Establishment of pharmacovigilance system for heamocogulase agents triggered by venous thrombosis events due to the off?label drug use
Department of Pharmacy, Chengdu Women′s and Children′s Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu 611731, China
Abstract：Chengdu Women and Children′s Central Hospital started the construction of a pharmacovigilance system in 2017. In August of that year, 3 venous thrombosis events related to off-label use of heamocogulase agents occurred consecutively within 1 month, which aroused the vigilance of the hospital pharmacovigilance department. And these events were designated as the risk signals of pharmacovigilance. Then the application of heamocogulase agents in the whole hospital was investigated. Intervention measures including formulation of clinical application standard of heamocogulase agents, strengthening of the prescription and medical order management, and strengthening the training of medical staff on the rational use of heamocogulase agents were formulated in connection with the medication risk links, and the pharmacovigilance system of heamocogulase agents was established. From December 2017 to February 2018 after the implementation of the intervention, the consumption of heamocogulase agents decreased by 90.8% (from 6-767 to 624) and the incidences of unreasonable medication indication, irrational course of treatment, and unjustified daily dose decreased significantly, compared with those from June to August 2017 before the intervention. As of the end of 2019, no more heamocogulase agents-related venous thrombotic events have occurred.
江永贤，陈文文，杨佳，陶婉君，李根. 超说明书用药致静脉血栓事件触发的蛇毒血凝酶类药物警戒制度建立[J]. 药物不良反应杂志, 2021, 23(2): 91-94.
Jiang Yongxian, Chen Wenwen, Yang Jia, Tao Wanjun, Li Gen. Establishment of pharmacovigilance system for heamocogulase agents triggered by venous thrombosis events due to the off?label drug use. Adverse Drug Reactions Journal, 2021, 23(2): 91-94.
