Obstetrics

While almost all internists and family physicians feel a responsibility to ask about patients’ immunization status at least annually, most refer them to another source for all but basic seasonal vaccines.

A national survey determined that less than a third of these primary care providers stocked all 11 of the recommended adult vaccines. Financial issues were the biggest barrier to keeping all of the vaccines on hand and administering them, Dr. Laura Hurley and her colleagues wrote in the February issue of Annals of Internal Medicine (Ann. Int. Med. 2014;160:161-70).

"Although primary care physicians appear motivated to ensure that patients are up to date on vaccinations, many barriers exist. Implementation of system changes, including adopting practices that improve communication between primary care physicians and alternate vaccinators, more widespread use of effective tools ... and removing policy-related barriers, could improve adult vaccination in the United States," wrote Dr. Hurley of the Wellington E. Webb Center for Primary Care, Denver, and her coauthors.

Conducted by the Vaccine Policy Collaborative Initiative (VPCI), the survey assessed how responsible primary care physicians feel about adult vaccination, how often they assess and provide it, and what the barriers are to how vaccination is handled. The survey was mailed to 443 general internists and 409 family physicians, of whom 352 and 255 physicians, respectively, responded.

Ninety-seven percent of both groups said they assessed vaccination status at annual visits, but only about a third reported doing so at each visit.

Automated systems were fairly low down on the list of assessment techniques, although more family doctors than internists reported using them (36% vs. 8%). About half of all the respondents said it was moderately to very difficult to get up-to-date information on anything but the seasonal influenza vaccine.

In addition to the flu vaccine, most physicians checked on the status of pneumococcal; tetanus, diphtheria, and pertussis (Td and Tdap); and shingles vaccines. Family doctors were more likely to check on hepatitis A and B; MMR; and varicella vaccines.

Most physicians reported stocking influenza, pneumococcal, Td, and Tdap vaccines. Family physicians were more likely to stock both hepatitis vaccines, as well as those for human papillomavirus, varicella, meningitis, and shingles. Thirty-one percent of family physicians and 20% of internists said they routinely stocked all 11 of the recommended adult vaccines.

Money issues were the biggest barriers to stocking and administering vaccines, the respondents said. Commonly cited problems were lack of reimbursement for purchasing and administering; lack of insurance coverage for vaccines; and the up-front cost of buying the vaccine. Some providers worried the vaccine would expire before it could all be used, and others said patients simply refused them because they couldn’t pay.

Physicians in private and small group practices reported the biggest financial barriers, as did those who served a large number of Medicare Part D patients.

But even if they couldn’t provide the service themselves, respondents were sending patients to places that could – mostly pharmacies and public health departments. Still, financial issues were the biggest reasons for referrals; lack of insurance coverage or low insurance reimbursement figured prominently.

That can be a tricky proposition, however, said Dr. Jonathan Temte, chair of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices.

Section 317 of the Public Health Service Act provides federally purchased vaccine for free immunizations for qualifying patients, including uninsured adults. But underinsured adults or those who have very high insurance deductibles can’t get free immunizations with 317-purchased vaccines.

"Changes in the federal 317 rules prohibit adult patients who are insured from receiving vaccines without charge through public health agencies," Dr. Temte said in an interview. "Accordingly, the practice of ‘referring adults to public health’ for immunization doesn’t work too well."

When they did send patients to another source, most respondents were able to follow up on vaccination status. The most common way was to communicate with the vaccination provider. About a third of the two groups used an immunization information system. The information was usually recorded in the patient’s electronic health record or in a written chart or vaccine record.

"Of note," the authors said, "almost all physicians agreed that it was the primary care physician’s responsibility to see that patients receive recommended vaccines, even if they did so elsewhere."

The CDC sponsored the survey; none of the authors had any financial disclosures.

[email protected]

While almost all internists and family physicians feel a responsibility to ask about patients’ immunization status at least annually, most refer them to another source for all but basic seasonal vaccines.

A national survey determined that less than a third of these primary care providers stocked all 11 of the recommended adult vaccines. Financial issues were the biggest barrier to keeping all of the vaccines on hand and administering them, Dr. Laura Hurley and her colleagues wrote in the February issue of Annals of Internal Medicine (Ann. Int. Med. 2014;160:161-70).

"Although primary care physicians appear motivated to ensure that patients are up to date on vaccinations, many barriers exist. Implementation of system changes, including adopting practices that improve communication between primary care physicians and alternate vaccinators, more widespread use of effective tools ... and removing policy-related barriers, could improve adult vaccination in the United States," wrote Dr. Hurley of the Wellington E. Webb Center for Primary Care, Denver, and her coauthors.

Conducted by the Vaccine Policy Collaborative Initiative (VPCI), the survey assessed how responsible primary care physicians feel about adult vaccination, how often they assess and provide it, and what the barriers are to how vaccination is handled. The survey was mailed to 443 general internists and 409 family physicians, of whom 352 and 255 physicians, respectively, responded.

Ninety-seven percent of both groups said they assessed vaccination status at annual visits, but only about a third reported doing so at each visit.

Automated systems were fairly low down on the list of assessment techniques, although more family doctors than internists reported using them (36% vs. 8%). About half of all the respondents said it was moderately to very difficult to get up-to-date information on anything but the seasonal influenza vaccine.

In addition to the flu vaccine, most physicians checked on the status of pneumococcal; tetanus, diphtheria, and pertussis (Td and Tdap); and shingles vaccines. Family doctors were more likely to check on hepatitis A and B; MMR; and varicella vaccines.

Most physicians reported stocking influenza, pneumococcal, Td, and Tdap vaccines. Family physicians were more likely to stock both hepatitis vaccines, as well as those for human papillomavirus, varicella, meningitis, and shingles. Thirty-one percent of family physicians and 20% of internists said they routinely stocked all 11 of the recommended adult vaccines.

Money issues were the biggest barriers to stocking and administering vaccines, the respondents said. Commonly cited problems were lack of reimbursement for purchasing and administering; lack of insurance coverage for vaccines; and the up-front cost of buying the vaccine. Some providers worried the vaccine would expire before it could all be used, and others said patients simply refused them because they couldn’t pay.

Physicians in private and small group practices reported the biggest financial barriers, as did those who served a large number of Medicare Part D patients.

But even if they couldn’t provide the service themselves, respondents were sending patients to places that could – mostly pharmacies and public health departments. Still, financial issues were the biggest reasons for referrals; lack of insurance coverage or low insurance reimbursement figured prominently.

That can be a tricky proposition, however, said Dr. Jonathan Temte, chair of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices.

Section 317 of the Public Health Service Act provides federally purchased vaccine for free immunizations for qualifying patients, including uninsured adults. But underinsured adults or those who have very high insurance deductibles can’t get free immunizations with 317-purchased vaccines.

"Changes in the federal 317 rules prohibit adult patients who are insured from receiving vaccines without charge through public health agencies," Dr. Temte said in an interview. "Accordingly, the practice of ‘referring adults to public health’ for immunization doesn’t work too well."

When they did send patients to another source, most respondents were able to follow up on vaccination status. The most common way was to communicate with the vaccination provider. About a third of the two groups used an immunization information system. The information was usually recorded in the patient’s electronic health record or in a written chart or vaccine record.

"Of note," the authors said, "almost all physicians agreed that it was the primary care physician’s responsibility to see that patients receive recommended vaccines, even if they did so elsewhere."

The CDC sponsored the survey; none of the authors had any financial disclosures.

[email protected]

While almost all internists and family physicians feel a responsibility to ask about patients’ immunization status at least annually, most refer them to another source for all but basic seasonal vaccines.

A national survey determined that less than a third of these primary care providers stocked all 11 of the recommended adult vaccines. Financial issues were the biggest barrier to keeping all of the vaccines on hand and administering them, Dr. Laura Hurley and her colleagues wrote in the February issue of Annals of Internal Medicine (Ann. Int. Med. 2014;160:161-70).

"Although primary care physicians appear motivated to ensure that patients are up to date on vaccinations, many barriers exist. Implementation of system changes, including adopting practices that improve communication between primary care physicians and alternate vaccinators, more widespread use of effective tools ... and removing policy-related barriers, could improve adult vaccination in the United States," wrote Dr. Hurley of the Wellington E. Webb Center for Primary Care, Denver, and her coauthors.

Conducted by the Vaccine Policy Collaborative Initiative (VPCI), the survey assessed how responsible primary care physicians feel about adult vaccination, how often they assess and provide it, and what the barriers are to how vaccination is handled. The survey was mailed to 443 general internists and 409 family physicians, of whom 352 and 255 physicians, respectively, responded.

Ninety-seven percent of both groups said they assessed vaccination status at annual visits, but only about a third reported doing so at each visit.

Automated systems were fairly low down on the list of assessment techniques, although more family doctors than internists reported using them (36% vs. 8%). About half of all the respondents said it was moderately to very difficult to get up-to-date information on anything but the seasonal influenza vaccine.

In addition to the flu vaccine, most physicians checked on the status of pneumococcal; tetanus, diphtheria, and pertussis (Td and Tdap); and shingles vaccines. Family doctors were more likely to check on hepatitis A and B; MMR; and varicella vaccines.

Most physicians reported stocking influenza, pneumococcal, Td, and Tdap vaccines. Family physicians were more likely to stock both hepatitis vaccines, as well as those for human papillomavirus, varicella, meningitis, and shingles. Thirty-one percent of family physicians and 20% of internists said they routinely stocked all 11 of the recommended adult vaccines.

Money issues were the biggest barriers to stocking and administering vaccines, the respondents said. Commonly cited problems were lack of reimbursement for purchasing and administering; lack of insurance coverage for vaccines; and the up-front cost of buying the vaccine. Some providers worried the vaccine would expire before it could all be used, and others said patients simply refused them because they couldn’t pay.

Physicians in private and small group practices reported the biggest financial barriers, as did those who served a large number of Medicare Part D patients.

But even if they couldn’t provide the service themselves, respondents were sending patients to places that could – mostly pharmacies and public health departments. Still, financial issues were the biggest reasons for referrals; lack of insurance coverage or low insurance reimbursement figured prominently.

That can be a tricky proposition, however, said Dr. Jonathan Temte, chair of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices.

Section 317 of the Public Health Service Act provides federally purchased vaccine for free immunizations for qualifying patients, including uninsured adults. But underinsured adults or those who have very high insurance deductibles can’t get free immunizations with 317-purchased vaccines.

"Changes in the federal 317 rules prohibit adult patients who are insured from receiving vaccines without charge through public health agencies," Dr. Temte said in an interview. "Accordingly, the practice of ‘referring adults to public health’ for immunization doesn’t work too well."

When they did send patients to another source, most respondents were able to follow up on vaccination status. The most common way was to communicate with the vaccination provider. About a third of the two groups used an immunization information system. The information was usually recorded in the patient’s electronic health record or in a written chart or vaccine record.

"Of note," the authors said, "almost all physicians agreed that it was the primary care physician’s responsibility to see that patients receive recommended vaccines, even if they did so elsewhere."

The CDC sponsored the survey; none of the authors had any financial disclosures.

[email protected]

The 2014 childhood and adolescent immunization schedule has been approved, with additions that include the use of one of the meningococcal conjugate vaccines (Menveo) in certain groups of high-risk infants and a list specifying the groups of people at increased risk of hepatitis A.

The schedule will be published in the February 2014 issue of Pediatrics, and is being made available online on Jan. 31 (Pediatrics 2014 [doi: 10.1542/peds.2013-3965]).

Guidance on the use of Menveo (Meningococcal Groups A, C, W-135, and Y Oligosaccharide Diphtheria CRM197 conjugate vaccine) for certain groups of infants at increased risk of disease starting at age 2 months has been added to the meningococcal vaccine footnote. This is based on the Food and Drug Administration licensure of Menveo for use starting at age 2 months in August 2013. Some of the high-risk categories include anatomic or functional asplenia, including sickle cell disease; children with persistent complement component deficiency; and those who travel to or live in an area hyperendemic area for meningococcal disease.

This is the first time that a meningococcal vaccine has been available for use starting at age 2 months, Dr. H. Cody Meissner, professor of pediatrics at Tufts University, Boston, pointed out in an interview.

The hepatitis A vaccine footnote now provides a list of groups at increased risk for hepatitis A. While these groups are well recognized, "it was useful to itemize these groups in the footnote," noted Dr. Meissner, who is a member of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices work group on the harmonized immunization schedule.

The list includes people traveling to or working in countries where there is a high or intermediate endemicity of infection; men having sex with men; people with clotting factor disorders; people with chronic liver disease; users of injection and noninjection illicit drugs; and personal contacts – such as household contacts or regular babysitters – of international adoptees during the first 2 months of arrival in the United States "from a country with high or intermediate endemicity."

The footnote on the tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine now states that a dose of the vaccine is recommended for pregnant adolescents every time they get pregnant – preferably during week 27 through week 36 of gestation. Last year, the American Academy of Pediatrics agreed that this vaccine should be given to a pregnant woman, but it withheld the recommendation to vaccinate during every pregnancy until more data became available, Dr. Meissner said. "Additional data now indicate the safety and efficacy of administration of Tdap each time a woman becomes pregnant." This will protect most infants during the first 2 months of life when pertussis can be most severe and until they receive their first DTaP dose at 2 months, he noted.

Other changes include clarification of the intervals between doses in the human papillomavirus (HPV) vaccines footnote, to avoid any misunderstanding of the schedule, said Dr. Meissner, who is also chief of pediatric infectious disease at the Floating Hospital for Children at Tufts Medical Center.

The recommendation for pneumococcal vaccines has not changed from last year, but the footnote provides clarification about the recommendations for PCV13 (Prevnar 13) and PPSV23 in children and adolescents, "which have been stratified according to age and according to degree of risk," he added.

The footnote on Haemophilus influenzae type b (Hib) conjugate vaccine now includes clarification of who should receive the vaccine if immunocompromised.

This is the second year that recommendations and footnotes for ages 0-18 years are included in one schedule, as opposed to previous years, when there were separate schedules and footnotes for 0-7 years and 8-18 years.

The 2014 schedules have been approved by the American Academy of Pediatrics, the Advisory Committee on Immunization Practices, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists.

Dr. Meissner said he has no relevant financial disclosures.

You can view the 2014 schedule at our Resources section here.

[email protected]

The 2014 childhood and adolescent immunization schedule has been approved, with additions that include the use of one of the meningococcal conjugate vaccines (Menveo) in certain groups of high-risk infants and a list specifying the groups of people at increased risk of hepatitis A.

The schedule will be published in the February 2014 issue of Pediatrics, and is being made available online on Jan. 31 (Pediatrics 2014 [doi: 10.1542/peds.2013-3965]).

Guidance on the use of Menveo (Meningococcal Groups A, C, W-135, and Y Oligosaccharide Diphtheria CRM197 conjugate vaccine) for certain groups of infants at increased risk of disease starting at age 2 months has been added to the meningococcal vaccine footnote. This is based on the Food and Drug Administration licensure of Menveo for use starting at age 2 months in August 2013. Some of the high-risk categories include anatomic or functional asplenia, including sickle cell disease; children with persistent complement component deficiency; and those who travel to or live in an area hyperendemic area for meningococcal disease.

This is the first time that a meningococcal vaccine has been available for use starting at age 2 months, Dr. H. Cody Meissner, professor of pediatrics at Tufts University, Boston, pointed out in an interview.

The hepatitis A vaccine footnote now provides a list of groups at increased risk for hepatitis A. While these groups are well recognized, "it was useful to itemize these groups in the footnote," noted Dr. Meissner, who is a member of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices work group on the harmonized immunization schedule.

The list includes people traveling to or working in countries where there is a high or intermediate endemicity of infection; men having sex with men; people with clotting factor disorders; people with chronic liver disease; users of injection and noninjection illicit drugs; and personal contacts – such as household contacts or regular babysitters – of international adoptees during the first 2 months of arrival in the United States "from a country with high or intermediate endemicity."

The footnote on the tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine now states that a dose of the vaccine is recommended for pregnant adolescents every time they get pregnant – preferably during week 27 through week 36 of gestation. Last year, the American Academy of Pediatrics agreed that this vaccine should be given to a pregnant woman, but it withheld the recommendation to vaccinate during every pregnancy until more data became available, Dr. Meissner said. "Additional data now indicate the safety and efficacy of administration of Tdap each time a woman becomes pregnant." This will protect most infants during the first 2 months of life when pertussis can be most severe and until they receive their first DTaP dose at 2 months, he noted.

Other changes include clarification of the intervals between doses in the human papillomavirus (HPV) vaccines footnote, to avoid any misunderstanding of the schedule, said Dr. Meissner, who is also chief of pediatric infectious disease at the Floating Hospital for Children at Tufts Medical Center.

The recommendation for pneumococcal vaccines has not changed from last year, but the footnote provides clarification about the recommendations for PCV13 (Prevnar 13) and PPSV23 in children and adolescents, "which have been stratified according to age and according to degree of risk," he added.

The footnote on Haemophilus influenzae type b (Hib) conjugate vaccine now includes clarification of who should receive the vaccine if immunocompromised.

This is the second year that recommendations and footnotes for ages 0-18 years are included in one schedule, as opposed to previous years, when there were separate schedules and footnotes for 0-7 years and 8-18 years.

The 2014 schedules have been approved by the American Academy of Pediatrics, the Advisory Committee on Immunization Practices, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists.

Dr. Meissner said he has no relevant financial disclosures.

You can view the 2014 schedule at our Resources section here.

[email protected]

The 2014 childhood and adolescent immunization schedule has been approved, with additions that include the use of one of the meningococcal conjugate vaccines (Menveo) in certain groups of high-risk infants and a list specifying the groups of people at increased risk of hepatitis A.

The schedule will be published in the February 2014 issue of Pediatrics, and is being made available online on Jan. 31 (Pediatrics 2014 [doi: 10.1542/peds.2013-3965]).

Guidance on the use of Menveo (Meningococcal Groups A, C, W-135, and Y Oligosaccharide Diphtheria CRM197 conjugate vaccine) for certain groups of infants at increased risk of disease starting at age 2 months has been added to the meningococcal vaccine footnote. This is based on the Food and Drug Administration licensure of Menveo for use starting at age 2 months in August 2013. Some of the high-risk categories include anatomic or functional asplenia, including sickle cell disease; children with persistent complement component deficiency; and those who travel to or live in an area hyperendemic area for meningococcal disease.

This is the first time that a meningococcal vaccine has been available for use starting at age 2 months, Dr. H. Cody Meissner, professor of pediatrics at Tufts University, Boston, pointed out in an interview.

The hepatitis A vaccine footnote now provides a list of groups at increased risk for hepatitis A. While these groups are well recognized, "it was useful to itemize these groups in the footnote," noted Dr. Meissner, who is a member of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices work group on the harmonized immunization schedule.

The list includes people traveling to or working in countries where there is a high or intermediate endemicity of infection; men having sex with men; people with clotting factor disorders; people with chronic liver disease; users of injection and noninjection illicit drugs; and personal contacts – such as household contacts or regular babysitters – of international adoptees during the first 2 months of arrival in the United States "from a country with high or intermediate endemicity."

The footnote on the tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine now states that a dose of the vaccine is recommended for pregnant adolescents every time they get pregnant – preferably during week 27 through week 36 of gestation. Last year, the American Academy of Pediatrics agreed that this vaccine should be given to a pregnant woman, but it withheld the recommendation to vaccinate during every pregnancy until more data became available, Dr. Meissner said. "Additional data now indicate the safety and efficacy of administration of Tdap each time a woman becomes pregnant." This will protect most infants during the first 2 months of life when pertussis can be most severe and until they receive their first DTaP dose at 2 months, he noted.

Other changes include clarification of the intervals between doses in the human papillomavirus (HPV) vaccines footnote, to avoid any misunderstanding of the schedule, said Dr. Meissner, who is also chief of pediatric infectious disease at the Floating Hospital for Children at Tufts Medical Center.

The recommendation for pneumococcal vaccines has not changed from last year, but the footnote provides clarification about the recommendations for PCV13 (Prevnar 13) and PPSV23 in children and adolescents, "which have been stratified according to age and according to degree of risk," he added.

The footnote on Haemophilus influenzae type b (Hib) conjugate vaccine now includes clarification of who should receive the vaccine if immunocompromised.

This is the second year that recommendations and footnotes for ages 0-18 years are included in one schedule, as opposed to previous years, when there were separate schedules and footnotes for 0-7 years and 8-18 years.

The 2014 schedules have been approved by the American Academy of Pediatrics, the Advisory Committee on Immunization Practices, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists.

Dr. Meissner said he has no relevant financial disclosures.

You can view the 2014 schedule at our Resources section here.

[email protected]

The U.S. House of Representatives has passed a bill that would bar the use of any federal funds in paying for an abortion, including tax subsidies to purchase insurance under the Affordable Care Act.

On Jan. 28, the House voted 227 to 188, with one lawmaker voting "present," to approve H.R. 7, the No Taxpayer Funding for Abortion Act. The bill would make permanent the Hyde Amendment, an annual rider placed on spending bills that prohibits federal funds from being used to pay for abortions. H.R. 7 would also bar individuals and small businesses from using federal tax subsidies under the Affordable Care Act (ACA) to purchase health plans that include coverage for abortion.

The bill includes exceptions in cases of rape or incest, or when the mother’s life is endangered.

The bill is not expected to advance in the Senate.

The bill’s sponsor, Rep. Chris Smith (R-N.J.), said that without the new legislation, the ACA would create a massive expansion of public funding for abortion. He estimated that of the 112 health plans available to members of Congress and their staff through the ACA, 103 include coverage of abortion services.

But reproductive health advocates said the bill interferes with a woman’s private health care decisions and attempts to restrict the health care services that can be offered in private insurance plans.

"This bill is as callous as it is cynical, denying insurance coverage of critical health care to millions of women across the U.S. and worsening especially the hardship of women already struggling under challenging economic conditions," Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement.

[email protected]

On Twitter @maryellenny

The U.S. House of Representatives has passed a bill that would bar the use of any federal funds in paying for an abortion, including tax subsidies to purchase insurance under the Affordable Care Act.

On Jan. 28, the House voted 227 to 188, with one lawmaker voting "present," to approve H.R. 7, the No Taxpayer Funding for Abortion Act. The bill would make permanent the Hyde Amendment, an annual rider placed on spending bills that prohibits federal funds from being used to pay for abortions. H.R. 7 would also bar individuals and small businesses from using federal tax subsidies under the Affordable Care Act (ACA) to purchase health plans that include coverage for abortion.

The bill includes exceptions in cases of rape or incest, or when the mother’s life is endangered.

The bill is not expected to advance in the Senate.

The bill’s sponsor, Rep. Chris Smith (R-N.J.), said that without the new legislation, the ACA would create a massive expansion of public funding for abortion. He estimated that of the 112 health plans available to members of Congress and their staff through the ACA, 103 include coverage of abortion services.

But reproductive health advocates said the bill interferes with a woman’s private health care decisions and attempts to restrict the health care services that can be offered in private insurance plans.

"This bill is as callous as it is cynical, denying insurance coverage of critical health care to millions of women across the U.S. and worsening especially the hardship of women already struggling under challenging economic conditions," Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement.

[email protected]

On Twitter @maryellenny

The U.S. House of Representatives has passed a bill that would bar the use of any federal funds in paying for an abortion, including tax subsidies to purchase insurance under the Affordable Care Act.

On Jan. 28, the House voted 227 to 188, with one lawmaker voting "present," to approve H.R. 7, the No Taxpayer Funding for Abortion Act. The bill would make permanent the Hyde Amendment, an annual rider placed on spending bills that prohibits federal funds from being used to pay for abortions. H.R. 7 would also bar individuals and small businesses from using federal tax subsidies under the Affordable Care Act (ACA) to purchase health plans that include coverage for abortion.

The bill includes exceptions in cases of rape or incest, or when the mother’s life is endangered.

The bill is not expected to advance in the Senate.

The bill’s sponsor, Rep. Chris Smith (R-N.J.), said that without the new legislation, the ACA would create a massive expansion of public funding for abortion. He estimated that of the 112 health plans available to members of Congress and their staff through the ACA, 103 include coverage of abortion services.

But reproductive health advocates said the bill interferes with a woman’s private health care decisions and attempts to restrict the health care services that can be offered in private insurance plans.

"This bill is as callous as it is cynical, denying insurance coverage of critical health care to millions of women across the U.S. and worsening especially the hardship of women already struggling under challenging economic conditions," Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement.

[email protected]

On Twitter @maryellenny

November 2013

“WHAT DO THE LATEST DATA REVEAL ABOUT THE SAFETY OF HOME BIRTH IN THE UNITED STATES?
”ERROL R. NORWITZ, MD, PHD (EXAMINING THE EVIDENCE; NOVEMBER 2013)

We need honest, respectful discussion about the risks of home birth
I object to the tone of the recent commentary by Dr. Errol Norwitz. Although I agree with the concerns he raised, I object to his “tactics.” The subject line of the email I received about this commentary (“Let’s keep home delivery where it belongs…for pizza!”) and some of the comments in the article were inflammatory and almost seem to be making fun of a topic about which many women in our country feel passionately.

As health-care providers, we are skilled at explaining risks and helping people understand how their choices and actions affect those risks. We do this daily without offering insult to patients regarding their beliefs. You don’t need to convince ObGyns that home birth is unsafe—I daresay that most of them already believe that. Awareness of the data and even some of Dr. Norwitz’s insights surely are valuable to the people who are actually pursuing and performing home births—but I feel that the subject line and closing remarks were mean-spirited and serve only to push practitioners and even patients—who need information to make informed decisions—farther away from what Dr. Norwitz argues is the safest care. No one responds well to mockery.

I practice the full scope of nurse-midwifery in a hospital-based practice with excellent physicians to support me and my patients. I do not attend home births, and I, too, have concerns about some home-birth practices and statistics. Honest, respectful communication about the facts is what is needed to improve patient safety and outcomes—not marginalization and disrespect.

Jamie A. Otremba, CNM
Waconia, Minnesota

Hospital deliveries can have problems, too
This article was insulting. When the study by Cheng and colleagues¹ was first published, it received enormous criticism, so why has it been revived? Planned home birth with an appropriate provider is safe. The absolute numbers for maternal and newborn problems are very low but sound high when couched in warning language. Let’s not forget the mothers and babies who have problems in the hospital. In fact, the United States has a terrible record when it comes to maternal and neonatal morbidity and mortality—figures based almost entirely on hospital deliveries.

Low-risk women choose home birth to avoid a delivery that often results in far too many non-evidence-based interventions. Why don’t we change the system to make it work? If ObGyns would participate in a collaborative system of care that allows seamless integration of midwives into the acute-care setting when women are no longer low-risk, home-birth statistics would improve tremendously.

ObGyns are surgeons and specialists in problem-solving. Midwives are specialists in low-risk care, and they are adept at continuously assessing their patients to assure that they remain low-risk, consulting or transferring when necessary. Far too many physicians are “turf-conscious,” refusing to collaborate with midwives. It sounds to me as though the risk in home birth is iatrogenic, caused by the very physicians who claim that it is unsafe.

Chris Hilderbrandt, ARNP, CNM
Largo, Florida

Why are real changes taking so long?
I believe that the risk figures—bolded and supersized at the beginning of Dr. Norwitz’s commentary—are somewhat misleading. The intended message is clear but something very important is missing: The scores and risk values for home births were not isolated and compared between skilled midwives attending the births versus unskilled and untrained “other midwives.” In that light, when one considers the difference in risk—0.37% risk for an Apgar score of less than 4 for a home birth (which involves mainly nonprofessional labor attendants) and 0.24% for a hospitalized, medically managed birth, it is remarkable that the difference—0.13%—is so small.

I realize the importance of striving to bring any risk close to zero, but the way the data were presented unfairly implies that home births are essentially more risky than hospital births. It simply may be that they are attended by less-skilled people. 

In addition, Dr. Norwitz noted that, in countries where home birth is integrated into the health-care system, there is a twofold to threefold increase in neonatal death. However, a 2011 article by van der Kooy and colleagues² contradicts that claim, showing no significant difference in neonatal deaths between planned home birth and hospital birth for low-risk women in the Netherlands. I suppose, depending on the vantage point, there is a study somewhere that will support any of our beliefs.

Please make no mistake. I have never been a proponent of home birth. Even a small risk becomes 100% for the individual who suffers any kind of ill effects or damage. But I am a promoter of natural birth and minimal medical intervention. I abandoned obstetrics years ago when I saw firsthand that the increasing focus on technology and medical intervention moved the woman and her experience to the outer margins. The situation has not improved, and the strides made early on by the women’s movement have all but disappeared as women are aggressively convinced that technology and “controlled” interventions will grant them safe passage. In the process, they lose a sense of their autonomy and participation in one of the most important events in their lives.

At the end of the article, Dr. Norwitz leaves us with a notion that obstetric care providers need to do more in the way of providing emotional and social support. My question is… What in the world are you waiting for?

Obstetric care has a very long way to go before the focus moves meaningfully toward handing back some of the power of choice to the pregnant woman, something early feminists championed. That would require the obstetrician to honor and listen to the woman as she begins to formulate a delivery plan, to support her input at every step of decision-making, to provide her with or refer her to sources of information about delivery alternatives—the very types of alternatives that are readily available in midwife-attended births.

Jacquelynn Cunliffe, MSN, PhD
Wayne, Pennsylvania

Dr. Norwitz responds

We all want a healthy infant
Regardless of the type of training or level of experience, all obstetric care providers want the same outcome: an uncomplicated delivery of a healthy infant under conditions that are safe and supportive.

Contrary to popular belief, Nature is not a good obstetrician. It is estimated that between 1 in 50 and 1 in 500 fetuses reach maturity in utero and are subsequently involved in a catastrophic event that results in severe neurologic damage or perinatal death.³ Many of these catastrophic events occur during labor. Even a woman categorized as “low-risk” throughout her pregnancy can become “high-risk” in a matter of minutes if she develops a complication during labor such as cord prolapse or placental abruption. Risk factors for such intrapartum complications have been described, but these complications can develop in anyone at any time, even in women with no risk factors at all.

As noted in the letter from Dr. Cunliffe and the article by Cheng and colleagues,⁴ the level of training of the person attending the planned home birth may well affect the outcome. The less skilled the provider, the less likely he or she is to anticipate and recognize a complication and the more likely an adverse event. The existing literature on this topic should not be interpreted as a criticism of the training or skill of certified nurse midwives. Even the most skilled birth attendant is ill-prepared to deal with the potential catastrophe of an intrapartum complication during a planned home birth, given the limited resources of a home environment.

The issue of planned home birth is an emotive one. Although every effort should be made to ensure that the birthing experience is a positive one, it should not be done at the expense of safety. Ms. Hilderbrandt’s claim that “Planned home birth with an appropriate provider is safe” is not supported by the existing data. Even in countries where home births are integrated fully into the medical care system, such deliveries are associated with a twofold to threefold increase in the odds of neonatal death.⁵ In the United States, where no such integration exists, a planned home birth is simply dangerous, although the absolute risk of a serious adverse event is low.

If a pregnant woman ever wants to know the safest place to deliver her baby, the unequivocal answer is: in a hospital setting. The question of who is best suited to attend the birth is far less critical, so long as the person—either a physician or a certified nurse midwife—has completed an accredited training program.  

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected]

November 2013

“WHAT DO THE LATEST DATA REVEAL ABOUT THE SAFETY OF HOME BIRTH IN THE UNITED STATES?
”ERROL R. NORWITZ, MD, PHD (EXAMINING THE EVIDENCE; NOVEMBER 2013)

We need honest, respectful discussion about the risks of home birth
I object to the tone of the recent commentary by Dr. Errol Norwitz. Although I agree with the concerns he raised, I object to his “tactics.” The subject line of the email I received about this commentary (“Let’s keep home delivery where it belongs…for pizza!”) and some of the comments in the article were inflammatory and almost seem to be making fun of a topic about which many women in our country feel passionately.

As health-care providers, we are skilled at explaining risks and helping people understand how their choices and actions affect those risks. We do this daily without offering insult to patients regarding their beliefs. You don’t need to convince ObGyns that home birth is unsafe—I daresay that most of them already believe that. Awareness of the data and even some of Dr. Norwitz’s insights surely are valuable to the people who are actually pursuing and performing home births—but I feel that the subject line and closing remarks were mean-spirited and serve only to push practitioners and even patients—who need information to make informed decisions—farther away from what Dr. Norwitz argues is the safest care. No one responds well to mockery.

I practice the full scope of nurse-midwifery in a hospital-based practice with excellent physicians to support me and my patients. I do not attend home births, and I, too, have concerns about some home-birth practices and statistics. Honest, respectful communication about the facts is what is needed to improve patient safety and outcomes—not marginalization and disrespect.

Jamie A. Otremba, CNM
Waconia, Minnesota

Hospital deliveries can have problems, too
This article was insulting. When the study by Cheng and colleagues¹ was first published, it received enormous criticism, so why has it been revived? Planned home birth with an appropriate provider is safe. The absolute numbers for maternal and newborn problems are very low but sound high when couched in warning language. Let’s not forget the mothers and babies who have problems in the hospital. In fact, the United States has a terrible record when it comes to maternal and neonatal morbidity and mortality—figures based almost entirely on hospital deliveries.

Low-risk women choose home birth to avoid a delivery that often results in far too many non-evidence-based interventions. Why don’t we change the system to make it work? If ObGyns would participate in a collaborative system of care that allows seamless integration of midwives into the acute-care setting when women are no longer low-risk, home-birth statistics would improve tremendously.

ObGyns are surgeons and specialists in problem-solving. Midwives are specialists in low-risk care, and they are adept at continuously assessing their patients to assure that they remain low-risk, consulting or transferring when necessary. Far too many physicians are “turf-conscious,” refusing to collaborate with midwives. It sounds to me as though the risk in home birth is iatrogenic, caused by the very physicians who claim that it is unsafe.

Chris Hilderbrandt, ARNP, CNM
Largo, Florida

Why are real changes taking so long?
I believe that the risk figures—bolded and supersized at the beginning of Dr. Norwitz’s commentary—are somewhat misleading. The intended message is clear but something very important is missing: The scores and risk values for home births were not isolated and compared between skilled midwives attending the births versus unskilled and untrained “other midwives.” In that light, when one considers the difference in risk—0.37% risk for an Apgar score of less than 4 for a home birth (which involves mainly nonprofessional labor attendants) and 0.24% for a hospitalized, medically managed birth, it is remarkable that the difference—0.13%—is so small.

I realize the importance of striving to bring any risk close to zero, but the way the data were presented unfairly implies that home births are essentially more risky than hospital births. It simply may be that they are attended by less-skilled people. 

In addition, Dr. Norwitz noted that, in countries where home birth is integrated into the health-care system, there is a twofold to threefold increase in neonatal death. However, a 2011 article by van der Kooy and colleagues² contradicts that claim, showing no significant difference in neonatal deaths between planned home birth and hospital birth for low-risk women in the Netherlands. I suppose, depending on the vantage point, there is a study somewhere that will support any of our beliefs.

Please make no mistake. I have never been a proponent of home birth. Even a small risk becomes 100% for the individual who suffers any kind of ill effects or damage. But I am a promoter of natural birth and minimal medical intervention. I abandoned obstetrics years ago when I saw firsthand that the increasing focus on technology and medical intervention moved the woman and her experience to the outer margins. The situation has not improved, and the strides made early on by the women’s movement have all but disappeared as women are aggressively convinced that technology and “controlled” interventions will grant them safe passage. In the process, they lose a sense of their autonomy and participation in one of the most important events in their lives.

At the end of the article, Dr. Norwitz leaves us with a notion that obstetric care providers need to do more in the way of providing emotional and social support. My question is… What in the world are you waiting for?

Obstetric care has a very long way to go before the focus moves meaningfully toward handing back some of the power of choice to the pregnant woman, something early feminists championed. That would require the obstetrician to honor and listen to the woman as she begins to formulate a delivery plan, to support her input at every step of decision-making, to provide her with or refer her to sources of information about delivery alternatives—the very types of alternatives that are readily available in midwife-attended births.

Jacquelynn Cunliffe, MSN, PhD
Wayne, Pennsylvania

Dr. Norwitz responds

We all want a healthy infant
Regardless of the type of training or level of experience, all obstetric care providers want the same outcome: an uncomplicated delivery of a healthy infant under conditions that are safe and supportive.

Contrary to popular belief, Nature is not a good obstetrician. It is estimated that between 1 in 50 and 1 in 500 fetuses reach maturity in utero and are subsequently involved in a catastrophic event that results in severe neurologic damage or perinatal death.³ Many of these catastrophic events occur during labor. Even a woman categorized as “low-risk” throughout her pregnancy can become “high-risk” in a matter of minutes if she develops a complication during labor such as cord prolapse or placental abruption. Risk factors for such intrapartum complications have been described, but these complications can develop in anyone at any time, even in women with no risk factors at all.

As noted in the letter from Dr. Cunliffe and the article by Cheng and colleagues,⁴ the level of training of the person attending the planned home birth may well affect the outcome. The less skilled the provider, the less likely he or she is to anticipate and recognize a complication and the more likely an adverse event. The existing literature on this topic should not be interpreted as a criticism of the training or skill of certified nurse midwives. Even the most skilled birth attendant is ill-prepared to deal with the potential catastrophe of an intrapartum complication during a planned home birth, given the limited resources of a home environment.

The issue of planned home birth is an emotive one. Although every effort should be made to ensure that the birthing experience is a positive one, it should not be done at the expense of safety. Ms. Hilderbrandt’s claim that “Planned home birth with an appropriate provider is safe” is not supported by the existing data. Even in countries where home births are integrated fully into the medical care system, such deliveries are associated with a twofold to threefold increase in the odds of neonatal death.⁵ In the United States, where no such integration exists, a planned home birth is simply dangerous, although the absolute risk of a serious adverse event is low.

If a pregnant woman ever wants to know the safest place to deliver her baby, the unequivocal answer is: in a hospital setting. The question of who is best suited to attend the birth is far less critical, so long as the person—either a physician or a certified nurse midwife—has completed an accredited training program.  

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected]

November 2013

“WHAT DO THE LATEST DATA REVEAL ABOUT THE SAFETY OF HOME BIRTH IN THE UNITED STATES?
”ERROL R. NORWITZ, MD, PHD (EXAMINING THE EVIDENCE; NOVEMBER 2013)

We need honest, respectful discussion about the risks of home birth
I object to the tone of the recent commentary by Dr. Errol Norwitz. Although I agree with the concerns he raised, I object to his “tactics.” The subject line of the email I received about this commentary (“Let’s keep home delivery where it belongs…for pizza!”) and some of the comments in the article were inflammatory and almost seem to be making fun of a topic about which many women in our country feel passionately.

As health-care providers, we are skilled at explaining risks and helping people understand how their choices and actions affect those risks. We do this daily without offering insult to patients regarding their beliefs. You don’t need to convince ObGyns that home birth is unsafe—I daresay that most of them already believe that. Awareness of the data and even some of Dr. Norwitz’s insights surely are valuable to the people who are actually pursuing and performing home births—but I feel that the subject line and closing remarks were mean-spirited and serve only to push practitioners and even patients—who need information to make informed decisions—farther away from what Dr. Norwitz argues is the safest care. No one responds well to mockery.

I practice the full scope of nurse-midwifery in a hospital-based practice with excellent physicians to support me and my patients. I do not attend home births, and I, too, have concerns about some home-birth practices and statistics. Honest, respectful communication about the facts is what is needed to improve patient safety and outcomes—not marginalization and disrespect.

Jamie A. Otremba, CNM
Waconia, Minnesota

Hospital deliveries can have problems, too
This article was insulting. When the study by Cheng and colleagues¹ was first published, it received enormous criticism, so why has it been revived? Planned home birth with an appropriate provider is safe. The absolute numbers for maternal and newborn problems are very low but sound high when couched in warning language. Let’s not forget the mothers and babies who have problems in the hospital. In fact, the United States has a terrible record when it comes to maternal and neonatal morbidity and mortality—figures based almost entirely on hospital deliveries.

Low-risk women choose home birth to avoid a delivery that often results in far too many non-evidence-based interventions. Why don’t we change the system to make it work? If ObGyns would participate in a collaborative system of care that allows seamless integration of midwives into the acute-care setting when women are no longer low-risk, home-birth statistics would improve tremendously.

ObGyns are surgeons and specialists in problem-solving. Midwives are specialists in low-risk care, and they are adept at continuously assessing their patients to assure that they remain low-risk, consulting or transferring when necessary. Far too many physicians are “turf-conscious,” refusing to collaborate with midwives. It sounds to me as though the risk in home birth is iatrogenic, caused by the very physicians who claim that it is unsafe.

Chris Hilderbrandt, ARNP, CNM
Largo, Florida

Why are real changes taking so long?
I believe that the risk figures—bolded and supersized at the beginning of Dr. Norwitz’s commentary—are somewhat misleading. The intended message is clear but something very important is missing: The scores and risk values for home births were not isolated and compared between skilled midwives attending the births versus unskilled and untrained “other midwives.” In that light, when one considers the difference in risk—0.37% risk for an Apgar score of less than 4 for a home birth (which involves mainly nonprofessional labor attendants) and 0.24% for a hospitalized, medically managed birth, it is remarkable that the difference—0.13%—is so small.

I realize the importance of striving to bring any risk close to zero, but the way the data were presented unfairly implies that home births are essentially more risky than hospital births. It simply may be that they are attended by less-skilled people. 

In addition, Dr. Norwitz noted that, in countries where home birth is integrated into the health-care system, there is a twofold to threefold increase in neonatal death. However, a 2011 article by van der Kooy and colleagues² contradicts that claim, showing no significant difference in neonatal deaths between planned home birth and hospital birth for low-risk women in the Netherlands. I suppose, depending on the vantage point, there is a study somewhere that will support any of our beliefs.

Please make no mistake. I have never been a proponent of home birth. Even a small risk becomes 100% for the individual who suffers any kind of ill effects or damage. But I am a promoter of natural birth and minimal medical intervention. I abandoned obstetrics years ago when I saw firsthand that the increasing focus on technology and medical intervention moved the woman and her experience to the outer margins. The situation has not improved, and the strides made early on by the women’s movement have all but disappeared as women are aggressively convinced that technology and “controlled” interventions will grant them safe passage. In the process, they lose a sense of their autonomy and participation in one of the most important events in their lives.

At the end of the article, Dr. Norwitz leaves us with a notion that obstetric care providers need to do more in the way of providing emotional and social support. My question is… What in the world are you waiting for?

Obstetric care has a very long way to go before the focus moves meaningfully toward handing back some of the power of choice to the pregnant woman, something early feminists championed. That would require the obstetrician to honor and listen to the woman as she begins to formulate a delivery plan, to support her input at every step of decision-making, to provide her with or refer her to sources of information about delivery alternatives—the very types of alternatives that are readily available in midwife-attended births.

Jacquelynn Cunliffe, MSN, PhD
Wayne, Pennsylvania

Dr. Norwitz responds

We all want a healthy infant
Regardless of the type of training or level of experience, all obstetric care providers want the same outcome: an uncomplicated delivery of a healthy infant under conditions that are safe and supportive.

Contrary to popular belief, Nature is not a good obstetrician. It is estimated that between 1 in 50 and 1 in 500 fetuses reach maturity in utero and are subsequently involved in a catastrophic event that results in severe neurologic damage or perinatal death.³ Many of these catastrophic events occur during labor. Even a woman categorized as “low-risk” throughout her pregnancy can become “high-risk” in a matter of minutes if she develops a complication during labor such as cord prolapse or placental abruption. Risk factors for such intrapartum complications have been described, but these complications can develop in anyone at any time, even in women with no risk factors at all.

As noted in the letter from Dr. Cunliffe and the article by Cheng and colleagues,⁴ the level of training of the person attending the planned home birth may well affect the outcome. The less skilled the provider, the less likely he or she is to anticipate and recognize a complication and the more likely an adverse event. The existing literature on this topic should not be interpreted as a criticism of the training or skill of certified nurse midwives. Even the most skilled birth attendant is ill-prepared to deal with the potential catastrophe of an intrapartum complication during a planned home birth, given the limited resources of a home environment.

The issue of planned home birth is an emotive one. Although every effort should be made to ensure that the birthing experience is a positive one, it should not be done at the expense of safety. Ms. Hilderbrandt’s claim that “Planned home birth with an appropriate provider is safe” is not supported by the existing data. Even in countries where home births are integrated fully into the medical care system, such deliveries are associated with a twofold to threefold increase in the odds of neonatal death.⁵ In the United States, where no such integration exists, a planned home birth is simply dangerous, although the absolute risk of a serious adverse event is low.

If a pregnant woman ever wants to know the safest place to deliver her baby, the unequivocal answer is: in a hospital setting. The question of who is best suited to attend the birth is far less critical, so long as the person—either a physician or a certified nurse midwife—has completed an accredited training program.  

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected]

Just over one in five live, singleton births in 2012 were delivered by cesarean section for first-time mothers, showing slight declines in the rates since 2009 among the U.S. states included in a recent report.

The overall primary cesarean delivery rate was 21.5% for the 38 states – plus the District of Columbia and New York City – that had implemented the 2003 U.S. Standard Certificate of Live Birth (revised) by, at latest, Jan. 1, 2012, according to a National Vital Statistics Report from the National Center for Health Statistics.

State-specific rates in 2012 ranged from a low of 12.5% in Utah to a high of 26.9% in Florida and Louisiana, the investigators reported Jan. 23 (Natl. Vital Stat. Rep. 2014;63:1-10).

The report did not include any data from states that used the 1989 U.S. Standard Certificate of Live Birth (unrevised) through 2012 since the 1989 certificate reports on the "method of delivery" differently than the 2003 revised certificate. The data are, therefore, not generalizable to the entire country since the births are not a random sample or representative of the national demographics, especially in terms of Hispanics’ distribution.

Instead, the report’s data are presented based on when states implemented the revised 2003 certificate, a process that occurred gradually over about a decade. Among the 19 states (excluding New York City) that had implemented the 2003 certificate by Jan. 1, 2006, the primary cesarean rate first increased from 21.9% in 2006 to 22.4% in 2009 and then dropped to 21.9% in 2012. The lower rate in 2012 resulted from declines in 11 of the 19 states since 2009 while the other eight states had no significant changes in their rates.

The 28 states plus New York City that implemented the 2003 certificate by Jan. 1, 2009, also showed a decline from 2009, when the primary cesarean rate was 22.1%, to 2012, when the rate was 21.5%. This overall decline resulted from decreases in the cesarean rates in 16 of the 29 total areas included, while the other 13 areas’ rates did not significantly change. Utah’s rate during this time dropped 15%, while Delaware, New York, New York City, North Dakota, and Oregon saw drops of 5% to 10% from 2009 to 2012.

"Although significant declines were observed for total 2006 and 2009 revised reporting area rates and for many state-specific rates between 2009 and 2012, the pace of the decline has slowed," the authors wrote. For example, only two of the 19 states using the revised certificate by 2006 saw declines from 2011 to 2012, even though 13 states from this group saw declines from 2009 to 2010.

Few changes occurred in cesarean rates based on gestational age at the state level, with the only statistically significant change across multiple states occurring among babies born at 38 weeks. Among 18 of the 29 areas that adopted the 2003 certificate by 2009, the rate for this gestational age dropped an average of 10% from 2009 to 2012.

The decline varied from a 5% drop in Michigan to an 18% drop in Utah. States seeing a drop of at least 10% in primary cesarean rates at 38 weeks for those years included Georgia, Kansas, Nebraska, New Mexico, New York, New York City, Ohio, Oregon, Utah, and Washington. The overall primary cesarean rates for all 29 areas combined did show decreases for each gestational age from 37 weeks to 41 weeks and for 42 or more weeks.

The report was funded by the National Center for Health Statistics. No disclosures were reported.

Just over one in five live, singleton births in 2012 were delivered by cesarean section for first-time mothers, showing slight declines in the rates since 2009 among the U.S. states included in a recent report.

The overall primary cesarean delivery rate was 21.5% for the 38 states – plus the District of Columbia and New York City – that had implemented the 2003 U.S. Standard Certificate of Live Birth (revised) by, at latest, Jan. 1, 2012, according to a National Vital Statistics Report from the National Center for Health Statistics.

State-specific rates in 2012 ranged from a low of 12.5% in Utah to a high of 26.9% in Florida and Louisiana, the investigators reported Jan. 23 (Natl. Vital Stat. Rep. 2014;63:1-10).

The report did not include any data from states that used the 1989 U.S. Standard Certificate of Live Birth (unrevised) through 2012 since the 1989 certificate reports on the "method of delivery" differently than the 2003 revised certificate. The data are, therefore, not generalizable to the entire country since the births are not a random sample or representative of the national demographics, especially in terms of Hispanics’ distribution.

Instead, the report’s data are presented based on when states implemented the revised 2003 certificate, a process that occurred gradually over about a decade. Among the 19 states (excluding New York City) that had implemented the 2003 certificate by Jan. 1, 2006, the primary cesarean rate first increased from 21.9% in 2006 to 22.4% in 2009 and then dropped to 21.9% in 2012. The lower rate in 2012 resulted from declines in 11 of the 19 states since 2009 while the other eight states had no significant changes in their rates.

The 28 states plus New York City that implemented the 2003 certificate by Jan. 1, 2009, also showed a decline from 2009, when the primary cesarean rate was 22.1%, to 2012, when the rate was 21.5%. This overall decline resulted from decreases in the cesarean rates in 16 of the 29 total areas included, while the other 13 areas’ rates did not significantly change. Utah’s rate during this time dropped 15%, while Delaware, New York, New York City, North Dakota, and Oregon saw drops of 5% to 10% from 2009 to 2012.

"Although significant declines were observed for total 2006 and 2009 revised reporting area rates and for many state-specific rates between 2009 and 2012, the pace of the decline has slowed," the authors wrote. For example, only two of the 19 states using the revised certificate by 2006 saw declines from 2011 to 2012, even though 13 states from this group saw declines from 2009 to 2010.

Few changes occurred in cesarean rates based on gestational age at the state level, with the only statistically significant change across multiple states occurring among babies born at 38 weeks. Among 18 of the 29 areas that adopted the 2003 certificate by 2009, the rate for this gestational age dropped an average of 10% from 2009 to 2012.

The decline varied from a 5% drop in Michigan to an 18% drop in Utah. States seeing a drop of at least 10% in primary cesarean rates at 38 weeks for those years included Georgia, Kansas, Nebraska, New Mexico, New York, New York City, Ohio, Oregon, Utah, and Washington. The overall primary cesarean rates for all 29 areas combined did show decreases for each gestational age from 37 weeks to 41 weeks and for 42 or more weeks.

The report was funded by the National Center for Health Statistics. No disclosures were reported.

Just over one in five live, singleton births in 2012 were delivered by cesarean section for first-time mothers, showing slight declines in the rates since 2009 among the U.S. states included in a recent report.

The overall primary cesarean delivery rate was 21.5% for the 38 states – plus the District of Columbia and New York City – that had implemented the 2003 U.S. Standard Certificate of Live Birth (revised) by, at latest, Jan. 1, 2012, according to a National Vital Statistics Report from the National Center for Health Statistics.

State-specific rates in 2012 ranged from a low of 12.5% in Utah to a high of 26.9% in Florida and Louisiana, the investigators reported Jan. 23 (Natl. Vital Stat. Rep. 2014;63:1-10).

The report did not include any data from states that used the 1989 U.S. Standard Certificate of Live Birth (unrevised) through 2012 since the 1989 certificate reports on the "method of delivery" differently than the 2003 revised certificate. The data are, therefore, not generalizable to the entire country since the births are not a random sample or representative of the national demographics, especially in terms of Hispanics’ distribution.

Instead, the report’s data are presented based on when states implemented the revised 2003 certificate, a process that occurred gradually over about a decade. Among the 19 states (excluding New York City) that had implemented the 2003 certificate by Jan. 1, 2006, the primary cesarean rate first increased from 21.9% in 2006 to 22.4% in 2009 and then dropped to 21.9% in 2012. The lower rate in 2012 resulted from declines in 11 of the 19 states since 2009 while the other eight states had no significant changes in their rates.

The 28 states plus New York City that implemented the 2003 certificate by Jan. 1, 2009, also showed a decline from 2009, when the primary cesarean rate was 22.1%, to 2012, when the rate was 21.5%. This overall decline resulted from decreases in the cesarean rates in 16 of the 29 total areas included, while the other 13 areas’ rates did not significantly change. Utah’s rate during this time dropped 15%, while Delaware, New York, New York City, North Dakota, and Oregon saw drops of 5% to 10% from 2009 to 2012.

"Although significant declines were observed for total 2006 and 2009 revised reporting area rates and for many state-specific rates between 2009 and 2012, the pace of the decline has slowed," the authors wrote. For example, only two of the 19 states using the revised certificate by 2006 saw declines from 2011 to 2012, even though 13 states from this group saw declines from 2009 to 2010.

Few changes occurred in cesarean rates based on gestational age at the state level, with the only statistically significant change across multiple states occurring among babies born at 38 weeks. Among 18 of the 29 areas that adopted the 2003 certificate by 2009, the rate for this gestational age dropped an average of 10% from 2009 to 2012.

The decline varied from a 5% drop in Michigan to an 18% drop in Utah. States seeing a drop of at least 10% in primary cesarean rates at 38 weeks for those years included Georgia, Kansas, Nebraska, New Mexico, New York, New York City, Ohio, Oregon, Utah, and Washington. The overall primary cesarean rates for all 29 areas combined did show decreases for each gestational age from 37 weeks to 41 weeks and for 42 or more weeks.

The report was funded by the National Center for Health Statistics. No disclosures were reported.

Excessive evaluations of well-appearing neonates declined markedly, as intended, when the most recent (2010) CDC guidelines for assessing early-onset group B streptococcal sepsis were implemented, according to a report from one hospital published online Jan. 20 in Pediatrics.

This decrease was accompanied by a marked drop in health care costs and was not associated with any apparent harmful effects, indicating that the evaluations that were avoided were indeed unnecessary, said Dr. Sagori Mukhopadhyay of Boston Children’s Hospital and Harvard Medical School and her associates.

The guidelines from the Centers for Disease Control and Prevention (CDC) were revised so that healthy-appearing infants born to mothers who had inadequate intrapartum antibiotic prophylaxis for group B streptococcus would only be evaluated for early-onset GBS sepsis if they had additional indications: gestational age of less than 37 weeks, rupture of membranes that preceded delivery by 18 hours or longer, maternal fever, or chorioamnionitis. Preliminary studies indicated that implementing these more restrictive guidelines would decrease excessive evaluations of healthy newborns by approximately 25%, "but the real-life impact of changes in medical policy is rarely straightforward," the investigators said.

© Janice Haney Carr/CDC

There was concern that some well-appearing infants who weren’t closely evaluated might go on to develop early-onset GBS sepsis that could have been prevented. So Dr. Mukhopadhyay and her colleagues performed a retrospective cohort study involving 14,286 live births to assess the effect of implementing the new guidelines.

They compared infants born at Brigham and Women’s Hospital, Boston, during two time periods: 7,282 born the year before the new guidelines were adopted (spring 2009–spring 2010), and 7,004 born the year afterward (spring 2011–spring 2012).

Typical evaluations for early-onset GBS sepsis involved immediate transfer to the neonatal intensive care unit, measurement of vital signs, blood sampling, peripheral IV catheter insertion, empiric antibiotic therapy, and close observation for several hours.

The number of such evaluations declined substantially after implementation of the new guidelines, from 920 to 476. This represents a rate decrease from 126 per 1,000 live births to 68 per 1,000 live births, the investigators reported (Pediatrics 2014;33:196-203).

The number of infants given empiric antibiotics also declined, from 527 to 365.

There was no increase in the number of infants who developed early-onset GBS sepsis between the two study periods. The overall rate of culture-confirmed infection was 0.25 per 1,000 live births in 2009-2010, which was not significantly different from the rate of 0.39 per 1,000 in 2011-2012.

Costs of care dramatically decreased along with the decline in "unnecessary" newborn evaluations. "The resources expended over the study periods among asymptomatic infants at risk for early-onset sepsis were considerable: more than 2,200 nursing hours were required to evaluate 1,396 infants, including 890 uninfected infants treated with antibiotics, at an estimated cost of nearly $400,000. These efforts detected only 2 early-onset sepsis cases," Dr. Mukhopadhyay and her associates said.

They added that the American Academy of Pediatrics’ Committee on the Fetus and Newborn recently published its own guidelines for early-onset sepsis evaluation and prevention. Because these AAP guidelines differ somewhat from the CDC guidelines, implementing them will likely have a somewhat different effect on the frequency and costs of such evaluations, the investigators said.

This study was supported by the National Institutes of Health, the Harvard Catalyst/Harvard Clinical and Translational Science Center, the National Center for Research Resources, the National Center for Advancing Translational Sciences, and Harvard University. No financial conflicts of interest were reported.

Excessive evaluations of well-appearing neonates declined markedly, as intended, when the most recent (2010) CDC guidelines for assessing early-onset group B streptococcal sepsis were implemented, according to a report from one hospital published online Jan. 20 in Pediatrics.

This decrease was accompanied by a marked drop in health care costs and was not associated with any apparent harmful effects, indicating that the evaluations that were avoided were indeed unnecessary, said Dr. Sagori Mukhopadhyay of Boston Children’s Hospital and Harvard Medical School and her associates.

The guidelines from the Centers for Disease Control and Prevention (CDC) were revised so that healthy-appearing infants born to mothers who had inadequate intrapartum antibiotic prophylaxis for group B streptococcus would only be evaluated for early-onset GBS sepsis if they had additional indications: gestational age of less than 37 weeks, rupture of membranes that preceded delivery by 18 hours or longer, maternal fever, or chorioamnionitis. Preliminary studies indicated that implementing these more restrictive guidelines would decrease excessive evaluations of healthy newborns by approximately 25%, "but the real-life impact of changes in medical policy is rarely straightforward," the investigators said.

© Janice Haney Carr/CDC

There was concern that some well-appearing infants who weren’t closely evaluated might go on to develop early-onset GBS sepsis that could have been prevented. So Dr. Mukhopadhyay and her colleagues performed a retrospective cohort study involving 14,286 live births to assess the effect of implementing the new guidelines.

They compared infants born at Brigham and Women’s Hospital, Boston, during two time periods: 7,282 born the year before the new guidelines were adopted (spring 2009–spring 2010), and 7,004 born the year afterward (spring 2011–spring 2012).

Typical evaluations for early-onset GBS sepsis involved immediate transfer to the neonatal intensive care unit, measurement of vital signs, blood sampling, peripheral IV catheter insertion, empiric antibiotic therapy, and close observation for several hours.

The number of such evaluations declined substantially after implementation of the new guidelines, from 920 to 476. This represents a rate decrease from 126 per 1,000 live births to 68 per 1,000 live births, the investigators reported (Pediatrics 2014;33:196-203).

The number of infants given empiric antibiotics also declined, from 527 to 365.

There was no increase in the number of infants who developed early-onset GBS sepsis between the two study periods. The overall rate of culture-confirmed infection was 0.25 per 1,000 live births in 2009-2010, which was not significantly different from the rate of 0.39 per 1,000 in 2011-2012.

Costs of care dramatically decreased along with the decline in "unnecessary" newborn evaluations. "The resources expended over the study periods among asymptomatic infants at risk for early-onset sepsis were considerable: more than 2,200 nursing hours were required to evaluate 1,396 infants, including 890 uninfected infants treated with antibiotics, at an estimated cost of nearly $400,000. These efforts detected only 2 early-onset sepsis cases," Dr. Mukhopadhyay and her associates said.

They added that the American Academy of Pediatrics’ Committee on the Fetus and Newborn recently published its own guidelines for early-onset sepsis evaluation and prevention. Because these AAP guidelines differ somewhat from the CDC guidelines, implementing them will likely have a somewhat different effect on the frequency and costs of such evaluations, the investigators said.

This study was supported by the National Institutes of Health, the Harvard Catalyst/Harvard Clinical and Translational Science Center, the National Center for Research Resources, the National Center for Advancing Translational Sciences, and Harvard University. No financial conflicts of interest were reported.

Excessive evaluations of well-appearing neonates declined markedly, as intended, when the most recent (2010) CDC guidelines for assessing early-onset group B streptococcal sepsis were implemented, according to a report from one hospital published online Jan. 20 in Pediatrics.

This decrease was accompanied by a marked drop in health care costs and was not associated with any apparent harmful effects, indicating that the evaluations that were avoided were indeed unnecessary, said Dr. Sagori Mukhopadhyay of Boston Children’s Hospital and Harvard Medical School and her associates.

The guidelines from the Centers for Disease Control and Prevention (CDC) were revised so that healthy-appearing infants born to mothers who had inadequate intrapartum antibiotic prophylaxis for group B streptococcus would only be evaluated for early-onset GBS sepsis if they had additional indications: gestational age of less than 37 weeks, rupture of membranes that preceded delivery by 18 hours or longer, maternal fever, or chorioamnionitis. Preliminary studies indicated that implementing these more restrictive guidelines would decrease excessive evaluations of healthy newborns by approximately 25%, "but the real-life impact of changes in medical policy is rarely straightforward," the investigators said.

© Janice Haney Carr/CDC

There was concern that some well-appearing infants who weren’t closely evaluated might go on to develop early-onset GBS sepsis that could have been prevented. So Dr. Mukhopadhyay and her colleagues performed a retrospective cohort study involving 14,286 live births to assess the effect of implementing the new guidelines.

They compared infants born at Brigham and Women’s Hospital, Boston, during two time periods: 7,282 born the year before the new guidelines were adopted (spring 2009–spring 2010), and 7,004 born the year afterward (spring 2011–spring 2012).

Typical evaluations for early-onset GBS sepsis involved immediate transfer to the neonatal intensive care unit, measurement of vital signs, blood sampling, peripheral IV catheter insertion, empiric antibiotic therapy, and close observation for several hours.

The number of such evaluations declined substantially after implementation of the new guidelines, from 920 to 476. This represents a rate decrease from 126 per 1,000 live births to 68 per 1,000 live births, the investigators reported (Pediatrics 2014;33:196-203).

The number of infants given empiric antibiotics also declined, from 527 to 365.

There was no increase in the number of infants who developed early-onset GBS sepsis between the two study periods. The overall rate of culture-confirmed infection was 0.25 per 1,000 live births in 2009-2010, which was not significantly different from the rate of 0.39 per 1,000 in 2011-2012.

Costs of care dramatically decreased along with the decline in "unnecessary" newborn evaluations. "The resources expended over the study periods among asymptomatic infants at risk for early-onset sepsis were considerable: more than 2,200 nursing hours were required to evaluate 1,396 infants, including 890 uninfected infants treated with antibiotics, at an estimated cost of nearly $400,000. These efforts detected only 2 early-onset sepsis cases," Dr. Mukhopadhyay and her associates said.

They added that the American Academy of Pediatrics’ Committee on the Fetus and Newborn recently published its own guidelines for early-onset sepsis evaluation and prevention. Because these AAP guidelines differ somewhat from the CDC guidelines, implementing them will likely have a somewhat different effect on the frequency and costs of such evaluations, the investigators said.

This study was supported by the National Institutes of Health, the Harvard Catalyst/Harvard Clinical and Translational Science Center, the National Center for Research Resources, the National Center for Advancing Translational Sciences, and Harvard University. No financial conflicts of interest were reported.

The Food and Drug Administration authorized for marketing a postnatal diagnostic test that helps detect genetic causes of developmental delay or intellectual disabilities in children, but it is not intended to be used as a stand-alone test, the agency announced on Jan 17.

With a blood sample, the CytoScan Dx Assay analyzes the entire genome and detects chromosomal variations in regions of the genome that are associated with intellectual and developmental disabilities, such as DiGeorge syndrome, according to the FDA statement. The statement emphasized that is should not be used as a stand-alone diagnostic test, or for preimplantation or prenatal testing or screening; population screening; "or for the detection of, or screening for acquired or genetic aberrations occurring after birth, such as cancer."

Moreover, test results "should only be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, evaluation of parental samples, clinical genetic evaluation, and counseling as appropriate," the statement said. Results should only be interpreted by health care professionals who are board certified in clinical cytogenetics or molecular genetics.

Evaluation of the test included a comparison of results of almost 1,000 blood samples, which found the test was better at detecting certain chromosomal abnormalities than karyotyping and fluorescence in situ hybridization (FISH) chromosomal tests.

"This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing health care providers and parents to intervene with appropriate care and support for the child," Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the statement.

The test is manufactured by Affymetrix.

[email protected]

The Food and Drug Administration authorized for marketing a postnatal diagnostic test that helps detect genetic causes of developmental delay or intellectual disabilities in children, but it is not intended to be used as a stand-alone test, the agency announced on Jan 17.

With a blood sample, the CytoScan Dx Assay analyzes the entire genome and detects chromosomal variations in regions of the genome that are associated with intellectual and developmental disabilities, such as DiGeorge syndrome, according to the FDA statement. The statement emphasized that is should not be used as a stand-alone diagnostic test, or for preimplantation or prenatal testing or screening; population screening; "or for the detection of, or screening for acquired or genetic aberrations occurring after birth, such as cancer."

Moreover, test results "should only be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, evaluation of parental samples, clinical genetic evaluation, and counseling as appropriate," the statement said. Results should only be interpreted by health care professionals who are board certified in clinical cytogenetics or molecular genetics.

Evaluation of the test included a comparison of results of almost 1,000 blood samples, which found the test was better at detecting certain chromosomal abnormalities than karyotyping and fluorescence in situ hybridization (FISH) chromosomal tests.

"This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing health care providers and parents to intervene with appropriate care and support for the child," Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the statement.

The test is manufactured by Affymetrix.

[email protected]

The Food and Drug Administration authorized for marketing a postnatal diagnostic test that helps detect genetic causes of developmental delay or intellectual disabilities in children, but it is not intended to be used as a stand-alone test, the agency announced on Jan 17.

With a blood sample, the CytoScan Dx Assay analyzes the entire genome and detects chromosomal variations in regions of the genome that are associated with intellectual and developmental disabilities, such as DiGeorge syndrome, according to the FDA statement. The statement emphasized that is should not be used as a stand-alone diagnostic test, or for preimplantation or prenatal testing or screening; population screening; "or for the detection of, or screening for acquired or genetic aberrations occurring after birth, such as cancer."

Moreover, test results "should only be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, evaluation of parental samples, clinical genetic evaluation, and counseling as appropriate," the statement said. Results should only be interpreted by health care professionals who are board certified in clinical cytogenetics or molecular genetics.

Evaluation of the test included a comparison of results of almost 1,000 blood samples, which found the test was better at detecting certain chromosomal abnormalities than karyotyping and fluorescence in situ hybridization (FISH) chromosomal tests.

"This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing health care providers and parents to intervene with appropriate care and support for the child," Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the statement.

The test is manufactured by Affymetrix.

[email protected]

SAN FRANCISCO – Because of significant limitations in the Food and Drug Administration’s pregnancy categories, it’s important to have another reliable resource handy to guide prescribing during pregnancy, Dr. Elizabeth S. Harleman believes.

Three out of four attendees at a conference on women’s health sponsored by the University of California, San Francisco, said that they use the FDA categories to determine a drug’s safety during pregnancy, an informal electronic poll at the meeting showed. There are good reasons for that, Dr. Harleman told the audience. The FDA categories are easily accessible, quick to read, and provide some information.

But they’re also hard to remember and don’t provide sufficient information, she added. "I think it’s going to become increasingly important, as we take care of more women with chronic diseases earlier in life, to think about the implications of conceiving while on the medications that we’re prescribing," said Dr. Harleman, of the department of medicine at the university.

The FDA categories do not provide any gradation of risk. Drugs in the A or B categories are not necessarily safer than category D drugs, she said. A medication can get a B categorization without any human data. The FDA categories give no information about dosing or the timing of administration. "If you give a drug in the first trimester, there may be very different implications than if you give a drug in the third trimester, and you can’t get that information from this classification system," she said.

There’s also no information on the change in risk from one category to another. "We don’t know if this increases the risk from 1% to 5% or from 1% to 80%," Dr. Harleman said. "It’s very hard to make an informed decision about prescribing a medication just using the FDA classification."

Approximately 60% of drugs in category X have no human data behind that classification. A drug can end up in category X simply because it has no utility during pregnancy, such as oral contraceptives. Physicians who don’t know that, however, may erroneously tell a woman who conceived while on an oral contraceptive that the drug increases her baby’s risk for malformation.

The FDA categories rarely get updated. "It’s really more of a legal system" than a helpful clinical tool, she said.

Half of pregnant women who are on medications take category C, D, or X drugs, studies have shown. One in six women of reproductive age receives a category D or X drug, mainly antibiotics, anticonvulsants, statins, benzodiazepines, or warfarin. A study of 488,175 women found that those taking category D or X drugs were no more likely to have documentation in their physicians’ charts of a discussion about contraception.

"In our hurried practices, sometimes it’s hard to remember this, but we need to think about which drugs are absolutely contraindicated and make sure that we are discussing them with our patients," Dr. Harleman said.

The main drugs to avoid during pregnancy are ACE inhibitors, tetracycline, fluoroquinolones, systemic retinoids, warfarin, valproic acid, nonsteroidal anti-inflammatory drugs, and live vaccines. "It’s a pretty short list," she said. "A lot of other drugs are safe in pregnancy; we may just not have as much familiarity with using them."

Dr. Harleman gave three pieces of advice on prescribing during pregnancy: Think hard before starting or stopping any medication. Remember that changes in blood volume and metabolism during pregnancy may mandate increased frequency of dosing or higher doses. And keep one of the following pregnancy prescribing resources available instead of relying solely on the FDA categories:

• The clinical reference tool Micromedex. It has an excellent "ReproRisk" section, she said (micromedex.com).

• Reprotox, a service of the nonprofit Reproductive Toxicology Center, Washington. It synthesizes all the published information on drug safety and provides quick-take summaries that Dr. Harleman believes are worth the low fee for use (reprotox.org/Default.aspx).

• The American College of Physicians’ "Medical Care of the Pregnant Patient," 2nd ed. (Hanover, Pa.: Sheridan Press, 2008) is a good source.

• Motherisk is a service affiliated with the Hospital for Sick Children, Toronto (motherisk.org).

• MotherToBaby is a service of the Organization of Teratology Information Specialists (mothertobaby.org).

• The reference guide "Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk," 9th ed. (Philadelphia: Lippincott Williams and Wilkins, 2011) is a good source.

• The book "Medications and Mother’s Milk" (Amarillo, Tex.: Hale Publishing, 2012) is helpful.

Dr. Harleman reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Because of significant limitations in the Food and Drug Administration’s pregnancy categories, it’s important to have another reliable resource handy to guide prescribing during pregnancy, Dr. Elizabeth S. Harleman believes.

Three out of four attendees at a conference on women’s health sponsored by the University of California, San Francisco, said that they use the FDA categories to determine a drug’s safety during pregnancy, an informal electronic poll at the meeting showed. There are good reasons for that, Dr. Harleman told the audience. The FDA categories are easily accessible, quick to read, and provide some information.

But they’re also hard to remember and don’t provide sufficient information, she added. "I think it’s going to become increasingly important, as we take care of more women with chronic diseases earlier in life, to think about the implications of conceiving while on the medications that we’re prescribing," said Dr. Harleman, of the department of medicine at the university.

The FDA categories do not provide any gradation of risk. Drugs in the A or B categories are not necessarily safer than category D drugs, she said. A medication can get a B categorization without any human data. The FDA categories give no information about dosing or the timing of administration. "If you give a drug in the first trimester, there may be very different implications than if you give a drug in the third trimester, and you can’t get that information from this classification system," she said.

There’s also no information on the change in risk from one category to another. "We don’t know if this increases the risk from 1% to 5% or from 1% to 80%," Dr. Harleman said. "It’s very hard to make an informed decision about prescribing a medication just using the FDA classification."

Approximately 60% of drugs in category X have no human data behind that classification. A drug can end up in category X simply because it has no utility during pregnancy, such as oral contraceptives. Physicians who don’t know that, however, may erroneously tell a woman who conceived while on an oral contraceptive that the drug increases her baby’s risk for malformation.

The FDA categories rarely get updated. "It’s really more of a legal system" than a helpful clinical tool, she said.

Half of pregnant women who are on medications take category C, D, or X drugs, studies have shown. One in six women of reproductive age receives a category D or X drug, mainly antibiotics, anticonvulsants, statins, benzodiazepines, or warfarin. A study of 488,175 women found that those taking category D or X drugs were no more likely to have documentation in their physicians’ charts of a discussion about contraception.

"In our hurried practices, sometimes it’s hard to remember this, but we need to think about which drugs are absolutely contraindicated and make sure that we are discussing them with our patients," Dr. Harleman said.

The main drugs to avoid during pregnancy are ACE inhibitors, tetracycline, fluoroquinolones, systemic retinoids, warfarin, valproic acid, nonsteroidal anti-inflammatory drugs, and live vaccines. "It’s a pretty short list," she said. "A lot of other drugs are safe in pregnancy; we may just not have as much familiarity with using them."

Dr. Harleman gave three pieces of advice on prescribing during pregnancy: Think hard before starting or stopping any medication. Remember that changes in blood volume and metabolism during pregnancy may mandate increased frequency of dosing or higher doses. And keep one of the following pregnancy prescribing resources available instead of relying solely on the FDA categories:

• The clinical reference tool Micromedex. It has an excellent "ReproRisk" section, she said (micromedex.com).

• Reprotox, a service of the nonprofit Reproductive Toxicology Center, Washington. It synthesizes all the published information on drug safety and provides quick-take summaries that Dr. Harleman believes are worth the low fee for use (reprotox.org/Default.aspx).

• The American College of Physicians’ "Medical Care of the Pregnant Patient," 2nd ed. (Hanover, Pa.: Sheridan Press, 2008) is a good source.

• Motherisk is a service affiliated with the Hospital for Sick Children, Toronto (motherisk.org).

• MotherToBaby is a service of the Organization of Teratology Information Specialists (mothertobaby.org).

• The reference guide "Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk," 9th ed. (Philadelphia: Lippincott Williams and Wilkins, 2011) is a good source.

• The book "Medications and Mother’s Milk" (Amarillo, Tex.: Hale Publishing, 2012) is helpful.

Dr. Harleman reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Because of significant limitations in the Food and Drug Administration’s pregnancy categories, it’s important to have another reliable resource handy to guide prescribing during pregnancy, Dr. Elizabeth S. Harleman believes.

Three out of four attendees at a conference on women’s health sponsored by the University of California, San Francisco, said that they use the FDA categories to determine a drug’s safety during pregnancy, an informal electronic poll at the meeting showed. There are good reasons for that, Dr. Harleman told the audience. The FDA categories are easily accessible, quick to read, and provide some information.

But they’re also hard to remember and don’t provide sufficient information, she added. "I think it’s going to become increasingly important, as we take care of more women with chronic diseases earlier in life, to think about the implications of conceiving while on the medications that we’re prescribing," said Dr. Harleman, of the department of medicine at the university.

The FDA categories do not provide any gradation of risk. Drugs in the A or B categories are not necessarily safer than category D drugs, she said. A medication can get a B categorization without any human data. The FDA categories give no information about dosing or the timing of administration. "If you give a drug in the first trimester, there may be very different implications than if you give a drug in the third trimester, and you can’t get that information from this classification system," she said.

There’s also no information on the change in risk from one category to another. "We don’t know if this increases the risk from 1% to 5% or from 1% to 80%," Dr. Harleman said. "It’s very hard to make an informed decision about prescribing a medication just using the FDA classification."

Approximately 60% of drugs in category X have no human data behind that classification. A drug can end up in category X simply because it has no utility during pregnancy, such as oral contraceptives. Physicians who don’t know that, however, may erroneously tell a woman who conceived while on an oral contraceptive that the drug increases her baby’s risk for malformation.

The FDA categories rarely get updated. "It’s really more of a legal system" than a helpful clinical tool, she said.

Half of pregnant women who are on medications take category C, D, or X drugs, studies have shown. One in six women of reproductive age receives a category D or X drug, mainly antibiotics, anticonvulsants, statins, benzodiazepines, or warfarin. A study of 488,175 women found that those taking category D or X drugs were no more likely to have documentation in their physicians’ charts of a discussion about contraception.

"In our hurried practices, sometimes it’s hard to remember this, but we need to think about which drugs are absolutely contraindicated and make sure that we are discussing them with our patients," Dr. Harleman said.

The main drugs to avoid during pregnancy are ACE inhibitors, tetracycline, fluoroquinolones, systemic retinoids, warfarin, valproic acid, nonsteroidal anti-inflammatory drugs, and live vaccines. "It’s a pretty short list," she said. "A lot of other drugs are safe in pregnancy; we may just not have as much familiarity with using them."

Dr. Harleman gave three pieces of advice on prescribing during pregnancy: Think hard before starting or stopping any medication. Remember that changes in blood volume and metabolism during pregnancy may mandate increased frequency of dosing or higher doses. And keep one of the following pregnancy prescribing resources available instead of relying solely on the FDA categories:

• The clinical reference tool Micromedex. It has an excellent "ReproRisk" section, she said (micromedex.com).

• Reprotox, a service of the nonprofit Reproductive Toxicology Center, Washington. It synthesizes all the published information on drug safety and provides quick-take summaries that Dr. Harleman believes are worth the low fee for use (reprotox.org/Default.aspx).

• The American College of Physicians’ "Medical Care of the Pregnant Patient," 2nd ed. (Hanover, Pa.: Sheridan Press, 2008) is a good source.

• Motherisk is a service affiliated with the Hospital for Sick Children, Toronto (motherisk.org).

• MotherToBaby is a service of the Organization of Teratology Information Specialists (mothertobaby.org).

• The reference guide "Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk," 9th ed. (Philadelphia: Lippincott Williams and Wilkins, 2011) is a good source.

• The book "Medications and Mother’s Milk" (Amarillo, Tex.: Hale Publishing, 2012) is helpful.

Dr. Harleman reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert