[Cost-effectiveness analysis of fracture liaison services in Catalonia]. / Análisis de coste-efectividad de las Unidades de Coordinación de Fracturas en Cataluña.

OBJECTIVE: To assess the cost-effectiveness of Fracture Liaison Service (FLS) compared to the standard of care for secondary prevention of fragility fractures form the perspective of the Catalan Health Service. METHODS: Cost-utility assessment through a Markov model that simulated disease progression of a patients' cohort candidates to initiate antiosteoporotic treatment after a fragility fracture. A time horizon of 10 years and a 6-month duration per cycle was established. Clinical, economics and quality of life parameters were obtained from the literature and derived from four Catalan FLS. The Catalan Health Service perspective was adopted, considering direct health costs expressed in 2022 euros. A 3% discount rate was applied on costs and outcomes. Uncertainty was assessed through multiple sensitivity analyses. RESULTS: Compared to the standard of care, FLS would promote antiosteoporotic initiation and persistence, reducing the incidence and mortality associated with subsequent fragility fractures. This incremental clinical benefit was estimated at 0.055 years and 0.112 quality-adjusted life years (QALYs) per patient. A higher cost (€1,073.79 per patient) was estimated, resulting into an incremental cost-utility ratio of €9,602.72 per QALYs gained. The sensitivity analyses performed were consistent, corroborating the robustness and conservative approach of the base-case. CONCLUSIONS: The introduction of FLS for the secondary prevention of FF would represent a cost-effective strategy from the Catalan Health Service perspective.

[Translated article] Cost of Treating Cutaneous T-Cell Lymphoma in Spain: Analysis of MICADOS Study Data by Disease Stage.

BACKGROUND AND OBJECTIVE: The cost of treating cutaneous T-cell lymphoma (CTCL) in Spain is unknown. With the advent of new treatments, it is more important than ever to gain an accurate picture of the true costs involved. The MICADOS study had 2 primary objectives: 1)to evaluate the impact of CTCL on patient quality of life, and 2)to evaluate the costs associated with the disease. This article reports the results of the cost analysis. METHODS: We estimated the cost of treating CTCL over a period of 1year from the perspective of the Spanish National Health System. Twenty-three dermatologists and hematologists from 15 public hospitals analyzed data for adult patients with mycosis fungoides (MF) or Sézary syndrome (SS). RESULTS: A total of 141 patients (57.4% male) with a mean age of 63.6 years (95%CI: 61.4-65.7 years) were included. The mean direct annual cost of treating CTCL was €34,214 per patient. The corresponding costs by stage were €11,952.47 for stageI disease, €23,506.21 for stageII disease, €38,771.81 for stageIII disease, and €72,748.84 for stageIV disease. The total direct annual cost of treating MF/SS in public hospitals in Spain was estimated at €78,301,171; stageI disease accounted for 81% of all costs, stageII for 7%, and stagesIII andIV for 6% each. CONCLUSIONS: The MICADOS study offers an accurate picture of the direct cost of treating CTCL in patients with MF/SS in Spain and shows that costs vary significantly according to disease stage. Patient-borne and indirect costs should be analyzed in future studies.

Cost of Treating Cutaneous T-Cell Lymphoma in Spain: Analysis of MICADOS Study Data by Disease Stage. / Evaluación de los costes asociados a la enfermedad de pacientes con linfoma cutáneo de células T en España: análisis en función del estadio clínico (estudio MICADOS).

BACKGROUND AND OBJECTIVE: The cost of treating cutaneous T-cell lymphoma (CTCL) in Spain is unknown. With the advent of new treatments, it is more important than ever to gain an accurate picture of the true costs involved. The MICADOS study had 2 primary objectives: 1)to evaluate the impact of CTCL on patient quality of life, and 2)to evaluate the costs associated with the disease. This article reports the results of the cost analysis. METHODS: We estimated the cost of treating CTCL over a period of 1year from the perspective of the Spanish National Health System. Twenty-three dermatologists and hematologists from 15 public hospitals analyzed data for adult patients with mycosis fungoides (MF) or Sézary syndrome (SS). RESULTS: A total of 141 patients (57.4% male) with a mean age of 63.6 years (95%CI: 61.4-65.7 years) were included. The mean direct annual cost of treating CTCL was €34,214 per patient. The corresponding costs by stage were €11,952.47 for stageI disease, €23,506.21 for stageII disease, €38,771.81 for stageIII disease, and €72,748.84 for stageIV disease. The total direct annual cost of treating MF/SS in public hospitals in Spain was estimated at €78,301,171; stageI disease accounted for 81% of all costs, stageII for 7%, and stagesIII andIV for 6% each. CONCLUSIONS: The MICADOS study offers an accurate picture of the direct cost of treating CTCL in patients with MF/SS in Spain and shows that costs vary significantly according to disease stage. Patient-borne and indirect costs should be analyzed in future studies.

Cost-Effectiveness Analysis of Rituximab for Chronic Lymphocytic Leukemia Using a Semi-Markovian Model Approach in R.

OBJECTIVES: This study aims to compare the strategies fludarabine, cyclophosphamide, and rituximab and fludarabine and cyclophosphamide for the treatment of chronic lymphocytic leukemia in Brazil. METHODS: A three-states clock-reset semi-Markovian model was constructed in R. The time horizon of the analysis was 15 years and monthly cycles were used. Transition probabilities were derived from the survival curves of the CLL-8 study. Other probabilities were also derived from the medical literature. Costs included in the model referred to the application of injectable drugs, prescription cost, cost of treating adverse events, and costs of supportive care. The model was evaluated by microsimulation. To determine the study result, multiple cost-effectiveness threshold values were used. RESULTS: In the main analysis, an incremental cost-effectiveness ratio of 19 029.38 PPP-US dollars (USD)/quality-adjusted life-year (QALY) (41 141.52 Brazilian real/QALY) was observed. In 1.8% of the iterations, fludarabine and cyclophosphamide was considered dominant over fludarabine, cyclophosphamide, and rituximab. It can be shown that at 1 gross domestic product (GDP) per capita/QALY, 36.1% of the iterations would consider the technology cost-effective. At 2 GDP per capita/QALY, this number rises to 82.1%. At 50 000 USD/QALY, 92.8% of the iterations would suggest the technology to be cost-effective. In terms of some threshold accepted or proposed around the world, the technology would be considered cost-effective at 50 000 USD/QALY, 3 GDP per capita/QALY, and 2 GDP per capita/QALY. It would not be cost-effective at 1 GDP per capita/QALY or the opportunity costs threshold. CONCLUSION: It can be considered that rituximab is cost-effective for the treatment of chronic lymphocytic leukemia in Brazil.

Efficacy and marginal cost of treatment with tocilizumab in COVID-19 patients. / Resultados en la práctica asistencial y coste marginal del tratamiento con tocilizumab en pacientes COVID-19.

OBJECTIVE: To describe the marginal cost and survival of patients treated with tocilizumab in a university hospital under real-life conditions and to evaluate factors that could influence costs and health outcomes will be evaluated. METHODS: Observational, single-center, retrospective study of a cohort of adult patients infected with SARS-CoV-2 treated with tocilizumab. The one-year restricted mean survival time was analyzed in life-years gained (LYG). The influence of sex, age and severity on patient survival was evaluated. The marginal cost/LYG and marginal cost/survivor ratios were calculated. RESULTS: 508 patients (66 ± 13 years; 32% women) were included. Seventeen percent were admitted to the ICU. Overall survival was 77%. Age older than 71.5 years (HR = 1.08; 95% CI 1.07-1.10; p < 0.001) and ICU admission at initiation of treatment (HR = 2.01; 95% CI 1.30-3.09; p = 0.002) were identified as risk factors. The total budgetary impact of tocilizumab in the period analyzed was 206,466 euros. The patients with the highest cost per unit of health outcome were those admitted to the ICU and those over 71.5 years, with a marginal cost/LYG of € 966 and a marginal cost/survivor of € 1,136. CONCLUSION: The efficiency of treatment with tocilizumab is associated with the age and severity of the patients. The figures are lower in all subgroups than the thresholds usually used in cost-effectiveness evaluations. The results of the present study suggest that early first dose of tocilizumab is an efficient strategy.

[Translated article] Efficacy and marginal cost of treatment with tocilizumab in COVID-19 patients.

OBJECTIVE: To describe the marginal cost and survival of patients treated with tocilizumab in a university hospital under real-life conditions and to evaluate factors that could influence costs and health outcomes will be evaluated. METHODS: Observational, single-center, retrospective study of a cohort of adult patients infected with SARS-COV2 treated with tocilizumab. The 1 year restricted mean survival time was analyzed in life-years gained (LYG). The influence of sex, age and severity on patient survival was evaluated. The marginal cost/LYG and marginal cost/survivor ratios were calculated. RESULTS: 508 patients (66 ±â€¯13 years; 32% women) were included. Seventeen percent were admitted to the ICU. Overall survival was 77%. Age older than 71.5 years (HR = 1.08; 95% CI 1.07-1.10; p < 0.001) and ICU admission at initiation of treatment (HR = 2.01; 95% CI 1.30-3.09; p = 0.002) were identified as risk factors. The total budgetary impact of tocilizumab in the period analyzed was 206,466 euros. The patients with the highest cost per unit of health outcome were those admitted to the ICU and those over 71.5 years, with a marginal cost/LYG of €966 and a marginal cost/survivor of €1136. CONCLUSION: The efficiency of treatment with tocilizumab is associated with the age and severity of the patients. The figures are lower in all subgroups than the thresholds usually used in cost-effectiveness evaluations. The results of the present study suggest that early first dose of tocilizumab is an efficient strategy.

Análise das solicitações de medicamentos não padronizados de um hospital universitário terciário / Analysis of requests for non-standard medicines from a tertiary university hospital

Introdução: O uso extensivo de medicamentos não padronizados causa aumento de custos em saúde, além de potencial redução de segurança e uso racional de medicamentos. A Comissão de Farmácia e Terapêutica orienta a prescrição de medicamentos, por meio da avaliação e seleção de medicamentos a serem incluídos no formulário de medicamentos padronizados, com base nas melhores evidências científicas disponíveis e no perfil dos pacientes locais, promovendo o uso racional de medicamentos. O objetivo deste trabalho foi analisar as solicitações de fornecimento de medicamentos não padronizados na instituição. Métodos: Trata-se de um estudo observacional e descritivo onde foram analisadas as solicitações de medicamentos não padronizados realizadas entre fevereiro de 2016 e dezembro de 2021, identificando os medicamentos envolvidos e seus respectivos custos. Resultados: Foram realizadas 203 solicitações no período, sendo 174 incluídas no estudo. Os medicamentos que tiveram mais solicitações foram o rituximabe (41), a imunoglobulina humana (31), o sucralfato (23), a nitazoxanida (12) e o eltrombopague (7). As solicitações com maior custo foram as de imunoglobulina humana (US$ 799,702.38), rituximabe (US$ 717,320.26), eltrombopague (US$ 281,062.50), ruxolitinibe (US$ 167,867.46) e bortezomibe (US$ 149,033.52). As principais clínicas que solicitaram medicamentos não padronizado foram a neurologia (47), a hematologia (30), as moléstias infecciosas e parasitárias (17), e a anestesiologia (12). As solicitações de maior custo foram realizadas pela neurologia (US$ 145,519.08), hematologia (US$ 120,980.25), transplante de medula óssea (US$ 51,635.11) e dermatologia (US$ 44,813.40). Conclusão: O estudo demonstrou que há um fluxo estruturado de solicitação de medicamentos não padronizados na instituição, sendo uma importante ferramenta de gerenciamento dessas solicitações, evitando a aquisição desnecessária de itens que não compõem o elenco terapêutico do hospital.

Introduction: Widespread use of non-formulary drugs (NFD) increases cost and may reduce safety and rational use of medicines. The Pharmacy and Therapeutics Committee provides guidance on drug prescription by evaluating and selecting medications to be included in a hospital's formulary based on best scientific evidence available and local patients' profile, promoting rational use of medicines. The objective of this study was to assess non-formulary drugs prescriptions at a tertiary hospital. Methods: This was a retrospective study. NFD prescribed and its associated costs were assessed through NFD request forms received from February 2016 to December 2021. Results: A total of 203 NFD request forms were received, from which 174 were included in this study. The most frequently prescribed NFD included rituximab (n = 41), immunoglobulin (31), sucralfate (23), nitazoxanide (12), and eltrombopag (7), with the highest costs being with immunoglobulin (US$ 799,702.38), rituximab (US$ 717,320.26), eltrombopag (US$ 281,062.50), ruxolitinib (US$ 167,867.46), and bortezomib (US$ 149,033.52). The most frequent requesting specialties were neurology (n = 47), hematology (30), infectious disease (17) and anesthesiology (12), and highest costs requests were from neurology (US$ 145,519.08), hematology (US$ 120,980.25), bone marrow transplant unit (US$ 51,635.11), and dermatology (US$ 44,813.40). Conclusion: This study showed that a structured request flow for NFD prescription is a critical procedure in order to better manage drug prescription within the hospital, promoting rational use of medicines and preventing unnecessary spending with drugs for which the clinical indication may be covered by a drug already in the hospital's formulary.

Análise farmacoeconômica do uso de omeprazol por idosos em uma das unidades básicas de saúde do Brasil / Pharmacoeconomic Analysis of the Use of Omeprazole by Elderly Patients in One of the Primary Healthcare Centers in Brazil

O omeprazol é inibidor de bomba de prótons mais prescrito no Brasil e é indicado para o tratamento de doenças por refluxos gastroesofágicos, úlcera péptica, esofagite erosiva, erradicação de Helicobacter pylori, síndrome de Zollinger-Ellison, gastrinomas, gastrite e distúrbios hipersecretores e prevenção de úlcera péptica. O uso indiscriminado e desnecessário, principalmente por idosos, é uma importante questão de saúde pública a ser tratada. Apesar de ser conhecida a existência do uso indiscriminado do omeprazol, identifica-se a necessidade de se verificar como ocorre a prescrição desse medicamento no contexto do Sistema Único de Saúde (SUS) do Brasil. Além disso, acredita-se que estudos que analisam de modo famacoeconômico a prescrição do omeprazol podem contribuir para a revisão ou implementação de diretrizes e protocolos que envolvam o uso desse medicamento. O objetivo foi caracterizar e realizar análise farmacoeconômica do uso do omeprazol em Unidade de Atenção Primária a Saúde (UAPS) em Minas Gerais, Brasil. Trata-se de estudo descritivo com análise das prescrições de 41 pacientes idosos atendidos no período de abril/maio de 2018 e foram identificadas as seguintes variáveis: idade, sexo, dose, indicação, realização de endoscopia, demais medicamentos em uso e custo do tratamento. Na análise farmacoeconômica realizou-se o cálculo do custo médio da quantidade de omeprazol prescrita por paciente e considerou-se a realização ou não de endoscopia. Na população estudada, 29 (70,3%) do sexo feminino com mediana de idade: 69 anos. Apenas em 4 prontuários (9,8%) havia indicação para uso e em 18 (43,9%) pacientes, a utilização era feita há mais de dois anos e em 7 (17,1%) a mais de cinco anos. Apenas 3 (7,3%) realizaram endoscopia e foram utilizados 371 meses totalizando um valor financeiro de R$35.657,23. Os achados sugerem prescrições em longo prazo e sem registro da indicação em prontuário. O custo referente às prescrições poderia ser otimizado com a realização de endoscopia e suspensão do uso, quando constatada ausência de indicação.

Omeprazole is the most prescribed proton pump inhibitor in Brazil and is indicated for the treatment of diseases caused by gastroesophageal reflux, peptic ulcer, erosive esophagitis, eradication of Helicobacter pylori, Zollinger-Ellison syndrome, gastrinomas, gastritis, and hypersecretory disorders, as well as peptic ulcer prevention. The indiscriminate and unnecessary use, mainly by the elderly, is an important public health issue to be addressed. Despite the existence of indiscriminate use of omeprazole being known, there is a need to verify how this medication is prescribed in the context of the Unified Health System (UHS) in Brazil. In addition, it is believed that studies that aim to analyze the prescription of omeprazole in a pharmacoeconomic way can contribute to the review or implementation of guidelines and protocols involving the use of this drug. The objective of this study was to characterize and perform a pharmacoeconomic analysis of the use of omeprazole in a Primary Healthcare Centers (PHC) in Minas Gerais, Brazil. This is a descriptive study analyzing the prescriptions of 41 elderly patients treated in the period of April/May 2018 and the following variables were identified: age, sex, dose, indication, endoscopy, other medications in use, and cost of treatment. In the pharmacoeconomic analysis, the average cost of the amount of omeprazole prescribed per patient was calculated and whether or not endoscopy was performed was considered. In the studied population, 29 (70.3%) were female with a median age: 69 years. Only in 4 medical records (9.8%) was there indication for use, and 18 (43.9%) patients had been using omeprazole for more than two years and 7 (17.1%) for more than five years. Only 3 (7.3%) patients underwent endoscopy, and 371 months-worth of omeprazole were used, totaling a financial value of R$35,657.23. The findings suggest long-term prescriptions and no record of their indication on medical records. The cost related to prescriptions could be optimized by performing endoscopy and discontinuing its use when no indication is found.

Intervenções farmacêuticas em Unidade de Pronto Atendimento: uma análise farmacoterapêutica e farmacoeconômica / Pharmaceutical interventions in Emergency Care Unit: a pharmacotherapeutic and pharmacoeconomic analysis

Objetivo: Esclarecer o impacto farmacoterapêutico e farmacoeconômico das intervenções farmacêuticas em serviços de urgência e emergência. Métodos: Estudo de intervenção conduzido em uma Unidade de Pronto Atendimento. Os pacientes admitidos na pesquisa receberam acompanhamento farmacoterapêutico por meio de avaliação e intervenção na farmacoterapia. Resultados: Participaram do estudo 197 pacientes majoritariamente feminino, comórbidos, com média de idade de 43 anos ± 13. Foram realizadas intervenções em 130 destes, com aceitação de 83% por parte da equipe de assistência. As intervenções também repercutiram na farmacoeconomia, proporcionando uma redução de custos de 35% em comparação ao semestre anterior. Conclusão: Nossos resultados expressaram que a presença do farmacêutico clínico é essencial para farmacoterapias otimizadas e redução de custos hospitalares.

Objective: To clarify pharmaceutical interventions' pharmacotherapeutic and pharmacoeconomic impact on urgent and emergency services. Methods: Intervention study conducted in an Emergency Care Unit. Patients enrolled in the research received pharmacotherapeutic follow-up through evaluation and intervention in pharmacotherapy. Results: One hundred and ninety seven patients, mostly female, with comorbid conditions, with a mean age of 43 years ± 13, participated in the study. Interventions were performed in 130 of them, with an acceptance of 83% by the care team. The interventions also impacted pharmacoeconomics, providing a cost reduction of 35% compared to the previous semester. Conclusion: Our results expressed that the presence of the clinical pharmacist is essential for optimized pharmacotherapies and hospital cost reduction.

Avaliação econômica de uma estratégia individual de empoderamento farmacoterapêutico: um modelo em longo prazo aplicado do diabetes mellitus tipo II / Economic evaluation of an individual pharmacotherapeutic empowerment strategy: an applied long-term model for type II diabetes mellitus

Objetivos: contribuir para a geração de dados de avaliação econômica de estratégias de empoderamento farmacoterapêutico para pacientes com Diabetes Mellitus tipo 2 (DM tipo 2). Métodos: este estudo farmacoeconômico é aninhado a um ensaio clínico com controle não randomizado que incluiu pacientes ≥18 anos de idade, cadastrados no HIPERDIA. Os pacientes foram alocados em um modelo de Markov conforme valores de hemoglobina glicada do acompanhamento. As probabilidades do surgimento de complicações relativas ao DM, incluindo-se óbito, foram estimadas por dez anos. Cada complicação do DM tipo 2 teve seu custo estabelecido para determinação do custo anual. Resultados: entre os participantes da intervenção, não ocorrem óbitos ocasionados por DM tipo 2, e a progressão de complicações mantém-se estável durante os anos simulados, enquanto, no grupo controle, 60% dos pacientes podem evoluir para óbito nos dez anos, e a probabilidade de serem acometidos por complicações relacionadas ao DM tipo 2 é crescente. Com relação aos custos, ao final de dez anos, os pacientes que participaram da Estratégia Individual de Empoderamento Farmacoterapêutico (EIEF) tiveram um custo médio de UU$134,45 poupando a vida de 100% dos pacientes, e os pacientes do atendimento convencional um custo médio de UU$237,12 e 40% dos pacientes acompanhados chegariam ao final do ciclo com vida. Conclusão: a EIEF parece ser uma alternativa economicamente viável em longo prazo, bem como para a promoção do controle glicêmico.

Objectives: contribute to the data generation for the economic evaluation of pharmacotherapeutic empowerment strategies for type 2 diabetes mellitus patients (type 2 DM). Method: This pharmacoeconomic study is nested in a clinical trial with non-randomized control that included patients ≥18 years old, registered in HIPERDIA. The patients were allocated to a Markov model according to the follow-up glycated hemoglobin values. The probabilities of the appearance of complications related to DM, including death, have been estimated for ten years. Each complication of type 2 DM had its cost established to determine the annual cost. Results: Among the participants in the intervention, there are no deaths caused by type 2 DM, and the progression of complications remains stable during the simulated years, whereas in the control group, 60% of the patients can progress to death in ten years and the probability of being affected by complications related to type 2 DM is increasing. Regarding costs, at the end of ten years, patients who participated in Individual Pharmacotherapeutic Empowerment Strategy (IPES) had an average cost of US$ 134.45, saving 100% of patient's lives, and conventional care patients cost an average of US$ 237.12 and 40% of the patients followed would reach the end of the life cycle. Conclusion: The IPES seems like an economically viable and long-term economic alternative and promotes glycemic control.

A vigilancia farmacológica no cenário brasileiro do sáculo 21 / Pharmacological surveillance in the Brazilian scenario of the 21st century / La vigilancia farmacológica en el escenario brasileño del siglo XXI

Resumo Os estudos em vigilancia farmacológica e ecofarmacológicas possibilitam o monitoramento, identificagao e minimi-zagao de efeitos nocivos advindos do uso de medicamentos. Diante disso, o presente estudo teve como objetivo descrever o cenário atual da farmacoepidemiologia e ecofarmacovigilancia no Brasil, no que se refere a produgao, registro, comerciali-zagao e uso de medicamentos. Foi realizado um levantamento sistemático, através dos bancos de dados PubMed/Medline, Lilacs e SciELO, cuja temática envolveu pesquisas em farmacoeconomia, farmacovigilancia, ecofarmacovigilancia e estudo da utilizagao de medicamentos no Brasil de 2001 a 2019. As publicagóes distribuíram-se de forma desigual entre as regióes brasileiras. Pacientes hipertensos, oncológicos e as gestantes foram os grupos de risco mais citados e os antimicrobianos, psicotrópicos e antineoplásicos os grupos farmacológicos mais discutidos. Custo de cuidados em saúde foi a temática mais abordada no contexto da farmacoeconomia e grande parte dos trabalhos destinou-se a análise e obtengao de dados referentes ao uso de medicamentos e suas reagóes adversas. Em relagao a ecofarmacovigilancia nao foram encontradas publicagóes no Brasil que contemplem essa área. Apesar dos avangos da legislagao farmacoepidemiológica e melhorias nos processos de fiscalizagao, no que tange a vigilancia da produgao, registro, comercializagao e uso de medicamentos, ainda permanecem carencias, quanto ao aporte de uma visao científica direcionada, sobretudo ao gerenciamento e diferentes usos dos recursos terapéuticos, e económicos do sistema de saúde brasileiro, bem como uma visao ambiental referente ao uso de medicamentos.

Abstract Studies in pharmacological and ecopharmacological surveillance make it possible to monitor, identify and minimize harmful effects arising from the use of drugs. Therefore, the present study aimed to describe the current scenario of pharmacoepidemiology and ecopharmacovigilance in Brazil, about the production, registration, marketing, and use of medicines. A systematic survey was carried out through the PubMed/Medline, Lilacs, and SciELO databases, whose theme involved research in pharmacoeconomics, pharmacovigilance, ecopharmacovigilance, and the study of drug use in Brazil from 2001 to 2019. Publications were unevenly distributed between Brazilian regions. Hypertensive patients, cancer patients, and pregnant women were the most cited risk groups, and antimicrobials, psychotropics, and antineoplastics were the most discussed pharmacological groups. Cost of health care was the most discussed topic in the context of pharmacoeconomics and most of the work was aimed at analyzing and obtaining data regarding the use of drugs and their adverse reactions. Regarding ecopharmacovigilance, no publications were found in Brazil covering this area. Despite advances in pharmacoepidemiological legislation and improvements in inspection processes, regarding the surveillance of the production, registration, commercialization, and use of medicines, there are still gaps regarding the contribution of a directed scientific vision, especially to the management and different uses of resources. therapeutic and economic aspects of the Brazilian health system, as well as an environmental vision regarding the use of medicines.

Resumen Los estudios de vigilancia farmacológica y ecofarmacológica permiten controlar, identificar y minimizar los efectos nocivos derivados del uso de los medicamentos. Ante esto, el presente estudio tuvo como objetivo describir el escenario actual de la farmacoepidemiología y la ecofarmacovigilancia en Brasil, en relación con la producción, el registro, la comercialización y el uso de los medicamentos. Se realizó una encuesta sistemática, a través de las bases de datos PubMed/Medline, Lilacs y SciELO, cuya temática involucró investigaciones sobre farmacoepidemiología, farmacovigilancia, ecofarmacovigilancia y estudio del uso de medicamentos en Brasil desde 2001 hasta 2019. Las publicaciones se distribuyeron de forma desigual entre las regiones brasileñas. Los pacientes hipertensos, los pacientes oncológicos y las mujeres embarazadas fueron los grupos de riesgo más citados y los antimicrobianos, los psicotrópicos y los antineoplásicos fueron los grupos farmacológicos más discutidos. El coste de la asistencia sanitaria fue el tema más abordado en el contexto de la farmacoeconomía y la mayoría de los trabajos estaban dirigidos a analizar y obtener datos sobre el uso de los medicamentos y sus reacciones adversas. En cuanto a la ecofarmacovigilancia, no se encontraron publicaciones en Brasil que aborden esta área. A pesar de los avances en la legislación farmacoepidemiológica y de las mejoras en los procesos de inspección, en lo que respecta a la vigilancia de la producción, registro, comercialización y uso de los medicamentos, todavía falta una visión científica dirigida, sobre todo, a la gestión y a los diferentes usos de los recursos terapéuticos y económicos del sistema de salud brasileño, así como una visión ambiental en cuanto al uso de los medicamentos.

Análise de custo-efetividade do uso de inibidores da via de sinalização mTOR x micofenolato em receptores de transplante renal sem profilaxia para citomegalovírus s / Cost-effectiveness analysis of the use of mTOR signaling pathway inhibitors x mycophenolate in kidney transplantation recipients without cytomegalovirus prophylaxis

Objetivo: Avaliar a relação de custo-efetividade dos regimes imunossupressores utilizados em pacientes receptores de transplante renal, no Hospital Santa Casa de Misericórdia de Juiz de Fora, MG, basiliximabe, micofenolato de sódio, tacrolimo e prednisona (Grupo 1 = 93 pacientes), comparados com a associação de timoglobulina, everolimo, tacrolimo e prednisona (Grupo 2 = 91 pacientes). Métodos: Para a análise farmacoeconômica, foi utilizado o modelo de Árvore de Decisão, desenvolvido no software Treeage Suite 2011. Foi considerada uma coorte real de pacientes submetidos ao transplante renal entre janeiro de 2013 e março de 2017, os quais foram acompanhados por um período de um ano, sendo mensurados os benefícios clínicos, bem como os custos associados, na perspectiva do Sistema Único de Saúde. O método de custeio utilizado foi o botton-up. Foram adotados os limiares de custo-efetividade (LCEs) equivalentes a 1 PIB per capita e 1 a 3 PIB, considerando o ano de 2017. Resultados: No que diz respeito à sobrevida, a RCEI foi de cerca de R$ 214.234,12 para 1 ano de vida ganho. Em relação aos eventos adversos, a RCEI foi de cerca de R$ 43.682,98 para 1 ano sem incidência de eventos adversos. Conclusões: Ao avaliar a sobrevida e a incidência de eventos adversos, timoglobulina+everolimo não é considerado custo-efetivo em relação ao esquema contendo basiliximabe+micofenolato de sódio diante do LCE de 1 PIB per capita. No entanto, ao adotarmos o LCE até 3 PIB per capita, o regime contendo moglobulina+everolimo é custo-efetivo, ultrapassando cerca de 38% do PIB per capita.

Objective: Evaluate the cost-effectiveness of immunosuppressive regimens used in kidney transplant recipients at the Santa Casa de Misericórdia, Hospital in Juiz de Fora, MG, compared with basiliximab, mycophenolate sodium, tacrolimus and prednisone (Group 1 = 93 patients) with the association of thymoglobulin, everolimus, tacrolimus and prednisone (Group 2 = 91 patients). Methods: For the pharmacoeconomic analysis, the Decision Tree model was used, developed in the TreeAge Suite 2011 software. A real cohort of patients undergoing kidney transplantation between January 2013 and March 2017 was considered, they were followed up for a period of 1 year, where the clinical benefits were measured, as well as the associated costs, from the perspective

Transição de via de linezolida endovenosa para via oral: uma análise de custo-minimização / Switching from intravenous to oral linezolid therapy: a cost-minimization analysis

Objetivo: Comparar custos da terapia endovenosa exclusiva com linezolida com os custos da terapia iniciada por via endovenosa com transição para via oral após 72 horas, como estratégia de intervenção em programas de gestão de antimicrobianos. Métodos: Avaliação econômica de custo-minimização comparando custos diretos da terapia endovenosa exclusiva com linezolida com a terapia endovenosa seguida de transição para via oral em cenário simulado, sob a perspectiva do Sistema Único de Saúde (SUS), com árvore de decisão como modelo para tomada de decisão. Resultados: A alternativa englobando a transição de via mostrou-se a mais econômica em todos os cenários analisados. Para 28 dias de tratamento com linezolida, houve redução de 22% nos custos, considerando o paciente internado. Ao considerar alta após o sexto dia de tratamento, a redução de custos variou de 26%, com financiamento pelo SUS do restante do tratamento, a 84%, com financiamento do tratamento pós-alta pelo paciente. Conclusão: Conclui-se que a transição de via de linezolida é uma importante estratégia nos programas de gerenciamento de antimicrobianos, capaz de gerar economia significativa para a instituição. As avaliações econômicas de custo-minimização, nesse contexto, são uma importante ferramenta para demonstrar o aspecto econômico com potencial para sensibilizar gestores e tomadores de decisão.

Objective: To compare the direct costs of linezolid intravenous therapy with the costs of intravenous therapy switching to oral therapy after 72 hours as an intervention strategy in antimicrobial stewardship programs. Methods: Economic evaluation cost-minimization comparing direct costs of exclusive linezolid intravenous therapy with intravenous therapy for 72 hours and after switching to oral therapy in a simulated scenario, from the perspective of the National Health Service, with a decision tree as a decision modeling. Results: The alternative encompassing the therapy transition proved to be the most economical in all analyzed scenarios. For 28 days of treatment with linezolid, there was a 22% reduction in costs, considering the hospitalized patient. When considering discharge after the sixth day of treatment, the cost reduction ranged from 26%, with funding from the National Health Service for the rest of the treatment, to 84%, with funding for the post-discharge treatment by the patient. Conclusion: It was concluded that the linezolid therapy transition is an important strategy in antimicrobial management programs, capable of generating significant savings for the institution. In this context, economic cost-minimization assessments are an important tool to demonstrate the economic aspect with the potential to raise awareness among managers and decision-makers.

Estudios farmacoeconómicos en Cuba en los últimos 20 años / Pharmacoeconomic studies in Cuba in the last 20 years

Introducción: Cuba es un país con desarrollo en el área biotecnológica y de medicamentos, donde los estudios farmacoeconómicos aportan evidencia significativa para la toma de decisiones, principalmente en la actualidad que el país se encuentra inmerso en la Tarea ordenamiento y a la vez es afectado por la pandemia del nuevo coronavirus. Objetivo: Caracterizar los estudios farmacoeconómicos en Cuba en los últimos 20 años. Métodos: Se realizó una investigación bibliométrica para la que se recuperó la producción científica cubana sobre farmacoeconomía en la base de datos Scopus del periodo 2001-2020. Se utilizaron indicadores bibliométricos para obtener número de documentos, años de publicación, fuentes, colaboración, tipo y patrones de colaboración institucional y de países, así como coocurrencia de palabras clave. Resultados: Se recuperaron 648 documentos. El año más productivo fue 2010. Los documentos se publicaron en 273 revistas, 17 (6,2 por ciento) cubanas y 256 (93,8 por ciento) extranjeras. Hubo 449 (69,3 por ciento) documentos en colaboración institucional y 199 (30,7 por ciento) sin colaboración. Las instituciones más productivas fueron Centro de Ingeniería Genética y Biotecnología 82 (12,7 por ciento) y Centro de Inmunología Molecular, 77 (11,9 por ciento). La red de colaboración entre países mostró tres áreas definidas, Latinoamérica, Norteamérica-Europa-India y España. Los temas más publicados fueron efectividad y seguridad de medicamentos, las vacunas y los relacionados con el cáncer. Conclusiones: Las publicaciones se caracterizaron por ser en colaboración, con ligero predominio de las nacionales sobre las internacionales. Es necesario ampliar la realización de evaluaciones económicas completas(AU)

Introduction: Cuba is a country with development in the biotechnology and medicines field, where pharmacoeconomic studies provide significant evidence for decision-making; mainly at present when the country is immersed in the Task of Ordering and at the same time is affected by the pandemic of the new coronavirus. Objective: Characterize pharmacoeconomic studies in Cuba in the last 20 years. Methods: A bibliometric research was carried out for which the Cuban scientific production on pharmacoeconomics was recovered in the Scopus database for the period 2001-2020. Bibliometric indicators were used to obtain the number of documents, years of publication, sources, collaboration, type and patterns of institutional and country collaboration, as well as co-occurrence of keywords. Results: 648 documents were retrieved. The most productive year was 2010. The documents were published in 273 journals, 17 (6.2percent) Cuban ones and 256 (93.8percent) foreign. There were 449 documents (69.3percent) in institutional collaboration and 199 (30.7percent) without collaboration. The most productive institutions were the Center for Genetic Engineering and Biotechnology with 82 (12.7percent) and the Center of Molecular Immunology, with 77 (11.9percent). The collaboration network between countries showed three defined areas: Latin America, North America-Europe-India and Spain. The most published topics were effectiveness and safety of drugs, vaccines, and those related to cancer. Conclusions: The publications were characterized by being collaborative, with a slight predominance of national over international ones. Comprehensive economic assessments need to be expanded(AU)

Disposição a pagar e Método de Valoração Contingente na avaliação econômica de serviços farmacêuticos / Willingness to pay and Contingent Valuation Method in the economic evaluation of pharmacy services

Objetivo: Sintetizar os principais pontos abordados em investigações de Disposição a Pagar (DAP) por serviços farmacêuticos, com foco no Método de Valoração Contingente (MVC). Métodos: Foi realizada uma revisão não sistemática com recuperação e análise de manuscritos publicados até novembro de 2020. A busca por estudos ocorreu nas bases MEDLINE, LILACS e SciELO. Resultados: Foram discutidos os fundamentos teóricos e processos metodológicos da análise, apresentando o MVC como principal perspectiva de abordagem. Enquanto delineamento do questionário, é sugerida uma estrutura que apresente, sequencialmente, os elementos: "conhecimento do participante sobre a intervenção", "apresentação da intervenção", "cenário hipotético", "pergunta DAP", "estado de saúde percebido" e "informações socioeconômicas". No mais, é enfatizada a importância da execução de etapas de validação, tanto do instrumento quanto da avaliação. Conclusão: Avaliar a preferência declarada da população por serviços farmacêuticos é uma estratégia ainda limitada. Se realizado adequadamente, esse tipo de investigação pode auxiliar gestores e tomadores de decisão no processo de implementação de novas tecnologias de cuidado.

Objective: To synthesize key points addressed in investigations of Willingness to Pay (WTP) for pharmaceutical care services, focusing on the Contingent Valuation Method (CVM). Methods: We performed a non-systematic review with recovery and analysis of manuscript published until November 2020. Three databases were majorly searched, including MEDLINE, LILACS and SciELO. Results: The theoretical foundations and methodological process were discussed, presenting the CVM as the main perspective. For questionnaire design, is suggested a structure that sequentially presents the elements: "participant knowledge on intervention", "intervention presentation", "hypothetical scenario", "WTP question", "perceived health status", and "socioeconomic information". In addition, we emphasize the importance of executing validation steps for the instrument of measurement as well as the evaluation process. Conclusion: Assessing the population's declared preference for pharmaceutical services is still a limited strategy. If carried out properly, this type of investigation can help managers and decision makers in the process of implementing technologies of care.

Impacto da unitarização de ceftazidima + avibactam em um hospital público universitário durante a pandemia de COVID-19 / Impact of ceftazidime + avibactam unitarization in a university public hospital during the COVID-19 pandemic

Introdução: A pandemia de COVID-19 fez aumentar a demanda de medicamentos utilizados em hospitais, como a Ceftazidima + Avibactam. Nesse contexto, a Central de Misturas Intravenosas (CMIV) de um hospital público universitário passou a unitarizar as doses prescritas. O objetivo deste trabalho foi avaliar o impacto da unitarização no consumo deste antibacteriano de alto custo em um hospital público universitário. Métodos: Trata-se de uma análise farmacoeconômica de custos diretos, sobre a utilização de frascos-ampola de Ceftazidima + Avibactam no período de 01/07/2020 a 31/05/2021. Foram unitarizadas todas as doses que correspondiam a uma fração da dose total do frasco-ampola, em Cabine de Segurança Biológica classe II B2. Os frascos-ampola foram utilizados à exaustão, através do compartilhamento e organização dos horários de manipulação. Resultados: O número total de preparos realizados pela CMIV do referido hospital no período foi de 837. O consumo projetado sem a centralização dos preparos seria de 837 (um frasco por dose). Entretanto, o consumo real foi de 437 frascos. A eficiência de unitarização foi de 101%, com economia real de 400 frascos (R$ 244.832,00) para a instituição. Conclusão: A pandemia de COVID-19 sobrecarregou os sistemas de saúde do mundo todo, sendo que a atuação farmacêutica foi fundamental para garantir o acesso aos medicamentos essenciais. A CMIV assumiu a unitarização da Ceftazidima + Avibactam, antibiótico em risco de desabastecimento, gerando um consumo 47,8% menor, contribuindo para o acesso deste medicamento de forma ininterrupta durante os 11 meses avaliados na referida instituição.

Introduction: COVID-19 pandemic has increased the demand for drugs used in hospitals, such as Ceftazidime + Avibactam. In this context, the Central of Intravenous Admixtures (CMIV) of a public university hospital started to unitarize the prescribed doses. The objective of this study was to evaluate the impact of unitarization on the consumption of this high-cost antibacterial in a public university hospital. Methods: This is a pharmacoeconomic analysis of direct costs, on the Ceftazidime + Avibactam vials use, in the period from 07/01/2020 to 05/31/2021. All doses that corresponded to a fraction of the entire vial were unitarized in a Class II B2 Biological Safety Cabin. The vials were used to exhaustion, by sharing them, and organizing the manipulation schedules. Results: The total number of preparations made by the CMIV of that hospital in the period was 837 doses. The projected consumption would be 837 vials (one vial per dose). However, the actual consumption was 437 vials. The unitarization efficiency was of 101%, with real savings of 400 vials (R$ 244,832.00) for the institution. Conclusion: COVID-19 pandemic has overburdened health systems around the world, and pharmaceutical actions have been fundamental to guaranteeing access to essential medicines. CMIV took over the unitarization of Ceftazidime + Avibactam, an antibiotic at risk of shortages, leading to a 47.8% lower consumption, contributing to uninterrupted access to this drug during the 11 months evaluated at that institution.

Costo beneficio de acetaminofén en tableta en establecimientos farmacéuticos de Lima / Cost benefit of acetaminophen in tablet in pharmaceutical establishments of Lima

Introducción: La economía de los medicamentos se puede considerar como el estudio y cálculo económico detallados del medicamento, que ayuda a satisfacer las necesidades del paciente según costo, beneficio y eficacia de dicho medicamento. Objetivo: El objetivo de la investigación fue evaluar si la valoración económica de la tableta de acetaminofén 500 mg. permitirá conocer el beneficio en el costo del fármaco en los establecimientos farmacéuticos de Lima. Métodos: La investigación presenta un diseño no experimental, transversal, descriptivo y analítico. Población: 25 trabajadores de la DIGEMID con conocimientos de farmacoeconomía; muestra: 100 por ciento de la población. Para la evaluación se utilizó un cuestionario de escala Likert, basado en las dos variables cuantitativas: Valoración económica y Coste-beneficio. El tratamiento estadístico se realizó con el programa SPSS v.25. Traducción realizada con la versión gratuita del traductor www.DeepL.com/Translator Resultados: De un total de 44 presentaciones de tabletas de acetaminofén vendidas en 41 distritos de Lima, se obtuvieron siete presentaciones que ofrecen el producto a un precio elevado, siendo estas no beneficiosas en el 15,9 por ciento y se encontraron 37 establecimientos que ofrecen el medicamento a un precio medio beneficioso (84,1 por ciento). Conclusiones: La farmacoeconomía aplicada al medicamento acetaminofén presentación tableta 500 mg permitió conocer que dicho producto tiene un costo de bajo a moderado, por lo que es asequible a la población de bajos recursos. Asimismo, la evaluación económica efectuada permitirá la toma de decisiones del consumidor al momento de la compra(AU)

Introduction: The economics of medicines can be considered as the detailed economic study and calculation of the treatment, which helps to satisfy the needs of the patient according to the cost, benefit, and efficacy of said medicine. Objective: The objective of the research was to evaluate if the economic valuation of the acetaminophen 500 mg. tablet will allow to know the benefit in the cost of the drug in pharmaceutical establishments in Lima. Methods: The research presents a non-experimental, cross-sectional, descriptive, and analytical design. Population: 25 DIGEMID workers with knowledge of pharmacoeconomics; sample: 100 percent of the population. A Likert scale questionnaire was used for the evaluation, based on the two quantitative variables: Economic valuation and Cost-benefit. Statistical processing was carried out using the SPSS v.25 program. Results: From a total of 44 presentations of acetaminophen tablets sold in 41 districts of Lima, seven presentations have been obtained that offer the product at a high price, these being not beneficial and reaching 15.9 percent, 37 establishments were found They offer the drug at a helpful average price reaching 84.1 percent. Conclusions: The pharmacoeconomics applied to the drug acetaminophen 500 mg tablet presentation allowed us to know that this product has a low to moderate cost, making it affordable to the low-income population. Likewise, the economic evaluation carried out will allow decision-making at the time of purchase, which will enable the people to identify the price(AU)

Comparative analysis of kidney transplant costs related to recovery of renal function after the procedure / Análise comparativa dos custos do transplante renal relacionados à recuperação da função renal após o procedimento

Abstract Introduction: The number of kidney transplants (KTx) is increasing in Brazil and, consequently, the costs of this procedure increase the country's health budget. We retrospectively evaluated the data of kidney transplant procedures until hospital discharge, according to kidney function recovery after the procedure. Methods: Retrospective analysis of the non-sensitized, 1st KTx from deceased donors performed between Jan/2010 to Dec/2017. Results: Out of the 1300 KTx from deceased donors performed in this period, 730 patients were studied and divided into 3 groups: Immediate Renal Function (IRF) - decrease in serum creatinine ≥ 10% on two consecutive days; Delayed Graft Function (DGF) - decrease in serum creatinine <10% on two consecutive days, without the need for dialysis, and Dialysis (D) - need for dialysis during the first week. Patients in group D stayed longer in the hospital compared to DGF and IRF (21, 11 and 8 days respectively, p < 0.001). More D patients (21%) were admitted to the ICU and performed a greater number of laboratory tests (p < 0.001) and renal biopsies (p < 0.001), in addition to receiving a higher amount of immunosuppressants. Total hospital costs were higher in group D and DGF compared to IRF (U$ 7.021,48; U$ 3.603,42 and U$ 2.642,37 respectively, p < 0.001). Conclusion: The costs of the transplant procedure is impacted by the recovery of kidney function after the transplant. The reimbursement for each of these different kidney function outcomes should be individualized in order to cover their real costs.

Resumo Introdução: O número de transplantes renais (KTx, do inglês kidney transplant) está aumentando no Brasil e, consequentemente, os custos deste procedimento aumentam o orçamento de saúde do país. Avaliamos retrospectivamente dados dos procedimentos de transplantes renais até a alta hospitalar, de acordo com a recuperação da função renal após o procedimento. Métodos: Análise retrospectiva dos 1º KTx de doadores falecidos, não sensibilizados, realizados entre Jan/2010 a Dez/2017. Resultados: Dos 1300 KTx de doadores falecidos realizados neste período, 730 pacientes foram estudados e divididos em 3 grupos: Função Renal Imediata (FRI) - diminuição na creatinina sérica ≥ 10% em dois dias consecutivos; Função Retardada do Enxerto (FRE) - diminuição na creatinina sérica <10% em dois dias consecutivos, sem necessidade de diálise, e Diálise (D) - necessidade de diálise durante a primeira semana. Pacientes no grupo D permaneceram mais tempo no hospital em comparação com FRE e FRI (21, 11 e 8 dias dias respectivamente, p < 0,001). Mais pacientes do grupo D (21%) foram admitidos na UTI e realizaram um maior número de testes laboratoriais (p < 0,001) e biópsias renais (p < 0,001), além de receberem uma quantidade maior de imunossupressores. Os custos hospitalares totais foram mais elevados nos grupos D e FRE em comparação com FRI (U$ 7.021,48; U$ 3.603,42 e U$ 2.642,37 respectivamente, p < 0,001). Conclusão: Os custos do procedimento de transplante são impactados pela recuperação da função renal após o transplante. O reembolso para cada um desses diferentes desfechos da função renal deve ser individualizado a fim de cobrir seus custos reais.

Evaluación económico ambiental de productos médicos de uso corriente en un hospital público de la Ciudad de Buenos Aires / Economic-environmental evaluation of commonly used medical devices in a public hospital of the City of Buenos Aires

INTRODUCCIÓN: Los establecimientos de atención de la salud utilizan sustancias y productos potencialmente peligrosos para la salud de los pacientes, los trabajadores, la comunidad o el entorno, ya sea en forma directa o transformados en residuos con potencial impacto ambiental. En el marco de la estrategia de Hospitales Sostenibles, se tiende a limitar la exposición a estos insumos minimizando su uso o reemplazándolos gradualmente por equivalentes de riesgo menor. Sin embargo, y con independencia de los márgenes de seguridad establecidos, la evaluación del impacto ambiental a lo largo de la cadena de valor no forma parte constitutiva del análisis costo-beneficio que antecede a la decisión de su adquisición y empleo. Este trabajo se propuso evaluar una herramienta de análisis económico-ambiental que permita seleccionar la alternativa más sostenible. MÉTODOS: Se utilizó el Proceso de Análisis Jerárquico para incorporar atributos ambientales en la evaluación de múltiples criterios aplicables a productos de similares propiedades e intención de uso con materiales potencialmente peligrosos. RESULTADOS: Se relevaron 125 productos o familias de productos médicos, y 93 cumplían los criterios de inclusión. Se observó una alta prevalencia de productos fabricados en PVC. DISCUSIÓN: La herramienta, que introduce criterios ambientales en el proceso de evaluación, es un instrumento eficaz para decidir una adquisición o incorporación al activo tecnológico de un establecimiento sanitario.