Vida Róbert György, Merczel Sára, Jáhn Eszter, Fittler András
University of Pécs, Faculty of Pharmacy, Department of Pharmaceutics and Central Clinical Pharmacy, Honvéd Street 3, 7624 Pécs, Hungary.
Department of Pharmacy, Somogy County Kaposi Mór Teaching Hospital, Tallián Gyula Street 20-32, 7400 Kaposvár, Hungary.
Saudi Pharm J. 2020 Dec;28(12):1733-1742. doi: 10.1016/j.jsps.2020.10.018. Epub 2020 Nov 6.
Today, the increasing number of illicit internet pharmacies is a global phenomenon, however, the size of the online pharmaceutical market is still relatively unknown and the dubious quality of products is questionable and warrants investigation. Descriptive data from this black market channel are derived from studies analyzing the online availability of different medications procured over the internet and their methodology is quite heterogeneous. Our aim was to develop a comprehensive and specific risk assessment for selecting high patient safety risk medications from the online pharmaceutical market. A rapid tool was developed based upon the two quality and safety standard resolutions in pharmaceutical practice, published by the European Directorate for the Quality of Medicines, and was illustrated on eye drops. We developed five dimensions in support of the risk assessment including intrinsic, extrinsic and potential risks of counterfeiting. The five criteria were integrated in a comprehensively weighted risk-scoring format. The probability of procuring the product from the internet was also assessed based on the number of relevant links within the first twenty search engine results and the cost of the products. With the application of the tool a dorzolamide & timolol combination eye drop represented the highest overall patient safety risk score. In consideration of our literature review of the past 20 years, there is no current, standardized methodology to effectively identify pharmaceutical products associated with high patient safety risks. Notably, the fully comprehensive analysis of the internet pharmaceutical market and the test purchase of all online available medicines is unrealistic. Therefore, we developed a method to aid online surveillance researches and targeted international organizational led joint actions against the uncontrolled sale of falsified and substandard medications (e.g.: Operation Pangea).
如今，非法网上药店数量不断增加已成为一种全球现象，然而，在线药品市场的规模仍相对不明，产品质量存疑，值得调查。这个黑市渠道的描述性数据来自对通过互联网采购的不同药物的在线可得性进行分析的研究，其方法相当不一致。我们的目的是制定一项全面且具体的风险评估，以从在线药品市场中筛选出对患者安全风险高的药物。基于欧洲药品质量理事会发布的两项药品实践质量与安全标准决议，开发了一种快速工具，并以眼药水为例进行说明。我们制定了五个维度以支持风险评估，包括假药的内在、外在和潜在风险。这五个标准被整合到一个综合加权风险评分形式中。还根据前二十个搜索引擎结果中的相关链接数量以及产品成本评估了从互联网上采购该产品的可能性。通过应用该工具，多佐胺与噻吗洛尔复方眼药水的总体患者安全风险评分最高。考虑到我们对过去20年的文献综述，目前尚无有效的标准化方法来识别与高患者安全风险相关的药品。值得注意的是，对互联网药品市场进行全面分析以及对所有在线可得药品进行测试采购是不现实的。因此，我们开发了一种方法来协助在线监测研究，并针对国际组织牵头的联合行动，打击假药和不合格药品的无节制销售（例如：“盘古行动”）。
