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March 8, 1976

The "Patient Package Insert"

Author Affiliations

Michigan State University College of Human Medicine East Lansing

JAMA. 1976;235(10):1003-1004. doi:10.1001/jama.1976.03260360013008

To the Editor.—  While your editorial on the Food and Drug Administration-developed patient package insert (233:1089, 1975) avoids taking a totally negative stance, the emphasis is nevertheless on the possible harm of such inserts, with no mention of potential good. The insert policy could be viewed as either harmful or superfluous if one makes two assumptions: first, that physicians already do an adequate job of passing along essential information to patients, and second, that patients as a group are unable to handle a frank discussion of possible harmful effects of medication.There is growing documentation that the first assumption is overly optimistic. Rather, the common practice is for physicians to give information in terms that the patient cannot understand and for the physician to give the impression to the patient that the physician is too busy to be bothered with questions.1,2 While it is going much too far to