Episode 304: Nursing Roles in FDA: The Drug Labeling and Package Insert Process

“The prescribing information is really a reliable data-driven and comprehensively reviewed tool. That’s not just for healthcare providers when writing a prescription, but also, for example, it is a tool that can be used to generate educational content for healthcare systems as they update formularies and create drug information,” Elizabeth Everhart, MSN, RN, ACNP, associate director for labeling at the U.S. Food and Drug Administration (FDA) in Silver Spring, MD, told Jaime Weimer, MSN, RN, AGCNS-BS, AOCNS®, manager of oncology nursing practice at ONS, during a conversation about drug package inserts and labeling. Music Credit: “Fireflies and Stardust” by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0  Earn 0.25 contact hours of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at myoutcomes.ons.org by March 22, 2026. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of NCPD by the American Nurses Credentialing Center’s Commission on Accreditation. Learning outcome: Learners will report an increase in knowledge related to FDA drug labeling. Episode Notes Complete this evaluation for free NCPD. Oncology Nursing Podcast episodes: Episode 126: Oncology Clinical Trials and Drug Development Episode 242: Oncology Pharmacology 2023: Today’s Treatments and Tomorrow’s Breakthroughs Episode 273: Updates in Chemotherapy and Immunotherapy ONS Voice articles: Oncology Drug Reference Sheets FDA Updates ONS books: Chemotherapy and Immunotherapy Guidelines and Recommendations for Practice (second edition) Clinical Guide to Antineoplastic Therapy: A Chemotherapy Handbook (fourth edition) ONS Drug Development Learning Library ONS and Hematology/Oncology Pharmacy Association: Safe Handling Q&A;: How to Determine if a Drug is Hazardous National Library of Medicine: DailyMed FDA Prescribing Information Resources Drugs@FDA: FDA-Approved Drugs National Institute for Occupational Safety and Health: Hazardous Drug Exposures in Health Care To discuss the information in this episode with other oncology nurses, visit the ONS Communities. To find resources for creating an ONS Podcast Club in your chapter or nursing community, visit the ONS Podcast Library. To provide feedback or otherwise reach ONS about the podcast, email [email protected]. Highlights From This Episode “Nurses can be involved in several ways in creating the labeling. They can be members of the FDA multidisciplinary team that reviews the information submitted by the drug maker. Also in the review and development of the patient package insert or medication guide or the instructions for use that are used to help a healthcare practitioner, patients, or family members use the drug safely and accurately.” TS 2:08 “[Nurses] can use the sections to guide their teaching and instruction to patients, particularly about dosing and any tests that will be done to monitor for adverse reactions and any needed changes in the dosing, like whether they need to hold the medication or take less of it. They can also use the information to describe what the expected and serious adverse reactions for the drug are and how frequently they occurred in clinical trials.” TS 9:12 “The patient package inserts and medication guides that I mentioned are written in patient-friendly language and are good resources for nurses to use to educate patients and their caregivers or family members about what the product is used for, what its main and most serious side effects are, as well as what to expect in terms of the need for any special tests.” TS 11:04 “In the FDA’s public Prescribing Information Resources page, there are several excellent resources for healthcare providers to learn more about specific sections of the label, as well as to find good educational material for patients and their caregivers. There are also several presentations and videos available related to many sections of the label that are excellent resources for oncology nurses.” TS 14:26