在处方药推广中定义生物类似药的认知和偏好。

IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Mihaela Johnson, Jessica E Thompson, Avery A Tilley, Amie C O'Donoghue, Kathryn J Aikin
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引用次数: 0

摘要

背景:处方生物仿制药与现有fda批准的参考产品高度相似,没有临床意义上的差异。尽管市场上的产品越来越多,但消费者和临床医生对这些产品缺乏认识。我们的研究通过实验测试了人们对虚构处方药广告中披露声明形式的生物仿制药简短描述的理解和偏好。方法:消费者(n = 379)和医护人员(n = 368)观看模拟广告并回答在线调查。研究参与者被随机分配到7个生物仿制药披露定义中的1个或一个对照组。披露条件在以下方面有所不同:1)将产品确定为生物类似药;2)定义中提供的信息;3)命名参考产品。我们测试了披露条件对理解、感知、态度、意图和偏好的影响。结果:总体而言,即使提供了定义,消费者和医疗服务提供者对生物类似药披露信息的理解程度也低于最佳水平(分别为48.5%-62.0%和68.4%-88.4%)。对获益、相对疗效和安全性的看法是中性的。生物类似药定义的内容通常不影响结果,除了HCPs报告对生物类似药的态度更积极,并且在提供扩展定义时更倾向于开处方。两组人都喜欢扩展的定义,而HCPs更喜欢看到命名的参考产品。HCPs普遍同意生物仿制药可以与参考产品“互换”使用的说法。结论:我们的研究结果表明,消费者和医疗保健提供者之间存在一些关于生物仿制药的知识差距和不确定性。关于这些产品的进一步教育是有必要的,两个群体之间的沟通需要仔细的测试,以确保信息被理解,不会导致对产品的负面看法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Perceptions and Preferences for Defining Biosimilar Products in Prescription Drug Promotion.

Background: Prescription biosimilars are highly similar to and have no clinically meaningful differences from existing FDA-approved reference products. Despite increased availability in the marketplace, consumers and clinician lack awareness of these products. Our study experimentally tested understanding of and preference for brief descriptions of biosimilars in the form of disclosure statements in a fictitious prescription drug advertisement.

Methods: Consumers (n = 379) and HCPs (n = 368) viewed a mock advertisement and responded to an online survey. Study participants were randomized to 1 of 7 biosimilar disclosure definitions or a control. Disclosure conditions varied with regard to 1) identifying the product as a biosimilar; 2) information provided in the definition; and 3) naming the reference product. We tested the effects of disclosure conditions on comprehension, perceptions, attitudes, intentions, and preferences.

Results: Overall, comprehension of information in the biosimilar disclosure was less than optimal (48.5%-62.0% and 68.4%-88.4% for consumers and HCPs, respectively), even when provided with a definition. Perceptions of benefit, comparative efficacy, and safety were neutral. Content of the biosimilar definition generally did not influence outcomes, except that HCPs reported more positive attitudes toward the biosimilar and stronger intentions to prescribe when provided with expanded definitions. Both groups preferred the expanded definitions, and HCPs preferred seeing a named reference product. HCPs generally agreed with a statement that biosimilars could be used "interchangeably" with the reference product.

Conclusions: Our findings signal some knowledge gaps and uncertainty regarding biosimilars among consumers and HCPs. Further education is warranted around these products, and communications for both groups require careful testing to ensure that the information is understood and does not result in a negative perception of the product.

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来源期刊
CiteScore
4.90
自引率
6.90%
发文量
168
审稿时长
4-8 weeks
期刊介绍: Published since 1988, the Journal of the American Board of Family Medicine ( JABFM ) is the official peer-reviewed journal of the American Board of Family Medicine (ABFM). Believing that the public and scientific communities are best served by open access to information, JABFM makes its articles available free of charge and without registration at www.jabfm.org. JABFM is indexed by Medline, Index Medicus, and other services.
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