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O sistema prisional brasileiro tem sido ao longo da história, forjado por perspectivas de controle e punição, de certo modo, influenciado por políticas de drogas fundamentadas no modelo proibicionista alavancado pelos Estados Unidos da América (EUA), resultando, em desafios significativos para a superação destas medidas no Brasil. O objetivo do estudo foi compreender como a política sobre drogas tem sido aplicada nas prisões de Mato Grosso do Sul, na perspectiva de seus servidores. O estudo é de natureza qualitativa, descritiva, transversal, com abordagem fenomenológica desenvolvida em unidades do órgão gestor no estado, com um total aleatório de onze locais avaliados. Os principais desafios a serem superados para a aplicação da política sobre drogas nas prisões, são a ausência de normativos legais, investimentos insuficientes nos servidores prisionais, estrutura inadequada para a prestação das assistências, e ainda, a ausência de amparo institucional. Para a aplicação da política sobre drogas no sistema prisional brasileiro é necessário haver normativos específicos para a efetivação de práticas ressocializadoras voltadas a prevenção e tratamento da dependência química, assim como investimentos nos servidores prisionais, melhorias estruturais e apoio institucional. Faz-se urgente reconhecer que, a prisão não pode ser único instrumento legal às pessoas que cometeram crimes em decorrência de suas vulnerabilidades com as drogas, e que o sistema prisional precisa ser ressignificado em suas funções com atuação do Estado e da sociedade, para superar os desafios históricos e estabelecer um sistema mais justo e respeitoso dos direitos humanos.

approach developed in units of the managing body in the state, with a random total of eleven locations evaluated. The main challenges to be overcome for the application of drug policy in prisons are the absence of legal regulations, insufficient investment in prison staff, an inadequate structure for providing assistance, and also the absence of institutional support. For the application of drug policy in the Brazilian prison system, it is necessary to have specific regulations for the implementation of resocializing practices aimed at preventing and treating chemical dependency, as well as investments in prison staff, structural improvements and institutional support. It is urgent to recognize that prison cannot be the only legal instrument for people who have committed crimes as a result of their vulnerability to drugs, and that the prison system needs to be given new meaning in its functions with the action of the State and society, to overcome historical challenges and establish a fairer and more respectful system for human.

El sistema penitenciario brasileño ha sido, a lo largo de la historia, forjado por perspectivas de control y castigo, en cierta medida, influenciadas por políticas de drogas basadas en el modelo prohibicionista apalancado por los Estados Unidos de América (EE.UU.), resultando en importantes desafíos para la superación de estas medidas en Brasil. El objetivo del estudio fue comprender cómo se ha aplicado la política de drogas en las prisiones de Mato Grosso do Sul, desde la perspectiva de sus funcionarios. El estudio es de carácter cualitativo, descriptivo, transversal, con enfoque fenomenológico desarrollado en unidades de la entidad gestora del estado, con un total aleatorio de once localidades evaluadas. Los principales desafíos a superar para la aplicación de la política de drogas en las prisiones son la ausencia de regulaciones legales, una inversión insuficiente en personal penitenciario, una estructura inadecuada para brindar asistencia y también la ausencia de apoyo institucional. Para la aplicación de la política de drogas en el sistema penitenciario brasileño, es necesario contar con regulaciones específicas para la implementación de prácticas resocializadoras destinadas a prevenir y tratar la dependencia química, así como inversiones en personal penitenciario, mejoras estructurales y apoyo institucional. Es urgente reconocer que la prisión no puede ser el único instrumento jurídico para las personas que han cometido delitos producto de su vulnerabilidad a las drogas, y que el sistema penitenciario necesita resignificarse en sus funciones con la acción del Estado y la sociedad, para superar desafíos históricos y establecer un sistema más justo y respetuoso de los derechos humanos.

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

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In this paper, we study whether leadership and community organisation can explain differences in the presence and expansion of coca crops in rural Afro-Colombian collective territories. Following a mixed-method approach that combines the analysis of satellite imagery, semi-structured interviews and household surveys, our results suggest that leadership and community organisation help explain differences in the presence of illegal coca crops by activating pre-existing 'stocks' of social capital that enable rural Afro-Colombian communities in the country's southern Pacific region to resist the penetration and/or expansion of illegal coca crops. Results also show that resistance is more effective when the interests and strategies of leadership and communities are aligned. We argue that the effectiveness and sustainability of resistance depend on: (a) the stock of social capital that determines organisational capabilities, (b) the specific normative content with which this capital is infused, (c) the legitimacy and influence of leadership on the community, and (d) synergies among different levels of grass-root community organisation. We conclude that investing in social capital and community capabilities is thus one way to reorient policy interventions, a goal to which the Colombian state can only partially contribute given its policy priorities and structural limitations.

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A common drug policy in source countries -forced eradication- has unintended consequences in multiple dimensions. Aerial spraying in particular, has social and environmental costs including, increased violence, deforestation, and adverse health outcomes. However, there is less evidence of the unintended consequences of illicit crop substitution programs, another widely used intervention. This paper illustrates an unintended effect of the largest crop substitution program in the world, namely increased violence against social leaders. Examining the recent Colombian illicit crop substitution program implemented in 2017, this paper estimates the effect on violence towards social leaders employing an event study econometric strategy. The program increased the rate of social leader killings by 481% and the probability of a killing by 122%. The findings reveal a greater effect on municipalities where leaders oppose the expansion of illicit crops, where organized crime does not hold consolidated power, and where there is a presence of illegal armed groups. This study contributes to the literature on antidrug policies by providing empirical evidence of unintended consequences for local communities.

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The 2019 novel coronavirus (COVID-19) pandemic has placed a significant strain on hepatitis programs and interventions (screening, diagnosis, and treatment) at a critical moment in the context of hepatitis C virus (HCV) elimination. We sought to quantify changes in Direct Acting Antiviral (DAA) utilization among different countries during the pandemic. We conducted a cross-sectional time series analysis between 1 September 2018 and 31 August 2020, using the IQVIA MIDAS database, which contains DAA purchase data for 54 countries. We examined the percent change in DAA units dispensed (e.g., pills and capsules) from March to August 2019 to the same period of time in 2020 across the 54 countries. Interrupted time-series analysis was used to examine the impact of COVID-19 on monthly rates of DAA utilization across each of the major developed economies (G7 nations). Overall, 46 of 54 (85%) jurisdictions experienced a decline in DAA utilization during the pandemic, with an average of -43% (range: -1% in Finland to -93% in Brazil). All high HCV prevalence (HCV prevalence > 2%) countries in the database experienced a decline in utilization, average -49% (range: -17% in Kazakhstan to -90% in Egypt). Across the G7 nations, we also observed a decreased trend in DAA utilization during the early months of the pandemic, with significant declines (p < 0.01) for Canada, Germany, the United Kingdom, and the United States of America. The global response to COVID-19 led to a large decrease in DAA utilization globally. Deliberate efforts to counteract the impact of COVID-19 on treatment delivery are needed to support the goal of HCV elimination.

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

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

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BACKGROUND: In 2013, Uruguay became the first country in the world to legalize recreational cannabis, instituting a non-commercial state regulatory model of production and supply. This study provides the first empirical evidence on its impacts on adolescent use of cannabis and related risks. METHODS: We use a generalization of the synthetic control method (SCM) to estimate the impact of legalization in Uruguay on adolescent past year and month cannabis use, perceived availability of cannabis and perceived risk of cannabis use. We compare biennial high school student self-reported survey data from Montevideo and regions in the interior of Uruguay post-legalization (2014-2018) and post initial implementation (2015-2018) to a synthetic counterfactual constructed using a weighted combination of 15 control regions in Chile. RESULTS: We find no evidence of an impact on cannabis use or the perceived risk of use. We find an increase in student perception of cannabis availability (58% observed vs. 51% synthetic control) following legalization. CONCLUSION: Our findings provide some support for the thesis that Uruguay's state regulatory approach to cannabis supply may minimize the impact of legalization on adolescent cannabis use. At the same time, our study period represents a period of transition: pharmacy access, by far the most popular means of access, was not available until the summer of 2017. Additional study will be important to assess the longer-term impacts of the fully implemented legalization regime on substance use outcomes.

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BACKGROUND: Naloxone is a safe and effective medication to help reverse opioid overdose. Providing take-home naloxone to patients in opioid treatment settings is a critical step to reducing opioid overdose deaths. In New Mexico, a US state with one of the highest rates of opioid overdose deaths, legislation was passed in 2017 (House Bill 370) to support take-home naloxone, and followed by naloxone training of Opioid Treatment Program staff to increase distribution. METHODS: Naloxone training was offered to all New Mexico Opioid Treatment Programs along with a baseline survey to assess current practices and barriers to take-home naloxone distribution. Focus groups were conducted approximately 1 year post-training with staff at a subset of the trained Opioid Treatment Programs to assess the impact of the legislation and training provided. RESULTS: Baseline survey results show most Opioid Treatment Program staff were unfamiliar with House Bill 370, reported conflicting understandings of their agency's current take-home naloxone practices, and reported a number of barriers at the patient, agency, and policy level. Follow-up focus groups revealed support for House Bill 370 but persistent barriers to its implementation at the patient, agency, and policy level including patient receptivity, cost of naloxone, staff time, and prohibitive pharmacy board regulations. CONCLUSIONS: In spite of targeted legislation and training, provision of take-home naloxone at remained low. This is alarming given the need for this lifesaving medication among the Opioid Treatment Program patient population, and high opioid death rate in New Mexico. Locally, important next steps include clarifying regulatory guidelines and supporting policy/billing changes to offset costs to Opioid Treatment Programs. Globally, additional research is needed to identify the prevalence of take-home naloxone distribution in similar settings, common barriers, and best practices that can be shared to increase access to this vital lifesaving medication in this critical context.

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BACKGROUND: People who inject drugs (PWID) experience multiple risk factors for mortality; yet, we know little about causes of death among PWID in Tijuana, Mexico, an area with high levels of injecting and changes in policy/law enforcement responses to substance use. This study examines rates, causes, and predictors of mortality among Tijuana PWID. METHODS: Data come from a community-based cohort of PWID aged ≥18 who injected drugs in the past month. Mortality was confirmed by death certificate over 78 months during 2011-2018. Predictors of mortality were identified using time-updated Cox regression, controlling for age. RESULTS: Among 734 participants, there were 130 deaths (54 confirmed, 76 unconfirmed), with an incidence rate of 17.74 deaths per 1000 person-years for confirmed deaths (95% Confidence Interval (CI)=13.01, 22.48) and 39.52 for unconfirmed deaths (CI=32.72, 46.31). Confirmed deaths resulted from homicide/trauma (26%), overdose (26%), septic shock (18%) and HIV-related causes (9%). In multivariable analysis of confirmed deaths, baseline HIV seropositivity (adjusted Hazard Ratio [aHR]=6.77, CI=1.98, 23.17), incident HIV infection (aHR=3.19, CI=1.02, 9.96), and number of times being beaten by police in the past 6 months at baseline (aHR=1.08 per time, CI=1.04, 1.12) were predictive of death; whereas, injection cessation for 6+ months during time at risk (aHR=0.25, CI=0.33, 0.79) was protective. CONCLUSION: In addition to overdose and HIV prevention efforts, attention to structural conditions that potentiate mortality is needed, including improved access to medication-assisted treatment to support injection cessation and a shift from police as a source of harm to harm reduction.

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The Dominican Republic is thought to have significant epidemics of illicit drug use but lacks surveillance and formal analyses of the policy context of drug prevention and treatment services. We conducted an institutional ethnography of 15 drug service organisations in Santo Domingo and Boca Chica, Dominican Republic, to explore barriers and resources for drug abuse prevention and treatment. Here, we present a typology of drug service organisations based on their services, methods, and approach. We then draw on interviews with representatives of drug service institutions to describe the primary barriers to drug treatment and prevention services for drug users. We conclude with a focus on the policy priorities that could improve the conditions of health care for marginalised drug users in the Dominican Republic.

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

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

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

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

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

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

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

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Abstract Introduction Mexico northern border has high levels of heroin use. For more than 10 years, the country has implemented several harm reduction interventions to reduce the risks associated with drug use. New strategies such as Safe Consumption Sites (SCS) must be considered as a next step to service vulnerable populations and increase their health outcomes. Objective This report seeks to measure and compare attitudes on a potential SCS intervention in Tijuana among police and people with lived experience (PLE) in heroin use in the city. Method Two parallel studies on police practices and everyday experiences of heroin users in Tijuana were able to ask similar questions about attitudes toward SCS and its implementation in the city. They conducted quantitative interviews with 771 active police officers and 200 PLE while in rehabilitation services. Results Both groups showed a high personal support for SCS of nearly 82% and a perceived implementation success around 80%. Officers reported 58.9% peer support for SCS while PLE 79%. Around 76% of both groups agreed that a SCS would help to improve their personal health. Finally, 86.2% of the officers would refer people to a SCS while 62.5% of PLE would use the service. Discussion and conclusions The strong positive attitudes from police officers and PLE towards SCS in the city of Tijuana reported in both studies indicate the possibility of a successful implementation of a SCS. This intervention would represent an innovative way to protect PLE from police harassment and victimization, helping reduce HIV and HCV risk behaviors while improving community health.

Resumen Introducción En la frontera norte de México hay niveles altos de consumo de heroína. Durante más de 10 años, el país ha implementado diversas intervenciones de reducción de daños para minimizar los riesgos asociados con el uso de sustancias. Los sitios de consumo seguro (SCS) se deben considerar como una opción que brinde servicios a poblaciones vulnerables para mejorar su salud. Objetivo Este reporte mide y compara actitudes entre policías y personas con experiencia vivida (PEV) en uso de heroína en Tijuana, relacionadas con una posible implementación de SCS en la ciudad. Método Dos estudios paralelos sobre prácticas policiales y experiencias cotidianas de usuarios de heroína en Tijuana incluyeron preguntas similares sobre actitudes hacia los SCS y su implementación en la ciudad. Se realizaron 771 entrevistas cuantitativas con oficiales de policía y 200 con PEV internadas en centros de rehabilitación. Resultados Ambos grupos mostraron un alto apoyo hacia los SCS cercano al 82% y un éxito percibido en implementación del 80%. Los oficiales reportaron 58.9% de apoyo entre pares a las SCS y del 79% entre PEV. Un 76% en ambos grupos coincidieron que un SCS ayudaría a mejorar su salud personal. Finalmente, el 86.2% de los oficiales referirían hacia un SCS, mientras que 62.5% de PEV las usarían. Discusión y conclusiones Las actitudes hacia los SCS indican una posible implementación exitosa de SCS en la ciudad. Esta intervención representaría una forma innovadora de disminuir el acoso y victimización policial hacia las PEV, reduciendo los factores de riesgo de VIH y VHC, mejorando la salud comunitaria.

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ABSTRACT OBJECTIVE To evaluate trends in the use of generic and non-generic medicines to treat hypertension and diabetes under the Farmácia Popular Program (FP) and its impact on generic medicines sales volume and market share in the Brazilian pharmaceutical market. METHODS This longitudinal, retrospective study used interrupted time series design to analyze changes in monthly sales volume and proportion of medicines sales (market share) for oral antidiabetic and antihypertensive medicines for generic versus non-generic products. Analyses were conducted in a combined dataset that aggregate monthly sales volumes from the Farmácia Popular program and from the QuintilesIMS™ (IQVIA) national market sales data from January 2007 to December 2012. The Farmácia Popular program phases analyzed included: a) 2009 reductions in medicines reference prices (AFP-II) and b) 2011 implementation of free medicines program for hypertension and diabetes, the Saúde não tem preço (SNTP - Health has no price). RESULTS Patterns of use for FP-covered antidiabetic and antihypertensive medicines were similar to their use in the market in general. After one year of the decreases in government subsidies in April 2010, market share of antidiabetic and antihypertensive medicines experienced relative declines of -54.5% and -59.9%, respectively. However, when FP-covered medicines were made free to patients, overall market volume for antidiabetic and antihypertensive generics increased dramatically, with 242.6% and 277.0% relative increases by February 2012, as well as non-generics with relative increase of 209.7% and 279% for antidiabetic and antihypertensive medicines, respectively. CONCLUSIONS Ministry of Health policies on the amount of patient cost sharing and on the choice of medicines on coverage lists have substantial impacts on overall generic sales volume in retail pharmacies.

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Relata-se a experiência do Curso de Atenção Psicossocial em Álcool e outras Drogas, ofertado pelo Centro Regional de Referência para Formação em Políticas sobre Drogas da Universidade Federal de São João del-Rei (CRR/UFSJ), com relação aos desafios para formação em Redução de Danos (RD). Foram constituídos grupos com 16 alunos em média, entre profissionais e lideranças comunitárias de 18 municípios da microrregião administrativa de São João del-Rei, MG. Com base nos registros de diários de campo e relatórios do curso, foram elaboradas três unidades de sentido relacionadas ao processo educativo sobre RD: (a) estranhamentos em torno da RD; (b) problematizações, resistências e apropriações da RD; e (c) impactos da RD nas práticas dos cursistas. Observou-se que o Curso favoreceu um primeiro passo para mudança e sensibilização com relação à RD, desafio fundamental para a reforma nas políticas de drogas.(AU)

Se relata la experiencia del Curso de Atención Psicosocial para Alcohol y otras Drogas, ofrecido para el Centro Regional de Referencia para Formación en Políticas sobre Drogas de la Universidad Federal de São João Del Rei (CRR/UFSJ), en relación a los desafíos para formación en reducción de Daños (RD). Se constituyeron grupos con un promedio de 16 alumnos, entre profesionales y liderazgos comunitarios de 18 municipios de la micro-región administrativa de São João del Rei, Estado de Minas Gerais. Con base en los registros de diarios de campo e informes del curso, se elaboraron tres unidades de sentido relacionadas con el proceso educativo sobre RD: (a) extrañezas sobre la RD; (b) problemáticas, resistencias y apropiaciones de RD; e (c) impactos de la RD en las prácticas de los participantes. Se observó que el Curso favoreció un primer paso para cambio y sensibilización con relación a la RD, desafío fundamental para la reforma en las políticas de drogas.(AU)

Report about the Psychosocial Care Course on Alcohol and Other Drugs, offered by Centro Regional de Referência para Formação em Políticas sobre Drogas, Universidade Federal de São João Del Rei (CRR/UFSJ), oriented towards to Harm Reduction (HR) training. Groups of around sixteen students were gathered, encompassing professionals and community leaders from 18 cities within the region of São João del Rei, MG, Brazil. Through field notes and management reports the study elaborated three units of meaning related to the educational process of HR: (a) estrangements regarding the HR proposal; (b) problematizations, resistances and appropriations of HR; and (c) impacts of the HR proposal on students' practices. The involvement in the Course promoted a first step towards change and produced awareness of HR, a major challenge on drug policy reform.(AU)

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Relata-se a experiência do Curso de Atenção Psicossocial em Álcool e outras Drogas, ofertado pelo Centro Regional de Referência para Formação em Políticas sobre Drogas da Universidade Federal de São João del-Rei (CRR/UFSJ), com relação aos desafios para formação em Redução de Danos (RD). Foram constituídos grupos com 16 alunos em média, entre profissionais e lideranças comunitárias de 18 municípios da microrregião administrativa de São João del-Rei, MG. Com base nos registros de diários de campo e relatórios do curso, foram elaboradas três unidades de sentido relacionadas ao processo educativo sobre RD: (a) estranhamentos em torno da RD; (b) problematizações, resistências e apropriações da RD; e (c) impactos da RD nas práticas dos cursistas. Observou-se que o Curso favoreceu um primeiro passo para mudança e sensibilização com relação à RD, desafio fundamental para a reforma nas políticas de drogas.(AU)

Se relata la experiencia del Curso de Atención Psicosocial para Alcohol y otras Drogas, ofrecido para el Centro Regional de Referencia para Formación en Políticas sobre Drogas de la Universidad Federal de São João Del Rei (CRR/UFSJ), en relación a los desafíos para formación en reducción de Daños (RD). Se constituyeron grupos con un promedio de 16 alumnos, entre profesionales y liderazgos comunitarios de 18 municipios de la micro-región administrativa de São João del Rei, Estado de Minas Gerais. Con base en los registros de diarios de campo e informes del curso, se elaboraron tres unidades de sentido relacionadas con el proceso educativo sobre RD: (a) extrañezas sobre la RD; (b) problemáticas, resistencias y apropiaciones de RD; e (c) impactos de la RD en las prácticas de los participantes. Se observó que el Curso favoreció un primer paso para cambio y sensibilización con relación a la RD, desafío fundamental para la reforma en las políticas de drogas.(AU)

Report about the Psychosocial Care Course on Alcohol and Other Drugs, offered by Centro Regional de Referência para Formação em Políticas sobre Drogas, Universidade Federal de São João Del Rei (CRR/UFSJ), oriented towards to Harm Reduction (HR) training. Groups of around sixteen students were gathered, encompassing professionals and community leaders from 18 cities within the region of São João del Rei, MG, Brazil. Through field notes and management reports the study elaborated three units of meaning related to the educational process of HR: (a) estrangements regarding the HR proposal; (b) problematizations, resistances and appropriations of HR; and (c) impacts of the HR proposal on students' practices. The involvement in the Course promoted a first step towards change and produced awareness of HR, a major challenge on drug policy reform.(AU)

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BACKGROUND: Mexican law permits syringe purchase and possession without prescription. Nonetheless, people who inject drugs (PWID) frequently report arrest for syringe possession. Extrajudicial arrests not only violate human rights, but also significantly increase the risk of blood-borne infection transmission and other health harms among PWID and police personnel. To better understand how police practices contribute to the PWID risk environment, prior research has primarily examined drug user perspectives and experiences. This study focuses on municipal police officers (MPOs) in Tijuana, Mexico to identify factors associated with self-reported arrests for syringe possession. METHODS: Participants were active police officers aged ≥18 years, who completed a self-administered questionnaire on knowledge, attitudes and behaviors related to occupational safety, drug laws, and harm reduction strategies. Univariable and multivariable logistic regression was used to identify correlates of recent syringe possession arrest. RESULTS: Among 1044 MPOs, nearly half (47.9%) reported always/sometimes making arrests for syringe possession (previous 6mo). Factors independently associated with more frequent arrest included being male (Adjusted Odds Ratio [AOR] = 1.62; 95% Confidence Interval [95% CI] =1.04-2.52; working in a district along Tijuana River Canal (where PWID congregate) (AOR = 2.85; 95%CI = 2.16-3.77); having recently experienced a physical altercation with PWID (AOR = 2.83; 95% CI = 2.15-3.74); and having recently referred PWID to social and health services (AOR = 1.97; 95% CI = 1.48-2.61). Conversely, odds were significantly lower among officers reporting knowing that syringe possession is legal (AOR = 0.61; 95% CI = 0.46-0.82). CONCLUSIONS: Police and related criminal justice stakeholders (e.g., municipal judges, prosecutors) play a key role in shaping PWID risk environment. Findings highlight the urgent need for structural interventions to reduce extra-judicial syringe possession arrests. Police training, increasing gender and other forms of diversity, and policy reforms at various governmental and institutional levels are necessary to reduce police occupational risks, improve knowledge of drug laws, and facilitate harm reduction strategies that promote human rights and community health.

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BACKGROUND: In 2009, Mexican Federal Government enacted "narcomenudeo" reforms decriminalizing possession of small amounts of drugs, delegating prosecution of retail drug sales to the state courts, and mandating treatment diversion for habitual drug users. There has been insufficient effort to formally assess the decriminalization policy's population-level impact, despite mounting interest in analagous reforms across the globe. METHODS: Using a dataset of municipal police incident reports, we examined patterns of drug possession, and violent and non-violent crime arrests between January 2009 and December 2014. A hierarchical panel data analysis with random effects was conducted to assess the impact of narcomenudeo's drug decriminalization provision. RESULTS: The reforms had no significant impact on the number of drug possession or violent crime arrests, after controlling for other variables (e.g. time trends, electoral cycles, and precinct-level socioeconomic factors). Time periods directly preceding local elections were observed to be statistically associated with elevated arrest volume. CONCLUSIONS: Analysis of police statistics parallel prior findings that Mexico's reform decriminalizing small amounts of drugs does not appear to have significantly shifted drug law enforcement in Tijuana. More research is required to fully understand the policy transformation process for drug decriminalization and other structural interventions in Mexico and similar regional and international efforts. Observed relationship between policing and political cycles echo associations in other settings whereby law-and-order activities increase during mayoral electoral campaigns.

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