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.
ABSTRACT
OBJECTIVE:To investigate the situation of ADR reporting entities in Henan province and Hebei province to pro-vide reference for the improvement of ADR monitoring. METHODS:Literatures were consulted to investigate the ADR monitoring at home and abroad. With the subject of ADR reporting entities(pharmaceutical manufacturers,drug distributors and medical insti-tutions)in Henan and Hebei province,questionnaires and descriptive statistical analysis were conducted to analyze the results. RE-SULTS:186 valid questionnaires were received. There were respectively 58 and 62 ADR reporting entities with ADR monitoring de-partment in Henan and Hebei province,all of them had personnel who were responsible for ADR;ADR monitoring mostly belonged to quality control department in pharmaceutical manufacturers and drug distributors,and pharmacy department in medical institu-tions;most were equipped with computer,printer,phone and other basic office equipments;most were not clearly for major duty;there were respectively 24 and 2 entities with special budget for ADR monitoring;95.7% and 96.8% had communication with the local ADR monitoring centers,however,the information feedback was not ideal;86.7%and 98.9%had training for the stuff;stan-dard operation procedure was relatively good in Hebei province;96.7% and 98.9% would report ADR immediately after finding ADR,92.3% and 97.8% would record and backup the reported ADR;the form mainly by network report;the average degree of satisfaction evaluation in Henan province was higher than Hebei. CONCLUSIONS:According to the results,it is suggested to pro-mote the implementation of ADR monitoring by optimizing the work conditions,ensuring work fund and strengthening work feed-back.