药品上市后临床安全性再评价医院集中监测方案的实施要点

Key Points of Enforcing Hospital-based Monitoring Scheme for Clinical Safety Reevaluation after Marketing

医院集中监测是指在一定的时间(数月或数年)、一定的范围内对某一医院或某一地区内所发生的不良事件/反应及药物利用作详细记录,以探讨不良事件/反应的发生规律。目前我国仍处于不良反应监测的初期阶段,集中监测的技术仍不成熟。结合河南中医药大学药学部主持参与的多项中药注射液上市后临床安全性再评价医院集中监测研究,总结医院集中监测方案的实施要点,以供参鉴。

Hospital-based monitoring are conducted to identify adverse events/adverse drug reac- tions （AEs/ADRsl） within a particular hospital or a region during a certain period of time （several months or years）, or to some extent as well as drug use, thus observing the occurrence laws of AEs/ADRs. Cur- rently, hospital-based ADR monitoring in China, as a newly developed research field, is just in start-up stage. Hospital-based ADR monitoring technologies are not mature. Key points of enforcing a number of hospital-based monitoring schemes were summarized by combining clinical safety reevaluation on patent Chinese herbal injections after marketing hosted and participated at Pharmacy Department, Henan Uni- versity of Traditional Chinese Medicine.