Farmacovigilância

O conteúdo trata da Farmacovigilância e apresenta conhecimentos, métodos e ferramentas que podem subsidiar as ações de farmacovigilância no cotidiano dos serviços. Apresenta endereços eletrônicos de Agências ou autoridades reguladoras na área de medicamentos, e Publicações, Boletins, Guias, Revistas e Manuais na área de farmacovigilância no mundo, auxiliando na obtenção de informações sobre os medicamentos. Discute, também, o papel do profissional nas ações relacionadas à farmacovigilância.2.

Evaluation of demands of inclusion, exclusion and alteration of technologies in the Brazilian Health System submitted to the National Committee on Technology Incorporation

The steady increase in the number of health technologies and advances in associated research generate management challenges in the choice of technologies to be made available to the public. From 2011, the process of inclusion, exclusion and alteration of technologies to the Brazilian Unified Health System (SUS) has undergone major transformations, such as the creation of the National Committee on Technology Incorporation (CONITEC). This study analyzed the decisions of CONITEC since its inception until July 2015. The analyzed variables were: type of technology, reason for application, name of the technology, indication, claimant and CONITEC decision status. We found that the Government was the main claimant, accounting for 58.1% of the 420 cases. The most frequent request was inclusion (93.8%) and the technology type was medicine (61.4%). Of the incorporated medicines, the classes of antineoplastic/immunomodulatory were the most frequent (39.47%). Society's desire for inclusion of an increasing amount of health technology contrasts with the limited resources available to management, which causes budget concerns. Using Health Technology Assessment (HTA), advances resulting from these innovations in the process were highlighted, and challenges were identified for the management and the academic community

The presence of pharmaceutical excipients as possible cause of adverse drug reactions (ADR) - situation in Brazil

Os excipientes farmacêuticos podem ser os responsáveis por inúmeras Reações Adversas a Medicamentos (RAM). O objetivo do trabalho foi identificar a presença de possíveis excipientes indutores de RAM em medicamentos comercializados no Brasil. Foram listados os 12 produtos mais vendidos no mercado brasileiro para análise. A detecção dos excipientes ocorreu a partir da consulta à composição da fórmula farmacêutica dos produtos, realizada de Agosto a Setembro/04, no Dicionário de Especialidades Farmacêuticas, sites SAC do laboratório produtor, e ficha técnica disponível no site da ANVISA. A identificação dos excipientes, possíveis causadores de RAM, foi realizada a partir de consulta à literatura. Foram identificadas 35 apresentações farmacêuticas, 26 classificadas como medicamentos de venda livre (71,4%) e 15 de uso pediátrico (42,8%). Entre os excipientes identificados (n=100), nove eram possíveis causadores de RAM: metilparabeno, propilparabeno, corante amarelo tartrazina, bissulfito de sódio, benzoato de sódio, lactose, cloreto de benzalcônio, sorbitol e álcool benzílico, sendo identificados em sete apresentações de uso pediátrico (18,9%) e doze de venda livre (32,4%). Os resultados demonstram a necessidade de maior atenção por parte dos profissionais de saúde, dos usuários de medicamentos e da avaliação pelos sistemas de farmacovigilância, da presença de excipientes como possíveis indutores de RAM.Pharmaceutical excipients can be responsible for many ADR. The objectives of this study were to identify the presence of possible excipients as cause of ADR in drugs commercialized in Brazil. Twelve medicines with high indices of sales in Brazil, were selected to analysis. The bibliographic research about the Pharmaceutical Preparations (PP) was carried from August to September/04. The sources of information used were Pharmaceutical Specialties Dictionary, web sites and customer services from the manufacturers and technical files of the National Agency of Sanitary Vigilance. The excipients were detected as a whole and also the compounds that may cause adverse reactions and its risks to the health. They were identified 35 PP. Of these, 26 were classified as Over-The-Counter medicines (OTC) (71.4%) and 15 of paediatric use (42.8%). Between the excipients identified (n=100), 9 were possible causes of ADR: metylparaben, propylparaben, yellow dye tartrazine, sodium bissulfit, sodium benzoate, lactose, benzalkonium chloride, sorbitol and benzílic alcohol, being identified in 7 use in paediatric (19.0%) and 12 of OTC (32.4%). The results shows the need of more attention from the health professionals, the patient and the development of evaluation by the pharmacovigilance systems, of the presence of excipients as possible inductors of ADR

Inappropriate use of medicines and associated factors in Brazil : an approach from a national household survey

This article aims to describe the inappropriate use of medicines in the Brazilian urban population and to identify associated factors. We conducted a data analysis of a household survey carried out in Brazil in 2013–14. The sampling plan was done by clusters with representativeness of the urban population and large regions of the country, according to gender and age domains. For this analysis, we considered a sample of adults ( 20 years) who reported having chronic noncommunicable diseases, medical indication for drug treatment and medicine use (n¼12 283). We evaluated the prevalence of inappropriate use in the domains: non-adherence, inappropriate use behaviour and inadequate care with medicines, all verified in the following groups of independent variables: demographic and socio-economic characteristics, health and pharmaceutical care, health status and use of medicines. Crude and adjusted prevalence ratios were obtained using robust Poisson regression. It was found 46.1% of people having at least one behaviour of inappropriate use of medicines. The worst results were found for the domain of inappropriate use behaviour, a situation of 36.6% of the users, which included unauthorized prescriber, inadequate source of information and indication of the medicines by non-authorized prescribers. The best result was found for the lack of medicines care, informed by only 4.6% of users who kept expired drugs at home. The inappropriate use of medicines was associated with gender (female), region of residence (Northeast), not visiting the doctor regularly or visiting more than one doctor, not having free access to medicines and using of five or more medicines. There was a high prevalence of inappropriate use, which was associated with both individual and health system characteristics pointing out the need to set priorities as for health education and public interventions

Prevalencia y características de los eventos adversos con medicamentos en Brasil

The aim of this study was to describe the prevalence of adverse drug events (ADEs) and associated factors reported by users of medicines in Brazil. This was a cross-sectional population-based study conducted from September 2013 to February 2014 with data from the Brazilian National Survey on Access, Use, and Promotion of Rational Use of Medicines (PNAUM). The study included all individuals that reported the use of medicines and identified, among them, all those reporting at least one problem with the medicine’s use. A descriptive analysis was performed to estimate ADE prevalence and 95% confidence intervals (95%CI) among the target variables. Crude and adjusted prevalence ratios were calculated using Poisson regression to investigate factors associated with ADEs. Overall ADE prevalence in Brazil was 6.6% (95%CI: 5.89-7.41), and after multivariate analysis, higher prevalence was associated with female gender, residence in the Central and Northeast regions, consumption of more medicines, “bad” self-rated health, and self-medication. The drugs most frequently reported with ADEs were fluoxetine, diclofenac, and amitriptyline. The most frequent ADEs were somnolence, epigastric pain, and nausea. Most reported ADEs were mild, avoidable, and associated with medicines used frequently by the population. The study provided knowledge on the size of the problem with use of medicines in Brazil.O presente trabalho tem como objetivo descrever a prevalência e fatores associados a eventos adversos a medicamentos (EAM) referidos por usuários de medicamentos no Brasil. Trata-se de um estudo transversal de base populacional, realizado no período de setembro de 2013 a fevereiro de 2014, com dados coletados na Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM). Foram consideradas todas as pessoas que referiram o uso de medicamentos; entre elas, foram identificadas as que referiram pelo menos um problema com o uso do medicamento. Realizou- se uma análise descritiva para estimar a prevalência e os intervalos de 95% de confiança (IC95%) de EAM entre as variáveis estudadas, e foram calculadas as razões de prevalência bruta e ajustada, pela regressão de Poisson, na investigação dos fatores associados aos EAM. A prevalência de EAM no Brasil foi de 6,6% (IC95%: 5,89-7,41), sendo maior e estatisticamente significante após a realização da análise multivariada, entre pessoas do sexo feminino; residentes nas regiões Centro-oeste e Nordeste; que consumiam maior número de medicamentos; que percebiam seu estado de saúde como “ruim”; e que se automedicavam. Os EAM foram mais relatados para os medicamentos fluoxetina, diclofenaco e amitriptilina. Os EAM mais referidos pelos entrevistados foram sonolência, dor epigástrica e náuseas. Os EAM mais referidos pelos entrevistados foram de natureza leve, considerados evitáveis e estiveram associados a medicamentos de uso frequente pela população. Em razão desse estudo, foi possível conhecer a dimensão do problema ocasionado pelo uso de medicamentos no Brasil

Benzodiazepines utilization in Brazilian older adults : a population-based study

OBJECTIVE: To evaluate the utilization of benzodiazepines (BZD) in Brazilian older adults, based on the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM - National Survey of Access, Use and Promotion of Rational Use of Medicines). METHODS: The PNAUM is a cross-sectional study conducted between 2013 and 2014, representing the Brazilian urban population. In the present study, we included 60 years or older (n = 9,019) individuals. We calculated the prevalence of BZD utilization in the 15 days prior to survey data collection according to independent variables, using a hierarchical Poisson regression model. A semistructured interview performed empirical data collection (household interview). RESULTS: The prevalence of BZD utilization in the older adults was 9.3% (95%CI: 8.3–10.4). After adjustments, BZD utilization was associated with female sex (PR = 1.88; 95%CI: 1.52–2.32), depression (PR = 5.31; 95%CI: 4.41–6, 38), multimorbidity (PR = 1.44; 95%CI: 1.20–1.73), emergency room visit or hospitalization in the last 12 months (PR = 1.42; 95%CI: 1.18–1.70 ), polypharmacy (PR = 1.26; 95%CI: 1.01–1.57) and poor or very poor self-rated health (PR = 4.16; 95%CI: 2.10–8.22). Utilization was lower in the North region (PR = 0.18; 95%CI: 0.13–0.27) and in individuals who reported abusive alcohol consumption in the last month (PR = 0.42; 95%CI: 0.19–0.94). CONCLUSION: Despite contraindications, results showed a high prevalence of BZD utilization in older adults, particularly in those with depression, and wide regional and sex differences