A Study On Organization And Sustainable Development In Basic Adverse Drug Reaction Monitoring

Object: The status and problems of basic adverse drug reaction (ADR) monitoring system are first studied in this paper. On this basis, the need and form for the establishment of ADR monitoring organizations, its functions and the sustainable development strategy below provincial level are deeply studied.Method: A combined method of literature retrieval, surveys, on-site investigation and practice is used in the study. First the literature of foreign and domestic ADR monitoring organizations is reviewed and analyzed. Then the survey program is designed, which combined large-scale field research and on-site investigation. Practice is taken in region with proper conditions, whose experience is then summarized and promoted. Based on the study, ideas and proposals for ADR monitoring organization framework and sustainable development in China are put forward.Results: In recent years, the majority of the provinces in China have begun to establish municipal ADR monitoring bodies, and most of the early work was done mainly by part-time officers, and only a few monitoring bodies are approved by the government. Some provinces began to establish county ADR monitoring agencies, the staffs of which are mostly part-time workers, and the majority of the ADR monitoring agencies are set up at the Food and Drug Administration. The survey show that most of the respondents supported the establishment of an independent provincial and the municipal monitoring bodies, the county monitoring bodies should have full-time professionals. The survey also revealed that the functions of monitoring bodies at all levels are not clear, and an effective mechanism is lacked, which are the main cause of hindering sustainable development.Conclusion: To guarantee the long-term sustainable development of ADR monitoring, it is highly necessary to establish the provincial level ADR monitoring bodies, and form the basic ADR monitoring system. Concerning China's actual conditions, provincial and municipal levels should establish an independent monitoring body, and county ADR monitoring can be done as a routine function of the county Food and Drug Administration, in which a person is assigned full-time responsibility. In summary, clear function of monitoring body at all levels, sound and effective protection mechanism for monitoring, are the keys to development of the ADR monitoring career.