ABSTRACT
OBJECTIVE:To establish drug safety performance indicator system in Beijing,and to provide reference for evaluat-ing work quality of administration department and drug market safety reasonably. METHODS:Through literature survey,expert brainstorming and maximum difference scaling,the indicators of drug safety performance evaluation system in Beijing were select-ed,and internet questionnaire survey was conducted among 20 regulators by using SSI Web software. The weight of each indicator was analyzed. RESULTS & CONCLUSIONS:4 factors of drug safety performance have been selected involving 27 indicators,ig. Results of drug sampling test(Oc)which reflect drug market safety directly;results of special drug sampling test(So)which mea-sure the quality of essential medicine;drug sampling operation standard (Na) which measure the completion of drug sampling by procedure or plan;rationality of drug sampling (Ra) which guarantee the rationality of sampling procedure and representativeness of sampled drugs. Finally,20 indicators are identified by experts. The weight of 4 factors are 21%,14%,40% and 25%,respec-tively. Established drug safety performance evaluation system can achieve quantitative check of drug supervision departments,and dispose several problems as rely on subjective factor greatly,lack of objective and uniform standard,only check the results. It pro-vides reference for the formulation of drug safety performance evaluation indicators in other provinces,cities and municipalities.
ABSTRACT
OBJECTIVE:To provide reference for the management of re-use of single-use devices (SUDs) in China. METH-ODS:The management situation of SUDs use in China and the management policy of SUDs re-use in America and Germany were introduced,the published literature of SUDs re-use was researched and the safety and ethicality were analyzed and discussed. RE-SULTS:China had no regulation for the clear definition of the range,standards and requirements of SUDs re-use;America and Germany had well-management for the SUDs re-use with different modes. Literature analysis showed that there were 3 results for the SUDs re-use,including supporting,opposition and classified management. In terms of safety,SUDs re-use needs the base of specific species and disinfection operations;in terms of ethicality,SUDs re-use should focus on the right to know of patients and the effects on cost savings and environment. CONCLUSIONS:China should establish and improve the management policy of SUDs re-use,develop the classification assessment of re-use,encourage third-party organizations participating in the recycling of SUDs and strengthen the monitoring of adverse reactions,etc.