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The Patient Package Insert

F. Gilbert McMahon, MD
JAMA. 1975;233(10):1089. doi:10.1001/jama.1975.03260100059022.
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The Food and Drug Administration (FDA), as the government regulatory agency responsible for labeling prescription drugs for safe and effective use, has recently issued a patient package insert (PPI) which accompanies each package of prescribed oral contraceptives. Physicians need to be made aware that the FDA is proceeding to develop PPI's for many other prescription drugs. Some categories of drugs such as anticancer agents may not be required to have a PPI, but it is likely that PPIs will appear soon for the antihypertensives, digitalis, minor tranquilizers, and for other categories. The FDA is responding to pressure from legislative and consumer groups who are demanding that patients have "a right to know" more about medication doctors prescribe. The assumption is made that physicians are doing an inadequate job of instructing patients about possible adverse drug effects. In some hospitals, the clinical pharmacist is assuming more and more of a role


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