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AJN, American Journal of Nursing:
doi: 10.1097/01.NAJ.0000451673.13082.d6
Drug Watch

Tutorials on Medwatch Reporting are Now Available

Aschenbrenner, Diane S. MS, RN

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Author Information

Diane S. Aschenbrenner recently retired as course coordinator for undergraduate pharmacology at Johns Hopkins University School of Nursing in Baltimore, MD. She also coordinates Drug Watch: daschen1@jhu.edu.

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Abstract

* The Food and Drug Administration (FDA) offers online tutorials to help students, health care professionals, and consumers learn how to complete forms used in the FDA MedWatch program.

Drug Watch frequently recommends that any adverse event related to a product be reported to the Food and Drug Administration (FDA) by contacting MedWatch. Reporting adverse effects and errors to the FDA MedWatch program, although voluntary, is an important responsibility of all health care providers. Information from this national database is reviewed and used by the FDA to help promote public safety related to medications, health care products, and foods and beverages. The FDA has now created online tutorials for students and health care professionals who want to practice completing FDA Form 3500 (which is strictly for health care professionals).

Case examples used in the tutorials are based on actual reports submitted to MedWatch. Four of the cases concern adverse effects (from a drug, a biologic product, medical food, and a dietary supplement). Two involve errors related to product use (human factors and medication errors). Two depict a product problem (from drugs and from devices), and one concerns a problem related to a particular manufacturer of a medicine (which led to therapeutic failure).

The FDA also offers a parallel site for consumers to complete FDA Form 3500B. Links for both of these tutorials can be found at www.accessdata.fda.gov/scripts/MedWatchLearn. Nurses should encourage patients and families to explore the site, especially if they have a concern about a medication or a product. No new case information can be submitted at either of these links because they're designed for practice only. To submit an actual report to the FDA MedWatch system, go to www.accessdata.fda.gov/scripts/medwatch.

© 2014 Lippincott Williams & Wilkins. All rights reserved.

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