Rasheed Huma, Höllein Ludwig, Holzgrabe Ulrike
Institute of Pharmacy and Food Chemistry, University of Wuerzburg, Wuerzburg, Germany.
Institute of Pharmaceutical Sciences, University of Veterinary and Animal Sciences, Lahore, Pakistan.
Front Pharmacol. 2018 Aug 31;9:995. doi: 10.3389/fphar.2018.00995. eCollection 2018.
Substandard and falsified (SF) medicines have emerged as a global public health issue within the last two decades especially in low- and middle-income countries (LMICs). Serious consequences of this problem include a loss of trust and increased financial costs due to less disease control and more frequent complications during therapy. Of note, antimicrobial resistance is an additional long-term implication of poor-quality antimicrobials. This review covers information technology tools including medicines authentication tools (MAT) as mobile apps and messaging service, 2D barcoding approaches with drug safety alert systems, web based drug safety alerts, radiofrequency identification tags, databases to support visual inspection, digital aids to enhance the performance of quality evaluation kits, reference libraries for identification of falsified and substandard medicines, and quality evaluation kits based on machine learning for field testing. While being easy to access and simple to use, these initiatives are gaining acceptance in LMICs. Implementing 2D barcoding based on end-to-end verification and "Track and Trace" systems has emerged as a step toward global security in the supply chain. A breakthrough in web-based drug safety alert systems and data bases was the establishment of the Global Surveillance and Monitoring System by the World Health Organization in 2013. Future applications include concepts including "lab on a chip" and "paper analytical devices" and are claimed to be convenient and simple to use as well as affordable. The principles discussed herein are making profound impact in the fight against substandard and falsified medicines, offering cheap and accessible solutions.
在过去二十年中，不合格和伪造药品已成为一个全球公共卫生问题，尤其在低收入和中等收入国家。这一问题的严重后果包括信任丧失以及因治疗期间疾病控制不佳和并发症频发导致的财务成本增加。值得注意的是，抗菌药物耐药性是劣质抗菌药物带来的另一个长期影响。本综述涵盖了信息技术工具，包括作为移动应用程序和消息服务的药品认证工具（MAT）、带有药品安全警报系统的二维条形码方法、基于网络的药品安全警报、射频识别标签、支持目视检查的数据库、增强质量评估试剂盒性能的数字辅助工具、用于识别伪造和不合格药品的参考库以及基于机器学习的现场测试质量评估试剂盒。这些举措易于获取且使用简单，在低收入和中等收入国家正逐渐得到认可。实施基于端到端验证和“追踪溯源”系统的二维条形码已成为迈向全球供应链安全的一步。基于网络的药品安全警报系统和数据库的一个突破是世界卫生组织于2013年建立了全球监测系统。未来的应用包括“芯片实验室”和“纸质分析设备”等概念，据称这些概念使用方便、简单且价格低廉。本文讨论的原则正在对打击不合格和伪造药品的斗争产生深远影响，提供了廉价且易于获取的解决方案。
