Prescription medications for use in pregnancy-perspective from the US Food and Drug Administration.

Obstetrical healthcare providers frequently field questions about the safety of medications recommended or prescribed to their pregnant patients. Most women use as least 1 medication during pregnancy; however, there is little information about the safety or appropriate dosing of many medications during this phase of life. In addition, the development of drugs for use in pregnant women trails behind the development of drugs intended for other sectors of the population. Our goal is to inform the obstetrics community about the US Food and Drug Administration authority and their role in approving drugs for marketing. We begin with the statutes that led to the creation of the Food and Drug Administration and its current organization. We then cover drug development and the Food and Drug Administration review process, including the role of the advisory committee. The different types of drug approvals are discussed, with some specific examples. Finally, we enumerate the drugs specifically approved for use in obstetrics and contrast them with drugs commonly used by pregnant women and drugs used "off-label" during pregnancy. The Food and Drug Administration is committed to protecting and advancing the public health of pregnant women by guiding the development and ensuring the availability of effective and safe therapeutics for obstetrical indications and for medical conditions during pregnancy. We hope this review will inspire more research addressing drug use during pregnancy.

African American and Latino patient versus provider perceptions of determinants of prenatal care initiation.

Few studies have compared provider and patient perceptions of barriers, motivators and facilitators of prenatal care (PNC) initiation. The current study compared these perceptions in providers and patients in Washington, DC, a city characterized by infant mortality and low birth weight rates that are among the highest in the nation, and poor utilization of PNC, particularly among minority groups. The results reported here were part of a larger study of barriers, motivators and facilitators influencing PNC utilization in Washington, DC. A convenience sample of 331 African American and Latino patients and 61 providers were interviewed to identify which of 63 motivators, facilitators, and barriers significantly influenced PNC initiation. Both sample groups were recruited at 14 PNC facilities, selected to represent all sites in DC known to serve high-risk, low-income minority women, including hospital-based clinics, community-based clinics, and private practices. Data were analyzed using Fisher exact tests and Kendall's concordance tests. Results indicated that there was good agreement between patients and providers about the relative importance of the various barriers (especially psychosocial), motivators, and facilitators. However, differences were found between patients and providers in the response frequencies. Providers were more likely to report barriers while patients were more likely to report certain motivators (especially learning better health habits and how to protect health). These results indicate that despite widespread agreement on most issues, especially psychosocial barriers, patients rated health education higher than providers.