Problems Identified in the Package Leaflets of the Portuguese Non-Generic Medicines
Autor(a) principal: | |
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Data de Publicação: | 2015 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | por eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526 |
Resumo: | Introduction: All medicines for human use are marketed with a package leaflet. Every package leaflet must contain an initial list mentioning all sections of the document in accordance to the European template Quality Review of Documents, being not to extensive, i.e. comprising approximately 1500 words. The so-called mixed leaflets contain information about medicines with more than one strength/ pharmaceutical form, and only exceptionally are authorized. In this context, the objectives of the present study comprised the identification of issues in all package leaflets of Portuguese non-generic medicines: 1. to confirm the presence of an initial list, 2. to quantify the number of mixed leaflets, and 3. to evaluate their length (in number of pages).Material and Methods: Consultation of the leaflets, in a public database (Infomed), according to the classification of the National Prescribing Guide (1st trimester 2012). The data collected was subject to quality control and statistical analysis.Results: Identification of 2729 package leaflets, representing 3080 medicines. A total of 2042 leaflets were evaluated, with 181 (8.9%) missing the initial list and 351 (17.2%) being mixed. The average number of pages was 6.9 (SD=2.6), the minimum = 2 and the maximum = 26.Discussion: In some cases, readability and comprehension of some Portuguese leaflets might be compromised since: 1) some leaflets did not contain an initial list, 2) were classified as mixed leaflets, and/or 3) were classified as too extensive.Conclusion: Regulatory authorities and marketing authorization holders might need to take into consideration these issues during the development and approval of package leaflets.Keywords: Pamphlets; Drug Labeling; Portugal. |
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Problems Identified in the Package Leaflets of the Portuguese Non-Generic MedicinesProblemas Identificados nos Folhetos Informativos dos Medicamentos Não Genéricos PortuguesesIntroduction: All medicines for human use are marketed with a package leaflet. Every package leaflet must contain an initial list mentioning all sections of the document in accordance to the European template Quality Review of Documents, being not to extensive, i.e. comprising approximately 1500 words. The so-called mixed leaflets contain information about medicines with more than one strength/ pharmaceutical form, and only exceptionally are authorized. In this context, the objectives of the present study comprised the identification of issues in all package leaflets of Portuguese non-generic medicines: 1. to confirm the presence of an initial list, 2. to quantify the number of mixed leaflets, and 3. to evaluate their length (in number of pages).Material and Methods: Consultation of the leaflets, in a public database (Infomed), according to the classification of the National Prescribing Guide (1st trimester 2012). The data collected was subject to quality control and statistical analysis.Results: Identification of 2729 package leaflets, representing 3080 medicines. A total of 2042 leaflets were evaluated, with 181 (8.9%) missing the initial list and 351 (17.2%) being mixed. The average number of pages was 6.9 (SD=2.6), the minimum = 2 and the maximum = 26.Discussion: In some cases, readability and comprehension of some Portuguese leaflets might be compromised since: 1) some leaflets did not contain an initial list, 2) were classified as mixed leaflets, and/or 3) were classified as too extensive.Conclusion: Regulatory authorities and marketing authorization holders might need to take into consideration these issues during the development and approval of package leaflets.Keywords: Pamphlets; Drug Labeling; Portugal.Introdução: Todos os medicamentos de uso humano são comercializados com um folheto informativo. Estes documentos devem ter uma lista inicial com a identificação de todas as secções, de acordo com o modelo europeu Quality Review of Documents e não serem muito extensos, i.e. com cerca de 1500 palavras. Apenas excepcionalmente são autorizados folhetos relativos a mais de uma dose e/ ou forma farmacêutica (folhetos mistos). Neste contexto, os objectivos incluem a identificação de problemas nos folhetos informativos de todos os medicamentos não genéricos portugueses quanto à presença da lista inicial, à frequência de folhetos mistos e ao número de páginas.Material e Métodos: Consulta dos folhetos na base pública Infomed de acordo com a classificação do Prontuário Terapêutico – 10 (1ºtrimestre 2012). Os dados recolhidos foram sujeitos a controlo de qualidade e tratamento estatístico.Resultados: Identificação de 2729 folhetos em 3080 especialidades farmacêuticas. Foram avaliados 2042 folhetos (687 não estavam disponíveis), em que 181 (8,9%) não apresentaram lista inicial e 351 (17,2%) eram mistos. O número médio de páginas foi 6,9 (DP = 2,6), o mínimo = 2 e o máximo = 26.Discussão: A leitura e compreensão adequadas dos folhetos portugueses em alguns casos podem estar comprometidas, dado que 1) alguns dos folhetos analisados não continham a lista inicial necessária à adequada localização das informações, 2) foram detetados folhetos mistos e/ou 3) foram encontrados folhetos com uma extensão acima do desejável.Conclusão: Os resultados deste estudo devem informar o processo de desenvolvimento e aprovação dos folhetos pelos titulares da autorização da introdução no mercado e pelas autoridades reguladoras.Palavras-chave: Folhetos Informativos; Rotulagem de Medicamentos; Portugal.Ordem dos Médicos2015-02-27info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfapplication/pdfapplication/pdfhttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526oai:ojs.www.actamedicaportuguesa.com:article/5526Acta Médica Portuguesa; Vol. 28 No. 1 (2015): January-February; 21-28Acta Médica Portuguesa; Vol. 28 N.º 1 (2015): Janeiro-Fevereiro; 21-281646-07580870-399Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPporenghttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526/4232https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526/4304https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526/7525Pires, CarlaCavaco, AfonsoVigário, Marinainfo:eu-repo/semantics/openAccess2022-12-20T11:04:23Zoai:ojs.www.actamedicaportuguesa.com:article/5526Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T16:19:05.976617Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Problems Identified in the Package Leaflets of the Portuguese Non-Generic Medicines Problemas Identificados nos Folhetos Informativos dos Medicamentos Não Genéricos Portugueses |
title |
Problems Identified in the Package Leaflets of the Portuguese Non-Generic Medicines |
spellingShingle |
Problems Identified in the Package Leaflets of the Portuguese Non-Generic Medicines Pires, Carla |
title_short |
Problems Identified in the Package Leaflets of the Portuguese Non-Generic Medicines |
title_full |
Problems Identified in the Package Leaflets of the Portuguese Non-Generic Medicines |
title_fullStr |
Problems Identified in the Package Leaflets of the Portuguese Non-Generic Medicines |
title_full_unstemmed |
Problems Identified in the Package Leaflets of the Portuguese Non-Generic Medicines |
title_sort |
Problems Identified in the Package Leaflets of the Portuguese Non-Generic Medicines |
author |
Pires, Carla |
author_facet |
Pires, Carla Cavaco, Afonso Vigário, Marina |
author_role |
author |
author2 |
Cavaco, Afonso Vigário, Marina |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Pires, Carla Cavaco, Afonso Vigário, Marina |
description |
Introduction: All medicines for human use are marketed with a package leaflet. Every package leaflet must contain an initial list mentioning all sections of the document in accordance to the European template Quality Review of Documents, being not to extensive, i.e. comprising approximately 1500 words. The so-called mixed leaflets contain information about medicines with more than one strength/ pharmaceutical form, and only exceptionally are authorized. In this context, the objectives of the present study comprised the identification of issues in all package leaflets of Portuguese non-generic medicines: 1. to confirm the presence of an initial list, 2. to quantify the number of mixed leaflets, and 3. to evaluate their length (in number of pages).Material and Methods: Consultation of the leaflets, in a public database (Infomed), according to the classification of the National Prescribing Guide (1st trimester 2012). The data collected was subject to quality control and statistical analysis.Results: Identification of 2729 package leaflets, representing 3080 medicines. A total of 2042 leaflets were evaluated, with 181 (8.9%) missing the initial list and 351 (17.2%) being mixed. The average number of pages was 6.9 (SD=2.6), the minimum = 2 and the maximum = 26.Discussion: In some cases, readability and comprehension of some Portuguese leaflets might be compromised since: 1) some leaflets did not contain an initial list, 2) were classified as mixed leaflets, and/or 3) were classified as too extensive.Conclusion: Regulatory authorities and marketing authorization holders might need to take into consideration these issues during the development and approval of package leaflets.Keywords: Pamphlets; Drug Labeling; Portugal. |
publishDate |
2015 |
dc.date.none.fl_str_mv |
2015-02-27 |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526 oai:ojs.www.actamedicaportuguesa.com:article/5526 |
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https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526 |
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https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526 https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526/4232 https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526/4304 https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/5526/7525 |
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openAccess |
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Ordem dos Médicos |
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Ordem dos Médicos |
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Acta Médica Portuguesa; Vol. 28 No. 1 (2015): January-February; 21-28 Acta Médica Portuguesa; Vol. 28 N.º 1 (2015): Janeiro-Fevereiro; 21-28 1646-0758 0870-399X reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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