Public Programs for Essential Medicine Access in a Small Municipality: A Cross-Sectional Analysis

Abstract Background: Public programs that provide access to essential medications have played an important role in the care of hypertensive and diabetic patients. However, access in small municipalities has been poorly studied. Objectives: To describe the sociodemographic profile and the medication and health service usage of patients with systemic arterial hypertension and/or diabetes mellitus in a small municipality who use the public medication access programs Health has no Price (Saúde Não Tem Preço - SNTP) and the Minas Pharmacy Network. Methods: This cross-sectional study with 341 participants was conducted in 2019. Home interviews were conducted using a standardized, semi-structured questionnaire. The data are expressed as absolute and relative frequencies, and Pearson's chi-square test was used for comparisons between proportions (α = 5%). Results: Most of the participants (70.68%) had hypertension only, 11.14% had diabetes only, and 18.18% had both. Regarding the origin of the hypertension medications, 82.67% were provided by the Minas Pharmacy Network and/or SNTP programs. Regarding oral hypoglycemic agents and insulins, 88.61% were provided by the Minas Pharmacy Network and/or SNTP. Most participants were female (63.1%), at least 65 years of age (50.30%), non-White (66.96%), resided in an urban area (67.16%), were illiterate or had a low education level (89.94%), and had a maximum income ≤ 2 times the federal minimum salary (89.19%). Overall user perception was significantly better for SNTP (p=0.010). Conclusion: The results of this study indicate that programs which provide access to essential medications are important sources of hypertension and diabetes medications in the study area, especially for people with low incomes.

Effect of free trade agreements on pharmaceutical market competition: The case of the 2009 US-Peru free trade agreement and its implementation as national drug policy.

Free Trade Agreements (FTA) are controversial for threatening essential aspects of health, especially access to affordable medicines. The US-Peru FTA required changes in the Peruvian pharmaceutical legislation that resulted in the implementation of the National Drug Policy (NDP) of 2009. The NDP included more robust technical requirements for registration, a Peruvian Good Manufacturing Practices certificate, a longer timeline for drug registration, and an increase in registration fees. This study evaluated the impact of the FTA on the number of registrations and competition in the Peruvian pharmaceutical market. Data for the period January 2005 to April 2014 were provided by the Peruvian drug regulatory authority (Dirección General de Medicamentos, Insumos y Drogas, DIGEMID). A total of 31,114 pharmaceutical products with unique registration numbers were evaluated. Brand drug new registrations decreased from 1789 in 2005 to 455 in 2013, and the number of generic registrations decreased from 621 in 2005 to 114 in 2013. Brand re-registrations also decreased from 714 in 2005 to 58 in 2013. There were 228 brand products awaiting registration in 2009 and 1,908 in 2013. The proportion of products awaiting registration was three times greater for brand than for generic products in 2009-2013. Registration of brand and generic medicines significantly declined after the implementation of the US-Peru FTA in 2009. The decline in the number of registrations was associated with more robust technical requirements, a longer DIGEMID registration timeline, and an increase in registration fees. The stronger registration requirements are expected to increase the quality of the drugs marketed in the country, but also less competition and a reduction in domestic registrations.

Practice Guidelines for Clinical Pharmacists in Middle to Low Income Countries.

The profession of pharmacy is maturing as a clinical profession in South Africa and has experienced significant development over the past 10 years. The development of clinical pharmacy in Southern Africa started in the late 1980s. The Director-General of Health and Welfare requested an expansion of the pharmacist's role in Southern Africa, in 1988, when he challenged pharmacists to be "more than just dispensers." South Africa experience human resource challenges in terms of healthcare service delivery and the shortage of pharmacists has been acknowledged. Due to the human resource shortage, it is very difficult to allocate pharmacists to work in a clinical unit on a daily basis. This document serves to set out practice guidelines for clinical pharmacy in South Africa, and to indicate areas where clinical pharmacist should concentrate to build practice.

International Experience in Therapeutic Value and Value-Based Pricing: A Rapid Review of the Literature.

OBJECTIVES: To characterize at a global level the concept of therapeutic value (TV) and describe the experience of value-based pricing (VBP) policies in 6 reference countries. METHODS: We conducted a rapid review of the literature that addressed 2 exploratory research questions. A systematic and exhaustive search was carried out up to July 2018 in MEDLINE (Ovid), Embase, Scopus, and Web of Science. RESULTS: The concepts of TV and VBP are related; value frameworks for medicines should include social preferences, comparative effectiveness, safety, adoption viability, social impact, high quality of evidence, severity of illness, and innovation. The added therapeutic value (ATV) is the manner of measuring the therapeutic advantages of new medicines compared with existing ones in terms of comparative effectiveness and safety. There are variations in the mechanisms of reimbursement and drug pricing regulation between the countries of study. CONCLUSION: In a VBP system it is essential to establish the TV and ATV of a new medicine. Although there are no methodological guidelines for the implementation of VBP policies, the process implies from the beginning the definition of TV categories that will be included in the drug pricing and reimbursement systems. Agreements between the pharmaceutical industry and governments have become a useful tool as a negotiating mechanism in most countries.

The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health / O caso do eculizumabe: judicialização e compras pelo Ministério da Saúde

ABSTRACT OBJECTIVES This study examined the purchases of eculizumab, a high-cost monoclonal antibody used in the treatment of rare diseases by Brazilian federal agencies, in terms of purchased quantities, expenditures, and prices. METHODS Eculizumab purchases made between March 2007 and December 2018 were analyzed, using secondary data extracted from the Federal Government Purchasing System (SIASG in Portuguese). The following aspects were assessed: number of purchases, purchased quantities, number of daily doses defined per 1,000 inhabitants per year, annual expenditures, and prices. The prices were adjusted by the National Broad Consumer Price Index for December 2018. Linear regression was used for trend analysis. RESULTS All acquisitions by federal agencies were made by the Brazilian Ministry of Health. The purchases began in 2009 with tender waiver to comply with legal demand. There was an increasing trend in the number of purchases and quantities acquired over time. Two hundred and eighty-three purchases were made, totaling 116,792 units purchased, 28.2% of them in 2018. The adjusted total expenses summed more than R$ 2.44 billion. After market approval by the Brazilian Health Regulatory Agency, the weighted average price fell approximately 35%, to values under the Medicines Market Chamber of Regulation established prices. CONCLUSION Eculizumab represented extremely significant expenditures for the Brazilian Ministry of Health during the period. All purchases were made to meet demands from lawsuits, outside the competitive environment. The market approval of eculizumab promoted an important price reduction. This study indicates the relevance of licensing and the need for permanent monitoring and auditing of drug purchases to meet legal demands.

RESUMO OBJETIVOS O estudo examinou as aquisições de eculizumabe, um anticorpo monoclonal de alto custo utilizado no tratamento de doenças raras, pelos órgãos federais brasileiros, em termos das quantidades compradas, gastos e preços. MÉTODOS Foram analisadas compras de eculizumabe realizadas entre março de 2007 e dezembro de 2018, por meio de dados secundários extraídos do sistema de compras do governo federal (Siasg). Foram examinados o número de compras, quantidades adquiridas, número de doses diárias definidas por 1.000 habitantes por ano, gastos anuais e preços praticados. Os preços foram corrigidos pelo índice nacional de preços ao consumidor amplo para dezembro de 2018. Regressão linear foi utilizada para análises de tendência. RESULTADOS Todas as aquisições por órgãos federais foram realizadas pelo Ministério da Saúde. As compras se iniciaram em 2009, sendo efetuadas por dispensa de licitação e para atendimento de demanda judicial. Houve tendência crescente no número de compras e quantidades adquiridas ao longo do tempo. Foram realizadas 283 compras, totalizando 116.792 unidades adquiridas, 28,2% compradas em 2018. Os gastos totais contratados corrigidos somaram mais de R$ 2,44 bilhões. Após a aprovação do registro pela Agência Nacional de Vigilância Sanitária, o preço médio ponderado caiu aproximadamente 35%, para valores abaixo dos preços estabelecidos pela Câmara de Regulação do Mercado de Medicamentos. CONCLUSÃO O eculizumabe representou gastos extremamente significativos para o Ministério da Saúde no período. Todas as compras foram feitas para atendimento de demandas judiciais, fora do ambiente competitivo. Seu registro promoveu queda importante nos preços praticados. O estudo aponta a relevância do registro sanitário e da necessidade de monitoramento e auditoria permanentes das compras de medicamentos para atendimento de demandas judiciais.

Análise das demandas judiciais por medicamentos no Estado do Rio Grande do Norte / Analysis of lawsuits for medicines in the State of Rio Grande do Norte

A judicialização da saúde, especialmente no acesso a medicamentos, é um fenômeno complexo, multifatorial que envolve aspectos técnico-científicos, legais, econômicos e sociais, podendo trazer implicações diversas para a saúde pública. Com o reconhecimento constitucional da saúde como um direito e a implantação do Sistema Único de Saúde (SUS), um número cada vez maior de cidadãos tem buscado o Poder Judiciário para garantir a promessa constitucional, e o número de processos tem crescido ao longo dos anos. Dada sua relevância, o tema da judicialização vêm sendo debatido em diversos espaços: na sociedade, no meio acadêmico, por instituições jurídicas e por gestores da saúde. Entretanto ainda não foi possível traçar um panorama nacional da judicialização de medicamentos no Brasil, havendo uma marcante concentração de pesquisas nas regiões Sudeste e Sul do país. Nesse contexto, o objetivo desse estudo foi identificar e analisar as demandas judicias por medicamentos no Estado do Rio Grande do Norte, buscando descrever as características sociodemográficas, médico-sanitárias e judiciais das ações, fazendo uma análise à luz das políticas de medicamentos vigentes e analisando suas possíveis interfaces com o processo de incorporação de tecnologias no SUS. Para tanto, foi conduzido um estudo descritivo, exploratório e retrospectivo, cuja unidade de análise foram os processos individuais solicitando medicamentos ao Estado do Rio Grande do Norte, entre os anos de 2013 a 2017. Os dados foram obtidos junto a Secretaria Estadual de Saúde Pública (SESAP/RN), e as informações dos processos foram coletadas através de consulta ao sítio eletrônico do Tribunal de Justiça do RN. Foram analisados 987 processos, em que foram solicitados 1517 medicamentos. A maioria dos demandantes foi do sexo feminino (58,8%), residentes no interior do Estado, com idade média de 48,3 anos, representadas predominantemente por assistência jurídica pública (52,8%) e com prescrição oriunda de serviços médicos privados (38,1%). A maioria dos medicamentos pleiteados (61,7%) não estavam incorporados ao SUS, porém, em 75% dos casos, havia alternativa terapêutica. Em 13,6% das ações, ao menos 1 medicamento foi prescrito para uso off-label. Mesmo os medicamentos judicializados que faziam parte da Relação Nacional de Medicamentos Essenciais (Rename), foram constantemente solicitados para indicações não recomendadas nos protocolos oficiais. Em 68% dos casos, houve acesso ao medicamento, sendo o autor responsável pela compra em 56,1% deles, via bloqueio de verbas públicas. O medicamento mais solicitado foi a insulina glargina (74 pedidos). Medicamentos não disponíveis no SUS e frequentemente solicitados nas demandas judiciais tendem a ser incorporados posteriormente, passando a integrar a política de saúde. Dos 10 medicamentos com maior número de ações judiciais, 4 foram posteriormente incorporados ao SUS, com destaque para as insulinas análogas. Em relação ao processo de incorporação desses medicamentos, observou-se que predominaram demandas internas (60%), e a minoria contou com avaliações econômicas (40%), sendo a principal justificativa utilizada no embasamento das decisões, a presença de evidência científica. Porém, foi observada mudança de posicionamento após a expressiva participação em consultas públicas e a judicialização dos medicamentos é mencionada em alguns relatórios. Os resultados mostraram que a via judicial tem se consolidado como forma de acesso a medicamentos no Rio Grande do Norte, inclusive por cidadãos residentes no interior do Estado, que conseguem assistência jurídica gratuita. Foram solicitados principalmente medicamentos ainda não incorporados ao SUS, e essas solicitações frequentemente violaram regras sanitárias e de gestão da Assistência Farmacêutica. O bloqueio de verbas públicas para o cumprimento dessas decisões é outro fator preocupante para o gestor do SUS, pois compromete a execução das políticas de medicamentos programadas, podendo enfraquecer a execução dessas. No processo de incorporação de medicamentos alvo de demandas judiciais, observou-se que apesar da preponderância do embasamento técnico-científico nas decisões de incorporação de medicamentos no SUS, houve influência indireta da judicialização no processo de tomada de decisão (AU).

The judicialization of health, especially in access to medicines, is a complex and multifactorial phenomenon that involves technical-scientific, legal, economic and social aspects, and may have different implications for public health. With the constitutional recognition of health as a right and the implementation of the Unified Health System (Sistema Único de Saúde - SUS), an increasing number of citizens have sought the Judiciary to guarantee the constitutional promise, and the number of lawsuits has grown over the years. As a relevant question, the theme of judicialization has been debated in several spaces: in society, in academia, by legal institutions and by health managers. However, it has not yet been possible to draw a national panorama of the judicialization of medicines in Brazil, with a marked concentration of research in the Southeast and South regions of the country. In this context, the aim of this study was to identify and analyze the lawsuits for medicines in the State of Rio Grande do Norte, describing the sociodemographic, medical-sanitary and judicial characteristics of the processes, making an analysis in the light of current drug policies and evaluating its possible interfaces with the process of incorporating technologies into SUS. It was conducted a descriptive, exploratory and retrospective, whose unit of analysis was the individual processes requesting medicines from the State of Rio Grande do Norte, between the years 2013 to 2017. The data were collected from the State Department of Public Health (SESAP/RN), and the information on the cases was collected through consultation with the website of the Court of Justice of RN. Nine hundred eighty-seven (987) processes were analyzed, in which 1517 medicines were requested. Most of the claimants were female (58.8%), residing in the interior of the State, with an average age of 48.3 years, represented predominantly by public legal assistance (52.8%) and with prescription from private medical services (38.1%). Most of the requested drugs (61.7%) were not incorporated into SUS, however, in 75% of the cases, there was a therapeutic alternative. In 13.6% of the actions, at least 1 medicine was prescribed for off-label use. Even the judicialized drugs that were part of the National List of Essential Medicines (Rename), were constantly requested for indications not recommended in official protocols. In 68% of the cases, access to the drug was available, with the author responsible for the purchase in 56.1% of them, through blocking public funds. The most requested medicine was insulin glargine (74 lawsuits). Drugs not available in SUS and frequently requested in court demands tend to be incorporated later, becoming part of health policy. Of the 10 drugs with the highest number of lawsuits, 4 were subsequently incorporated into SUS, mainly insulin analogues. Regarding the process of incorporating these drugs, it was observed that internal demands predominated (60%), and the minority had economic assessments (40%), the main justification used to support decisions being the presence of scientific evidence. However, a change of position was observed after the expressive participation in public consultations and the judicialization of medicines is mentioned in some reports. The results showed that the judicial system has been consolidated as a way of accessing medicines in Rio Grande do Norte, including by citizens residing in the interior of the State, who obtain free legal assistance. The most of the drugs requested were not yet incorporated into SUS, and these requests frequently violated health and Pharmaceutical Assistance management rules. The blocking of public funds for the fulfillment of these decisions is another worrying factor for the SUS manager, as it compromises the execution of the programmed medicines policies, which impair their execution. In the process of incorporating drugs targeted by lawsuits, it was observed that despite the preponderance of the technical-scientific basis in decisions to incorporate drugs into SUS, there was an indirect influence of judicialization in the decision-making process (AU).

A regra de solidariedade dos entes federados na área da saúde e sua atual interpretação pelo Supremo Tribunal Federal / The rule of solidarity of federated entities in the health area and its current interpretation by the Brazilian Federal Supreme Court

Objetivo: analisar a atual interpretação da regra constitucional de solidariedade no âmbito do Sistema Único de Saúde (SUS), após a manifestação da Suprema Corte em julgamento de recurso com fixação de precedente. Método: utilizou-se o método dedutivo para compreender e interpretar o sentido da solidariedade e suas consequências práticas; e método empírico-analítico para análise das premissas fixadas pela Suprema Corte. Resultados: observou-se aproximação entre o fundamento do precedente firmado e as manifestações dos enunciados 8 e 78, que são anteriores ao julgamento do recurso. Conclusão: o enfrentamento da judicialização da saúde se torna mais sólido a partir do julgamento do recurso e da criação dos enunciados. (AU).

Objective: to analyze the current interpretation of the constitutional rule of solidarity within the scope of the Brazilian Unified Health System (SUS), after the Supreme Court ruled in appeal judgment with precedent setting. Method: the deductive method was used to understand and interpret the meaning of solidarity and its practical consequences; and empirical-analytical method for analysis of the premises set by the Supreme Court. Results: we observed an approximation between the ground of precedent and the statements of statements 8 and 78, which are prior to the judgment of the appeal. Conclusion: the confrontation of the judicialization of health becomes more solid from the judgment of the appeal and the creation of the statements. (AU).

Objetivo: analizar la interpretación actual de la norma constitucional de solidaridad en el ámbito del Sistema Único de Salud (SUS) de Brasil, luego de que la Corte Suprema dictaminó en un juicio de apelación con un precedente. Método: el método deductivo se utilizó para comprender e interpretar el significado de solidaridad y sus consecuencias prácticas; y método empírico-analítico para el análisis de las premisas establecidas por la Corte Suprema. Resultados: Observamos una aproximación entre el fundamento del precedente y las declaraciones de las declaraciones 8 y 78, que son anteriores a la sentencia de la apelación. Conclusión: la confrontación de la judicialización de la salud se vuelve más sólida a partir del juicio de la apelación y la creación de las declaraciones. (AU).

Analysis of essential drugs lists of a regional healthcare coordination center in Rio Grande do Sul / Análise das listas de medicamentos essenciais de uma regional de saúde do Rio Grande do Sul

In Brazil municipalities are responsible for initiating the guarantee of access to essential medicines by selecting those that will be included in their lists. This study aimed to analyze how the Municipal Lists of Essential Medicines (MLEM) are prepared, as well as their comparison with the National List of Essential Medicines (RENAME) 2014, and what their similarities and differences are. The municipalities belong to the 11th Regional Healthcare Coordination Center of Rio Grande do Sul State. A questionnaire was applied to the Pharmaceutical Assistance managers to characterize the preparation of the lists that were compared between themselves and with RENAME 2014, later Cluster Analysis was used to determine similarities. A total of 23 municipalities and 22 lists were received for the analysis. The main criteria for elaboration were medical prescription, presence in RENAME and need of the population. RENAME was cited as the most widely used source of information. Ten drugs were present in all lists and the percentage of agreement with RENAME was 60.6%. These results point to the need for a balance between what is accomplished by the municipalities and what is recommended in selecting essential medications.

No Brasil os municípios são responsáveis pelo início da garantia de acesso aos medicamentos essenciais ao selecionar aqueles que farão parte de suas listas. Esta pesquisa objetivou analisar a elaboração, similaridades e diferenças das Relações Municipais de Medicamentos Essenciais (REMUMEs) dos municípios pertencentes a 11ª Coordenadoria Regional de Saúde do Estado do Rio Grande do Sul, bem como a comparação com a Relação Nacional de Medicamentos Essenciais (RENAME) 2014. A aplicação de um questionário aos gestores da Assistência Farmacêutica caracterizou a elaboração das listas que foram comparadas entre si e com a RENAME 2014, posteriormente foi utilizada análise de agrupamentos para as similaridades. Responderam ao questionário 23 municípios e 22 listas foram recebidas para a análise. Como principais critérios de elaboração, foram citadas a prescrição médica, presença na RENAME e necessidade da população. A RENAME foi referenciada como fonte de informação mais utilizada. Dez medicamentos estavam presentes em todas as listas e o percentual de concordância com a RENAME foi de 60,6%. Estes resultados apontam a necessidade de um equilíbrio entre o que é realizado pelos municípios e o que é recomendado para seleção de medicamentos essenciais.

National Survey on Access, Use and Promotion of Rational Use of Medicines: methods / Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos: métodos

ABSTRACT The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos -Serviços (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines - Services) aimed to characterize the organization of pharmaceutical services in the Primary Health Care of the Brazilian Unified Health System (SUS). PNAUM - Services is a cross-sectional and evaluative study, with planned sample of 600 cities, held between 2014 and 2015, composed of a remote phase, with telephone interviews with health managers. Of these 600 cities, 300 were selected for a survey on health services. We selected the 27 capitals, the 0.5% largest cities of each region, and the remaining cities were drawn. The estimate of the representative national sample size considered three levels: cities, medicine dispensing services, and patients. The interviews were carried out with a structured questionnaire specific for: municipal secretaries of health, professionals responsible for pharmaceutical services in the city, professionals responsible for the dispensing of medicines, physicians, and patients. The secondary data were obtained in official databases, in the latest update date. PNAUM - Services was the first nationwide research aimed at the assessment and acquisition of national and regional indicators on access to medicines, as well as use and rational use, from the perspective of various social subjects.

RESUMO A Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM) - componente Serviços teve por objetivo caracterizar a organização dos serviços de assistência farmacêutica na Atenção Básica do Sistema Único Saúde. A PNAUM - Serviços foi um estudo transversal, avaliativo, com amostra planejada de 600 municípios, realizado entre 2014 e 2015, composto por uma fase remota, com entrevistas telefônicas com gestores. Desses 600 municípios foram selecionados 300 para um inquérito em serviços de saúde. Foram selecionadas as 27 capitais, 0,5% dos maiores municípios de cada região e realizado um sorteio dos demais municípios. O cálculo do tamanho da amostra representativa nacional considerou três níveis: municípios, serviços de dispensação de medicamentos e usuários. As entrevistas foram realizadas com a utilização de um questionário estruturado específico para: secretário municipal de saúde, responsável pela assistência farmacêutica no município, responsável pela entrega de medicamentos, médico e usuário. Os dados secundários foram obtidos em bases oficiais, na data mais recente de atualização. A PNAUM - Serviços foi a primeira pesquisa de âmbito nacional visando a avaliação e obtenção de indicadores nacionais e regionais acerca de acesso a medicamentos, bem como utilização e uso racional, sob a ótica de variados atores sociais.

Management of pharmaceutical services in the Brazilian primary health care / Gestão da assistência farmacêutica na atenção primária no Brasil

ABSTRACT OBJECTIVE To identify limiting factors in the management of pharmaceutical services in the primary health care provided by the Brazilian Unified Health System (SUS). METHODS This study was based on the data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines), and it was conducted by interviews with professionals responsible for pharmaceutical services in Brazilian cities, in 2015. To identify the management limiting factors, we considered the organizational, operational, and sustainability indicators of the management. For the analyses, we included the weights and structure of analysis plan for complex samples. The results were expressed by frequencies and measures of central tendency with 95% confidence interval, considering the Brazilian geographic regions. RESULTS We identified the following limiting factors: lack of pharmaceutical services in the Municipal Health Secretariat organization chart (24%) and in the health plan (18%); lack of participation of managers in the Health Board and the absence of reference to this topic in the agenda of meetings (58.4%); lack of financial autonomy (61.5%) and lack of knowledge on the available values (81.7%); lack of adoption of operational procedures (about 50%) for selection, scheduling, and acquisition; and the fact that most professionals evaluate the organization of pharmaceutical services as good and great (58.8%), despite the worrisome indicators. CONCLUSIONS Pharmaceutical services management is currently supported by a legal and political framework that should guide and contribute to improve the pharmaceutical services in the Brazilian Unified Health System primary health care. However, there is a mismatch between the goals established by these guidelines and what is actually happening.

RESUMO OBJETIVO Identificar fatores condicionantes da gestão da assistência farmacêutica na atenção primária no âmbito do Sistema Único de Saúde. MÉTODOS Estudo com dados obtidos da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil (PNAUM) - Serviços, realizada por meio de entrevistas com responsáveis pela assistência farmacêutica em municípios, em 2015. Para identificar os fatores condicionantes da gestão foram considerados indicadores organizacionais, operacionais e de sustentabilidade da gestão. Para as análises consideraram-se os pesos amostrais e a estrutura do plano de análise para amostras complexas. Os resultados foram expressos por meio de frequências e medidas de tendência central com intervalo de confiança de 95%, por regiões geográficas do Brasil. RESULTADOS Foram identificados os fatores condicionantes: a ausência da assistência farmacêutica no organograma da secretaria (24%) e no plano de saúde (18%), a não participação dos gestores no conselho de saúde e a não referência desse tema na pauta das reuniões (58,4%), falta de autonomia financeira (61,5%) e conhecimento dos valores disponíveis (81,7%), falta de adoção de procedimentos operacionais em cerca de 50% para seleção, programação e aquisição e o fato da maioria avaliar a organização da assistência farmacêutica como boa e ótima (58,8%), apesar dos indicadores preocupantes apontados. CONCLUSÕES A gestão da assistência farmacêutica encontra-se respaldada em um arcabouço legal e político, que deveria nortear e contribuir para melhoria da assistência farmacêutica na atenção primária no Sistema Único de Saúde. No entanto, há um descompasso entre os objetivos fixados por essas normativas e o que se observa na realidade.

Free access to medicines for the treatment of chronic diseases in Brazil / Acesso gratuito a medicamentos para tratamento de doenças crônicas no Brasil

ABSTRACT OBJECTIVE To analyze the free access to medicines for the treatment of chronic diseases in the Brazilian population, according to demographic and socioeconomic factors. We also analyzed the most used pharmacological groups, according to funding source: free-of-charge or out-of-pocket paid. METHODS Analysis of data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines), a population-based household survey, of cross-sectional design, based on probabilistic sample of the Brazilian population. We analyzed as outcome the prevalence of free access (free-of-charge) to all medicines for treatment of the reported chronic diseases, in the last 30 days. We studied the following independent variables: sex, age group, education in complete years of school, economic class, health plan, and geographical region of residence. We estimated the prevalences and 95% confidence intervals (95%CI) and applied the Pearson’s Chi-squared test to assess the differences between the groups, considering a 5% significance level. RESULTS About half of adults and older adults who have had full access to the treatment of chronic diseases in Brazil obtained all needed medicines for free (47.5%; 95%CI 45.1–50.0). The prevalences of free access were higher among men (51.4%; 95%CI 48.1–54.8), age group of 40-59 years (51.1%; 95%CI 48.1–54.2), and in the poorest social classes (53.9%; 95%CI 50.2–57.7). The majority of medicines that act on the cardiovascular system, such as diuretics (C03) (78.0%; 95%CI 75.2–80.5), beta-blockers (C07) (62.7%; 95%CI 59.4–65.8), and the agents that work in the renin-angiotensin system (C09) (73.4%; 95%CI 70.8–75.8), were obtained for free. Medicines that act on the respiratory system, such as agents against obstructive airway diseases (R03) (60.0%; 95%CI 52.7–66.9) were mostly paid with own resources. CONCLUSIONS Free access to medicines for treatment of chronic diseases occurs to a considerable portion of the Brazilian population, especially for the poorest ones, indicating decreased socioeconomic inequalities, but with differences between regions and between some classes of medicines.

RESUMO OBJETIVO Analisar o acesso gratuito ao tratamento medicamentoso para doenças crônicas na população brasileira, segundo fatores socioeconômicos e demográficos. Analisaram-se também os grupos farmacológicos mais utilizados, segundo fonte de financiamento: gratuito ou pago do próprio bolso. MÉTODOS Análise de dados oriundos da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM), inquérito domiciliar de base populacional, de delineamento transversal, baseado em amostra probabilística da população brasileira. O desfecho analisado foi a prevalência de acesso gratuito (sem pagamento) a todos os medicamentos para tratamento das doenças crônicas referidas, nos últimos 30 dias. As variáveis independentes investigadas foram: sexo, faixa etária, escolaridade em anos completos de estudo, classe econômica, plano de saúde e região geográfica de residência. Foram estimadas as prevalências e calculados intervalos de 95% de confiança (IC95%) e aplicado o teste Qui-quadrado de Pearson para avaliação das diferenças entre os grupos, considerando nível de significância de 5%. RESULTADOS Cerca de metade dos adultos e idosos que tiveram acesso total ao tratamento de doenças crônicas no Brasil obtiveram todos os medicamentos que necessitavam gratuitamente (47,5%; IC95% 45,1–50,0). As prevalências de acesso gratuito foram maiores entre os homens (51,4%; IC95% 48,1–54,8), na faixa etária de 40-59 anos (51,1%; IC95% 48,1–54,2) e nas classes sociais mais pobres (53,9%; IC95% 50,2–57,7). Grande parte dos medicamentos que atuam no sistema cardiovascular, como os diuréticos (C03) (78,0%; IC95% 75,2–80,5), betabloqueadores (C07) (62,7%; IC95% 59,4–65,8) e os agentes que atuam no sistema renina-angiotensina (C09) (73,4%; IC95% 70,8–75,8) foram obtidos de forma gratuita. Os medicamentos que atuam no sistema respiratório como os agentes contra doenças obstrutivas das vias aéreas (R03) (60,0%; IC95% 52,7–66,9) foram na sua maioria pagos do próprio bolso. CONCLUSÕES O acesso gratuito aos medicamentos para tratamento das doenças crônicas ocorre para uma considerável parcela da população brasileira, principalmente para os mais pobres, indicando diminuição das desigualdades socioeconômicas, mas com diferenças regionais e entre algumas classes de medicamentos.

Determinantes de la equidad en el financiamiento de los medicamentos en Argentina: un estudio empírico / Determinants of equity in financing medicines in Argentina: an empirical study / Determinantes da equidade no financiamento de medicamentos na Argentina: um estudo empírico

Resumen Los medicamentos constituyen un alto porcentaje del gasto en salud de los hogares, por eso, tener un sistema progresivo de financiamiento de medicamentos es fundamental para lograr un sistema de salud equitativo. Se ha propuesto que los determinantes de la equidad en el financiamiento son socioeconómicos, demográficos y asociados a la intervención pública, sin embargo, se ha avanzado poco en su evaluación empírica y en la cuantificación de su importancia relativa. En este trabajo estimamos regresiones por cuantiles a nivel provincial en Argentina y encontramos que la población mayor a 65 años, el desempleo, la existencia de laboratorios públicos de producción de medicamentos, las transferencias de tratamientos y la orientación del sistema de salud a la atención primaria, son importantes predictores de la progresividad en el esquema de pagos. Ingresos bajos, instituciones débiles, infraestructura y provisión de servicios insuficientes redundan en respuestas sociales más regresivas a las necesidades sanitarias, empeorando las condiciones de vida y limitando las oportunidades de desarrollo.

Abstract Medicines are an important part of household health spending. A progressive system for financing drugs is thus essential for an equitable health system. Some authors have proposed that the determinants of equity in drug financing are socioeconomic, demographic, and associated with public interventions, but little progress has been made in the empirical evaluation and quantification of their relative importance. The current study estimated quantile regressions at the provincial level in Argentina and found that old age (> 65 years), unemployment, the existence of a public pharmaceutical laboratory, treatment transfers, and a health system orientated to primary care were important predictors of progressive payment schemes. Low income, weak institutions, and insufficient infrastructure and services were associated with the most regressive social responses to health needs, thereby aggravating living conditions and limiting development opportunities.

Resumo Medicamentos são uma parte importante dos gastos em saúde do agregado familiar, portanto, ter um sistema progressivo de financiamento de medicamentos é fundamental para alcançar um sistema de saúde equitativo. Foi proposto que os determinantes da equidade no financiamento são fatores socioeconômicos, demográficos e ligados à intervenção pública, mas se avançou pouco em sua avaliação empírica e na quantificação de sua importância relativa. Neste trabalho, estimamos regressões por quantis no nível provincial na Argentina e encontramos que a população maior de 65 anos, o desemprego, a existência de laboratório de produção pública de medicamentos, transferências de tratamentos e orientação do sistema de saúde para atenção primária são importantes preditores da progressividade dos sistemas de pagamento. Baixa renda, instituições fracas, infraestrutura e oferta insuficiente de serviços resultam em mais regressivas respostas sociais às necessidades de saúde, agravando as condições de vida e limitando as oportunidades de desenvolvimento.

Research about Rational Drug Use Policy in Some Developing Countries / 中国药房

OBJECTIVE:To provide reference for improving the rational drug use of China. METHODS:By referring to In-dia,South Africa and Argentina's policy in this regard,the rational drug policy rules and supporting measures in the national drug policy of these states were analyzed and summarized to put forward related policies for China. RESULTS & CONCLUSIONS:Pro-moting the rational drug use required multi-angle managements towards the supply-side,the demand-side as well as third-party, and relevant supporting measures needed to be improved. Firstly,the managements on the supply-side is particularly important,in-cluding measures such as strengthening prescription management,formulating and implementing the standard treatment guidelines, intensifing the functions of pharmacists,establishing serious irrational drug use and specific diseases medication management sys-tem;then,the demand-side needs the investigation and feedback about the patients with drug use to eliminate irrational drug use, and through the internet and other media to raise public awareness of the medicine information as well;besides,the third-party needs to establish a non-profit organization to regulate pharmaceutical advertisements,and increase information about rational drug use;finally,improving the rational drug policy also needs to improve needs to promote the separation of medicine,reform Medi-care payment and other supporting measures.

Estructuración y formulación de la política pública farmacéutica regional y territorial en Colombia / Structuring and Development of Regional and Territorial Pharmaceutical Public Policy in Colombia / Estruturação e formulação da política pública farmacêutica regional e territorial na Colômbia

Problema: radica en la estructuración y formulación de la política pública farmacéutica regional y territorial en Colombia. Justificación: el documento Conpes 155 exige la definición del marco de política pública farmacéutica en Colombia, y por ende a escala departamental y territorial. Método: la fundamentación analítica de dicho Conpes, al igual que el uso de la metodología de marco lógico, fungen como herramientas metódicas para la postulación del trabajo. Marco de referencia: revisión en materia de definición u observancia de políticas públicas farmacéuticas internacionales. Principales resultados: el planteamiento de la respectiva política pública farmacéutica en el departamento de Antioquia y la postulación de dicho escenario en la ciudad capital de Medellín. Conclusiones: la construcción de la política pública farmacéutica nacional aún está en ciernes, obstáculo que impide registrarla en la política pública territorial.

The problem lies on the structuring and development of regional and territorial public drug policy in Colombia. Justification: The document Conpes 155 requires the definition of the public pharmaceutical policy framework in Colombia, and therefore defining it at the departmental and local level. Method: the analytical foundation of the Conpes like the use of the logical framework methodology, serve as methodical tools for the application of the project. Framework: review of the definition or compliance of international drug policies. Main results: the approach of the public pharmaceutical policy in the department of Antioquia and the application of such a scenario in the capital city of Medellin. Conclusions: the construction of a public national drug policy is still in its infancy, fact that hinders the establishment of a territorial public policy.

Problema: reside na estruturação e formulação da política pública farmacêutica regional e territorial na Colômbia. Justificação: o documento Conpes 155 exige a definição do quadro de política pública farmacêutica na Colômbia, e, portanto, na escala departamental e territorial. Método: a fundamentação analítica de tal Conpes, mesmo que o uso da metodologia de quadro lógico, agem como ferramentas metódicas para a execução do trabalho. Quadro de referência: revisão em matéria de definição ou observância de políticas públicas farmacêuticas internacionais. Principais resultados: a colocação da respetiva política pública farmacêutica no departamento de Antioquia e a proposição de tal cenário na cidade capital de Medellín. Conclusões: a construção da política pública farmacêutica nacional ainda está na infância, obstáculo que impede cadastrá-la na política pública territorial.

Health policy evolution in Lao People's Democratic Republic: context, processes and agency.

During the last 20 years Lao People's Democratic Republic has successfully developed and adopted some 30 health policies, strategies, decrees and laws in the field of health. Still, the implementation process remains arduous. This article aims at discussing challenges of health policy development and effective implementation by contextualizing the policy evolution over time and by focusing particularly on the National Drug Policy and the Health Care Law. Special attention is given to the role of research in policymaking. The analysis was guided by the conceptual framework of policy context, process, content and actors, combined with an institutional perspective, and showed that effective implementation of a health policy is highly dependent on both structures and agency of those involved in the policy process. The National Drug Policy was formulated and adopted in a short period of time in a resource-scarce setting, but with dedicated policy entrepreneurs and support of concerned international collaborators. Timely introduction of operational health systems research played a crucial role to support the implementation, as well as the subsequent revision of the policy. The development of the Health Care Law took several years and once adopted, the implementation was delayed by institutional legacies and issues concerning the choice of institutional design and financing, despite strong support of the law among the policymakers. Among many factors, timing of the implementation appeared to be of crucial importance, in combination with strong leadership. These two examples show that more research, that problematizes the complex policy environment in combination with improved communication between researchers and policymakers, is necessary to inform about measures for effective implementation. A way forward can be to strengthen the domestic research capacity and the international research collaboration regionally as well as globally.

Problems in the regulatory policy of the drug market / Problemas na política regulatória do mercado de medicamentos

OBJECTIVE Analyze the implementation of drug price regulation policy by the Drug Market Regulation Chamber.METHODS This is an interview-based study, which was undertaken in 2012, using semi-structured questionnaires with social actors from the pharmaceutical market, the pharmaceuticals industry, consumers and the regulatory agency. In addition, drug prices were compiled based on surveys conducted in the state of Sao Paulo, at the point of sale, between February 2009 and May 2012.RESULTS The mean drug prices charged at the point of sale (pharmacies) were well below the maximum price to the consumer, compared with many drugs sold in Brazil. Between 2009 and 2012, 44 of the 129 prices, corresponding to 99 drugs listed in the database of compiled prices, showed a variation of more than 20.0% in the mean prices at the point of sale and the maximum price to the consumer. In addition, many laboratories have refused to apply the price adequacy coefficient in their sales to government agencies.CONCLUSIONS The regulation implemented by the pharmaceutical market regulator was unable to significantly control prices of marketed drugs, without succeeding to push them to levels lower than those determined by the pharmaceutical industry and failing, therefore, in its objective to promote pharmaceutical support for the public. It is necessary reconstruct the regulatory law to allow market prices to be reduced by the regulator as well as institutional strengthen this government body.

OBJETIVO Analisar a implementação da política de regulação de preços de medicamentos pela Câmara de Regulação do Mercado de Medicamentos.MÉTODOS Estudo baseado na realização de entrevistas, em 2012, usando questionários semiestruturados, com atores sociais do mercado de medicamentos, representantes da indústria farmacêutica, de consumidores e do órgão regulador. Foram também compilados preços de medicamentos obtidos em pesquisas realizadas no Estado de São Paulo, nos pontos de venda, entre fevereiro de 2009 e maio de 2012.RESULTADOS As médias dos preços de medicamentos praticadas nos pontos de venda (farmácias e drogarias) estiveram muito abaixo do preço máximo ao consumidor, em relação à grande parte dos medicamentos comercializados no Brasil. Entre 2009 e 2012, 44 dos 129 preços praticados, correspondentes a 99 medicamentos constantes do banco de preços compilados, apresentaram variação superior a 20,0% entre a média de preços praticados nos pontos de venda e o preço máximo ao consumidor. Ademais, muitos laboratórios se recusaram a aplicar o coeficiente de adequação de preços nas vendas a órgãos públicos.CONCLUSÕES A regulação implementada pelo órgão regulador do mercado de medicamentos foi incapaz de controlar os preços de quantidade significativa dos medicamentos comercializados, pressionando-os a patamares inferiores àqueles determinados pela indústria farmacêutica e falhando, portanto, no seu objetivo de promover assistência farmacêutica. É necessária reforma da lei regulamentadora para permitir a redução de preços praticados no mercado pelo órgão regulador, bem como fortalecimento institucional desse órgão.

Strategies for price reduction of HIV medicines under a monopoly situation in Brazil / Estratégias de redução de preços de medicamentos para aids em situação de monopólio no Brasil

ABSTRACT OBJECTIVE To analyze Government strategies for reducing prices of antiretroviral medicines for HIV in Brazil. METHODS Analysis of Ministry of Health purchases of antiretroviral medicines, from 2005 to 2013. Expenditures and costs of the treatment per year were analyzed and compared to international prices of atazanavir. Price reductions were estimated based on the terms of a voluntary license of patent rights and technology transfer in the Partnership for Productive Development Agreement for atazanavir. RESULTS Atazanavir, a patented medicine, represented a significant share of the expenditures on antiretrovirals purchased from the private sector. Prices in Brazil were higher than international references, and no evidence was found of a relationship between purchase volume and price paid by the Ministry of Health. Concerning the latest strategy to reduce prices, involving local production of the 200 mg capsule, the price reduction was greater than the estimated reduction. As for the 300 mg capsule, the amounts paid in the first two years after the Partnership for Productive Development Agreement were close to the estimated values. Prices in nominal values for both dosage forms remained virtually constant between 2011 (the signature of the Partnership for Productive Development Agreement), 2012 and 2013 (after the establishment of the Partnership). CONCLUSIONS Price reduction of medicines is complex in limited-competition environments. The use of a Partnership for Productive Development Agreement as a strategy to increase the capacity of local production and to reduce prices raises issues regarding its effectiveness in reducing prices and to overcome patent barriers. Investments in research and development that can stimulate technological accumulation should be considered by the Government to strengthen its bargaining power to negotiate medicines prices under a monopoly situation.

RESUMO OBJETIVO Analisar as estratégias governamentais para redução de preço de medicamentos antirretrovirais para aids no Brasil. MÉTODOS Realizada análise das compras de medicamentos antirretrovirais pelo Ministério da Saúde, de 2005 a 2013. Foram analisados o gasto e o custo do tratamento por ano e comparados com os preços internacionais para o atazanavir. Foram estimadas as reduções com base no contrato da Parceria para Desenvolvimento Produtivo para obtenção de licença voluntária de patente e transferência de tecnologia do atazanavir. RESULTADOS O atazanavir teve peso expressivo nos gastos com antirretrovirais adquiridos no setor privado. Os preços praticados no Brasil foram mais altos que aqueles de referência internacional e não houve evidências da relação entre volume de compra e preço pago pelo Ministério da Saúde, por ser medicamento patenteado. Em relação à estratégia mais recente para reduzir preços, envolvendo produção local da cápsula de 200 mg, as reduções foram menores do que as estimadas. Quanto à cápsula de 300 mg, os valores pagos nos dois primeiros anos após a Parceria para Desenvolvimento Produtivo foram próximos aos estimados. Os preços em valores nominais mantiveram-se praticamente constantes entre 2011 (assinatura da Parceria para Desenvolvimento Produtivo), 2012 e 2013 (após estabelecida a Parceria). CONCLUSÕES A redução do preço de medicamentos é complexa em ambiente de concorrência limitada. O uso da Parceria para Desenvolvimento Produtivo como método para aumentar a capacidade de produção local e reduzir preços levanta questões em relação à redução efetiva dos preços e ao enfrentamento da barreira patentária. Investimentos em pesquisa e desenvolvimento que possam estimular a acumulação tecnológica devem ser considerados pelo governo para fortalecer seu poder de barganha ao negociar preços de medicamentos em situação de monopólio.

Disponibilidade de medicamentos nas unidades básicas de saúde e fatores relacionados: uma abordagem transversal / Availability of medicines in primary health care facilities and related factors: a cross sectional approach

Este estudo objetivou a caracterização da disponibilidade de medicamentos nas unidades básicas de saúde (UBS) do Brasil e a identificação de fatores organizacionais a ela associados, utilizando banco de dados secundários do Programa Nacional de Melhoria do Acesso e da Qualidade da Atenção Básica. O desfecho relacionado à disponibilidade de medicamentos, expresso de três diferentes formas, foi explorado em relação a variáveis explicativas relacionadas a características da UBS e à assistência farmacêutica. Encontrou-se disponibilidade média de 58,5%, que foi também baixa em todos os estratos populacionais; houve associação estatisticamente significativa da variável desfecho com todas as explicativas. Foi baixa a disponibilidade de medicamentos, mostrando-se inversamente associada com a organização geral da unidade de saúde em geral e da assistência farmacêutica em particular.

The study aimed to characterize the availability of medicines in public Primary Health Care facilities in Brazil and to identify its related organizational factors Using data from the National Program for Access and Quality Improvement in Primary Care (PMAQ-AB) were used. The outcome related to de availability of medicine, expressed in three different ways, was explored in relation to explanatory variables concerned to health facilities and pharmaceutical services organizational characteristics. We found an average of 58,5% of availability, which was also low in all population strata; there was a statistically significant association of the outcome variable with all the explanatory ones. The availability of medicine was low and inversely associated to the general organization of the health facility in general and to the pharmaceutical services.

Utilización y accesibilidad a medicamentos en el Sistema Nacional de Seguro Social de Argentina / Medicine access and utilization in a population covered by National Social Security System of Argentina

Objetivo: Investigar la utilización y accesibilidad a los medicamentos en pacientes cubiertos por el Sistema Nacional del Seguro Social de Argentina (SNSSA). Material y Métodos: Se estudió la accesibilidad a los medicamentos que eran consumidos los últimos 15 días antes de ser hospitalizados, en 500 pacientes en 5 hospitales en el área de Buenos Aires. Resultados: Del total de encuestados, 292 pacientes tuvieron prescripción médica 15 días antes de ser hospitalizados, 171 (58,6%) pacientes no tuvieron accesibilidad a medicamentos. La media de edad fue: 47,4 + 18,8 y rango de 0.1 a 89 años; 173 (34,6%) fueron de sexo masculino y 327 (65,4%) femenino. La distribución de la cobertura de los pacientes estudiados fue predominantemente perteneciente al Sistema Público con 280 (56,0%), Obra Social 175 (35,0%) y Prepago 45 (9,0%). Las razones de la no accesibilidad, fueron principalmente: errores en los procesos que van desde la emisión de las recetas, llenado incorrecto de los formularios hasta la no disponibilidad de los medicamentos en las farmacias. Conclusiones: La falta de accesibilidad a medicamentos en pacientes cubiertos por el SNSSA es un fenómeno frecuente.

Objective: To investigate the use and accessibility to drugs in patients covered by the National Social Security Argentina (SNSSA). Material and Methods: We studied the accessibility to drugs that were consumed the last 15 days before hospitalization, in 500 patients in 5 hospitals in the area of Buenos Aires. Results: Of the 500 patients surveyed, 292 patients had medical prescription 15 days before being hospitalized, 171 (58.6%) patients had no access to medicines. The mean age was 47.4 + 18.8 and range of 0.1 to 89 years; 173 (34.6%) were male and 327 (65.4%) female. The distribution of coverage of patients studied was predominantly belonging to the Public System with 280 (56.0 %), Social Work 175 (35.0 %) and Prepay 45 (9.0%). The reasons for non- accessibility were mainly: the errors in processes ranging from issuing prescriptions, improper filling of forms to non-availability of medicines in pharmacies. Conclusions: The lack of access to medicines for patients covered by SNSSA is a common phenomenon.

Examining the construction and representation of drugs as a policy problem in Australia's National Drug Strategy documents 1985-2010.

BACKGROUND: National drug policies are often regarded as inconsequential, rhetorical documents, however this belies the subtlety with which such documents generate discourse and produce (and re-produce) policy issues over time. Critically analysing the ways in which policy language constructs and represents policy problems is important as these discursive constructions have implications for how we are invoked to think about (and justify) possible policy responses. METHODS: Taking the case of Australia's National Drug Strategies, this paper used an approach informed by critical discourse analysis theory and aspects of Bacchi's (2009) 'What's the Problem Represented to be' framework to critically explore how drug policy problems are constructed and represented through the language of drug policy documents over time. RESULTS: Our analysis demonstrated shifts in the ways that drugs have been 'problematised' in Australia's National Drug Strategies. Central to these evolving constructions was the increasing reliance on evidence as a way of 'knowing the problem'. Furthermore, by analysing the stated aims of the policies, this case demonstrates how constructing drug problems in terms of 'drug-related harms' or alternately 'drug use' can affect what is perceived to be an appropriate set of policy responses. The gradual shift to constructing drug use as the policy problem altered the concept of harm minimisation and influenced the development of the concepts of demand- and harm-reduction over time. CONCLUSIONS: These findings have implications for how we understand policy development, and challenge us to critically consider how the construction and representation of drug problems serve to justify what are perceived to be acceptable responses to policy problems. These constructions are produced subtly, and become embedded slowly over decades of policy development. National drug policies should not merely be taken at face value; appreciation of the construction and representation of drug problems, and of how these 'problematisations' are produced, is essential.