Spotlight on the FDA Pregnancy and Lactation Labeling Rule
Pregnant and lactating women are cared for by Advanced Practice Nurses in multiple specialty areas. These women often need to start and/or continue prescription drugs. A new tool for defining the safety of drugs during pregnancy and lactation is the FDA’s Pregnancy and Lactation Labeling Rule (PLLR), which as of June 30, 2015, replaces the FDA’s older ABCDX pregnancy drug safety categories. All drugs are required to be labeled according to the PLLR categories. Please provide an educational summary about the Pregnancy and Lactation Labeling Rule (PLLR) targeting your peer Advanced Practice Nurses (APNs) that covers these four (4) required elements:
1. Define the categories in the new FDA Pregnancy and Lactation Labeling Rule
2. WHAT DILEMMAS MAY APNS FACE WHEN MANAGING PRESCRIPTION DRUGS IN PREGNANT/LACTATING WOMEN
3. Suggestions for how to implement the new FDA Pregnancy and Lactation Labeling Rule in practice
4. Key points and further education resources to support APNs in following evidence-based practice with regard to using prescription medications in pregnant and lactating women.
See Explanation and Instructions for further guidelines. Remember, be simple and brief!
Stimulus questions you may use to guide your research (NOT required to cover; only elements 1-4 above are required): What are the pregnancy drug categories and what does each mean? Where can this information be found for different drugs? What are common ‘safe’ medications and common ‘contraindicated’ medications? What decision-making tools and step-by-step guidance would you suggest to APN’s managing prescription medications for pregnant and lactating women?
A resource to get you started: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm