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

Authors: Silva, Tatiane da; Dal-Pizzol, Felipe; Bello, Carina M; Mengue, Sotero S; Schenkel, Eloir P;

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

Abstract

OBJETIVO: Avaliar a adequação da forma e conteúdo da seção de "informações ao paciente" das bulas de medicamentos, freqüentemente prescritos no ambulatório de medicina interna de um hospital universitário. MÉTODOS: Foram selecionadas 48 bulas disponíveis em três redes de farmácia e três farmácias de pequeno porte de Porto Alegre, em junho de 1998. Por meio de um formulário, foi verificada a presença de frases de formato padronizado e outras informações exigidas pela Portaria 110, que regulamenta o conteúdo das bulas de medicamentos. RESULTADOS: Em nenhuma das bulas analisadas foi verificada a presença de todas as frases e demais informações exigidas pela legislação. Cuidados com o armazenamento e com o prazo de validade dos medicamentos foram as informações mais freqüentemente apresentadas nas bulas analisadas. CONCLUSÕES: Ausência de informações importantes para o usuário, sobre o medicamento nas bulas, reduz o seu valor enquanto material educativo para o paciente.

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.

Keywords

informações ao paciente, Legislation, Legislação de medicamentos, Patient education, Rotulagem de medicamentos^i1^slegislação e jurisprudên, drugs, Drug labeling^i2^sstanda, Patient Education as Topic, Prazo de validade dos medicamentos, Armazenagem de medicamentos, Evaluation Studies as Topic, Educação do paciente, Medicamentos, Drug patient information, Rotulagem de medicamentos^i1^snor, Humans, Drug labeling^i2^slegislation and jurisprude, Drug Labeling

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
27
Average
Top 10%
Average
Green
gold