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Drug package inserts and the adequacy of patient's drug information

OBJECTIVE: To investigate the adequacy of the content and format of the patient information section in package inserts of commonly prescribed drugs at the internal medicine service of a school hospital. METHODS: Forty eight package inserts were collected from six pharmacies of the city of Porto Alegre in June 1998. The presence of mandatory notification and other information required by Brazilian laws that regulate inserts content was examined. RESULTS: No one package inserts contained all the notification required by law. Warnings about medication storage and expiration date were the most frequently information found in package inserts analyzed. CONCLUSION: Important information for the drug user was not presented in package inserts analyzed, limiting the purpose of inserts as an instrument for patient education.

Drug labeling; Drug labeling; Legislation, drugs; Patient education; Drug patient information


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