Thiago Botelho Azeredo

Access to medicines in Latin America and the Caribbean (LAC): a scoping study

Objective To assess scientific publication and map research gaps on access to medicines (ATM) in Latin American and the Caribbean low-income and middle-income countries (LMIC). Design Scoping review. Two independent reviewers assessed studies for inclusion and extracted data from each study. Information sources Search strategies were developed and the following databases were searched: MEDLINE, ISI, SCOPUS and Lilacs, from 2000 to 2010. Eligibility criteria Research articles and reviews published in English, Spanish and Portuguese were included. Studies including only high-income countries were excluded, as well as those carried out in very limited settings and discussion papers. Results The 77 articles retained were categorised through consensus among the research team according to the level of the health system addressed, ATM domain and research issues covered. Publications on ATM have increased over time during the study period (r 0.93, p=0.00; R2 0.85). The top five countries covered were Brazil (68.8%), Mexico (15.6%), Colombia (11.7%), Argentina (10.4%) and Peru (10.4%). ‘Health services delivery’ and ‘patients, household and communities’ were the health system levels most frequently covered. The ATM domains ‘leadership and governance’, ‘sustainable financing, affordability and price of medicines’, ‘medicines selection and use’ and ‘availability of medicines’ were the top four explored. There are research gaps in important areas such as ‘human resources for health’, ‘global policies and human rights’, ‘production of medicines’ and ‘traditional medicine’. Conclusions The upward trend on scientific publication reflects a growing research capacity in the region, which is concentrated on research teams in selected countries. The gaps on research capacity could be overcome through research collaboration among countries. It is important to strengthen these collaborations, assuring that interests and needs from the LMIC are addressed and local capacity building is promoted.

Logic models from an evaluability assessment of pharmaceutical services for people living with HIV/AIDS

Brazil was the first developing country to provide people living with HIV/AIDS (PLWA) with comprehensive, universal, free access to antiretroviral medicines (ARV). Pharmaceutical services are considered a strategic action that has the goal of providing access to rational use of quality medicines while also promoting user satisfaction. User satisfaction is a complex concept, and evaluation models for pharmaceutical services for PLWA were not found in the literature. Therefore, an evaluation approach to help assess this issue had to be developed. This article seeks to describe a theoretical evaluation model of user satisfaction with the dispensing of ARV, developed as part of an Evaluability Assessment (EA). It presents a brief review of the EA and user satisfaction and describes the development of models created during the EA. The lessons learned in the process are presented as a conclusion.O Brasil foi o primeiro pais em desenvolvimento a fornecer medicamentos antiretrovirais (ARV) de forma integral, universal e gratuita as pessoas vivendo com HIV/Aids (PVHA). A Assistencia Farmaceutica e considerada uma acao estrategica e busca prover acesso a medicamentos de qualidade, com uso racional, promovendo a satisfacao dos usuarios. Satisfacao do usua-rio e um conceito complexo e modelos para avaliarem servicos farmaceuticos para PVHA nao sao encontrados na literatura. Este artigo objetiva descrever o desenvolvimento de tres modelos criados em um Estudo de Avaliabilidade (EA). E apresentada uma breve revisao dos conceitos de EA e de Satisfacao do Usuario. As licoes apreendidas no processo sao apresentadas como conclusao.

Construindo Critérios de Julgamento em Avaliação: especialistas e satisfação dos usuários com a dispensação do tratamento do HIV/Aids

A criterion is a typical tool in the evaluation field that can be defined as a standard-dimension under which the object of an evaluation receives qualitative or quantitative judgments. During an evaluation, several rigorous methodological procedures are involved in development and application of suitable criteria to determine the value of the object being evaluated. This article presents a set of criteria to evaluate user satisfaction with HIV/Aids-related pharmaceutical delivery services. The criteria construction process involved consensus amongst different experts, from academia, NGOs, management, by means of the Delphi technique. This technique prescribes a series of formal steps towards a consensus of experts, based on pre-structured methodology and processes. The findings were systematically organized in a structure under which the resulting satisfaction criteria are hierarchically organized. Results suggest the importance of developing a methodological strategy in evaluation that involves participation of different actors and of enhancing knowledge on user satisfaction and pharmaceutical delivery services for HIV/Aids.

Policy change and the National Essential Medicines List development process in Brazil between 2000 and 2014: has the Essential Medicine concept been abandoned?

Brazil has had a National Essential Medicines List (EML) since 1964. From 2000 to 2010, five consecutive evidence‐based editions were produced, building on the essential medicine concept. In 2012, the government changed course to establish a new paradigm, introducing adoption of new medicines as the main aim within the recommendation process. The objective of the article was to report efforts to develop Brazils national EML, policy changes from 2000 to 2014, discussing results, challenges and perspectives. Brazilian EML history and development process were collected from legislation, minutes, reports and legal ordinances, from 2000 to 2014. The Brazilian EML and the WHO Model Lists were compared using the Anatomical Therapeutic Chemical system. Overlap between lists was verified, and linear trends were produced. Type of membership, inclusion criteria, procedures, flow and listed medicines varied greatly between the selection committees acting before and after 2012. Paradigm‐changing legislation aiming at linking list compliance to public financing in 2012 produced (i) greater importance given to political and administrative stakeholders, (ii) increasing trends in number of medicines over the years, (iii) decrease in use of WHO Model List as a reference and (iv) substitution of an essential medicines list review and update process by an adoption decision output. Other issues remained unchanged. Insufficient efforts for list implementation, such as lack of physician education, presented consequences to the health system. Substantial efforts were made to produce and update the list from 2000 to 2014. However, continuous and intense health litigation disproves process outcome effectiveness.

Política Nacional de Medicamentos em retrospectiva: um balanço de (quase) 20 anos de implementação

Resumo A assistencia farmaceutica (AF) e a formulacao de politicas de medicamentos sao campos de atuacao do Sistema Unico de Saude (SUS). Assim, em 1998, apos um processo participativo, a Politica Nacional de Medicamentos (PNM) foi aprovada e publicada em portaria. A PNM traz em seu cerne, baseadas nos principios e diretrizes do SUS, diretrizes e prioridades para balizar as acoes das tres esferas de Governo no alcance do objetivo essencial da politica. A fim de conduzir o leitor a momentos de reflexao sobre esse periodo de vida da politica, o artigo se propoe a fazer um balanco dos quase 20 anos da PNM, com a discussao de algumas diretrizes especificas a luz de principios do SUS. Nao se pretendeu exaurir todas as atividades do periodo, mas aproximar se daquelas que se destacaram por apontar avancos e dilemas, com potenciais riscos de retrocessos. Vislumbrou-se esforcos de implementacao de uma agenda ambiciosa para a AF, que tentou lidar com desafios de enfrentamento do mercado farmaceutico, da operacionalizacao da AF dentro do SUS. Apesar dos principios do SUS serem reconhecidos nas diferentes iniciativas, identifica-se tambem que a operacionalizacao traz uma serie de contradicoes e riscos que podem comprometer alguns desses principios.Pharmaceutical services and the formulation of a medicines policy are SUS areas ensured by the organic health care law 8,080/90. Thus, after a widely participative process, involving stakeholders, the National Medicines Policy (NMP) was approved in 1998 by Ordinance 3,916.The NMP presents directives and priorities, aligned with organic health care law, which should guide the federal, states and municipals entities actions to achieve the policy goals. Considering almost 20 years of the NMP, this paper took stock discussed some of the directives in light of the SUS principles. It was not the objective to provide an exhaustive review of all the activities performed during this period. The authors tried to get close to those that have brought advances and dilemmas, with potential risk of regression. Efforts to implement an ambitious agenda applied to pharmaceutical services were identified. This agenda tried to deal with different challenges like the dynamics of the pharmaceutical market and the operation of pharmaceutical services to guarantee the supply of medicines aligned with principles and directives of SUS.

Adaptacao brasileira de questionario para avaliar adesao terapeutica em hipertensao arterial

OBJECTIVE To describe the cross-cultural adaptation of the questionnaire evaluating adhesion to treatment for arterial hypertension from its original Spanish version to a Portuguese version, to be applied in Brazil. METHODS In order to establish conceptual, semantic and operational equivalents of the items, two independent translations to Portuguese, and two back-translations into Spanish were performed. The translations and back-translations were assessed for changes in referential and general meanings. The synthesis of the translations was applied in pre-tests with patients with arterial hypertension and/or diabetes, which were important to identify different problems and confirm earlier decisions. RESULTS In general, the second translation and back translation were evaluated more positively because the translation process did not affect the meanings in five of the twelve items of the questionnaire. Operational changes were made and a vignette with response options and an example included in the instrument facilitated application in interviews. CONCLUSIONS The results obtained in the process of evaluating the items’ conceptual, semantic and operational equivalence allowed the construction of a Portuguese version of the MBG questionnaire to assess adherence to treatment which can be applied in the Brazilian context.

Sustainability of ARV provision in developing countries: challenging a framework based on program history

The provision of ARVs is central to HIV/AIDS programs, because of its impact on the course of the disease and on quality of life. Although first-line treatments costs have declined, treatment-associated expenses are steeper each year. Sustainability is therefore an important variable for the success of treatment programs. A conceptual framework on sustainability of ARV provision was developed, followed by data collection instruments. The pilot study was undertaken in Brazil. Bolivia, Peru and Mozambique, were visited. Key informants were identified and interviewed. Investigation of sustainability related to ARV provision involved implementation and routinization events of provision schemes. Evidence of greater sustainability potential was observed in Peru, where provision is implemented and routinized by the National HIV/AIDS program and expenditures met by the government. In Mozambique, provision is dependent on donations and external aid, but the country displays a great effort to incorporate ARV provision and care in routine healthcare activities. Bolivia, in addition to external dependence on financing and management of drug supply, presents problems regarding implementation and routinization. The conceptual framework was useful in recognizing events that influence sustainable ARV provision in these countries.

Stakeholders’ perspectives on access-to-medicines policy and research priorities in Latin America and the Caribbean: face-to-face and web-based interviews

BackgroundThis study aims to rank policy concerns and policy-related research issues in order to identify policy and research gaps on access to medicines (ATM) in low- and middle-income countries in Latin America and the Caribbean (LAC), as perceived by policy makers, researchers, NGO and international organization representatives, as part of a global prioritization exercise.MethodsData collection, conducted between January and May 2011, involved face-to-face interviews in El Salvador, Colombia, Dominican Republic, and Suriname, and an e-mail survey with key-stakeholders. Respondents were asked to choose the five most relevant criteria for research prioritization and to score policy/research items according to the degree to which they represented current policies, desired policies, current research topics, and/or desired research topics. Mean scores and summary rankings were obtained. Linear regressions were performed to contrast rankings concerning current and desired policies (policy gaps), and current and desired research (research gaps).ResultsRelevance, feasibility, and research utilization were the top ranked criteria for prioritizing research. Technical capacity, research and development for new drugs, and responsiveness, were the main policy gaps. Quality assurance, staff technical capacity, price regulation, out-of-pocket payments, and cost containment policies, were the main research gaps. There was high level of coherence between current and desired policies: coefficients of determination (R2) varied from 0.46 (Health system structure; r = 0.68, P <0.01) to 0.86 (Sustainable financing; r = 0.93, P <0.01). There was also high coherence between current and desired research on Rational selection and use of medicines (r = 0.71, P <0.05, R2 = 0.51), Pricing/affordability (r = 0.82, P <0.01, R2 = 0.67), and Sustainable financing (r = 0.76, P <0.01, R2 = 0.58). Coherence was less for Health system structure (r = 0.61, P <0.01, R2 = 0.38).ConclusionsThis study combines metrics approaches, contributing to priority setting methodology development, with country and regional level stakeholder participation. Stakeholders received feedback with the results, and we hope to have contributed to the discussion and implementation of ATM research and policy priorities in LAC.

Brazilian adaptation of the questionnaire to assess adherence to treatment for arterial hypertension.

OBJECTIVE To describe the cross-cultural adaptation of the questionnaire evaluating adhesion to treatment for arterial hypertension from its original Spanish version to a Portuguese version, to be applied in Brazil. METHODS In order to establish conceptual, semantic and operational equivalents of the items, two independent translations to Portuguese, and two back-translations into Spanish were performed. The translations and back-translations were assessed for changes in referential and general meanings. The synthesis of the translations was applied in pre-tests with patients with arterial hypertension and/or diabetes, which were important to identify different problems and confirm earlier decisions. RESULTS In general, the second translation and back translation were evaluated more positively because the translation process did not affect the meanings in five of the twelve items of the questionnaire. Operational changes were made and a vignette with response options and an example included in the instrument facilitated application in interviews. CONCLUSIONS The results obtained in the process of evaluating the items’ conceptual, semantic and operational equivalence allowed the construction of a Portuguese version of the MBG questionnaire to assess adherence to treatment which can be applied in the Brazilian context.

Adaptacion brasilena de cuestionario para evaluar adhesion terapeutica en hipertension arterial

OBJECTIVE To describe the cross-cultural adaptation of the questionnaire evaluating adhesion to treatment for arterial hypertension from its original Spanish version to a Portuguese version, to be applied in Brazil. METHODS In order to establish conceptual, semantic and operational equivalents of the items, two independent translations to Portuguese, and two back-translations into Spanish were performed. The translations and back-translations were assessed for changes in referential and general meanings. The synthesis of the translations was applied in pre-tests with patients with arterial hypertension and/or diabetes, which were important to identify different problems and confirm earlier decisions. RESULTS In general, the second translation and back translation were evaluated more positively because the translation process did not affect the meanings in five of the twelve items of the questionnaire. Operational changes were made and a vignette with response options and an example included in the instrument facilitated application in interviews. CONCLUSIONS The results obtained in the process of evaluating the items’ conceptual, semantic and operational equivalence allowed the construction of a Portuguese version of the MBG questionnaire to assess adherence to treatment which can be applied in the Brazilian context.