Study on the Adverse Drug Reaction Reporting Entities in Jiangsu Province and Guangdong Province / 中国药房

ABSTRACT

OBJECTIVE:To investigate the present situation of adverse drug reaction(ADR)reporting entities in Jiangsu prov-ince and Guangdong province,and provide reference for the improvement of ADR monitoring. METHODS:With the overview of ADR monitoring at home and abroad by reading literatures,the ADR reporting entities(drug manufacturers,drug distributors and medical institutions) in Jiangsu province and Guangdong province were selected as objects for cluster sampling by questionnaires, and descriptive statistical analysis and other methods were adopted to process and analyze the results. RESULTS:There were totally 205 effective questionnaires. In Jiangsu province and Guangdong province,67 and 60 of the surveyed ADR reporting entities had specialized ADR monitoring departments,98.1% and 99.0% had equipped with specialized personnel for ADR work;ADR moni-toring mostly belonged to quality management department in drug manufacturers and distributors,and pharmacy department in medi-cal institutions;most entities were equipped with computers,printers,copiers and other basic office equipments;but most entities’ responsibilities were not clear enough;27 and 15 entities had specialized budget for ADR monitoring;97.2% and 96.9% had com-munication with ADR ,monitoring center,but the feedback information was unsatisfactory;85.0% and 86.7% had related training for personnel;establishing standard operating procedures of the system construction was relatively good,the other related system construction was still not ideal;91.6% and 90.8% would report ADR immediately after discovery,92.5% and 97.9% would back-up recording the ADR,mainly by internet reporting;the average scores in terms of job satisfaction in Jiangsu province were higher than Guangdong province. CONCLUSIONS:According to the results,it is suggested to improve the system construction of ADR monitoring,optimize working conditions,ensure financial support of ADR monitoring,and strengthen work communication and system construction and other measures to promote conduct of ADR monitoring.