Institutional pharmacists' guide to complying with PPI regulations.

The implications for institutional pharmacists of the recent Food and Drug Administration omnibus regulation that mandates patient package inserts (PPIs) are discussed. FDA issued a final rule on September 12, 1980, establishing a three-year trial period during which PPIs must be dispensed with each new prescription for 10 specific drugs or drug classes. Involved are the drugs cimetidine, clofibrate, propoxyphene, phenytoin, warfarin, digoxin, and methoxsalen, and the drug classes ampicillins, benzodiazepines, and thiazides. FDA will evaluate costs and benefits of this program during the three-year period and will issue a regulatory analysis before additional drugs are added to the rule. Institutions may adopt an alternate system to make PPIs available to inpatients. Specific recommendations for implementation of the PPI program in institutions are made.