Drug safety evidence ecosystem: from detecting adverse drug reaction signals to optimizing risk management
10.3760/cma.j.cn114015-20240806-00699
- VernacularTitle:药物安全性证据生态体系：从发现药物不良反应信号到优化风险管理
- Author:
Na HE
1
;
Ziyang WU
1
;
Suodi ZHAI
1
Author Information
1. 北京大学第三医院药学部，北京大学医学部药物评价中心，北京 100191
- Publication Type:Journal Article
- Keywords:
Drug safety;
Pharmacovigilance;
Evidence ecosystem;
Evidence-based practice
- From:
Adverse Drug Reactions Journal
2024;26(10):584-587
- CountryChina
- Language:Chinese
-
Abstract:
Pre-marketing clinical trials may fail to detect rare or delayed adverse drug reactions (ADRs) due to insufficient sample size and short follow-up periods. Therefore, continuous post-marketing safety evaluation is necessary. Evidence generation relies on discovering ADR signals and conducting studies to verify specific risks. Integrating evidence from multiple sources through methods like meta-analysis can further enhance the comprehensiveness and reliability of drug safety evaluations. Additionally, risk management in clinical practice should be emphasized by developing standardized clinical guidelines and establishing decision support systems to facilitate the dissemination and application of evidence, ensuring its practical use. Constructing an evidence ecosystem not only helps identify and understand potential medication safety issues, but also enhance the scientific and practical aspects of risk management, ultimately reducing patient harm from ADRs.
