RESUMO

Resumo Este estudo analisa as situações de trabalho vividas pelos profissionais na fiscalização sanitária de medicamentos da Agência Nacional de Vigilância Sanitária, durante a pandemia de COVID-19. Estudo de caso único, de natureza qualitativa, com abordagem ergológica. Os dados foram produzidos entre 2020 e 2021, por meio de 18 entrevistas e observação participante em três reuniões de trabalho online. As práticas discursivas foram sistematizadas em mapas ergodialógicos, resultando em três categorias: os trabalhos vividos na fiscalização dos medicamentos; as variabilidades do contexto organizacional e as renormalizações frente à pandemia. As fragilidades dos sistemas de informação, o marco regulatório desatualizado, o modelo de atuação, a fragmentação do trabalho, dentre outros, ocasionaram entraves à realização da atividade pelo profissional. A conformação de novo modo de fazer fiscalização envolve a combinação de intervenções direcionadas à prevenção, detecção e resposta ao consumo de medicamentos nocivos à saúde. A transformação necessária ultrapassa a função restrita de controle e punição e se consolida como um novo modelo de atuação proativo e dinâmico, baseado na gestão do risco sanitário e na implantação das Boas Práticas de Fiscalização.

Abstract This study analyzes the work situations experienced by professionals in the sanitary fiscalization of medicines at the Brazilian Health Regulatory Agency, during the COVID-19 pandemic. This is a single-case study, qualitative in nature, with an ergological approach. The data were collected from 2020 to 2021. During this period, 18 interviews and 3 online work meetings were conducted. The discursive practices were systematized in ergodialogical maps, resulting in three categories: the works experienced in the sanitary enforcement of medicines; the variabilities of the organizational context and the renormalizations facing the pandemic. The fragilities of the information systems, the outdated regulatory framework, the performance model, the fragmentation of the work, among others, have caused barriers to the professional's activity. The conformation of a new way of performing the sanitary fiscalization of medicines involves the combination of interventions aimed at prevention, detection, and response to the consumption of medicines that are harmful to health. The necessary transformation goes beyond the restricted function of control and punishment and consolidates itself as a new proactive and dynamic action model, based on health risk management and the implementation of Good Fiscalization Practices.

RESUMO

Supervised by three or four medical doctors and one nurse in rotating shifts, the medical clinic in Costa Rica's Moín Container Terminal is open 24/7 for visits from port workers. In our study, we aimed to identify the sociodemographic and clinical characteristics of a consecutive series of patients who attended the medical clinic for outpatient services during an 8-month period. Our descriptive study involved collecting patient records from the medical clinic during the first 8 months of 2021 (i.e., 1 January-31 August 2021), during which 3050 visits from 1301 port workers were registered. Terminal tractor drivers, crane operators, and stevedores were the most frequent job categories among the patients. Doping (i.e., ICD-10 Z03.6) was observed in 64% of the visits. The top ICD-10 codes among all other patients not observed to have engaged in doping (n = 469) were diseases of the musculoskeletal system (7.2%) and abnormal clinical and laboratory symptoms (6.2%). Problems with the musculoskeletal system were primarily back pain (36.0%), muscle contracture (30.1%), and secondary headache (25.2%). Two-thirds of the visits were due to screening for alcohol and drugs or doping; however, inconsistency in the coding system complicates the analysis of data, and a dropdown menu in the registration is therefore needed to prevent errors. Relative risk calculations are impossible due to a lack of data about the at-risk population but should be pursued under different circumstances in future studies. In the support chain of goods, the medical clinic in the port plays a key role in saving time in shipping, which means that the injured or sick employees in most cases can continue working. For the shipping industry, quick un- and offloading is very important to stay competitive in the market for transport.

Assuntos

RESUMO

Resumo A fiscalização sanitária busca proteger a saúde da população impedindo que medicamentos fora do padrão, falsificados ou não registrados sejam consumidos e causem danos à saúde. Este ensaio objetiva contribuir para o debate acerca da fiscalização sanitária de medicamentos, num contexto de exposição contínua dos indivíduos a riscos que interferem no processo saúde-doença. Baseado nas reflexões sobre o risco sanitário e a sociedade de risco, associado à filosofia da vida de Canguilhem e à ergologia de Schwartz, discorre sobre a necessidade de se compreender a atividade humana e o trabalho para agir sobre o risco. Foram identificados possíveis desafios para a ação da fiscalização sanitária: (1) revisão conceitual; (2) atualização normativa; (3) desenvolvimento de mecanismos e ferramentas regulatórias; e (4) ampliação da capacidade técnica - formativa. Para enfrentá-los, considera-se um caminho promissor o envolvimento e a participação dos diversos atores nos espaços de cooperação e colaboração, bem como a construção de fórum permanente de debates ou de câmeras técnicas/setoriais. Estudos que dão visibilidade ao trabalho concreto das equipes de fiscalização sanitária e que analisam a atividade humana na relação entre o prescrito e o real podem ajudar a compreender a experiência de lidar com o risco, a adequação das normas, as necessidades de formação, entre outros.

Abstract Drug health surveillance protects the health of the population by preventing substandard, falsified, or unregistered drugs from being consumed and causing harm. This essay discusses drug health surveillance in a context of continuous exposure of individuals to risks that directly interfere with the health-disease process. Based on reflections about health risk and risk society, associated with Canguilhem's philosophy of life and Schwartz's ergology, it argues for the need to understand human activity and work to act on risk. Possible challenges for health inspection action include: (1) conceptual review; (2) regulatory updating; (3) development of regulatory mechanisms and tools; and (4) expansion of technical and training capacity. To face them, the involvement and participation of the various actors in cooperation and collaboration spaces, as well as the construction of a permanent forum of discussion or technical/sectorial meetings, is considered promising. Studies that highlight the concrete work of supervision teams and that analyze human activity in the relationship between the prescribed and the real can help to understand the experience of dealing with risk, the adequacy of standards, training needs, among others.

Assuntos

RESUMO

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the cause, but rather the consequence of misoprostol's double life. In the last section, it draws on an outlier judgment of the case law to chart a regulatory future for misoprostol and its supply in the informal sector as a site of harm reduction and safe abortion in public health policy.

RESUMO

Coronavirus disease 2019 (COVID-19) is a virulent viral disease that has now become a public health emergency of global significance and still without an approved treatment regimen or cure. In the absence of curative drugs and with vaccines development still in progress, alternative approaches to stem the tide of the pandemic are being considered. The potential of a phytotherapeutic approach in the management of the dreaded disease has gained attention, especially in developing countries, with several claims of the development of anti-COVID-19 herbal formulations. This is a plausible approach especially with the increasing acceptance of herbal medicine in both alternative and orthodox medical practices worldwide. Also, the established efficacy of herbal remedies in the treatment of numerous viral diseases including those caused by coronaviruses, as well as diseases with symptoms associated with COVID-19, presents a valid case for serious consideration of herbal medicine in the treatment of COVID-19. However, there are legitimate concerns and daunting challenges with the use of herbs and herbal products. These include issues of quality control, unethical production practice, inadequate information on the composition, use and mechanisms, weak regulatory policies, herb-drug interactions and adverse reactions, and the tendency for abuse. This review discusses the feasibility of intervention with herbal medicine in the COVID-19 pandemic and the need to take proactive measures to protect public health by improving the quality and safety of herbal medicine deployed to combat the disease. Graphical abstract. Supplementary Information: The online version contains supplementary material available at 10.1007/s43450-021-00132-x.

RESUMO

Legal reforms in the Americas are influencing the public debate on cannabis policy. Uruguay and the two US states of Colorado and Washington have taken steps to regulate and legitimize the production, distribution, and use of cannabis and its derivatives. Earlier experiences with medical cannabis in the United States and limited access and production models in Europe have been insightful. However, these reforms are going further still, venturing into a new area of cannabis policy. A lack of empirical evidence regarding the effects of such reforms poses a challenge for policymakers. These examples will inform the design and implementation of any future cannabis policies. Therefore, a clear understanding of the details of each jurisdiction is necessary in developing future legal changes. Literature comparing the models of Uruguay, Colorado, and Washington is thin. This paper is based on an exhaustive examination of the laws, regulations, and discussions with regulators and functionaries of each jurisdiction. The research and analysis herein will provide policymakers with a greater understanding of the laws and regulations relevant to legal cannabis in these three jurisdictions, as well as draw to their attention some potential impacts and challenges of cannabis reform that require additional consideration to ensure public safety and health.

Assuntos

RESUMO

Raloxifene hydrochloride (RH) is considered to be an antiproliferative agent of mammary tissue. The aim of this study was to investigate the effect of the encapsulation of RH in polymeric nanocapsules with anionic or cationic surface on its release profile and antiproliferative activity. They were prepared by interfacial deposition of preformed polymer, followed by wide physicochemical characterization. The in vitro RH release was assessed by the dialysis membrane method and the data analyzed by mathematical modeling. The antiproliferative effect on MCF-7 cell viability was investigated by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay as well as by counting viable cells. They had high encapsulation efficiency, low polydispersity, and nanometric mean size. Nanocapsules prepared with Eudragit(®) RS100 and Eudragit(®) S100 presented positive and negative zeta potentials, respectively. Drug release studies demonstrated controlled release of RH from anionic nanocapsules, which could be explained due to a stronger interaction of the drug to these nanocapsules and the larger amount of entrapped drug. On the other hand, this control was not observed from cationic nanocapsules due to the larger amount of drug adsorbed onto their surface. MCF-7 cell viability studies and cell counting showed that RH-loaded Eudragit(®) RS100 nanocapsules promote the best antiproliferative activity after 24 hours of treatment, whereas the best activity was observed for RH-loaded Eudragit(®) S100 nanocapsules after 72 hours. Furthermore, the combined treatment of these formulations improved the antiproliferative effect during the entire treatment.

Assuntos

RESUMO

Colorado, Washington state and Uruguay are currently designing legal non-medical markets for cannabis. These clearly contravene the 1961 and 1988 drug conventions; options for what may happen next are discussed. The current provisions in the three regulatory schemes are summarized. From a public health perspective, the emphasis should be on holding down consumption with regulatory measures, but the public health agenda does not seem to be a strong consideration in the implementation of the US schemes, and they are paying little attention to what can be learned from the history of alcohol and tobacco regulation. While alternative paths to a cannabis market under the conventions are noted, the legalization initiatives underline the need to revise the drug conventions, making prohibition of domestic markets an optional matter. Such changes would also ease the path for including alcohol under the conventions, which would be an important step forward in global health.

Assuntos

RESUMO

The use of thalidomide was never discontinued in Brazil where it is prescribed for leprosy type 2 reaction. Babies with birth defects compatible with the thalidomide embryopathy phenotype were born after 1965, an indication that control on drug dispensing and use failed in the country. The article reports data on thalidomide dispensing and clinical uses in the Federal District in 2011/12, when new rules were put into effect, and data on drug dispensing and use obtained ten years earlier. It was found that the number of patients making use of thalidomide declined from 819 in 2001 to 369 in 2011/12. Leprosy accounted for over 70% of prescriptions in both time periods analyzed in this study. In the same time interval, however, use for lupus erythematosus decreased from 13.7 to 4.9%, while that for multiple myeloma increased from 2.9 to 20.3% of all prescriptions. Thalidomide prescription for the remaining approved indications was far less frequent, and so was the use for off label indications that accounted for <1% of prescriptions in 2001 and 2011/12. Registration of prescribing doctors, patients and dispensing units at the state department of health, apparently rendered this control more effective and reliable.

O uso da talidomida nunca foi interrompido no Brasil, sendo prescrita para tratar a reação tipo 2 da hanseníase. Crianças com defeitos congênitos compatíveis com o fenótipo da embriopatia causada pela talidomida nasceram após 1965, evidenciando que o controle do uso e da dispensação do medicamento falhou no país. O artigo relata dados sobre a dispensação e usos clínicos da talidomida no Distrito Federal em 2011/12, quando a nova regulamentação passou a vigorar, e dados sobre a dispensação e uso do medicamento 10 anos antes. Os resultados mostraram que o número de pacientes que usaram talidomida decresceu de 819 em 2001 para 369 em 2011/12. A hanseníase foi a indicação clínica para mais de 70% das prescrições nos períodos analisados no estudo. No mesmo período, entretanto, o uso para lupus eritematoso reduziu de 13,7 para 4,9%, enquanto o uso para mieloma múltiplo cresceu de 2.9 para 20,3% de todas as prescrições. A prescrição de talidomida para as outras indicações aprovadas foi muito menor, enquanto para indicações não aprovadas correspondeu a < 1% das prescrições em 2001 e 2011/12. O cadastro dos prescritores, pacientes e unidades dispensadoras na secretaria estadual de saúde, aparentemente tornou esse controle mais eficiente e confiável.

Assuntos

RESUMO

OBJETIVO: Identificar las estrategias empleadas por la industria tabacalera en México para contener tanto la adopción del Convenio Marco para el Control de Tabaco como la implementación adecuada de las políticas que contempla. DISCUSIÓN: La interferencia de la IT en el diseño, adopción e implementación de las políticas de control de tabaco se ha intensificado desde la firma del CMCT. A partir de 1997, las estrategias se adaptaron al cambio político en México. Esta adaptación consistió en identificar los puntos de veto en el desarrollo de las políticas de control de tabaco. CONCLUSIÓN: Las estrategias de interferencia de la industria tabacalera son eficaces en la afectación de las decisiones públicas.

OBJECTIVO: To identify tobacco industry´s strategies aimed at containing the full adoption of public health policies established by the Framework Convention on Tobacco Control. DISCUSSION: Tobacco industry interference in the design, adoption and implementation of tobacco control policies has intensified since the signing of the FCTC. However, it is back in 1997 when one can trace a shift in tobacco industry strategies, adapting to political change in Mexico. This adaptation has consisted mostly in identifying emerging veto points in the chain of public policy development. CONCLUSION: Tobacco industry´s interfering strategies have success y fully affected Mexican policies.

Assuntos

RESUMO

FUNDAMENTO: Dosagens inapropriadas e subterapêuticas anticoagulantes podem resultar em sérias complicações tromboembólicas. O uso dessa terapêutica requer especial atenção e precisa de um acompanhamento clínico e laboratorial rigoroso. OBJETIVO: Identificar fatores associados ao controle adequado dos níveis de anticoagulação oral, verificando o conhecimento e a percepção dos pacientes relacionados à terapêutica empregada. MÉTODOS: Estudo transversal que incluiu 140 pacientes acompanhados no ambulatório de anticoagulação oral, de novembro de 2005 a junho de 2006. Um questionário estruturado foi elaborado e aplicado para obtenção de características clínicas, conhecimento sobre a terapêutica, adesão ao tratamento (teste de Morisky) e percepção do paciente. RESULTADOS: As principais indicações para uso do anticoagulação oral foram fibrilação atrial (61,4 por cento) e prótese metálica (55 por cento). O tempo de uso variou entre 24 e 72 meses, e o femprocumona (58 por cento) foi o mais empregado. Em relaçãoà percepção da terapêutica, 95 por cento dos pacientes mencionaram preocupação com o uso diário dessa medicação. A realização periódica de exames de sangue (21,4 por cento) e a tomada rigorosa de anticoagulação oral (12,8 por cento) foram compreendidas como limitantes. Observou-se conhecimento adequado entre os pacientes com international normalized ratio (INR) fora da faixa (64 por cento) e na aderência entre os pacientes com INR dentro da faixa terapêutica (54 por cento), porém sem significância estatística. CONCLUSÃO: Os resultados deste estudo demonstraram uma prevalência de pacientes em uso de anticoagulação oral com o INR dentro dos valores ideais, embora tenha sido grande a porcentagem de pacientes não-aderentes à terapêutica. O conhecimento insatisfatório quanto à terapêutica empregada e ao autocuidado torna-se evidente nessa população.

BACKGROUND: Inappropriate and subtherapeutic anticoagulants dosages may result in severe thromboembolic and bleeding complications. The use of this treatment requires special attention and strict clinical and laboratory follow-up. OBJECTIVE: To identify factors associated with appropriate control of the oral anticoagulant use, assessing the patients' knowledge and perception of the treatment. METHODS: A cross-sectional study which included 140 patients followed in the oral anticoagulation outpatient clinic from November 2005 to June 2006. A structured questionnaire was drafted and applied to obtain the clinical characteristics of the patients and their knowledge about the treatment, their compliance with the treatment (Morisky´s test) and their perception of the treatment. RESULTS: The main indications for the use of oral anticoagulation therapy were atrial fibrillation (61.4 percent) and a prosthetic heart valve (55 percent). The duration of anticoagulation ranged from 24 to 72 months, and phenprocoumon (58 percent) was the most commonly used anticoagulant. As to the perception of the treatment, 95 percent of the patients mentioned concern about daily use of this medication. Periodic blood tests (21.4 percent) and the strict intake of oral anticoagulant (12.8 percent) were considered limiting factors. Adequate knowledge was outstanding in patients with an international normalized ratio (INR) outside the therapeutic range (64 percent), compared to patients with an INR within the therapeutic range (62 percent), as well as compliance with treatment in patients with an INR within the therapeutic range (54 percent), but with no statistical significance. CONCLUSION: The results of this study show a prevalence of patients using oral anticoagulant with an INR within optimal values, although a high percentage of patients do not comply with the treatment. In this population it is clearly seen that they do not fully understand the treatment.

FUNDAMENTO: Dosis inapropiadas y subterapéuticas anticoagulantes pueden resultar en serias complicaciones tromboembólicas. El uso de esta terapéutica requiere especial atención y precisa un seguimiento clínico y analítico riguroso. OBJETIVO: Identificar factores asociados al control adecuado de los niveles de anticoagulación oral, verificando el conocimiento y la percepción de los pacientes relacionados a la terapéutica empleada. MÉTODOS: Estudio transversal que incluyó a 140 pacientes seguidos en el ambulatorio de anticoagulación oral, desde noviembre de 2005 a junio de 2006. Se elaboró y se aplicó un cuestionario estructurado para la obtención de características clínicas, conocimiento sobre la terapéutica, adhesión al tratamiento (test de Morisky) y percepción del paciente. RESULTADOS: Las principales indicaciones para uso de anticoagulación oral fueron fibrilación atrial (61,4 por ciento) y prótesis metálica (55 por ciento). El tiempo de uso varió entre 24 y 72 meses, y el fenprocumona (58 por ciento) fue el más empleado. Con relación a la percepción de la terapéutica, el 95 por ciento de los pacientes mencionaron preocupación con el uso diario de esta medicación. La realización periódica de análisis de sangre (21,4 por ciento) y el tomar anticoagulación oral rigurosamente (12,8 por ciento) fueron comprendidos como limitantes. Se observó conocimiento adecuado entre los pacientes con international normalized ratio (INR) fuera del intervalo (64 por ciento) y en la adhesión entre los pacientes con INR dentro del intervalo terapéutico (54 por ciento), aunque sin significancia estadística. CONCLUSIÓN: Los resultados de este estudio mostraron una prevalencia de pacientes en uso de anticoagulación oral con el INR dentro de los valores ideales, aunque haya sido grande el porcentaje de pacientes no adheridos a la terapéutica. El conocimiento insatisfactorio con relación a la terapéutica empleada y al autocuidado se vuelve evidente en esa población.

Assuntos