The Present Situation And Improving Measures Of Adverse Drug Reaction Periodic Report Reporting

Objective:To describe the present situation of periodic report of our country, to put forward feasible suggestion and provide working references and evidence for our ADR job. And to find out the experiences and methods of foreign ADR reporting system which are proven to be successful. To revise our periodic report table and bring up corresponding suggestion, so as to upgrade the quality of periodic report work.Methods:1.Literature: To search the relative literature.Search the website of WHO and other official websites, CNKI, PubMed database. Study the ADR report standards and requirements of developed countries, like that of the US and Europe.2. Analysis: To use prevalence survey to inquire about the reporting situation and export the data, and to study the requirements of PSUR and SOP. To make a comparison of periodic report and personal database of three typical drugs.3.Interview of key persons: To interview the professional stuff who pursue the career of ADR, to know the background and situations of the periodic report job of our country, and to communicate the case of PSUR implentation and SOP.Results:1. The reporting rate of 2004 is 3.47 percentage, the quality of key information is quite poor. For example, the period report of Gatifloxacin reports only three cases of ADR,but there are 71 individual cases in ADR personal database.2. The foreign countries adopt ICH E2C guideline to report PSUR,"overall sfety evaluation""conclusion"can be cited and the explanation of"studies""world-wide market authorization status"also could be used for our country.3. The ADR reports quality of Canada's health administration is beneficial and can be used by our country.Conclusions: The enterprises'reporting rate and quality of the form is quite low, and the design of the form lack of some important items. There is need to form new periodic report table based on the present one, to make the explanation of filling the table more particular, and to come up with corresponding requirements of regulations.Suggestion: To add new items to periodic form and instruction of filling the form; To set up evaluation system and standard of period report of our country; To increase corresponding law requirements to regulate the reporting behavior of medical enterprises.