Widening Consumer Access to Medicines through Switching Medicines to Non-Prescription: A Six Country Comparison

BackgroundSwitching or reclassifying medicines with established safety profiles from prescription to non-prescription aims to increase timely consumer access to medicines, reduce under-treatment and enhance self-management. However, risks include suboptimal therapy and adverse effects. With a long-standing government policy supporting switching or reclassifying medicines from prescription to non-prescription, the United Kingdom is believed to lead the world in switch, but evidence for this is inconclusive. Interest in switching medicines for certain long-term conditions has arisen in the United Kingdom, United States, and Europe, but such switches have been contentious. The objective of this study was then to provide a comprehensive comparison of progress in switch for medicines across six developed countries: the United States; the United Kingdom; Australia; Japan; the Netherlands; and New Zealand.MethodsA list of prescription-to-non-prescription medicine switches was systematically compiled. Three measures were used to compare switch activity across the countries: “progressive” switches from 2003 to 2013 (indicating incremental consumer benefit over current non-prescription medicines); “first-in-world” switches from 2003 to 2013; and switch date comparisons for selected medicines.ResultsNew Zealand was the most active in progressive switches from 2003 to 2013, with the United Kingdom and Japan not far behind. The United States, Australia and the Netherlands showed the least activity in this period. Few medicines for long-term conditions were switched, even in the United Kingdom and New Zealand where first-in-world switches were most likely. Switch of certain medicines took considerably longer in some countries than others. For example, a consumer in the United Kingdom could self-medicate with a non-sedating antihistamine 19 years earlier than a consumer in the United States.ConclusionProactivity in medicines switching, most notably in New Zealand and the United Kingdom, questions missed opportunities to enhance consumers' self-management in countries such as the United States.

研究背景：将已确立安全特性的处方药转换或重新分类为非处方药，旨在提升消费者及时获取药物的可及性、减少治疗不足情况，并强化自我管理能力。然而，此类操作亦存在治疗方案欠优化及引发不良反应的风险。英国长期推行支持处方药转换或重新分类为非处方药的政府政策，被认为是全球处方药转换领域的领跑者，但相关佐证尚无定论。目前英国、美国及欧洲地区均对针对部分慢性疾病的药物转换举措表现出关注，但此类转换始终颇具争议。本研究旨在全面比较美国、英国、澳大利亚、日本、荷兰及新西兰这六个发达国家的药物转换进展情况。
研究方法：系统梳理处方药向非处方药转换的药物清单，并采用三项指标对各国的转换活动开展对比分析：一是2003年至2013年间的「渐进式转换」（即相较于现有非处方药，可为消费者带来逐步提升的获益）；二是2003年至2013年间的「全球首创转换」；三是选定药物的转换时间对比。
研究结果：2003年至2013年间，新西兰在渐进式转换方面最为活跃，英国与日本紧随其后；美国、澳大利亚及荷兰同期的转换活动则相对低迷。即便在全球首创转换最为集中的英国与新西兰，针对慢性疾病的药物转换数量仍寥寥无几。部分药物的转换耗时在不同国家间差异显著，例如英国消费者可在比美国早19年的时间里，以非处方方式使用非镇静类抗组胺药。
研究结论：药物转换领域的积极性（尤以新西兰与英国为甚），对美国等国家错失提升消费者自我管理能力的机遇提出了审视与质疑。