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Substandard and falsified medicines: proposed methods for case finding and sentinel surveillance

机译：不合标准和伪造的药物：案例发现和哨兵监测的方法

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The World Health Organization and others warn that substandard and falsified medicines harm health and waste money, especially in low- and middle-income countries. However, no country has measured the market-wide extent of the problem, and no standardized methods exist to estimate the prevalence of either substandard or falsified medicines. This is, in part, because the task seems overwhelming; medicine markets are huge and diverse, and testing medicines is expensive. Many countries do operate some form of postmarket surveillance of medicine, but their methods and goals differ. There is currently no clear guidance on which surveillance method is most appropriate to meet specific public health goals. In this viewpoint, we aimed to discuss the utility of both case finding and risk-based sentinel surveillance for substandard and falsified medicines, linking each to specific public health goals. We posit that choosing the system most appropriate to the goal, as well as implementing it with a clear understanding of the factors driving the production and sale of substandard and falsified medicines, will allow for surveillance resources to be concentrated most efficiently. We adapted principles used for disease outbreak responses to suggest a case-finding system that uses secondary data to flag poor-quality medicines, proposing risk-based indicators that differ for substandard and falsified medicines. This system potentially offers a cost-effective way of identifying “cases” for market withdrawal, enhanced oversight, or another immediate response. We further proposed a risk-based sentinel surveillance system that concentrates resources on measuring the prevalence of substandard and falsified medicines in the risk clusters where they are most likely to be found. The sentinel surveillance system provides base data for a transparent, spreadsheet-based model for estimating the national prevalence of substandard and falsified medicines. The methods we proposed are based on ongoing work in Indonesia, a large and diverse middle-income country currently aiming to achieve universal health coverage. Both the case finding and the sentinel surveillance system are designed to be adaptable to other resource-constrained settings.
机译：世界卫生组织和其他人警告说，不合格和伪造的药品危害健康和废金，特别是在低收入和中等收入国家。但是，没有国家在全球范围内衡量问题的范围，并且没有存在标准化方法来估计不合标准或伪造的药物的患病率。部分是，部分原因是任务似乎压倒了;医药市场是巨大的多样化，测试药物价格昂贵。许多国家确实经营着某种形式的邮费市场监测，但它们的方法和目标差异。目前没有明确的指导，监测方法最适合满足特定的公共卫生目标。在这方面，我们旨在讨论案例寻找和基于风险的哨兵监测的效用，以应对和伪造的药物，各到特定的公共卫生目标联系起来。我们选择最适合目标的系统，并通过清楚地了解推动促进生产和销售不合标准和伪造的药物的因素，将允许监控资源最有效地集中。我们适用于疾病爆发反应的原理，建议一个案例发现系统，该系统使用次要数据来标记质量劣质药物，提出基于风险的指标，这些指标因不合标准和伪造的药物而异。该系统可能提供一种成本效益的方式，可以为市场提取，增强监督或另一种立即响应来识别“案例”。我们进一步提出了一种基于风险的Sentinel监测系统，专注于测量最有可能被发现的风险集群中不合格和伪造的药物的资源。 Sentinel监控系统为透明，电子表格的基础数据提供了基于透明的电子表格，以估计不合标准和伪造的药物的国家流行。我们提出的方法是基于印度尼西亚的持续工作，目前旨在实现普遍健康覆盖的大型和多元化的中等收入国家。案例查找和Sentinel监控系统均旨在适应其他资源约束的设置。

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