Commentary

One of the great honors of my professional career was being nominated to the presidency of the Society of Gynecologic Surgeons and being given the opportunity to deliver the presidential address at the Society’s 42nd annual scientific meeting in Palm Springs, Calif.

One of the core principles of the SGS mission statement is supporting excellence in gynecologic surgery and, to that end, the main focus of my term was to address the decline in vaginal hysterectomy rates. What follows is an excerpt from my speech explaining the rationale for vaginal hysterectomy (VH) and steps the SGS is taking to reverse the decline.

Unfortunately, what is happening in today’s practice environment is declining use of vaginal hysterectomy, with concomitant increases in endoscopic hysterectomy, mostly with the use of robotic assistance. Being the president of a society previously known as the Vaginal Surgeons Society, it would not be surprising to hear that I have been accused of being “anti-robot.”

Nothing could be further from the truth.

When we talk about the surgical treatment of patients with endometrial and cervical cancer, I do not need a randomized clinical trial to know that not making a laparotomy incision is probably a good thing when you’re treating these patients. There are benefits to using robotic techniques in this subpopulation; it is cost effective due to the reduced morbidity and straight stick laparoscopy for these patients is difficult to perform; therefore it’s not been as widely published or performed. I believe that robotic hysterectomy for these disorders should be the standard of care. In this regard, I am pro robot (Gynecologic Oncol. 2015;138[2]:457-71).

On the other hand, I also don’t need a randomized trial (even though randomized trials exist) to know that if you have a choice to make, or not make, extra incisions during surgery, it’s better to not make the extra incisions.

It’s certainly not rocket science to know that a Zeppelin or Heaney clamp is orders of magnitude cheaper than equipment required to perform an endoscopic hysterectomy – $22.25 USD for instrument and $3.19 USD to process per case (Am J Obstet Gynecol. 2016;214[4]:S461-2]).

Level I evidence demonstrates that when compared to other minimally invasive hysterectomy techniques, vaginal hysterectomy is cheaper, the convalescence is stable or reduced, and the complication rates are lower (Cochrane Database Syst Rev. 2015 Aug. 12;8:CD003677).

Moreover, if you don’t place a port, you can’t get a port site complication (these complications are rare, but potentially serious when they occur). You can’t perforate the common iliac vein. You can’t put a Veress needle through the small bowel. You can’t get a Richter’s hernia. And finally, while you can get cuff dehiscence with vaginal hysterectomy, I’ve never seen it, and this is a real issue with the endoscopic approaches (Cochrane Database Syst Rev. 2012 Feb. 15;2:CD006583 ).

This isn’t just my opinion. Every major surgical society has recommended vaginal hysterectomy when technically feasible.

Of course, “technical feasibility” is the kicker and it’s important to ask what this means.

First, we have to look at what I call the hysterectomy continuum. There are the young, sexually-active women with uterovaginal procidentia where an endoscopic approach for sacral colpopexy might be considered. Then you have patients who are vaginally parous, have a mobile uterus less than 12 weeks in size, and have a basic gynecologic condition such as dysfunctional uterine bleeding, cervical intraepithelial neoplasia, or painful menses (this is about 40%-50% of patients when I reviewed internal North Valley Permanente Group data in 2012); these patients are certainly excellent candidates for vaginal hysterectomy. Then there are patients with 30-week-size fibroid uterus, three prior C-sections, and known stage 4 endometriosis (where an open or robotic approach would be justified).

Second, we have to address the contradictory data presented in the literature regarding vaginal hysterectomy rates. On one hand, we have data from large case series and randomized, controlled trials which demonstrate that it’s feasible to perform a high percentage of vaginal hysterectomies (Obstet Gynecol. 2004;103[6]:1321-5and Arch Gynecol Obstet. 2014;290[3]:485-91). On the other hand, 40 years of population data show the opposite (Obstet Gynecol. 2009;114[5]:1041-8).

In the pre-endoscopic era, 80% and 20% of hysterectomies were performed via the abdominal and vaginal routes, respectively. During the laparoscopic era, 64%, 22%, and 14% of hysterectomies were performed via the abdominal, vaginal, and laparoscopic routes, respectively. And during the current robotic era, it is now 32%, 16%, 28%, and 25% performed via the abdominal, vaginal, laparoscopic, and robotic routes, respectively.

During this 40-year time frame, despite data and recommendations that support vaginal hysterectomy, there has never been an obvious incentive to perform this procedure (e.g. to my knowledge, no one has ever been paid more to do a vaginal hysterectomy, or been prominently featured on a hospital’s website regarding his or her ability to perform an “incision-less” hysterectomy (Am J Obstet Gynecol. 2012;207[3]:174.e1-174.e7). Why weren’t and why aren’t we outraged about this? I have always been under the impression that cheaper and safer is better!

The first thing I hear to explain this – mostly from robotic surgeons and from the robotic surgery device sales representatives – is that the decline in the proportion of vaginal hysterectomies is irrelevant in that it has taken the robot to meaningfully reduce open hysterectomy rates. The other argument I hear – mostly from the laparoscopic surgeons – is that vaginal hysterectomy rates have not changed because most gynecologists cannot and will never be able to perform the procedure. So, what is the point of even discussing solutions?

I disagree with the laparoscopic and robotic surgeons. We should be outraged and do something to effect change. Vaginal hysterectomy offers better value (for surgeons who aren’t thinking about value right now, I suggest that you start. Value-based reimbursement is coming soon) and we know that a high percentage of vaginal hysterectomies are feasible in general gynecologic populations. Surgeons who perform vaginal hysterectomy are not magicians or better surgeons, just differently trained. We have to recognize that many, or even most, patients are candidates for vaginal hysterectomy.

Finally, when we look at robotics for benign disease, we spend more money than on other minimally invasive hysterectomy techniques but we don’t get better outcomes (J Minim Invasive Gynecol. 2010;17[6]:730-8and Eur J Obstet Gynecol Reprod Biol. 150[1]:92-6). Yet surgeons currently use robotics for 25% or more of benign hysterectomies.

What are we thinking and how can we afford to continue this?

We need to counsel our patients (and ourselves) that a total hysterectomy requires an incision in the vagina, and there can be a need for additional abdominal incisions of varying size and number. Fully informed consent must include a discussion of all types of hysterectomy including both patient and surgeon factors associated with the recommended route. Ultimately, the route of hysterectomy should be based on the patient and not the surgeon (Obstet Gynecol. 2014;124[3]:585-8).

It is easy to say, and supported by the evidence, that we should do more vaginal hysterectomies. It is also easy to note that the rate of vaginal hysterectomy has been stable to declining over the last 4 decades and that there are significant issues with residency training in gynecologic surgery (serious issues, but beyond the scope of this editorial).

So, what are we at SGS doing to support increased rates of vaginal hysterectomy? Every December we sponsor a postgraduate course on vaginal hysterectomy techniques. This is an excellent learning opportunity. (Visit www.sgsonline.org for more information regarding dates and costs). We’re starting partnerships with the American College of Obstetricians and Gynecologists (ACOG), the Foundation for Exxcellence in Women’s Health and others, to begin a “train the trainer” program to teach junior faculty how to do and teach vaginal hysterectomy. We’ve developed CREOG (Council on Resident Education in Obstetrics and Gynecology) modules to educate residents about the procedure, and we are in the process of communicating with residency and fellowship program directors about what else we can do to assist them with vaginal hysterectomy teaching. Other goals are to work with ACOG to develop quality metrics for hysterectomy and to develop physician-focused alternative payment models that recognize the value of vaginal hysterectomy.

I believe that in this country we should train for, incentivize, and insist upon a vaginal hysterectomy rate of at least 40% (this albeit arbitrary percentage is based upon the majority of vaginally parous women with uteri less than 12 weeks in size and a minority of the more difficult patients getting a vaginal hysterectomy). And before you say “it’s never been 40%,” please consider the famous quotation by Dr. William Mayo: “The best interest of the patient is the only interest to be considered.” Clearly, the best interest of the patient, if she is a candidate, is to have a vaginal hysterectomy. Our mission at SGS is to facilitate surgical education to make more patients candidates for vaginal hysterectomy so that we can achieve the 40% goal.

Dr. Walter is director of urogynecology and pelvic pain at The Permanente Medical Group, Roseville, Calif. He is also the immediate past president of the Society of Gynecologic Surgeons. He reported having no financial disclosures.

One of the great honors of my professional career was being nominated to the presidency of the Society of Gynecologic Surgeons and being given the opportunity to deliver the presidential address at the Society’s 42nd annual scientific meeting in Palm Springs, Calif.

One of the core principles of the SGS mission statement is supporting excellence in gynecologic surgery and, to that end, the main focus of my term was to address the decline in vaginal hysterectomy rates. What follows is an excerpt from my speech explaining the rationale for vaginal hysterectomy (VH) and steps the SGS is taking to reverse the decline.

Unfortunately, what is happening in today’s practice environment is declining use of vaginal hysterectomy, with concomitant increases in endoscopic hysterectomy, mostly with the use of robotic assistance. Being the president of a society previously known as the Vaginal Surgeons Society, it would not be surprising to hear that I have been accused of being “anti-robot.”

Nothing could be further from the truth.

When we talk about the surgical treatment of patients with endometrial and cervical cancer, I do not need a randomized clinical trial to know that not making a laparotomy incision is probably a good thing when you’re treating these patients. There are benefits to using robotic techniques in this subpopulation; it is cost effective due to the reduced morbidity and straight stick laparoscopy for these patients is difficult to perform; therefore it’s not been as widely published or performed. I believe that robotic hysterectomy for these disorders should be the standard of care. In this regard, I am pro robot (Gynecologic Oncol. 2015;138[2]:457-71).

On the other hand, I also don’t need a randomized trial (even though randomized trials exist) to know that if you have a choice to make, or not make, extra incisions during surgery, it’s better to not make the extra incisions.

It’s certainly not rocket science to know that a Zeppelin or Heaney clamp is orders of magnitude cheaper than equipment required to perform an endoscopic hysterectomy – $22.25 USD for instrument and $3.19 USD to process per case (Am J Obstet Gynecol. 2016;214[4]:S461-2]).

Level I evidence demonstrates that when compared to other minimally invasive hysterectomy techniques, vaginal hysterectomy is cheaper, the convalescence is stable or reduced, and the complication rates are lower (Cochrane Database Syst Rev. 2015 Aug. 12;8:CD003677).

Moreover, if you don’t place a port, you can’t get a port site complication (these complications are rare, but potentially serious when they occur). You can’t perforate the common iliac vein. You can’t put a Veress needle through the small bowel. You can’t get a Richter’s hernia. And finally, while you can get cuff dehiscence with vaginal hysterectomy, I’ve never seen it, and this is a real issue with the endoscopic approaches (Cochrane Database Syst Rev. 2012 Feb. 15;2:CD006583 ).

This isn’t just my opinion. Every major surgical society has recommended vaginal hysterectomy when technically feasible.

Of course, “technical feasibility” is the kicker and it’s important to ask what this means.

First, we have to look at what I call the hysterectomy continuum. There are the young, sexually-active women with uterovaginal procidentia where an endoscopic approach for sacral colpopexy might be considered. Then you have patients who are vaginally parous, have a mobile uterus less than 12 weeks in size, and have a basic gynecologic condition such as dysfunctional uterine bleeding, cervical intraepithelial neoplasia, or painful menses (this is about 40%-50% of patients when I reviewed internal North Valley Permanente Group data in 2012); these patients are certainly excellent candidates for vaginal hysterectomy. Then there are patients with 30-week-size fibroid uterus, three prior C-sections, and known stage 4 endometriosis (where an open or robotic approach would be justified).

Second, we have to address the contradictory data presented in the literature regarding vaginal hysterectomy rates. On one hand, we have data from large case series and randomized, controlled trials which demonstrate that it’s feasible to perform a high percentage of vaginal hysterectomies (Obstet Gynecol. 2004;103[6]:1321-5and Arch Gynecol Obstet. 2014;290[3]:485-91). On the other hand, 40 years of population data show the opposite (Obstet Gynecol. 2009;114[5]:1041-8).

In the pre-endoscopic era, 80% and 20% of hysterectomies were performed via the abdominal and vaginal routes, respectively. During the laparoscopic era, 64%, 22%, and 14% of hysterectomies were performed via the abdominal, vaginal, and laparoscopic routes, respectively. And during the current robotic era, it is now 32%, 16%, 28%, and 25% performed via the abdominal, vaginal, laparoscopic, and robotic routes, respectively.

During this 40-year time frame, despite data and recommendations that support vaginal hysterectomy, there has never been an obvious incentive to perform this procedure (e.g. to my knowledge, no one has ever been paid more to do a vaginal hysterectomy, or been prominently featured on a hospital’s website regarding his or her ability to perform an “incision-less” hysterectomy (Am J Obstet Gynecol. 2012;207[3]:174.e1-174.e7). Why weren’t and why aren’t we outraged about this? I have always been under the impression that cheaper and safer is better!

The first thing I hear to explain this – mostly from robotic surgeons and from the robotic surgery device sales representatives – is that the decline in the proportion of vaginal hysterectomies is irrelevant in that it has taken the robot to meaningfully reduce open hysterectomy rates. The other argument I hear – mostly from the laparoscopic surgeons – is that vaginal hysterectomy rates have not changed because most gynecologists cannot and will never be able to perform the procedure. So, what is the point of even discussing solutions?

I disagree with the laparoscopic and robotic surgeons. We should be outraged and do something to effect change. Vaginal hysterectomy offers better value (for surgeons who aren’t thinking about value right now, I suggest that you start. Value-based reimbursement is coming soon) and we know that a high percentage of vaginal hysterectomies are feasible in general gynecologic populations. Surgeons who perform vaginal hysterectomy are not magicians or better surgeons, just differently trained. We have to recognize that many, or even most, patients are candidates for vaginal hysterectomy.

Finally, when we look at robotics for benign disease, we spend more money than on other minimally invasive hysterectomy techniques but we don’t get better outcomes (J Minim Invasive Gynecol. 2010;17[6]:730-8and Eur J Obstet Gynecol Reprod Biol. 150[1]:92-6). Yet surgeons currently use robotics for 25% or more of benign hysterectomies.

What are we thinking and how can we afford to continue this?

We need to counsel our patients (and ourselves) that a total hysterectomy requires an incision in the vagina, and there can be a need for additional abdominal incisions of varying size and number. Fully informed consent must include a discussion of all types of hysterectomy including both patient and surgeon factors associated with the recommended route. Ultimately, the route of hysterectomy should be based on the patient and not the surgeon (Obstet Gynecol. 2014;124[3]:585-8).

It is easy to say, and supported by the evidence, that we should do more vaginal hysterectomies. It is also easy to note that the rate of vaginal hysterectomy has been stable to declining over the last 4 decades and that there are significant issues with residency training in gynecologic surgery (serious issues, but beyond the scope of this editorial).

So, what are we at SGS doing to support increased rates of vaginal hysterectomy? Every December we sponsor a postgraduate course on vaginal hysterectomy techniques. This is an excellent learning opportunity. (Visit www.sgsonline.org for more information regarding dates and costs). We’re starting partnerships with the American College of Obstetricians and Gynecologists (ACOG), the Foundation for Exxcellence in Women’s Health and others, to begin a “train the trainer” program to teach junior faculty how to do and teach vaginal hysterectomy. We’ve developed CREOG (Council on Resident Education in Obstetrics and Gynecology) modules to educate residents about the procedure, and we are in the process of communicating with residency and fellowship program directors about what else we can do to assist them with vaginal hysterectomy teaching. Other goals are to work with ACOG to develop quality metrics for hysterectomy and to develop physician-focused alternative payment models that recognize the value of vaginal hysterectomy.

I believe that in this country we should train for, incentivize, and insist upon a vaginal hysterectomy rate of at least 40% (this albeit arbitrary percentage is based upon the majority of vaginally parous women with uteri less than 12 weeks in size and a minority of the more difficult patients getting a vaginal hysterectomy). And before you say “it’s never been 40%,” please consider the famous quotation by Dr. William Mayo: “The best interest of the patient is the only interest to be considered.” Clearly, the best interest of the patient, if she is a candidate, is to have a vaginal hysterectomy. Our mission at SGS is to facilitate surgical education to make more patients candidates for vaginal hysterectomy so that we can achieve the 40% goal.

Dr. Walter is director of urogynecology and pelvic pain at The Permanente Medical Group, Roseville, Calif. He is also the immediate past president of the Society of Gynecologic Surgeons. He reported having no financial disclosures.

One of the great honors of my professional career was being nominated to the presidency of the Society of Gynecologic Surgeons and being given the opportunity to deliver the presidential address at the Society’s 42nd annual scientific meeting in Palm Springs, Calif.

One of the core principles of the SGS mission statement is supporting excellence in gynecologic surgery and, to that end, the main focus of my term was to address the decline in vaginal hysterectomy rates. What follows is an excerpt from my speech explaining the rationale for vaginal hysterectomy (VH) and steps the SGS is taking to reverse the decline.

Unfortunately, what is happening in today’s practice environment is declining use of vaginal hysterectomy, with concomitant increases in endoscopic hysterectomy, mostly with the use of robotic assistance. Being the president of a society previously known as the Vaginal Surgeons Society, it would not be surprising to hear that I have been accused of being “anti-robot.”

Nothing could be further from the truth.

When we talk about the surgical treatment of patients with endometrial and cervical cancer, I do not need a randomized clinical trial to know that not making a laparotomy incision is probably a good thing when you’re treating these patients. There are benefits to using robotic techniques in this subpopulation; it is cost effective due to the reduced morbidity and straight stick laparoscopy for these patients is difficult to perform; therefore it’s not been as widely published or performed. I believe that robotic hysterectomy for these disorders should be the standard of care. In this regard, I am pro robot (Gynecologic Oncol. 2015;138[2]:457-71).

On the other hand, I also don’t need a randomized trial (even though randomized trials exist) to know that if you have a choice to make, or not make, extra incisions during surgery, it’s better to not make the extra incisions.

It’s certainly not rocket science to know that a Zeppelin or Heaney clamp is orders of magnitude cheaper than equipment required to perform an endoscopic hysterectomy – $22.25 USD for instrument and $3.19 USD to process per case (Am J Obstet Gynecol. 2016;214[4]:S461-2]).

Level I evidence demonstrates that when compared to other minimally invasive hysterectomy techniques, vaginal hysterectomy is cheaper, the convalescence is stable or reduced, and the complication rates are lower (Cochrane Database Syst Rev. 2015 Aug. 12;8:CD003677).

Moreover, if you don’t place a port, you can’t get a port site complication (these complications are rare, but potentially serious when they occur). You can’t perforate the common iliac vein. You can’t put a Veress needle through the small bowel. You can’t get a Richter’s hernia. And finally, while you can get cuff dehiscence with vaginal hysterectomy, I’ve never seen it, and this is a real issue with the endoscopic approaches (Cochrane Database Syst Rev. 2012 Feb. 15;2:CD006583 ).

This isn’t just my opinion. Every major surgical society has recommended vaginal hysterectomy when technically feasible.

Of course, “technical feasibility” is the kicker and it’s important to ask what this means.

First, we have to look at what I call the hysterectomy continuum. There are the young, sexually-active women with uterovaginal procidentia where an endoscopic approach for sacral colpopexy might be considered. Then you have patients who are vaginally parous, have a mobile uterus less than 12 weeks in size, and have a basic gynecologic condition such as dysfunctional uterine bleeding, cervical intraepithelial neoplasia, or painful menses (this is about 40%-50% of patients when I reviewed internal North Valley Permanente Group data in 2012); these patients are certainly excellent candidates for vaginal hysterectomy. Then there are patients with 30-week-size fibroid uterus, three prior C-sections, and known stage 4 endometriosis (where an open or robotic approach would be justified).

Second, we have to address the contradictory data presented in the literature regarding vaginal hysterectomy rates. On one hand, we have data from large case series and randomized, controlled trials which demonstrate that it’s feasible to perform a high percentage of vaginal hysterectomies (Obstet Gynecol. 2004;103[6]:1321-5and Arch Gynecol Obstet. 2014;290[3]:485-91). On the other hand, 40 years of population data show the opposite (Obstet Gynecol. 2009;114[5]:1041-8).

In the pre-endoscopic era, 80% and 20% of hysterectomies were performed via the abdominal and vaginal routes, respectively. During the laparoscopic era, 64%, 22%, and 14% of hysterectomies were performed via the abdominal, vaginal, and laparoscopic routes, respectively. And during the current robotic era, it is now 32%, 16%, 28%, and 25% performed via the abdominal, vaginal, laparoscopic, and robotic routes, respectively.

During this 40-year time frame, despite data and recommendations that support vaginal hysterectomy, there has never been an obvious incentive to perform this procedure (e.g. to my knowledge, no one has ever been paid more to do a vaginal hysterectomy, or been prominently featured on a hospital’s website regarding his or her ability to perform an “incision-less” hysterectomy (Am J Obstet Gynecol. 2012;207[3]:174.e1-174.e7). Why weren’t and why aren’t we outraged about this? I have always been under the impression that cheaper and safer is better!

The first thing I hear to explain this – mostly from robotic surgeons and from the robotic surgery device sales representatives – is that the decline in the proportion of vaginal hysterectomies is irrelevant in that it has taken the robot to meaningfully reduce open hysterectomy rates. The other argument I hear – mostly from the laparoscopic surgeons – is that vaginal hysterectomy rates have not changed because most gynecologists cannot and will never be able to perform the procedure. So, what is the point of even discussing solutions?

I disagree with the laparoscopic and robotic surgeons. We should be outraged and do something to effect change. Vaginal hysterectomy offers better value (for surgeons who aren’t thinking about value right now, I suggest that you start. Value-based reimbursement is coming soon) and we know that a high percentage of vaginal hysterectomies are feasible in general gynecologic populations. Surgeons who perform vaginal hysterectomy are not magicians or better surgeons, just differently trained. We have to recognize that many, or even most, patients are candidates for vaginal hysterectomy.

Finally, when we look at robotics for benign disease, we spend more money than on other minimally invasive hysterectomy techniques but we don’t get better outcomes (J Minim Invasive Gynecol. 2010;17[6]:730-8and Eur J Obstet Gynecol Reprod Biol. 150[1]:92-6). Yet surgeons currently use robotics for 25% or more of benign hysterectomies.

What are we thinking and how can we afford to continue this?

We need to counsel our patients (and ourselves) that a total hysterectomy requires an incision in the vagina, and there can be a need for additional abdominal incisions of varying size and number. Fully informed consent must include a discussion of all types of hysterectomy including both patient and surgeon factors associated with the recommended route. Ultimately, the route of hysterectomy should be based on the patient and not the surgeon (Obstet Gynecol. 2014;124[3]:585-8).

It is easy to say, and supported by the evidence, that we should do more vaginal hysterectomies. It is also easy to note that the rate of vaginal hysterectomy has been stable to declining over the last 4 decades and that there are significant issues with residency training in gynecologic surgery (serious issues, but beyond the scope of this editorial).

So, what are we at SGS doing to support increased rates of vaginal hysterectomy? Every December we sponsor a postgraduate course on vaginal hysterectomy techniques. This is an excellent learning opportunity. (Visit www.sgsonline.org for more information regarding dates and costs). We’re starting partnerships with the American College of Obstetricians and Gynecologists (ACOG), the Foundation for Exxcellence in Women’s Health and others, to begin a “train the trainer” program to teach junior faculty how to do and teach vaginal hysterectomy. We’ve developed CREOG (Council on Resident Education in Obstetrics and Gynecology) modules to educate residents about the procedure, and we are in the process of communicating with residency and fellowship program directors about what else we can do to assist them with vaginal hysterectomy teaching. Other goals are to work with ACOG to develop quality metrics for hysterectomy and to develop physician-focused alternative payment models that recognize the value of vaginal hysterectomy.

I believe that in this country we should train for, incentivize, and insist upon a vaginal hysterectomy rate of at least 40% (this albeit arbitrary percentage is based upon the majority of vaginally parous women with uteri less than 12 weeks in size and a minority of the more difficult patients getting a vaginal hysterectomy). And before you say “it’s never been 40%,” please consider the famous quotation by Dr. William Mayo: “The best interest of the patient is the only interest to be considered.” Clearly, the best interest of the patient, if she is a candidate, is to have a vaginal hysterectomy. Our mission at SGS is to facilitate surgical education to make more patients candidates for vaginal hysterectomy so that we can achieve the 40% goal.

Dr. Walter is director of urogynecology and pelvic pain at The Permanente Medical Group, Roseville, Calif. He is also the immediate past president of the Society of Gynecologic Surgeons. He reported having no financial disclosures.

YES: Immediate and safe patient access

Pharmacist-prescribed contraception laws are an opportunity to safely and easily improve access to contraception for women. While over-the-counter access remains an important goal, there are many practical considerations that must be addressed prior to implementation.

For example, in order to change the status of a medication to OTC, each product’s manufacturer needs to apply to the Food and Drug Administration for the change. This application includes studies that demonstrate their product can be safely used by the general public, without guidance from a health professional. The American College of Obstetricians and Gynecologists has already weighed in on the overall safety of oral contraceptives, and some studies have been done that show women can accurately complete a health questionnaire related to their OC eligibility. While these are good steps toward demonstrating safe use, they do not satisfy FDA requirements for OTC status. These initial studies never went to the next step of having women interpret the questions in an “actual use study,” an FDA requirement.

On the other hand, there have been studies demonstrating that pharmacists can safely provide hormonal contraception (J Am Pharm Assoc. 2008 Mar-Apr;48[2]:212-21). State laws can’t overrule the FDA and make hormonal contraception OTC, but they can change the scope of what pharmacists are permitted to do. In Oregon and California, specific laws allowing pharmacists to prescribe hormonal contraception have already been implemented. Speaking from our experience in Oregon, this change has solved many concerns that have been raised about hormonal contraception going OTC.

Maintaining insurance coverage

Since pharmacists are able to write prescriptions, they can bill insurance plans for the product in the same way as for any other prescription. The majority of OTC medications are not covered by insurance and if a future law required insurance to cover contraception obtained OTC, pharmacists would still be involved in billing.

Patients will continue to get counseling

Pharmacists need to undergo training/certification in order to prescribe hormonal contraception. In Oregon, the certification was developed by pharmacists and physicians with input from the Oregon Health Authority and the Oregon Board of Pharmacy. Having a trained health care professional involved in counseling means that accurate and important information is still conveyed, including ensuring women are aware that hormonal contraception is not going to protect against sexually transmitted infections, and teaching women about the importance of adherence, but also how to deal with missed pills and problems. The importance of accessing other preventive health services can also be stressed.

Patients will be appropriately screened for their eligibility

Women who are unable to safely use hormonal contraceptives will be referred for more appropriate methods.

We have the opportunity to act now to prevent unintended pregnancy through pharmacist-prescribed hormonal contraceptives. In addition, allowing pharmacists to directly prescribe hormonal contraceptives provides the opportunity to evaluate the safety, efficacy, and acceptability of the practice. This evidence can then be used to look at the feasibility and possible mechanisms that could be undertaken to safely move hormonal contraceptives to OTC, which helps the OTC movement rather than distracting from it.

Dr. Anderson is an instructor at the Oregon State University College of Pharmacy in Corvallis. Dr. Rodriguez is an assistant professor of ob.gyn. at Oregon Health & Science University in Portland. Dr. Edelman is a professor of ob.gyn. and director of the Oregon Family Planning Fellowship at OHSU. They reported having no relevant financial disclosures.

NO: Exchanging one barrier for another

Birth control is an essential part of women’s health care and the value of contraception has been proven time and again. Not only do oral contraceptives provide women with the ability to choose if, and when, they want to become pregnant, they allow women to have more control over their lives by timing pregnancy around education, careers, and other life goals. Nearly 90% of women in the United States between the ages of 15 and 44 will use a highly effective, reversible method of contraception, such as oral contraceptives, injected contraceptives, cervical rings, contraceptive implants, or intrauterine devices.

Ob.gyns. know from evidence and experience that oral contraceptives are safe enough for OTC access. In fact, oral contraceptives are safer than many other medications that are already available OTC, such as acetaminophen. Of note, thromboembolism, the most common serious risk associated with oral contraceptives, is not only exceedingly low but is also much lower than the risk for thromboembolism during pregnancy and the postpartum period. After all, no diagnosis is required to prescribe oral contraceptives. Of course, ob.gyns. and other women’s health care providers do screen for easily recognizable risk factors, such as smoking. However, research shows that women are very adept at self-screening for any potential risks.

For these reasons, ACOG has long been a public supporter of OTC access to oral contraceptives, as it already is in many countries around the world. ACOG supports efforts to increase affordable, reliable access for American women to the contraceptives they need, when they need them.

However, the pharmacist-prescribing laws do not go far enough in expanding access to contraception. A pharmacist’s prescription simply exchanges one barrier – a physician’s prescription – for another.

Women still need to arrange a consultation with a pharmacist during pharmacy hours and any potential cost associated with that consultation would add out-of-pocket expenses. This will not allow us to reach women who remain underserved by the current prescribing requirements. For example, this may prevent women who are uninsured or underinsured from accessing contraception. For some, the need to visit a health care provider prevents access to contraception.

ACOG continues to stand by full, no-copay coverage of all FDA-approved methods of birth control, under the Affordable Care Act, as we recognize that OTC access to birth control is not a blanket solution. We also continue to strongly advocate for access to long-acting reversible contraceptive methods, the most effective method of preventing pregnancy.

Pharmacists and ob.gyns. alike share a commitment to quality patient care. However, if our shared goal is increasing access to safe, effective contraception, women should be trusted to control their reproductive lives and should be able to do so without barriers.

Dr. DeFrancesco is an ob.gyn. in Cheshire, Conn., and the president of the American College of Obstetricians and Gynecologists. He reported having no relevant financial disclosures.

YES: Immediate and safe patient access

Pharmacist-prescribed contraception laws are an opportunity to safely and easily improve access to contraception for women. While over-the-counter access remains an important goal, there are many practical considerations that must be addressed prior to implementation.

For example, in order to change the status of a medication to OTC, each product’s manufacturer needs to apply to the Food and Drug Administration for the change. This application includes studies that demonstrate their product can be safely used by the general public, without guidance from a health professional. The American College of Obstetricians and Gynecologists has already weighed in on the overall safety of oral contraceptives, and some studies have been done that show women can accurately complete a health questionnaire related to their OC eligibility. While these are good steps toward demonstrating safe use, they do not satisfy FDA requirements for OTC status. These initial studies never went to the next step of having women interpret the questions in an “actual use study,” an FDA requirement.

On the other hand, there have been studies demonstrating that pharmacists can safely provide hormonal contraception (J Am Pharm Assoc. 2008 Mar-Apr;48[2]:212-21). State laws can’t overrule the FDA and make hormonal contraception OTC, but they can change the scope of what pharmacists are permitted to do. In Oregon and California, specific laws allowing pharmacists to prescribe hormonal contraception have already been implemented. Speaking from our experience in Oregon, this change has solved many concerns that have been raised about hormonal contraception going OTC.

Maintaining insurance coverage

Since pharmacists are able to write prescriptions, they can bill insurance plans for the product in the same way as for any other prescription. The majority of OTC medications are not covered by insurance and if a future law required insurance to cover contraception obtained OTC, pharmacists would still be involved in billing.

Patients will continue to get counseling

Pharmacists need to undergo training/certification in order to prescribe hormonal contraception. In Oregon, the certification was developed by pharmacists and physicians with input from the Oregon Health Authority and the Oregon Board of Pharmacy. Having a trained health care professional involved in counseling means that accurate and important information is still conveyed, including ensuring women are aware that hormonal contraception is not going to protect against sexually transmitted infections, and teaching women about the importance of adherence, but also how to deal with missed pills and problems. The importance of accessing other preventive health services can also be stressed.

Patients will be appropriately screened for their eligibility

Women who are unable to safely use hormonal contraceptives will be referred for more appropriate methods.

We have the opportunity to act now to prevent unintended pregnancy through pharmacist-prescribed hormonal contraceptives. In addition, allowing pharmacists to directly prescribe hormonal contraceptives provides the opportunity to evaluate the safety, efficacy, and acceptability of the practice. This evidence can then be used to look at the feasibility and possible mechanisms that could be undertaken to safely move hormonal contraceptives to OTC, which helps the OTC movement rather than distracting from it.

Dr. Anderson is an instructor at the Oregon State University College of Pharmacy in Corvallis. Dr. Rodriguez is an assistant professor of ob.gyn. at Oregon Health & Science University in Portland. Dr. Edelman is a professor of ob.gyn. and director of the Oregon Family Planning Fellowship at OHSU. They reported having no relevant financial disclosures.

NO: Exchanging one barrier for another

Birth control is an essential part of women’s health care and the value of contraception has been proven time and again. Not only do oral contraceptives provide women with the ability to choose if, and when, they want to become pregnant, they allow women to have more control over their lives by timing pregnancy around education, careers, and other life goals. Nearly 90% of women in the United States between the ages of 15 and 44 will use a highly effective, reversible method of contraception, such as oral contraceptives, injected contraceptives, cervical rings, contraceptive implants, or intrauterine devices.

Ob.gyns. know from evidence and experience that oral contraceptives are safe enough for OTC access. In fact, oral contraceptives are safer than many other medications that are already available OTC, such as acetaminophen. Of note, thromboembolism, the most common serious risk associated with oral contraceptives, is not only exceedingly low but is also much lower than the risk for thromboembolism during pregnancy and the postpartum period. After all, no diagnosis is required to prescribe oral contraceptives. Of course, ob.gyns. and other women’s health care providers do screen for easily recognizable risk factors, such as smoking. However, research shows that women are very adept at self-screening for any potential risks.

For these reasons, ACOG has long been a public supporter of OTC access to oral contraceptives, as it already is in many countries around the world. ACOG supports efforts to increase affordable, reliable access for American women to the contraceptives they need, when they need them.

However, the pharmacist-prescribing laws do not go far enough in expanding access to contraception. A pharmacist’s prescription simply exchanges one barrier – a physician’s prescription – for another.

Women still need to arrange a consultation with a pharmacist during pharmacy hours and any potential cost associated with that consultation would add out-of-pocket expenses. This will not allow us to reach women who remain underserved by the current prescribing requirements. For example, this may prevent women who are uninsured or underinsured from accessing contraception. For some, the need to visit a health care provider prevents access to contraception.

ACOG continues to stand by full, no-copay coverage of all FDA-approved methods of birth control, under the Affordable Care Act, as we recognize that OTC access to birth control is not a blanket solution. We also continue to strongly advocate for access to long-acting reversible contraceptive methods, the most effective method of preventing pregnancy.

Pharmacists and ob.gyns. alike share a commitment to quality patient care. However, if our shared goal is increasing access to safe, effective contraception, women should be trusted to control their reproductive lives and should be able to do so without barriers.

Dr. DeFrancesco is an ob.gyn. in Cheshire, Conn., and the president of the American College of Obstetricians and Gynecologists. He reported having no relevant financial disclosures.

YES: Immediate and safe patient access

Pharmacist-prescribed contraception laws are an opportunity to safely and easily improve access to contraception for women. While over-the-counter access remains an important goal, there are many practical considerations that must be addressed prior to implementation.

For example, in order to change the status of a medication to OTC, each product’s manufacturer needs to apply to the Food and Drug Administration for the change. This application includes studies that demonstrate their product can be safely used by the general public, without guidance from a health professional. The American College of Obstetricians and Gynecologists has already weighed in on the overall safety of oral contraceptives, and some studies have been done that show women can accurately complete a health questionnaire related to their OC eligibility. While these are good steps toward demonstrating safe use, they do not satisfy FDA requirements for OTC status. These initial studies never went to the next step of having women interpret the questions in an “actual use study,” an FDA requirement.

On the other hand, there have been studies demonstrating that pharmacists can safely provide hormonal contraception (J Am Pharm Assoc. 2008 Mar-Apr;48[2]:212-21). State laws can’t overrule the FDA and make hormonal contraception OTC, but they can change the scope of what pharmacists are permitted to do. In Oregon and California, specific laws allowing pharmacists to prescribe hormonal contraception have already been implemented. Speaking from our experience in Oregon, this change has solved many concerns that have been raised about hormonal contraception going OTC.

Maintaining insurance coverage

Since pharmacists are able to write prescriptions, they can bill insurance plans for the product in the same way as for any other prescription. The majority of OTC medications are not covered by insurance and if a future law required insurance to cover contraception obtained OTC, pharmacists would still be involved in billing.

Patients will continue to get counseling

Pharmacists need to undergo training/certification in order to prescribe hormonal contraception. In Oregon, the certification was developed by pharmacists and physicians with input from the Oregon Health Authority and the Oregon Board of Pharmacy. Having a trained health care professional involved in counseling means that accurate and important information is still conveyed, including ensuring women are aware that hormonal contraception is not going to protect against sexually transmitted infections, and teaching women about the importance of adherence, but also how to deal with missed pills and problems. The importance of accessing other preventive health services can also be stressed.

Patients will be appropriately screened for their eligibility

Women who are unable to safely use hormonal contraceptives will be referred for more appropriate methods.

We have the opportunity to act now to prevent unintended pregnancy through pharmacist-prescribed hormonal contraceptives. In addition, allowing pharmacists to directly prescribe hormonal contraceptives provides the opportunity to evaluate the safety, efficacy, and acceptability of the practice. This evidence can then be used to look at the feasibility and possible mechanisms that could be undertaken to safely move hormonal contraceptives to OTC, which helps the OTC movement rather than distracting from it.

Dr. Anderson is an instructor at the Oregon State University College of Pharmacy in Corvallis. Dr. Rodriguez is an assistant professor of ob.gyn. at Oregon Health & Science University in Portland. Dr. Edelman is a professor of ob.gyn. and director of the Oregon Family Planning Fellowship at OHSU. They reported having no relevant financial disclosures.

NO: Exchanging one barrier for another

Birth control is an essential part of women’s health care and the value of contraception has been proven time and again. Not only do oral contraceptives provide women with the ability to choose if, and when, they want to become pregnant, they allow women to have more control over their lives by timing pregnancy around education, careers, and other life goals. Nearly 90% of women in the United States between the ages of 15 and 44 will use a highly effective, reversible method of contraception, such as oral contraceptives, injected contraceptives, cervical rings, contraceptive implants, or intrauterine devices.

Ob.gyns. know from evidence and experience that oral contraceptives are safe enough for OTC access. In fact, oral contraceptives are safer than many other medications that are already available OTC, such as acetaminophen. Of note, thromboembolism, the most common serious risk associated with oral contraceptives, is not only exceedingly low but is also much lower than the risk for thromboembolism during pregnancy and the postpartum period. After all, no diagnosis is required to prescribe oral contraceptives. Of course, ob.gyns. and other women’s health care providers do screen for easily recognizable risk factors, such as smoking. However, research shows that women are very adept at self-screening for any potential risks.

For these reasons, ACOG has long been a public supporter of OTC access to oral contraceptives, as it already is in many countries around the world. ACOG supports efforts to increase affordable, reliable access for American women to the contraceptives they need, when they need them.

However, the pharmacist-prescribing laws do not go far enough in expanding access to contraception. A pharmacist’s prescription simply exchanges one barrier – a physician’s prescription – for another.

Women still need to arrange a consultation with a pharmacist during pharmacy hours and any potential cost associated with that consultation would add out-of-pocket expenses. This will not allow us to reach women who remain underserved by the current prescribing requirements. For example, this may prevent women who are uninsured or underinsured from accessing contraception. For some, the need to visit a health care provider prevents access to contraception.

ACOG continues to stand by full, no-copay coverage of all FDA-approved methods of birth control, under the Affordable Care Act, as we recognize that OTC access to birth control is not a blanket solution. We also continue to strongly advocate for access to long-acting reversible contraceptive methods, the most effective method of preventing pregnancy.

Pharmacists and ob.gyns. alike share a commitment to quality patient care. However, if our shared goal is increasing access to safe, effective contraception, women should be trusted to control their reproductive lives and should be able to do so without barriers.

Dr. DeFrancesco is an ob.gyn. in Cheshire, Conn., and the president of the American College of Obstetricians and Gynecologists. He reported having no relevant financial disclosures.

Voice recognition software has come a long way. I tried it 15 years ago, but gave up in frustration. Recently, I took another look and found that technology has advanced a lot. Although I can now dictate fast and see the words pour out with impressive accuracy, there are still plenty of errors – some of them quite … interesting. Below is a case summary made up of examples from my growing collection of things the computer seems to have thought I said.

The moral: If you dictate with voice recognition software, proofread!

Chief Complaint

This 43-year-old woman presents with chief complaints of “facial and skin issues.”

Past Medical History

She reports that he has been engaged in a prolonged bottle with acne. It has lasted 18 months, urinary half. A previous physician prescribed an oral antibiotic, either doxycycline or minor cycling. She reports recurrent tachycardia on the forehead and cheeks. Although her outbreaks are not always hormonal, she sometimes gets worse around her. I said around her.! Her menstrual.!! Oh, never mind. It’s good that her name isn’t Cohen, because the computer hears that as :

She has scalp itch and here loss, and is convinced she has pediculosis capitis because of head Lausten chief found. There is a remote history of localized baldness, but not of alopecia universe Alice.

Though free of eczema in recent years, she recalls ataxic childhood.

She was recently exposed to chicken pox but did not contract Maricella. Her history of viral illnesses includes Molested contagiosum.

When she goes in the sun, she is not able to get a 10. She takes no narcotic analgesics, especially Oxyclean.

Occasional scaly rashes have been treated with both antifungal and antibiotic East creams, and sometimes with topical spheroids.

The patient has undergone various medical anesthetic procedures.

Personal and social history

The last 4 digits of her Social Security number are 1/6/09.

She is Director of Marketing for an appetizing agency. Her uncle is a scientist who won the No Bell Prize.

Hobbies: Skiing in Aspirin, Colorado. Competitive barbecue in dialysis, Texas.

Physical Examination

Eyes: There is a cystic lesion on the right I. This is a she’ll lazy on.

Face: Her breakouts are popular. The facial lesions are robbed because of Washington with vigor. Several are just above the nose on the club Ella. There is also sun damage: She has to saltwater keratoses on the 4 head.

Neck: Shotty notes. There is dark thickening typical of a cantholysis Neighbor can’t. There are firm lesions on the occipital scalp consistent with folliculitis Keloid Dallas. The redness on both sides of her neck represents Poikilokderma of survived.

Hands: Xerosis, aggravated by frequent hand washing with puerile. Nails demonstrate the partial separation of cholelithiasis.

Torso: There is a lichenoid rash that sometimes loses. This rash is all over and is very expensive. It is lichenoid and shows a violent color. She has many demented lesions. All are B9.

Upper extremities: There are four systolic keratoses on the vulvar forearm.

Lower extremities: There is a bleeding red lesion of recent onset on the left thigh. It is a high and Janet granuloma.

Groin: Her penile wart is not visible.

Assessment and plan

I will desiccate her high and Janet granuloma.

Will treat her losing rash with Burro solution soaks, followed by topical spheroids.

She was worried that she has precancerous cemented lesions, but I see no indication that she dies.

She will clean her hands less often, otherwise he will have Cirrhosis from Washington. She will moisturize with Aqua 4.

While outdoors, she will protect herself from the son.

For acne, recommended isotretinoin, enrolled patient in iPledge program. She cannot have a fasting blood test today, as she 8 this morning. He will obtain a pregnancy test, and I will confirm patient’s cuddling.

My staph will send a report of today’s visit to the patient’s Coronary Physician.

Dr. Rockoff practices dermatology in Brookline, Mass. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.

Voice recognition software has come a long way. I tried it 15 years ago, but gave up in frustration. Recently, I took another look and found that technology has advanced a lot. Although I can now dictate fast and see the words pour out with impressive accuracy, there are still plenty of errors – some of them quite … interesting. Below is a case summary made up of examples from my growing collection of things the computer seems to have thought I said.

The moral: If you dictate with voice recognition software, proofread!

Chief Complaint

This 43-year-old woman presents with chief complaints of “facial and skin issues.”

Past Medical History

She reports that he has been engaged in a prolonged bottle with acne. It has lasted 18 months, urinary half. A previous physician prescribed an oral antibiotic, either doxycycline or minor cycling. She reports recurrent tachycardia on the forehead and cheeks. Although her outbreaks are not always hormonal, she sometimes gets worse around her. I said around her.! Her menstrual.!! Oh, never mind. It’s good that her name isn’t Cohen, because the computer hears that as :

She has scalp itch and here loss, and is convinced she has pediculosis capitis because of head Lausten chief found. There is a remote history of localized baldness, but not of alopecia universe Alice.

Though free of eczema in recent years, she recalls ataxic childhood.

She was recently exposed to chicken pox but did not contract Maricella. Her history of viral illnesses includes Molested contagiosum.

When she goes in the sun, she is not able to get a 10. She takes no narcotic analgesics, especially Oxyclean.

Occasional scaly rashes have been treated with both antifungal and antibiotic East creams, and sometimes with topical spheroids.

The patient has undergone various medical anesthetic procedures.

Personal and social history

The last 4 digits of her Social Security number are 1/6/09.

She is Director of Marketing for an appetizing agency. Her uncle is a scientist who won the No Bell Prize.

Hobbies: Skiing in Aspirin, Colorado. Competitive barbecue in dialysis, Texas.

Physical Examination

Eyes: There is a cystic lesion on the right I. This is a she’ll lazy on.

Face: Her breakouts are popular. The facial lesions are robbed because of Washington with vigor. Several are just above the nose on the club Ella. There is also sun damage: She has to saltwater keratoses on the 4 head.

Neck: Shotty notes. There is dark thickening typical of a cantholysis Neighbor can’t. There are firm lesions on the occipital scalp consistent with folliculitis Keloid Dallas. The redness on both sides of her neck represents Poikilokderma of survived.

Hands: Xerosis, aggravated by frequent hand washing with puerile. Nails demonstrate the partial separation of cholelithiasis.

Torso: There is a lichenoid rash that sometimes loses. This rash is all over and is very expensive. It is lichenoid and shows a violent color. She has many demented lesions. All are B9.

Upper extremities: There are four systolic keratoses on the vulvar forearm.

Lower extremities: There is a bleeding red lesion of recent onset on the left thigh. It is a high and Janet granuloma.

Groin: Her penile wart is not visible.

Assessment and plan

I will desiccate her high and Janet granuloma.

Will treat her losing rash with Burro solution soaks, followed by topical spheroids.

She was worried that she has precancerous cemented lesions, but I see no indication that she dies.

She will clean her hands less often, otherwise he will have Cirrhosis from Washington. She will moisturize with Aqua 4.

While outdoors, she will protect herself from the son.

For acne, recommended isotretinoin, enrolled patient in iPledge program. She cannot have a fasting blood test today, as she 8 this morning. He will obtain a pregnancy test, and I will confirm patient’s cuddling.

My staph will send a report of today’s visit to the patient’s Coronary Physician.

Dr. Rockoff practices dermatology in Brookline, Mass. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.

Voice recognition software has come a long way. I tried it 15 years ago, but gave up in frustration. Recently, I took another look and found that technology has advanced a lot. Although I can now dictate fast and see the words pour out with impressive accuracy, there are still plenty of errors – some of them quite … interesting. Below is a case summary made up of examples from my growing collection of things the computer seems to have thought I said.

The moral: If you dictate with voice recognition software, proofread!

Chief Complaint

This 43-year-old woman presents with chief complaints of “facial and skin issues.”

Past Medical History

She reports that he has been engaged in a prolonged bottle with acne. It has lasted 18 months, urinary half. A previous physician prescribed an oral antibiotic, either doxycycline or minor cycling. She reports recurrent tachycardia on the forehead and cheeks. Although her outbreaks are not always hormonal, she sometimes gets worse around her. I said around her.! Her menstrual.!! Oh, never mind. It’s good that her name isn’t Cohen, because the computer hears that as :

She has scalp itch and here loss, and is convinced she has pediculosis capitis because of head Lausten chief found. There is a remote history of localized baldness, but not of alopecia universe Alice.

Though free of eczema in recent years, she recalls ataxic childhood.

She was recently exposed to chicken pox but did not contract Maricella. Her history of viral illnesses includes Molested contagiosum.

When she goes in the sun, she is not able to get a 10. She takes no narcotic analgesics, especially Oxyclean.

Occasional scaly rashes have been treated with both antifungal and antibiotic East creams, and sometimes with topical spheroids.

The patient has undergone various medical anesthetic procedures.

Personal and social history

The last 4 digits of her Social Security number are 1/6/09.

She is Director of Marketing for an appetizing agency. Her uncle is a scientist who won the No Bell Prize.

Hobbies: Skiing in Aspirin, Colorado. Competitive barbecue in dialysis, Texas.

Physical Examination

Eyes: There is a cystic lesion on the right I. This is a she’ll lazy on.

Face: Her breakouts are popular. The facial lesions are robbed because of Washington with vigor. Several are just above the nose on the club Ella. There is also sun damage: She has to saltwater keratoses on the 4 head.

Neck: Shotty notes. There is dark thickening typical of a cantholysis Neighbor can’t. There are firm lesions on the occipital scalp consistent with folliculitis Keloid Dallas. The redness on both sides of her neck represents Poikilokderma of survived.

Hands: Xerosis, aggravated by frequent hand washing with puerile. Nails demonstrate the partial separation of cholelithiasis.

Torso: There is a lichenoid rash that sometimes loses. This rash is all over and is very expensive. It is lichenoid and shows a violent color. She has many demented lesions. All are B9.

Upper extremities: There are four systolic keratoses on the vulvar forearm.

Lower extremities: There is a bleeding red lesion of recent onset on the left thigh. It is a high and Janet granuloma.

Groin: Her penile wart is not visible.

Assessment and plan

I will desiccate her high and Janet granuloma.

Will treat her losing rash with Burro solution soaks, followed by topical spheroids.

She was worried that she has precancerous cemented lesions, but I see no indication that she dies.

She will clean her hands less often, otherwise he will have Cirrhosis from Washington. She will moisturize with Aqua 4.

While outdoors, she will protect herself from the son.

For acne, recommended isotretinoin, enrolled patient in iPledge program. She cannot have a fasting blood test today, as she 8 this morning. He will obtain a pregnancy test, and I will confirm patient’s cuddling.

My staph will send a report of today’s visit to the patient’s Coronary Physician.

Dr. Rockoff practices dermatology in Brookline, Mass. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years.

Editor’s Note: This is the fifth and final installment of a five-part monthly series that will discuss the biologic, genomic, and health system factors that contribute to the racial survival disparity in breast cancer. The series was adapted from an article that originally appeared in CA: A Cancer Journal for Clinicians,¹ a journal of the American Cancer Society.

As discussed in the last installment of this series, multifaceted interventions that address all stakeholders are needed to close the racial disparity gap in breast cancer. The Patient Protection and Affordable Care Act (PPACA) emphasizes delivery system reform with a focus on the triple aim of better health, better health care, and lower costs.² One component of this reform will be accountable care organizations (ACOs). ACOs potentially could assist in closing the racial mortality gap, because provider groups will take responsibility for improving the health of a defined population and will be held accountable for the quality of care delivered.

In the ACO model, an integrated network of providers, led by primary care practitioners, will evaluate the necessity, quality, value, and accountable delivery of specialty diagnostic and therapeutic procedures, including cancer care.³ ACOs will also collect extensive patient data through the meaningful use of medical records.³ These detailed data can then be used to shape locoregional protocols for clinical decision making in oncology and evaluate physician performance. Intermountain Healthcare is an example of an organization that has had success with instituting these clinical protocols to highlight best practices and improve the quality of care.⁴ In breast cancer, oncologists will need to be prepared to develop and follow protocols tailored for their communities, which will lead to standardized, improved care for minority populations.

The oncology medical home is one example of an ACO delivery system reform that has the potential to reduce the racial mortality gap. The oncology medical home replaces episodic care with long-term coordinated care and replaces the fee-for-service model with a performance and outcomes-based system. A key trait of the oncology medical home is care that is continuously improved by measurement against quality standards.⁵ The model oncology home accomplishes this by incorporating software to extract clinical data as well as provider compliance with locoregional guidelines to give oncologists feedback regarding the quality of care that they are providing.⁶ Through this system reform, oncologists will be held accountable for the care they deliver, and it is hoped that this will eliminate the delays, misuse, and underuse of treatment. This could be especially important for optimizing use of hormone therapy for estrogen receptor-positive breast cancer. Trial oncology medical homes in North Carolina and Michigan have yielded promising results regarding improved care (fewer emergency department visits and inpatient admissions) and high adherence to national and practice-selected guidelines.^7,8

PPACA also increases funding for community health centers and provides grants to support community health workers; this highlights again the importance of place in racial health care disparities.⁹ Encouraging collaboration between community health centers and academic institutions, this funding could build bridges between minority communities and high-quality health care institutions while also improving patient communication and education.⁹ As this series has discussed, a failure to provide culturally appropriate clinical information can lead to issues with follow-up and adjuvant treatment compliance and further widen the breast cancer racial mortality gap.

Frontline Medical News

Delivery system reform has the potential to help close the disparity gap by improving the quality of care delivered to minority breast cancer patients. As Chin et al¹⁰ describe in their analysis of effective strategies for reducing health disparities, successful interventions are “culturally tailored to meet patients’ needs, employ multidisciplinary teams of care providers, and target multiple leverage points along a patient’s pathway of care.” ACOs have the financial incentive to meet these features of a successful intervention and improve quality across the continuum of breast cancer care. In addition, the PPACA “incentivized experimentation” with health care delivery, such as the oncology medical home and novel telemedicine interventions, to provide higher quality care outside of hospital settings, which could impact the disparity gap.¹¹

In the face of this new era of organizational structures focused on coordinated, population-based care, oncology providers put themselves at financial risk if they do not position themselves for policy and reimbursement changes that reduce disparities.¹⁰ However, ongoing research will be needed to ensure that as these changes are implemented, the racial mortality gap in breast cancer decreases, and that no vulnerable patient populations are left out.

Precision medicine for all

In addition, as discussed earlier in this series, there are differences in the tumor biology and genomics of breast cancer in African American patients. Beyond quality interventions, initiatives to reduce the mortality gap should focus on precision medicine for all. These initiatives should allow researchers to better understand biologic and genomic differences among breast cancer patients and tailor treatments accordingly. The PPACA has taken steps in this direction and is the first federal law to require group health plans and state-licensed health insurance companies to cover standard-of-care costs associated with participation in clinical trials as well as genetic testing for prevention.¹²

The clinical trial regulations also expressly require plans to show that administrative burdens are not used to create barriers to cancer care for anyone who might benefit from participation in a clinical trial.⁹ The overarching goal of this push to eliminate financial and administrative barriers is to increase the enrollment of minority patients, especially those who do not live close to academic medical centers. In his April 2016 address at the annual meeting of the American Association for Cancer Research, Vice President Joseph Biden identified increased clinical trial participation as a key component of the administration’s cancer “moonshot” as well. Community medical oncologists will be called upon to facilitate and encourage clinical trial participation by their minority patients and should be supported in this endeavor by academic medical centers. With greater minority patient involvement, however, there also should be further research on how trial designs can better lead to clinically significant findings for minority patients. As Polite et al¹³ argue, at a bare minimum, basic sociodemographic and detailed comorbidity information should be prospectively collected and integrated with tumor and host biology data to better examine racial differences in cancer outcomes.

Initiatives also are needed to address the gap in referrals to cancer risk clinics so that more data are available on African American genetic variants, allowing the creation of more robust risk assessment models. Risk assessment relies on predictive statistical models to estimate an individual’s risk of developing cancer, and without accurate estimates of mutation prevalence in minority subgroups, these models’ reliability is compromised.¹⁴ As shown in a recent study at the University of Chicago’s Comprehensive Cancer Risk and Prevention Clinic using targeted genomic capture and next-generation sequencing, nearly one in four African American breast cancer patients referred to the clinic had inherited at least one damaging mutation that increased their risk for the most aggressive type of breast cancer.¹⁵

To identify damaging mutations only after a diagnosis of incurable breast cancer is a failure of prevention. As has been documented in Ashkenazi Jewish populations, there is evidence of high rates of inherited mutations in genes that increase the risk for aggressive breast cancers in populations of African ancestry. This is a fertile area for further research to better understand how these mutations affect the clinical course of breast cancer, what targeted interventions will increase the proportion of breast cancer diagnosed at stage 1, and what molecularly targeted treatments will produce a response in these tumors. Churpek et al¹⁵ also demonstrated the need for continued technological innovation to reduce the disparity gap, because next-generation sequencing is a faster and more cost-efficient way to evaluate multiple variants in many genes. This approach is particularly valuable for African Americans, who tend to have greater genetic diversity.¹⁶ The current administration is also heralding this approach to cancer care. In his 2015 State of the Union address, President Obama announced a precision medicine initiative, including a request for $70 million for the National Cancer Institute to investigate genes that may contribute to the risk of developing cancer.¹⁷ African American women should no longer be left behind in the push for personalized medicine that caters to a patient’s tumor biology and genetic profile. As Subbiah and Kurzrock state, universal genomic testing is not necessarily cost prohibitive, as the cost to obtain a “complete diagnosis and to select appropriate therapy may be miniscule compared with the money wasted on ill-chosen therapies.”¹⁸ 

In conclusion, there is an opportunity in the current climate of health care reform ushered in by the Affordable Care Act to address many of the discussed elements leading to the persistent racial mortality gap in breast cancer. We have argued that two substantial factors lead to this eroding gap. One is differences in tumor biology and genomics, and the second is a quality difference in patterns of care. In describing the perfect storm, Sebastian Junger¹⁹ wrote of the collision of two forces – a hurricane’s warm-air, low-pressure system and an anticyclone’s cool-air, high-pressure system – that combined to create a more powerful and devastating meteorological force. Similarly, we argue that it is the collision of these two factors – tumor biology and genomics with patterns of care – that leads to the breast cancer mortality gap. The delays, misuse, and underuse of treatment that we have underscored are of increased significance when patients present with more aggressive forms of breast cancer. Interventions to close this gap will take leaders at the patient, provider, payer, and community levels to drive system change.

1. Daly B, Olopade OI: A perfect storm: How tumor biology, genomics, and health care delivery patterns collide to create a racial survival disparity in breast cancer and proposed interventions for change. CA Cancer J Clin. 2015 Apr;65:221-38.

2. Fox J: Lessons from an oncology medical home collaborative. Am J Manag Care. 2013; 19:SP5-9.

3. Mehta AJ, Macklis RM: Overview of accountable care organizations for oncology specialists. J Oncol Pract. 2013 Jul; 9(4):216-21.

4. Daly B, Mort EA: A decade after to Err is Human: what should health care leaders be doing? Physician Exec. 2014 May-Jun; 40(3):50-2, 54.

5. Dangi-Garimella S: Oncology medical home: improved quality and cost of care. Am J Manag Care. 2014 Sep.

6. McAneny BL: The future of oncology? COME HOME, the oncology medical home. Am J Manag Care. 2013 Feb.

7. Goyal RK, Wheeler SB, Kohler RE, et al: Health care utilization from chemotherapy-related adverse events among low-income breast cancer patients: effect of enrollment in a medical home program. N C Med J. 2014 Jul-Aug;75(4):231-8.

8. Kuntz G, Tozer JM, Snegosky J, et al: Michigan Oncology Medical Home Demonstration Project: first-year results. J Oncol Pract. 2014 Sep. 10:294-7.

9. Moy B, Polite BN, Halpern MT, et al: American Society of Clinical Oncology policy statement: opportunities in the patient protection and affordable care act to reduce cancer care disparities. J Clin Oncol. 2011 Oct;29(28):3816-24.

10. Chin MH, Clarke AR, Nocon RS, et al: A roadmap and best practices for organizations to reduce racial and ethnic disparities in health care. J Gen Intern Med. 2012 Aug; 27(8):992-1000.

11. Emanuel EJ: How Well Is the Affordable Care Act Doing?: Reasons for Optimism. JAMA 315:1331-2, 2016.

12. Zhang SQ, Polite BN: Achieving a deeper understanding of the implemented provisions of the Affordable Care Act. Am Soc Clin Oncol Educ Book. 2014:e472-7.

13. Polite BN, Sylvester BE, Olopade OI: Race and subset analyses in clinical trials: time to get serious about data integration. J Natl Cancer Inst. 2011 Oct. 103(20):1486-8.

14. Hall MJ, Olopade OI: Disparities in genetic testing: thinking outside the BRCA box. J Clin Oncol. 2006 May; 24(14):2197-203.

15. Churpek JE, Walsh T, Zheng Y, et al: Inherited predisposition to breast cancer among African American women. Breast Cancer Res Treat. 2015 Jan;149(1):31-9.

16. Easton J: Genetic mutations more common among African American women with breast cancer: early testing could protect patients and their relatives. news.uchicago.edu/article/2013/06/03/genetic-mutations-more-common-among-african-american-women-breast-cancer. Published June 3, 2013. Accessed April 20, 2016.

17. Pear R: U.S. to collect genetic data to hone care. New York Times. January 30, 2015.

18. Subbiah V, Kurzrock R: Universal Genomic Testing Needed to Win the War Against Cancer: Genomics IS the Diagnosis. JAMA Oncol, 2016.

19. Junger S: The Perfect Storm. New York, NY: WW Norton and Co; 2009.

Bobby Daly, MD, MBA, is the chief fellow in the section of hematology/oncology at the University of Chicago Medicine. His clinical focus is breast and thoracic oncology, and his research focus is health services. Specifically, Dr. Daly researches disparities in oncology care delivery, oncology health care utilization, aggressive end-of-life oncology care, and oncology payment models. He received his MD and MBA from Harvard Medical School and Harvard Business School, both in Boston, and a BA in Economics and History from Stanford (Calif.) University. He was the recipient of the Dean’s Award at Harvard Medical and Business Schools.

Olufunmilayo Olopade, MD, FACP, OON, is the Walter L. Palmer Distinguished Service Professor of Medicine and Human Genetics, and director, Center for Global Health at the University of Chicago. She is adopting emerging high throughput genomic and informatics strategies to identify genetic and nongenetic risk factors for breast cancer in order to implement precision health care in diverse populations. This innovative approach has the potential to improve the quality of care and reduce costs while saving more lives.

Disclosures: Dr. Olopade serves on the Medical Advisory Board for CancerIQ. Dr. Daly serves as a director of Quadrant Holdings Corporation and receives compensation from this entity. Frontline Medical Communications is a subsidiary of Quadrant Holdings Corporation.

Published in conjunction with Susan G. Komen®.

Editor’s Note: This is the fifth and final installment of a five-part monthly series that will discuss the biologic, genomic, and health system factors that contribute to the racial survival disparity in breast cancer. The series was adapted from an article that originally appeared in CA: A Cancer Journal for Clinicians,¹ a journal of the American Cancer Society.

As discussed in the last installment of this series, multifaceted interventions that address all stakeholders are needed to close the racial disparity gap in breast cancer. The Patient Protection and Affordable Care Act (PPACA) emphasizes delivery system reform with a focus on the triple aim of better health, better health care, and lower costs.² One component of this reform will be accountable care organizations (ACOs). ACOs potentially could assist in closing the racial mortality gap, because provider groups will take responsibility for improving the health of a defined population and will be held accountable for the quality of care delivered.

In the ACO model, an integrated network of providers, led by primary care practitioners, will evaluate the necessity, quality, value, and accountable delivery of specialty diagnostic and therapeutic procedures, including cancer care.³ ACOs will also collect extensive patient data through the meaningful use of medical records.³ These detailed data can then be used to shape locoregional protocols for clinical decision making in oncology and evaluate physician performance. Intermountain Healthcare is an example of an organization that has had success with instituting these clinical protocols to highlight best practices and improve the quality of care.⁴ In breast cancer, oncologists will need to be prepared to develop and follow protocols tailored for their communities, which will lead to standardized, improved care for minority populations.

The oncology medical home is one example of an ACO delivery system reform that has the potential to reduce the racial mortality gap. The oncology medical home replaces episodic care with long-term coordinated care and replaces the fee-for-service model with a performance and outcomes-based system. A key trait of the oncology medical home is care that is continuously improved by measurement against quality standards.⁵ The model oncology home accomplishes this by incorporating software to extract clinical data as well as provider compliance with locoregional guidelines to give oncologists feedback regarding the quality of care that they are providing.⁶ Through this system reform, oncologists will be held accountable for the care they deliver, and it is hoped that this will eliminate the delays, misuse, and underuse of treatment. This could be especially important for optimizing use of hormone therapy for estrogen receptor-positive breast cancer. Trial oncology medical homes in North Carolina and Michigan have yielded promising results regarding improved care (fewer emergency department visits and inpatient admissions) and high adherence to national and practice-selected guidelines.^7,8

PPACA also increases funding for community health centers and provides grants to support community health workers; this highlights again the importance of place in racial health care disparities.⁹ Encouraging collaboration between community health centers and academic institutions, this funding could build bridges between minority communities and high-quality health care institutions while also improving patient communication and education.⁹ As this series has discussed, a failure to provide culturally appropriate clinical information can lead to issues with follow-up and adjuvant treatment compliance and further widen the breast cancer racial mortality gap.

Frontline Medical News

Delivery system reform has the potential to help close the disparity gap by improving the quality of care delivered to minority breast cancer patients. As Chin et al¹⁰ describe in their analysis of effective strategies for reducing health disparities, successful interventions are “culturally tailored to meet patients’ needs, employ multidisciplinary teams of care providers, and target multiple leverage points along a patient’s pathway of care.” ACOs have the financial incentive to meet these features of a successful intervention and improve quality across the continuum of breast cancer care. In addition, the PPACA “incentivized experimentation” with health care delivery, such as the oncology medical home and novel telemedicine interventions, to provide higher quality care outside of hospital settings, which could impact the disparity gap.¹¹

In the face of this new era of organizational structures focused on coordinated, population-based care, oncology providers put themselves at financial risk if they do not position themselves for policy and reimbursement changes that reduce disparities.¹⁰ However, ongoing research will be needed to ensure that as these changes are implemented, the racial mortality gap in breast cancer decreases, and that no vulnerable patient populations are left out.

Precision medicine for all

In addition, as discussed earlier in this series, there are differences in the tumor biology and genomics of breast cancer in African American patients. Beyond quality interventions, initiatives to reduce the mortality gap should focus on precision medicine for all. These initiatives should allow researchers to better understand biologic and genomic differences among breast cancer patients and tailor treatments accordingly. The PPACA has taken steps in this direction and is the first federal law to require group health plans and state-licensed health insurance companies to cover standard-of-care costs associated with participation in clinical trials as well as genetic testing for prevention.¹²

The clinical trial regulations also expressly require plans to show that administrative burdens are not used to create barriers to cancer care for anyone who might benefit from participation in a clinical trial.⁹ The overarching goal of this push to eliminate financial and administrative barriers is to increase the enrollment of minority patients, especially those who do not live close to academic medical centers. In his April 2016 address at the annual meeting of the American Association for Cancer Research, Vice President Joseph Biden identified increased clinical trial participation as a key component of the administration’s cancer “moonshot” as well. Community medical oncologists will be called upon to facilitate and encourage clinical trial participation by their minority patients and should be supported in this endeavor by academic medical centers. With greater minority patient involvement, however, there also should be further research on how trial designs can better lead to clinically significant findings for minority patients. As Polite et al¹³ argue, at a bare minimum, basic sociodemographic and detailed comorbidity information should be prospectively collected and integrated with tumor and host biology data to better examine racial differences in cancer outcomes.

Initiatives also are needed to address the gap in referrals to cancer risk clinics so that more data are available on African American genetic variants, allowing the creation of more robust risk assessment models. Risk assessment relies on predictive statistical models to estimate an individual’s risk of developing cancer, and without accurate estimates of mutation prevalence in minority subgroups, these models’ reliability is compromised.¹⁴ As shown in a recent study at the University of Chicago’s Comprehensive Cancer Risk and Prevention Clinic using targeted genomic capture and next-generation sequencing, nearly one in four African American breast cancer patients referred to the clinic had inherited at least one damaging mutation that increased their risk for the most aggressive type of breast cancer.¹⁵

To identify damaging mutations only after a diagnosis of incurable breast cancer is a failure of prevention. As has been documented in Ashkenazi Jewish populations, there is evidence of high rates of inherited mutations in genes that increase the risk for aggressive breast cancers in populations of African ancestry. This is a fertile area for further research to better understand how these mutations affect the clinical course of breast cancer, what targeted interventions will increase the proportion of breast cancer diagnosed at stage 1, and what molecularly targeted treatments will produce a response in these tumors. Churpek et al¹⁵ also demonstrated the need for continued technological innovation to reduce the disparity gap, because next-generation sequencing is a faster and more cost-efficient way to evaluate multiple variants in many genes. This approach is particularly valuable for African Americans, who tend to have greater genetic diversity.¹⁶ The current administration is also heralding this approach to cancer care. In his 2015 State of the Union address, President Obama announced a precision medicine initiative, including a request for $70 million for the National Cancer Institute to investigate genes that may contribute to the risk of developing cancer.¹⁷ African American women should no longer be left behind in the push for personalized medicine that caters to a patient’s tumor biology and genetic profile. As Subbiah and Kurzrock state, universal genomic testing is not necessarily cost prohibitive, as the cost to obtain a “complete diagnosis and to select appropriate therapy may be miniscule compared with the money wasted on ill-chosen therapies.”¹⁸ 

In conclusion, there is an opportunity in the current climate of health care reform ushered in by the Affordable Care Act to address many of the discussed elements leading to the persistent racial mortality gap in breast cancer. We have argued that two substantial factors lead to this eroding gap. One is differences in tumor biology and genomics, and the second is a quality difference in patterns of care. In describing the perfect storm, Sebastian Junger¹⁹ wrote of the collision of two forces – a hurricane’s warm-air, low-pressure system and an anticyclone’s cool-air, high-pressure system – that combined to create a more powerful and devastating meteorological force. Similarly, we argue that it is the collision of these two factors – tumor biology and genomics with patterns of care – that leads to the breast cancer mortality gap. The delays, misuse, and underuse of treatment that we have underscored are of increased significance when patients present with more aggressive forms of breast cancer. Interventions to close this gap will take leaders at the patient, provider, payer, and community levels to drive system change.

1. Daly B, Olopade OI: A perfect storm: How tumor biology, genomics, and health care delivery patterns collide to create a racial survival disparity in breast cancer and proposed interventions for change. CA Cancer J Clin. 2015 Apr;65:221-38.

2. Fox J: Lessons from an oncology medical home collaborative. Am J Manag Care. 2013; 19:SP5-9.

3. Mehta AJ, Macklis RM: Overview of accountable care organizations for oncology specialists. J Oncol Pract. 2013 Jul; 9(4):216-21.

4. Daly B, Mort EA: A decade after to Err is Human: what should health care leaders be doing? Physician Exec. 2014 May-Jun; 40(3):50-2, 54.

5. Dangi-Garimella S: Oncology medical home: improved quality and cost of care. Am J Manag Care. 2014 Sep.

6. McAneny BL: The future of oncology? COME HOME, the oncology medical home. Am J Manag Care. 2013 Feb.

7. Goyal RK, Wheeler SB, Kohler RE, et al: Health care utilization from chemotherapy-related adverse events among low-income breast cancer patients: effect of enrollment in a medical home program. N C Med J. 2014 Jul-Aug;75(4):231-8.

8. Kuntz G, Tozer JM, Snegosky J, et al: Michigan Oncology Medical Home Demonstration Project: first-year results. J Oncol Pract. 2014 Sep. 10:294-7.

9. Moy B, Polite BN, Halpern MT, et al: American Society of Clinical Oncology policy statement: opportunities in the patient protection and affordable care act to reduce cancer care disparities. J Clin Oncol. 2011 Oct;29(28):3816-24.

10. Chin MH, Clarke AR, Nocon RS, et al: A roadmap and best practices for organizations to reduce racial and ethnic disparities in health care. J Gen Intern Med. 2012 Aug; 27(8):992-1000.

11. Emanuel EJ: How Well Is the Affordable Care Act Doing?: Reasons for Optimism. JAMA 315:1331-2, 2016.

12. Zhang SQ, Polite BN: Achieving a deeper understanding of the implemented provisions of the Affordable Care Act. Am Soc Clin Oncol Educ Book. 2014:e472-7.

13. Polite BN, Sylvester BE, Olopade OI: Race and subset analyses in clinical trials: time to get serious about data integration. J Natl Cancer Inst. 2011 Oct. 103(20):1486-8.

14. Hall MJ, Olopade OI: Disparities in genetic testing: thinking outside the BRCA box. J Clin Oncol. 2006 May; 24(14):2197-203.

15. Churpek JE, Walsh T, Zheng Y, et al: Inherited predisposition to breast cancer among African American women. Breast Cancer Res Treat. 2015 Jan;149(1):31-9.

16. Easton J: Genetic mutations more common among African American women with breast cancer: early testing could protect patients and their relatives. news.uchicago.edu/article/2013/06/03/genetic-mutations-more-common-among-african-american-women-breast-cancer. Published June 3, 2013. Accessed April 20, 2016.

17. Pear R: U.S. to collect genetic data to hone care. New York Times. January 30, 2015.

18. Subbiah V, Kurzrock R: Universal Genomic Testing Needed to Win the War Against Cancer: Genomics IS the Diagnosis. JAMA Oncol, 2016.

19. Junger S: The Perfect Storm. New York, NY: WW Norton and Co; 2009.

Bobby Daly, MD, MBA, is the chief fellow in the section of hematology/oncology at the University of Chicago Medicine. His clinical focus is breast and thoracic oncology, and his research focus is health services. Specifically, Dr. Daly researches disparities in oncology care delivery, oncology health care utilization, aggressive end-of-life oncology care, and oncology payment models. He received his MD and MBA from Harvard Medical School and Harvard Business School, both in Boston, and a BA in Economics and History from Stanford (Calif.) University. He was the recipient of the Dean’s Award at Harvard Medical and Business Schools.

Olufunmilayo Olopade, MD, FACP, OON, is the Walter L. Palmer Distinguished Service Professor of Medicine and Human Genetics, and director, Center for Global Health at the University of Chicago. She is adopting emerging high throughput genomic and informatics strategies to identify genetic and nongenetic risk factors for breast cancer in order to implement precision health care in diverse populations. This innovative approach has the potential to improve the quality of care and reduce costs while saving more lives.

Disclosures: Dr. Olopade serves on the Medical Advisory Board for CancerIQ. Dr. Daly serves as a director of Quadrant Holdings Corporation and receives compensation from this entity. Frontline Medical Communications is a subsidiary of Quadrant Holdings Corporation.

Published in conjunction with Susan G. Komen®.

Editor’s Note: This is the fifth and final installment of a five-part monthly series that will discuss the biologic, genomic, and health system factors that contribute to the racial survival disparity in breast cancer. The series was adapted from an article that originally appeared in CA: A Cancer Journal for Clinicians,¹ a journal of the American Cancer Society.

As discussed in the last installment of this series, multifaceted interventions that address all stakeholders are needed to close the racial disparity gap in breast cancer. The Patient Protection and Affordable Care Act (PPACA) emphasizes delivery system reform with a focus on the triple aim of better health, better health care, and lower costs.² One component of this reform will be accountable care organizations (ACOs). ACOs potentially could assist in closing the racial mortality gap, because provider groups will take responsibility for improving the health of a defined population and will be held accountable for the quality of care delivered.

In the ACO model, an integrated network of providers, led by primary care practitioners, will evaluate the necessity, quality, value, and accountable delivery of specialty diagnostic and therapeutic procedures, including cancer care.³ ACOs will also collect extensive patient data through the meaningful use of medical records.³ These detailed data can then be used to shape locoregional protocols for clinical decision making in oncology and evaluate physician performance. Intermountain Healthcare is an example of an organization that has had success with instituting these clinical protocols to highlight best practices and improve the quality of care.⁴ In breast cancer, oncologists will need to be prepared to develop and follow protocols tailored for their communities, which will lead to standardized, improved care for minority populations.

The oncology medical home is one example of an ACO delivery system reform that has the potential to reduce the racial mortality gap. The oncology medical home replaces episodic care with long-term coordinated care and replaces the fee-for-service model with a performance and outcomes-based system. A key trait of the oncology medical home is care that is continuously improved by measurement against quality standards.⁵ The model oncology home accomplishes this by incorporating software to extract clinical data as well as provider compliance with locoregional guidelines to give oncologists feedback regarding the quality of care that they are providing.⁶ Through this system reform, oncologists will be held accountable for the care they deliver, and it is hoped that this will eliminate the delays, misuse, and underuse of treatment. This could be especially important for optimizing use of hormone therapy for estrogen receptor-positive breast cancer. Trial oncology medical homes in North Carolina and Michigan have yielded promising results regarding improved care (fewer emergency department visits and inpatient admissions) and high adherence to national and practice-selected guidelines.^7,8

PPACA also increases funding for community health centers and provides grants to support community health workers; this highlights again the importance of place in racial health care disparities.⁹ Encouraging collaboration between community health centers and academic institutions, this funding could build bridges between minority communities and high-quality health care institutions while also improving patient communication and education.⁹ As this series has discussed, a failure to provide culturally appropriate clinical information can lead to issues with follow-up and adjuvant treatment compliance and further widen the breast cancer racial mortality gap.

Frontline Medical News

Delivery system reform has the potential to help close the disparity gap by improving the quality of care delivered to minority breast cancer patients. As Chin et al¹⁰ describe in their analysis of effective strategies for reducing health disparities, successful interventions are “culturally tailored to meet patients’ needs, employ multidisciplinary teams of care providers, and target multiple leverage points along a patient’s pathway of care.” ACOs have the financial incentive to meet these features of a successful intervention and improve quality across the continuum of breast cancer care. In addition, the PPACA “incentivized experimentation” with health care delivery, such as the oncology medical home and novel telemedicine interventions, to provide higher quality care outside of hospital settings, which could impact the disparity gap.¹¹

In the face of this new era of organizational structures focused on coordinated, population-based care, oncology providers put themselves at financial risk if they do not position themselves for policy and reimbursement changes that reduce disparities.¹⁰ However, ongoing research will be needed to ensure that as these changes are implemented, the racial mortality gap in breast cancer decreases, and that no vulnerable patient populations are left out.

Precision medicine for all

In addition, as discussed earlier in this series, there are differences in the tumor biology and genomics of breast cancer in African American patients. Beyond quality interventions, initiatives to reduce the mortality gap should focus on precision medicine for all. These initiatives should allow researchers to better understand biologic and genomic differences among breast cancer patients and tailor treatments accordingly. The PPACA has taken steps in this direction and is the first federal law to require group health plans and state-licensed health insurance companies to cover standard-of-care costs associated with participation in clinical trials as well as genetic testing for prevention.¹²

The clinical trial regulations also expressly require plans to show that administrative burdens are not used to create barriers to cancer care for anyone who might benefit from participation in a clinical trial.⁹ The overarching goal of this push to eliminate financial and administrative barriers is to increase the enrollment of minority patients, especially those who do not live close to academic medical centers. In his April 2016 address at the annual meeting of the American Association for Cancer Research, Vice President Joseph Biden identified increased clinical trial participation as a key component of the administration’s cancer “moonshot” as well. Community medical oncologists will be called upon to facilitate and encourage clinical trial participation by their minority patients and should be supported in this endeavor by academic medical centers. With greater minority patient involvement, however, there also should be further research on how trial designs can better lead to clinically significant findings for minority patients. As Polite et al¹³ argue, at a bare minimum, basic sociodemographic and detailed comorbidity information should be prospectively collected and integrated with tumor and host biology data to better examine racial differences in cancer outcomes.

Initiatives also are needed to address the gap in referrals to cancer risk clinics so that more data are available on African American genetic variants, allowing the creation of more robust risk assessment models. Risk assessment relies on predictive statistical models to estimate an individual’s risk of developing cancer, and without accurate estimates of mutation prevalence in minority subgroups, these models’ reliability is compromised.¹⁴ As shown in a recent study at the University of Chicago’s Comprehensive Cancer Risk and Prevention Clinic using targeted genomic capture and next-generation sequencing, nearly one in four African American breast cancer patients referred to the clinic had inherited at least one damaging mutation that increased their risk for the most aggressive type of breast cancer.¹⁵

To identify damaging mutations only after a diagnosis of incurable breast cancer is a failure of prevention. As has been documented in Ashkenazi Jewish populations, there is evidence of high rates of inherited mutations in genes that increase the risk for aggressive breast cancers in populations of African ancestry. This is a fertile area for further research to better understand how these mutations affect the clinical course of breast cancer, what targeted interventions will increase the proportion of breast cancer diagnosed at stage 1, and what molecularly targeted treatments will produce a response in these tumors. Churpek et al¹⁵ also demonstrated the need for continued technological innovation to reduce the disparity gap, because next-generation sequencing is a faster and more cost-efficient way to evaluate multiple variants in many genes. This approach is particularly valuable for African Americans, who tend to have greater genetic diversity.¹⁶ The current administration is also heralding this approach to cancer care. In his 2015 State of the Union address, President Obama announced a precision medicine initiative, including a request for $70 million for the National Cancer Institute to investigate genes that may contribute to the risk of developing cancer.¹⁷ African American women should no longer be left behind in the push for personalized medicine that caters to a patient’s tumor biology and genetic profile. As Subbiah and Kurzrock state, universal genomic testing is not necessarily cost prohibitive, as the cost to obtain a “complete diagnosis and to select appropriate therapy may be miniscule compared with the money wasted on ill-chosen therapies.”¹⁸ 

In conclusion, there is an opportunity in the current climate of health care reform ushered in by the Affordable Care Act to address many of the discussed elements leading to the persistent racial mortality gap in breast cancer. We have argued that two substantial factors lead to this eroding gap. One is differences in tumor biology and genomics, and the second is a quality difference in patterns of care. In describing the perfect storm, Sebastian Junger¹⁹ wrote of the collision of two forces – a hurricane’s warm-air, low-pressure system and an anticyclone’s cool-air, high-pressure system – that combined to create a more powerful and devastating meteorological force. Similarly, we argue that it is the collision of these two factors – tumor biology and genomics with patterns of care – that leads to the breast cancer mortality gap. The delays, misuse, and underuse of treatment that we have underscored are of increased significance when patients present with more aggressive forms of breast cancer. Interventions to close this gap will take leaders at the patient, provider, payer, and community levels to drive system change.

1. Daly B, Olopade OI: A perfect storm: How tumor biology, genomics, and health care delivery patterns collide to create a racial survival disparity in breast cancer and proposed interventions for change. CA Cancer J Clin. 2015 Apr;65:221-38.

2. Fox J: Lessons from an oncology medical home collaborative. Am J Manag Care. 2013; 19:SP5-9.

3. Mehta AJ, Macklis RM: Overview of accountable care organizations for oncology specialists. J Oncol Pract. 2013 Jul; 9(4):216-21.

4. Daly B, Mort EA: A decade after to Err is Human: what should health care leaders be doing? Physician Exec. 2014 May-Jun; 40(3):50-2, 54.

5. Dangi-Garimella S: Oncology medical home: improved quality and cost of care. Am J Manag Care. 2014 Sep.

6. McAneny BL: The future of oncology? COME HOME, the oncology medical home. Am J Manag Care. 2013 Feb.

7. Goyal RK, Wheeler SB, Kohler RE, et al: Health care utilization from chemotherapy-related adverse events among low-income breast cancer patients: effect of enrollment in a medical home program. N C Med J. 2014 Jul-Aug;75(4):231-8.

8. Kuntz G, Tozer JM, Snegosky J, et al: Michigan Oncology Medical Home Demonstration Project: first-year results. J Oncol Pract. 2014 Sep. 10:294-7.

9. Moy B, Polite BN, Halpern MT, et al: American Society of Clinical Oncology policy statement: opportunities in the patient protection and affordable care act to reduce cancer care disparities. J Clin Oncol. 2011 Oct;29(28):3816-24.

10. Chin MH, Clarke AR, Nocon RS, et al: A roadmap and best practices for organizations to reduce racial and ethnic disparities in health care. J Gen Intern Med. 2012 Aug; 27(8):992-1000.

11. Emanuel EJ: How Well Is the Affordable Care Act Doing?: Reasons for Optimism. JAMA 315:1331-2, 2016.

12. Zhang SQ, Polite BN: Achieving a deeper understanding of the implemented provisions of the Affordable Care Act. Am Soc Clin Oncol Educ Book. 2014:e472-7.

13. Polite BN, Sylvester BE, Olopade OI: Race and subset analyses in clinical trials: time to get serious about data integration. J Natl Cancer Inst. 2011 Oct. 103(20):1486-8.

14. Hall MJ, Olopade OI: Disparities in genetic testing: thinking outside the BRCA box. J Clin Oncol. 2006 May; 24(14):2197-203.

15. Churpek JE, Walsh T, Zheng Y, et al: Inherited predisposition to breast cancer among African American women. Breast Cancer Res Treat. 2015 Jan;149(1):31-9.

16. Easton J: Genetic mutations more common among African American women with breast cancer: early testing could protect patients and their relatives. news.uchicago.edu/article/2013/06/03/genetic-mutations-more-common-among-african-american-women-breast-cancer. Published June 3, 2013. Accessed April 20, 2016.

17. Pear R: U.S. to collect genetic data to hone care. New York Times. January 30, 2015.

18. Subbiah V, Kurzrock R: Universal Genomic Testing Needed to Win the War Against Cancer: Genomics IS the Diagnosis. JAMA Oncol, 2016.

19. Junger S: The Perfect Storm. New York, NY: WW Norton and Co; 2009.

Bobby Daly, MD, MBA, is the chief fellow in the section of hematology/oncology at the University of Chicago Medicine. His clinical focus is breast and thoracic oncology, and his research focus is health services. Specifically, Dr. Daly researches disparities in oncology care delivery, oncology health care utilization, aggressive end-of-life oncology care, and oncology payment models. He received his MD and MBA from Harvard Medical School and Harvard Business School, both in Boston, and a BA in Economics and History from Stanford (Calif.) University. He was the recipient of the Dean’s Award at Harvard Medical and Business Schools.

Olufunmilayo Olopade, MD, FACP, OON, is the Walter L. Palmer Distinguished Service Professor of Medicine and Human Genetics, and director, Center for Global Health at the University of Chicago. She is adopting emerging high throughput genomic and informatics strategies to identify genetic and nongenetic risk factors for breast cancer in order to implement precision health care in diverse populations. This innovative approach has the potential to improve the quality of care and reduce costs while saving more lives.

Disclosures: Dr. Olopade serves on the Medical Advisory Board for CancerIQ. Dr. Daly serves as a director of Quadrant Holdings Corporation and receives compensation from this entity. Frontline Medical Communications is a subsidiary of Quadrant Holdings Corporation.

Published in conjunction with Susan G. Komen®.

A tic is described by the DSM-5 as a sudden, rapid, recurrent, nonrhythmic movement or vocalization. Tics are a common occurrence in childhood and can range from mild to severe, transient to chronic, simple to complex. It is not uncommon for parents to ask pediatric care providers when and how to manage tics in children. Here, we present a case to illustrate just such an issue.

Case summary

Adam is an 8-year-old with a previous diagnosis of attention-deficit/hyperactivity disorder (ADHD) who is being seen for follow-up after being started on a stimulant 3 months ago because of declining performance in school and at home, despite adequate accommodations, parent education, and nonpharmacologic treatments. He has done well on a small dose of methylphenidate (0.5 mg/kg per day), but in the context of being asked about other symptoms, his mother, Mary, mentions that she has noticed that Adam is frequently clearing his throat. This began about 6 weeks ago after experiencing allergic rhinitis for almost a week. Since that time, Mary has noticed that he clears his throat as frequently as once every 5 minutes.

The behavior was reported to occur in the classroom, but not nearly with the frequency experienced at home. If asked to not clear his throat, Adam can suppress it. None of his classmates have said anything or appear to have noticed. His parents have never noticed any tics previously. There is a family history of ADHD in his father. There is no other family history of neurodevelopmental disorders, including no obsessive compulsive disorder (OCD), Tourette’s disorder, or other chronic tic disorders. There is nothing else of concern on physical or mental status examination. His mother has concerns that the stimulant medication may be inducing a tic and wonders about stopping it.

Case discussion

Adam has a mild simple vocal tic. The vast majority of tics that develop in childhood will not last the requisite 1 year required to make the diagnosis of a persistent (chronic) motor or vocal tic, nor will they occur with both vocal and motor tics over 1 year required to make the diagnosis of Tourette’s disorder. In the DSM-IV, tics lasting less than 1 year would have been given the diagnosis of transient tic disorder.

In the DSM-5, the diagnosis is now provisional tic disorder because there is no way to tell which tics will be transient and which will be persistent or chronic. Chronic tics occur with a prevalence of between 0.5% and 3%¹, with a male predominance, and are more common in children with ADHD and OCD. In addition, children with chronic tic disorders often have higher incidence of learning problems and, perhaps, autism spectrum disorders. Simple motor and vocal tics (those involving a single muscle group) are more common than complex tics, in which coordinated movements are made. Despite the portrayal in the popular media, it is particularly rare to have complex tics that include copropraxia (an obscene gesture), coprolalia (an obscene movement), echolalia (repeating another’s words), or echopraxia (repeating another’s actions).

Tics tend to have their onset in early school age, with the highest prevalence and severity between the ages of 9 and 12 years.² When present, tics tend to be somewhat suppressed when the child is in school or when the child is engaged in a task. Furthermore, most tics, even when chronic, do not lead to impairment. When impairment does occur, it is often the result of social problems from teasing by peers. Most tics wax and wane over time, but eventually resolve without intervention.

In the case of Adam, there is no clear reason to begin to treat immediately. If one wanted to follow his tics, there are several parent and clinic measures that are available. Taking a history of his case would include ensuring that there are no other predisposing causes and no other psychiatric comorbidities. Induction of tics by the initiation of a stimulant might be considered, although recent data suggest that stimulants are less likely to induce or worsen tics in the course of treatment for ADHD than previously thought.^3,4 If concerned, however, alternative ADHD treatment such as alpha-2 agonist treatment could be considered. Education could be provided to the parents regarding the likelihood of resolution. Should the tics worsen in severity and/or become chronic, there are several behavioral interventions, including habit reversal training and the Comprehensive Behavioral Intervention for Tics, which could be considered as first line.

Medications could be considered if the tics are moderate to severe and behavioral interventions are not sufficient to reduce impairment. The only Food and Drug Administration–approved agents are haloperidol and pimozide, although there is ample support for other agents, and practitioners are most likely to use alternatives, given the side-effect profiles of these typical antipsychotics. Co-occurring symptoms should be considered when thinking about medication. Alpha-2 agonists appear to be most effective in the context of ADHD, while second-generation antipsychotics appear to be more useful if OCD is comorbid. In general, though, in cases like Adam’s, taking a watchful-waiting approach will most often lead to symptom resolution.

References

1. Eur Child Adolesc Psychiatry. 2012 Jan;21(1):5-13.

2. J Am Acad Child Adolesc Psychiatry. 2013 Dec;52(12):1341-59.

3. J Am Acad Child Adolesc Psychiatry. 2015 Sep;54(9):728-36.

4. Cochrane Database Syst Rev. 2011 Apr 13;(4):CD007990.

Dr. Althoff is associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Email him at [email protected].

A tic is described by the DSM-5 as a sudden, rapid, recurrent, nonrhythmic movement or vocalization. Tics are a common occurrence in childhood and can range from mild to severe, transient to chronic, simple to complex. It is not uncommon for parents to ask pediatric care providers when and how to manage tics in children. Here, we present a case to illustrate just such an issue.

Case summary

Adam is an 8-year-old with a previous diagnosis of attention-deficit/hyperactivity disorder (ADHD) who is being seen for follow-up after being started on a stimulant 3 months ago because of declining performance in school and at home, despite adequate accommodations, parent education, and nonpharmacologic treatments. He has done well on a small dose of methylphenidate (0.5 mg/kg per day), but in the context of being asked about other symptoms, his mother, Mary, mentions that she has noticed that Adam is frequently clearing his throat. This began about 6 weeks ago after experiencing allergic rhinitis for almost a week. Since that time, Mary has noticed that he clears his throat as frequently as once every 5 minutes.

The behavior was reported to occur in the classroom, but not nearly with the frequency experienced at home. If asked to not clear his throat, Adam can suppress it. None of his classmates have said anything or appear to have noticed. His parents have never noticed any tics previously. There is a family history of ADHD in his father. There is no other family history of neurodevelopmental disorders, including no obsessive compulsive disorder (OCD), Tourette’s disorder, or other chronic tic disorders. There is nothing else of concern on physical or mental status examination. His mother has concerns that the stimulant medication may be inducing a tic and wonders about stopping it.

Case discussion

Adam has a mild simple vocal tic. The vast majority of tics that develop in childhood will not last the requisite 1 year required to make the diagnosis of a persistent (chronic) motor or vocal tic, nor will they occur with both vocal and motor tics over 1 year required to make the diagnosis of Tourette’s disorder. In the DSM-IV, tics lasting less than 1 year would have been given the diagnosis of transient tic disorder.

In the DSM-5, the diagnosis is now provisional tic disorder because there is no way to tell which tics will be transient and which will be persistent or chronic. Chronic tics occur with a prevalence of between 0.5% and 3%¹, with a male predominance, and are more common in children with ADHD and OCD. In addition, children with chronic tic disorders often have higher incidence of learning problems and, perhaps, autism spectrum disorders. Simple motor and vocal tics (those involving a single muscle group) are more common than complex tics, in which coordinated movements are made. Despite the portrayal in the popular media, it is particularly rare to have complex tics that include copropraxia (an obscene gesture), coprolalia (an obscene movement), echolalia (repeating another’s words), or echopraxia (repeating another’s actions).

Tics tend to have their onset in early school age, with the highest prevalence and severity between the ages of 9 and 12 years.² When present, tics tend to be somewhat suppressed when the child is in school or when the child is engaged in a task. Furthermore, most tics, even when chronic, do not lead to impairment. When impairment does occur, it is often the result of social problems from teasing by peers. Most tics wax and wane over time, but eventually resolve without intervention.

In the case of Adam, there is no clear reason to begin to treat immediately. If one wanted to follow his tics, there are several parent and clinic measures that are available. Taking a history of his case would include ensuring that there are no other predisposing causes and no other psychiatric comorbidities. Induction of tics by the initiation of a stimulant might be considered, although recent data suggest that stimulants are less likely to induce or worsen tics in the course of treatment for ADHD than previously thought.^3,4 If concerned, however, alternative ADHD treatment such as alpha-2 agonist treatment could be considered. Education could be provided to the parents regarding the likelihood of resolution. Should the tics worsen in severity and/or become chronic, there are several behavioral interventions, including habit reversal training and the Comprehensive Behavioral Intervention for Tics, which could be considered as first line.

Medications could be considered if the tics are moderate to severe and behavioral interventions are not sufficient to reduce impairment. The only Food and Drug Administration–approved agents are haloperidol and pimozide, although there is ample support for other agents, and practitioners are most likely to use alternatives, given the side-effect profiles of these typical antipsychotics. Co-occurring symptoms should be considered when thinking about medication. Alpha-2 agonists appear to be most effective in the context of ADHD, while second-generation antipsychotics appear to be more useful if OCD is comorbid. In general, though, in cases like Adam’s, taking a watchful-waiting approach will most often lead to symptom resolution.

References

1. Eur Child Adolesc Psychiatry. 2012 Jan;21(1):5-13.

2. J Am Acad Child Adolesc Psychiatry. 2013 Dec;52(12):1341-59.

3. J Am Acad Child Adolesc Psychiatry. 2015 Sep;54(9):728-36.

4. Cochrane Database Syst Rev. 2011 Apr 13;(4):CD007990.

Dr. Althoff is associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Email him at [email protected].

A tic is described by the DSM-5 as a sudden, rapid, recurrent, nonrhythmic movement or vocalization. Tics are a common occurrence in childhood and can range from mild to severe, transient to chronic, simple to complex. It is not uncommon for parents to ask pediatric care providers when and how to manage tics in children. Here, we present a case to illustrate just such an issue.

Case summary

Adam is an 8-year-old with a previous diagnosis of attention-deficit/hyperactivity disorder (ADHD) who is being seen for follow-up after being started on a stimulant 3 months ago because of declining performance in school and at home, despite adequate accommodations, parent education, and nonpharmacologic treatments. He has done well on a small dose of methylphenidate (0.5 mg/kg per day), but in the context of being asked about other symptoms, his mother, Mary, mentions that she has noticed that Adam is frequently clearing his throat. This began about 6 weeks ago after experiencing allergic rhinitis for almost a week. Since that time, Mary has noticed that he clears his throat as frequently as once every 5 minutes.

The behavior was reported to occur in the classroom, but not nearly with the frequency experienced at home. If asked to not clear his throat, Adam can suppress it. None of his classmates have said anything or appear to have noticed. His parents have never noticed any tics previously. There is a family history of ADHD in his father. There is no other family history of neurodevelopmental disorders, including no obsessive compulsive disorder (OCD), Tourette’s disorder, or other chronic tic disorders. There is nothing else of concern on physical or mental status examination. His mother has concerns that the stimulant medication may be inducing a tic and wonders about stopping it.

Case discussion

Adam has a mild simple vocal tic. The vast majority of tics that develop in childhood will not last the requisite 1 year required to make the diagnosis of a persistent (chronic) motor or vocal tic, nor will they occur with both vocal and motor tics over 1 year required to make the diagnosis of Tourette’s disorder. In the DSM-IV, tics lasting less than 1 year would have been given the diagnosis of transient tic disorder.

In the DSM-5, the diagnosis is now provisional tic disorder because there is no way to tell which tics will be transient and which will be persistent or chronic. Chronic tics occur with a prevalence of between 0.5% and 3%¹, with a male predominance, and are more common in children with ADHD and OCD. In addition, children with chronic tic disorders often have higher incidence of learning problems and, perhaps, autism spectrum disorders. Simple motor and vocal tics (those involving a single muscle group) are more common than complex tics, in which coordinated movements are made. Despite the portrayal in the popular media, it is particularly rare to have complex tics that include copropraxia (an obscene gesture), coprolalia (an obscene movement), echolalia (repeating another’s words), or echopraxia (repeating another’s actions).

Tics tend to have their onset in early school age, with the highest prevalence and severity between the ages of 9 and 12 years.² When present, tics tend to be somewhat suppressed when the child is in school or when the child is engaged in a task. Furthermore, most tics, even when chronic, do not lead to impairment. When impairment does occur, it is often the result of social problems from teasing by peers. Most tics wax and wane over time, but eventually resolve without intervention.

In the case of Adam, there is no clear reason to begin to treat immediately. If one wanted to follow his tics, there are several parent and clinic measures that are available. Taking a history of his case would include ensuring that there are no other predisposing causes and no other psychiatric comorbidities. Induction of tics by the initiation of a stimulant might be considered, although recent data suggest that stimulants are less likely to induce or worsen tics in the course of treatment for ADHD than previously thought.^3,4 If concerned, however, alternative ADHD treatment such as alpha-2 agonist treatment could be considered. Education could be provided to the parents regarding the likelihood of resolution. Should the tics worsen in severity and/or become chronic, there are several behavioral interventions, including habit reversal training and the Comprehensive Behavioral Intervention for Tics, which could be considered as first line.

Medications could be considered if the tics are moderate to severe and behavioral interventions are not sufficient to reduce impairment. The only Food and Drug Administration–approved agents are haloperidol and pimozide, although there is ample support for other agents, and practitioners are most likely to use alternatives, given the side-effect profiles of these typical antipsychotics. Co-occurring symptoms should be considered when thinking about medication. Alpha-2 agonists appear to be most effective in the context of ADHD, while second-generation antipsychotics appear to be more useful if OCD is comorbid. In general, though, in cases like Adam’s, taking a watchful-waiting approach will most often lead to symptom resolution.

References

1. Eur Child Adolesc Psychiatry. 2012 Jan;21(1):5-13.

2. J Am Acad Child Adolesc Psychiatry. 2013 Dec;52(12):1341-59.

3. J Am Acad Child Adolesc Psychiatry. 2015 Sep;54(9):728-36.

4. Cochrane Database Syst Rev. 2011 Apr 13;(4):CD007990.

Dr. Althoff is associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Email him at [email protected].