Department of Infectious Disease Epidemiology, Imperial College London School of Public Health, London, UK
Department of Infectious Disease Epidemiology, Imperial College London School of Public Health, London, UK.
BMJ Glob Health. 2024 Sep 23;9(9):e015402. doi: 10.1136/bmjgh-2024-015402.
Substandard and falsified medicines (SFMs) are a public health concern of global importance. Postmarket surveillance in the form of medicine sampling and quality testing can prevent and detect SFM, however, there is remarkably scarce evidence about the cost and value for money of these activities: how much do they cost and how effective are they in detecting SFM?
Between February and October 2022, Systematic Tracking of At Risk Medicines (STARmeds) collected and analysed for quality 1274 samples of 5 medicines from physical and online retail outlets in 7 Indonesian districts. We collated data on the resources consumed by STARmeds, related to all stages of medicines sampling and quality testing including design, fieldwork and laboratory analysis. We used activity-based costing principles to calculate the financial and economic cost of medicine quality surveillance from the perspective of a hypothetical medicines' regulator. We calculated the cost per day and per week of fieldwork, per sample collected and per substandard sample. We used bootstrapping to capture uncertainty in the number of samples collected, by seller location type (urban, rural and online).
The total cost of sampling and testing medicines from the market was US$712 964 (current 2022 values). Laboratory costs represented the largest share (70%), followed by other direct costs (12%) and indirect costs (7%). On average, it costs STARmeds US$479 (95% CI US$462 to US$516) to collect one medicine sample and US$5990 (95% CI US$5601 to US$6258) to identify one substandard sample.
Our findings bring urgently needed and novel information on the cost and value for money of medicine quality surveillance. These may support planning and budgeting of the Indonesian pharmaceutical regulator, but also of regulators and researchers elsewhere, particularly in low-income and middle-income settings, as well as international organisations with health regulation and quality of care remits.
劣药和假药（SFMs）是一个具有全球重要意义的公共卫生关注点。以药品抽样和质量检测为形式的上市后监测可以预防和发现劣药和假药，但关于这些活动的成本和性价比的证据非常稀缺：它们的成本是多少，在发现劣药和假药方面的效果如何？
在 2022 年 2 月至 10 月期间，系统性跟踪风险药品（STARmeds）从印度尼西亚 7 个地区的实体店和线上零售店收集并分析了 5 种药品的 1274 个样本。我们整理了与药品抽样和质量检测的所有阶段相关的 STARmeds 所消耗的资源数据，包括设计、实地工作和实验室分析。我们采用基于活动的成本核算原则，从假设的药品监管机构的角度计算药品质量监测的财务和经济成本。我们计算了实地工作、每批采集样本、每批劣药样本的日成本和周成本。我们使用自举法来捕捉按卖家地点类型（城市、农村和线上）收集样本数量的不确定性。
从市场上抽样和检测药品的总成本为 712964 美元（2022 年现行价值）。实验室成本占比最大（70%），其次是其他直接成本（12%）和间接成本（7%）。STARmeds 平均每采集一个药品样本的成本为 479 美元（95%CI 462 美元至 496 美元），每鉴定一个劣药样本的成本为 5990 美元（95%CI 5601 美元至 6258 美元）。
我们的研究结果提供了关于药品质量监测成本和性价比的急需和新颖信息。这些信息可能为印度尼西亚药品监管机构的规划和预算提供支持，也可能为其他地区、特别是低收入和中等收入国家的监管机构和研究人员以及具有卫生监管和医疗质量授权的国际组织提供支持。
