Quality Assurance and Safety: Medicines, Essential Medicines and Health Products, WHO, 20 Avenue Appia 1211, Geneva 27, Switzerland.
Drug Saf. 2013 Feb;36(2):75-81. doi: 10.1007/s40264-012-0014-6.
Globally, national pharmacovigilance systems rely on spontaneous reporting in which suspected adverse drug reactions (ADRs) are reported to a national coordinating centre by health professionals, manufacturers or patients. Spontaneous reporting systems are the easiest to establish and the cheapest to run but suffer from poor-quality reports and underreporting. It is difficult to estimate rates and frequencies of ADRs through spontaneous reporting. Public health programmes need to quantify and characterize risks to individuals and communities from their medicines, to minimize harm and improve use, to sustain public confidence in the programmes, and to track problems due to medication errors and poor quality medicines. Additional methods are therefore needed to monitor the quantitative aspects of medicine safety, to better identify specific risk factors and high-risk groups, and to characterize ADRs associated with specific medicines and in specific populations. The present paper introduces two methods, cohort event monitoring and targeted spontaneous reporting, that are being implemented by the WHO, in its public health programmes, to complement spontaneous reporting. The advantages and disadvantages of these methods and how each can be applied in clinical practice are discussed.
在全球范围内，国家药物警戒系统依赖于自发报告，即由卫生专业人员、制造商或患者向国家协调中心报告疑似药物不良反应（ADR）。自发报告系统最容易建立，运行成本最低，但报告质量差且报告不足。通过自发报告很难估计 ADR 的发生率和频率。公共卫生计划需要量化和描述个人和社区从其药物中面临的风险，以最大程度地减少伤害和改善使用，维持公众对这些计划的信心，并跟踪因用药错误和劣质药物引起的问题。因此，需要额外的方法来监测药物安全性的定量方面，以更好地确定特定的风险因素和高风险群体，并描述与特定药物和特定人群相关的 ADR。本文介绍了世卫组织在其公共卫生计划中实施的两种方法，即队列事件监测和目标性自发报告，以补充自发报告。讨论了这些方法的优缺点，以及每种方法如何在临床实践中应用。
