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

BACKGROUND: This 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. METHODS: Data 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). RESULTS: Relevance, 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). CONCLUSIONS: This 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.

Exploring the biofilm inhibitory potential of Candida sp. UFSJ7A glycolipid on siliconized latex catheters.

Biosurfactants, sustainable alternatives to petrochemical surfactants, are gaining attention for their potential in medical applications. This study focuses on producing, purifying, and characterizing a glycolipid biosurfactant from Candida sp. UFSJ7A, particularly for its application in biofilm prevention on siliconized latex catheter surfaces. The glycolipid was extracted and characterized, revealing a critical micellar concentration (CMC) of 0.98 mg/mL, indicating its efficiency at low concentrations. Its composition, confirmed through Fourier transform infrared spectroscopy (FT-IR) and thin layer chromatography (TLC), identified it as an anionic biosurfactant with a significant ionic charge of -14.8 mV. This anionic nature contributes to its biofilm prevention capabilities. The glycolipid showed a high emulsification index (E24) for toluene, gasoline, and soy oil and maintained stability under various pH and temperature conditions. Notably, its anti-adhesion activity against biofilms formed by Escherichia coli, Enterococcus faecalis, and Candida albicans was substantial. When siliconized latex catheter surfaces were preconditioned with 2 mg/mL of the glycolipid, biofilm formation was reduced by up to 97% for E. coli and C. albicans and 57% for E. faecalis. These results are particularly significant when compared to the efficacy of conventional surfactants like SDS, especially for E. coli and C. albicans. This study highlights glycolipids' potential as a biotechnological tool in reducing biofilm-associated infections on medical devices, demonstrating their promising applicability in healthcare settings.

Recent Patents on the Industrial Application of Biosurfactants.

BACKGROUND: Biosurfactants are natural bioactive compounds produced from fungi, bacteria and plants. These molecules have several properties that enable them to be involved in various industrial applications. The surface-active properties of biosurfactants allow their use in various sectors, such as agriculture, health, cosmetics, bioremediation/ petroleum, mining, and bioprocess. OBJECTIVE: The objective of this study was to analyze the patents deposited in intellectual property databases for applications of biosurfactants in the areas of agriculture, health, cosmetics, bioremediation/petroleum, mining, and bioprocesses, with the research period consisting of the last six years. METHODS: This study targeted the use of biosurfactants in various industrial sectors. The patent search was carried out using the Google Patents platform, a platform that is commonly used for this purpose and freely accessible. RESULTS: During the search for patents related to applications of biosurfactants in industry filed in the last 6 years, results were found to be distributed in the following areas: agriculture (70), cosmetics (2311), bioremediation/petroleum (179), health (1794), mining (5), and bioprocess (133). Six patents were selected from each area, except for health and mining, for which the search resulted in only 5 and 4 patents, respectively, to be discussed and provide information on the biotechnological applications of biosurfactants in the industry. CONCLUSION: The present study showed a wide area of application of biosurfactants in industry. The interest in the inclusion of biosurfactants in the industry is directly related to the need for more sustainable solutions to solve real market problems. The cosmetics sector presented the most patents that employ the use of biosurfactants.

Benzodiazepines utilization in Brazilian older adults: a population-based study.

OBJECTIVE: To evaluate the utilization of benzodiazepines (BZD) in Brazilian older adults, based on the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM - National Survey of Access, Use and Promotion of Rational Use of Medicines). METHODS: The PNAUM is a cross-sectional study conducted between 2013 and 2014, representing the Brazilian urban population. In the present study, we included 60 years or older (n = 9,019) individuals. We calculated the prevalence of BZD utilization in the 15 days prior to survey data collection according to independent variables, using a hierarchical Poisson regression model. A semistructured interview performed empirical data collection (household interview). RESULTS: The prevalence of BZD utilization in the older adults was 9.3% (95%CI: 8.3-10.4). After adjustments, BZD utilization was associated with female sex (PR = 1.88; 95%CI: 1.52-2.32), depression (PR = 5.31; 95%CI: 4.41-6, 38), multimorbidity (PR = 1.44; 95%CI: 1.20-1.73), emergency room visit or hospitalization in the last 12 months (PR = 1.42; 95%CI: 1.18-1.70 ), polypharmacy (PR = 1.26; 95%CI: 1.01-1.57) and poor or very poor self-rated health (PR = 4.16; 95%CI: 2.10-8.22). Utilization was lower in the North region (PR = 0.18; 95%CI: 0.13-0.27) and in individuals who reported abusive alcohol consumption in the last month (PR = 0.42; 95%CI: 0.19-0.94). CONCLUSION: Despite contraindications, results showed a high prevalence of BZD utilization in older adults, particularly in those with depression, and wide regional and sex differences.

[Access to medicines and South-South cooperation: a case study on joint drug price negotiations in South America]. / Acesso a medicamentos e cooperação Sul-Sul: um estudo de caso de negociação conjunta de preços na América do Sul.

This article aims to analyze joint negotiation of prices on high-cost drugs, which began in 2015 in the frameworks of the Southern Common Market (Mercosur) and the Union of South American Nations (USAN), with the participation of the Pan-Americana Health Organization (PAHO). This is a case study based on document research and in-depth interviews, describing the first face-to-face stage in the price negotiations led by the Mercosur Ad Hoc Committee on Drug Price Negotiations. The process resulted in the establishment of price caps in South America for darunavir and sofosbuvir. In the case of darunavir, there was a reduction in the global price, including the price in the Global Fund to Fight AIDS, Tuberculosis, and Malaria. In conclusion, price negotiation was successful in the above-mentioned cases, and participation by the PAHO Strategic Fund in the drug purchases streamlined their procurement and their availability in the countries.

Este artigo tem como objetivo analisar a negociação conjunta de preços de medicamentos de alto custo, que iniciou em 2015 nos âmbitos do Mercado Comum do Sul (Mercosul) e da União de Nações Sul-Americanas (Unasul), com a participação da Organização Pan-Americana da Saúde (OPAS). Apresenta-se como um estudo de caso, baseado em pesquisa documental e entrevistas em profundidade, que descreve a primeira etapa presencial do processo de negociação de preços conduzido pelo Comitê Ad Hoc de Negociação de Preços de Medicamentos de Alto Custo (CAHPM) do Mercosul. Tal processo resultou no estabelecimento de preços-teto na região para o darunavir e o sofosbuvir. No caso do darunavir, houve uma redução do preço global do medicamento, inclusive no preço do Fundo Global de Luta Contra aids, Tuberculose e Malária. Conclui-se que a negociação de preços foi bem-sucedida nos casos mencionados, e a participação do Fundo Estratégico da OPAS na compra dos medicamentos agilizou o processo de compra e a disponibilidade destes nos países.

El objetivo de este artículo es analizar la negociación conjunta de precios de medicamentos de alto costo, que comenzó en 2015 en los ámbitos del Mercado Común del Sur (Mercosur) y Unión de Naciones Suramericanas (Unasur), con la participación de la Organización Panamericana de Salud (OPAS). Se presenta como un estudio de caso, basado en investigación documental y entrevistas en profundidad, que describe la primera etapa presencial del proceso de negociación de precios, llevado a cabo por el Comité Ad Hoc de Negociación de Precios de Medicamentos del Mercosur. Tal proceso resultó en el establecimiento de precios-techo en la región para el darunavir y el sofosbuvir. En el caso del darunavir, hubo una reducción del precio global del medicamento, incluso en el precio del Fondo Global de Lucha Contra el SIDA, Tuberculosis y Malaria. Se concluye que la negociación de precios fue muy exitosa en los casos mencionados, y la participación del Fondo Estratégico de la OPAS en la compra de los medicamentos agilizó el proceso de compra y la disponibilidad de los mismos en los países.

User evaluation of public pharmacy services in Brazil. / Avaliação dos usuários sobre as farmácias públicas no Brasil.

Objective of this article is to evaluate aspects related to the services provided in SUS pharmacies in Brazil, according to users' perception. Data from the National Survey of Access, Use and Promotion of Rational Use of Medicines carried out between 2013 and 2014 were used. Individuals who obtained drugs from public pharmacies were analyzed. To calculate prevalence estimates, the total number of users of drugs with 95%CI was used as denominator. From the age group of 20 to 24 years up to 60 to 64 years, there were significant differences between men and women in terms of use of public pharmacies. More than 30% of people from all socioeconomic classes who did not obtain drugs from SUS pharmacies never thought about this possibility. Not having to wait much time to obtain the medication and a positive evaluation of the opening hours had a strong association with the positive evaluation of users of SUS pharmacies. Opening hours and waiting time are potential barriers in SUS pharmacies. The evaluation of users of SUS was positive, but it pointed to regional differences, and the identification of the magnitude of such differences can contribute to the planning of more effective and equitable policies.

O objetivo deste artigo é avaliar aspectos relacionados aos serviços prestados nas farmácias do SUS do Brasil, segundo a percepção dos usuários. Utilizou-se dados da Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos, realizada entre 2013 e 2014. Analisou-se indivíduos que obtiveram algum medicamento nas farmácias públicas. Para o cálculo das estimativas de prevalências, foi usado como denominador o total de usuários de medicamentos com IC95%. A partir da faixa etária de 20 a 24 anos até 60 a 64 anos observa-se diferenças significativas entre homens e mulheres, em relação ao uso de farmácias públicas. Mais de 30% das pessoas de todas as classes socioeconômica que não obtiveram medicamentos nas farmácias do SUS, nunca pensaram nessa possibilidade. Não costumam esperar para obtenção dos medicamentos e avaliação positiva do horário de funcionamento tiveram uma associação mais forte em relação a avaliação positiva dos usuários das farmácias do SUS. O horário de funcionamento e o tempo de espera são potenciais barreiras nas farmácias do SUS. A avaliação dos usuários que utilizam o SUS é positiva, mas aponta diferenças regionais e a identificação da magnitude dessas pode contribuir na formulação de políticas mais eficazes e equânimes.

Correction to: Public procurement of medicines: scoping review of the scientific literature in South America.

[This corrects the article DOI: 10.1186/s40545-019-0195-9.].

Inappropriate use of medicines and associated factors in Brazil: an approach from a national household survey.

This article aims to describe the inappropriate use of medicines in the Brazilian urban population and to identify associated factors. We conducted a data analysis of a household survey carried out in Brazil in 2013-14. The sampling plan was done by clusters with representativeness of the urban population and large regions of the country, according to gender and age domains. For this analysis, we considered a sample of adults (≥20 years) who reported having chronic non-communicable diseases, medical indication for drug treatment and medicine use (n = 12 283). We evaluated the prevalence of inappropriate use in the domains: non-adherence, inappropriate use behaviour and inadequate care with medicines, all verified in the following groups of independent variables: demographic and socio-economic characteristics, health and pharmaceutical care, health status and use of medicines. Crude and adjusted prevalence ratios were obtained using robust Poisson regression. It was found 46.1% of people having at least one behaviour of inappropriate use of medicines. The worst results were found for the domain of inappropriate use behaviour, a situation of 36.6% of the users, which included unauthorized prescriber, inadequate source of information and indication of the medicines by non-authorized prescribers. The best result was found for the lack of medicines care, informed by only 4.6% of users who kept expired drugs at home. The inappropriate use of medicines was associated with gender (female), region of residence (Northeast), not visiting the doctor regularly or visiting more than one doctor, not having free access to medicines and using of five or more medicines. There was a high prevalence of inappropriate use, which was associated with both individual and health system characteristics pointing out the need to set priorities as for health education and public interventions.

Medicine package inserts from the users' perspective: are they read and understood?

INTRODUCTION: The written information on medicines has been acknowledged as an important tool for health education. OBJECTIVE: To analyze the use and understanding of medicine package inserts by users and assess sociodemographic and medical factors associated with their comprehension. METHOD: Data in this analysis are part of the PNAUM National Survey - a cross-sectional population-based study conducted in Brazil. Descriptive statistics and the Pearson χ2 tests were performed to compare proportions between sociodemographic and medical characteristics, as well as use and understanding of medicine package inserts. RESULTS: A total of 28.427 individuals responded to questions related to medicine package inserts. From these, 59.6% (95%CI 57.7 - 61.5) said they usually read the inserts, and 98.4% (95%CI 98.0 - 98.8) considered them necessary. Among people who read the medicine package inserts, more than half indicated difficulties with legibility (57.4%; 95%CI 55,2 - 59,6) and readability (54.1%; 95%CI 52.1 - 56.1). People from a lower education level reported greater difficulty in understanding them. CONCLUSION: The larger portion of the population usually read medicine package inserts. Nevertheless, people have difficulty in reading and understanding them.

[Use of artificial sweeteners in Brazil: a household survey approach]. / Utilização de adoçantes no Brasil: uma abordagem a partir de um inquérito domiciliar.

The objective was to estimate the prevalence of artificial sweetener use by the adult Brazilian population and users' characteristics. Analysis of data from the Brazilian National Survey on Access, Utilization, and Promotion of Rational Use of Medicines (PNAUM, 2014), a nationwide population-based survey. The target outcome was self-reported use of sweeteners by Brazilians 20 years and older. The independent variables were sex, age, major geographic region of Brazil, schooling in complete years, and economic status according to the Brazilian Economic Classification Criterion of the Brazilian Association of Research Companies (ABEP). The health condition indicators were: self-reported noncommunicable diseases (NCDs), number of NCDs, and body mass index (BMI). Prevalence of sweetener use in the Brazilian adult population was 13.4% (95%CI: 12.5-14.3), and it was higher in females and in persons 60 years or older, in the Northeast and Southeast, among individuals from economic classes A and B, and among obese individuals. Persons with chronic diseases (especially diabetes) showed the highest prevalence of use of sweeteners, and their use increased with the number of reported comorbidities. Prevalence of use of artificial sweeteners was 13.4% and was associated with sociodemographic and health characteristics.

O objetivo foi estimar a prevalência do uso de adoçantes pela população adulta brasileira e características dos usuários. Análise de dados da Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM, 2014), um inquérito nacional de base populacional. O desfecho de interesse foi o uso autorreferido de adoçantes entre brasileiros com 20 anos ou mais. As variáveis analisadas foram sexo, idade em anos completos, região do Brasil, escolaridade em anos completos e classificação econômica segundo o Critério Classificação Econômica Brasil da Associação Brasileira de Empresas de Pesquisa (ABEP). Os indicadores das condições de saúde foram: relato de doença crônica não transmissíveis (DCNT), número de DCNT e índice de massa corporal (IMC). A prevalência do uso de adoçantes na população adulta brasileira foi de 13,4% (IC95%: 12,5-14,3), sendo maior entre as pessoas do sexo feminino e no grupo com 60 anos ou mais, nas regiões Nordeste e Sudeste, entre pessoas da classe econômica A/B e entre indivíduos obesos. As pessoas com doenças crônicas (em especial diabetes) foram as que mostraram maior prevalência de uso de adoçantes, sendo o uso maior quanto maior o número de comorbidades relatadas. A prevalência de uso de adoçantes foi de 13,4% e mostrou-se associada a características sociodemográficas e de saúde.

El objetivo fue estimar la prevalencia del uso de edulcorantes por parte de la población adulta brasileña y las características de los usuarios. Análisis de datos de la Encuesta Nacional de Acceso, Utilización y Promoción del Uso Racional de Medicamentos (PNAUM, 2014), una encuesta nacional de base poblacional. El resultado de interés fue el uso autoinformado de edulcorantes entre brasileños con 20 años o más. Las variables analizadas fueron: sexo, edad (años completados), región de Brasil, escolaridad (años completados), así como la clasificación económica según el Criterio Clasificación Económica Brasil de la Asociación Brasileña de Empresas de Investigación (ABEP). Los indicadores de las condiciones de salud fueron: informe de enfermedades crónicas (DCNT), número de DCNT e índice de masa corporal (IMC). La prevalencia del uso de edulcorantes en la población adulta brasileña fue de un 13,4% (IC95%: 12,5-14,3), siendo mayor entre las personas de sexo femenino y en el grupo con 60 años o más, en las regiones Nordeste y Sudeste, entre personas de clase económica A/B y entre individuos obesos. Las personas con enfermedades crónicas (en especial diabetes) fueron las que mostraron una mayor prevalencia de uso de edulcorantes, siendo el uso mayor, cuanto mayor fuera el número de comorbilidades informadas. Conclusiones: la prevalencia de uso de edulcorantes fue de un 13,4% y se mostró asociada a características sociodemográficas y de salud.

Pharmaceutical Services and comprehensiveness 30 years after the advent of Brazil's Unified Health System. / Assistência Farmacêutica nos 30 anos do SUS na perspectiva da integralidade.

This article examines pharmaceutical services and access to essential medicines in Brazil during the 30 years since the advent of Brazil's Unified Health System from a comprehensiveness perspective. The following topics are addressed: the "realignment" of pharmaceutical services; human resources in pharmaceutical services; the essential medicines concept; the rational use of medicines; technological advances and drug manufacturing; and ethical regulation. With a strong regulatory focus and a structural framework centered on the National Medicines Policy, the past three decades represent a mixture of progress and setbacks, considering the national complexities of the healthcare system and the political, economic and social changes that have influenced policy and access to medicines, which is a key concern even in the world's richest countries, as the forums of discussion on global health have demonstrated. We show that major steps forward have been taken, highlighting that the recent fiscal austerity measures imposed by the government threaten to seriously undermine social progress.

Os autores analisam a Assistência Farmacêutica (AF) e o acesso a medicamentos no Brasil na perspectiva do princípio da integralidade nos 30 anos do SUS. A partir da sua inclusão no movimento de reforma sanitária, foram selecionados temas relevantes, incluindo a reorientação da AF, a questão de recursos humanos, o conceito de medicamentos essenciais, o uso apropriado de medicamentos, o desenvolvimento tecnológico e a produção industrial e a regulação ética. Com fortes componentes regulatórios e tendo a política nacional de medicamentos como eixo estruturante, as três décadas do SUS são confrontadas entre avanços e retrocessos, considerando a complexidade nacional, as mudanças políticas, econômicas e sociais que impactaram políticas públicas e o acesso a medicamentos, tema que hoje mostra sua importância mesmo nas economias mais ricas do mundo, a partir de foros de discussão relacionados com Saúde Global. As conquistas ao longo do tempo são destacadas, considerando a preocupação decorrente do regime fiscal que compromete as áreas sociais.

Prevalence and characteristics of adverse drug events in Brazil. / Prevalência e características dos eventos adversos a medicamentos no Brasil.

The aim of this study was to describe the prevalence of adverse drug events (ADEs) and associated factors reported by users of medicines in Brazil. This was a cross-sectional population-based study conducted from September 2013 to February 2014 with data from the Brazilian National Survey on Access, Use, and Promotion of Rational Use of Medicines (PNAUM). The study included all individuals that reported the use of medicines and identified, among them, all those reporting at least one problem with the medicine's use. A descriptive analysis was performed to estimate ADE prevalence and 95% confidence intervals (95%CI) among the target variables. Crude and adjusted prevalence ratios were calculated using Poisson regression to investigate factors associated with ADEs. Overall ADE prevalence in Brazil was 6.6% (95%CI: 5.89-7.41), and after multivariate analysis, higher prevalence was associated with female gender, residence in the Central and Northeast regions, consumption of more medicines, "bad" self-rated health, and self-medication. The drugs most frequently reported with ADEs were fluoxetine, diclofenac, and amitriptyline. The most frequent ADEs were somnolence, epigastric pain, and nausea. Most reported ADEs were mild, avoidable, and associated with medicines used frequently by the population. The study provided knowledge on the size of the problem with use of medicines in Brazil.

O presente trabalho tem como objetivo descrever a prevalência e fatores associados a eventos adversos a medicamentos (EAM) referidos por usuários de medicamentos no Brasil. Trata-se de um estudo transversal de base populacional, realizado no período de setembro de 2013 a fevereiro de 2014, com dados coletados na Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM). Foram consideradas todas as pessoas que referiram o uso de medicamentos; entre elas, foram identificadas as que referiram pelo menos um problema com o uso do medicamento. Realizou-se uma análise descritiva para estimar a prevalência e os intervalos de 95% de confiança (IC95%) de EAM entre as variáveis estudadas, e foram calculadas as razões de prevalência bruta e ajustada, pela regressão de Poisson, na investigação dos fatores associados aos EAM. A prevalência de EAM no Brasil foi de 6,6% (IC95%: 5,89-7,41), sendo maior e estatisticamente significante após a realização da análise multivariada, entre pessoas do sexo feminino; residentes nas regiões Centro-oeste e Nordeste; que consumiam maior número de medicamentos; que percebiam seu estado de saúde como "ruim"; e que se automedicavam. Os EAM foram mais relatados para os medicamentos fluoxetina, diclofenaco e amitriptilina. Os EAM mais referidos pelos entrevistados foram sonolência, dor epigástrica e náuseas. Os EAM mais referidos pelos entrevistados foram de natureza leve, considerados evitáveis e estiveram associados a medicamentos de uso frequente pela população. Em razão desse estudo, foi possível conhecer a dimensão do problema ocasionado pelo uso de medicamentos no Brasil.

El presente trabajo tiene como objetivo describir la prevalencia y factores asociados a eventos adversos con medicamentos (EAM), informados por usuarios de medicamentos en Brasil. Se trata de un estudio transversal de base poblacional, realizado durante el período de septiembre de 2013 a febrero de 2014, con datos recogidos en la Encuesta Nacional sobre el Acceso, Utilización y Promoción del Uso Racional de Medicamentos en Brasil (PNAUM). Se consideraron a todas las personas que informaron del uso de medicamentos; entre ellas, se identificaron a las que informaron de por lo menos un problema con el uso del medicamento. Se realizó un análisis descriptivo para estimar la prevalencia y los intervalos de confianza a 95% (IC95%) de EAM entre las variables estudiadas, y se calcularon las razones de prevalencia bruta y ajustada, por la regresión de Poisson, en la investigación de los factores asociados a los EAM. La prevalencia de EAM en Brasil fue de un 6,6% (IC95%: 5,89-7,41), siendo mayor y estadísticamente significante tras la realización del análisis multivariado, entre personas del sexo femenino; residentes en las regiones Centro-Oeste y Nordeste; que consumían un mayor número de medicamentos; que percibían su estado de salud como "malo"; y que se automedicaban. Se informaron de más EAM en medicamentos como: fluoxetina, diclofenaco y amitriptilina. Los EAM más referidos por los entrevistados fueron somnolencia, dolor epigástrico y náuseas. Los EAM más referidos por los entrevistados fueron de naturaleza leve, considerados evitables y estuvieron asociados a medicamentos de uso frecuente por la población. Con motivo de este estudio, fue posible conocer la dimensión del problema ocasionado por el uso de medicamentos en Brasil.

[Evolution of the international intellectual property rights system: patent protection for the pharmaceutical industry and access to medicines]. / A evolução do sistema internacional de propriedade intelectual: proteção patentária para o setor farmacêutico e acesso a medicamentos.

This article discusses the evolution of the international intellectual property rights system in three phases and the implications for public health, especially for the implementation of policies for access to medicines. During the first phase, characterized by the Paris and Berne Convention, signatory countries defined which technological fields should be protected (or not). Under the second phase, with the enforcement of the WTO TRIPS Agreement, countries are obliged to grant patent protection for all technological fields, including for the pharmaceutical industry. Within their national legislations, countries also have the opportunity to implement access to TRIPS flexibilities for medicines. With the third phase, characterized by the negotiation and signing of bilateral and regional free trade agreements, countries will have to implement TRIPS-plus provisions which may have negative implications for the TRIPS flexibilities as well as for policies for access to medicines. The authors conclude that the currently proposed international intellectual property rights system favors patent-holder rights and that a balance is needed between patent holders' and health rights.

Public procurement of hepatitis C medicines in Brazil from 2005 to 2015. / Compras públicas de medicamentos para hepatite C no Brasil no período de 2005 a 2015.

This paper analyzes the Minister of Health's (MoH) procurement of medicines for hepatitis C from 2005 to 2015. Data sources were the Integrated General Services Administration (SIASG), to estimate annual expenditure for selected medicines of the MoH Clinical Protocols and Therapeutic Guidelines (PCDT) for Hepatitis C. All presentations and strengths recorded on SIASG were included. The unit prices were estimated based on the purchase with the highest volume each year. There was a 159.5 fold increase in expenditure of the selected medicines from 2005 to 2006, because procurement of those medicines became centralized. In 2007 there was 730% increase in spending due to the incorporation of pegainterferons alfa 2a and 2b. In 2012 the purchase of only two new direct-acting antivirals (DAA) accounted for 99% of total annual expenditure. In 2015 the adoption of a new DAA led to an increase of 230% (R$945 million) in MoH spending. The significant increase of MoH expenditure on medicines for hepatitis C from 2005 to 2015 was due to the increase of volumes purchased as well as the incorporation of alfapeginterferon and new DAAs. Ensuring universal access to treatment for hepatitis C will depend on the implementation of strategies that strengthen the MoH's bargaining power in price reduction negotiations with the manufacturers of monopoly medicines.

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.

Benzodiazepines utilization in Brazilian older adults: a population-based study / Utilização de benzodiazepínicos em idosos brasileiros: um estudo de base populacional

ABSTRACT OBJECTIVE To evaluate the utilization of benzodiazepines (BZD) in Brazilian older adults, based on the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM - National Survey of Access, Use and Promotion of Rational Use of Medicines). METHODS The PNAUM is a cross-sectional study conducted between 2013 and 2014, representing the Brazilian urban population. In the present study, we included 60 years or older (n = 9,019) individuals. We calculated the prevalence of BZD utilization in the 15 days prior to survey data collection according to independent variables, using a hierarchical Poisson regression model. A semistructured interview performed empirical data collection (household interview). RESULTS The prevalence of BZD utilization in the older adults was 9.3% (95%CI: 8.3-10.4). After adjustments, BZD utilization was associated with female sex (PR = 1.88; 95%CI: 1.52-2.32), depression (PR = 5.31; 95%CI: 4.41-6, 38), multimorbidity (PR = 1.44; 95%CI: 1.20-1.73), emergency room visit or hospitalization in the last 12 months (PR = 1.42; 95%CI: 1.18-1.70 ), polypharmacy (PR = 1.26; 95%CI: 1.01-1.57) and poor or very poor self-rated health (PR = 4.16; 95%CI: 2.10-8.22). Utilization was lower in the North region (PR = 0.18; 95%CI: 0.13-0.27) and in individuals who reported abusive alcohol consumption in the last month (PR = 0.42; 95%CI: 0.19-0.94). CONCLUSION Despite contraindications, results showed a high prevalence of BZD utilization in older adults, particularly in those with depression, and wide regional and sex differences.

RESUMO OBJETIVO Avaliar a utilização de benzodiazepínicos (BZD) em idosos brasileiros,a partir de dados da Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM). MÉTODOS A PNAUM é um estudo transversal, conduzido entre 2013 e 2014, com representatividade da população urbana brasileira. No presente estudo, foram incluídos indivíduos com 60 anos ou mais (n = 9.019). Foi calculada a prevalência de utilização de BZD nos 15 dias anteriores à coleta dos dados da pesquisa, geral e segundo as variáveis independentes, por meio de análise bruta e ajustada, utilizando modelo hierárquico de regressão de Poisson. A coleta de dados foi realizada por meio de entrevista domiciliar. RESULTADOS A prevalência de utilização de BZD em idosos foi de 9,3% (IC95%: 8,3-10,4). Após análise ajustada, foram associados à maior utilização de BZD: sexo feminino (RP = 1,88; IC95%: 1,52-2,32), depressão (RP = 5,31; IC95%: 4,41-6,38), multimorbidade (RP = 1,44; IC95%: 1,20-1,73), visita à emergência ou internação hospitalar nos últimos 12 meses (RP = 1,42; IC95%: 1,18-1,70), polifarmácia (RP = 1,26; IC95%: 1,01-1,57) e autopercepção de saúde ruim ou muito ruim (RP = 4,16; IC95%: 2,10-8,22). A utilização foi menor na região Norte (RP = 0,18; IC95%: 0,13-0,27) e em indivíduos que relataram consumo abusivo de álcool no último mês (RP = 0,42; IC95%: 0,19-0,94). CONCLUSÃO Apesar das recomendações contrárias ao uso, os resultados demonstraram elevada prevalência de utilização de BZD em idosos, particularmente naqueles que apresentam depressão, além de amplas diferenças em relação às regiões do país e ao sexo do indivíduo.

Acesso a medicamentos e cooperação Sul-Sul: um estudo de caso de negociação conjunta de preços na América do Sul / Access to medicines and South-South cooperation: a case study on joint drug price negotiations in South America / Acceso a medicamentos y cooperación Sur-Sur: un estudio de caso de negociación conjunta de precios en Suramérica

Resumo: Este artigo tem como objetivo analisar a negociação conjunta de preços de medicamentos de alto custo, que iniciou em 2015 nos âmbitos do Mercado Comum do Sul (Mercosul) e da União de Nações Sul-Americanas (Unasul), com a participação da Organização Pan-Americana da Saúde (OPAS). Apresenta-se como um estudo de caso, baseado em pesquisa documental e entrevistas em profundidade, que descreve a primeira etapa presencial do processo de negociação de preços conduzido pelo Comitê Ad Hoc de Negociação de Preços de Medicamentos de Alto Custo (CAHPM) do Mercosul. Tal processo resultou no estabelecimento de preços-teto na região para o darunavir e o sofosbuvir. No caso do darunavir, houve uma redução do preço global do medicamento, inclusive no preço do Fundo Global de Luta Contra aids, Tuberculose e Malária. Conclui-se que a negociação de preços foi bem-sucedida nos casos mencionados, e a participação do Fundo Estratégico da OPAS na compra dos medicamentos agilizou o processo de compra e a disponibilidade destes nos países.

Abstract: This article aims to analyze joint negotiation of prices on high-cost drugs, which began in 2015 in the frameworks of the Southern Common Market (Mercosur) and the Union of South American Nations (USAN), with the participation of the Pan-Americana Health Organization (PAHO). This is a case study based on document research and in-depth interviews, describing the first face-to-face stage in the price negotiations led by the Mercosur Ad Hoc Committee on Drug Price Negotiations. The process resulted in the establishment of price caps in South America for darunavir and sofosbuvir. In the case of darunavir, there was a reduction in the global price, including the price in the Global Fund to Fight AIDS, Tuberculosis, and Malaria. In conclusion, price negotiation was successful in the above-mentioned cases, and participation by the PAHO Strategic Fund in the drug purchases streamlined their procurement and their availability in the countries.

Resumen: El objetivo de este artículo es analizar la negociación conjunta de precios de medicamentos de alto costo, que comenzó en 2015 en los ámbitos del Mercado Común del Sur (Mercosur) y Unión de Naciones Suramericanas (Unasur), con la participación de la Organización Panamericana de Salud (OPAS). Se presenta como un estudio de caso, basado en investigación documental y entrevistas en profundidad, que describe la primera etapa presencial del proceso de negociación de precios, llevado a cabo por el Comité Ad Hoc de Negociación de Precios de Medicamentos del Mercosur. Tal proceso resultó en el establecimiento de precios-techo en la región para el darunavir y el sofosbuvir. En el caso del darunavir, hubo una reducción del precio global del medicamento, incluso en el precio del Fondo Global de Lucha Contra el SIDA, Tuberculosis y Malaria. Se concluye que la negociación de precios fue muy exitosa en los casos mencionados, y la participación del Fondo Estratégico de la OPAS en la compra de los medicamentos agilizó el proceso de compra y la disponibilidad de los mismos en los países.

Prevalence of self-medication in Brazil and associated factors.

OBJECTIVE: To analyze the prevalence and associated factors regarding the use of medicines by self-medication in Brazil. METHODS: This cross-sectional population-based study was conducted using data from the PNAUM (National Survey on Access, Use and Promotion of Rational Use of Medicines), collected between September 2013 and February 2014 by interviews at the homes of the respondents. All people who reported using any medicines not prescribed by a doctor or dentist were classified as self-medication practitioners. Crude and adjusted prevalence ratios (Poisson regression) and their respective 95% confidence intervals were calculated in order to investigate the factors associated with the use of self-medication by medicines. The independent variables were: sociodemographic characteristics, health conditions and access to and use of health services. In addition, the most commonly consumed medicines by self-medication were individually identified. RESULTS: The self-medication prevalence in Brazil was 16.1% (95%CI 15.0-17.5), with it being highest in the Northeast region (23.8%; 95%CI 21.6-26.2). Following the adjusted analysis, self-medication was observed to be associated with females, inhabitants from the North, Northeast and Midwest regions and individuals that have had one, or two or more chronic diseases. Analgesics and muscle relaxants were the therapeutic groups most used for self-medication, with dipyrone being the most consumed medicines. In general, most of the medicines used for self-medication were classified as non-prescriptive (65.5%). CONCLUSIONS: Self-medication is common practice in Brazil and mainly involves the use of non-prescription medicines; therefore, the users of such should be made aware of the possible risks. OBJETIVO: Analisar a prevalência e os fatores associados à utilização de medicamentos por automedicação no Brasil. MÉTODOS: Este estudo transversal de base populacional foi realizado com dados da Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de medicamentos (PNAUM), coletados de setembro de 2013 a fevereiro de 2014, por meio de entrevistas em domicílio. Todas as pessoas que referiram usar qualquer medicamento sem prescrição por médico ou dentista foram classificadas como praticantes de automedicação. Foram calculadas razões de prevalência bruta e ajustada (regressão de Poisson) e seus respectivos intervalos de confiança de 95% na investigação dos fatores associados ao consumo de medicamentos por automedicação. As variáveis independentes foram: aspectos sociodemográficos, de condições de saúde e de acesso e utilização de serviços de saúde. Adicionalmente, foram identificados os medicamentos mais consumidos por automedicação. RESULTADOS: A prevalência da automedicação no Brasil foi de 16,1% (IC95% 15,0-17,5), sendo maior na região Nordeste (23,8%; IC95% 21,6-26,2). Após análise ajustada, automedicação mostrou-se associada a ser do sexo feminino, pertencer às faixas etárias 10-19 anos, 20-29 anos, 40-59 anos e 60 anos ou mais, residir na região Norte, Nordeste ou Centro-Oeste, e ter uma ou duas ou mais doenças crônicas. Os analgésicos e os relaxantes musculares foram os grupos terapêuticos mais utilizados por automedicação, sendo a dipirona o fármaco mais consumido. No geral, a maioria dos medicamentos usados por automedicação foram classificados como isentos de prescrição (65,5%). CONCLUSÕES: A automedicação é prática corrente no Brasil e envolve, principalmente, o uso de medicamentos isentos de prescrição, devendo os usuários ficarem atentos aos seus possíveis riscos.

Use of medicines and other products for therapeutic purposes among children in Brazil.

OBJECTIVE: To assess the prevalence of the use of medicines and other products for therapeutic purposes in the Brazilian pediatric population and test whether demographic, socioeconomic and health factors are associated with use. METHODS: A cross-sectional population-based study (National Survey on Access, Use and Promotion of Rational Use of Medicines - PNAUM), including 7,528 children aged 12 or younger, living in urban areas in Brazil. Medicine use to treat chronic or acute diseases was reported by the primary caregiver present at the household interview. Associations between independent variables and medicine use were investigated by Poisson regression. RESULTS: The overall prevalence of medicine use was 30.7% (95%CI 28.3-33.1). The prevalence of medicine use for chronic diseases was 5.6% (95%CI 4.7-6.7) and for acute conditions, 27.1% (95%CI 24.8-29.4). The factors significantly associated with overall use were five years old or under, living in the Northeast region, having health insurance and using health services in the last 12 months (emergency visits and hospitalizations). The following were associated with drug use for chronic diseases: age ≥ 2 years, Southeast and South regions, and use of health services. For drug use in treating acute conditions, the following associated factors were identified: ≤ 5 years, North, Northeast or Midwest regions, health insurance, and one or more emergency visits. The most commonly used drugs among children under two years of age were paracetamol, ascorbic acid, and dipyrone; for children aged two years or over they were dipyrone, paracetamol, and amoxicillin. CONCLUSIONS: The use of medicine by children is considerable, especially in treating acute medical conditions. Children using drugs for chronic diseases have a different demographic profile from those using drugs for acute conditions in relation to gender, age, and geographic region. OBJETIVO: Estimar a prevalência de uso de medicamentos e outros produtos com finalidade terapêutica na população pediátrica brasileira e testar se fatores demográficos, socioeconômicos e médicos estão associados ao uso. MÉTODOS: Estudo transversal de base populacional (Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - PNAUM), incluindo 7.528 crianças com 12 anos ou menos de idade, residentes na zona urbana do território brasileiro. O uso de medicamentos para tratar doenças crônicas ou agudas foi referido pelo principal cuidador da criança presente na entrevista domiciliar. Associações entre as variáveis independentes e o uso de medicamentos foram investigadas por meio de regressão de Poisson. RESULTADOS: A prevalência de uso global de medicamentos foi de 30,7% (IC95% 28,3-33,1). A prevalência de uso de medicamentos para doenças crônicas foi de 5,6% (IC95% 4,7-6,7) e para condições agudas, 27,1% (IC95% 24,8-29,4). Os fatores significativamente associados com o uso global foram ter no máximo cinco anos de idade, residir na região Nordeste, ter plano de saúde e utilizar serviços de saúde nos últimos 12 meses (consultas de emergência e internações). Associaram-se ao uso de medicamentos para doenças crônicas: idade ≥ 2 anos, regiões Sudeste e Sul e utilização de serviços de saúde. Para o uso de medicamentos em condições agudas, foram identificados os seguintes fatores associados: ≤ 5 anos, Norte, Nordeste ou Centro-Oeste, plano de saúde e uma ou mais consultas de emergência. Os medicamentos com maior prevalência de uso pelas crianças menores de dois anos foram paracetamol, ácido ascórbico e dipirona; nas crianças com 2 ou mais anos, foram dipirona, paracetamol e amoxicilina. CONCLUSÕES: O uso de medicamentos na população infantil é substancial, principalmente no tratamento de condições médicas agudas. As crianças usuárias de medicamentos para doenças crônicas apresentam perfil demográfico diferente das usuárias de medicamentos para condições agudas, em relação ao sexo, à idade e à região geográfica.

Free access to medicines for the treatment of chronic diseases in Brazil.

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. 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.