The medicine selection process in four large university hospitals in Brazil: Does the DTC have a role?

Knowledge about evidence-based medicine selection and the role of the Drug and Therapeutics Committee (DTC) is an important topic in the literature but is scarcely discussed in Brazil. Our objective, using a qualitative design, was to analyze the medicine selection process performed in four large university hospitals in the state of Rio de Janeiro. Information was collected from documents, interviews with key informants and direct observations. Two dimensions were analyzed: the structural and organizational aspects of the selection process and the criteria and methods used in medicine selection. The findings showed that the DTC was active in two hospitals. The structure for decision-making was weak. DTC members had little experience in evidence-based selection, and their everyday functions did not influence their participation in DTC activities. The methods used to evaluate evidence were inadequate. The uncritical adoption of new medicines in these complex hospital facilities may be hampering pharmaceutical services, with consequences for the entire health system. Although the qualitative approach considerably limits the extent to which the results can be extrapolated, we believe that our findings may be relevant to other university hospitals in the country

Interaction between prescribers, dispensers, and patients: shared information as a possible therapeutic benefit

Submitted by Fátima Lopes ([email protected]) on 2019-02-19T15:52:48Z No. of bitstreams: 1 InteraçãoPrescritores.pdf: 46529 bytes, checksum: 8ff22be1c2236f0b70cb276d891d916f (MD5)Approved for entry into archive by Fátima Lopes ([email protected]) on 2019-02-19T16:32:11Z (GMT) No. of bitstreams: 1 InteraçãoPrescritores.pdf: 46529 bytes, checksum: 8ff22be1c2236f0b70cb276d891d916f (MD5)Made available in DSpace on 2019-02-19T16:32:11Z (GMT). No. of bitstreams: 1 InteraçãoPrescritores.pdf: 46529 bytes, checksum: 8ff22be1c2236f0b70cb276d891d916f (MD5) Previous issue date: 2000Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Rio de Janeiro, RJ, Brasil.O texto apresenta uma visão crítica da interação entre prescritores, dispensadores e pacientes, vislumbrando, na informação, um dos fatores-chave para o desenvolvimento qualitativo dessa complexa relação. Descreve, além do aporte de informações por parte desses profissionais de saúde, as fontes às quais possivelmente terão acesso e alguns fatores envolvidos na transformação da informação em conhecimento. Relata os papéis dos profissionais que exercem o ato da prescrição e da dispensação, as expectativas do paciente como alvo dos serviços prestados e as conseqüências das ações de saúde envolvidas no processo.The article presents a critical view of the interaction between prescribers, dispensers, and patients, considering information one of the key issues in enhancing the qualitative aspects involved in this complex relationship. It describes the acquisition of information by health professionals, possible sources of this information, and the process involved in transforming it into knowledge. Briefly discussed are the physician's and pharmacist's roles, the patient's expectations as recipient, and consequences of pertinent health interventions

A methodological approach for the evaluation of preparedness of pharmaceutical services

OBJECTIVE: The aim of this article is to provide an outcome evaluation model for preparedness of pharmaceutical services (PS) in disaster situations. METHODS: A five-step evaluation model development was conducted. The first step was a search of disaster preparedness and PS literature. The second step consisted of a description of the political and organizational aspects, external context, implementation, and performance of PS in disaster preparedness. A theoretical model on PS preparedness in disaster situations, encompassing pharmaceutical services variables and measures of preparedness, was developed as the third step. The fourth step produced a comprehensive theoretical model for evaluating PS preparedness, combining the two approaches used in steps two and three. The fifth and final step examined the development of the indicator framework. RESULTS: The results of this methodological approach are presented in the logic model of PS preparedness and the indicator framework, both of which were developed based on the disaster preparedness and PS literature and organized to provide a structured evaluation approach. CONCLUSIONS: PS was conceptualized as a program that can be evaluated by measurable effects. These effects can only be measured based on documented, on-site conditions before and after an event recognized as a disaster situation. This conceptual approach is context-modulated and therefore only applicable where the logistic cycle has been adopted as the rationale for PS

Proposed methodology for monitoring antiretroviral drugs price negotiations in Latin America and the Caribbean Propuesta de metodología para monitorear la negociación de precios de los medicamentos antirretrovirales en América Latina y el Caribe

OBJECTIVES: The spread of HIV/AIDS challenges governments to provide antiretroviral (ARV) treatment at affordable prices, and various initiatives have been developed with that intent. In Latin America and the Caribbean, four subregional negotiations were conducted during 2002-2005 to reduce drug prices and thus broaden access to ARVs. Studies were carried out to monitor the negotiations, and the development of a monitoring methodology was recommended. The objective of the current study was to develop and describe a potential methodology for monitoring ARV price negotiations. METHODS: The study, carried out in 2006-2007, consisted of a design phase and validation phase. The design phase included an extensive literature review and development of a theoretical framework. Validation was performed using health professional consensus and pilot studies in three countries-Barbados, Honduras, and Peru-representing the Caribbean, Central American, and Andean subregions. RESULTS: The results included a detailed logic model and a 40-indicator framework. Both were tested in the field. Indicators were evaluated for feasibility, pertinence, and sensitivity, based on the outcome of the pilot study. CONCLUSIONS: This monitoring methodology is designed to help countries self-evaluate progress toward implementation of ARV price negotiations. The results of the pilot study indicate that its implementation in the field helped elucidate the ARV price negotiation process by identifying local conditions and indirectly measuring countries' negotiating capacities.<br>OBJETIVO: La diseminación del VIH/sida exige de los gobiernos suministrar el tratamiento antirretroviral (ARV) a precios asequibles y se han desarrollado varias iniciativas con ese fin. En América Latina y el Caribe se han realizado cuatro negociaciones subregionales entre 2002 y 2005 para reducir los precios de los medicamentos y así ampliar el acceso a los ARV. Se han realizado estudios para monitorear las negociaciones y se ha propuesto crear una metodología de monitoreo. El objetivo del presente trabajo fue desarrollar y describir una posible metodología para el monitoreo de las negociaciones de los precios de los ARV. MÉTODOS: El estudio, realizado en 2006-2007, constó de las fases de diseño y validación. En la fase de diseño se hizo una extensa revisión de la literatura y se desarrolló un marco teórico. La validación se realizó mediante un análisis de consenso de profesionales de la salud y un estudio piloto en tres países -Barbados, Honduras y Perú- en representación del Caribe, América Central y la subregión andina. RESULTADOS: Se obtuvo un detallado modelo logístico y un marco conceptual de 40 indicadores. Ambos se probaron en el terreno. Se evaluaron la factibilidad, pertinencia y sensibilidad de los indicadores según los resultados del estudio piloto. CONCLUSIONES: Esta metodología de monitoreo se diseñó para ayudar a los países a autoevaluar sus progresos en la implementación de la negociación de precios de los ARV. Los resultados del estudio piloto indican que su implementación en el terreno ayudó a esclarecer el proceso de negociación de los precios de los ARV mediante la identificación de las condiciones locales y la medición indirecta de la capacidad de negociación de los países

Dispensing and determinants of non-adherence to treatment for non complicated malaria caused by Plasmodium vivax and Plasmodium falciparum in high-risk municipalities in the Brazilian Amazon

Background: In Brazil, 99.7 % of malaria cases occur in the Amazon region. Although the number of cases is decreasing, the country accounted for almost 60 % of cases in the Americas Region, in 2013. Novel approaches for malaria treatment open the possibility of eliminating the disease, but suboptimal dispensing and lack of adherence influence treatment outcomes. The aim of this paper is to show the results on dispensing practices, non-adherence and determinants of non-adherence to treatment of non-complicated malaria. Methods: The study was conducted in six high-risk municipalities with Plasmodium vivax and Plasmodium falciparum transmission in the Brazilian Amazon and based on the theoretical framework of the Mafalda Project, which included investigation of dispensing and adherence. The World Health Organization Rapid Evaluation Method has been used to estimate sample size. Individuals over 15 years of age with malaria were approached at health facilities and invited to participate through informed consent. Data was collected in chart review forms focusing on diagnosis, Plasmodium type, prescribing, and dispensing (kind, quantity, labelling and procedures). Follow-up household interviews complemented data collection at health facility. Non-adherence was measured during the implementation phase, by self-reports and pill-counts. Analysis was descriptive and statistical tests were carried out. Determinants of non-adherence and quality of dispensing were assessed according to the literature. Results: The study involved 165 patients. Dispensing was done according to the national guidelines. Labelling was adequate for P. vivax but inadequate for P. falciparum medicines. Non-adherent patients were 12.1 % according to self-reports and 21.8 % according to pill-counts. Results point to greater non-adherence among all P. falciparum patients and among malaria non-naive patients. More patients informed understanding adverse effects than `how to use' anti-malarials. Conclusions: Non-adherent patients were mostly those with a P. falciparum diagnosis and those in their second or more malaria episode. New taxonomies and concepts on adherence stress the importance of focusing on the individual patient. Interventions targeted to and tailored for malaria patients must be addressed by health policy and implemented by managers and clinicians

Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis

Background. Most cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings. The study examined whether characteristics of available evidence at FDA approval influenced time-to-marketing authorisation (MA) in Brazil, and price differences between the two countries. Methods. All new FDA-approved cancer drugs from 2010-2019 were matched to drugs with MA and prices approved in Brazil by December 2020. Characteristics of main studies, availability of randomised controlled trials (RCTs), overall survival (OS) benefit, added therapeutic benefit, and prices were compared. Findings. Fifty-six FDA-approved cancer drugs with matching indications received Brazilian MA after a median of 522 days following US approval (IQR: 351-932). Earlier authorisation in Brazil was associated with availability of RCT (median: 506 vs 760 days, p=0·031), and evidence of OS benefit (390 vs 543 days, p=0·019) at FDA approval. At Brazilian marketing authorisation, a greater proportion of cancer drugs had main RCTs (75% vs 60·7%), and OS benefit (42·9% vs 21·4%) than that in the US. Twenty-eight (50%) drugs did not demonstrate added therapeutic benefit over drugs for the same indication in Brazil. Median approved prices of new cancer drugs were 12·9% lower in Brazil compared to the US (adjusted by Purchasing Power Parity). However, for drugs with added therapeutic benefit median prices were 5·9% higher in Brazil compared to the US, while 17·9% lower for those without added benefit. Interpretation. High-quality clinical evidence accelerated the availability of cancer medicines in Brazil. The combination of marketing and pricing authorisation in Brazil may favour the approval of cancer drugs with better supporting evidence, and more meaningful clinical benefit albeit with variable degree of success in achieving lower prices compared to the US