Investigation and Analysis on the Status quo of Post-marketing Risk Monitoring System of TCM Formula Granules

Abstract

Abstract: Objective To understand the status quo of post-marketing risk monitoring system of TCM formula granules and guide enterprises to build a perfect safety monitoring system, so as to provide references for enterprises to carry out follow-up safety and effectiveness evaluations and provide basis for supervision of TCM formula granules. Methods The data were collected mainly by electronic questionnaires and supplemented by interviews, a total of 37 questions were set in the questionnaire for enterprises producing TCM formula granules, and 6 enterprises were investigated; Questionnaires for medical institutions were distributed online with 45 questions in total and 161 ones were collected. Results All six enterprises have established the organizational structure and basic system for adverse reaction monitoring. Two enterprises considered that clinical studies needed to be carried out to evaluate the safety of varieties, two tended to carry out centralized post-marketing safety monitoring, and three tended to carry out randomized controlled clinical trials. The questionnaires collected from doctors showed that doctors are currently informed of adverse reactions mainly through patients' active feedback (73.56%). For the adverse reaction monitoring methods carried out in the future, 83.90% of clinicians considered that clinical studies needed to be carried out to evaluate the safety of varieties, 56.90% of clinicians tended to carry out centralized post-marketing safety monitoring, and 51.72% of clinicians tended to carry out randomized controlled clinical trials. Conclusions Enterprises did not pay enough attention to the safety monitoring of TCM formula granules. It is suggested that enterprises should summarize and analyze the safety data of previous clinical studies, implement the systems of main responsibility and direct reporting of adverse drug reactions at the same time, and actively monitor, analyze and evaluate the adverse drug reactions.

Key words: TCM formula granules, post-marketing, risk monitoring system

CLC Number:

R932

LIU Zhen, YU Jinyang, ZHOU Jie. Investigation and Analysis on the Status quo of Post-marketing Risk Monitoring System of TCM Formula Granules[J]. Chinese Journal of Pharmacovigilance, 2019, 16(8): 473-477.

References

[1] 胡群,王慧玉,张晓芹.基于文献对中药配方颗粒应用现状与发展趋势的研究[J].中医药管理杂志,2019,27(2):1-3.
[2] 袁武军, 殷网虎, 谢新方. 中药配方颗粒应用情况浅析[J]. 内蒙古中医药, 2013, 32(20):50-51.
[3] 楼益平,章小飞,王祝英,等.右归饮加减方配方颗粒与饮片汤剂治疗老年肾阳虚证疗效比较[J].浙江中医杂志,2018,53(11):806.
[4] 李建雄. 养阴清热解毒中药配方颗粒治疗慢性乙型肝炎临床观察[J].实用中医药杂志,2018,34(9):1042-1043.
[5] 姚廷周. 中药配方颗粒健脾理气合剂治疗慢性非萎缩性胃炎351例[J].中医药临床杂志,2018,30(5):947-949.
[6] 吴用彦,李青蔚,李红亮.中药配方颗粒的研究现状及存在问题的思考[J].中南药学,2019,17(1):78-83.
[7] 张泰. 临床中药学视角下单味配方颗粒存在问题及对策[J].山东中医药大学学报,2018,42(6):549-551,564.
[8] 梅安存,孙静,严学玲,等.4例中药配方颗粒不良反应报告及分析[J].山西中医学院学报,2017,18(6):70-71.
[9] 李莉,丁柳美,方忠宏.中药配方颗粒致急性胃黏膜病变一例[J].中国医院用药评价与分析,2018,18(11):1583-1584.
[10] 张敏丽. 中药配方颗粒剂与饮片煎剂治疗风咳的临床疗效比较[J].中国高等医学教育,2018(10):144-145.
[11] 李细山. 良附丸中药配方颗粒与饮片汤剂治疗胃脘痛的有效性和安全性[J].临床合理用药杂志,2018,11(5):44-45.
[12] 冯红云, 吴桂芝, 范燕, 等. 药品生产企业在我国的上市后药品风险监测和控制现状分析[J].中国药物警戒, 2018,15(1):16-19.
[13] 田克仁, 高菁, 缪健, 等. 我省药品生产企业药品不良反应监测和工作体系分析[J].中国药物警戒, 2014, 11(5):285-287.
[14] 李嘉伟, 刘佐仁, 曾颖珊, 等. 广东省药品生产企业不良反应监测现状调查分析[J]. 中国药事, 2015, 29(5):552-558.
[15] 林志健, 张晓朦, 张冰, 等. 印度传统医学药物警戒体系概况与实践[J]. 实用药物与临床, 2018,21(3):354-358.