ABSTRACT
OBJECTIVE:To promote effective supervision of key monitoring drugs by provincial pharmaceutical quality control center,and to improve rational drug use. METHODS:The effects of No.2 district of Sichuan province pharmaceutical quality con-trol center on 3 categories of key monitoring drugs guidance and supervision,through urging medical institution in the area to estab-lish key monitoring drugs supervision system,formulating prescription review guideline for 3 categories of key monitoring drugs [TCM injection,adjunctive drug,proton pump inhibitors (PPIs)],developing baseline data survey,inspecting the application of key monitoring drug in medical instaurations on the spot and other measures,were introduced. Through collecting the reports of re-gional quality control center to the provincial quality control center,supervision system of medical institutions were analyzed statisti-cally. Key monitoring drugs of medical institutions in the area were analyzed statistically in respects of rational utilization ratio,uti-lization quantity,utilization amount,etc.,so as to evaluate supervision effects. RESULTS:Up to Apr. 2016,92.26%medical insti-tutions had been aware of the relevant requirements of the documents;84.25% had established the hospital supervision system. 3 categories of key monitoring drugs prescription(orders)comment guideline had been developed in Mar. 2016. 18 third-grade class-A general medical institutions were randomly selected;among 3 categories,irrational utilization ratio of TCM injection decreased by 12.35%(35.41% vs. 47.76%);that of adjunctive drugs decreased by 9.64%(20.95% vs. 30.59%);that of PPIs decreased by 7.44%(40.49% vs. 47.93%) in May 2016,compare to Jan. 2016. Average consumption sum of them decreased by 12.07%, 13.30%,9.49%,respectively in Apr. 2016,compared to Jan. 2016. 55.02% medical institutions had started to collect the baseline data. CONCLUSIONS:The provincial pharmaceutical quality control center has played an important role on establishing a supervi-sion system,it can promote the effective supervision by guiding and supervising the medical institutions evaluating the supervision of medical institutions and pointing out the problems.
ABSTRACT
O setor magistral representa um importante segmento do mercado brasileiro de medicamentos. Entretanto, a qualidade dos produtos fornecidos pelos estabelecimentos é frequentemente discutida e a Agência Nacional de Vigilância Sanitária (ANVISA) tem demonstrado uma preocupação com os produtos magistrais, pela promoção de consultas públicas abordando o assunto e pelo aumento do rigor nas legislações específicas. Assim sendo, as farmácias magistrais desempenham um importante papel no contexto da Política Nacional de Medicamentos, que objetiva garantir a promoção do uso racional e o acesso da população a medicamentos essenciais. Tendo em vista a importância da abordagem da qualidade dos produtos manipulados, este artigo apresenta relevantes informações sobre o perfil de qualidade do serviço de saúde prestado por esse setor, mediante a revisão da legislação e de trabalhos científicos que englobam o assunto.
The magistral sector represents a significant segment in the Brazilian pharmaceutical market. However, the quality of magistral formulations is often questioned and the National Agency of Sanitary Vigilance (ANVISA) has demonstrated a concern regarding these products, which has been verified in many public consultations approaching this subject and in new legislation aiming to improve public health. Thus, magistral pharmacies play an important role in the context of the National Medicine Politics, which aim to assure promotion of rational use and population access to essential medicines. Due to the paramount importance of the magistral formulation quality, this article presents information about the basic importance and the quality profile of these products, through the revision of the legislation and of scientific works that approach the subject.
El sector magistral representa un importante segmento del mercado brasileño de medicinas. Sin embargo, la calidad de los productos ofrecidos por estos establecimientos es frecuentemente discutida y la Agencia Nacional de Vigilância Sanitária (ANVISA), ha demostrado preocupación con los productos magistrales, por la promoción de consultas públicas abordando el asunto y por el aumento del rigor en las legislaciones específicas. Siendo así, las farmacias magistrales desempeñan importante rol en el contexto de la política Nacional de Medicinas, que busca garantizar la promoción del uso racional y el acceso de la población a las medicinas esenciales. Considerando la importancia del abordaje sobre la calidad de los productos manipulados, este artículo presenta relevantes informaciones sobre el perfil de la calidad del servicio de la salud ofrecido por ese sector, a través de la revisión de la legislación y de trabajos científicos que engloban el asunto.