Characterizing changes in drug use behaviour following supply shortages of 5-MeO-DIPT, alkyl nitrites and new psychoactive substances among men living with HIV in Japan.

BACKGROUND: Since 2005, Japan has incrementally banned a range of new psychoactive substances (NPS), including 5-MeO-DIPT (5MO; foxy) and alkyl nitrites (AN; rush, poppers) that have commonly been used among men who have sex with men (MSM). After the largest ban in 2014, these drugs were reported to have disappeared from the domestic market. Given that 5MO/AN/NPS use has been prevalent among men living with HIV in Japan, a population largely comprised of MSM, we sought to characterize changes in their drug use behavior following the supply shortages. METHODS: Using data from two waves of a nationwide survey of people living with HIV in Japan in 2013 and 2019-20 (n = 1042), we employed multivariable modified Poisson regression to identify correlates of self-reported reactions to the 5MO/AN/NPS shortages and changes in drug use behavior in 2019-20 vs. 2013. RESULTS: Among 391 men (96.7% MSM) surveyed in 2019-20, following the supply shortages, 234 (59.8%) stopped using 5MO/AN/NPS, 52 (13.3%) retained access to the supply, and 117 (29.9%) used substitute drugs: most commonly, methamphetamine (60.7%). Individuals who used substitutes were more likely to report unprotected sex (adjusted relative risk [ARR]=1.67; 95% confidence interval [CI]: 1.13-2.47) as well as low (ARR=2.35; 95% CI: 1.46-3.79) and lower middle (vs. upper middle to high) socioeconomic status (ARR=1.55; 95% CI: 1.00-2.41). The prevalence of past-year methamphetamine use (ARR=1.93; 95% CI: 1.11-3.35) and self-reported uncontrollable drug use (ARR=1.62; 95% CI: 1.07-2.53) were significantly higher in 2019-20 compared to 2013. CONCLUSION: Following the supply shortages, approximately one-fifth of our participants used methamphetamine as a substitute for 5MO/AN/NPS. Methamphetamine use and perceived uncontrollable drug use also appeared to have increased at the population level after the supply shortages. These findings suggest a potentially harmful substance displacement effect of the aggressive ban. Harm reduction interventions are needed in this population.

Reasons for use and experiences of using phenibut, a mixed methods analysis of online reports.

Background: Phenibut is a drug similar in structure to gabapentin and pregabalin. It is available online without prescription, often marketed as a dietary supplement or amino acid derivative. Little is known about phenibut use despite its increased popularity in the United States over the last decade.Objective: To clarify reasons for taking phenibut, circumstances, and effects of use.Methods: Reports of phenibut, gabapentin, and pregabalin use were downloaded from a publicly-available database, Erowid.org. A mixed methods approach utilizing qualitative content analysis was used.Results: Of 229 reports, 211 were from male authors. People usually purchased phenibut online and reportedly used it for recreation, to manage a medical or psychiatric problem (primarily insomnia, anxiety), as a substitute for other drugs (especially benzodiazepines), to manage withdrawal from another substance (including benzodiazepines, opioids), and/or for performance enhancement. While it shared many reported effects with pregabalin and gabapentin such as anxiolysis, increased talkativeness, and impaired motor coordination, reports of gastrointestinal distress and sedation were more commonly attributed to phenibut. Several people reported difficulty in restricting their use and managing withdrawal.Conclusions: Phenibut reports suggest that phenibut may have some benefits for some people. Use also, however, carries risks of adverse effects, a potentially dangerous withdrawal syndrome, and addiction. Not dissimilar to unprescribed gabapentin or pregabalin, self-medication is a common motive for phenibut use. Physicians should continue to ask their patients about use of any non-prescribed medications, dietary supplements, or "amino acid derivatives."Abbreviation: PWUPh: people who use phenibut; PWUG: people who use gabapentin; PWUPr: people who use pregabalin.

Current legislation on medical cannabis in the European Union: historical background, movements, trends, and counter-trends lessons for Brazil / Legislação atual sobre cannabis medicinal na União Europeia: históricos, movimentos, tendências e contratendências. Lições para o Brasil

ABSTRACT BACKGROUND AND OBJECTIVES: The growing interest in the medical use of cannabis and phytocannabinoids has led European Union (EU) countries to regulate the production and access to cannabis products for their citizens. This regulation is based on international conventions, the European Medicines Agency (EMA) guidelines and legal loopholes that grant autonomy to EU member countries to authorize the production and marketing of cannabis-based drugs and foods. This summary aims to present the current status of medical cannabis legislation in the EU, highlighting the authorization of drugs, regulatory processes and the autonomy of member states in the production of magistral formulas. CONTENTS: Most EU countries allow, in some form, the legal use of cannabis and its derivatives as a drug. Since 2019, three drugs containing nabiximols, dronabinol or nabilone have been authorized on the markets of EU member states. In addition to the EMA centralized procedure for marketing authorization, cannabinoid-based products can also be authorized through regional or national processes in EU countries. This autonomy extends to the production of magistral formulas in compounding pharmacies, allowing pharmacists to prepare formulas containing cannabis for use according to a specific medical prescription and, in some situations, at scale. CONCLUSION: While it is not possible to conclude which is the ideal approach to the regulation of medical cannabis that all countries should adopt, the experience of the EU provides valuable lessons. The autonomy granted to the member states allows the expansion of the medical use of cannabis through the authorization of drugs and the production of magistral formulas. These experiences can be used as a basis for reformulations in Brazilian regulations, aiming to expand access and medical use of cannabis in the country.

RESUMO JUSTIFICATIVA E OBJETIVOS: O crescente interesse no uso medicinal da cannabis e fitocanabinoides tem levado os países da União Europeia (UE) a regulamentarem a produção e acesso a produtos canábicos para seus cidadãos. Esta regulamentação se baseia em convenções internacionais, orientações da Agência Europeia de Medicamentos (EMA) e brechas legais que concedem autonomia aos países-membros da UE para autorizar a produção e comercialização de fármacos e alimentos à base de cannabis. Este estudo teve o objetivo de apresentar a situação atual da legislação sobre cannabis medicinal na UE, destacando a autorização de fármacos, os processos de regulamentação e a autonomia dos estados-membros na produção de fórmulas magistrais. CONTEÚDO: A maioria dos países da UE permite, de alguma forma, o uso legal da cannabis e seus derivados como fármaco. Desde 2019, três fármacos contendo nabiximols, dronabinol ou nabilona foram autorizados nos mercados dos estados-membros da UE. Além do procedimento centralizado da EMA para a autorização de comercialização, os produtos à base de canabinoides também podem ser autorizados por meio de processos regionais ou nacionais dos países da UE. Essa autonomia se estende à produção de fórmulas magistrais em farmácias de manipulação, permitindo que os farmacêuticos preparem fórmulas contendo cannabis para uso de acordo com prescrição médica específica e, em algumas situações, em escala. CONCLUSÃO: Embora não seja possível concluir qual é a abordagem ideal para a regulamentação da cannabis medicinal que deve ser adotada por todos os países, a experiência da UE fornece lições valiosas. A autonomia concedida aos estados-membros permite a ampliação do uso medicinal da cannabis por meio da autorização de fármacos e da produção de fórmulas magistrais. Essas experiências podem ser utilizadas como base para reformulações na regulamentação brasileira, visando ampliar o acesso e uso medicinal da cannabis no país.

Deaths from 'diseases of despair' in Britain: comparing suicide, alcohol-related and drug-related mortality for birth cohorts in Scotland, England and Wales, and selected cities.

BACKGROUND: The contribution of increasing numbers of deaths from suicide, alcohol-related and drug-related causes to changes in overall mortality rates has been highlighted in various countries. In Scotland, particular vulnerable cohorts have been shown to be most at risk; however, it is unclear to what extent this applies elsewhere in Britain. The aim here was to compare mortality rates for different birth cohorts between Scotland and England and Wales (E&W), including key cities. METHODS: Mortality and population data (1981-2017) for Scotland, E&W and 10 cities were obtained from national statistical agencies. Ten-year birth cohorts and cohort-specific mortality rates (by age of death, sex, cause) were derived and compared between countries and cities. RESULTS: Similarities were observed between countries and cities in terms of peak ages of death, and the cohorts with the highest death rates. However, cohort-specific rates were notably higher in Scotland, particularly for alcohol-related and drug-related deaths. Across countries and cities, those born in 1965-1974 and 1975-1984 had the highest drug-related mortality rates (peak age at death: 30-34 years); the 1965-1974 birth cohort also had the highest male suicide rate (peak age: 40-44 years). For alcohol-related causes, the highest rates were among earlier cohorts (1935-1944, 1945-1954, 1955-1964)-peak age 60-64 years. CONCLUSIONS: The overall similarities suggest common underlying influences across Britain; however, their effects have been greatest in Scotland, confirming greater vulnerability among that population. In addressing the socioeconomic drivers of deaths from these causes, the cohorts identified here as being at greatest risk require particular attention.

Trends in hydrocodone combination product exposures reported to California Poison Control System (CPCS) following DEA rescheduling.

CONTEXT: On October 6, 2014, the United States Drug Enforcement Administration (DEA) implemented a regulatory change for hydrocodone combination products (HCPs), moving them from Schedule III to II, in an effort to decrease drug overdoses. Existing research suggests this regulatory action reduced HCP prescribing and dispensing; however, there is limited research assessing its possible effects on overdoses and accidental exposures. OBJECTIVE: To analyze the changes in opioid exposures reported to the California Poison Control System (CPCS) before and after DEA rescheduling of HCPs. METHODS: We collected monthly exposure data reported to CPCS from 2012 to 2019 and conducted interrupted time series analyses to assess changes in exposures after rescheduling for HCPs, tramadol, oxycodone, morphine, codeine, fentanyl, and heroin. Additional analyses were done to assess any changes in exposures resulting in severe outcomes (moderate or major health effects). For HCPs, we also conducted logistic regressions to identify characteristics of exposures resulting in severe outcomes before and after rescheduling. RESULTS: Overall monthly opioid exposures reported to CPCS decreased after DEA rescheduling of HCPs. These decreases were significant for HCP, tramadol, and morphine (p < 0.001). Exposures significantly increased for heroin and fentanyl (p < 0.001). There were no significant changes in the share of severe outcomes attributed to HCP exposures after rescheduling. DISCUSSION: The DEA rescheduling of HCPs was associated with a significant decrease in HCP exposures and prescription opioid exposures overall, but was associated with increased fentanyl and heroin exposures. While other initiatives may have contributed to this decrease, our findings suggest that rescheduling may be a useful regulatory strategy to reduce drug exposures. CONCLUSION: DEA rescheduling of HCPs was associated with a significant reduction in prescription opioid exposures, suggesting that rescheduling high-risk drugs may be an effective strategy to improve public health.

Paradoxo nas políticas sobre drogas: embates discursivos sobre a Lei 13. 840/2019 em portais de notícia / Paradox in drug policies: discursive clashes on news websites over Law 13. 840/2019

Resumo Parte-se da premissa de que as políticas sobre drogas são objetos construídos discursivamente a partir do envolvimento de diversos atores e de sua capacidade de produzir consensos. Dessa forma, o discurso jornalístico assume um importante papel de mediação entre os leitores e a realidade das políticas sobre drogas. Assim, objetivou-se analisar os discursos sobre a Lei 13.840/2019 em portais de notícias de massa. Trata-se de um estudo documental, de abordagem qualitativa, com aporte da Análise de Discurso Crítica, segundo o método de análise tridimensional de Fairclough. Realizou-se uma busca por notícias sobre a Lei, no período de março a junho de 2020, publicadas on-line nos portais G1, R7, Carta Capital e The Intercept Brasil. Os portais foram escolhidos por serem de acesso gratuito e apresentarem vertentes ideológicas diversas. Destaca-se o conhecimento sobre o contexto de produção da referida Lei, bem como a reprodução do discurso proibicionista hegemônico nas notícias, apesar de algumas contestações pouco claras quanto à alternativa. Observam-se representações distintas sobre a Lei de acordo com o portal em que a notícia foi publicada. Contudo, em geral, o impacto da Lei para a Rede de Atenção Psicossocial, quando mencionado, foi abordado de forma superficial.

Abstract This study is based on the premise that drug policies are discursively constructed by the engagement of different social actors and their capacity to forge consensus. Considering that people tend not to seek information on policies by themselves, the journalistic discourse plays an important role in mediating the contact between readers and the reality of drug policies. Thus, this work aims to analyze the discourses around the Act 13.840 of 2019, published at mass media portals online. This is a documental study based on the three-dimensional model for critical discourse analysis developed by Fairclough. The portals G1, R7, Carta Capital, and The Intercept Brasil (chosen due to granting free access and having different ideological perspectives) were searched for articles approaching the Act. Our results indicate that the published articles demonstrate knowledge on policy making and reinforce the hegemonic prohibitionist discourse, despite some unclear objections about possible alternatives. The representations of the Act 13.840 differed according to the publishing portal, but, in general, the articles made few considerations about the impact of the Act on the Psychosocial Support Network.

Reducing Postoperative Opioids for Outpatient Endoscopic Urological Surgery: A Resident Driven Quality Improvement Initiative.

INTRODUCTION: Opioid dependency has become a public health crisis in the United States and surplus prescriptions of opioids after surgery may be contributing to this problem. This resident driven quality improvement initiative sought to study the prescribing patterns of opioids for patients undergoing outpatient urological surgery at our institution, reduce prescriptions where possible and monitor patient outcomes. METHODS: A chart review and telephone survey were conducted of patients undergoing outpatient endourological surgery. Type and quantity of narcotics prescribed were identified, and patients were surveyed on quantity of medication consumed. Physicians were then counseled on prescribing quantities closer to the average amounts reportedly used by patients. After 30 days we assessed emergency room visits, readmissions and telephone calls related to pain. RESULTS: Before our initiative patients were prescribed an average of 156.6 morphine milligram equivalents (median 150) after endourological surgery. Patients reported using between 0-37.5 morphine milligram equivalents, with 71% reporting using no narcotics. Following 30 days of surgeon advisement, the average prescription decreased to 38.6 morphine milligram equivalents (median 0), representing a 75.3% reduction. Following reductions there were no significant differences in emergency room visits, telephone calls, readmissions or rate of drug refills. CONCLUSIONS: Resident driven quality improvement initiatives can lead to reductions in the prescription of surplus opioids after certain types of urological surgery. These efforts can play an important role in reducing the supply of available narcotics at the local level.

Logística reversa de medicamentos: um relato de experiência do estado do Paraná / Pharmaceutical reverse logistics: an experience report from the state of Paraná

O presente trabalho descreve o relato de experiência da Divisão de Vigilância Sanitária de Produtos da Secretaria de Estado da Saúde do Paraná na Campanha de Logística Reversa de Medicamentos Domiciliares Vencidos ou em Desuso realizada no ano de 2018 pelo Governo do Estado, em parceria com o Sindicato da Indústria de Produtos Farmacêuticos no Estado de São Paulo e outras entidades. A ação teve duração de 60 dias com a participação de 250 pontos de coleta distribuídos em farmácias públicas e privadas de todas as Regionais de Saúde do Estado. Os resíduos de medicamentos coletados ultrapassaram duas toneladas. Foi possível identificar os recursos necessários para implantação dessa política com participação de atores da cadeia farmacêutica. A atuação do Governo do Estado foi essencial para aproximação dos setores e articulação na Campanha. Contudo, salienta-se a necessidade de interlocução dos entes responsáveis pelo processo para execução permanente desta política no Estado. (AU)

This paper describes the experience report of the Health Surveillance Division of the State Health Department of Paraná in the Pharmaceutical Reverse Logistics Campaign for Expired or Unused Home Medicines held in 2018 by the State Government, in partnership with the Pharmaceuticals Industry Union of the State of São Paulo and other entities. The action lasted 60 days with the participation of 250 collection points distributed in public and private pharmacies of all State Health Units. The drug residues collected exceeded two tons. It was possible to identify the resources required to implement this policy with the participation of actors from the pharmaceutical chain. The participation of the State Government was essential to bring the sectors together, and to articulate the Campaign. However, the need of dialogue amongentities in charge of the process, for the permanent implementation of this policy in the State, shall be highlighted. (AU)

Cross-country Comparison of Treatment Policies Facing the Drug Abuse in Five Selected Countries.

BACKGROUND: Drug abuse is one of the main problems of human's life; thus communities have been thinking about the solution of this problem. The present study aimed to compare the general features of drug abuse treatment policies, war on drugs (WOD), and harm reduction (HR), in the selected countries. METHODS: The present study was a comparative and desk research that sought to compare context, stewardship, financing, type of substance abuse treatment services, reasons of paradigm shift, and executive challenges of treatment policies in the selected countries (China, Malaysia, Germany, Netherland, and Iran). The necessary data for comparison of the countries were collected through valid databases, review of documents, and reports of international organizations. FINDINGS: Context conditions were better in the HR countries. In most countries, the central government played a key role in the stewardship, financing, and service providing. In WOD countries, the presence of judicial structure was higher in the treatment of drug abuse. The policy-making approach was ideological in WOD countries, but evidence-based in HR countries. CONCLUSION: It seems that performance of HR countries is better than WOD countries.

Impact of hydrocodone reclassification on analgesic prescribing in the Veterans Health Administration.

PURPOSE: The impact of hydrocodone reclassification on analgesic prescribing in the Veterans Health Administration (VHA) was quantified. METHODS: In this retrospective observational study, the volume of opioid medication dispensed was calculated quarterly from October 2011 to September 2015 using national VHA administrative data. Four volume measures were examined (prescription count, tablets dispensed, days' supply dispensed, and unique patients) for 4 opioid groups: hydrocodone combination products (HCPs), other opioid combination products, tramadol, and single-agent Schedule II opioids. HCP prescription count was further tabulated within longitudinal course of receipt groups: short-term, intermediate-term, and long-term. The initiation frequency of alternative analgesic pharmacotherapy, including opioid and nonopioid medications, was assessed among patients who discontinued long-term HCP receipt at reclassification. RESULTS: HCP prescriptions declined by 172,535 (19.4%) in the quarter after reclassification, whereas other opioid categories remained unchanged. The number of HCP prescriptions decreased by 10.7% among patients with short-term opioid receipt, and by 23.3% and 19.4% for intermediate- and long-term receipt groups, respectively. Among 13,416 individuals who discontinued receipt of long-term HCPs, replacement analgesics were not identified in 8,055 (60.0%) patients, whereas prescriptions for alternative opioids were observed in 3,557 (26.5%) and nonopioids in 2,753 (20.5%). CONCLUSION: HCP dispensing in VHA declined by 19.4% in the quarter after reclassification, which was driven largely by patients receiving long-term therapy. More than 13,000 veterans discontinued receipt of long-term HCP therapy after reclassification and the majority did not receive a replacement analgesic through VHA.

Evaluation of the fentanyl patch-for-patch program in Ontario, Canada.

BACKGROUND: Rising use of prescription opioids is a major public health concern associated with increased risk of mortality worldwide. Fentanyl, a synthetic opioid available in patch form, is particularly concerning given its high potency. To curb the misuse and diversion of fentanyl patches, a Patch-for-Patch (P4P) program was implemented in some counties in Ontario between 2012 and 2015. The program requires that patients prescribed fentanyl must return used patches to the pharmacy before receiving more patches. OBJECTIVE: To evaluate the impact of the P4P program on fentanyl and non-fentanyl dispensing and opioid-related hospitalizations and deaths. METHODS: We conducted a repeated cross-sectional time-series analysis among counties that implemented the P4P program using Ontario administrative claims data. Because intervention dates varied by county due to staggered program initiation, we aligned all intervention months and examined outcome rates in the 5 years preceding and 12 and 24 months following implementation. We explored the monthly rate of prescriptions dispensed for fentanyl and non-fentanyl opioids, opioid toxicity-related hospital and emergency department visits, and opioid-related deaths. We modeled each outcome using an interventional autoregressive integrated moving average (ARIMA) model and tested the impact of the P4P program using a ramp function. RESULTS: We analyzed 16 counties that implemented the P4P program and had at least 12 months of follow-up. The introduction of the P4P program was associated with a 30.5% decline in the volume of fentanyl patches dispensed at 24 months (from 1,277-888 patches per 10,000 population; p = 0.04). In contrast, there was no significant change in the rate of non-fentanyl opioid dispensing (p = 0.32), opioid toxicity related hospitalizations and emergency department visits (p = 0.4) or opioid-related deaths (p = 0.96) in the 12 months following implementation of the program. CONCLUSIONS: We found that the implementation of a P4P program in select counties in Ontario was associated with a lower volume of fentanyl patches dispensed by pharmacies, without an increase in use of other opioids. The program had no measurable impact on rates of opioid toxicity-related hospital visits or deaths. Policymakers should consider the use of P4P programs as part of larger opioid strategy.

"Go Ask Alice": The Case for Researching Schedule I Drugs.

The available treatments for disorders affecting large segments of the population are often costly, complex, and only marginally effective, and many have numerous side effects. These disorders include dementias, debilitating neurological disorders, the multiple types of drug addiction, and the spectrum of mental health disorders.Preliminary studies have shown that a variety of psychedelic and similar U.S. Drug Enforcement Administration Schedule I drugs may offer better treatment options than those that currently exist and pose potentially the same or even less risk than do legal psychoactive (alcohol, caffeine, nicotine) and nonpsychoactive (aspirin, acetaminophen, ibuprofen) substances. The pharmaceutical industry and academia, however, have largely avoided this avenue of research.Fairness to the affected populations demands that these drugs be adequately studied and, if they or their congeners are shown to be effective, made available with the proper caveats, instructions, and protections that other potentially abused medications (e.g., narcotics) receive. These substances may prove to relieve patients' struggles with less effective treatments and decrease mortality from nontreatment of some conditions.

Crack cocaine use scene in the capital of the state of Santa Catarina/Brazil: the (in)visibility of users / Escenas del consumo de crack en la capital de Santa Catarina/Brasil: la (in)visibilidad del usuario / Cenas de uso do crack na capital de Santa Catarina/Brasil: a (in)visibilidade do usuário

ABSTRACT Objective: to describe the characteristics of the crack cocaine use scene, its surroundings and consequences. Method: this study was based on the Time-location Sampling methodology. Between January and June 2011, 41 crack use scenes were mapped in Florianópolis (Brazil). After randomly selecting the scenes to be observed, the days and shifts for in-depth observation were selected by lottery, for a total of 98 scenes/shifts, this atep was performed between December 2011 and March 2012. The observations were recorded in a field diary, and were examined using content analysis and discussed based on the Brazilian and international literature on the topic. Results: the results show that crack cocaine use scenes were more concentrated in the central regions of Florianópolis. Policing was very ostensive in the communities surrounding these areas, which are strongly marked by drug trafficking. Healthcare, prevention and authority actions were incipient in the locations of substance use, which shows the invisibility of crack users in society. Conclusions: more investments are needed so that public policies work to help drug users access social and healthcare services.

RESUMEN Objetivo: describir características de la escena del consumo de crack, su entorno y evoluciones. Método: utilizada metodología Time-Location Sampling. Entre enero y junio de 2011 fueron mapeadas 41 escenarios de consumo de crack en Florianópolis (Brasil). Escenarios a observarse elegidos aleatoriamente, se sortearon días y turnos para la tarea, totalizando 98 escenas/turno, etapa realizada entre diciembre 2011 u marzo 2012. Observaciones registradas en cuaderno de campo, examinadas por análisis de contenido y discutidas según literatura nacional e internacional. Resultados: los escenarios de consumo de crack se concentraron en regiones centrales de Florianópolis. Vigilancia ostensiblemente aplicada en comunidades cercanas, marcadas por el tráfico de drogas. Las acciones de cuidado, prevención y autoridad resultaron ser incipientes en lugares de consumo de la substancia, expresando la invisibilidad del usuario de crack frente a la sociedad. Conclusiones: se requieren mayores inversiones para que las políticas públicas actúen permitiendo que el consumidor de la droga acceda a equipos sociales y de cuidado.

RESUMO Objetivo: descrever as características da cena de uso do crack, seu entorno e desdobramentos. Método: o projeto se valeu da metodologia Time-Location Sampling. De janeiro a junho de 2011 foram mapeadas 41 cenas de uso de crack em Florianópolis (Brasil). Após seleção aleatória das cenas a serem observadas, sortearam-se os dias e turnos em que essas seriam observadas em detalhe, totalizando 98 cenas/turno, atapa realizada entre dezembro de 2011 a março de 2012. As observações, registradas em caderno de campo, foram examinadas via análise de conteúdo e discutidas à luz da literatura nacional e internacional. Resultados: o estudo identificou que as cenas de uso de crack se concentram nas regiões centrais de Florianópolis. O policiamento ocorre de maneira ostensiva nas comunidades próximas a estas áreas, fortemente marcadas pelo tráfico de drogas. As ações de cuidado, prevenção e autoridade se mostraram incipientes nos locais de uso da substância, o que denota a invisibilidade do usuário de crack perante a sociedade. Conclusões: são necessários maiores investimentos para que as políticas públicas atuem a fim de possibilitar que o usuário da droga acesse os equipamentos sociais e de cuidados.

O uso do Twitter como minerador de eventos adversos de medicamentos de combate à malária: o caso da doxiciclina / El uso de Twitter como localizador de eventos adversos con medicamentos de combate a la malaria: el caso de la doxiciclina / Mining in Twitter for adverse events from malaria drugs: the case of doxycycline

Durante o período de pós-comercialização, quando medicamentos são usados por grandes populações e por períodos de tempo maiores, eventos adversos (EA) inesperados podem ocorrer, o que pode alterar a relação risco-benefício dos medicamentos o suficiente para exigir uma ação regulatória. Eventos adversos são agravos à saúde que podem surgir durante o tratamento com um produto farmacêutico, os quais, no período de pós-comercialização do medicamento, podem requerer um aumento significativo de cuidados de saúde e resultar em danos desnecessários aos pacientes, muitas vezes fatais. Portanto, o quanto antes, a descoberta de EA no período de pós-comercialização é um objetivo principal do sistema de saúde. Alguns países possuem sistemas de vigilância farmacológica responsáveis pela coleta de relatórios voluntários de EA na pós-comercialização, mas estudos já demonstraram que, com a utilização de redes sociais, pode-se conseguir um número maior e mais rápido de relatórios. O objetivo principal deste projeto é construir um sistema totalmente automatizado que utilize o Twitter como fonte para encontrar EA novos e já conhecidos e fazer a análise estatística dos dados obtidos. Para isso, foi construído um sistema que coleta, processa, analisa e avalia tweets em busca de EA, comparando-os com dados da Agência Americana de Controle de Alimentos e Medicamentos (FDA) e do padrão de referência construído. Nos resultados obtidos, conseguimos encontrar EA novos e já existentes relacionados ao medicamento doxiciclina, o que demonstra que o Twitter, quando utilizado em conjunto com outras fontes de dados, pode ser útil para a farmacovigilância.

Durante el período de poscomercialización, cuando grandes poblaciones consumen medicamentos durante períodos más prolongados de tiempo, se pueden producir eventos adversos (EA) inesperados, lo que puede alterar la relación riesgo-beneficio de los medicamentos. Esta situación es suficiente para exigir una acción regulatoria. Los EA son agravios a la salud que pueden surgir durante el tratamiento con un producto farmacéutico, los cuales, durante el período de poscomercialización del medicamento, pueden requerir un aumento significativo de cuidados de salud y resultar en lesiones innecesarias para los pacientes, muchas veces fatales. Por lo tanto, el hallazgo anticipado de EA durante el período de poscomercialización es un objetivo primordial del sistema de salud. Algunos países cuentan con sistemas de vigilancia farmacológica, responsables de la recogida de informes voluntarios de EA durante la poscomercialización, pero algunos estudios ya demostraron que, con la utilización de las redes sociales, se puede conseguir un número de informes mayor y más rápido. El objetivo principal de este proyecto es construir un sistema totalmente automatizado que utilice Twitter como fuente para encontrar nuevos EA y ya conocidos, además de realizar un análisis estadístico de los datos obtenidos. Para tal fin, se construyó un sistema que recoge, procesa, analiza y evalúa tweets en búsqueda de eventos adversos, comparándolos con datos de la Agencia Americana de Control de Alimentos y Medicamentos (FDA) y del estándar de referencia construido. En los resultados obtenidos, conseguimos encontrar nuevos eventos adversos y ya existentes, relacionados con el medicamento doxiciclina, lo que demuestra que Twitter, cuando es utilizado junto a otras fuentes de datos, puede ser útil para la farmacovigilancia.

During the post-marketing period, when medicines are used by large population contingents and for longer periods, unexpected adverse events (AE) can occur, potentially altering the drug's risk-benefit ratio enough to demand regulatory action. AE are health problems that can occur during treatment with a pharmaceutical product, which in the drug's post-marketing period can require a significant increase in health care and result in unnecessary and often fatal harm to patients. Therefore, a key objective for the health system is to identify AE as soon as possible in the post-marketing period. Some countries have pharmacovigilance systems responsible for collecting voluntary reports of post-marketing AE, but studies have shown that social networks can be used to obtain more and faster reports. The current project's main objective is to build a totally automated system using Twitter as a source to detect both new and previously known AE and conduct the statistical analysis of the resulting data. A system was thus built to collect, process, analyze, and assess tweets in search of AE, comparing them to U.S. Food and Drug Administration (FDA) data and the reference standard. The results allowed detecting new and existing AE related to the drug doxycycline, showing that Twitter can be useful in pharmacovigilance when employed jointly with other data sources.

Política de drogas e Saúde Coletiva: diálogos necessários / Política de drogas y Salud Colectiva: diálogos necesarios / Drug policy and Collective Health: necessary dialogues

A hegemonia atual das políticas de drogas ilícitas tem implicações à Saúde Coletiva que necessitam ser discutidas de forma aprofundada. Este ensaio procura explorar, à luz das melhores evidências, o impacto das políticas sobre drogas focadas na criminalização do plantio, comércio e consumo de substâncias psicoativas sobre a saúde das populações. O contexto de análise principal será o brasileiro. Os pontos principais abordados por este trabalho incluem a questão social das drogas e a definição do paradigma proibicionista, as evidências da relação insalubre entre tal paradigma e a saúde das populações, a problemática de um modelo de assistência aos usuários de substâncias psicoativas focado nas comunidades terapêuticas, e futuros caminhos a serem explorados na superação da proibição de drogas ilícitas como a principal forma de abordar a questão. Entre os principais elementos problemáticos da abordagem repressiva no contexto brasileiro podem ser destacados a violência e a mortalidade por homicídios, os impactos sanitários do encarceramento e o bloqueio de acesso ao sistema de saúde e a novas terapias derivadas de substâncias psicoativas atualmente proscritas. Como propostas de mudanças políticas futuras, ressalta-se a descriminalização do uso, posse e pequenas vendas de drogas; a redução da violência e da discriminação associadas ao policiamento; o foco em políticas de redução de danos; a abordagem das especificidades relacionadas ao gênero; incluir variáveis sociais como métrica do sucesso no tratamento do uso problemático de drogas. Concluindo, é relevante que a questão social e política das drogas se torne objeto de mais estudos no campo da Saúde Coletiva.

La hegemonía actual de las políticas de drogas ilícitas tiene implicaciones para la Salud Colectiva que necesitan discutirse profundamente. Este trabajo estudia, a la luz de las mejores evidencias, el impacto de las políticas sobre las drogas, enfocadas en la criminalización del cultivo, tráfico y consumo de sustancias psicoactivas, para la salud de la población. El contexto de análisis principal será el brasileño. Los puntos principales abordados por este trabajo incluyen: cuestión social de las drogas y la definición del paradigma prohibicionista; evidencias de la relación insana entre este paradigma y la salud de las poblaciones; así como la problemática de un modelo de asistencia a los consumidores de sustancias psicoactivas centrado en comunidades terapéuticas, y los futuros caminos que se exploran para que se supere la prohibición de las drogas ilícitas como la vía principal de abordaje de esta cuestión. Entre los elementos primordiales y problemáticos del enfoque represivo en el contexto brasileño se pueden destacar: violencia y mortalidad por homicidios; impactos sanitarios con conlleva el encarcelamiento y el bloqueo del acceso al sistema de salud; así como las nuevas terapias, derivadas de sustancias psicoactivas, actualmente proscritas. A modo de propuestas para posibles cambios políticos futuros, se resalta la descriminalización del consumo, posesión y venta de pequeñas cantidades de droga; la reducción de la violencia y discriminación, asociadas a la vigilancia policial; situar el centro de la cuestión en políticas de reducción de perjuicios para la salud; plantear las especificidades relacionadas con el género; así como incluir variables sociales como medir el éxito de los tratamientos relacionados con el consumo problemático de drogas. A modo de conclusión, es relevante que la cuestión social y política de las drogas se convierta en objeto de más estudios en el campo de la Salud Colectiva.

The current status of policies on illicit drugs has implications for Collective Health that need to be discussed in depth. This essay aims to explore, in light of the best evidence, the public health impact of drug policies focused on the criminalization of growing, selling, and consuming psychoactive substances. Brazil provides the context for the main analysis. The principal points addressed in this work include drugs as a social issue and the definition of the prohibitionist paradigm, evidence of the unhealthy relationship between this paradigm and the population's health, the issue of a model of care for users of psychoactive substances focused on therapeutic communities, and future paths to be explored to overcome the prohibition of illicit drugs as the principal approach to the issue. Among the main problematic elements in the repressive approach in the Brazilian context, the study highlights violence and homicides, the health impacts of incarceration and blocked access to the health system, and potential new therapies derived from currently banned psychoactive substances. As proposals for future policy changes, the study highlights decriminalization of the use, possession, and small-scale sale of drugs; the reduction of the violence and discrimination associated with policing; focus on harm reduction policies; approach to gender-related specificities; and inclusion of social variables as metrics for successful treatment of problematic drug use. In conclusion, it is relevant that the social issue and drug policy have become the object of more studies in the field of Collective Health.

Programa Farmácia Popular do Brasil: uma análise política de sua origem, seus desdobramentos e inflexões / Popular Pharmacy Program of Brazil: a political analysis of its origin, unfoldings and inflections

RESUMO O artigo se refere a uma investigação qualitativa que analisa as origens, os desdobramentos, resultados e desafios do Programa Farmácia Popular do Brasil, face à necessária integralidade da assistência farmacêutica. Para a produção dos dados, foram utilizados documentos e entrevistas semiestruturadas com informantes envolvidos com o movimento da Reforma Sanitária Brasileira e/ou a questão medicamentos/assistência farmacêutica, considerando o período de 2003 a 2016; notícias produzidas entre 2013 e 2018, disponíveis em sítios eletrônicos de instituições entendidas como atores no processo de implementação de políticas farmacêuticas. A análise dos dados revelou que, apesar dos conflitos em torno da construção da proposta, o programa resultou em ampliação do acesso aos medicamentos essenciais, redução da mortalidade e de internações por doenças crônicas. Por esse motivo, inflexões no programa, como o fechamento da modalidade rede própria, resultaram em posicionamentos de organizações da sociedade civil, também motivados diante da conjuntura de perdas de direitos sociais. Permanecem lacunas concernentes à qualidade do acesso em suas diversas dimensões de análise e à promoção do uso racional de medicamentos, na perspectiva da integralidade da Assistência Farmacêutica.

ABSTRACT The article refers to a qualitative research that analyzes the origins, unfoldings, results and challenges of the Brazilian Popular Pharmacy Program, in view of the necessary integrality of pharmaceutical assistance. For the production of the data, documents and semi-structured interviews were used with informants involved with the Brazilian Health Reform movement and the issue of medicines/pharmaceutical assistance, considering the period from 2003 to 2016; news produced between 2013 to 2018, available on electronic sites of institutions understood as actors in the process of implementing pharmaceutical policies. Analysis of the data revealed that, despite the conflicts surrounding the proposal's construction, the program resulted in increased access to essential drugs, reduced mortality and hospitalizations for chronic diseases. For this reason, inflections in the program, such as the closing of the first modality, have resulted in positions of civil society organizations, also motivated by the conjuncture of losses of social rights. Gaps remain regarding the quality of access in its various dimensions of analysis and the promotion of rational use of medicines, from the perspective of the integrality of Pharmaceutical Assistance.

Effect of European Medicines Agency's restrictions on trimetazidine utilization in Portugal.

PURPOSE: Following safety concerns regarding trimetazidine, the European Medicines Agency (EMA) recommended restrictions on its use. Our objective was to determine the impact of regulatory actions on trimetazidine utilization in Portugal. METHODS: Retrospective interrupted time-series analysis of monthly ambulatory pharmacy reimbursement records for the Portuguese National Health Service between January 2006 and December 2015. Regulatory actions were identified by searching the EMA, Portuguese Medicines Authority, and European Commission's websites. Concurrent factors in the same period were also identified. The main outcome was the dispensing of trimetazidine-containing products per month in Portugal. RESULTS: Two interruption periods were defined in the series: May 2011, when EMA announced it would review trimetazidine safety, and June 2012 to January 2013, when EMA announced it had reached a final opinion recommending restrictions; the European Commission approved EMA's recommendation; the Portuguese Medicines Authority issued safety alerts, changed the summary of product characteristics, and approved a direct health-care professional letter; and a regional bulletin was issued. Interruption 1 had no effect on trimetazidine use, but interruption 2 resulted in decreases in level and trend-from 8.3 million defined daily doses in 2010 to 2.8 million in 2015. After interruption 2, trimetazidine use tended towards a lower steady state. CONCLUSIONS: There was a significant decrease in trimetazidine use in Portugal following a complex intervention that included safety alerts, changes to the summary of product characteristics, a direct health-care professional letter, and a regional drug bulletin. No effect was seen when EMA announced its review of trimetazidine safety.