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首页> 外文期刊>Pharmacoepidemiology and drug safety >The safety of drugs for OTC use: what evidence is required for an NSAID switch?
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The safety of drugs for OTC use: what evidence is required for an NSAID switch?

机译：OTC用药的安全性：NSAID转换需要什么证据？

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In recent years there has been a growing demand for safe and effective over-the-counter (OTC) drugs. The demonstration of the safety of OTC products in actual conditions of use is crucial for their wide distribution, since the circumstances of their use may be different from the prescription-only setting. A group of experts met in Geneva, Switzerland, with the aim of exploring the criteria required to show safety equivalence of OTC medications, with specific reference to low-dose non-steroidal anti-inflammatory drugs (NSAIDs) used for analgesia. It was agreed that an acceptable surrogate marker for safety as the primary endpoint in a study designed to show that a new NSAID was not inferior to a current NSAID would be any adverse event leading the patient to consult a physician. A sample size of 10,000 patients in each arm of a two-arm study would be sufficient to show non-inferiority with acceptable relative risk equal to 1.2 with at least 90% power for an event rate of 5%. An example of a possible pharmacy-based randomized study design to demonstrate safety equivalence of OTC analgesics is given.
机译：近年来，对安全有效的非处方（OTC）药物的需求不断增长。证明OTC产品在实际使用条件下的安全性对于其广泛分发至关重要，因为其使用环境可能与仅处方环境不同。一组专家在瑞士日内瓦举行了会议，目的是探讨显示OTC药物安全等效性的标准，并特别提及用于镇痛的低剂量非甾体类抗炎药（NSAID）。同意将一项安全性可接受的替代标志物作为一项旨在表明新的NSAID不逊于当前NSAID的研究的主要终点指标，将是导致患者就医的任何不良事件。在两臂研究的每臂中，10,000名患者的样本量足以显示非劣效性，可接受的相对危险度等于1.2，且至少有90％的机会发生率为5％。给出了一个可能的基于药房的随机研究设计实例，以证明OTC镇痛药的安全性等效。

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