[The evolution of Brazilian human health policies for the prevention and control of antimicrobial resistance: a scoping reviewEvolución de las políticas de prevención y control de la resistencia a los antimicrobianos desde la perspectiva de la salud humana en Brasil: revisión exploratoria]. / Evolução das políticas brasileiras de saúde humana para prevenção e controle da resistência aos antimicrobianos: revisão de escopo.

Objective: To map the policies related to the prevention and control of antimicrobial resistance from a human health perspective in Brazil and systematize the historical course of these policies. Method: A scoping review was performed following Joana Briggs Institute and PRISMA guidelines. A literature search was performed in December 2020 in the LILACS, PubMed and EMBASE databases. The terms "antimicrobial resistance" AND "Brazil" as well as their synonyms were used. Using the same keywords, Brazilian government websites were searched for documents published until December 2021. Studies of all designs were included, with no language or date restrictions. Clinical documents, reviews and epidemiological studies that did not focus on antimicrobial resistance management policies in Brazil were excluded. Categories based on World Health Organization documents were used for data systematization and analysis. Results: In Brazil, policies related to antimicrobial resistance such as the National Immunization Program and hospital infection control programs can be traced back to before the creation of the Unified Health System. In the late 1990s and 2000s, the first specific policies on antimicrobial resistance (surveillance networks and programs) and education strategies were established; especially noteworthy is The National Action Plan for the Prevention and Control of Antimicrobial Resistance in the Single Health Scope (PAN-BR) of 2018. Conclusions: Despite the long history of policies related to antimicrobial resistance in Brazil, gaps were identified, particularly in monitoring the use of antimicrobials and surveillance of antimicrobial resistance. The PAN-BR, the first government document prepared from a One Health perspective, represents an important milestone.

Objetivo: Determinar qué políticas de prevención y control de la resistencia a los antimicrobianos desde la perspectiva de la salud humana se han adoptado en Brasil y sistematizar su evolución histórica. Método: Se hizo una revisión exploratoria según las directrices del Instituto Joana Briggs y de PRISMA. La búsqueda bibliográfica se realizó en diciembre del 2020 en las bases de datos LILACS, PubMed y EMBASE. Se utilizaron los términos "antimicrobial resistance" AND "Brazil" y sinónimos. Se efectuó una investigación documental con los mismos términos en los sitios web del gobierno brasileño hasta diciembre del 2021. Se incluyeron estudios de todos los diseños, sin restricciones de idioma ni de fecha. Se excluyeron los documentos clínicos, revisiones y estudios epidemiológicos que no hicieran referencia a las políticas de gestión de la resistencia a los antimicrobianos en Brasil. Para la recolección y el análisis de datos se establecieron categorías basadas en documentos de la Organización Mundial de la Salud. Resultados: Desde antes de la creación del Sistema Único de Salud, Brasil tenía políticas de resistencia a los antimicrobianos, como el Programa Nacional de Inmunización y los programas de control de infecciones hospitalarias. A finales de las décadas de 1990 y 2000 se establecieron las primeras políticas específicas de resistencia a los antimicrobianos (redes y programas de vigilancia) y estrategias de educación. Entre ellas se destaca el Plan de Acción Nacional de Prevención y Control de la Resistencia a los Antimicrobianos en el marco del enfoque de "Una salud" (PAN-BR) del 2018. Conclusiones: A pesar de la larga historia de las políticas de resistencia a los antimicrobianos en Brasil, se encontraron lagunas, particularmente en el seguimiento del uso de antimicrobianos y la vigilancia de la resistencia a los mismos. El PAN-BR, primer documento gubernamental elaborado desde la perspectiva de "Una salud", marca un hito en las políticas formuladas en Brasil.

Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

PURPOSE: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known. We compiled the potential data sources for DUR in the LatAm region. METHODS: A network of DUR experts from nine LatAm countries was assembled and experts conducted: (i) a website search of the government, academic, and private health institutions; (ii) screening of eligible data sources, and (iii) liaising with national experts in pharmacoepidemiology (via an online survey). The data sources were characterized by accessibility, geographic granularity, setting, sector of the data, sources and type of the data. Descriptive analyses were performed. RESULTS: We identified 125 data sources for DUR in nine LatAm countries. Thirty-eight (30%) of them were publicly and conveniently available; 89 (71%) were accessible with limitations, and 18 (14%) were not accessible or lacked clear rules for data access. From the 125 data sources, 76 (61%) were from the public sector only; 46 (37%) were from pharmacy records; 43 (34%) came from ambulatory settings and; 85 (68%) gave access to individual patient-level data. CONCLUSIONS: Although multiple sources for DUR are available in LatAm countries, the accessibility is a major challenge. The procedures for accessing DUR data should be transparent, feasible, affordable, and protocol-driven. This inventory could permit a comparison of drug utilization between countries identifying potential medication-related problems that need further exploration.

Oral cancer patient's profile and time to treatment initiation in the public health system in Rio de Janeiro, Brazil.

BACKGROUND: This paper aims to describe the profile of oral cancer (OC) patients, their risk classification and identify the time between screening and treatment initiation in Rio de Janeiro Municipality. METHOD: Data were obtained from the healthcare Regulation System (SISREG) regarding the period January 2013 to September 2015. Descriptive, bivariate and multivariate analysis were performed identifying the factors associates with a diagnosis of OC as well as the time to treatment initiation (TTI) differences between groups. RESULTS: From 3,862 individuals with a potential OC lesion, 6.9 % had OC diagnosis. OC patients were 62.3 y.o. (mean), 64.7 % male, 36.1 % were white and 62.5 % of the records received a red/yellow estimated risk classification. Being older, male, white and receiving a high-risk classification was associated with having an OC diagnosis. OC TTI was in average 59.1 days and median of 50 days significantly higher than non-OC individuals (p = 0.007). TTI was higher for individuals older than 60 years old, male, and white individuals and for risk classification red and yellow, nevertheless while in average none of these differences were statistically significant, the median of individuals classified as low risk was significantly (p = 0.044) lower than those with high risk. CONCLUSIONS: Time to treatment initiation (TTI) was higher for OC patients related to non OC. Despite OC confirmed was associated with risk at screening classified as urgent or emergent, a high percentage of OC patients had their risk classified for elective care when specialized care was requested.

Implementation of pharmaceutical services in Brazilian primary health care: a cross-sectional study.

BACKGROUND: In the Brazilian public health system, primary health care (PHC) is provided by the municipalities and is considered the entry level of the Unified Health System (SUS). Governmental pharmaceutical services (PharmSes) are part of the SUS, including PHC, and are the most significant way in which patients access medicine and services. Considering the diversity of the country, the municipalities have the autonomy to decide how PharmSes are implemented. Even though policies and procedures should be implemented as expected by policy makers and experts, municipality characteristics may interfere with implementation fidelity. Therefore, this study evaluated the degree to which the PharmSes in PHC were delivered as intended in Brazilian municipalities. METHODS: We analysed data from a secondary database originating from a cross-sectional nationwide study carried out by the Ministry of Health and the World Bank from 2013 to 2015. Data on 465 municipalities and the Federal District were collected from 4939 governmental PharmSes. A rating system comprising 43 indicators was developed and applied to the dataset to obtain the implementation degree (ID) of each PharmSe. Additionally, the IDs of the two PharmSes dimensions and the nine components were measured. RESULTS: Overall, the ID of the PharmSes in Brazilian PHC was evaluated as critical. The ID was critical in 81% of the municipalities (n = 369), incipient in 14% (n = 65) and unsatisfactory in 4.8% (n = 22). Regarding the PharmSes dimensions, the 'medicine management' (MM) ID was considered critical (Mean = 46%), while the 'care management' (CM) ID was incipient (Mean = 22%). In terms of the PharmSes components, the highest ID was achieved by 'forecasting' (58%). In contrast, 'continuing education and counselling' showed the lowest figure (ID = 11%) in the whole sample, followed by 'information and communication' and 'teamwork'. CONCLUSIONS: The degree to which PharmSes were implemented was critical (ID< 50%). This analysis demonstrated that PharmSes were implemented with low fidelity, which may be related to the low availability of medicine in PHC. Although the care management component requires more attention, considering their incipient ID, all components must be reviewed. Municipalities must increase their investment in PharmSes implementation in order to maximize the benefits of these services and guarantee the essential right of access to medicine.

Hypertension and diabetes treatment affordability and government expenditures following changes in patient cost sharing in the "Farmácia popular" program in Brazil: an interrupted time series study.

BACKGROUND: Increasing medicines availability and affordability is a key goal of Brazilian health policies. "Farmácia Popular" (FP) Program is one of the government's key strategies to achieve this goal. Under FP, antihypertension (HTN) and antiglycemic (DM) medicines have been provided at subsidized prices in private retail settings since 2006, and free of charge since 2011. We aim to assess the impact of sequential changes in FP benefits on patient affordability and government expenditures for HTN and DM treatment under the FP, and examine their implications for public financing mechanisms and program sustainability. METHODS: Longitudinal, retrospective study using interrupted time series to analyze: HTN and DM treatment coverage; total and per capita expenditure; percentage paid by MoH; and patient cost sharing. Analyzes were conducted in the dispensing database of the FP program (from 2006 to 2012). RESULTS: FP has increased its coverage over time; by December 2012 FP covered on average 13% of DM and 11.5% of HTN utilization, a growth of over 600 and 1500%, respectively. The overall cost per treatment to the MoH declined from R$36.43 (R$ = reais, the Brazilian currency) to 18.74 for HTN and from R$33.07to R$15.05 for DM over the period analyzed, representing a reduction in per capita cost greater than 50%. The amount paid by patients for the medicines covered increased over time until 2011, but then declined to zero. We estimate that to treat all patients in need for HTN and DM in 2012 under FP, the Government would need to expend 97% of the total medicines budget. CONCLUSIONS: FP rapidly increased its coverage in terms of both program reach and proportion of cost subsidized during the period analyzed. Costs of individual HTN and DM treatments in FP were reduced after 2011 for both patients (free) and government (better negotiated prices). However, overall FP expenditures by MoH increased due to markedly increased utilization. The FP is sustainable as a complementary policy but cannot feasibly substitute for the distribution of medicines by the SUS.

Barriers in household access to medicines for chronic conditions in three Latin American countries.

BACKGROUND: Access to medicines is one of the major challenges in health policy. The high out-of-pocket expenditures on medicines in the Latin American and Caribbean (LAC) region represents important barrier to affordable access to care for NCDs. This paper aim to identify key barriers in access to medicines for household members with a diagnosed chronic condition in three Central America countries. METHODS: This was a cross-sectional analytic study, based on data from three household surveys using a common methodology. We examined associated factors to: (1) seeking care for chronic illness from a trained clinician in the formal health system, and (2) obtaining all medicines sought for the chronic conditions reported. RESULTS: A chronic condition was reported in 29.8 % (827) of 2761 households - 47.0, 30.7 and 11.8 % in Nicaragua, Honduras and Guatemala, respectively. The three main chronic conditions reported were hypertension, arthritis, and diabetes. Seeking care in the formal health system ranged from 73.4 % in Nicaragua to 83.1 % in Honduras, while full access to medicines varied from 71.6 % in Guatemala to 88.0 % in Honduras. The main associated factors of seeking care in the formal health system were geographic location, household head gender, Spanish literacy, patient age, perceived health status, perceived quality of public sector care, household economic level, and having health insurance. Seeking care in the formal health system was the main bivariate associated factor of obtaining full access to medicines (OR: 4.3 95 % CI 2.6 - 7.0). The odds of full access to medicines were significantly higher when the household head was older than 65 years, medicines were obtained for free, households had higher socioeconomic status, and health care was sought in the private sector. CONCLUSIONS: The nature of the health system plays an important role in access to medicines. Access is better when public facilities are available and function effectively, or when private sector care is affordable. Thus, understanding how people seek care in a given setting and strengthening key health system components will be important strategies to improve access to medicines, especially for populations at high risk of poor access.

Pharmaceutical policies: effects of cap and co-payment on rational use of medicines.

BACKGROUND: Growing expenditures on prescription medicines represent a major challenge to many health systems. Cap and co-payment policies are intended as an incentive to deter unnecessary or marginal utilisation, and to reduce third-party payer expenditures by shifting parts of the financial burden from insurers to patients, thus increasing their financial responsibility for prescription medicines. Direct patient payment policies include caps (maximum numbers of prescriptions or medicines that are reimbursed), fixed co-payments (patients pay a fixed amount per prescription or medicine), co-insurance (patients pay a percentage of the price), ceilings (patients pay the full price or part of the cost up to a ceiling, after which medicines are free or are available at reduced cost) and tier co-payments (differential co-payments usually assigned to generic and brand medicines). This is the first update of the original review. OBJECTIVES: To determine the effects of cap and co-payment (cost-sharing) policies on use of medicines, healthcare utilisation, health outcomes and costs (expenditures). SEARCH METHODS: For this update, we searched the following databases and websites: The Cochrane Central Register of Controlled Trials (CENTRAL) (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register, Cochrane Library; MEDLINE, Ovid; EMBASE, Ovid; IPSA, EBSCO; EconLit, ProQuest; Worldwide Political Science Abstracts, ProQuest; PAIS International, ProQuest; INRUD Bibliography; WHOLIS, WHO; LILACS), VHL; Global Health Library WHO; PubMed, NHL; SCOPUS; SciELO, BIREME; OpenGrey; JOLIS Library Network; OECD Library; World Bank e-Library; World Health Organization, WHO; World Bank Documents & Reports; International Clinical Trials Registry Platform (ICTRP), WHO; ClinicalTrials.gov, NIH. We searched all databases during January and February 2013, apart from SciELO, which we searched in January 2012, and ICTRP and ClinicalTrials.gov, which we searched in March 2014. SELECTION CRITERIA: We defined policies in this review as laws, rules or financial or administrative orders made by governments, non-government organisations or private insurers. We included randomised controlled trials, non-randomised controlled trials, interrupted time series studies, repeated measures studies and controlled before-after studies of cap or co-payment policies for a large jurisdiction or system of care. To be included, a study had to include an objective measure of at least one of the following outcomes: medicine use, healthcare utilisation, health outcomes or costs (expenditures). DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed study limitations. We reanalysed time series data for studies with sufficient data, if appropriate analyses were not reported. MAIN RESULTS: We included 32 full-text articles (17 new) reporting evaluations of 39 different interventions (one study - Newhouse 1993 - comprises five papers). We excluded from this update eight controlled before-after studies included in the previous version of this review, because they included only one site in their intervention or control groups. Five papers evaluated caps, and six evaluated a cap with co-insurance and a ceiling. Six evaluated fixed co-payment, two evaluated tiered fixed co-payment, 10 evaluated a ceiling with fixed co-payment and 10 evaluated a ceiling with co-insurance. Only one evaluation was a randomised trial. The certainty of the evidence was found to be generally low to very low.Increasing the amount of money that people pay for medicines may reduce insurers' medicine expenditures and may reduce patients' medicine use. This may include reductions in the use of life-sustaining medicines as well as medicines that are important in treating chronic conditions and medicines for asymptomatic conditions. These types of interventions may lead to small decreases in or uncertain effects on healthcare utilisation. We found no studies that reliably reported the effects of these types of interventions on health outcomes. AUTHORS' CONCLUSIONS: The diversity of interventions and outcomes addressed across studies and differences in settings, populations and comparisons made it difficult to summarise results across studies. Cap and co-payment polices may reduce the use of medicines and reduce medicine expenditures for health insurers. However, they may also reduce the use of life-sustaining medicines or medicines that are important in treating chronic, including symptomatic, conditions and, consequently, could increase the use of healthcare services. Fixed co-payment with a ceiling and tiered fixed co-payment may be less likely to reduce the use of essential medicines or to increase the use of healthcare services.

Strengthening the capacity of managers in pharmaceutical services based on Primary Health Care (PHC) at different levels of the health system.

INTRODUCTION: Distance learning methods have been widely used because of their advantages to continuing professional development processes. The Primary Health Care (PHC) is a strategy which has been implemented in order to improve the efficiency of health systems. Due to the need for access to medicines and technologies regardless of the strengthening of health systems, a new approach that better integrates both pharmaceutical services and health systems has been implemented. CASE DESCRIPTION: This is a case study which consists of describing the process of restructuring, developing and implementing the second version of the Virtual Course on Primary Health Care-based Pharmaceutical Services for managers (CVSERVFAPS-12). The main objective is to strengthen the capacity of managers in pharmaceutical services, based on PHC at different levels of the health system, in order to support the restructuring and empowering of these services and, consequently, the health systems in the American region. DISCUSSION AND EVALUATION: Many evaluation tools were applied to identify the achievement/improvement of planned competencies. The intervention proposals were collectively built and intended to be more than an academic exercise, looking forward to being implemented as a strategic intervention to promote changes in the pharmaceutical services of the American region. The main strengths identified for the second version of the course were related to the quality of the didactic material and content. Additionally, the tutors' support was commented upon as a positive aspect. The main challenges faced in this rebuilding process related to the due dates of the activities and lectures as well as the time to capture and assimilate the content. CONCLUSIONS: The CVSERVFAPS-Pilot was reformulated and CVSERVFAPS-12 is consistent with the issues raised in the pilot course's evaluation in 2011, which were successfully implemented. The use of the distance learning strategy, through a virtual environment, for the application of the Virtual Course on PHC- based pharmaceutical services for managers, is appropriate and confirmed its role in public policy promotion through effective retention and distribution of health workers.

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.

[Social determinants of exclusion from health services and medicines in three Central American countries]. / Determinantes sociales de la exclusión a los servicios de salud y a medicamentos en tres países de América Central.

OBJECTIVE: Examine the social determinants that affect population behavior with regard to the search for and acquisition of medicines, and their relationship to exclusion from health services based on aggregate data from three Central American countries: Guatemala, Honduras, and Nicaragua. METHODS: A descriptive, observational cross-sectional study was conducted by administration of a household survey. The study sample was selected in accordance with the conglomerate method. Data was analyzed with the SPSS® V.17 program using descriptive statistics, bivariate, multivariate, and principal components analysis (PCA). RESULTS: Although the majority of the persons could access health care, health exclusion (odds ratio [OR] 4.10; 95% confidence interval [95% CI]) was the main determinant of lack of access to medicines. The characteristics of housing (OR 0.747, 95% CI), formal employment of head of the household (OR 0.707, 95% CI), and socioeconomic status of the household (OR 0.462, 95% CI) were also important determinants of lack of access to medicines. CONCLUSIONS: The phenomena of lack of access to health services and medicines are not independent from one another. It was corroborated that the health system, as an intermediate social determinant of health, is an important factor for improvement of access to medicines. Public policies that aim to achieve universal coverage should consider this relationship in order to be effective.

[Drug regulatory authorities in South America: an analysis based on organizational rules]. / Autoridades reguladoras de medicamentos sul-americanas: uma análise a partir de regras organizacionais.

OBJECTIVE: To describe the organization of national drug regulatory authorities (DRAs) in Argentina, Brazil, Chile, and Peru through the analysis of categories representing organizational rules. METHODS: The DRAs were selected using the following criteria: being in a South American country, having been identified as DRAs at Encuentros de Autoridades Competentes en Medicamentos de los Países Iberoamericanos (Conferences of Ibero-American Drug Regulatory Authorities), and having good availability of electronic data regarding organizational structure and the process of drug regulation. The main source of data were websites, which were reviewed between May 2010 and March 2011. The analytical categories were: organizational structure, competencies, directionality (mission and vision statements), and forms of accountability. RESULTS: The DRAs of Argentina and Brazil functioned as autonomous agencies, while those of Chile and Peru were directly subordinated to the ministries of health. Except for the Brazilian DRA, the agencies in the other three countries were dependent on their health ministries to issue sanitary regulations. The scope of action of each DRA differed in terms of the goods and services covered, with the Peruvian DRA being the only one exclusively dedicated to the regulation of drugs. The four DRAs performed all the processes identified by the World Health Organization as essential for effective drug regulation. CONCLUSIONS: The results show an effort by the studied countries to improve their regulatory structure. Nevertheless, all four DRAs need to improve some mechanisms to ensure that, at the end of the regulatory chain, the drugs they regulate have the desired quality and safety, with more transparency in decision-making processes and social accountability.

Reversal of the recommendations issued by the National Commission for the Incorporation of Technologies in SUS after Public Consultations. / Reversão das recomendações emitidas pela Comissão Nacional de Incorporação de Tecnologias no SUS após Consultas Públicas.

The work analyzed the effect of Public Consultations (PC) and their contributions to the recommendations of the National Commission for the Incorporation of Technologies (CONITEC). This is a descriptive and retrospective study with a qualitative-quantitative approach using a secondary data source of public access, between 2012 and 2017. A database was developed to characterize the PC of medications and their contributions, which allowed the identification of cases of reversals between the preliminary and final recommendation of CONITEC. We analyzed the contributions in cases of reversal for characterization of argumentative axes and type of basis. Of the 307 demands for incorporation of medications, 205 went through PC, with 23,894 contributions. The reversal of the recommendations occurred in 9% of the open PC (15 medications), all in the sense of non-incorporation for incorporation. Main argumentative axes dealt with clinical benefits and minor adverse events, with prevalence of the submission of clinical experiences and opinions. Advances in the processes of incorporation of technologies in the SUS by performing PC were found and the challenge that decision makers face in institutional spaces for the improvement of social participation to strengthen the public benefit was clear.

O trabalho analisou o efeito das Consultas Públicas (CP) e suas contribuições nas recomendações da Comissão Nacional de Incorporação de Tecnologias (CONITEC). Trata-se de estudo descritivo e retrospectivo, com abordagem qualiquantitativa, com fonte de dados secundárias de acesso público, entre 2012 e 2017. Elaborou-se banco de dados para caracterizar as CP de medicamentos e suas contribuições, o que permitiu identificar casos de reversões entre a recomendação preliminar e final da CONITEC. Analisou-se as contribuições nos casos de reversão para caracterização de eixos argumentativos e tipo de embasamento. Das 307 demandas de incorporação, 205 destes passaram por CP, com 23.894 contribuições. A reversão das recomendações ocorreu em 9% das CP abertas (15 medicamentos), todas no sentido da não incorporação para incorporação. Principais eixos argumentativos trataram de benefícios clínicos e menores eventos adversos, prevalecendo o envio de experiências clínicas e opiniões. Evidencia-se avanços nos processos de incorporação de tecnologias no SUS pela realização da CP e ficou claro o desafio que os tomadores de decisão enfrentam nos espaços institucionais para o aprimoramento da participação social no sentido de fortalecer o benefício público.

Drugs for rheumatoid arthritis provided by the Unified Health System in 2019 in Brazil: a cohort study. / Medicamentos para artrite reumatoide fornecidos pelo Sistema Único de Saúde em 2019 no Brasil: estudo de coorte.

This study analyzes supply characteristics and factors associated with the treatment of rheumatoid arthritis in Brazil, with a focus on disease course-modifying biological drugs (bioDMARDs). A retrospective study was conducted with secondary data from the Outpatient Information System of the Unified Health System. Patients aged 16 years or older who were treated in 2019 were eligible. The analyses were performed with exposure factors in relation to the outcomes: bioDMARD use and population size. The study included 155,679 patients, 84.6% of whom were women. There was a greater exchange of bioDMARDs and a greater supply of rheumatologists in the larger municipalities (more than 500,000 inhabitants). Almost 40% of the patients used bioDMARDs, and they showed greater adherence to treatment (57.0% versus 64%, p=0.001). The dispensing of bioDMARDs occurred in more than one-third of the patients treated for rheumatoid arthritis (RA) in Brazil and was associated with a higher percentage of availability of rheumatologists and larger population size.

Este artigo tem como objetivo analisar características do fornecimento e fatores associados ao tratamento da artrite reumatoide no Brasil, com foco nos medicamentos biológicos modificadores do curso da doença (MMCDbio). Foi realizado um estudo retrospectivo com dados secundários do Sistema de Informação Ambulatorial do Sistema Único de Saúde. Foram incluídos pacientes com 16 anos ou mais, atendidos nos doze meses do ano de 2019. As análises foram feitas com fatores de exposição em relação aos desfechos: uso de MMCDbio e porte populacional. O estudo incluiu 155.679 pacientes, sendo 84,6% mulheres. Observou-se maior troca de MMCDbio e maior provisão de médicos reumatologistas nos municípios de maior porte (mais de 500 mil habitantes). Quase 40% dos pacientes utilizaram MMCDbio e estes apresentaram maior adesão ao tratamento (57,0% versus 64%, p=0,001). A dispensação de MMCDbio ocorreu para mais de um terço dos pacientes tratados para AR no Brasil e esteve associada ao maior percentual de disponibilidade de médicos reumatologistas e ao maior porte populacional dos municípios.

Regulations on the Use of Antibiotics in Livestock Production in South America: A Comparative Literature Analysis.

As a global health problem, antimicrobial resistance (AMR) crosses national borders, leading UN (United Nations) multilateral agencies to call for all countries to improve the stewardship of antibiotics in humans and animals. South American countries have changed their regulations regarding antibiotic use in livestock production. This literature review examines how far the five largest meat-producing countries in South America (Argentina, Brazil, Chile, Colombia, and Uruguay) have come in terms of the relevant legislation. Rules on market entry (marketing authorization and official distribution systems) are already set in all countries examined. Four countries do not allow growth promoters based on critically important antibiotics, and countries have also begun to set guidelines and minimum welfare and biosecurity requirements to reduce the therapeutic demand for antibiotics. Nonetheless, there are aspects related to the distribution, use, and disposal of antibiotics that need to be developed further. In conclusion, legislation in South American countries is moving towards the goals set by UN multilateral agencies, but more can be done. Differences between countries' rules and the gold standards set by the World Organization for Animal Health (OIE), World Health Organization (WHO), and Food and Agriculture Organization of the United Nations (FAO) reveal possible adaptations to the countries' realities. Further studies must examine compliance with the legislation already set and investigate other tools that can be used alongside legislation as a driving force to change stakeholder behaviour.

[From community pharmacies to big pharmacy chains: private provision of medicines, health system, and financialization of the Brazilian retail pharmacy market]. / Das farmácias comunitárias às grandes redes: provisão privada de medicamentos, sistema de saúde e financeirização no varejo farmacêutico brasileiro.

The provision of medicines in Brazil is marked by the predominance of private expenditures and supply in pharmacies and by the historically liberal regulation of retail drug sales. The first two decades of the 21st century witnessed the expansion and concentration of the retail pharmaceutical sector and growing financialization of the health sector. The article analyzes the characteristics of financialization of Brazilian retail pharmaceutical companies, considering the following three crosscutting dimensions: ownership structure, financial/accounting, and political. Quantitative and qualitative data from various sources were analyzed including ownsership and account informations of the ten biggest Brazilian retail pharmacies chains and political action of four business associations. The information collected was stored in the source project database. The ownership structure dimension revealed verticalization, diversification, capitalization via financial and shareholding operations, intensification of mergers and acquisitions, opening of pharmacy branches, entry of investors, and changes in internal management and organization. The financial/accounting dimension revealed an increase in size (revenues, assets, net worth) and good performance (return on equity capital, capital turnover, and third-party capital) of the networks compared to Brazilian companies and health companies. The policy arena revealed both clashes and collaborations between representative associations and government (Executive, Legislative, and Judiciary), depending on the issue, with outcomes that were generally favorable to the pharmaceutical sector and leadership by the Brazilian Association of Pharmacy and Drugstore Networks (Abrafarma). The financialization of the retail pharmaceutical companies' accumulation pattern and the strengthening of their political action proved relevant for understanding the changes in the provision of medicines and in the pharmaceutical market.

No Brasil a provisão de medicamentos é marcada pelo predomínio dos gastos e da oferta privada em farmácias e pela regulação historicamente liberal sobre a comercialização. Nos anos 2000 e 2010 houve expansão e concentração do varejo farmacêutico e crescente financeirização no setor saúde. O artigo analisa as expressões da financeirização em empresas do varejo farmacêutico brasileiro considerando três dimensões transversais: patrimonial, contábil-financeira e política. Foram analisados dados quantitativos e qualitativos de variadas fontes sobre as dimensões patrimonial e contábil das 10 maiores redes de farmácias brasileiras e à dimensão política da ação de quatro entidades representativas do subsetor. As informações coletadas foram reunidas no banco de dados da pesquisa fonte (Banco de Dados sobre Empresariamento na Saúde - BDES). Na dimensão patrimonial, identificou-se verticalização, diversificação, capitalização por operações financeiras e patrimoniais, intensificação de fusões e aquisições, abertura de farmácias, entrada de investidores, mudanças na gestão e organização interna. Na contábil-financeira, constatou-se aumento de porte (receitas, ativos, patrimônio) e bom desempenho (retorno sobre capital próprio, giro do ativo e capitais de terceiros) das redes em comparação à empresas brasileiras e da saúde. Na política houve embates e colaborações entre entidades e o poder público (Executivo, Legislativo e Judiciário) a depender da pauta, com desfechos geralmente favoráveis ao subsetor e protagonismo da Associação Brasileira de Farmácias e Drogarias (Abrafarma). A financeirização do padrão de acumulação de empresas do varejo farmacêutico e o fortalecimento de sua atuação política se mostraram relevantes para compreensão das mudanças na provisão de medicamentos e no setor farmacêutico.

En Brasil la provisión de medicamentos está marcada por el predominio de los gastos y oferta privada en farmacias, así como por la regulación históricamente liberal sobre su comercialización. En los años 2000 y 2010 hubo una expansión y concentración de la red minorista farmacéutica y una creciente financiarización en el sector salud. El artículo analiza las expresiones de la financiarización en empresas de la red minorista farmacéutica brasileña, considerando tres dimensiones transversales: patrimonial, contable-financiera y política. Se analizaron datos cuantitativos y cualitativos de variadas fuentes, reunidos en el banco de datos del estudio fuente, relacionados con las dimensiones patrimonial y contable de las diez mayores redes de farmacias brasileñas, y con la dimensión de la actuación política de cuatro entidades representativas del subsector. En la dimensión patrimonial, se identificaron: verticalización, diversificación, capitalización por operaciones financieras y patrimoniales, intensificación de fusiones y adquisiciones, apertura de farmacias, entrada de inversores, cambios en la gestión y organización interna. En la contable-financiera, se constató un aumento de tamaño (ingresos, activos, patrimonio) y buen desempeño (rendimiento sobre capital propio, rotación del activo y capitales de terceros) de las redes, en comparación con empresas brasileñas y de salud. En política hubo enfrentamientos y colaboraciones entre entidades y poder público (Ejecutivo, Legislativo y Judicial) dependiendo de la agenda de cada uno, con desenlaces generalmente favorables al subsector y protagonismo de la Asociación Brasileña de Farmacias y Droguerías (Abrafarma). La financiarización del patrón de acumulación de empresas en la red minorista farmacéutica y el fortalecimiento de su actuación política fueron relevantes para la comprensión de los cambios en la provisión de medicamentos y en el sector farmacéutico.

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.

Longevity and cost of care: the challenge of a self-managed health plan. / Longevidade e custo da assistência: o desafio de um plano de saúde de autogestão.

This paper aims to analyze the relationship between the cost of health care and the aging of the population assisted by a self-managed plan, reflecting on the ways to address the challenge arising from this conjunction of population demographic changes. This is a descriptive study of the 1997-2016 period based on secondary data from the management operator of the health plan under study and from another administrative database of a self-managing provider with broad nationwide coverage. Older adults (over 60 years) increased 55% during the study period. On the other hand, the so-called "very old" (over 80 years) grew 332.8%. The population above 60 years corresponds to 25.7% of the total, and accounts for 68.8% of expenses. Most of the population covered (84,6%) is located in the State of Rio de Janeiro, which has the highest per capita health care cost in Brazil. We found a relationship between aging of the beneficiary population and increased expenditure. It is imperative to invest in health promotion and disease prevention initiatives as a way of improving the quality of life and financial sustainability of the plan, and define a subsystem that delimits and regulates access to the network and is accepted by the beneficiaries.

O objetivo deste artigo é analisar a relação entre o custo da assistência e o envelhecimento da população assistida por um plano de autogestão, refletindo sobre possibilidades de enfrentamento do desafio advindo dessa conjunção de fatores. Trata-se de um estudo descritivo do período 1997 a 2016, efetivado a partir de dados secundários provenientes da operadora do plano de saúde em estudo, e outro banco administrativo de operadora de autogestão de grande abrangência nacional. Os idosos (mais de 60 anos) aumentaram no período do estudo 55,5%. Já os chamados "muito idosos" (acima de 80 anos) cresceram em quantidade 332,8%. A população acima de 60 anos corresponde a 25,7% do total sendo responsável por 68,8% das despesas. A grande maioria da população atendida (84,6%) está localizada no Estado no Rio de Janeiro, o qual tem o mais alto custo per capita em saúde no País. Foi encontrada relação entre o envelhecimento da população beneficiária e o aumento das despesas. É imperioso investir em iniciativas de promoção da saúde e prevenção de doenças como forma de melhora da qualidade de vida e viabilidade financeira do plano, além de definir um sub-sistema que delimite e discipline o acesso à rede e seja aceito pelos beneficiários.

Does socioeconomic inequality occur in the multimorbidity among Brazilian adults?

OBJECTIVE: To assess the prevalence of multimorbidity among Brazilian adults and its association with socioeconomic indicators. METHODS: Cross-sectional study that used data from the Pesquisa Nacional Sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil (PNAUM - Brazilian National Survey on Access, Use and Promotion of Rational Use of Medicines), carried out between 2013 and 2014. The definition of multimorbidity was the coexistence, in a single individual, of two or more chronic diseases, measured through a list of 14 morbidities (self-reported medical diagnosis throughout life). Economic status and educational level were the socioeconomic indicators used, being the inequalities assessed through the Slope Index of Inequality (SII) and the Concentration Index, stratified by gender. RESULTS: The study comprehended 23,329 adults (52.8% of which were women), with an average age of 37.9 years. Hypertension and high cholesterol levels were the most prevalent conditions. The prevalence of multimorbidity was of 10.9% (95%CI 10.1-11.7) representing nearly 11 million individuals in Brazil, of which 14.5% (95%CI 13.5-15.4) were women and 6.8% (95%CI 5.9-7.8) were men. The occurrence of multimorbidity was similar according to the socioeconomic indicators. In the inequality analysis, we observed absolute and relative differences in men with a higher purchasing power (SII = 3.7; 95%CI 0.3-7.0) and higher educational level (CIX = 7.1; 95%CI 0.9-14.7), respectively. CONCLUSIONS: The frequency of comorbidities in Brazilian adults is high, especially in absolute terms. We only observed socioeconomic inequalities in multimorbidities among men.

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.].