ABSTRACT
This study aims to compare the differences between clinical practice guidelines (CPGs) of the Ministry of Health (MoH) and those of other Brazilian health institutions. A systematic review of Brazilian CPGs was carried out. CPGs with recommendations for the pharmacological treatment of non-communicable disease (NCDs) were included. CPG methodological quality and transparency was independently assessed by 2 reviewers using the AGREE II. CPGs were rated as high, moderate, and low quality (ranging from A to C). Twenty-six CPGs were assessed for quality. MoH CPGs were published more recently, and were of better quality than the others: 6/6 (100%) were rated as Moderate-A. Although CPGs presented a wide range of methodological quality and transparency, MoH CPGs presented better consistency in the preparation method. To avoid confusion and to improve the quality of care within finite resources in Brazil, and to avoid potential bias, conflicts of interest, national CPGs used within SUS should be developed by Conitec with partners who have no conflict of interest.
Subject(s)
Delivery of Health Care/standards , Noncommunicable Diseases/drug therapy , Practice Guidelines as Topic , Brazil , Humans , National Health Programs/organization & administration , Quality of Health CareABSTRACT
Abstract This study aims to compare the differences between clinical practice guidelines (CPGs) of the Ministry of Health (MoH) and those of other Brazilian health institutions. A systematic review of Brazilian CPGs was carried out. CPGs with recommendations for the pharmacological treatment of non-communicable disease (NCDs) were included. CPG methodological quality and transparency was independently assessed by 2 reviewers using the AGREE II. CPGs were rated as high, moderate, and low quality (ranging from A to C). Twenty-six CPGs were assessed for quality. MoH CPGs were published more recently, and were of better quality than the others: 6/6 (100%) were rated as Moderate-A. Although CPGs presented a wide range of methodological quality and transparency, MoH CPGs presented better consistency in the preparation method. To avoid confusion and to improve the quality of care within finite resources in Brazil, and to avoid potential bias, conflicts of interest, national CPGs used within SUS should be developed by Conitec with partners who have no conflict of interest.
Resumo O objetivo deste estudo é comparar as diferenças entre as guias de prática clínica (GPCs) do Ministério da Saúde (MS) e as de outras instituições de saúde brasileiras. Foi realizada uma revisão sistemática das GPCs brasileiras. Foram incluídas GPCs com recomendações para o tratamento farmacológico de doenças crônicas não transmissíveis elencadas (DCNTs). A qualidade metodológica e a transparência das GPCs foram avaliadas de forma independente por 2 revisores utilizando o AGREE II. As GPCs foram classificadas como alta, moderada e baixa qualidade (variando de A a C). Vinte e seis GPCs foram avaliadas quanto à qualidade. As GPCs do MS foram publicadas mais recentemente, e apresentaram melhor qualidade do que as outras: 6/6 (100%) foram classificadas como Moderada-A. Embora as GPCs tenham apresentado uma ampla gama de qualidade metodológica e transparência, as GPCs do MS apresentaram melhor consistência no desenvolvimento. Para evitar confusão e melhorar a qualidade do cuidado com os recursos limitados no Brasil e, para evitar viés, conflitos de interesse, GPCs nacionais usadas no SUS devem ser desenvolvidas, sobretudo, pela Conitec e parceiros sem conflitos de interesse.
Subject(s)
Practice Guidelines as Topic , Delivery of Health Care/standards , Noncommunicable Diseases/drug therapy , Quality of Health Care , Brazil , National Health Programs/organization & administrationABSTRACT
O desenvolvimento de novos produtos farmacêuticos e as limitações dos ensaios clínicos controlados têm sido responsáveis pelo aumento das possibilidades de eventos adversos a medicamentos. A farmacovigilância é essencial para detectar e avaliar eventos adversos a medicamentos reduzindo riscos e evitando gastos excessivos em saúde pública. Este trabalho objetivou conhecer programas de farmacovigilância de indústrias farmacêuticas sediadas no Estado de São Paulo, Brasil. Os dados foram coletados utilizando-se questionário enviado eletronicamente a 105 empresas, das quais 41,9 por cento retornaram. O motivo principal para implantação de programas foi atender exigências regulatórias e a principal justificativa para sua ausência foi produção limitada aos produtos fitoterápicos, ofici-nais e suplementos. Discutem-se as dificuldades para implantação dos programas, os recursos utilizados e características de alguns deles. Conclusões: (a) a normatização é fonte de motivação para o aumento dos programas e do número de relatos mas é insuficiente sem esclarecimentos mais específicos; (b) os resultados dependem de envolvimento multisetorial; (c) o Serviço de Atendimento ao Consumidor é importante fonte de relatos; (d) a estrutura da operação do serviço pode ser pouco dispendiosa em termos de recursos humanos e materiais.
The development of new drugs and limitations of clinical trials have increased the likelihood of adverse drug events. Pharmacovigilance is essential to detect and evaluate adverse drug events, thereby reducing risks and avoiding excessive public health costs. This study focused on the pharmacovigilance programs in the pharmaceutical industry in São Paulo State, Brazil. Data were collected through questionnaires sent electronically to 105 companies, 41.9 percent of which responded. The main reason for implementing pharmacovigilance programs was to comply with legal requirements, while the main justification for its absence was production limited to herbal remedies, officinal products, and supplements. The article discusses the obstacles to program implementation, resources used, and characteristics of several such programs. Conclusions: (a) standardization is the reason for the increasing number of programs and reports, but more specific guidelines are needed; (b) results depend on multi-sector involvement; (c) customer service centers are an important source of reports; and (d) operation of the service requires only modest human and material resources.
Subject(s)
Drug Industry , Product Surveillance, Postmarketing , Adverse Drug Reaction Reporting Systems , Brazil , Clinical Trials as Topic , Drug Monitoring , Pharmacoepidemiology , Surveys and QuestionnairesABSTRACT
A política de medicamentos é apresentada como uma das estratégias para propiciar bom nível de saúde a uma população. Seu objetivo geral é assegurar a disponibilidade de medicamentos seguros e de boa qualidade a preços acessíveis, e promover seu uso racional. São apresentadas as razões para uma política de medicamentos, alguns de seus componentes e a atual situação da política de medicamentos no Brasil