Evolution of self-care with over-the-counter medications
Evolution of self-care with over-the-counter medications
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DOI：
10.1016/s0149-2918(98)80018-0
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发表时间：
1998-01-01
影响因子：
3.2
通讯作者：
Soller, RW
中科院分区：
文献类型：
--
作者：
Soller, RW
非处方（OTC）药物的自我护理已经从专利药物生产和销售的“黑暗时代”发展到涉及处方到OTC转换的新药开发的现代时代。这一演变在很大程度上要归功于OTC审查，该审查将科学置于非处方药安全性、有效性和标签的基石。随着非处方药自我保健的发展，药物从处方药到非处方药的转变产生了重要的好处，通过新的自我保健疗法创造了更多的自力更生的消费者，显著节省了医疗保健系统的成本，扩大了公司的市场，增强了监管决策的科学性，为所有非处方药提供了更友好的消费者标签，以及更一致和可预测的药物审批流程。处方药和膳食补充剂的潜在监管障碍和不断变化的索赔环境为当今的OTC行业带来了重要挑战。
Self-care with over-the-counter (OTC) medicines has evolved from the "dark ages" of patent medicine manufacture and sale to a modern era of new drug development involving prescription-to-OTC switch. This evolution is largely due to the OTC Review, which placed science at the cornerstone of safety, effectiveness, and labeling of nonprescription medicines. As self-care with OTC drugs has evolved, the switching of drugs from prescription to nonprescription status has produced important benefits, creating more self-reliant consumers through novel self-care therapeutics, significant cost savings to the health care system, expanded markets for companies, enhanced science for regulatory decisions, a more consumer-friendly label for all OTC agents, and a more consistent and predictable drug approval process. Potential regulatory barriers and an evolving claims environment for prescription drugs and dietary supplements present important challenges for the OTC industry today.