High prevalence of mental disorder symptoms among medical and other health specialties residents during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic put healthcare professionals, including residents (postgraduate trainees of health professions), under intense physical and psychological stress, hence at risk for mental disorders. We evaluated the prevalence of mental disorders among healthcare residents during the pandemic. METHODS: From July to September 2020, residents in medicine and other healthcare specialties in Brazil were recruited. The participants completed electronic forms with validated questionnaires (DASS-21, PHQ-9, BRCS) to screen for depression, anxiety, and stress, and to evaluate resilience. Data on potential predisposing factors for mental disorders were also collected. Descriptive statistics, chi-squared, students t, correlation and logistic regression models were applied. The study received ethical approval, and all participants provided informed consent. RESULTS: We included 1313 participants (51.3% medical; 48.7% nonmedical) from 135 Brazilian hospitals; mean (SD) age: 27.8 (4.4) years; 78.2% females; 59.3% white race. Of all participants, 51.3%, 53.4% and 52.6% presented symptoms consistent with depression, anxiety, and stress, respectively; 61.9% showed low resilience. Nonmedical residents exhibited higher anxiety compared to medical residents (DASS-21 anxiety score, mean difference: 2.26; 95% CI: 1.15-3.37; p < 0.001). In multivariate analyses, having any pre-existent, nonpsychiatric chronic disease was associated with higher prevalence of symptoms indicative of depression (odds ratio, OR: 2.05; 95% CI: 1.47-2.85, on DASS-21 | OR: 2.26; 95% CI: 1.59-3.20, on PHQ-9), anxiety (OR: 2.07; 95% CI: 1.51-2.83, on DASS-21), and stress (OR: 1.53; 95% CI: 1.12-2.09, on DASS-21); other predisposing factors were identified; by contrast, high resilience (BRCS score) was protective against symptoms of depression (OR 0.82; 95% CI: 0.79-0.85, on DASS-21 | OR 0.85; 95% CI: 0.82-0.88, on PHQ-9), anxiety (OR 0.90; 95% CI: 0.87-0.93, on DASS-21), and stress (OR 0.88; 95% CI: 0.85-0.91, on DASS-21); p < 0.05 for all outcomes. CONCLUSIONS: We found a high prevalence of mental disorder symptoms among healthcare residents during COVID-19 pandemic in Brazil. Nonmedical residents exhibited higher levels of anxiety than medical ones. Some predisposing factors for depression, anxiety and stress among residents were identified.

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

Abstract 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.

High prevalence of burnout syndrome among medical and nonmedical residents during the COVID-19 pandemic.

BACKGROUND: Since the beginning of the COVID-19 pandemic, health professionals have been working under extreme conditions, increasing the risk of physical and mental illness. We evaluated the prevalence of burnout and its associated factors among postgraduate student residents in health professions during the global health crisis. METHODS: Healthcare residents were recruited from all across Brazil between July and September 2020 through digital forms containing instruments for assessing burnout (Oldenburg Burnout Inventory (OLBI)), resilience (brief resilient coping scale (BRCS)) and anxiety, stress and depression (depression, anxiety and stress scale (DASS-21) and Patient Health Questionnaire (PHQ-9)). Additionally, the relationships between burnout and chronic diseases, autonomy and educational adequacy in the residency programme, personal protective equipment (PPE), workload and care for patients with COVID-19 were evaluated. The chi-square test, Student's t test, Pearson's correlation test and logistic regression were performed. RESULTS: A total of 1,313 participants were included: mean (standard deviation) age, 27.8 (4.4) years; female gender, 78.1%; white race, 59.3%; and physicians, 51.3%. The overall prevalence of burnout was 33.4%. The odds (odds ratio [95% confidence interval]) of burnout were higher in the presence of pre-existing diseases (1.76 [1.26-2.47]) and weekly work > 60 h (1.36 [1.03-1.79]) and were lower in the presence of high resilience (0.84 [0.81-0.88]), autonomy (0.87 [0.81-0.93]), and educational structure (0.77 [0.73-0.82]), adequate availability of PPE (0.72 [0.63-0.83]) and non-white race (0.63 [0.47-0.83]). Burnout was correlated with anxiety (r = 0.47; p < 0.05), stress (r: 0.58; p < 0.05) and depression (r: 0.65; p < 0.05). CONCLUSIONS: We observed a high prevalence of burnout among residents during the COVID-19 pandemic. Individual characteristics and conditions related to the work environment were associated with a higher or lower occurrence of the syndrome.

Impact of COVID-19 on the mental health of public university hospital workers in Brazil: A cohort-based analysis of 32,691 workers.

BACKGROUND: In early 2020, the COVID-19 pandemic paralyzed the world and exposed the fragility of health systems in the face of mass illness. Health professionals became protagonists, fulfilling their mission at the risk of physical and mental illness. The study aimed to evaluate absenteeism indirectly related to SARS-CoV-2 infection in a large population of health care professionals. METHODS: An observational longitudinal repeated measures study was performed, including workers linked to 40 public university hospitals in Brazil. All causes of absenteeism were analyzed, focusing on those not directly attributed to COVID-19. Results for the same population were compared over two equivalent time intervals: prepandemic and during the pandemic. FINDINGS: A total of 32,691 workers were included in the study, with health professionals comprising 82.5% of the sample. Comparison of the periods before and during the pandemic showed a 26.6% reduction in work absence for all causes, except for COVID-19 and mental health-related absence. Concerning work absence related to mental health, the odds ratio was 39.0% higher during the pandemic. At the onset of the pandemic, there was an increase in absenteeism (all causes), followed by a progressive reduction until the end of the observation period. INTERPRETATION: Work absence related to mental illness among health care professionals increased during the COVID-19 pandemic, highlighting the need for health care managers to prioritize and implement support strategies to minimize absenteeism.

Clinical pharmaceutical services of primary health care of the Federal District: A discussion based on the SWOT matrix

Abstract In the epistemic field, several studies demonstrate the importance of pharmaceutical services in health care networks. Nonetheless, literature still addresses the strengths and barriers present in the provision of these services in an incipient way. Thus, this study aimed to understand these contexts in the development of clinical services for primary health care in the Federal District, Brazil. A qualitative study adopted the technique of open-script interview, structured based on the logic of the SWOT matrix. Pharmacists reported weaknesses such as precariousness and scarcity of physical infrastructure, material, and human resources. As threats, they discussed the lack of social recognition, discontinuities of government actions, and lack of preparation of the pharmacist for the provision of clinical services. Regarding themes pertaining to the service's strengths and opportunities, the advances in propositions and executions of public policies, actions, and governmental programs that have expanded the pharmaceutical workforce in primary care and that are impelling the accomplishment of clinical services were listed. This study contributes to understanding the scenario of the development of clinical pharmaceutical services, and consequently provides subsidies for the actions of planning, evaluation and qualification of health services.

Clinical pharmaceutical services in primary health care of the Federal District: Performance frequency and conditioning factors

Abstract Pharmaceutical services correspond to a set of actions that aim to guarantee the integral access and rational use of drugs by the population. In this sense, this study aimed to identify the frequency and conditioning factors for clinical services of primary care in the Federal District, Brazil. A quantitative cross-sectional study was conducted, in which 34 pharmacists were interviewed. The most frequently developed clinical pharmaceutical services were dispensing, pharmaceutical guidance for users, and technical-pedagogical activities for the health team. There is a greater frequency of operation of clinical services by pharmacists working in pharmacies with physical infrastructure, with better levels of adequacy, greater support from management and health staff, and the inclusion in Family Health Support Nucleus activities. Although the clinical pharmaceutical services in primary care are incipient, the study raises important data for the reorientation and qualification of these actions.

Placebo use and outcome quality: A protocol for systematic review and meta-analysis.

BACKGROUND: The Pharmaceutical industry sponsorship, research outcome and quality has been already evaluated for clinical trials in order to analyze if this kind of sponsorship affects the results of clinical trials. In this sense, this study has the aim to investigate whether placebo use allows positive outcomes regarding efficacy and safety compared to synthetic medicines. METHODS: We designed and registered a study protocol for a systematic review for methodology data. We will only randomized clinical trials that use placebo as comparator. The main outcome will be the evaluation of placebo use regarding the tendency for positive results (efficacy and security) when comparing to synthetic medicines. PubMed, Cochrane, LILACS (BVS), Web of Science, Scopus, and Excerpta Medica dataBASE (EMBASE) databases will be searched. Gray literature will be identified through the databases Proquest (Dissertation and Theses), OpenGrey and Google Scholar. Two review authors will independently assess trial quality and will extract data in accordance with standard Cochrane methodology. If necessary, we will also contact authors for additional information. The Cochrane Collaboration's risk of bias tool will be used. If feasible, it means homogenous data, we will conduct random effects meta-analysis. Subgroup analyses will be conducted for different justifications for placebo use and for studies sponsored/not sponsored by the pharmaceutical industry. RESULTS: Our present findings will indicate the effects of placebo use as comparator regarding efficacy and safety of the oral synthetic medicines. DISCUSSION: This systematic review will identify, summarize, and analyze if there is a trend for positive efficacy and safety results for synthetic medicines in clinical trials when compared with placebo and if the justification for placebo use is considered ethically acceptable. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018110829.

Fatores relacionados à adesão ao tratamento sob a perspectiva da pessoa idosa / Factors related to adherence to treatment from the perspective of the old person

Resumo A adesão ao tratamento é fundamental para o sucesso da farmacoterapia da pessoa idosa. A respeito desse fenômeno, o objetivo deste estudo foi identificar e compreender os fatores associados à adesão ao tratamento medicamentoso. Para isso, foi realizado um estudo qualitativo com os idosos considerados não aderentes pelo instrumento de Morisky, Green e Levine. O cenário de pesquisa ocorreu no Hospital Universitário de Brasília no período de março a agosto de 2015. A relação das pessoas idosas com a adesão ao tratamento mostrou-se complexa e englobou os seguintes fatores: alterações na rotina, acesso aos medicamentos e aos serviços de saúde, polifarmácia, desdobramentos dos efeitos medicamentosos, medicalização e relações com os profissionais de saúde. Para os idosos considerados não aderentes, foram observadas intencionalidades e condutas de adesão ao tratamento. Ou seja, a "adesão" e a "não adesão" são fenômenos experienciados pelas pessoas idosas de forma simultânea, acompanhando a dinâmica de vida dos indivíduos. Não obstante, o reconhecimento e a compreensão dos fatores discutidos foram importantes para o aprofundamento do conhecimento acadêmico sobre o tema, além de subsidiar o levantamento de informações cruciais para a qualificação da assistência farmacêutica local.

Abstract Adherence to treatment is essential for the success of pharmacotherapy for old people. Regarding this phenomenon, the objective of this study was to identify and understand the factors associated with adherence to drug treatment. For this, a qualitative study was carried out with the old people considered non-adherent by the instrument of Morisky, Green and Levine. The research scenario took place at the Hospital Universitário de Brasília from March to August 2015. The relationship between the old people and treatment adherence proved to be complex and included the following factors: changes in routine, access to medicines and health services health, polypharmacy, consequences of medication effects, medicalization and relationships with health professionals. For the old people considered non-adherent, intentions and conduct of adherence to treatment were observed. In other words, "adherence" and "non-adherence" are phenomena experienced by old people simultaneously, following the life dynamics of individuals. Nevertheless, the recognition and understanding of the factors discussed were important for the deepening of academic knowledge on the topic, in addition to supporting the gathering of crucial information for the qualification of local pharmaceutical assistance.

Serviços farmacêuticos clínicos na atenção primária à saúde do brasil / Clinical pharmaceutical services in brazil's primary health care / Servicios farmacéuticos clínicos en la atención primaria de salud en brasil

Resumo O farmacêutico executa importante papel no cuidado ao usuário da atenção primária, ao proporcionar ações emancipadoras de autocuidado, educação em saúde, promoção da saúde e do uso racional de medicamentos. Nesse contexto, este estudo, por meio de uma revisão integrativa da literatura, objetivou analisar os tipos e os benefícios dos serviços farmacêuticos clínicos desenvolvidos na atenção primária à saúde do Brasil. Foram recrutados, no SciELO e no PubMed/MEDLINE, artigos que tratavam dos serviços farmacêuticos clínicos desenvolvidos na atenção primária no Brasil publicados nos idiomas português, inglês ou espanhol no período de 2007 a 2017. O seguimento farmacoterapêutico é o serviço mais estudado, enquanto a dispensação e a orientação são as atividades realizadas com maior frequência pelos farmacêuticos da atenção primária. Já na esteira dos benefícios, a literatura demonstra a coexistência, a importância e a multidimensionalidade dos serviços farmacêuticos clínicos na promoção da saúde e do uso racional de medicamentos pela comunidade adstrita.

Abstract The pharmacist plays an important role in the care for the users of primary health care by providing emancipatory self-care actions, education in health, promotion of health and of the reasonable use of medications. In this context, the present study, through an integrative review of the literature, had the goal of analyzing the types and benefits of the clinical pharmaceutic services developed in primary health care in Brazil. In the SciELO and PUBMED/MEDLINE databases, we gathered articles on the clinical pharmaceutic services developed in primary health care in Brazil published in Portuguese, English and Spanish between 2007 and 2017. The pharmacotherapeutic follow-up is the most studied service, while dispensation and guidance are the activities most often performed by the primary health care pharmacists. Regarding the benefits, the literature shows the coexistence, the importance and the multidimensionality of the clinical pharmaceutic services in the promotion of health and in the reasonable use of medications by the circumscribed community.

Resumen El farmacéutico ejecuta un importante papel en el cuidado al usuario de la atención primaria, al proporcionar acciones emancipadoras de autocuidado, educación en salud, promoción de la salud y del uso racional de medicamentos. En ese contexto, este estudio, por medio de una revisión integrante de la literatura, tuvo el objetivo de analizar los tipos y los beneficios de los servicios farmacéuticos clínicos desarrollados en la atención primaria de salud en Brasil. Buscamos, en las bases de datos SciELO y PubMed/MEDLINE, artículos que trataban de los servicios farmacéuticos clínicos desarrollados en la atención primaria de salud en Brasil publicados en los idiomas portugués, inglés o español entre 2007 y 2017. El seguimiento farmacoterapéutico es el servicio más estudiado, mientras la dispensación y la orientación son las actividades realizadas con más frecuencia por los farmacéuticos de la atención primaria. Con relación a los beneficios, la literatura demuestra la coexistencia, la importancia y la multidimensionalidad de los servicios farmacéuticos clínicos en la promoción de la salud y del uso racional de medicamentos por la comunidad circunscripta.

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.

Uso de ferramentas de gestão clínica e de segurança do paciente em uma unidade básica de saúde no distrito federal / Use of clinical management and patient safety tools in a basic health unit in the federal district

INTRODUÇÃO: Dentre as variadas demandas na Atenção Primária à Saúde, os cuidados para condições agudas e crônicas exigem ferramentas para aumento de eficiência de tratamento e maior segurança do usuário e da equipe de saúde. OBJETIVO: Descrever o desenvolvimento e incorporação, na rotina do serviço, de ferramentas de gestão clínica com benefício tanto para usuários quanto para profissionais ‑ Receita Simples, Pasta da Saúde, Prontuário por Idade, Pré‑estruturados e Planos de Cuidado. Métodos: A elaboração das ferramentas de gestão clínica foi feita utilizando‑se os aplicativos Word e Excel e teve início em fevereiro de 2016, com colaboração de servidores da SES e alunos de graduação de Universidade Federal, especialmente do curso de Medicina, em UBS palco de extensão universitária e laboratório da Planificação – CONASS. O compartilhamento é feito por meio de grupos de WhatsApp (“SOS UBS”), e‑mail, pasta compartilhada no Google Drive, pen drive e mais recentemente por pasta compartilhada em rede. RESULTADOS-DISCUSSÃO: A ferramenta Pré‑estruturados refere‑se a um formulário editável que dispõem dos principais temas da Atenção Primária, dividido em 5 campos. O primeiro refere‑se à anamnese, o segundo, à medicações, o terceiro a questionários, o quarto a Mapa de eventos e o quinto a orientações ao usuário com linguagem e formato adaptados. A ferramenta Receita Simples refere‑se a um modelo visual de receituário para usuários de risco (dificuldade de leitura por analfabetismo, baixa escolaridade ou baixa acuidade visual); com foco em períodos do dia de administração de medicamentos. Esse novo receituário inclui um impresso com separação por períodos do dia e refeições, associando cada liga elástica de cor específica com um determinado período do dia...

Implantação dos serviços clínicos farmacêuticos na atenção primária à saúde do distrito / Implantation of pharmaceutical clinical services in the primary health care of the federal district

Introdução: a implantação dos serviços clínicos farmacêuticos visa qualificar a assistência à saúde da população do DF e está em consonância com as Portarias 77 e 78 de 2017, que estabelecem e regulamentam a Política de Atenção Primária à Saúde do DF.Objetivo: descrever a experiência de implantar os serviços clínicos farmacêuticos no âmbito da Atenção Primária à Saúde do DF.Métodos: o trabalho é descritivo com modalidade de relato de experiência de implantação dos serviços clínicos farmacêuticos, a qual foi organizado em 6 etapas: 1. Seleção das UBS e farmacêuticos; 2. Capacitação dos Farmacêutico; 3. Pactuação com os Gestores regionais e locais; 4. Implantação do serviço, 5. Monitoramento e avaliação dos resultados e 6. Multiplicação para demais UBS.Resultados: capacitação de 100% dos profissionais; a publicação da Nota Técnica nº 2/2017, criada e elaborada em conjunto com os gestores das regiões de saúde, que estabelece os instrumentos para organização do Cuidado Farmacêutico nas Unidades Básicas de Saúde da SES/DF; e serviço clínico executado em 100% das UBS selecionadas.Conclusão: a implantação do cuidado farmacêutico reorganiza a Assistência Farmacêutica, traz resolutividade e qualificação para os serviços de saúde, uma vez que a farmácia passa a prestar serviços clínicos somados aos serviços de logística.

Introduction: The implementation of pharmaceutical clinical services aims to qualify the health care of the population of the Federal District and is in line with Directives 77 and 78 of 2017, which establish and regulate the Primary Health Care Policy of the Federal District.Objective: to describe the experience of implanting pharmaceutical clinical services within the Primary Health Care of the Federal District.Methods: the work is descriptive with experience modality of clinical pharmacy services, which was organized in 6 steps: 1. Selection of PHUs and pharmacists; 2. Pharmacist training; 3. Scheduling with Regional and Local Managers; 4. Implementation of the service, 5. Monitoring and evaluation of results and 6. Multiplication for other UBS.Results: training of 100% of professionals; the publication of Technical Note No. 2/2017, created and elaborated together with the managers of the health regions, which establishes the instruments for the organization of Pharmaceutical Care in the Basic Health Units of SES / DF; and clinical service performed in 100% of the selected UBS.Conclusion: the implementation of pharmaceutical care reorganizes the Pharmaceutical Assistance, brings resolution and qualification to the health services, once the pharmacy starts providing clinical services added to the logistics services.

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

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.

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

Abstract 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.

[Overview of regulatory aspects guiding tablet scoring]. / Panorama dos aspectos regulatórios que norteiam a partição de comprimidos.

Tablet scoring is a controversial but common practice used to adjust doses, facilitate drug intake, or lower the cost of drug treatment, especially in children and the elderly. The risks of tablet scoring are mainly related to inaccuracies in the resulting dose and stability problems. The aim of this article is to provide an overview of worldwide guidelines regarding tablet scoring. We found that regulatory health agencies in Mercosur countries as well as other South American countries do not have published standards addressing tablet splitting. Among the surveyed health agencies, the Food and Drug Administration (FDA) in the United States is the only one to present standards, ranging from splitting instructions to regulation of the manufacturing process. The concept of functional scoring implemented by the FDA has introduced some level of guarantee as to the ability of tablets to be split. In conclusion, technical and scientific bases are still insufficient to guide health rules on this subject, making the decision on scoring, in certain situations, random and highly risky to public health. The need for more detailed regulation is vital to ensure the safety of tablet medications.

Panorama dos aspectos regulatórios que norteiam a partição de comprimidos / Overview of regulatory aspects guiding tablet scoring

A partição de comprimidos é uma prática controversa no meio da saúde. Mesmo assim, é amplamente difundida, principalmente em tratamentos envolvendo crianças e idosos, para ajustar doses, facilitar a ingestão do medicamento ou baratear o custo do tratamento medicamentoso. Os riscos dessa prática estão relacionados principalmente à imprecisão na dosagem das frações e a problemas de estabilidade no medicamento partido. O objetivo deste trabalho foi traçar um panorama das bases sanitárias que norteiam esse tema no mundo. Constatamos que as agências regulatórias de saúde dos países que integram o Mercosul, além de outros países sul-americanos, não possuem normas publicadas que tratem de partição de comprimidos. Entre as agências sanitárias pesquisadas, a Food and Drug Administration (FDA), nos Estados Unidos, é a única a apresentar normas que abrangem desde instruções para orientar o fracionamento até a regulação do processo de fabricação. O conceito de sulco funcional implementado pela FDA estabelece algumas garantias quanto à capacidade do comprimido de ser fracionado. Pode-se concluir que ainda faltam bases técnicas e científicas para direcionar as normas sanitárias acerca desse tema, tornando a decisão sobre a partição de comprimidos, em determinadas situações, aleatória e de alto risco para a saúde pública. A necessidade de regulação mais pormenorizada é vital para garantir a segurança dos usuários de medicamentos.

Tablet scoring is a controversial but common practice used to adjust doses, facilitate drug intake, or lower the cost of drug treatment, especially in children and the elderly. The risks of tablet scoring are mainly related to inaccuracies in the resulting dose and stability problems. The aim of this article is to provide an overview of worldwide guidelines regarding tablet scoring. We found that regulatory health agencies in Mercosur countries as well as other South American countries do not have published standards addressing tablet splitting. Among the surveyed health agencies, the Food and Drug Administration (FDA) in the United States is the only one to present standards, ranging from splitting instructions to regulation of the manufacturing process. The concept of functional scoring implemented by the FDA has introduced some level of guarantee as to the ability of tablets to be split. In conclusion, technical and scientific bases are still insufficient to guide health rules on this subject, making the decision on scoring, in certain situations, random and highly risky to public health. The need for more detailed regulation is vital to ensure the safety of tablet medications.

Panorama dos aspectos regulatórios que norteiam a partição de comprimidos / Overview of regulatory aspects guiding tablet scoring

RESUMO A partição de comprimidos é uma prática controversa no meio da saúde. Mesmo assim, é amplamente difundida, principalmente em tratamentos envolvendo crianças e idosos, para ajustar doses, facilitar a ingestão do medicamento ou baratear o custo do tratamento medicamentoso. Os riscos dessa prática estão relacionados principalmente à imprecisão na dosagem das frações e a problemas de estabilidade no medicamento partido. O objetivo deste trabalho foi traçar um panorama das bases sanitárias que norteiam esse tema no mundo. Constatamos que as agências regulatórias de saúde dos países que integram o Mercosul, além de outros países sul-americanos, não possuem normas publicadas que tratem de partição de comprimidos. Entre as agências sanitárias pesquisadas, a Food and Drug Administration (FDA), nos Estados Unidos, é a única a apresentar normas que abrangem desde instruções para orientar o fracionamento até a regulação do processo de fabricação. O conceito de sulco funcional implementado pela FDA estabelece algumas garantias quanto à capacidade do comprimido de ser fracionado. Pode-se concluir que ainda faltam bases técnicas e científicas para direcionar as normas sanitárias acerca desse tema, tornando a decisão sobre a partição de comprimidos, em determinadas situações, aleatória e de alto risco para a saúde pública. A necessidade de regulação mais pormenorizada é vital para garantir a segurança dos usuários de medicamentos.

ABSTRACT Tablet scoring is a controversial but common practice used to adjust doses, facilitate drug intake, or lower the cost of drug treatment, especially in children and the elderly. The risks of tablet scoring are mainly related to inaccuracies in the resulting dose and stability problems. The aim of this article is to provide an overview of worldwide guidelines regarding tablet scoring. We found that regulatory health agencies in Mercosur countries as well as other South American countries do not have published standards addressing tablet splitting. Among the surveyed health agencies, the Food and Drug Administration (FDA) in the United States is the only one to present standards, ranging from splitting instructions to regulation of the manufacturing process. The concept of functional scoring implemented by the FDA has introduced some level of guarantee as to the ability of tablets to be split. In conclusion, technical and scientific bases are still insufficient to guide health rules on this subject, making the decision on scoring, in certain situations, random and highly risky to public health. The need for more detailed regulation is vital to ensure the safety of tablet medications.

Conduta do tratamento medicamentoso por cuidadores de idosos / Management of drug therapy by elderly people’s caregivers / Conducta del tratamiento medicamentoso por cuidadores de ancianos

O envelhecimento populacional está ampliando o número de cuidadores de idosos no Brasil. A farmacoterapia compreende um sistema complexo de atividades e a sua condução está presente no rol de tarefas desempenhadas por esses atores. Além disso, a conduta do tratamento pode estar sujeita a diversos problemas na sua execução, com destaque para: dificuldades de administração dos medicamentos, falta de acesso aos medicamentos, obstáculos na realização de observação clínica, assim como os desafios presentes no estabelecimento de uma comunicação efetiva com os idosos e profissionais de saúde. O presente estudo trata de uma revisão cujo objetivo é ampliar as discussões sobre os aspectos supracitados, de modo que este debate dê subsídios teóricos aos programas e serviços na área de gerontologia.

Aging of the population is increasing the number of caregivers of elderly people in Brazil. Pharmacotherapy involves a complex system of activities and its management is among the tasks performed these caregivers. Moreover, management of drug therapy may be subject to various problems relating to its implementation. In particular, there are difficulties in drug administration, lack of access to drugs, obstacles against conducting clinical observation and challenges in establishing effective communication between elderly people and healthcare professionals. The present study consists of a review that aims to expand the discussions on the abovementioned issues so as to provide theoretical support to programs and services within the field of gerontology.

El envejecimiento poblacional está ampliando el número de cuidadores de ancianos en Brasil. La farmacoterapia incluye un sistema complejo de actividades y su realización está presente en las diversas tareas desempeñadas por esos actores. Además, la conducta del tratamiento puede estar sujeta a diversos problemas en su realización, destacándose los siguientes: las dificultades de administración de los medicamentos, la falta de acceso a los medicamentos, los obstáculos en la realización de observación clínica, así como los desafíos presentes en el establecimiento de una comunicación efectiva con los ancianos y profesionales de la salud. El presente estudiose trata de una revisión cuyo objetivo es ampliar las discusiones sobre los aspectos anteriormente citados, de forma que tal debate proporcione subsidios teóricos a los programas y servicios en el área de la gerontología.