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

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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)

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