摘要
目的为提高公众上报不良反应(ADR)的积极性、促进药品生产企业提高公众ADR上报渠道的畅通性及承担药品安全主体责任的主动性提供建议,并为我国监管部门开展药品安全监管工作提供参考。方法编写调查问卷,以我国进入全球前1000位的180家药品生产企业为对象,选取企业联系电话、邮箱、官网和新媒体(包括微信和微博)4个渠道进行ADR上报渠道畅通性调查,内容包括公众上报渠道的建立情况、企业记录和反馈情况等,对调查发现的问题进行分析并提出建议。结果与结论我国超过70%的药品生产企业已建立公众ADR上报渠道,以联系电话和邮箱常规渠道为主,且每个渠道都存在ADR信息无法上报的现象;超过60%的企业建立的公众渠道缺少对上报信息遗漏部分的询问补充;仅收到24家企业对ADR信息的反馈,且反馈内容单一。建议药品生产企业加强对公众ADR监测的重视,在保障渠道畅通性的同时考虑增加多种上报渠道,加强对员工信息收集能力的培训以提高信息的质量,对公众上报的ADR信息及时进行反馈,增加公众较为关注的反馈内容。
OBJECTIVE To provide the suggestions for improving the 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 top1 000 in the world as the objects,the questionnaire was prepared to investigate the smoothness of ADR reporting channels through4 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 missing part of the reported information;only 24 pharmaceutical manufacturers provided feedback on ADR information,and the feedback contents were monotonous.It 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.
作者
林枭
伍红艳
王龙
黄艳
郝兴敏
李星辰
余江霞
田柳丹
荣艺
LIN Xiao;WU Hongyan;WANG Long;HUANG Yan;HAO Xingmin;LI Xingchen;YU Jiangxia;TIAN Liudan;RONG Yi(School of Medical and Health Management,Guizhou Medical University,Guiyang 550025,China;Guizhou Institute of Health Development,Guizhou Medical University,Guiyang 550025,China;Key Laboratory of Environmental Pollution and Disease Control of Ministry of Education,Guizhou Medical University,Guiyang 550025,China;Dept.of Pathology,Guiqian International General Hospital,Guiyang 550024,China;School of Public Health,Guizhou Medical University,Guiyang 550025,China)
出处
《中国药房》
CAS
北大核心
2022年第6期653-660,共8页
China Pharmacy
基金
贵州医科大学贵州省卫生发展研究院调研课题(No.gywf2021-11)。
关键词
公众报告
药物不良反应上报
药品生产企业
上报渠道
畅通性
public reports
reports of adverse drug reaction
pharmaceutical manufacturer
reporting channal
smoothness
