Page 29 - 2020年17期

Comparative Study on the Current Situation of Pharmacovigilance in Pharmaceutical Manufacturers of
Different Scales in Jiangsu Province
WANG Jiayu ，LIU Pengcheng ，CHEN Qiaoyun ，LI Ming ，HUANG Qianqian ，CHEN Jinmin ，SUN Jun 1
2
3
1
2
1
1
（1. Jiangsu Province Drug Adverse Reaction Monitoring Center， Nanjing 210002， China； 2. School of
International Pharmaceutical Business，China Pharmaceutical University，Nanjing 211198，China；3. Jiangsu
Drug Administration，Nanjing 210000，China）
ABSTRACT OBJECTIVE： To study the current situation of pharmacovigilance work in large， medium and small-scale
pharmaceutical manufacturers in Jiangsu Province，and to provide reference for the pharmacovigilance development of drug
manufacturers with different scales. METHODS：The situation of pharmacovigilance work in 108 manufacturers in Jiangsu province
was investigated through a questionnaire survey and related websites. The pharmacovigilance work（organization，personnel and
training，document，computer system），drug safety monitoring（case report，regular safety update report，post-marketing safety
research） and drug risk management （signal management， risk management plan， risk control measures， drug safety
communication）of different manufacturers were investigated to put forward the suggestions. RESULTS & CONCLUSIONS：There
was no significant difference in the organizational structure（independently established specialized agencies）among manufacturers
of different scales（P＝0.60）. Most of the manufacturers had less than 50％ of the proportion in the independent establishment of
specialized institutions for pharmacovigilance. There was significant difference in personnel and training（situation and number of
full-time staff in charge，medical and clinical pharmacy personnel number），document（formulating training management system，
entrusted management and key monitoring procedures），computer system （P＜0.05）. There was no difference in the main
collection ways of case reports among manufacturers of different scales；however，the number of independent reports in 2019（P＜
0.01），the proportion of quality control process for regular safety update reports（P＝0.01），and the proportion of carrying out
post-marketing safety research in recent five years（P＜0.01）in large-scale manufacturers were all significantly higher than small-
and medium-scale manufacturers. The proportions of large-scale manufacturers （70.00％ ） and medium-scale manufacturers
（84.38％），which considered“lack of technical guidelines”as an important factor affecting signal management，were higher than
that of small-scale manufacturers（53.57％）（P＝0.01）；the proportions of large-scale manufacturers（60.00％）and medium-scale
manufacturers（50.00％），which had carried out risk management plans in the past five years，were higher than that of small-scale
manufacturers（30.36％）（P＝0.04）；the proportion of large-scale manufacturers（50.00％），which adopted the measures in recent
5 year，was higher than medium-scale manufacturers （37.50％） and small-scale manufacturers （25.00％）；the proportions of
large-scale manufacturers （70.00％ ） and medium-scale manufacturers （59.38％ ）， which carried out communication for
pharmacists，were higher than small-scale manufacturers（32.14％）（P＜0.01）. Large-scale manufacturers outperformed small- and
medium-scale manufacturers in terms of pharmacovigilance system，drug safety monitoring and drug risk management. Large-scale
manufacturers had a certain degree of lack of initiative on performing risk management plans，medium-scale manufacturers on
full-time staffs in charge，and small-scale manufacturers on pharmacovigilance system. So，it is recommended that large-scale
manufacturers take effective control of variety risk as the goal and actively risk management；medium-scale manufacturers should
continuously enhance the awareness of responsibility and improve the investment of resources on pharmacovigilance work；
small-scale manufacturers should pay more attention to improving the pharmacovigilance system and the compliance of specific
work.
KEYWORDS Pharmacovigilance；Holder of drug marketing authorization；Drug manufacturers；Manufacturer scale；Current
situations

近年来，以落实药品生产企业主体责任为目的的政 展药物警戒工作的实际情况，为监管部门制定和实施药
策与举措不断出台 [1-2] ，企业在药品不良反应监测方面的 物警戒制度提供参考显得尤为必要，也利于持有人进一
意识和能力已有大幅提升，但其当前工作仍以“被动监 步完善药物警戒工作、切实承担主体责任。
测”药品不良反应/事件为主，主动监测及风险管理较为 目前，国内相关研究多根据国内外法律法规分析我
薄弱，同时大多数企业尚未建立贯穿药品全生命周期、 国药品生产企业应如何履行药品不良反应监测或药物
[3]
以风险管理为核心的监测体系——药物警戒体系 。新 警戒责任 [4-6] ，也有部分研究通过问卷调查分析企业工作
修订《药品管理法》于2019年12月1日施行后，药品上市 现状 [7-8] ，但比较不同规模企业工作情况的研究较少见。
许可持有人（以下简称“持有人”）制度正式实施，药物警 因此，在药品不良反应监测向药物警戒过渡转变的背景
戒制度也将逐步建立，在此背景下，探讨当前持有人开 下 ，本文拟通过研究药品生产企业药物警戒的工作现
[9]

中国药房 2020年第31卷第17期 China Pharmacy 2020 Vol. 31 No. 17 ·2071 ·