Study Of Evaluating Indicator System On The Risk Of Post-marketing Drugs By Delphi Method

Objective This study was aimed to establish an evaluating indicator system by Delphi method. This indicator system would be scientific, practical and suitable for the Chinese medical situation. It could reasonably evaluate the risk of post-marketing drugs, and provide some theoretical basis for clinical medication and reference for the relevant drug policy.Methods Since drug risk is from various aspects, it might be classified as internal risk and external risk in this paper. The internal risk is related to human body, drug and disease while external risk is related to irrational use of drug, drug quality, policy and regulations, medical professional and so on. Based on review of literatures, opinions of some experts and factors of drug risk, the prototype of the indicator system was established. A total of 26 national experts who have experiences on clinical, pharmacology, epidemiology and management, and have engaged in related specialty for more than ten years and specialized technical title above assistant professor academic rank were selected. The indicator system was filtered by Delphi method in two rounds of expert consultation. The data was analyzed by SPSS 16.0 statistical software. Experts valuations of each indicator could meet to the average>3.50, full marks ratio>0.20, and coefficient of variability<0.25, the final evaluation indicator system on the risk of post-marketing drugs was constructed. According to valuation of experts about each indicator, the weight of each indicator was identified with percentile.Results This study conducted two rounds of expert consultation.26 questionnaires were dispatched in first round of expert consultation, and 22 questionnaires were returned. The response rates was 84.62%; 22 questionnaires were dispatched in second round of expert consultation, and 21 questionnaires were returned, the response rates was 95.45%. The means of two rounds authorities were 0.74 and 0.75, respectively. After twice investigation,29 internal risk indicators and 36 external risk indicators remained in the final evaluation indicator system on the risk of post-marketing drugs. The internal risk indicators included 3 indicators of first grade. The weight coefficient of the first grade indicators, human, drug and disease was 0.3348,0.3867,0.2784, respectively. The internal risk indicators included 26 indicators of second grade. The human body was composed of 6 indicators; the drug was composed of 17 indicators; the disease was composed of 3 indicators. In the second grade indicators, drug dose, administration route, poor renal function, poor liver function, disease severity are more important. The harmonious coefficients of importance and feasibility were 0.330,0.326, respectively, and had statistic significance (P＜0.01). The external risk indicators included 4 indicators of first grade. The weight coefficient of the first grade indicators, patients, drug quality, medical professional, policy and regulations were 0.2336,0.2907,0.2734,0.2022, respectively. The external risk indicators included 32 indicators of second grade. The patient was composed of 3 indicators; the drug quality was composed of 6 indicators; the medical professional was composed of 17 indicators; the policy and regulations was composed of 6 indicators. In the second grade indicators, passing rate of drug quality, passing rate of drug storage, pharmacists dispensing accuracy, medication compliance rate of patients, adverse drug reaction monitoring and reporting system were more important. The harmonious coefficients of importance and feasibility were 0.326,0.143, respectively, and had statistic significance (P<0.01).Conclusion In the research, the scope covered by the indicator system is broad; the constructed indicators are representative; the enthusiasm, authority and harmony of experts are good. Initial indicator system of evaluating the risk of post-marketing drugs has been established. The internal risk indicators included 3 indicators of first grade and 26 indicators of second grade. The external risk indicators included 4 indicators of first grade and 32 indicators of second grade.