworth JE, et al. Understanding prescription adherence: pharmacy claims data from the Contraceptive CHOICE Project. Contraception. 2011;83:340-345.
  17. Rodriguez MI, Skye M, Edelman AB, et al. Association of pharmacist prescription and 12-month contraceptive continuation rates. Am J Obstet Gynecol. 2021;225:647.e1-647.e9.
  18. Secura GM, Allsworth JE, Madden T, et al. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010;203:115.e1-7.
  19. Rowe P, Farley T, Peregoudov A, et al. Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A. Contraception. 2016;93:498-506.
  20. Westhoff CL, Keder LM, Gangestad A, et al. Six-year contraceptive efficacy and continued safety of a levonorgestrel 52 mg intrauterine system. Contraception. 2020;101:159-161.
References
  1. Kirstein M, Jones RK, Philbin J. One month post-Roe: at least 43 abortion clinics across 11 states have stopped offering abortion care. Guttmacher Institute. July 28, 2022. Accessed September 14, 2022. https://www.guttmacher.org /article/2022/07/one-month-post-roe-least-43-abortion-clinics-across -11-states-have-stopped-offering
  2. Foster DG, Hulett D, Bradsberry M, et al. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol. 2011;117:566-572.
  3. Foster DG, Parvataneni R, de Bocanegra HT, et al. Number of oral contraceptive pill packages dispensed, method continuation, and costs. Obstet Gynecol. 2006;108:1107-114.
  4. Niu F, Cornelius J, Aboubechara N, et al. Real world outcomes related to providing an annual supply of short-acting hormonal contraceptives. Contraception. 2022;107:58-61.
  5. Curtis KM, Jatlaoui TC, Tepper NK, et al. US selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep. 2016;65:1-66.
  6. Women’s sexual and reproductive health services: key findings from the 2017 Kaiser Women’s Health Survey. KFF: Kaiser Family Foundation. March 13, 2018. Accessed September 14, 2022. https://www.kff.org/womens-health-policy /issue-brief/womens-sexual-and-reproductive-health-services-key-findings -from-the-2017-kaiser-womens-health-survey/
  7. Nikpour G, Allen A, Rafie S, et al. Pharmacy implementation of a new law allowing year-long hormonal contraception supplies. Pharmacy (Basel). 2020;8:E165.
  8. Rodriguez MI, Edelman AB, Skye M, et al. Association of pharmacist prescription with dispensed duration of hormonal contraception. JAMA Netw Open. 2020;3:e205252.
  9. Insurance coverage of contraceptives. Guttmacher Institute. Updated August 1, 2022. Accessed September 14, 2022. https://www.guttmacher.org/state-policy /explore/insurance-coverage-contraceptives
  10. Chim C, Sharma P. Pharmacists prescribing hormonal contraceptives: a status update. US Pharm. 2021;46:45-49.
  11. Rodriguez MI, Hersh A, Anderson LB, et al. Association of pharmacist prescription of hormonal contraception with unintended pregnancies and Medicaid costs. Obstet Gynecol. 2019;133:1238-1246.
  12. Pharmacist-prescribed contraceptives. Guttmacher Institute. Updated August 1, 2022. Accessed September 14, 2022. https://www.guttmacher.org/state -policy/explore/pharmacist-prescribed-contraceptives
  13. Anderson L, Hartung DM, Middleton L, et al. Pharmacist provision of hormonal contraception in the Oregon Medicaid population. Obstet Gynecol. 2019;133:1231-1237.
  14. Rodriguez MI, Edelman AB, Skye M, et al. Reasons for and experience in obtaining pharmacist prescribed contraception. Contraception. 2020;102:259-261.
  15. Rodriguez MI, Manibusan B, Kaufman M, et al. Association of pharmacist prescription of contraception with breaks in coverage. Obstet Gynecol. 2022;139:781-787.
  16. Pittman ME, Secura GM, Allsworth JE, et al. Understanding prescription adherence: pharmacy claims data from the Contraceptive CHOICE Project. Contraception. 2011;83:340-345.
  17. Rodriguez MI, Skye M, Edelman AB, et al. Association of pharmacist prescription and 12-month contraceptive continuation rates. Am J Obstet Gynecol. 2021;225:647.e1-647.e9.
  18. Secura GM, Allsworth JE, Madden T, et al. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010;203:115.e1-7.
  19. Rowe P, Farley T, Peregoudov A, et al. Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A. Contraception. 2016;93:498-506.
  20. Westhoff CL, Keder LM, Gangestad A, et al. Six-year contraceptive efficacy and continued safety of a levonorgestrel 52 mg intrauterine system. Contraception. 2020;101:159-161.
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Isotretinoin prescribers need better education on emergency contraception

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Fri, 09/09/2022 - 09:39

Only one-third of pediatric dermatologists who prescribed isotretinoin for acne reported feeling confident in their understanding of emergency contraception (EC), in a survey of 57 clinicians.

Pregnancies among patients on isotretinoin have declined since the iPLEDGE risk management program was introduced in 2005, but from 2011 to 2017, 210 to 310 pregnancies were reported to the Food and Drug Administration every year, wrote Catherine E. Smiley of Penn State University, Hershey, Pa., and coauthors Melissa Butt, DrPH, and Andrea L. Zaenglein, MD, of Penn State.

Dr. Andrea L. Zaenglein

For patients on isotretinoin, EC “becomes critical when abstinence fails or contraception is not used properly,” but EC merits only a brief mention in iPLEDGE materials for patients and providers, they noted.

Patients on isotretinoin who choose abstinence as their form of birth control are the group at greatest risk for pregnancy, Dr. Zaenglein, professor of dermatology and pediatric dermatology, Penn State University, said in an interview. “However, the iPLEDGE program fails to educate patients adequately on emergency contraception,” she explained.

To assess pediatric dermatologists’ understanding of EC and their contraception counseling practices for isotretinoin patients, the researchers surveyed 57 pediatric dermatologists who prescribed isotretinoin as part of their practices. The findings were published in Pediatric Dermatology.Respondents included 53 practicing dermatologists, 2 residents, and 2 fellows. Approximately one-third (31.6%) had been in practice for 6-10 years, almost 23% had been in practice for 3-5 years, and almost 20% had been in practice for 21 or more years. Almost two-thirds practiced pediatric dermatology only.

Overall, 58% of the respondents strongly agreed that they provided contraception counseling to patients at their initial visit for isotretinoin, but only 7% and 3.5% reported providing EC counseling at initial and follow-up visits, respectively. More than half (58%) said they did not counsel patients on the side effects of EC.

As for provider education, 7.1% of respondents said they had received formal education on EC counseling, 25% reported receiving informal education on EC counseling, and 68% said they received no education on EC counseling.

A total of 32% of respondents said they were at least somewhat confident in how to obtain EC in their state.

EC is an effective form of contraception if used after unprotected intercourse, and discounts can reduce the price to as low as $9.69, the researchers wrote in their discussion. “Given that most providers in this study did not receive formal education on EC, and most do not provide EC counseling to their patients of reproductive potential on isotretinoin, EC education should be a core competency in dermatology residency education on isotretinoin prescribing,” the researchers noted. In addition, EC counseling in the iPLEDGE program should be improved by including more information in education materials and reminding patients that EC is an option, they said.

The study findings were limited by several factors including the small sample size and the multiple-choice format that prevented respondents to share rationales for their responses, the researchers noted.



However, the results highlight the need to improve EC education among pediatric dermatologists to better inform patients considering isotretinoin, especially those choosing abstinence as a method of birth control, they emphasized.

“This study is very important at this specific time for two reasons,” Dr. Zaenglein said in an interview. “The first is that with the recent disastrous rollout of the new iPLEDGE changes, there have been many calls to reform the REMS program. For the first time in the 22-year history of the program, the isotretinoin manufacturers, who manage the iPLEDGE program as an unidentified group (the IPMG), have been forced by the FDA to meet with the AAD iPLEDGE Task Force,” said Dr. Zaenglein, a member of the task force.

“The task force is currently advocating for common sense changes to iPLEDGE and I think enhancing education on emergency contraception is vital to the goal of the program, stated as ‘to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure,’ ” she added. For many patients who previously became pregnant on isotretinoin, Plan B, an over-the-counter, FDA-approved form of contraception, might have prevented that pregnancy if the patients received adequate education on EC, she said.

The current study is especially relevant now, said Dr. Zaenglein. “With the reversal of Roe v. Wade, access to abortion is restricted or completely banned in many states, which makes educating our patients on how to prevent pregnancy even more important.”

Dr. Zaenglein said she was “somewhat surprised” by how many respondents were not educating their isotretinoin patients on EC. “However, these results follow a known trend among dermatologists. Only 50% of dermatologists prescribe oral contraceptives for acne, despite its being an FDA-approved treatment for the most common dermatologic condition we see in adolescents and young adults,” she noted.

“In general, dermatologists, and subsequently dermatology residents, are poorly educated on issues of reproductive health and how they are relevant to dermatologic care,” she added.

Dr. Zaenglein’s take home message: “Dermatologists should educate all patients of childbearing potential taking isotretinoin on how to acquire and use emergency contraception at every visit.” As for additional research, she said that since the study was conducted with pediatric dermatologists, “it would be very interesting to see if general dermatologists had the same lack of comfort in educating patients on emergency contraception and what their standard counseling practices are.”

The study received no outside funding. Dr. Zaenglein is a member of the AAD’s iPLEDGE Work Group and serves as an editor-in-chief of Pediatric Dermatology.

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Only one-third of pediatric dermatologists who prescribed isotretinoin for acne reported feeling confident in their understanding of emergency contraception (EC), in a survey of 57 clinicians.

Pregnancies among patients on isotretinoin have declined since the iPLEDGE risk management program was introduced in 2005, but from 2011 to 2017, 210 to 310 pregnancies were reported to the Food and Drug Administration every year, wrote Catherine E. Smiley of Penn State University, Hershey, Pa., and coauthors Melissa Butt, DrPH, and Andrea L. Zaenglein, MD, of Penn State.

Dr. Andrea L. Zaenglein

For patients on isotretinoin, EC “becomes critical when abstinence fails or contraception is not used properly,” but EC merits only a brief mention in iPLEDGE materials for patients and providers, they noted.

Patients on isotretinoin who choose abstinence as their form of birth control are the group at greatest risk for pregnancy, Dr. Zaenglein, professor of dermatology and pediatric dermatology, Penn State University, said in an interview. “However, the iPLEDGE program fails to educate patients adequately on emergency contraception,” she explained.

To assess pediatric dermatologists’ understanding of EC and their contraception counseling practices for isotretinoin patients, the researchers surveyed 57 pediatric dermatologists who prescribed isotretinoin as part of their practices. The findings were published in Pediatric Dermatology.Respondents included 53 practicing dermatologists, 2 residents, and 2 fellows. Approximately one-third (31.6%) had been in practice for 6-10 years, almost 23% had been in practice for 3-5 years, and almost 20% had been in practice for 21 or more years. Almost two-thirds practiced pediatric dermatology only.

Overall, 58% of the respondents strongly agreed that they provided contraception counseling to patients at their initial visit for isotretinoin, but only 7% and 3.5% reported providing EC counseling at initial and follow-up visits, respectively. More than half (58%) said they did not counsel patients on the side effects of EC.

As for provider education, 7.1% of respondents said they had received formal education on EC counseling, 25% reported receiving informal education on EC counseling, and 68% said they received no education on EC counseling.

A total of 32% of respondents said they were at least somewhat confident in how to obtain EC in their state.

EC is an effective form of contraception if used after unprotected intercourse, and discounts can reduce the price to as low as $9.69, the researchers wrote in their discussion. “Given that most providers in this study did not receive formal education on EC, and most do not provide EC counseling to their patients of reproductive potential on isotretinoin, EC education should be a core competency in dermatology residency education on isotretinoin prescribing,” the researchers noted. In addition, EC counseling in the iPLEDGE program should be improved by including more information in education materials and reminding patients that EC is an option, they said.

The study findings were limited by several factors including the small sample size and the multiple-choice format that prevented respondents to share rationales for their responses, the researchers noted.



However, the results highlight the need to improve EC education among pediatric dermatologists to better inform patients considering isotretinoin, especially those choosing abstinence as a method of birth control, they emphasized.

“This study is very important at this specific time for two reasons,” Dr. Zaenglein said in an interview. “The first is that with the recent disastrous rollout of the new iPLEDGE changes, there have been many calls to reform the REMS program. For the first time in the 22-year history of the program, the isotretinoin manufacturers, who manage the iPLEDGE program as an unidentified group (the IPMG), have been forced by the FDA to meet with the AAD iPLEDGE Task Force,” said Dr. Zaenglein, a member of the task force.

“The task force is currently advocating for common sense changes to iPLEDGE and I think enhancing education on emergency contraception is vital to the goal of the program, stated as ‘to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure,’ ” she added. For many patients who previously became pregnant on isotretinoin, Plan B, an over-the-counter, FDA-approved form of contraception, might have prevented that pregnancy if the patients received adequate education on EC, she said.

The current study is especially relevant now, said Dr. Zaenglein. “With the reversal of Roe v. Wade, access to abortion is restricted or completely banned in many states, which makes educating our patients on how to prevent pregnancy even more important.”

Dr. Zaenglein said she was “somewhat surprised” by how many respondents were not educating their isotretinoin patients on EC. “However, these results follow a known trend among dermatologists. Only 50% of dermatologists prescribe oral contraceptives for acne, despite its being an FDA-approved treatment for the most common dermatologic condition we see in adolescents and young adults,” she noted.

“In general, dermatologists, and subsequently dermatology residents, are poorly educated on issues of reproductive health and how they are relevant to dermatologic care,” she added.

Dr. Zaenglein’s take home message: “Dermatologists should educate all patients of childbearing potential taking isotretinoin on how to acquire and use emergency contraception at every visit.” As for additional research, she said that since the study was conducted with pediatric dermatologists, “it would be very interesting to see if general dermatologists had the same lack of comfort in educating patients on emergency contraception and what their standard counseling practices are.”

The study received no outside funding. Dr. Zaenglein is a member of the AAD’s iPLEDGE Work Group and serves as an editor-in-chief of Pediatric Dermatology.

Only one-third of pediatric dermatologists who prescribed isotretinoin for acne reported feeling confident in their understanding of emergency contraception (EC), in a survey of 57 clinicians.

Pregnancies among patients on isotretinoin have declined since the iPLEDGE risk management program was introduced in 2005, but from 2011 to 2017, 210 to 310 pregnancies were reported to the Food and Drug Administration every year, wrote Catherine E. Smiley of Penn State University, Hershey, Pa., and coauthors Melissa Butt, DrPH, and Andrea L. Zaenglein, MD, of Penn State.

Dr. Andrea L. Zaenglein

For patients on isotretinoin, EC “becomes critical when abstinence fails or contraception is not used properly,” but EC merits only a brief mention in iPLEDGE materials for patients and providers, they noted.

Patients on isotretinoin who choose abstinence as their form of birth control are the group at greatest risk for pregnancy, Dr. Zaenglein, professor of dermatology and pediatric dermatology, Penn State University, said in an interview. “However, the iPLEDGE program fails to educate patients adequately on emergency contraception,” she explained.

To assess pediatric dermatologists’ understanding of EC and their contraception counseling practices for isotretinoin patients, the researchers surveyed 57 pediatric dermatologists who prescribed isotretinoin as part of their practices. The findings were published in Pediatric Dermatology.Respondents included 53 practicing dermatologists, 2 residents, and 2 fellows. Approximately one-third (31.6%) had been in practice for 6-10 years, almost 23% had been in practice for 3-5 years, and almost 20% had been in practice for 21 or more years. Almost two-thirds practiced pediatric dermatology only.

Overall, 58% of the respondents strongly agreed that they provided contraception counseling to patients at their initial visit for isotretinoin, but only 7% and 3.5% reported providing EC counseling at initial and follow-up visits, respectively. More than half (58%) said they did not counsel patients on the side effects of EC.

As for provider education, 7.1% of respondents said they had received formal education on EC counseling, 25% reported receiving informal education on EC counseling, and 68% said they received no education on EC counseling.

A total of 32% of respondents said they were at least somewhat confident in how to obtain EC in their state.

EC is an effective form of contraception if used after unprotected intercourse, and discounts can reduce the price to as low as $9.69, the researchers wrote in their discussion. “Given that most providers in this study did not receive formal education on EC, and most do not provide EC counseling to their patients of reproductive potential on isotretinoin, EC education should be a core competency in dermatology residency education on isotretinoin prescribing,” the researchers noted. In addition, EC counseling in the iPLEDGE program should be improved by including more information in education materials and reminding patients that EC is an option, they said.

The study findings were limited by several factors including the small sample size and the multiple-choice format that prevented respondents to share rationales for their responses, the researchers noted.



However, the results highlight the need to improve EC education among pediatric dermatologists to better inform patients considering isotretinoin, especially those choosing abstinence as a method of birth control, they emphasized.

“This study is very important at this specific time for two reasons,” Dr. Zaenglein said in an interview. “The first is that with the recent disastrous rollout of the new iPLEDGE changes, there have been many calls to reform the REMS program. For the first time in the 22-year history of the program, the isotretinoin manufacturers, who manage the iPLEDGE program as an unidentified group (the IPMG), have been forced by the FDA to meet with the AAD iPLEDGE Task Force,” said Dr. Zaenglein, a member of the task force.

“The task force is currently advocating for common sense changes to iPLEDGE and I think enhancing education on emergency contraception is vital to the goal of the program, stated as ‘to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure,’ ” she added. For many patients who previously became pregnant on isotretinoin, Plan B, an over-the-counter, FDA-approved form of contraception, might have prevented that pregnancy if the patients received adequate education on EC, she said.

The current study is especially relevant now, said Dr. Zaenglein. “With the reversal of Roe v. Wade, access to abortion is restricted or completely banned in many states, which makes educating our patients on how to prevent pregnancy even more important.”

Dr. Zaenglein said she was “somewhat surprised” by how many respondents were not educating their isotretinoin patients on EC. “However, these results follow a known trend among dermatologists. Only 50% of dermatologists prescribe oral contraceptives for acne, despite its being an FDA-approved treatment for the most common dermatologic condition we see in adolescents and young adults,” she noted.

“In general, dermatologists, and subsequently dermatology residents, are poorly educated on issues of reproductive health and how they are relevant to dermatologic care,” she added.

Dr. Zaenglein’s take home message: “Dermatologists should educate all patients of childbearing potential taking isotretinoin on how to acquire and use emergency contraception at every visit.” As for additional research, she said that since the study was conducted with pediatric dermatologists, “it would be very interesting to see if general dermatologists had the same lack of comfort in educating patients on emergency contraception and what their standard counseling practices are.”

The study received no outside funding. Dr. Zaenglein is a member of the AAD’s iPLEDGE Work Group and serves as an editor-in-chief of Pediatric Dermatology.

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