美国Rx-OTC转换审评中消费者行为研究对我国的启示

摘要

Objective To provide a new"people-oriented"thinking on Rx-OTC switch review process for our country. Methods By studying consumer behavior studies in the U.S., introduce three research tools: label comprehension studies, self-selection studies, consumer actual use studies, compare these three tools and their relationship, summarize the importance of consumer behavior studies in Rx-OTC switch. Results Bringing consumer behavior studies into Rx-OTC switch contributes to pharmaceutical manufactarers on drug switch, and thus as a new OTC status in the market. Conclusion American"people-oriented"new thinking is worth concerning seriously for our regulatory review division and pharmaceutical manufactarers.%目的：为我国处方药转换为非处方药审评工作提供借鉴与参考。方法对美国处方药转换为非处方药审评程序中的消费者行为进行研究，介绍了消费者标签理解力研究、用药决策研究及消费者实际应用研究3种测试工具及其相互关系，总结出消费者行为研究在RX-OTC转换中的重要作用。结果Rx-OTC转换过程中引入消费者行为研究有助于生产企业顺利实现转换，从而继续以OTC药品进行销售。结论美国“以人为本”的审评模式值得我国监管审评部门和生产企业的关注重视。