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The Package Insert: Who Writes It and Why, What Are Its Implications, and How Well Does Medical School Explain It?


Journal of Psychiatric Practice®: July 2014 - Volume 20 - Issue 4 - p 284–290
doi: 10.1097/01.pra.0000452565.83039.20
COLUMNS: Psychopharmacology

The package insert, which is jointly authored by the U.S. Food and Drug Administration and the manufacturer of the drug, is a summary of all of the preclinical and clinical data accumulated during the successful development of a new drug. Despite the role of the package insert in the safe practice of medicine, prescribers often minimize, overlook, or misunderstand its importance, suggesting a gap in their training. An anonymous, three-question survey was administered to third year medical students (N=34) from two medical schools to assess how well they had been educated about the evidence-based origin, purpose, and implications of the package insert. The results indicate a deficiency in their medical education, and the authors contrast the student responses with the facts. These results underscore the need to revise medical school curricula to provide future prescribers with more education about the importance of the package insert and the relationship between pharmaceutical companies, the U.S. Food and Drug Administration, and prescribers. (Journal of Psychiatric Practice 2014;20:284–290)

McMAHON: Department of Psychiatry, University of Kansas School of Medicine–Wichita; PRESKORN: University of Kansas School of Medicine–Wichita and Kansas University–Wichita Clinical Trials Unit

Dr. McMahon declares no conflicts of interest.

Over his career, Dr. Preskorn has worked with over 125 pharmaceutical companies in the United States and throughout the world. Over the past year, Dr. Preskorn has received grants/research support from or has served as a consultant, on the advisory board, or on the speakers bureau for the following: Abbott, Assurex Health, AstraZeneca, Cubist/Trius, Eisai, Envivo, Impax Laboratories, Johnson & Johnson, Merck, National Institute of Mental Health, Naurex, Pfizer, Stanley Medical Research Institute, Sunovion, and Taisho.

Please send correspondence to: Sheldon H. Preskorn, MD, Kansas University-Wichita Clinical Trials Unit, 13605 E. Camden Chase St., Wichita KS 67228-8032,

© 2014 by Lippincott Williams & Wilkins, Inc.