Investigation and suggestions on the smoothness of reporting channels for adverse drug reaction of pharmaceutical manufacturers in China based on the public perspective
- VernacularTitle:基于公众视角的我国药品生产企业不良反应上报渠道畅通性现状调查及建议
- Author:
Xiao LIN
1
;
Hongyan WU
1
,
2
,
3
;
Long WANG
4
;
Yan HUANG
5
;
Xingmin HAO
1
;
Xingchen LI
1
;
Jiangxia YU
1
;
Liudan TIAN
5
;
Yi RONG
5
Author Information
1. School of Medical and Health Management，Guizhou Medical University，Guiyang 550025，China
2. Guizhou Institute of Health Development，Guizhou Medical University，Guiyang 550025，China
3. Key Laboratory of Environmental Pollution and Disease Control of Ministry of Education，Guizhou Medical University，Guiyang 550025，China
4. Dept. of Pathology，Guiqian International General Hospital，Guiyang 550024，China
5. School of Public Health，Guizhou Medical University，Guiyang 550025，China
- Publication Type:Journal Article
- Keywords:
public reports;
reports of adverse drug reaction;
pharmaceutical manufacturer;
reporting channal;
smoothness
- From:
China Pharmacy
2022;33(6):653-660
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide the suggestions for improving t he enthusiasm of the public to report adverse drug reactions （ADRs），promoting pharmaceutical manufacturers to improve the smoothness of ADR reporting channels by the public and the enthusiasm of assuming the main responsibility for drug safety ，and to provide reference for the performance of drug safety supervision by regulatory departments in China. METHODS Taking 180 pharmaceutical manufacturers that had entered the top 1 000 in the world as the objects ，the questionnaire was prepared to investigate the smoothness of ADR reporting channels through 4 channels：contact number ，e-mail，official website and new media （including Wechat and microblog ） of enterprise . The questionnaire involved the establishment of public reporting channels ，the records and the feedback of enterprises. The existing problems were analyzed and suggestions were put forward. RESULTS & CONCLUSIONS More than 70％ of pharmaceutical manufacturers in China had established the channels for reporting ADR by the public ，which were mainly regular channels such as contact numbers and e-mail ，and each channel had the phenomenon that ADR information couldn ’t be reported. More than 60％ of the public channels established by manufactures lacked inquiry and supplement for the miss ing part of th e reported information ； only 24 pharmaceutical manufacturers provided feedback on ADR information ，and the feedback contents were monotonous. gywf2021-11It is suggested that pharmaceutical manufacturers should pay more attention to ADR monitoring among the public ，consider increasing multiple reporting channels while ensuring the smoothness of channels ，strengthen the training of employee ’s information collection ability to improve the quality of information ，timely feed back the ADR information reported by the public ， and increase the feedback content concerned by the public.
