ABSTRACT Objective: To establish guidance for drug intensive monitoring by pharmaceutical enterprises in Beijing. Methods:Expert panel were set up as a heterogeneous group of experts before. Eighteen items of structured questionnaires were designed involving necessity and feasibility in each items. After questionnaires were completed in 3 rounds, we collected the experts’ opinions and determined directions to revise 18 items. Parameters including experts’ positive coefficient, authority coefficient, and coordination degree towards experts’ opinion were calculated using SPSS 17.0. Results:Eleven experts were selected and experts’ authority coefficient was 0.80±0.13. In the first and third round, experts’ positive coefficient were over 90%, and the range of coordination coefficient was 0.230-0.383. Group consensus was reached after the third round (P<0.05). The elements as follows should be involved in the guidance: scope and process of the intensive monitoring, recommendation of evidence based safety evaluation before intensive monitoring, principles when establishing science committee and implementation group, quality control, ethics, methodology, sample size, and form of records. Conclusion:With well authority and high rate of response in experts, this study defined key contents of guidance for drug intensive monitoring by pharmaceutical enterprises through modified Delphi method. |