RESUMO
Introdução: O uso e a prescrição inadequados de antimicrobianos e a pressão da indústria farmacêutica para a sua utilização transformaram a resistência bacteriana a esses medicamentos em um problema mundial de saúde pública. Objetivo: O objetivo do estudo foi analisar o processo de implantação da Resolução da Diretoria Colegiada (RDC) da Agência Nacional de Vigilância Sanitária (Anvisa) de nº 20/2011, que dispõe sobre o controle dos antimicrobianos. Método: Utilizou-se o Modelo de Múltiplos Fluxos de Kingdon para examinar a inserção do tema do controle dos antimicrobianos na agenda governamental e sua posterior conformação em política pública. Foram empregadas diversas estratégias metodológicas, como a revisão bibliográfica, a análise de documentos, a busca de notícias veiculadas na mídia e informações advindas de entrevistas com informantes-chave. Conclusão: Apesar da existência de legislações e regulamentações sobre o uso e a prescrição de antimicrobianos, além da ampliação do acesso da população aos profissionais de saúde para evitar a automedicação e promover o uso correto, esforços como a educação sanitária para profissionais e a população e o reforço da fiscalização sanitária devem ser efetivamente implementados, não apenas para alcançar o uso racional, mas também para diminuir a resistência aos antimicrobianos.(AU)
Introduction: Inappropriate use and prescription of antimicrobials and the pressure from the pharmaceutical industry for their use have turned bacterial resistance into a global public health problem. Objective: This study aimed to analyze the implementation process of ANVISA's Board of Directors Resolution (RDC) 20/2011 for antimicrobials control. Method: Kingdon's Multiple Streams Model was used to examine the inclusion of antimicrobial control into the government agenda and its subsequent shaping into public policy. Several methodological strategies were employed, such as bibliographic review, document analysis, the search for stories in the media and information from interviews with key informants. Conclusion: In addition to legislation and regulations of the use and prescription of antimicrobials, easier population's access to health professionals to avoid self-medication and promote correct use, it is necessary to implement efforts such as education of professionals and the general population, not only to achieve rational use, but also to reduce antimicrobial resistance.(AU)
Assuntos
Anti-Infecciosos/normas , Uso de Medicamentos/legislação & jurisprudência , Atenção Primária à Saúde , Brasil , Programas Nacionais de SaúdeRESUMO
Introducción: Los antimicrobianos constituyen uno de los grupos farmacológicos más utilizados en la práctica clínica y está demostrada su relación con la resistencia microbiana. El uso racional de antibióticos puede producir beneficios desde el punto de vista médico y social, pero su uso en ocasiones no es el más adecuado y debe ser objeto de una vigilancia especial y sistemática. Es necesaria una política antimicrobiana coherente en las unidades de salud. Objetivo: Revisar consensos y criterios nacionales e internacionales sobre política antimicrobiana para tratar de unificar criterios aplicables lo más uniforme posible en las instituciones de salud. Material y Método: Se realizó una búsqueda bibliográfica en diferentes bases de datos: Clinical Evidence, The Cochrane Library, PUBMED, Google Académico, MEDLINE, LIS, Scielo, Medscape, LILACS, Latindex, HINARI, MEDIGRAPHIC-NEWS, NIH Reporter y en la web de la OPS/OMS sobre política antimicrobiana, comisión de antibióticos, política de antibióticos. Desarrollo: Se consideraron conceptos de diferentes publicaciones cubanas y consensos internacionales, componentes humanos, objetivos, funciones, recursos, métodos, estrategias y control. Conclusiones: Introducir cualquier modificación terapéutica en la atención médica tiene que ser correctamente valorado en todas sus dimensiones: científica, tecnológica y social. La selección del antibiótico cuando no es posible el estudio microbiológico y/o se carece de antibiograma debe ser hecha sobre las bases clínicas y epidemiológicas locales. La creación de una Política Antimicrobiana con todos sus componentes, recursos y metodología es necesaria más que nunca en estos tiempos. Puede estar sujeta a modificaciones con nuevas evidencias; pero tiene que ser cumplida para disminuir la resistencia microbiana, los costos y obtener mejores resultados(AU)
Introduction: Antimicrobials are one of the most pharmacological groups used in the clinical practice, and its relation to microbial resistance is demonstrated. The rational use of antibiotics can be beneficial from the social and medical point of view, but occasionally, their use is not the most correct one and there should be a systematic and special surveillance. A rational antimicrobial policy is necessary in the health care centers. Objective: To review national and international consensuses and criteria on antimicrobial policy to try to unify criteria and apply them the most uniform way possible in health care centers. Material and method: A bibliographic review on antimicrobial policy, antibiotics commission, and antibiotics policy was made in different databases; some of them were: Clinical Evidence, The Cochrane Library, PUBMED, Academic Google, MEDLINE, LIS, Scielo, Medscape, LILACS, Latindex, HINARI, MEDIGRAPHIC-NEWS, NIH Reporter, and the Web sites of the PAHO/ WHO. Development: Concepts on different Cuban publications, international consensuses, human components, objectives, functions, resources, methods, strategies, and controls were considered. Conclusions: The implementation of any therapeutic modification in the medical attention has to be analyzed correctly in all its dimensions: scientific, technological, and social ones. When the microbiological study is not possible or there is no antibiogram, the selection of the antibiotic should be made on the local epidemiological and clinical basis. The creation of an Antimicrobial Policy with all its components, resources, and methodology is needed now more than ever. It can be submitted to modifications with new evidences, but it has to be fulfilled to reduce both microbial resistance and the costs, and obtain better results(AU)
Assuntos
Humanos , Serviço de Farmácia Hospitalar/normas , Formulação de Políticas , Gestão de Antimicrobianos/métodos , Antibacterianos , Farmacorresistência Bacteriana/efeitos dos fármacos , Estratégias de eSaúde , Instalações de Saúde/ética , Anti-Infecciosos/normasRESUMO
WHAT IS KNOWN AND OBJECTIVE: Generic manufacturers help decrease the cost of antiretroviral (ARV) and antimicrobial medications which are used to treat opportunistic infections (OIs) in developing countries. Concerns have been expressed about potential quality issues with such medications as a result of the identification of numerous counterfeit medications in developing countries. However, few studies have assessed the quality of these medications using the United States Pharmacopeia (USP) compendial standards. The goal of this study was to assess the quality of ARV and OI medications obtained from various sources, including South Africa, United States, China, Ethiopia, Thailand, Laos, Mexico, Nigeria and five Internet pharmacies. METHODS: Zidovudine, lamivudine, efavirenz, nevirapine, isoniazid and sulfamethoxazole/trimethoprim tablets/capsules were obtained from eight countries and five Internet pharmacies. The tablets/capsules were separated into distinct samples, based on the drug's active ingredient, manufacturer and drug control number. Each distinct sample was analysed for drug content, dissolution, content uniformity and breaking force using USP 32-National Formulary 27 (USP 32-NF 27) compendial methods and compared to the USP standards. RESULTS AND DISCUSSION: A total of 2027 tablets/capsules were obtained with 88 distinct samples identified. All samples met the USP 32-NF 27 standards for drug content with a range of 92.7-108.6%. Six of the 88 samples failed the dissolution test by 1.5-8.3% below the standard range. Ninety-eight per cent of all 88 samples met the USP criteria for content uniformity based on weight variation. One sample of isoniazid was found to have a low breaking force of 2.8 kiloponds. The results of this study show that there were no problems with the samples of ARV and OI medications tested for drug quality from the specified locations. As there are many studies and reports that discuss the poor quality of generic medications with only a few assessing drug quality, the implications of this study's results are to: (i) help better understand patient outcomes; (ii) help patients gain access to beneficial medications for HIV and OIs; and (iii) ensure an overall increase in access to medications where needed. WHAT IS NEW AND CONCLUSION: This study is one of the largest to date concerning medication type and sample size for the assessment of ARV and OI medications using drug content as a measure of quality. The samples were obtained from more diverse geographical locations compared to previous studies and, for the first time, included Internet pharmacies. In addition to drug content, this study evaluated a more complete quality profile including dissolution, content uniformity and breaking force. This study showed that drug quality should be assessed consistently in order to better identify counterfeit medications compared to current assessments and that there should be uniform guidelines for how to assess quality.
Assuntos
Anti-Infecciosos/normas , Antirretrovirais/normas , Medicamentos Genéricos/normas , Internet , Disponibilidade de Medicamentos Via Internet/normas , Farmácias/normas , Qualidade da Assistência à Saúde/normas , China , Países em Desenvolvimento , Etiópia , Humanos , Laos , México , Nigéria , Infecções Oportunistas/tratamento farmacológico , África do Sul , Tailândia , Estados UnidosRESUMO
The increasing use of antimicrobial agents such as sulfonamides by the pig industry is of concern, since residues in both pork and its by-products, when derived from animals treated improperly, can endanger human health. The aim of this study was to establish the production conditions and to evaluate the homogeneity and the stability of sulfamethazine in porcine liver quality control material, produced 'in-house' for use in ring tests of the laboratory network of residues and contaminants of the Ministry of Agriculture, Livestock and Food Supply, Brazil. In the process of preparing the material, a FOSS blender was used, where the samples were ground to obtain a homogeneous mass, which was packed in polypropylene bottles. The material resulting from this process of homogenisation was sampled and analysed by LC/MS/MS. The analytical results were statistically evaluated by one-way ANOVA. According to statistical evaluation, the material produced was considered homogeneous, with 95% confidence. Stability tests were performed with the bottles stored under the specified storage conditions. They were randomly selected and analysed in duplicate by the same analytical method as the homogeneity study. The analytical results were statistically evaluated by the procedures for a stability check described in ISO 13528:2005, indicating that the material was unstable under the conditions of storage.
Assuntos
Anti-Infecciosos/análise , Contaminação de Alimentos/análise , Sulfametazina/análise , Animais , Anti-Infecciosos/normas , Brasil , Cromatografia Líquida , Resíduos de Drogas/análise , Resíduos de Drogas/normas , Contaminação de Alimentos/legislação & jurisprudência , Contaminação de Alimentos/prevenção & controle , Contaminação de Alimentos/estatística & dados numéricos , Inocuidade dos Alimentos , Humanos , Fígado/química , Carne/análise , Controle de Qualidade , Padrões de Referência , Sulfametazina/normas , Sus scrofa , Espectrometria de Massas em Tandem , Drogas Veterinárias/análise , Drogas Veterinárias/normasRESUMO
A sensitive, precise, and specific high-performance liquid chromatography (HPLC) method was developed for the assay of lomefloxacin (LFLX) in raw material and tablet preparations. The method validation parameters yielded good results and included the range, linearity, precision, accuracy, specificity, and recovery. It was also found that the excipients in the commercial tablet preparation did not interfere with the assay. The HPLC separation was performed on a reversed-phase Phenomenex C18 column (150 x 4.6 mm id, 5 microm particle size) with a mobile phase composed of 1% acetic acid-acetonitrile-methanol (70 + 15 + 15, v/v/v), pumped isocratically at a flow rate of 1.0 mL/min. The effluent was monitored at 280 nm. The calibration graph for LFLX was linear from 2.0 to 7.0 mg/mL. The interday and intraday precisions (relative standard deviation) were less than 1.0%. The method was applied for the quality control of commercial LFLX tablets to quantitate the drug.
Assuntos
Cromatografia Líquida/métodos , Fluoroquinolonas/análise , Quinolonas/análise , Anti-Infecciosos/administração & dosagem , Anti-Infecciosos/análise , Anti-Infecciosos/normas , Cromatografia Líquida/normas , Cromatografia Líquida/estatística & dados numéricos , Fluoroquinolonas/administração & dosagem , Fluoroquinolonas/normas , Humanos , Controle de Qualidade , Quinolonas/administração & dosagem , Quinolonas/normas , Padrões de Referência , Sensibilidade e Especificidade , Comprimidos com Revestimento EntéricoRESUMO
A sunscreen formula with eight different preservative systems was evaluated by linear regression, pharmacopeial, and the CTFA (Cosmetic, Toiletry and Fragrance Association) methods. The preparations were tested against Staphylococcus aureus, Burkholderia cepacia, Shewanella putrefaciens, Escherichia coli, and Bacillus sp. The linear regression method proved to be useful in the selection of the most effective preservative system used in cosmetic formulation.
Assuntos
Anti-Infecciosos/normas , Protetores Solares/química , Anti-Infecciosos/farmacologia , Contagem de Colônia Microbiana , Modelos Lineares , Testes de Sensibilidade MicrobianaRESUMO
El documento plantea como objetivos: *Dar a conocer tanto a los odontólogos de las instituciones de los servicios, como de práctica privada las bases técnicas para el manejo de métodos de desinfección, agentes desinfectantes y barrera para el control de enfermedades infecciosas en salud bucal; y *Utilizar la información del documento una vez revisada por los diferentes niveles de competencia del Sector Salud, para su integración al proceso de actualización de normas de prevención y control de enfermedades bucales. Señala los métodos de esterilización, métodos de desinfección, los procedimientos para la prevención y control de infecciones y los procedimientos para el uso de métodos de barrera para la protección del operador y asisitente en contacto con agentes infecciosos