title: Medication Safety During Pregnancy: Improving Evidence-Based Practice.
abstract: Nearly 90% of women in the United States have taken medications during pregnancy. Medication exposures during pregnancy can result in adverse pregnancy and neonatal outcomes including birth defects, fetal loss, intrauterine growth restriction, prematurity, and longer-term neurodevelopmental outcomes. Advising pregnant women about the safety of medication use during pregnancy is complicated by a lack of data necessary to engage the woman in an informed discussion. Routinely, health care providers turn to the package insert, yet this information can be incomplete and can be based entirely on animal studies. Often, adequate safety data are not available. In a busy clinical setting, health care providers need to be able to quickly locate the most up-to-date information in order to counsel pregnant women concerned about medication exposure. Deciding where to locate the best available information is difficult, particularly when the needed information does not exist. Pregnancy registries are initiated to obtain more data about the safety of specific medication exposures during pregnancy; however, these studies are slow to produce meaningful information, and when they do, the information may not be readily available in a published form. Health care providers have valuable data in their everyday practice that can expand the knowledge base about medication safety during pregnancy. This review aims to discuss the limitations of the package insert regarding medication safety during pregnancy, highlight additional resources available to health care providers to inform practice, and communicate the importance of pregnancy registries for expanding knowledge about medication safety during pregnancy.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Sinclair
authors.forename: Richard K
authors.initials: RK
authors.lastname: Miller
authors.forename: Christina
authors.initials: C
authors.lastname: Chambers
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Cooper
mesh_terms: D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology / Q000517:prevention & control*; D055317:Evidence-Based Practice; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D011248:Pregnancy Complications / Q000209:etiology / Q000517:prevention & control*; D012042:Registries; D012449:Safety; D014481:United States
keywords: drug effects; evidence-based health care; fetus; patient safety; pregnancy; prescription drugs; teratogenesis