Welch Samuel A, Olsen Kristine, Nouri Sharikabad Mohammad, Tollefsen Knut Erik, Grung Merete, Moe S Jannicke
Norwegian Institute for Water Research, Oslo, NO-0579, Norway.
Norwegian Institute of Public Health, Oslo, NO-0213, Norway.
Open Res Eur. 2022 Sep 15;2:71. doi: 10.12688/openreseurope.14129.2. eCollection 2022.
The regulation and monitoring of pharmaceutical pollution in Europe lag behind that of more prominent groups. However, the repurposing of sales data to predict surface water environmental concentrations is a promising supplement to more commonly used market-based risk assessment and measurement approaches. The Norwegian Institute of Public Health (NIPH) has since the 1980s compiled the Drug Wholesale Statistics database - covering all sales of both human and veterinary pharmaceuticals to retailers, pharmacies, and healthcare providers. To date, most similar works have focused either on a small subset of Active Pharmaceutical Ingredients (APIs) or used only prescription data, often more readily available than wholesale data, but necessarily more limited. By using the NIPH's product wholesale records, with additional information on API concentrations per product from, we have been able to calculate sales weights per year for almost 900 human and veterinary APIs for the period 2016-2019. In this paper, we present our methodology for converting the provided NIPH data from a public health to an ecotoxicological resource. From our derived dataset, we have used an equation to calculate Predicted Environmental Concentration per API for inland surface waters, a key component of environmental risk assessment. We further describe our filtering to remove ecotoxicological-exempt and data deficient APIs. Lastly, we provide a limited comparison between our dataset and similar publicly available datasets for a subset of APIs, as a validation of our approach and a demonstration of the added value of wholesale data. This dataset will provide the best coverage yet of pharmaceutical sales weights for an entire nation. Moreover, our developed routines for processing 2016-2019 data can be expanded to older Norwegian wholesales data (1974-present). Consequently, our work with this dataset can contribute to narrowing the gap between desk-based predictions of exposure from consumption, and empirical but expensive environmental measurement.
欧洲对药品污染的监管和监测落后于其他更突出的领域。然而，利用销售数据重新预测地表水环境浓度，是对更常用的基于市场的风险评估和测量方法的一种有前景的补充。自20世纪80年代以来，挪威公共卫生研究所（NIPH）汇编了药品批发统计数据库，涵盖了向零售商、药店和医疗服务提供者销售的所有人类和兽用药品。迄今为止，大多数类似的研究要么只关注活性药物成分（API）的一小部分，要么只使用处方数据，处方数据通常比批发数据更容易获取，但必然更有限。通过使用NIPH的产品批发记录，并结合每个产品的API浓度的额外信息，我们能够计算出2016 - 2019年期间近900种人类和兽用API的年度销售权重。在本文中，我们展示了将提供的NIPH数据从公共卫生资源转化为生态毒理学资源的方法。从我们导出的数据集中，我们使用一个方程来计算内陆地表水每种API的预测环境浓度，这是环境风险评估的一个关键组成部分。我们进一步描述了我们的筛选过程，以去除生态毒理学豁免和数据不足的API。最后，我们对我们的数据集中的一部分API与类似的公开可用数据集进行了有限的比较，以验证我们的方法，并展示批发数据的附加价值。这个数据集将提供一个国家药品销售权重的最佳覆盖范围。此外，我们处理2016 - 2019年数据所开发的程序可以扩展到挪威更早的批发数据（1974年至今）。因此，我们对这个数据集的研究有助于缩小基于桌面的消费暴露预测与经验性但昂贵的环境测量之间的差距。
