Providing Contraception for Women Taking Potentially Teratogenic Medications:

A Survey of Internal Medicine Physicians’ Knowledge, Attitudes and Barriers.

Teratogen: Any agent that can disturb the development of an embryo or fetus. Teratogens may cause a birth defect in the child. Or a teratogen may halt the pregnancy outright. The classes of teratogens include radiation, maternal infections, chemicals, and drugs.    Leslie

J Gen Intern Med. 2010 Jan 20. [Epub ahead of print]

Department of Obstetrics & Gynecology, Division of Clinical Research, Washington
University in St. Louis School of Medicine, 4533 Clayton Ave, St. Louis, MO, 63110, USA, eisenbergd@wustl.edu

BACKGROUND: The majority of women prescribed category D or X medications may not receive adequate contraceptive counseling or a reliable contraceptive method. Physicians who prescribe potentially teratogenic medications have a responsibility to provide women with contraceptive counseling, a method of highly-effective contraception, or both. OBJECTIVE: Investigate the knowledge, beliefs and barriers of primary care physicians toward providing adequate contraception to women taking potential teratogens. DESIGN & PARTICIPANTS: Self-administered confidential survey of primary care internal medicine physicians at an urban, academic medical center. MEASUREMENTS: Knowledge of potential teratogenic medications and contraceptive failure rates was assessed. Participants’ beliefs about adequacy of their medical education, practice limitations and attitudes toward improving provision of contraception to women on potential teratogens were assessed. RESULTS: One hundred and ten physicians responded (57.3%). Nearly two-thirds (62.3%) of participants had cared for reproductive aged women taking category D or X medications in the past year. The mean percent of correctly identified category D or X medications was 58.4% (SD 22.1%). The mean percent correct for knowledge of published contraceptive failure rates was 64.6% (SD 23.1%). Most respondents (87.6%) felt it is the responsibility of primary care physicians to provide contraception. Time constraints were reported to be somewhat or very limiting by 61.3% and over half felt medical school (63.2%) or residency (58.1%) inadequately prepared them to prescribe or counsel about contraceptives. CONCLUSIONS: Primary care physicians commonly encounter reproductive age women taking category D or X medications, but may lack sufficient knowledge and time to counsel about potential teratogens and contraception to prevent fetal exposure to these drugs.
PMID: 20087677
Ann Intern Med. 2007 Sep 18;147(6):370-6.

United States FDA Pharmaceutical Pregnancy Categories
Pregnancy Category A Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Pregnancy Category B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Pregnancy Category C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Pregnancy Category D There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Pregnancy Category X Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Australia and Germany RX classifications are listed here:
http://en.wikipedia.org/wiki/Pregnancy_category
PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.