Medication package inserts do not present adequate information on potential risks for older adults in Brazil

Geriatrics Gerontology and Aging Pub Date : 2023-01-01 DOI:10.53886/gga.e0230011

Vinícius Augusto Andrade Freitas, Sharlene Lopes Pereira

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Abstract

Objective: To compare information on the risks of potentially inappropriate medications (PIMs) for older adults in the Beers criteria with data in the package inserts made available by the Brazilian Health Regulatory Agency. Methods: This is an observational, cross-sectional study that compared information on the package inserts of 33 brand-name drugs in the Brazilian market with specific recommendations for older adults contemplated in the Beers criteria, categorizing them into: complete, incomplete, absent, or discrepant. Results: Among the analyzed package inserts, 21.21% did not present a specific section dedicated to the use of these drugs by older adults and data were scattered throughout the text; 63.64% were classified as incomplete; 33.33% lacked data; and 3.03% had discrepant information. Conclusion: The analyzed package inserts presented incomplete data or lacked information characterizing the drugs as PIMs for older adults. This study demonstrated that some package inserts of drugs used in Brazil are not satisfactory, warranting higher caution in the medical community when prescribing these medications and guiding patients.

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在巴西，药物包装说明书没有提供足够的信息，说明老年人的潜在风险

目的:比较比尔斯标准中关于老年人潜在不适当药物(PIMs)风险的信息与巴西卫生监管机构提供的药品说明书中的数据。方法:这是一项观察性的横断面研究，比较了巴西市场上33种品牌药物的说明书信息与比尔斯标准中针对老年人的具体建议，将其分为:完整、不完整、缺失或差异。结果:在分析的说明书中，21.21%的说明书没有专门介绍老年人使用这些药物的章节，数据分散在整个文本中;不完全63.64%;33.33%缺乏资料;3.03%存在差异信息。结论:所分析的说明书数据不完整或缺乏将药物描述为老年人pim的信息。这项研究表明，在巴西使用的一些药物的说明书不令人满意，需要在医疗社区在开这些药物和指导患者时更加谨慎。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Geriatrics Gerontology and Aging

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审稿时长

24 weeks