[Twenty years since the publication of medication price regulation in Brazil: time to update?] / Vinte anos da publicação da regulamentação de preços de medicamentos no Brasil: momento de atualizar?

Criteria for setting medication prices in Brazil are set forth in CMED Resolution n. 2/2004 of the (Medicines Market Regulation Chamber). The stipulated prices influence the private and public markets, which makes it challenging to review pricing policies due to the need to harmonize social and economic interests. A proposal for reviewing this Resolution was made available through the SEAE Public Consultation n. 2/2021 of the Competition and Competitiveness Advocacy Secretariat/Brazilian Ministry of Economy; however, so far without publication of the consolidated results. Recent recommendations from the World Health Organization regarding the adoption of different thresholds for setting medication prices are adopted in this Resolution, although it was published 20 years ago. To interpret and describe the alignment, possible advances and setbacks between the legal texts related to medication price regulation, we conducted an analytical-descriptive and exploratory documentary research. As a result, the list of reference countries for international price verification and the thresholds for internal and external price referencing were maintained. The normative omissions of the Resolution remain in the Public Consultation, such as the absence of criteria for pricing radiopharmaceuticals, advanced therapies and medication without international and comparator prices in the Brazilian market, to revise prices and transpose provisional to definitive prices. A critical point was the creation of a 35% bonus above the stipulated price for medication that present additional clinical benefit without, however, defining clear contours as to the acceptable scientific evidence to prove such benefit. In short, few advances were noticed in the Public Consultation.

Os critérios para definir os preços de medicamentos no Brasil estão previstos na Resolução CMED nº 2/2004 da Câmara de Regulação do Mercado de Medicamentos. Os preços estipulados influenciam o mercado privado e público, o que torna desafiador a revisão de políticas de preços devido a necessidade de harmonizar interesses sociais e econômicos. Uma proposta de revisão dessa Resolução foi disponibilizada por meio da Consulta Pública SEAE nº 2/2021 da Secretaria de Advocacia da Concorrência e Competitividade/Ministério da Economia, porém, até o momento sem publicação dos resultados consolidados até o momento. Recomendações recentes da Organização Mundial da Saúde em relação à adoção de diferentes limiares para definição de preços de medicamentos são adotadas nessa Resolução, embora essa tenha sido publicada há 20 anos. Com o objetivo de interpretar e descrever o alinhamento e os possíveis avanços e retrocessos nos textos legais relacionados à regulação de preços de medicamentos, foi utilizado o método da pesquisa documental analítica-descritiva, de cunho exploratório. Como resultado, foram mantidas a lista de países referência para conferência de preço internacional e os limiares de referenciamento interno e externo de preços. As omissões normativas da Resolução permanecem na Consulta Pública, como a ausência de critérios para precificar radiofármacos, terapias avançadas e medicamentos sem preço internacional, e sem comparadores no mercado brasileiro para revisar preços e transpor preço provisório para definitivo. Um ponto crítico foi a criação de bônus de 35% acima do preço estipulado para medicamentos que apresentem benefício clínico adicional sem, contudo, definir contornos claros quanto às evidências científicas aceitáveis para a comprovação desse benefício. Em suma, poucos avanços foram percebidos na Consulta Pública.

Los criterios para definir los precios de los medicamentos en Brasil están establecidos en la Resolución CMED nº 2/2004 de la Cámara de Regulación del Mercado de Medicamentos. Los precios estipulados influyen en el mercado público y privado, lo que dificulta la revisión de las políticas de precios debido a la necesidad de armonizar los intereses sociales y económicos. Una propuesta para revisar esta Resolución se puso a disposición mediante la Consulta Pública SEAE nº 2/2021 de la Secretaría de Competencia y Promoción de la Competitividad/Ministerio de Economía, sin embargo, hasta el momento no se han publicado los resultados consolidados. En esta Resolución se adoptan recomendaciones recientes de la Organización Mundial de la Salud sobre la adopción de diferentes umbrales para fijar los precios de los medicamentos, aunque fue publicada hace 20 años. Con el objetivo de interpretar y describir el alineamiento, posibles avances y retrocesos, entre los textos legales relacionados con la regulación de precios de medicamentos, se utilizó el método de investigación documental analítica-descriptiva, de carácter exploratorio. Como resultado, se mantuvieron la lista de países de referencia para la verificación de precio internacional y los umbrales para la referenciación interna y externa de precios. Quedan en Consulta Pública las omisiones normativas de la Resolución, como la ausencia de criterios de fijación de precios de radiofármacos, terapias avanzadas y medicamentos sin precio internacional y comparadores en el mercado brasileño, para revisar precios y transponer el precio provisional al definitivo. Un punto crítico fue la creación de una bonificación del 35% sobre el precio estipulado para los medicamentos que presenten un beneficio clínico adicional sin definir, sin embargo, contornos claros sobre las evidencias científicas aceptables para demostrar dicho beneficio. En definitiva, se percibieron pocos avances en la Consulta Pública.

Judicialization of Zolgensma in the Ministry of Health: costs and clinical profile of patients.

OBJECTIVE: To investigate the costs and profile of patients who have filed a lawsuit against the Ministry of Health for the treatment of spinal muscular atrophy (SMA) with the onasemnogene abeparvovec (Zolgensma®). METHODS: This is a cross-sectional, descriptive study with a census design, based on records of lawsuits filed against the Ministry of Health between January 2019 and September 2022. Data was requested from the Ministry of Health via the Access to Information Act. Information was extracted on the epidemiological profile of the beneficiaries of the lawsuits, as well as the expenses spent by the Ministry of Health in cases where the requests were granted. RESULTS: 136 lawsuits were identified, of which 113 (83%) were favorable to patients at a cost of R$ 944.8 million in the period analyzed. Demographic (gender and age), clinical (SMA subtypes, use of ventilatory or nutritional support), and lawsuit (type of legal service) characteristics were not associated with the granting of lawsuits. Prior use of medication (nusinersena or ridisplam) was associated with the dismissal of lawsuits. Of the 113 lawsuits granted in favor of patients, only six (5.3%) would meet the criteria currently established by the National Committee for Health Technology Incorporation - Conitec (children up to six months without ventilatory and nutritional support). R$ 146 million was spent on supplying Zolgensma to children over the age of two, which is outside the recommendation contained in the drug's package leaflet. CONCLUSIONS: The Ministry of Health incurs a high cost with the judicialization of Zolgensma for SMA, representing 2.45% of total spending on medicines in the Unified Health System, including spending by the three administrative spheres. Some of the lawsuits have been granted in disagreement with the criteria established by health technology assessment agencies and the drug manufacturer's recommendations.

Clinical pharmacy key performance indicators for hospital inpatient setting: a systematic review.

BACKGROUND: Key performance indicators (KPIs) are quantifiable measures used to monitor the quality of health services. Implementation guidelines for clinical pharmacy services (CPS) do not specify KPIs. AIM: To assess the quality of the studies that have developed KPIs for CPS in inpatient hospital settings. METHOD: A systematic review was conducted by searching in Web of Science, Scopus, and PubMed, supplemented with citation analyses and grey literature searches, to retrieve studies addressing the development of KPIs in CPS for hospital inpatients. Exclusions comprised drug- or disease-specific studies and those not written in English, French, Portuguese, or Spanish. The Appraisal of Indicators through Research and Evaluation (AIRE) instrument assessed methodological quality. Domain scores and an overall score were calculated using an equal-weight principle. KPIs were classified into structure, process, and outcome categories. The protocol is available at https://doi.org/10.17605/OSF.IO/KS2G3 . RESULTS: We included thirteen studies that collectively developed 225 KPIs. Merely five studies scored over 50% on the AIRE instrument, with domains #3 (scientific evidence) and #4 (formulation and usage) displaying low scores. Among the KPIs, 8.4% were classified as structure, 85.8% as process, and 5.8% as outcome indicators. The overall methodological quality did not exhibit a clear association with a major focus on outcomes. None of the studies provided benchmarking reference values. CONCLUSION: The KPIs formulated for evaluating CPS in hospital settings primarily comprised process measures, predominantly suggested by pharmacists, with inadequate evidence support, lacked piloting or validation, and consequently, were devoid of benchmarking reference values.

Judicialization of Zolgensma in the Ministry of Health: costs and clinical profile of patients / Judicialização do Zolgensma no Ministério da Saúde: custos e perfil clínico dos pacientes

ABSTRACT OBJECTIVE To investigate the costs and profile of patients who have filed a lawsuit against the Ministry of Health for the treatment of spinal muscular atrophy (SMA) with the onasemnogene abeparvovec (Zolgensma®). METHODS This is a cross-sectional, descriptive study with a census design, based on records of lawsuits filed against the Ministry of Health between January 2019 and September 2022. Data was requested from the Ministry of Health via the Access to Information Act. Information was extracted on the epidemiological profile of the beneficiaries of the lawsuits, as well as the expenses spent by the Ministry of Health in cases where the requests were granted. RESULTS 136 lawsuits were identified, of which 113 (83%) were favorable to patients at a cost of R$ 944.8 million in the period analyzed. Demographic (gender and age), clinical (SMA subtypes, use of ventilatory or nutritional support), and lawsuit (type of legal service) characteristics were not associated with the granting of lawsuits. Prior use of medication (nusinersena or ridisplam) was associated with the dismissal of lawsuits. Of the 113 lawsuits granted in favor of patients, only six (5.3%) would meet the criteria currently established by the National Committee for Health Technology Incorporation - Conitec (children up to six months without ventilatory and nutritional support). R$ 146 million was spent on supplying Zolgensma to children over the age of two, which is outside the recommendation contained in the drug's package leaflet. CONCLUSIONS The Ministry of Health incurs a high cost with the judicialization of Zolgensma for SMA, representing 2.45% of total spending on medicines in the Unified Health System, including spending by the three administrative spheres. Some of the lawsuits have been granted in disagreement with the criteria established by health technology assessment agencies and the drug manufacturer's recommendations.

RESUMO OBJETIVO Investigar os custos e o perfil dos pacientes que demandaram judicialmente o onasemnogene abeparvoveque (Zolgensma®) para o tratamento da atrofia muscular espinhal (AME) no Ministério da Saúde. MÉTODOS Estudo transversal, de natureza descritiva e desenho censitário, com base em registros de ações judiciais movidas contra o Ministério da Saúde no período de janeiro de 2019 a setembro de 2022. Os dados foram solicitados ao Ministério da Saúde, via Lei de Acesso à Informação. Foram extraídas informações sobre o perfil epidemiológico dos beneficiários das ações judiciais, bem como os gastos dispendidos pelo Ministério da Saúde nos casos de deferimento das solicitações. RESULTADOS Foram identificados 136 processos judiciais, dos quais 113 (83%) foram favoráveis aos pacientes ao custo de R$ 944,8 milhões no período analisado. Características demográficas (sexo e idade), clínicas (subtipos da AME, uso de suporte ventilatório ou nutricional) e do processo judicial (tipo de serviço advocatício) não foram associadas com o deferimento das ações judiciais. O uso prévio de medicamento (nusinersena ou ridisplam) foi associado com o indeferimento dos processos judiciais. Das 113 ações judiciais concedidas em favor dos pacientes, apenas seis (5,3%) atenderiam aos critérios estabelecidos atualmente pela Comissão Nacional de Incorporação de Tecnologias - Conitec (crianças com até seis meses sem suporte ventilatório e nutricional). Houve dispêndio de R$ 146 milhões com o fornecimento do Zolgensma para crianças com idade superior a dois anos, que está fora da recomendação contida na bula do medicamento. CONCLUSÕES O Ministério da Saúde incorre em um alto custo com a judicialização do Zolgensma para AME, representando 2,45% do gasto total com medicamentos no Sistema Único de Saúde, incluindo gastos das três esferas administrativas. Parte das demandas judiciais tem sido deferida em divergência com os critérios estabelecidos por agências de avaliação de tecnologias em saúde e recomendações do fabricante do medicamento.

Drug-drug interactions of immunosuppressants and other drugs in kidney post-transplant recipients

Introduction: Immunosuppressants (ISS) are the most crucial tools used in the therapeutic regimens of transplant recipients. Nevertheless, these drugs are not the only ones adopted by patients; therefore, knowing the possible drug-drug interactions (DDIs) between immunosuppressants and other drugs commonly used in kidney transplant recipients is essential to ensure the effectiveness and safety of treatments. In this way, the objective is analyzing the DDIs between the immunosuppressants and other commonly used medications on kidney transplant adult recipients with active medical records undergoing post-transplant follow-up for 4.4 years (mean). Methods: First, we performed a cross-sectional study based on patients' records, in which the patient's profile and drugs used were examined, and after we analyzed DDIs by the Micromedex Drug Interactions® database. Results: We analyzed 176 patients with a mean age of 47.6(± 12.5); most were male (67.7%), and the majority received a kidney from a deceased donor (81.4%). Patients were exposed to 15.0 (± 5.4) different medicines after the transplantation, and 7.4 (± 4.0) of these medicines were simultaneous. After analyzing the DDIs according to the severity of interaction, documentation quality interaction effect, clinical management and probable interaction mechanism, the most frequent interaction was with tacrolimus, classified as moderate, and the 3 major causes of interaction occurred with azathioprine according to the Micromedex database. The primary medicines involved with immunosuppressant interactions were proton pump inhibitors, ranitidine, domperidone, amlodipine, enalapril, allopurinol, cyclobenzaprine, amitriptyline, fluoxetine, and ciprofloxacin. These DDIs' effects were related to, mainly, increase their immunosuppressant activity. Conclusion: Although the immunosuppressants analyzed lacked many clinical DDIs significance with other medicines, the healthcare team needs to monitor their DDIs' effects to prevent and minimize side effects in transplanted recipients.

O isolamento social para prevenção da Covid-19 pode aumentar o risco de queimaduras no domicílio / Social isolation for prevention of Covid-19 may increase the risk of Burns at household

Resumo Introdução Durante a pandemia de Covid-19, o uso do álcool a 70° GL foi amplamente recomendado para a higienização das mãos e superfícies. Acoplada à maior permanência das pessoas dentro do domicílio, essa recomendação pode contribuir para o aumento do risco de queimaduras. Objetivo Delinear os riscos de queimaduras no contexto da pandemia. Método Revisão por meio de análise documental. Resultados O álcool líquido 70° GL e o álcool isopropílico 70° GL são substâncias que apresentam maior risco de ignição no uso e armazenamento. O álcool 70° GL em gel deve ser priorizado tanto pela maior facilidade de uso para antissepsia das mãos como pelo menor risco de inflamabilidade. Esses materiais não devem ser manuseados durante o preparo de alimentos. Conclusão As autoridades sanitárias e governamentais devem se responsabilizar pela divulgação dos cuidados necessários para prevenção de queimaduras e incêndios no contexto da pandemia.

Abstract Background During the Covid-19 pandemic, the use of alcohol at 70° GL was widely recommended for hand and surface hygiene. Combined with greater permanency of individuals in the household, this recommendation may contribute to an increased risk of burns. Objective To outline the risks of burns in the context of the pandemic. Method A review through document analysis was carried out. Results Liquid alcohol 70° GL and isopropyl alcohol 70° GL are substances that present a greater risk of ignition during use and storage. Alcohol 70° GL in gel should be prioritized both for its greater easier of use for hand antisepsis and for its lower risk of flammability. These materials must not be handled during food preparation. Conclusion Health and government authorities must be responsible for disseminating the necessary care to prevent burns and fires in the context of the pandemic.

Transplante de células-tronco hematopoiéticas: iniquidades na distribuição em território brasileiro, 2001 a 2020 / Hematopoietic stem-cell transplants in Brazil: inequities in the distribution in Brazilian territory, 2001 to 2020

Resumo O objetivo deste artigo é descrever a distribuição de Centros Transplantadores (CTs) e transplantes de células-tronco hematopoiéticas (TCTH) no território brasileiro. Estudo descritivo, que reúne informações sobre a distribuição CTs e o número de procedimentos realizados entre 2001 e 2020, a partir das fontes dos dados: Sociedade Brasileira de Terapia celular e Transplantes de Medula Óssea (SBTMO); Associação Brasileira de Transplante de Órgãos (ABTO); Sistema de Informações Hospitalares do Sistema Único de Saúde (SIH/SUS); e Ministério da Saúde (MS). Foram identificados 86 CTs, com predominância na região Sudeste do país (64%). A região Norte não possui CTs. No período contabilizaram-se mais de 30 mil procedimentos, concentrados nas regiões Sudeste e Sul. O TCTH do tipo alogênico foi prevalente. Constataram-se divergências entre os números de transplantes realizados a depender da fonte consultada. Apesar do crescimento do número de procedimentos no período do estudo, tanto a distribuição de CTs quanto o número de TCTHs se concentrou em regiões mais desenvolvidas. Essa heterogeneidade pode ter propiciado iniquidades no acesso ao tratamento pela população.

Abstract The scope of this article is to describe the distribution of Transplant Centers (TCs) and hematopoietic stem-cell transplants (HSCTs) in the Brazilian territory. It is a descriptive study, which brings together information on the distribution of TCs and the number of procedures performed between 2001 and 2020, based on the following data sources: the Brazilian Cell Therapy and Bone Marrow Transplant Society of (SBTMO); the Brazilian Organ Transplant Association (ABTO); the Hospital Information System of the Unified Health System (SIH/SUS); and the Ministry of Health (MS). A total of 86 TCs were identified, predominantly in the Southeastern region of the country (64%). There are no TCs in the Northern region. Throughout the period, there were more than 30,000 procedures, concentrated in the Southeastern and Southern regions. The allogeneic type of HSCT was prevalent. Differences were found between the numbers of transplants performed depending on the source consulted. Despite the increase in the number of procedures during the period studied, both the distribution of TCs and the number of HSCTs were concentrated in more developed regions. This heterogeneity may have led to inequities in the access of the population to treatment.

[Hematopoietic stem-cell transplants in Brazil: inequities in the distribution in Brazilian territory, 2001 to 2020]. / Transplante de células-tronco hematopoiéticas: iniquidades na distribuição em território brasileiro, 2001 a 2020.

The scope of this article is to describe the distribution of Transplant Centers (TCs) and hematopoietic stem-cell transplants (HSCTs) in the Brazilian territory. It is a descriptive study, which brings together information on the distribution of TCs and the number of procedures performed between 2001 and 2020, based on the following data sources: the Brazilian Cell Therapy and Bone Marrow Transplant Society of (SBTMO); the Brazilian Organ Transplant Association (ABTO); the Hospital Information System of the Unified Health System (SIH/SUS); and the Ministry of Health (MS). A total of 86 TCs were identified, predominantly in the Southeastern region of the country (64%). There are no TCs in the Northern region. Throughout the period, there were more than 30,000 procedures, concentrated in the Southeastern and Southern regions. The allogeneic type of HSCT was prevalent. Differences were found between the numbers of transplants performed depending on the source consulted. Despite the increase in the number of procedures during the period studied, both the distribution of TCs and the number of HSCTs were concentrated in more developed regions. This heterogeneity may have led to inequities in the access of the population to treatment.

O objetivo deste artigo é descrever a distribuição de Centros Transplantadores (CTs) e transplantes de células-tronco hematopoiéticas (TCTH) no território brasileiro. Estudo descritivo, que reúne informações sobre a distribuição CTs e o número de procedimentos realizados entre 2001 e 2020, a partir das fontes dos dados: Sociedade Brasileira de Terapia celular e Transplantes de Medula Óssea (SBTMO); Associação Brasileira de Transplante de Órgãos (ABTO); Sistema de Informações Hospitalares do Sistema Único de Saúde (SIH/SUS); e Ministério da Saúde (MS). Foram identificados 86 CTs, com predominância na região Sudeste do país (64%). A região Norte não possui CTs. No período contabilizaram-se mais de 30 mil procedimentos, concentrados nas regiões Sudeste e Sul. O TCTH do tipo alogênico foi prevalente. Constataram-se divergências entre os números de transplantes realizados a depender da fonte consultada. Apesar do crescimento do número de procedimentos no período do estudo, tanto a distribuição de CTs quanto o número de TCTHs se concentrou em regiões mais desenvolvidas. Essa heterogeneidade pode ter propiciado iniquidades no acesso ao tratamento pela população.

Validation of a computerized decision support system to review pharmacotherapy treatment: scheduling guidelines.

BACKGROUND: The review of pharmacotherapy can be conceptualized as a service in which the drugs used by the patient are reviewed to control the risks as well as to improve the results of the drug therapy, detecting, solving, and preventing issues associated with the drug, readjusting the doses and times (schedule) so that the treatment is not incompatible or in duplicity. METHODS: The aim of the study was to validate an intelligent information system, which was developed to assist the scheduling activity in the pharmacotherapy review. The system used the concept of Genetic Algorithms. To validate the system, hypothetical cases were elaborated considering various aspects of pharmacotherapy such as underdose, overdose, drug interactions and contraindications. These cases were tested in the system and were also analyzed by pharmaceutical experts with clinical and research experience in the pharmacotherapy review process. The degree of agreement between the assessments of the appointments carried out by the pharmaceutical specialists and by the system were measured using the Kappa index with a 95% confidence interval. RESULTS: In detecting errors and make propositions, the system was able to identify 80% of errors, with pharmaceutical experts identifying between 20 and 70% of errors. In relation the results of kappa between the cases, the system had 87,3% of concordance, whereas the best pharmaceutical expert had 75,5% of concordance, considering the correct answer. CONCLUSION: It can be concluded that with the methodology used, the investigation met the objectives and confirmed the system is effective for pharmaceutical review process. There are indications that the system can help in the Pharmacotherapy review process, being able to find prescription errors as well as to establish times for the use of medications according to the patient's routine.

Dispensing of psychotropic drugs in the Brazilian capital city before and during the COVID-19 pandemic (2018-2020).

Objective: Evaluate the data on the psychotropic drugs dispensed by private community pharmacies before and during the SARS-CoV-2 pandemic. Methods: This cross-sectional study compared the quarterly and annual consumption of psychotropic drugs per Defined Daily Dose per 1000 inhabitants-day (DHD). Interrupted time series were also constructed to expose changes in the consumption pattern in the periods before and after March 2020. Results: Among the 20 most consumed psychoactive drugs, 12 were antidepressants, for example, escitalopram (DHD 7.996 and 10.626; p < 0.001), and sertraline (DHD 6.321 and 8.484; p < 0.001), in addition to the hypnotic zolpidem (DHD 6.202 and 8.526; p < 0.001). The time series reveals (R 2 value) a variation in drug dispensing, in DHD values, during the pandemic. Conclusion: Despite the higher variance, a significant increase is clearly seen in the consumption trends of psychoactive drugs, particularly antidepressants, consistent with the pandemic's influence on the general population's mental health.

Evaluation of pharmaceutical care in Brazilian primary health services settings: expanding objects and approaches

Abstract The objective of this work is to reflect on the objects and approaches usually employed in the evaluation of pharmaceutical care and their potential applicability in primary care settings. We conducted the review of the literature, and, to exemplify the advantages of expanding these objects and approaches, a real-world problem situation was selected: morbidity and mortality related to lack of treatment adherence by hypertensive patients in Brazilian primary health care services. Our reflections highlight the need to evaluate the effects of interventions, understood within Donabedian's normative model as 'outcomes,' which can be clinical, humanistic, or economic. Our findings show that most published studies, even those that set out to report outcomes, actually evaluate processes, such as number of visits, number of problems identified, types of problems, or acts of the practice performed by pharmacists. On the other hand, we also identify a need for study designs and indicators to enable 'finer' normative assessment. We also discuss the importance of shifting research toward an evaluative paradigm to allow strategic, logic, effects, production, efficiency, and implementation analyses. Finally, we suggest some possible indicators to evaluate pharmaceutical care interventions in the selected problem situation, through an extension of the objects and approaches proposed.

Percepções e uso do metilfenidato entre universitários da área da Saúde em Ceilândia, DF, Brasil / Perceptions and use of methylphenidate among health students in Ceilândia, DF, Brazil / Percepciones y uso del metilfenidato entre universitarios del área de la salud en Ceilândia, Distrito Federal - DF, Brasil

As percepções e o uso de metilfenidato entre universitários foram investigados em estudo descritivo realizado em duas etapas. A primeira, quantitativa, foi realizada por meio do preenchimento de um questionário semiestruturado on-line. Para a segunda etapa, qualitativa, foi realizado um grupo focal. Dos 337 participantes da primeira etapa, 14,5% relataram usar o metilfenidato. Entre os usuários, a prevalência de uso sem prescrição foi maior para o sexo masculino (65,3%), após ingresso na faculdade (57,1%), e 61,2% relataram eventos adversos. O principal motivo de uso foi o doping intelectual (65,3%). Já na etapa qualitativa, além de reforçar os achados anteriores, foram identificados tópicos temáticos como a pressão externa exercida por familiares, sociedade e a rotina universitária. Esses achados apontam para a necessidade de medidas de apoio e orientação aos universitários e de reformulação do processo ensino-aprendizagem.(AU)

This descriptive study investigated the use and perceptions of methylphenidate among university students. The study was conducted in two stages. In the first stage (quantitative), the students completed an online semi-structured questionnaire. The second stage (qualitative) consisted of focus group discussions. Of the 337 participants in the first stage, 14.5% reported using methylphenidate. The prevalence of methylphenidate use without a prescription was greater among men (65.3%) and after starting university (57.1%); 61.2% of the students reported adverse events. The main reason for using the drug was intellectual doping (65.3%). In the qualitative stage, which reinforced the findings of the quantitative stage, we identified themes such as external pressure from family, society and university routine. The findings underline the need to provide student support and advice and reformulate the teaching and learning process.(AU)

Se investigaron las percepciones y el uso del metilfenidato entre universitarios, en un estudio descriptivo realizado en dos etapas. La primera, cuantitativa, se realizó por medio del llenado de un cuestionario semiestructurado online. Para la segunda etapa, cualitativa, se realizó un grupo focal. De los 337 participantes de la primera etapa, el 14,5% relató que usaba metilfenidato. Entre los usuarios, la prevalencia de uso sin prescripción fue mayor para el sexo masculino (65,3%), después del ingreso en la facultad (57,1%) y el 61,2% relataron eventos adversos. El principal motivo de uso fue el dopping intelectual (65,3%). En la etapa cualitativa, además de reforzar los hallazgos anteriores, se identificaron tópicos temáticos tales como la presión externa ejercida por los familiares, la sociedad y la rutina universitaria. Esos hallazgos señalan la necesidad de medidas de apoyo y orientación a los universitarios y de reformulación del proceso enseñanza-aprendizaje.(AU)

A Qualitative Study on Noncommunicable Diseases in Waste Pickers in Brazil.

BACKGROUND: Noncommunicable chronic diseases are associated with multiple risks factors and negative outcomes that are long-lasting and difficult to treat. Some populations may be at greater risk because of their socioeconomic status, lack of healthcare, environment, and poor work and living conditions. Informal waste pickers may experience higher levels of chronic diseases and often do not have access to care to manage symptoms. OBJECTIVES: The aim of the present study was to understand the prevalence of chronic diseases in waste pickers, along with perceived associated risks and available treatments. METHODS: A qualitative study was conducted, using interviews with 24 waste pickers who worked at Estrutural dumpsite in Brasilia, Brazil which was historically the second largest open-air dumpsite in the world. RESULTS: Participants believed their commonly experienced chronic diseases were a result of working in the open-air dumpsite. Chronic diseases commonly noted in the interviews included hypertension, chronic pain, respiratory disease, diabetes, and kidney problems. Participants discussed self-medication or prescribed medication used to treat their conditions. Most participants had varying beliefs regarding prevention strategies to reduce disease; some ideas for prevention focused on religion, fate, and God when discussing outcomes related to illnesses. When answering questions regarding ideal working conditions to help prevent diseases, participants responded by expressing a desire for protective gear (e.g. PPE) which could help mitigate hazards associated with the dump. CONCLUSIONS: Recyclable collectors were aware of occupational hazards to which they were exposed and associated noncommunicable chronic diseases but lacked education on the importance of preventive measures and access to healthcare services. The findings of the present study confirm the need to strengthen intersectoral actions to protect and uphold the health rights of this vulnerable population. PARTICIPANT CONSENT: Obtained. ETHICS APPROVAL: This study was approved by the Research and Ethics Committee of the Health School of Brasília University under Opinion n. 1.517.670/2016. COMPETING INTERESTS: The authors declare no competing financial interests.

The Costs of Burn Victim Hospital Care around the World: A Systematic Review.

BACKGROUND: Burn injuries are very common and fire-related burns account for over 300,000 deaths per year globally. The costs of the treatment of these patients change around the world. The aim of the present study was to conduct a systematic literature review to identify the costs related to hospital stays of burn victims in countries with different Human Development Index (HDIs). METHODS: PubMed, CINAHL and BVIS databases were searched using the following terms: "burn," treatment" and "costs". The review included articles that presented cost studies or economic assessments of burn victims in which the costs were reported, and published between 2012 and 2019. The quality of the evidence was assessed using the Consensus on Health Economic Criteria. This review presents register in Prospero (CRD42019137580). RESULTS: The review included 19 economic studies conducted in 13 countries, most with a very high HDIs. Most studies estimated direct acute burn care costs through bottom-up costing and institutional data. Total hospital care costs ranged from US$ 10.58 to US$ 125,597.86 per patient, the cost of 1% of total body surface area burned ranged from US$ 2.65 to US$ 11,245.04, and the cost of hospital care per day, from US$ 24.23 to US$ 4,125.50. CONCLUSION: The costs are high and show wide discrepancies among countries. Medical costs and other losses caused by fatal and non-fatal burn injuries differ considerably among demographic groups, care protocols, and country HDIs.

A framework for action to improve patient and public involvement in health technology assessment.

BACKGROUND: Patient and public involvement (PPI) in the Brazilian Health Technology Assessment (HTA) process occurs in response to a legislative mandate for "social participation." This resulted in some limited patient participation activities, and, therefore, a more systematic approach was needed. The study describes the development of a suggested framework for action to improve PPI in HTA. METHODS: This work used formal methodology to develop a PPI framework based on three-phase mixed-methods research with desktop review of Brazilian PPI activities in HTA; workshop, survey, and interviews with Brazilian stakeholders; and a rapid review of international practices to enact effective patient involvement. Patient partners reviewed the draft framework. RESULTS: According to patient group representatives, their involvement in the Brazilian HTA process is important but could be improved. Different stakeholders perceived barriers, identified values, and made suggestions for improvement, such as expansion of communication, capacity building, and transparency, to support more meaningful patient involvement. The international practices identified opportunities for earlier, more active, and collaborative PPI during all HTA stages, based on values and principles that are relevant for Brazilian patients and the public. These findings were synthesized to design a framework that defines and systematizes actions to support PPI in Brazil, highlighting the importance of evaluating these strategies. CONCLUSIONS: Since the publication of this framework, some of its suggestions are being implemented in the Brazilian HTA process to improve PPI. We encourage other HTA organizations to consider a systematic and planned approach with regular evaluation when pursuing or strengthening involvement practices.

Incidencia y factores asociados a sepsis en victimas quemadas internadas en un hospital brasileño / Incidence and factors associated with sepsis in burned victims admitted to a Brazilian hospital

OBJETIVO: Conocer la incidencia de sepsis y los factores asociados en las víctimas de quemaduras. MÉTODO: Estudio retrospectivo, en que el diagnóstico de sepsis fue confirmado por los criterios de definición de sepsis de la Asociación Americana de Quemaduras. Se investigó la asociación entre sepsis y las características del paciente, las quemaduras y el tiempo de hospitalización. RESULTADOS: La incidencia de sepsis fue 14,5% (n=27) de los pacientes y 77,7% (n=21) evolucionaron para alta hospitalaria. La incidencia de sepsis fue asociada con el porcentaje de superficie corporal quemada mayor que 10% (p<0,001) y una estadía hospitalaria mayor que 10 días (p<0,001). La mortalidad fue mayor en pacientes con sepsis (p=0,002). Hubo un cambio en la frecuencia de prescripción de antimicrobianos con el diagnóstico de sepsis, algunos foram prescritos solamente antes (ciprofloxacina, cefalotina, ceftriaxona, amoxicilina y gentamicina) y otros solamente durante el episodio de sepsis (tigeciclina, piperacilina y tazobactam, fluconazol y linezolida). CONCLUSIÓN: La incidencia de sepsis fue baja y está asociada con muerte. Se identifico que, el porcentaje de superficie corporal quemada y la duración de la estadía hospitalaria, están significativamente asociados con la incidencia de sepsis. La sepsis cambió el perfil del uso de antimicrobianos.

OBJECTIVE: To assess the incidence of sepsis and factors associated with casualties of burns. METHODS: This is a retrospective study, in which the diagnosis of sepsis was confirmed by the criteria for definition of sepsis of the American Association of Burns. If we investigate the association between sepsis and patient characteristics, burns and hospitalization time. RESULTS: The incidence of sepsis was 14.5% (n=27) of patients and 77.7% (n=21) evolved to hospital discharge. The incidence of sepsis was associated with a body surface area percentage greater than 10% (p<0.001) and a greater state than 10 days (p <0.001). Mortality was higher in patients with sepsis (p=0.002). There was the change of antimicrobial profile. Same medicines was used only before the diagnosis (ciprofloxacin, cephalothin, ceftriaxone, amoxicillin and gentamicin) and other only after the sepsis diagnosis (tigecycline, piperacillin and tazobactam, fluconazol and linezolida). CONCLUSION: The incidence of sepsis is low and is associated with the disease. It has been found that the percentage of body surface burned and the length of hospital stay is significantly associated with the incidence of sepsis. The sepsis causes the change of antimicrobial use profile.

Percepções de atores sociais sobre Assistência Farmacêutica na atenção primária: a lacuna do cuidado farmacêutico / Perceptions of social actors on Pharmaceutical Assistance in primary care: the gap of pharmaceutical care

RESUMO O objetivo deste trabalho foi identificar marcos históricos relacionados com a Assistência Farmacêutica na atenção primária e compreender as percepções de atores envolvidos no processo de inclusão do cuidado farmacêutico. Trata-se de estudo exploratório qualitativo realizado por meio da análise de documentos e de entrevistas semiestruturadas com atores envolvidos na gestão nacional e distrital. Os documentos identificados demonstram evolução da inclusão do farmacêutico no processo de cuidado na atenção primária pela publicação de legislações, relatórios ou projetos. Os discursos foram divididos em categorias de análise, a partir das quais também foram elaboradas 'nuvens de palavras'. Os entrevistados concordaram que a Assistência Farmacêutica não está sendo corretamente avaliada e destacaram que é preciso maior enfoque na mensuração do alcance dos processos desenvolvidos nos serviços ofertados e na qualidade de vida dos usuários.

ABSTRACT The objective of this work was to identify historical landmarks related to Pharmaceutical Assistance in primary care and to understand the perceptions of actors involved in the process of including pharmaceutical care. This is a qualitative exploratory study carried out through the analysis of documents and semi-structured interviews with actors involved in national and district management. The documents an evolution towards the inclusion of the pharmacist in the primary care process by means of laws, reports or projects publication. The speeches were divided into categories of analysis, from which 'word clouds' were also elaborated. Respondents agreed that pharmaceutical care is not being properly evaluated and stressed that greater focus is needed on measuring the scope of the processes developed in the services offered for the users' quality of life.

Solid organ transplantation in Brazil: a descriptive study of distribution and access inequalities across the Brazilian territory, 2001-2017. / Transplantes de órgãos sólidos no Brasil: estudo descritivo sobre desigualdades na distribuição e acesso no território brasileiro, 2001-2017.

OBJECTIVE: to describe the distribution of solid organ transplants in Brazil, as well as information about the waiting list (demand) and origin of transplant patients by organ type and Federative Unit, from 2001 to 2017. METHODS: this was a descriptive study using data from State Transplantation Centers, the Brazilian Organ Transplant Association, and the Brazilian National Health System Hospital Information System (SIH/SUS). RESULTS: 153 transplant units were identified in 2017, with only 11.8% located in the Northern and Midwest regions; within the study period, 99,805 transplants were performed, ranging from 3,520 (2001) to 8,669 (2017); the highest number of transplants was concentrated in the Southern and Southeastern regions. CONCLUSION: there are inequalities in transplantation access, possibly due to lack of uniformity in service distribution.

Transplantes de órgãos sólidos no Brasil: estudo descritivo sobre desigualdades na distribuição e acesso no território brasileiro, 2001-2017 / Trasplantes de órganos sólidos en Brasil: estudio descriptivo sobre desigualdades en la distribución y acceso en el territorio brasileño, 2001-2017 / Solid organ transplantation in Brazil: a descriptive study of distribution and access inequalities across the Brazilian territory, 2001-2017

Objetivo: descrever a distribuição dos transplantes de órgãos sólidos no Brasil, bem como informações da lista de espera (demanda) e origem dos pacientes transplantados, por tipo de órgão e Unidade da Federação, de 2001 a 2017. Métodos: estudo descritivo, com dados das Centrais Estaduais de Transplantes, da Associação Brasileira de Transplantes de Órgãos e do Sistema de Informações Hospitalares do Sistema Único de Saúde (SIH/SUS). Resultados: 153 centros de transplante foram identificados em 2017, apenas 11,8% deles localizados nas regiões Norte e Centro-Oeste; no período em estudo, foram realizados 99.805 transplantes, variando de 3.520 (2001) a 8.669 (2017); as regiões Sul e Sudeste concentraram o maior número de transplantes. Conclusão: existem desigualdades regionais na realização dos transplantes, possivelmente por não haver uniformidade na distribuição dos serviços.

Objetivo: describir la distribución de los trasplantes de órganos sólidos en Brasil, así como informaciones de la lista de espera (demanda) y origen de los pacientes trasplantados por tipo de órgano y unidad federativa, entre 2001 y 2017. Métodos: estudio descriptivo usando datos extraídos de Centrales Estatales de Trasplantes, Asociación Brasileña de Trasplantes de Órganos y Sistema de Informaciones Hospitalarias del Sistema Único Nacional de Salud (SIH/SUS). Resultados: 153 centros de trasplante identificados en 2017, solamente 11,8% están ubicados en las regiones Norte y Centro-Oeste; se realizaron 99.805 trasplantes, desde 3.520 (2001) hasta 8.669 (2017); Sur y Sudeste concentran el mayor número de trasplantes. Conclusión: hay desigualdad en el acceso a los trasplantes, posiblemente debido a la falta de uniformidad en la distribución de los servicios.

Objective: to describe the distribution of solid organ transplants in Brazil, as well as information about the waiting list (demand) and origin of transplant patients by organ type and Federative Unit, from 2001 to 2017. Methods: this was a descriptive study using data from State Transplantation Centers, the Brazilian Organ Transplant Association, and the Brazilian National Health System Hospital Information System (SIH/SUS). Results: 153 transplant units were identified in 2017, with only 11.8% located in the Northern and Midwest regions; within the study period, 99,805 transplants were performed, ranging from 3,520 (2001) to 8,669 (2017); the highest number of transplants was concentrated in the Southern and Southeastern regions. Conclusion: there are inequalities in transplantation access, possibly due to lack of uniformity in service distribution.

Social participation in the health technology incorporation process into Unified Health System.

OBJECTIVE: To describe the current process of social participation in the incorporation of health technologies in Brazil, within the context of the Unified Health System (SUS). METHODS: A descriptive study was conducted based on the analysis of official records of the actions of the National Committee for Health Technology Incorporation into Unified Health System and its website, from the beginning of its activities in January 2012 until December 2017. RESULTS: The findings indicate that, in Brazil, there are legal instruments related to social participation in health, including the health technology assessment (HTA) field. However, its implementation is relatively recent and has been carried out gradually. In addition to the legal instruments (National Health Council representative, public consultation and public hearing forecast), other information and transparency strategies have been shown to be allied to social participation in the incorporation of health technologies. However, activities such as legally provided public hearings have not yet been carried out. CONCLUSIONS: Several actions to foster social participation were developed over the analyzed period, but they need to be evaluated in order to maintain or improve them. In addition, there is a need for more qualified social participation in the various existing spaces, including those prescribed by law.