Original research articleOpportunities missed: improving the rate of contraceptive counseling or provision when prescribing reproductive-aged women potentially teratogenic medications in a family medicine resident clinic☆
Introduction
Teratogenic medications, from the Latin terato-, meaning “monster,” and –genic, “producing,” are those medications that may cause alteration or malformation during fetal development. Given both medical and ethical considerations, these medications are poorly studied in reproductive-aged women, and information about dose, timing and exact effects on the fetus is often incompletely understood. In an effort to protect reproductive-aged women from potential adverse outcomes such as actual birth defects, but also from concerns about fetal exposure given poorly understood risks, the US Food and Drug Administration (FDA) instituted a lettered safety classification system [1] for all prescription drugs in 1979 (Table 1). Of greatest concern for prescribers, classes D and X are known to be teratogenic. Notably, this lettered system is currently under review and is slated to be changed and refined to more completely educate both patients and providers about the risks of these medications.
Two studies by Schwarz et al. [2], [3] examined the prescription of teratogenic medications largely in the primary care setting along with the associated documentation of contraceptive counseling rates. Using the National Ambulatory Medical Care Survey to examine over 12,000 outpatient visits, the first study determined that the most frequently prescribed class D and X medications included anxiolytics, anticonvulsants, antibiotics and “statins” (HMG-CoA reductase inhibitors) [2]. Prescription of these medications occurred at 1 in every 13 visits for women aged 14–44 years. They further noted that 45% of these prescriptions were given by primary care physicians practicing either family or internal medicine. Contraceptive counseling was documented during less than 20% of the visits and at rates equal to that of women receiving class A, B or C medications. A second study conducted in a large health maintenance organization setting with over 488,000 patients found one in every six women aged 15–44 years filled a prescription for a class D or X medication [3]. They documented near equal rates of contraceptive counseling for women filling class A or B medications (48%) versus class D or X medications (51%). They noted that family and internal medicine practitioners prescribed the greatest proportion of class D and X medications (48%). In rank order, psychiatrists, dermatologists, gynecologists, pediatricians and other subspecialists provided the remainder. These studies suggest that women are not receiving contraceptive counseling at adequate rates to prevent possible adverse outcomes, such as pregnancy termination or potential birth defects from exposure to teratogenic medicines. Appropriate to a larger study volume, rates were calculated by gathering data on prescriptions and contraceptive counseling or provision separately, and then statistically estimated by comparing these proportions [2], [3]. These studies were not practice-based models looking at actual documented rates at the time of prescription.
Family medicine encompasses a distinctive environment of providing prescriptive services across all areas of disease management, in addition to serving its patients' gynecological wellness and preventive health care needs. Family medicine physicians are typically able to provide access to all forms of birth control, including those procedure-related (specifically long-acting reversible contraceptives), unlike the internists, psychiatrists, dermatologists and other specialists included in the previously published work. Our practice is a large family medicine clinic in a community-based residency training program. We serve a 580-bed hospital system and staff a clinic following continuity patients with a population of approximately 18,000. As the largest medical practice in our community, we are staffed by 32 residents and 8 faculty, with both allopathic and osteopathic backgrounds. We serve both a rural and suburban patient population in a small southeastern city in an economically depressed area of our state. We have been using an electronic medical record (EMR) since October 2002.
Documentation of both contraceptive and risks/benefits counseling is critical in forming good prescribing habits among young physicians and also as a medicolegal necessity. Data that interventions help improve counseling rates support the inclusion of education about contraceptive counseling and the effects of teratogenic medications as a routine part of primary care residency training programs. Conducted through residency curriculum to teach and support quality improvement research in health care, the purpose of this study was to increase attentiveness both in our own practice and broadly to all primary care training practices about the risks of teratogenic medications and the need for adequate and comprehensive contraceptive counseling.
Section snippets
Phase 1: data collection
Using the EMR for retrospective chart review, inquiries were run to locate the charts of women of reproductive age taking selected FDA class D and X medications frequently prescribed in the primary care setting. These medications were as follows: paroxetine, methotrexate or warfarin; selected longer-term tetracyclines (minocycline or tetracycline); a benzodiazepine (defined as any medication containing either “azepam” or “azolam”) and any statin (defined as any medication containing “astatin”).
Results
In phase 1, 377 prescriptive encounters in 246 patient charts were reviewed, 265 prescriptive encounters with class D or X medications in 182 patient charts were included for analysis and 112 the met exclusion criteria. The overall rate of contraceptive counseling was found to be 46%. In phase 3, 233 prescriptive encounters with class D or X medications in 199 patient charts were reviewed, 35 prescriptive encounters in 32 patient charts were included for analysis and 198 met the exclusion
Improving counseling rate
The improvement in the documented contraceptive counseling rate over time is likely not entirely due to increased attentiveness to our specific study question, but rather to increased proficiency by the practice as a whole with the EMR. Numerous innovations in the EMR itself over this time period increased ease of charting and facilitated documentation of all aspects of medical record keeping for the practice. In ours, as in all residency practices, providers turn over annually in this 3-year
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Prescription of teratogenic medications in United States ambulatory practices
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(2005) - Federal Register. Content and format of labeling for human prescription drug and biological products; requirements for...
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Process Evaluation of a Task-Shifting Strategy in Hormonal Contraception: Does Training Translate into Practice?
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There was no funding received for this study.