Análise de situações de trabalho na fiscalização sanitária de medicamentos da agência reguladora federal / Analysis of work scenarios in the sanitary enforcement of medicines from the federal regulatory agency

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 The fragilities of the information systems, the outdated regulatory framework, the performance model, the fragmentation of the work, among others, have caused barriers to the professional's activity.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.

A fiscalização sanitária de medicamentos na sociedade de risco / Drug health surveillance in the risk society

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.

Research progress on treatment measures for pediatric acute lung injury / 中国小儿急救医学

Pediatric acute lung injury(ALI)is a common disease in pediatric intensive care unit with a high fatality rate.Because the etiology of ALI is complex, the exact pathogenesis of ALI is not clear.At present, it is known that the important factors leading to the incidence of ALI in children are oxidative stress and dysregulation of inflammatory response.Progressive hypoxemia and respiratory distress are the main clinical manifestations of ALI.Respiratory support and drug control are the common treatment measures.In recent years, stem cell and molecular targeted therapy as new treatment pathways of ALI, have achieved certain achievements in the research, and are expected to become new treatment methods of ALI in chidren.

Analyze prescription rules of Professor Jiang Liangduo treatment for abdominal mass based on traditional Chinese medicine inheritance platform / 中国中药杂志

To investigate the herbal prescription rules of Professor Jiang Liangduo in the treatment of abdominal mass based on the traditional Chinese medicine inheritance support system software (TCMISS) of version 2.5, find out new herbal formulas for the treatment of abdominal mass, and then provide new reference to its traditional Chinese medicine therapy. By the method of retrospective study, one hundred and thirty-two outpatient prescriptions of Professor Jiang for the treatment of abdominal mass were collected to establish a typical database with TCMISS. Four properties, five tastes, channel tropism, frequency count, Chinese herbal prescriptions rules and the new prescriptions were analyzed so as to dig out the prescription rules. There were 57 herbs with a frequency>=15, and then 91 core combinations of 2-5 herbs were evolved and 9 new prescriptions were created. It was found out that these drugs mainly had the effects of liver nourishing and soothing, soft-moist and dredging-tonifying, supporting right and dispeling evil, cooperating with the method of calming the liver and resolving hard lump according to the actual situation. It reflected the thought of treatment based on syndrome differentiation in TCM, and provided a new reference for its clinical treatment and research.

Design and Realization of Off-label Drug Use Control System Based on B/S Structure / 中国药房

OBJECTIVE:To build the off-label drug use control system,and to realize automatic prompt for off-label drug use by system when physicians prescribed drugs. METHODS:The module and flow chart of off-label drug use control system were de-signed based on B/S structure. The drugs of the prescriptions were verified one by one in terms of drug indication,drug dosage, age and gender of patient,route of administration,etc. The system prompted automatically off-label drug use when drug use didn’t agree with preset value;at the same time,the management effect of the system was evaluated by taken the amount of attention about antibiotics medical orders as an example. RESULTS:At present,265 kinds of drugs were involved in the system designed by our hospital. Since the system was applied,the system had prompted more than 50 thousand items of off-label drug use prescrip-tions/medical orders,accounting for 0.3% of total. Among the types of off-label drug use,the most number of medical orders were over single dose(745 items),followed by extra-indication(706 items)and over daily dose(671 items). Within 3 months after sys-tem used,the attention numbers of antibiotics medical orders of over daily dose decreased month by month. CONCLUSIONS:Es-tablished off-label drug use control system of our hospital has a stable running and convenient manipulation,and contains powerful practicability. It can monitor off-label drug use of some drugs.

Quality Study of Marketed Rose Bengal Agar Culture Medium for Drug Control / 中国药师

Objective:To investigate overall quality status of rose bengal agar culture medium for drug control in China to provide technical support for the drug standard revision. Methods:Four quality control microorganisms, namely Aspergillus niger, Candida al-bicans, Staphylococcus aureus and Escherichia coli, were used to evaluate the quality of rose bengal agar culture medium from 7 domes-tic and foreign manufacturers. Results:Including the control medium, the pH value of all the 8 media was different. The growth rate of Aspergillus niger and Candida albicans in the seven tested media were all above 0. 7 without significant difference (P>0. 05). The selectivity factors of Staphylococcus aureus in the seven media and the control medium was more than 6. The eight media showed differ-ences in the selectivity factors of Escherichia coli. Among them, A, B, C, E, G and the control medium had no inhibitory ( selectivi-ty) , while D and F showed certain selectivity. Conclusion:The rose bengal agar media from different manufacturers for drug control show similar growth-promoting ability with different pH value and selectivity to Escherichia coli.

The risk factors analysis and control for intrahepatic cholestasis of pregnancy / 重庆医学

Objective To investigate the clinical characteristics and risk factors for intrahepatic cholestasis of pregnancy(ICP), and put forward relevant control measures.Methods May 2009 to February 2013 in our hospital maternity clinic built card ICP 60 cases of pregnant women as the observation group,choosed the same period in our hospital 60 cases of childbirth without ICP as the control group,two groups have carried out surveys of maternal and neonatal outcomes,and laboratory tests.While observing the pa-tients were given drug therapy.Results All mothers were smooth delivery of the newborn,no maternal and neonatal mortality.Pro-duction of the observation group was significantly shorter than the control group gestational age,neonatal apgar 1 minute(s)and birth weight was significantly lower,cesarean section rate was significantly higher(P 0.05).Observation group BUN,LDH,PT,APTT,FIB levels higher,the differ-ence was statistically significant(P 0.05).blood pressure control and kidney damage and prenatal affecting intrahepatic cholestasis of pregnancy independent risk factor for the inci-dence(P<0.05).After treatment,the observation group 42 cases were cured,14 cases markedly effective,4 cases ecfectiveness and no case failure.markedly effective rate was 93.3%,the effective rate was 100.0%.Conclusion ICP for maternal and newborn have a certain influence,many accompanied by renal dysfunction,blood pressure control and kidney damage and check-ups during preg-nancy that affect the incidence of ICP independent risk factors,drug therapy can achieve better results.

Clinical use and control of the dispensing of thalidomide in Brasilia-Federal District, Brazil, from 2001 to 2012 / Uso clínico e controle sobre a dispensação de talidomida em Brasília-DF, Brasil, de 2001 a 2012

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.

Estrategias de la industria tabacalera en México para interferir en las políticas de control del tabaco / Undue tobacco industry interference in tobacco control policies in Mexico

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.

Uso crônico de anticoagulante oral: implicações para o controle de níveis adequados / Constant use of oral anticoagulants: implications in the control of their adequate levels / Uso crónico de anticoagulante oral implicaciones para el control de niveles adecuados

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.

Institutional Setup and Financial Management Model of Institute for Drug Control of China under Super-Ministry System / 中国药房

OBJECTIVE:To establish a set of scientific,standard management model and rational,impartial financial system in Chinese institutes for drug control.METHODS:The types of the established institutions and the financial appropriation model of institutes for drug control in China were studied by using the methods of classification,comparison and analysis.RESULTS & CONCLUSIONS:Under super-ministry system,local management in drug control institutions at all levels is expected to be put into practice soon.It is advisable to optimize the organization and management model and financial appropriation management system such as by shifting from county level institution to district level institution and carrying out a wage system in drug control institutes in accordance with the payment level of civil servants,etc.

Consideration on the Improvement of the Current Drug Computer Control Systems in Our Hospital / 中国药房

OBJECTIVE:To provide reference for the perfecting of hospital information system (HIS) on drug control. METHODS: The problems encountered in using two drug control systems in our hospital were analyzed, and the constructive suggestions on its improvemen was put forward. RESULTS & CONCLUSIONS: The new HIS should be designed to overcome the weaknesses of the current HIS in code design, assignment of authority limit, drug application and dispensing, drug stocktaking so as to make full use of the merit of the computer management.

Difference between Fake Drug and Adverse Drug Reactions in Law / 中国药房

OBJECTIVE: To clarify the difference between fake drug and adverse drug reaction in law. METHODS: To analyzed and the fake drug and adverse drug reactions from aspects of legal connotation, drug control institute, measures of management, legal responsibility etc. RESULT & CONCLUSION: Great importance should be attached to the correct understanding on the big difference between fake drug and adverse drug reactions in drug control and drug use.

Scientific Management in Outpatient Chemical Drug Pharmacy / 中国药房

OBJECTIVE:To explore a fair,reasonable and legal management for outpatient chemical drug pharmacy.METHODS:By combining our experiences in outpatient chemical drug pharmacy of our hospital reviewing a considerable literature,the problems occurred in daily pharmacy management were analyzed,and the coping strategies such as flexible shift arrangement system,comprehensive drug control and sustained improvement etc were applied.RESULTS:The scientific management contributed to a reasonable pharmacy management,reduced error rate,ensured the drug quality,greatly shortened the dispensing time,and due to which,high-quality service was available and the allocation of human resources was optimized to some degree.Patients' satisfaction degree raised to 97.8% of Mar.2008 from 80% of Apr.2006.CONCLUSI-ON:A fair,reasonable and legal pharmacy management was achieved by means of scientific,human and standard management,accordingly,the hardware and software in pharmacy brought about a maximal efficiency and effectiveness of management.

Classified Drug Control in Germany:A Brief Introduction / 中国药房

OBJECTIVE:To improve the classified drug control level and drug supervision in China by drawing advanced experiences from Germany.METHODS:The laws and regulations,standards for classified drug control in Germany were introduced.RESULTS & CONCLUSIONS:The humanized management,the management model on narcotic drugs,adopting advanced equipment and informationized management in Germany serve as a model for China to follow.

Application of 5S Theory in Ward Drug Control / 中国药房

OBJECTIVE:To discuss ward drug control to ensure safe.METHODS:We analyzed retrospectively the application of 5S theory in ward drug control.RESULTS & CONCLUSION:By this drug control mode,drugs were classified according to varieties,usage,frequency of use etc,drug control quality and work efficiency were enhanced,patients' needs could be satisfies and staff' s professional quality was enhanced.

Development of a quality assurance system for drug-control institute / 医疗卫生装备

Based on the requirements of quality assurance during drug control process,a quality assurance system is developed for drug control in the institute of drug and equipment control.The results show that the method developed in this paper is much suitable tothe process of drug control and can be applied tocontrolling the quality from the drug receiving tothe drug releasing.The quality assurance system guarantees that the detected data are achieved scientifically and efficiently.

Consideration on Licensed Pharmacist and Essential Drug System / 中国药房

OBJECTIVE:To provide reference for implementation of national essential drug system in China.METHODS:The roles of licensed pharmacists were analyzed as well as existed problems.RESULTS&CONCLUSION:The licensed pharmacist participates in all aspects of implementation,such as selection,production,circulation and appliance,etc.and takes important place in process of essential drug system.Essential drug system is carried out in ways of legislation for licensed pharmacist,classified drug control system and classified registering for licensed pharmacist.

Problems of Computer Network in Drug Control of Our Hospital and Its Solution / 中国药房

OBJECTIVE:To establish a more practical and more consummated computer network system on drug control.METHODS:The computer network in our hospital was analyzed,the problems in drug control and the corresponding solutions to which were studied.RESULTS&CONCLUSION:Only through a comprehensive improvement in software,hardware,usage and management and etc.can the advantages of the computer network be really brought into fully play.

Analysis of drugs with several components by UV-VIS MCA spectrophotometric technique - An application of informative industry in drug control

Some algorithms used in UV-Vis MCA spectrophotometry technique and some recent statistical approaches to the Advanced MCA technique were described. A number of pharmaceutical formulas containing 2-4 ingredients has been analyzed successfully using MCA technique. Basing on the basic algorithm of MCA and its statistical approaches, an applicable software for data processing had been established (running in Windows (environment - IBM compatible computer). This enables to use MCA technique for conventional spectrophotometers.