Hartigan-Go Kenneth
Asian Institute of Management, 123 Paseo De Roxas St., 1229, Makati City, Philippines,
Drug Saf. 2015 Apr;38(4):329-35. doi: 10.1007/s40264-015-0274-z.
Empowering consumers to contribute to adverse drug reaction reporting seems a sensible innovation, particularly when traditional reports emanating from healthcare professionals are neither increasing nor improving. This work, inspired by an EU-FP7-funded project, describes an attempt by the Philippines to introduce a consumer reporting system through education and an online platform for reporting, and the lessons that were captured in the process. While participating consumers did not contribute to the adverse drug reporting process in the traditional sense as originally expected, the reports received by the drug regulatory agency revealed consumers' concerns regarding health product legitimacy, quality and market claims, as well as the lack of available and accessible information. These reports led regulators to take action. Initial insights on consumer behavior are proposed for regulators and industry to consider in greater depth and how this may impact on consumers providing valued information that will promote other aspects of product safety.
让消费者参与药品不良反应报告似乎是一项明智的创新举措,尤其是在医疗保健专业人员提交的传统报告数量既未增加也未改善的情况下。这项工作受欧盟第七框架计划资助项目的启发,描述了菲律宾通过教育和在线报告平台引入消费者报告系统的尝试,以及在此过程中吸取的经验教训。虽然参与的消费者并未如最初预期的那样在传统意义上为药品不良反应报告流程做出贡献,但药品监管机构收到的报告揭示了消费者对健康产品合法性、质量和市场宣传的担忧,以及信息的缺乏和难以获取。这些报告促使监管机构采取行动。文中为监管机构和行业提出了关于消费者行为的初步见解,供其更深入地思考,以及这可能如何影响消费者提供有价值的信息,从而促进产品安全的其他方面。