中国对超说明书用药的监管。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY
Food and drug law journal Pub Date : 2013-01-01
Feng Ma, Nan Lou
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引用次数: 0

摘要

中国在药品说明书外使用的监管方面存在重大差距和弱点。和美国一样,如果有充分的科学依据,中国也不禁止超说明书开处方。如果医生遵循一定的要求,他们可以根据自己的医学判断开出标签外药物。如果患者因不当的超说明书处方而受到伤害,则医疗事故责任的施加对其开药权有一定的限制。然而,与美国的医疗事故损害赔偿相比,胜诉原告获得的损害赔偿通常微不足道。在中国,所有药品广告都必须经过预先批准,并且必须以批准的说明书中的信息为依据。然而,“广告”这个词的定义很差。因此,非广告推广药物的标签或标签外使用存在于一个不受监管的灰色地带。为了更好地解决不适当的超说明书推广和使用问题,中国应(i)根据要求超说明书使用具有可靠科学依据的标准对药品广告和非广告推广进行监管,(ii)引入更严厉的监管处罚,以及(iii)增加对医疗事故受害者的赔偿。这种改革不仅将通过对不当促销实行处罚(或增加现有处罚)来阻止不当的超说明书使用,而且还将为因超说明书使用而受到伤害的受害者提供合理的赔偿。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Chinese regulation of off-label use of drugs.

China has significant gaps and weaknesses in its regulatory oversight of the off-label use of drugs. As in the United States, the off-label prescribing of drugs is not prohibited in China if there is a sound scientific basis. Physicians are allowed to prescribe off-label drugs based on their medical judgment if they follow certain requirements. There is some constraint on the right to prescribe by the imposition of malpractice liability if patients are harmed from improper off-label prescribing. However, damages awarded to successful plaintiffs are usually insignificant compared to malpractice damage awards in the U.S. Advertisement of off-label use is prohibited in China. All drug advertisements in China are subject to pre-approval, and must be based on information included in the approved package insert. However, the term "advertisement" is poorly defined. As a result, non-advertisement promotion of drugs for on-label or off-label use exist in a unregulated gray area. To better address the problem of inappropriate off-label promotion and use, China should (i) regulate both drug advertisements and non-advertisement promotion under a standard requiring off-label use to have a sound scientific basis, (ii) introduce harsher regulatory penalties, and (iii) increase compensation available for victims of medical malpractice. Such reform would not only discourage improper off-label use by introducing penalties (or increasing existing penalties) for improper promotion, but would also provide reasonable compensation for victims harmed by off-label use.

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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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