Study on the ADR Reporting Entities in Henan Province and Hebei Province
10.6039/j.issn.1001-0408.2015.24.02
- VernacularTitle:河南省和河北省药品不良反应报告单位调查研究
- Author:
Xuemei ZHANG
;
Jiadong GUO
;
Bianling FENG
;
Shimin YANG
;
Xunxia XIAO
- Publication Type:Journal Article
- Keywords:
Henan province;
Hebei province;
ADR;
Report entity;
Investigation
- From:
China Pharmacy
2015;(24):3316-3318
- CountryChina
- Language:Chinese
-
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.
