OBJECTIVE: To assess the adequacy and quality of information available in package directions of basic medicines commercialized in Brazil, according to both the specialized technical and scientific literature and the current regulations on the subject. METHODS: One hundred and sixty-eight medication directions of medicines containing forty-one specific drugs selected from the Brazilian National Inventory of Essential Medication. The analysis was carried out using as reference the Brazilian Regulation (Portaria SVS 110/97) and USP-DI Technical and Scientific Reference Literature-1999. Data was collected using an evaluation form, elaborated based on the guide for medicine directions, and each section of the directions was then analyzed according to the level of satisfaction previously established in the literature. RESULTS: The results show that 91.4% of medication directions addressed to the patient were unsatisfactory, whereas 97.0% were inappropriate regarding their technical content. Information was either incomplete or incorrect. CONCLUSION: These circumstances are very likely a result of lack of appropriate official regulations and surveillance by government agencies associated with low level of social monitoring on the consumers' side.
Drugs, essential; Drug labeling; Legislation, drug; Evaluation; Health surveillance
