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.

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.

Health conditions and occupational risks in a novel group: waste pickers in the largest open garbage dump in Latin America.

BACKGROUND: The inadequate management of solid waste impacts populations' health and quality of life, and disproportionately affects developing countries. This study aims to describe a protocol for epidemiological diagnosis, the purpose being to estimate the prevalence of chronic and communicable and non communicable diseases in waste pickers, and the occupational and environmental risk factors to which these are exposed. METHODS: This is a cross-sectional study, based on survey design in an area of extreme social vulnerability - the largest garbage dump in Latin America. Using a multidimensional research protocol, divided in three stages: 1- The identification of the subjects, and the scheduling of tests; 2- Situational diagnosis through interviews, anthropometric evaluation, measuring blood pressure, collecting hair and nail samples to detect exposure to heavy metals and undertaking laboratory tests; 3- The return of the waste pickers to receive the test results, followed by referral to the health team and to report occupational accidents. RESULTS: One thousand twenty-five waste pickers undertook tests and interviews. The majority were women (67.0%), with 36-45 years old (45.7%), and 96.0% had children. In total, 27.3% of the participants did not attend to any school and 47.7% were educated only up to primary level. The majority of waste pickers (68.70%) reported accidents and most of them (89.69%) were related to sharp objects. The mean time working in this open dump was 15 years. According the anthropometric measure, 32.6% were overweight and 21.1% were obese. The most common reported diseases were: osteomuscular disorders (78.7%); arboviruses (28.6%); episodic diarrhea (24.9%); hypertension (24.2%); bronchitis (14.3%); intestinal worms (12.6%) and diabetes (10.1%). According to the blood tests, the values outside the reference limits were: Uric acid (23.89%); creatinine (54.06%); GGT range (16.04%); SGOT - Serum Glutamic Oxaloacetic Transaminase (5.29%); SGPT - serum Glutamic-Pyruvic Transaminase (35.52%). CONCLUSIONS: This study is the first to evaluate multiple risks and diseases in the majority of waste pickers working in the largest garbage dump of a continent. These findings highlight the importance to address urgently the environmental, social and health impacts related to the management of solid waste in developmental countries to protect these workers and their families.

[Human papillomavirus vaccine receptivity: a systematic reviewReceptividad con respecto a la vacuna contra el virus del papiloma humano: revisión sistemática]. / Receptividade à vacina contra o papilomavírus humano: uma revisão sistemática.

OBJECTIVE: To characterize the receptivity to human papillomavirus (HPV) vaccine and to describe factors that hinder or facilitate receptivity. METHOD: A systematic review was performed based on the 2015 PRISMA protocol. MEDLINE and Web of Science were searched using combinations of the terms papillomavirus, vaccine, adherence, and acceptance to identify articles published from 2006 to 2017. Original articles published in any language were included, and duplicate articles were excluded. Information was collected regarding article identification, methodological design, sample characteristics, and description of contents. Receptivity was characterized in terms of acceptance and adherence. RESULTS: Of 212 articles identified, 10 were selected for analysis. Most showed favorable, but heterogeneous, receptivity, with more acceptance than adherence, especially on the part of female adolescents. The analysis identified 11 facilitators and nine barriers to receptivity, especially knowledge of the theme and individual pattern of behavior regarding the problem. The analysis also detected the absence of a standardized method to evaluate receptivity and the imprecision of the concepts associated with acceptance and adherence. Therefore, a definition was proposed for acceptance (voluntary intention of receiving the vaccine or agreement that the vaccine is a good prevention strategy) and adherence (initiation and completion of the vaccination scheme). CONCLUSIONS: Additional studies are required to further investigate predictors of receptivity. For that, the development of an instrument based on the perceptions of target publics and employing precise concepts of acceptance and adherence is recommended, so as to allow a better understanding of the phenomenon and stimulate adherence and the achievement of adequate vaccine coverage.

OBJETIVO: Caracterizar la receptividad con respecto a la vacuna contra el virus del papiloma humano (VPH) y describir los factores inhibidores o facilitadores correspondientes. MÉTODOS: Se trata de una revisión sistemática según el protocolo PRISMA 2015. Se consultaron las bases de datos MEDLINE y Web of Science, utilizando combinaciones de los términos "papilomavirus", "vaccine" [vacuna], "adherence" [adhesión] y "acceptance" [aceptación] para encontrar artículos publicados desde el 2006 hasta el 2017. Se incluyeron artículos originales en cualquier idioma y se excluyeron los artículos duplicados. Se analizaron la identificación del artículo, la tipificación metodológica y las características de la muestra. La receptividad se caracterizó en términos de aceptación y adhesión. RESULTADOS: Se encontraron 212 artículos de los cuales se seleccionaron 10 para el análisis. En la mayoría de los estudios se demostró una receptividad favorable, pero heterogénea, con mayor aceptación que adhesión, principalmente por parte de adolescentes del sexo femenino. Se identificaron once factores facilitadores y nueve inhibidores de la receptividad, entre los cuales se destacan el conocimiento del tema y el patrón de comportamiento individual frente al problema. Se observó que faltaba un método normalizado que permitiera evaluar la receptividad y la imprecisión de los conceptos relacionados con la aceptación y la adhesión. Por lo tanto, se propuso una definición de aceptación (intención voluntaria de recibir una vacuna o expresión de acuerdo de que la vacuna representa una buena estrategia preventiva) y adhesión (acto de iniciar y finalizar el esquema de vacunación). CONCLUSIONES: Se necesitan nuevos estudios para profundizar el análisis de los factores de predicción de la receptividad. Para ello, se sugiere la creación de un instrumento basado en la percepción del público destinatario y el empleo de conceptos precisos de aceptación y adhesión, con el fin poder comprender mejor el fenómeno y fomentar la adhesión y el logro de tasas adecuadas de cobertura con la vacuna.

Factors associated with hepatitis C seropositivity in people living with HIV.

OBJECTIVE: To identify risk factors associated with hepatitis C virus (HCV) seropositivity in human immunodeficiency virus (HIV)-infected patients. METHODS: A paired case-control study adjusted by age and gender was conducted. It included adults coinfected with HIV and HCV (cases) and HIV mono-infected subjects (controls) using non-probability sampling. Data were collected through interviews and review of medical records. The chi-square test was used for comparing categorical variables and the Student's t-test or Wilcoxon (Mann-Whitney U) test for continuous variables. Confidence intervals (95%) were estimated along with crude and adjusted odds ratios using conditional logistic regression. RESULTS: A total of 165 patients were surveyed, including 55 cases and 110 controls. The mean age was 43.6 ± 8.4 years, ranging from 19 to 64 years; 70.9% were male. Independent risk factors for HIV/HCV coinfection were education (up to eight years of schooling); age at first intercourse < 15 years; having undergone tattooing; blood transfusion; and use of injecting drugs. CONCLUSIONS: Low level of education, early age at first sexual intercourse, tattooing, blood transfusions, and sharing needles and other drug injection equipment were factors that increased the risk of HIV/HCV coinfection. The results from this research can be compared with similar data from other regions to help direct preventive and educational efforts targeting people living with HIV.

[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.

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.

[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.

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 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.

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.

Vinte anos da publicação da regulamentação de preços de medicamentos no Brasil: momento de atualizar? / Twenty years since the publication of medication price regulation in Brazil: time to update? / Veinte años desde la publicación de la regulación de precios de medicamentos en Brasil: ¿es hora de actualizarla?

Resumo: 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.

Abstract: 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.

Resumen: 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.

Horizon scanning in Brazil: outputs and repercussions.

OBJECTIVE: To describe the four types of horizon scanning (HS) outputs developed by the National Committee for Health Technology Incorporation (CONITEC) and show their main repercussions on the decision-making processes of the Brazilian Ministry of Health (MH). METHODS: Descriptive study based on participant observation and document analysis of HS outputs (internal reports, alert reports, briefs and sections for CONITEC recommendation reports) developed between January 2014 and July 2018. RESULTS: Fifteen internal reports, six alert reports, two briefs and 57 HS sections were produced. Each output has a specific structure according to its purpose. The methodological approach adopted for developing HS outputs in Brazil is described by EuroScan International Network. The outputs had institutional and international repercussions. The activities resulted in the inclusion of HS as a tool for reducing health lawsuits in the legal framework of the MH. One of the internal reports on a high-cost drug not approved in Brazil for a rare disease was requested by the Health Technology Assessments Network for the Americas (RedETSA), showing the international relevance of the outputs. The HS sections in recommendation reports influenced discussions about incorporating technologies into the Unified Health System. CONCLUSIONS: The developed outputs have purposes ranging from helping build arguments for defense of the MH in cases of health judicialization to inform decision-making processes. In addition, HS sections in recommendation reports have grown in importance recently. CONITEC's HS system has been structured, and its role as a tool to inform health managers has shown to be been relevant.

Burns in the Brazilian Unified Health System: a review of hospitalization from 2008 to 2017.

BACKGROUND: Burns are a public health problem, especially in vulnerable populations. The costs of treatment remain poorly studied in developing countries. This study aimed to evaluate the incidence of burn admissions in the Brazilian public health care system between 2008 and 2017. METHODS: This study used publicly available data from hospital information and mortality systems. We investigated information as sex, age, length of stay, admission costs (reimbursement), and mortality. RESULTS: There were 170,554 admissions and most patients were male. Annual admission rates were between 1.32 and 1.87 for children aged ≤ nine years and between 0.58 and 0.71 for adults aged ≥ 60 years, per 10,000 population. Overall cost was US $158,332,891.11 (R$614,537,450.29). In-hospital mortality was 3.56%. CONCLUSION: Admissions showed a downward trend, while mortality remained stable and demanded substantial resources.

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.

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.

Continued Medical Waste Exposure of Recyclable Collectors Despite Dumpsite Closures in Brazil.

BACKGROUND: Brasilia, the capital of Brazil, currently has the largest dumpsite of the Americas at Estrutural, with over 30 million tons of waste accumulated. Recyclable waste collectors are a group of workers who, in addition to having a low socioeconomic status and residing in vulnerable areas, work sorting garbage in inadequate and unsanitary areas. This profession puts individuals at risk, resulting in death, mutilation, and disease for workers. OBJECTIVES: The aim of this study was to understand the effects of waste on recyclable collectors, along with their perceptions of associated risks. METHODS: A qualitative study was conducted, using interviews with 34 participants at Estrutural. RESULTS: Collectors were exposed to several hazards, including biological, physical, and more extreme hazards (e.g. being run over by waste trucks). Personal protective equipment was not adequately used, exposing recyclable collectors to injury. Accidents included cuts, burns, skin lesions, eyes lesions, and arm, leg, head, feet, and hand injuries and amputations. Often, homecare remedies and collected medical waste (e.g. pain killers) were used on these injuries instead of seeking out proper medical care. CONCLUSIONS: Recyclable collectors were aware of occupational hazards, but lacked education on the risks and consequences associated with exposure to medical hazards. Moreover, Brazil recently formally closed all dumpsites, complicating this issue. The findings of the present study confirm the need to address these hazards to provide a safe working environment for waste pickers. 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.

USE OF DRUGS IN CHILDREN AGED ZERO TO FIVE YEARS OLD IN TUBARÃO, SANTA CATARINA, BRAZIL. / USO DE MEDICAMENTOS EM CRIANÇAS DE ZERO A CINCO ANOS DE IDADE RESIDENTES NO MUNICÍPIO DE TUBARÃO, SANTA CATARINA.

OBJECTIVE: To analyze the context of drug use in children aged zero to five years old. METHODS: Cross-sectional study based on interviews conducted at home with caregivers (parents, uncles or grandparents) of the children enrolled in ten Family Health Strategy units across different geographical points of the city of Tubarão, Santa Catarina, Brazil. RESULTS: A total of 350 caregivers were interviewed, whose children's mean age was 2.6 years. Of these, 56.9% had used at least one drug in the 15 days prior to the interview, 31.1% had been exposed to self-medication and 35.7% had used at least one medication obtained by current prescription. The use of medication was associated with the age range up to 24 months, periodic consultation with pediatricians and diagnosis of chronic and acute diseases. Among medicated children, 19.1% inappropriately had been exposed to at least one medication (considering dose, dose interval or period of treatment). Regarding medication storage, 55.2% of interviewees stored them in unsafe places that could be accessed by children and 32.0% in inappropriate places, with exposure to light, heat or humidity. Moreover, 45.2% of the interviewees stored drugs out of their packages, 38.9% without secondary packaging, and 1.6% of drugs had expired date. CONCLUSIONS: Drug use is high among children in this age range, and actions aimed at the safe and rational use of these substances in this population should be encouraged.

OBJETIVO: Analisar o perfil de utilização de medicamentos em crianças de zero a cinco anos de idade. MÉTODOS: Estudo transversal baseado em entrevistas realizadas em domicílio com cuidadores (pais, tios ou avós) das crianças cadastradas em dez unidades de Estratégia Saúde da Família (ESF), distribuídas em diferentes pontos geográficos do município de Tubarão, Santa Catarina. RESULTADOS: Foram entrevistados 350 cuidadores, cujas crianças sorteadas possuíam, em média, 2,6 anos de idade. Destas, 56,9% utilizaram, pelo menos, um medicamento nos 15 dias anteriores à entrevista, sendo que 31,1% foram expostas à automedicação e 35,7% utilizaram, pelo menos, um medicamento obtido por prescrição atual. O uso de medicamentos foi associado à faixa etária de até 24 meses, consulta periódica com pediatra e diagnóstico de doenças agudas e doenças crônicas. Entre as crianças medicadas, 19,1% foram expostas a pelo menos um medicamento de forma inadequada (considerando dose, intervalo entre doses ou período de tratamento). Quanto ao armazenamento, 55,2% dos medicamentos estavam guardados em lugar inseguro, ou seja, ao acesso das crianças, e 32,0% em locais inadequados, por estarem expostos a luz, calor ou umidade. Ainda, 45,2% estavam sem bula, 38,9% sem embalagem secundária e 1,6% fora do prazo de validade. CONCLUSÕES: As crianças estudadas apresentam uma frequência elevada de uso de medicamentos, devendo ser incentivadas ações que visem ao uso seguro e racional de fármacos nessa população.