Pharmaceutical clinical services in basic care in a region of the municipality of São Paulo

Pharmaceutical care has undergone several transformations in the health context over the years. Thus, the pharmacist has suffered a reconfiguration of his performance, mainly with the incorporation of clinical services and patient approach. The study analyzed the results of the implementation of pharmaceutical clinical services in Primary Health Care, through the use of indicators of supply, demand and productivity, clinical and process quality related to pharmaceutical care. We included all the clinical visits (n=1,833) performed to 1,080 users in 12 Basic Health Unit facilities from May to November 2016, of which 40.8% (n=748) were consultations in the establishments and 50.2% (n=1,085) home visits. Most patients (73.5%) were referred by team and 17.5% were captured through active search. Of the total workload, 12.5% were dedicated to pharmaceutical consultations and 20.0% to home visits. In total, we identified 3,078 pharmacotherapy-related issues, an average of 2.8 per patient, and 6,882 pharmaceutical interventions were performed, equivalent to 6.3 interventions per patient. The problem with adherence to pharmacotherapy and the intervention of medication counseling were the most found. Results reinforce the importance of pharmaceutical clinical services in identifying the control of the most prevalent health conditions and monitoring the therapeutic results associated with drug use

Access and use of medicines by elderly individuals with dementia

The objective is to reveal the difficulties concerning the access and use of medicines by elderly individuals with dementia, reported by their caregivers. This qualitative study applied the participant observation method during pharmaceutical appointments performed in a specialized geriatrics service of the University Hospital of Brasília. Caregivers reported facing difficulties regarding the itinerary for medicines access in public pharmacies, as well as the high cost of these technologies in private establishments. Psychiatric symptoms, cognitive deficits, behavioral changes, apraxia, dysphagia, among other clinical manifestations of dementia syndromes, incapacitates the elderly for self-responsibility concerningthe use of drugs, which accentuates the complexity of medicines administration within the care process. In conclusion, it is fundamental to recognize caregivers’ role in promoting the rational use of medicines, and so this theme should be highlighted within the pharmaceutical services context

Ensaios clínicos com medicamentos no Brasil: uma análise das principais características

Introduction: The results of clinical trials (CT) are used by regulatory agencies around the world for the purposes of drug product’s registering and marketing. The Brazilian Health Surveillance Agency (Anvisa, in Portuguese) is responsible for the registration of health  technologies in Brazil and for creating the rules for the analysis of technical issues in clinical trials. Anvisa has been working to update its regulatory framework regarding clinical trials with drugs in the country, to reduce analysis time and harmonize the normative frame according to international guidelines. Objective: To characterize phase III clinical trials, with drug products, conducted in Brazil from the publication of RDC n° 9, on 20 February 2015 by  Anvisa. Method: Exploratory and descriptive study, carried out in three stages: (1) quantitative analysis before and after RDC n° 9/2015; (2) analysis of the population participating in clinical trials that supported medication records; (3) characterization of the clinical trial performed  in Brazil. Results: There was a 20% reduction in clinical trials conducted in Brazil when compared before and after RDC n° 9/2015 by Anvisa; only 33% of the clinical trials that supported drug product  registrations in Brazil were performed with the Brazilian population; synthetic and biological drugs account for 96% of the intervention studied in clinical trials; placebo is still widely used as a comparator (37%); the pharmaceutical industry is mostly the sponsor of the clinical trial (86%). Conclusions: In view of this scenario, it is imperative to  strengthen pharmacovigilance actions in Brazil, in order to learn about the effectiveness and safety profiles of medicines after exposure of the Brazilian population.Introdução: Os resultados de ensaios clínicos são utilizados pelas agências regulatórias de todo o mundo para fins de registro e comercialização de medicamentos. A Agência Nacional de Vigilância Sanitária (Anvisa) é a responsável pelos registros de tecnologias em saúde no Brasil e regras para análises técnicas de ensaios clínicos. A Anvisa vem atuando para atualizar seu arcabouço regulatório a respeito de ensaios clínicos com medicamentos no país, para reduzir tempo de análise e harmonizar conforme regras internacionais. Objetivo: Caracterizar os ensaios clínicos de fase III, com medicamentos, realizados no Brasil a partir da publicação da RDC n° 9, de 20 de fevereiro de 2015, da Anvisa. Método: Estudo exploratório e descritivo realizado em três etapas: (1) análise quantitativa pré e pós RDC n° 9/2015; (2) análise da população participante de ensaio clínico que embasou registros de medicamentos; (3) caracterização dos ensaios clínicos realizados no Brasil. Resultados: Houve redução em 20% de ensaios clínicos realizados no Brasil quando se compara o período anterior e posterior à publicação da RDC n° 9/2015 da Anvisa; apenas 33% dos ensaios clínicos que embasaram registros de medicamentos no país foram realizados com população brasileira; os medicamentos sintéticos e biológicos somam 96% da intervenção estudada nos ensaios clínicos; placebo ainda é muito utilizado como comparador (37%); a indústria farmacêutica é majoritariamente o patrocinador dos ensaios clínicos (86%). Conclusões: Diante deste cenário, é imperativo que se fortaleçam as ações de farmacovigilância no Brasil, a fim de conhecer os perfis de efetividade e segurança dos medicamentos após exposição da população brasileira. 

Translation, adaptation and validation of a learning style assessment instrument for pharmacists in Brazil / Tradução, adaptação e validação de um instrumento de avaliação de estilo de aprendizagem para farmacêuticos no Brasil

This study aims to perform the cross-cultural adaptation of the "Pharmacists' Inventory of Learning Styles" (PILS) instrument for its use in Brazil. The process involved five steps: (i) two independent translations, (ii) synthesis of said translations, (iii) back translation, (iv) review by expert committee and (v) pilot study. Discrepancies in the translations were resolved by consensus between the translators. The expert committee reviewed the semantic, idiomatic, conceptual and cultural equivalences between the original and the translated versions, suggesting changes in ten items (58%), with an agreement mean end of 92.4%. The modified version was rated by 48 people, among which were pharmacy students, residents and pharmacists, who considered it understandable and applicable. The adaptation process was successful, and the use of the instrument  as a tool for identifying learning styles is appropriate, which makes it an available resource for  continuing education and training practices of pharmaceutical professionals in the country

Do tornar-se professor à criação nos processos de formação em saúde: um estudo biografemático

This study critically examines training processes in healthcare. Its goal is to identify and analyze characteristics of teaching practices and their effects on classrooms. Several interviews with professors from the field were taken into consideration. We have employed a research method called Biographeme, a strategy that values life in its written form, as a folding of life and work in a movement towards becoming what one is. The data points to the relations between teaching and research, as well as between research and aspects of what one has experienced and the transformations that one wishes. We highlight the possibility of reinforcing the debate from the perspective of a didactic based upon a philosophy of difference, as a path through which professors and students may assume singular styles.Este estudio evalua criticamente procesos de formación en salud. Tiene como objetivo levantar y analisar características de la enseñanza y sus efectos en los espacios del aula. Se han utilizado entrevistas con professores de los cursos de este campo. Se ha elegido un método de investigación llamado Biografema, una estrategia que valoriza la vida grafada, como un pliegue de vida y obra, en movimiento hasta uno volverse lo que es. Los dados producidos apuntan a las relaciones entre enseñanza y investigación y entre esta última y los aspectos de lo vivido y las transformaciones deseadas. Se resalta la posibilidad de fortalecer les discusiones a partir de una uma didática basada en la filosofía de la diferencia, como un camino para que profesores y estudiantes de salud asuman estilos singulares.Cette étude reprend de manière critique - à partir de certains concepts nietzschéens et de la pensée de la différence - les processus d'enseignement et d'apprentissage en éducation à la santé. Elle se concentre sur l'art du style d'enseignement, dans le but d'analyser les caractéristiques des enseignants et effets sur les rencontres avec les étudiants. Des entretiens semi-structurés ont été utilisés avec des professeurs de cours dans le domaine de la santé; les entretiens ont été transcrits et les textes qui en ont résulté ont été analysés et discutés par les chercheurs. Une méthode de recherche qualitative appelée Biographeme a été utilisée, une stratégie qui valorise la vie épelée, dans les expressions de ce qui est interprété, inventé et ce qui bouge pour devenir ce que l'on est. Les données construites indiquent des expériences, qui sont associées à la constitution de styles d'enseignement uniques, tels que les œuvres d'art, et les sujets abordés déclenchent des réflexions et des changements dans les processus d'enseignement et d'apprentissage dans l'éducation à la Santé.Este estudo toma processos de formação em saúde com o objetivo de analisar características da docência e seus efeitos nos espaços educacionais. Foram utilizadas conversas com professores dos cursos de educação superior da área. Lançou-se mão de um método de pesquisa denominado Biografema, uma estratégia que valoriza dobras da vida com a obra, em movimento de tornar-se o que se é. Os dados produzidos apontam para as relações da docência com a pesquisa, desta com aspectos do vivido e com transformações desejadas. Destaca-se a possibilidade de fortalecer discussões a partir de uma didática baseada na filosofia da diferença, como caminho para que professores e alunos assumam estilos singulares

Compounded drugs as an alternative to the therapeutical gaps of inborn errors of metabolism

Inborn errors of metabolism are rare disorders with few therapeutic options for their treatments, which can make patients suffer with complications. Therefore, compounded drugs might be a promising option given that they have the ability of meeting the patient’s specific needs, (i) identification of the main drugs described in the literature; (ii) proposal of compounding systems and (iii) calculation of the budgetary addition for the inclusion of these drugs into the Brazilian Unified Health System. The research conducted a literature review and used management data as well as data obtained from official Federal District government websites. The study identified 31 drugs for the treatment of inborn errors of metabolism. Fifty eight percent (58%) (18) of the medicines had their current demand identified, which are currently unmet by the local Health System. The estimated budget for the production of compounded drugs was of R$363,16.98 per year for approximately 300 patients. This estimated cost represents a budgetary addition of only 0.17% from the total of expenditures planned for drug acquirement. There is a therapeutic gap for inborn errors of metabolism and compounding pharmacies show potential in ensuring access to medicine therapy with a low-cost investment

Adverse drug reactions among patients admitted with infectious diseases at a Brazilian hospital

Introduction: despite the therapeutic benefits of drugs, adverse drug reactions (ADRs) occur. Method: We assessed a series of suspected ADRs identified from notifications and intensive monitoring of inpatients from March 2013 to March 2014. Results: skin reactions predominated (31%). Systemic anti-infective agents were implicated in 16 (72%) reactions. Fifteen (68%) ADRs were classified as possible. The implicated drug was not correctly identified by the healthcare team in 12 cases. Conclusions: some reactions were not correctly attributed to the causative drug(s), suggesting that the use of a validated evaluation method can promote successful identification of causal links between ADRs and drugs