Shanghai Drug Safety Evaluation Index System Research

Drug safety is a major livelihood and public safety issues related to people’s health and social harmony and stability. Drug safety evaluation helps to make a profile of drug safety situation, helps decision-makers to predict the trend of drug safety situation and clarify the cause of drug safety issues. Drug safety evaluation is a prerequisite of implementing drug safety issues remediation, helps policy makers to control risk fact of drug safety and guarantee public safety.This article bases on the current drug safety situation of Shanghai, with literature search, site investigation, experts interviews and other methods, this article summarize the research of domestic and international drug safety evaluation, the definition of drug safety, risk sources and characteristics, and the theory of vulnerability assessment. This article contents a preliminary qualitative evaluation report of Shanghai drug safety:the overall quality of drugs in Shanghai is stable, the quality of drug made by Shanghai pharmaceutical manufacturers is controllable, risk of drug circulation increased, the supervision of medical institutions is relatively weak; the same time, this article found major problems concluded the illegal drug channels and illegal use of drugs, how to protect the quality of drug purchased, the irrational drug use in medical institutions, the illegal advertising and online sale of drugs. In addition, this article does questionnaire survey of the drug safety satisfaction.Finally, based on the results of Shanghai Drug Safety qualitative assessment and combined with the vulnerability assessment model, this article builds Shanghai drug safety quantitative evaluation index system. From economics, management, social and technical dimensions, exposure extent, hidden risk factor, resistance ability, recovery ability and outcome indicators comprised this index system.