Package leaflets of the most consumed medicines in Portugal
safety and regulatory compliance issues. A descriptive study
Keywords:
Product labeling, Consumer health information, Legislation as topic, Health communication, Drug industryAbstract
CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medi-cines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Phar-macoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compul-sory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only ad-dressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.
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References
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