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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 The fragilities of the information systems, the outdated regulatory framework, the performance model, the fragmentation of the work, among others, have caused barriers to the professional's activity.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.
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In 2003, the responsibility of radiation source safety supervision was redivided and transferred from the health department to the environmental protection department. After the promulgation and implementation of the Rule on the Administration of Radiodiagnosis and Radiotherapy in 2006, due to the incorporation of a large number of medical practice supervision rules, the radiation health supervision of medical institutions has evolved into the radiodiagnosis and radiotherapy supervision. In the past 16 years, radiation, occupational health supervision, and medical practice supervision have not been well integrated, and there are many legal problems in radiodiagnosis and radiotherapy supervision. The regulation rules of environmental protection, metrology, and other relevant departments on radiation sources and radiation devices have been constantly changing, resulting in overly complex regulatory requirements on radiodiagnosis and radiotherapy, which increases the burden of medical institutions. This paper reviews the historical evolution and legal system changes of radiodiagnosis and radiotherapy supervision, analyzes the problems and challenges faced by the relevant regulatory departments, and proposes ways to improve the supervision system.
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Objective To analyze the administrative penalties for radiation diagnosis and treatment in Xuzhou, China, 2018—2021, investigate the key illegal behaviors in radiation diagnosis and treatment, and provide a basis for effective supervision with targeted measures. Methods A total of 142 cases of administrative penalties were analyzed for the year of the case, the undertaker, the basic information of the subjects, the amount of penalty, and the specific illegal facts. Results From 2018 to 2021, the case number of administrative penalties for radiation diagnosis and treatment in Xuzhou was relatively stable. The cases were mainly undertaken by the municipal health supervision institution, while the number of cases handled by basic-level health supervision institutions was increasing. The administrative penalties were mainly imposed on persons and primary or non-classified medical institutions. Common illegal behaviors included occupational health management of radiation workers and personal protection during medical exposure. Conclusion We should focus on strengthening the publicity and supervision of personal protection in occupational health management and medical exposure, continue to improve the law enforcement ability of basic-level radiation health supervisors, develop a standardized management system for radiation diagnosis and treatment, innovate the supervision mode and radiation hazard notification mode, promote the “Internet + ” informatization supervision, and recommend to improve and revise radiation-related laws and regulations.
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Objective:To ascertain the current situation of new types of hairdressing business， to objectively evaluate the sanitary condition of quick barber and hair care shops， and to provide basis and support for relevant departments to formulate policies and management measures. Methods:A total of 12 quick barber shops and 14 hair care shops in one district of Shanghai were investigated by field survey questionnaire. Results:The quick barber shops and the hair care shops need to have public health permit. However， these new types of hairdressing business failed to follow the sanitary law and standard in many aspects. The government agencies also lack corresponding management means. Conclusion:The governments should review the rules and regulations， create the appropriate standards， and exercise accommodative and prudential regulation on these types of new business.
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More than 90% of artificial irradiation comes from medical irradiation. New radiation technologies are constantly emerging in the medical field, bringing benefits to patients. At the same time, the harm of medical irradiation has attracted more and more attention. There are many problems in the supervision and management of radiation health in medical institutions, such as many standards and specifications involved in radiation health in medical institutions, uneven professional ability of personnel in primary health supervision institutions, inadequate implementation of the main responsibility for the safety of radiation diagnosis and treatment in medical and health institutions, and non-standard service of radiation health technical service institutions, etc. In view of the above problems, the implementation plan of standardization of radiation health supervision, radiation diagnosis and treatment behavior, and radiation technical service behavior has been set. After the pilot operation, the effect is obvious.
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Objective To determine the effects of the"double random"supervision model of public places in Yangpu District, Shanghai. Methods Using the"double random"data of public places in Yangpu District of Shanghai from 2018 to 2019, we determined the proportion of unqualified public places assessed by daily supervision and"double random"supervision in 2018 and 2019. Moreover, we identified that if the public places that had been penalized in 2018 would be penalized in 2019, which may reflect the effects of the"double random"supervision model. Results The proportion of unqualified public places assessed by"double random"supervision was significantly higher than daily supervision in 2018(χ2 = 58.04, P < 0.05)and 2019(χ2 = 79.24, P < 0.05);however, the proportion of being penalized in the following year between"double random"supervision and daily supervision had no significant difference(χ2 = 1.81, P = 0.18). Conclusion "Double random"supervision may be easier to identify the problems of the supervision subjects than daily supervision; however, it warrants continual efforts to consolidate the regulatory effects.
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Objective:To construct an evaluation indicator system for emergency response capability in health supervision institutions.Methods:It made an initial indicator system by using brain storming,literature method and expert consulting,and constructed an evaluation indicator system by Delphi method.Results:Both the response rates of two round questionnaires survey were 100％.The means of authoritative coefficient for the first-dimension indicators was 0.82.For the second round of expert consulting,the coordination coefficients of the first,second and third-dimension indicators were 0.954,0.820 and 0.565 respectively (P＜0.05).It constructed an evaluation indicator system for emergency response capability among health supervision institutions.There were 4 first-dimension indicators,10 second-dimension indicators and 37 third-dimension indicators in the indicators system.Conclusion:Experts opinions had high reliability.The process of screening indicators was normative.The indicator system was comprehensive,which could be used and examined in practice.
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Objective:To construct an evaluation indicator system for emergency response capability in health supervision institutions.Methods:It made an initial indicator system by using brain storming,literature method and expert consulting,and constructed an evaluation indicator system by Delphi method.Results:Both the response rates of two round questionnaires survey were 100％.The means of authoritative coefficient for the first-dimension indicators was 0.82.For the second round of expert consulting,the coordination coefficients of the first,second and third-dimension indicators were 0.954,0.820 and 0.565 respectively (P＜0.05).It constructed an evaluation indicator system for emergency response capability among health supervision institutions.There were 4 first-dimension indicators,10 second-dimension indicators and 37 third-dimension indicators in the indicators system.Conclusion:Experts opinions had high reliability.The process of screening indicators was normative.The indicator system was comprehensive,which could be used and examined in practice.
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To train health supervision talents , one of the scarce talent cultivation plans of National Health and Family Planning Commission, the undergraduate of health supervision was set up by Harbin Medical University and approved by the Ministry of education in 2012. According to the problems of personnel training, the competency model of health supervision was established through empirical research, which covered six aspects and 33 factors, and based on the model, the personnel training model was developed to cultivate the compound health supervision talents to meet the demand of health supervision, and the curriculum system covered medical, law, supervision and management courses. In order to realize the target of talent training, some viable measures were taken such as re-forming the traditional teaching methods, establishing comprehensive teachers, strengthening teacher training, and so on.
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OBJECTIVE To investigate and analyze the problems and challenges of HIV/AIDS epidemic on public health supervision in China.METHODS The main problems were found out by retrospective survey method,and could be solved through establishing a system of management.RESULTS The laws,regulations and specializations were strengthened and the full of public health supervision efforts were made.CONCLUSIONS It is essential to actively participate in widespread mass media education efforts to mainstream knowledge about HIV/AIDS prevention and care.But also to strengthen laws and specializations,to improve the quality of supervision,and to prevent and control of HIV/AIDS epidemic.
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The authors attempt to combine medical ethics education and the professional training objectives of health supervision in the teaching practice of medical ethics for health supervision majors within the limited curriculum course.Under the premise of a standardized syllabus norm and scientific teaching goals,appropriate teaching forms,methods and trials are implemented to impart health supervision majors with medical ethics knowledge and meanwhile promote their quality and ability reserves.
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Objective To develop health supervision information system. Methods The operation needs for health supervision department are analyzed; the object-oriented method is used to build the structure based on C/S mode, the client software is programmed by Delphi languages and Oracle is adopted as the database for its server. Results The functions of the health supervision system are realized including permission, inspection, punishment, statistical analysis and instruments print and so on. Conclusion The information system can be fulfilled the business needs of the health supervision department and enhanced inspection efficiency.