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.

Application of physiologically based pharmacokinetic modeling for sertraline dosing recommendations in pregnancy.

Pregnancy is a period of significant change that impacts physiological and metabolic status leading to alterations in the disposition of drugs. Uncertainty in drug dosing in pregnancy can lead to suboptimal therapy, which can contribute to disease exacerbation. A few studies show there are increased dosing requirements for antidepressants in late pregnancy; however, the quantitative data to guide dose adjustments are sparse. We aimed to develop a physiologically based pharmacokinetic (PBPK) model that allows gestational-age dependent prediction of sertraline dosing in pregnancy. A minimal physiological model with defined gut, liver, plasma, and lumped placental-fetal compartments was constructed using the ordinary differential equation solver package, 'mrgsolve', in R. We extracted data from the literature to parameterize the model, including sertraline physicochemical properties, in vitro metabolism studies, disposition in nonpregnant women, and physiological changes during pregnancy. The model predicted the pharmacokinetic parameters from a clinical study with eight subjects for the second trimester and six subjects for the third trimester. Based on the model, gestational-dependent changes in physiology and metabolism account for increased clearance of sertraline (up to 143% at 40 weeks gestational age), potentially leading to under-dosing of pregnant women when nonpregnancy doses are used. The PBPK model was converted to a prototype web-based interactive dosing tool to demonstrate how the output of a PBPK model may translate into optimal sertraline dosing in pregnancy. Quantitative prediction of drug exposure using PBPK modeling in pregnancy will support clinically appropriate dosing and increase the therapeutic benefit for pregnant women.

Audio computerized self-report interview use in prenatal clinics: audio computer-assisted self interview with touch screen to detect alcohol consumption in pregnant women: application of a new technology to an old problem.

Computer interviewing to obtain sensitive information is not a new concept. However, concerns about the acceptance of computers in disadvantaged populations with potentially low literacy led us to combine audio- and touch-screen technologies with an audio computerized self-report interview to obtain information about alcohol use. This study evaluated acceptance and ease of use by a disadvantaged population of pregnant women in the District of Columbia. Patients attending an initial visit at prenatal clinics answered questions anonymously about their consumption of alcoholic beverages and other personal information. The questionnaire was programmed on a laptop computer. The computer administered the recorded questions via earphones, as well as displayed them on the screen, and patients answered by touching the computer screen. Results were immediately available. A total of 507 women were interviewed, who were primarily African American, non-Hispanic, and never married. Nearly 24% did not complete a high school education, 43% were unemployed, and 30% received public assistance. Most of the women (59%) used computers occasionally (a few days a month) or never. Nearly all patients (96%) reported that the computer was not difficult to use, and approximately 90% liked answering the questions by computer. The study demonstrates that using computers to screen for alcohol use in disadvantaged pregnant populations is feasible and acceptable to the patients.