"Enxugando Gelo?": o trabalho dos profissionais na fiscalização sanitária de medicamentos na internet / "Rolling a stone uphill?": the work of professionals in health inspection of medicines on the internet

Resumo A sociedade contemporânea convive com incertezas e vulnerabilidades que exigem a atuação dos sistemas regulatórios na fiscalização do comércio eletrônico de medicamentos não registrados e/ou falsificados. Investiga-se o trabalho dos profissionais da vigilância sanitária federal na fiscalização de medicamentos na internet e os elementos que orientam sua decisão técnica. A metodologia utilizada foi a pesquisa qualitativa, do tipo estudo de caso único, ancorada na abordagem ergológica, entre dezembro de 2020 e setembro de 2021, por meio de entrevistas e observação participante. Os mapas ergodialógicos, elaborados no Atlas.ti, subsidiaram a análise das práticas discursivas classificadas conforme esquema tripolar saber-agir-valor, resultando em três categorias. O profissional é sempre convocado a fazer escolhas e gerir situações imprevisíveis, havendo inquietações sobre a capacidade institucional para compreender e agir sobre o problema. O trabalho adquire, assim, o sentido de "enxugar gelo", em função do volume de demandas e dos poucos efeitos da fiscalização no mercado eletrônico de medicamentos. As normas, o conhecimento técnico, a experiência e a responsabilidade social, dentre outros elementos, estão presentes na tomada de decisão dos profissionais, conscientes de que, ao agir, protegem a saúde da população. Constata-se que diferentes saberes, científicos ou empíricos, podem qualificar melhor o sistema decisório na fiscalização, tornando-o mais efetivo, assertivo e transparente.

Abstract Contemporary society is plagued with uncertainties and vulnerabilities, demanding from regulatory systems the surveillance of unregistered and/or falsified medicines sold online. This study investigates the work of federal health surveillance professionals in the inspection of medicines sold online and the elements that guide their technical decision. A qualitative, single case study based on the ergological approach was conducted between December 2020 and September 2021, with data collected by interviews and participant observation. Ergodialogical maps, developed using Atlas.ti, underlined the analysis of discursive practices classified according to the tri-polar knowledge-action-value schema, resulting in three categories. Professionals are always called upon to decide on and manage unpredictable situations, questioning the institutional capacity to understand and act on the problem. The work thus takes on the sense of "rolling a stone uphill" due to the volume of demands and the limited effects of surveillance on the e-commerce of medicines. Norms, technical knowledge, experience, and social responsibility, among other elements, inform the decision-making process of professionals, who are aware that, by acting, they protect public health. Different forms of knowledge, scientific or experiential, can better qualify decision-making in surveillance, making it more effective, assertive, and transparent.

Postmarketing Assessment of Sildenafil in Terms of Safety and Efficacy / 대한남성과학회지

PURPOSE: The main purpose of postmarketing surveillance of drugs is to better characterize the safety profile of drug therapy in routine clinical practice. Another goal is to confirm the effectiveness of the tested drugs in clinical practice. A postmarketing survey was undertaken to monitor the safety and efficacy of sildenafil citrate (SC) as a treatment for erectile dysfunction in Korean men. MATERIALS AND METHODS: This 6-week, observational, open-label, uncontrolled, longitudinal, prospective study was conducted by 50 general hospitals across Korea. Men aged > or =20 years with erectile dysfunction who, in their physicians' opinion, should be treated with SC were enrolled for this study. To evaluate efficacy, the global efficacy assessment questionnaire (GEAQ) was administered before, and 2~4 weeks and 4~6 weeks following the initiation of SC therapy. Information regarding adverse drug reaction (ADR)s was collected on case-report forms designed for each visit and analyzed by the scientific committee of the study. RESULTS: A total of 935 patients were enrolled, and 818 patients were assessable for safety. A total of 561 patients satisfied the requirements for efficacy analysis. Seventy-two patients (8.8%) experienced 99 ADRs over the 6 weeks. The most common ADRs were facial flushing (5.7%) and headache (2.0%). Eight patients discontinued the medication due to ADR. In response to the global efficacy assessment question, 91.4% of patients reported that SC improved their erectile function. Unlike the results of clinical trials, 67.2% of the population studied required 50 mg sildenafil to attain satisfactory erection. CONCLUSIONS: In this postmarketing surveillance study of Korean patients with erectile dysfunction treated in routine clinical practice, SC showed a satisfactory tolerability and efficacy profile that was consistent with that seen in randomized, controlled trials.

Feasibility of Conducting Event Monitoring in Japan Similar to Prescription-Event Monitoring in England : A Report on a Health Sciences Research to Ministry of Health and Welfare Japan in 1996 / 薬剤疫学

Background : With a suppport from Ministry of Health and Welfare (MHW) Japan, we studied the feasibility of conducting event monitoring in Japan similar to Prescription-Event Monitoring in England. The manuscript presented is a report to MHW in 1996.<BR>Methods : Means available in Japan to identify drug, patient and doctor are examined. In addition, any modification needed to make on a questionnaire sent to doctors in PEM conducted in Japan is examined.<BR>Results and Conclusion : Monthly claims called as “Rezept” issued by individual hospitals and clinics and sent to insurers and outpatient prescriptions issued by hospitals to be dispensed by the pharmacies outside the hospitals are considered to be two available means to identify drug, patient and doctor. To have a sample representative of all drug users, the use of “Rezept” is needed as only a fraction of outpatient prescriptions are dispensed by independent pharmacies. However, the use of prescriptions dispensed by the independent pharmacies together with the cooperation of individual pharmacies is capable of finding a contemporary control which is a group of patients who have recently started “old” drugs comparable to the new “test drug”. In Japan no doctor may have a complete list of the hospitals and clinics a patient has visited and it is mandatory to ask doctors the last date when the patient visited the doctor. To clarify what problems arise when a PEM-like study is introduced to Japan, a pilot study is going to be done during 1997 and the feasibility will be examined further based on the results.

Voluntary Reporting on Suspected Drug Reactions Collected via Drug Companies in Japan : Companies' View / 薬剤疫学

Background : In Japan most (>85%) voluntary reports on suspected drug reactions are collected by drug companies.<BR>Objective : To know various aspects of case reports on suspected drug reactions collected by Japanese drug companies.<BR>Methods : Questionnaires were designed by our department and mailed to 96 major drug companies in late March 1997. They were reminded in mid-May and mid-June when not having responded.<BR>Results and Conclusion : Of 96 drug companies, 3 were found to be not eligible (e. g., selling only the OTC drugs) and excluded. Of the remaining 93 companies, 91 (98%) responded. Of all the case reports collected by drug companies (approximately 27, 000/year), 36%of serious or important cases are duly reported to Ministry of Health and Welfare (MHW) within 15 days or 30 days of receipt. In Japan individual case reports collected by drug companies and reported to MHW have been closed. Eleven companies are opposed to disclosing individual case reports while 6 agree unconditionally. Seventy companies agree to disclosing individual case reports with various conditions such as protecting patients' privacy, not disclosing the reporter's identity, and making individual case reports available to medical personnel only. Finally, 20 of 91 drug companies complained that MHW does not let them know individual case reports associated with their own products sent to MHW directly from medical doctors or via other companies. To promote pharmacoepidemiology, disclosing voluntary reports is pivotal and MHW is going to adopt this policy in two years for which however reporters and drug companies must be prepared in advance.

Future Perspective on Postmarketing Surveillance in Japan / 薬剤疫学

Objective : To have future perspective on postmarketing surveillance (PMS) in Japan<BR>Design and Methods : Several general principles considered of particular importance to PMS in Japan are outlined as follows ; (1) to help and encourage the voluntary cooperation with all health professionals, (2) to make data open to public but not exclusively to regulatory authority, (3) to conduct non-interventional or observational study which monitors the patients representative of the general population of users and (4) to encourage the development of multi-scheme system.<BR>Results and Conclusion : It is concluded that existing schemes may be improved and some may be newly created as follows ; (1) as to voluntary reporting system, the reports should be collected from all health professionals in all clinics and hospitals, (2) a new system similar to Prescription-Event Monitoring (PEM) in UK may be worth trying to establish in Japan because medical costs including those of drugs are itemized in monthly claims for individual patients made by all Japanese clinics and hospitals, (3) hospital-based database may be further developed and (4) a system for case registration to conduct high-quality case-control studies to detect rare adverse reactions may be newly created.