Patient Package Inserts: The Proper Prescription?

March 1995

Issue: 50 Food and Drug Law Journal95-124 (1995)

The late 1960s witnessed the emergence of the patient package insert (PPI). This article traces the history of PPIs, in light of recent calls to expand their usage and to be included in all prescription drugs. A review of the literature reveals that PPIs do comport with rationales given for their use, namely informed consent and patient education. The article concludes, however, that these rationales for PPIs strain rationales used to justify the prescription status of some drugs.


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