关键词: 不良反应, 机构建设, 研究, 对策

Abstract: Objective Conduct research on the construction status of the national adverse drug (provincial level) reaction monitoring organization, understand the basic situation of the current provincial monitoring organization setting, and provide reference for the provincial medicine supervision and administration department to develop provincial level monitoring organizations. Methods The author used questionnaire survey to conduct research on the construction status of the national adverse drug reaction monitoring system. Results 29 provincial level medicine supervision and administration departments have completed the organization reform, which is 93.55% of all departments; 35 provincial level adverse drug reaction monitoring organizations are established currently in the country; 13 organizations have been approved by local authority, which accounts 41%; 25 organizations are government affiliated institutions, which accounts 73.52%; the total head counts approved by local authorities of the provincial level monitoring organizations in the country is 544, actual employed staff quantity is 466. Conclusion Further develop provincial organization approval process; setup monitoring organization as separate legal entity; the provincial level monitoring organization should have unified functions, the basic four functions should be adopted: adverse drug reaction monitoring, medical device adverse events monitoring, drug abuse monitoring, adverse cosmetic products reaction monitoring; ensure at least one special personnel per one million population.

Key words: adverse reactions, system construction, research, countermeasures