Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA.
Drug Alcohol Depend. 2009 Dec 1;105 Suppl 1:S33-41. doi: 10.1016/j.drugalcdep.2009.05.019. Epub 2009 Jul 18.
Signal detection for pharmaceutical controlled substances presents unique challenges compared to other pharmacovigilance programs because risks are present in the patient and non-patient populations. Defining signals for controlled substances has been difficult because no specific empirical criteria have been established through regulatory actions or guidances. We start with a review of data sources available for decision making to regulators and industry. In this paper we present a framework for processing signals received during post-marketing surveillance: signal identification, verification and assessment, followed by intervention and evaluation. Signal identification involves processing qualitative and quantitative information in order to generate hypotheses describing concerns with controlled substances. Integration of heterogeneous data sources makes this process difficult and we describe multiple approaches utilized in practice today. Signal verification currently relies heavily on telephone interviews with stakeholders in local communities. Once information on a potential signal has been gathered signal assessment is a higher order process conducted with an eye towards broader societal expectations and the ability to intervene or further study the problem. Intervention and evaluation complete the cycle of signal assessment and triage. This paper is intended as a primer of the current practice of signal assessment in the post-marketing surveillance for controlled substances.
与其他药物警戒计划相比，药物管制物质的信号检测提出了独特的挑战，因为患者和非患者人群都存在风险。由于没有通过监管行动或指南确立特定的经验标准，因此管制物质的信号定义一直存在困难。我们首先回顾了决策者和行业可用的决策数据来源。在本文中，我们提出了一个在上市后监测期间处理接收到的信号的框架：信号识别、验证和评估，然后是干预和评估。信号识别涉及处理定性和定量信息，以便生成描述对管制物质关注的假设。异构数据源的集成使这一过程变得困难，我们描述了当今实践中使用的多种方法。目前，信号验证主要依赖于与当地社区利益相关者的电话访谈。一旦收集到关于潜在信号的信息，信号评估就是一个更高层次的过程，着眼于更广泛的社会期望和干预或进一步研究问题的能力。干预和评估完成了信号评估和分类的循环。本文旨在介绍管制物质上市后监测中信号评估的当前实践。
