Compounded glucagon-like peptide-1 receptor agonists for weight loss: the direct-to-consumer market in Colorado.

IF 2.5 Q1 HEALTH POLICY & SERVICES Journal of Pharmaceutical Policy and Practice Pub Date : 2024-12-24 eCollection Date: 2025-01-01 DOI:10.1080/20523211.2024.2441220
Michael J DiStefano, Mouna Dardouri, Gina D Moore, Joseph J Saseen, Kavita V Nair
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Abstract

Background: High prices and other access barriers have contributed to the rise of a market for compounded glucagon-like peptide-1 receptor agonists for weight loss in the United States. This market has not been systematically studied. We conducted a pilot study to assess the prevalence, characteristics, and advertising content of direct-to-consumer providers of compounded glucagon-like peptide-1 products for weight loss in Colorado.

Methods: We conducted a cross-sectional study of websites advertising compounded glucagon-like peptide-1 products for weight loss in Colorado. Websites were identified using Google searches focused on census-defined statistical areas. Searches were conducted between March 21 and April 12, 2024. Data collected from websites included physical addresses, business type, highest reported staff credential, advertised glucagon-like peptide-1 products, whether businesses referred to Food and Drug Administration approval when describing products, and whether businesses referred to products as 'generic'.

Results: We identified 93 business websites advertising compounded glucagon-like peptide-1 products for weight loss corresponding to 188 physical locations throughout Colorado. Most businesses were self-categorized as medical/health spas (33/93) or weight loss services (26/93). Advertised products included semaglutide (92/93), tirzepatide (40/93), liraglutide (2/93), and retatrutide (1/93). Advertised combination products included B vitamins (8/93), levocarnitine (1/93), mannitol (1/93), BPC-157 (1/93), and glycine (1/93). Seven websites advertised oral formulations. Additionally, 41/93 websites referred to Food and Drug Administration approval in their descriptions of compounded products and 5/93 referred to products as 'generic'.

Conclusion: This study identified several instances of unapproved glucagon-like peptide-1 products being compounded and advertised in Colorado. Additionally, 1 product was advertised as compounded with BPC-157, a substance determined by the Food and Drug Administration to be unsafe for compounding. This study also identified numerous examples of misleading claims regarding the regulatory status of compounded glucagon-like peptide-1 products. Regulatory action is needed to ensure the benefits of compounded GLP-1 products outweigh the risks.

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复合胰高血糖素样肽-1受体激动剂用于减肥:科罗拉多州直接面向消费者的市场。
背景:在美国,高价格和其他准入障碍促进了用于减肥的复合胰高血糖素样肽-1受体激动剂市场的兴起。这个市场还没有被系统地研究过。我们进行了一项试点研究,以评估科罗拉多州复合胰高血糖素样肽-1减肥产品直接面向消费者供应商的流行程度、特点和广告内容。方法:我们对科罗拉多州广告复合胰高血糖素样肽-1减肥产品的网站进行了横断面研究。网站是通过谷歌搜索来确定的,这些搜索集中在人口普查定义的统计领域。搜寻工作在2024年3月21日至4月12日期间进行。从网站收集的数据包括实际地址、业务类型、最高报告的员工证书、广告中的胰高血糖素样肽-1产品、企业在描述产品时是否提到食品和药物管理局的批准,以及企业是否将产品称为“通用”。结果:我们确定了93个商业网站广告复合胰高血糖素样肽-1减肥产品,对应于科罗拉多州188个物理位置。大多数企业将自己归类为医疗/健康水疗(33/93)或减肥服务(26/93)。广告产品包括semaglutide(92/93)、tizepatide(40/93)、liraglutide(2/93)和reatrutide(1/93)。广告中的组合产品包括B族维生素(8/93)、左卡尼汀(1/93)、甘露醇(1/93)、BPC-157(1/93)和甘氨酸(1/93)。七家网站宣传口服配方。此外,41/93的网站在其复合产品的描述中提到了食品和药物管理局的批准,5/93的网站将产品称为“仿制药”。结论:本研究确定了几个未经批准的胰高血糖素样肽-1产品在科罗拉多州复合和广告的实例。此外,有一种产品在广告中被称为含有BPC-157,这是一种被食品和药物管理局认定为不安全的物质。本研究还发现了许多关于复合胰高血糖素样肽-1产品监管地位的误导性声明的例子。需要采取监管行动,以确保复合GLP-1产品的益处大于风险。
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来源期刊
Journal of Pharmaceutical Policy and Practice
Journal of Pharmaceutical Policy and Practice Health Professions-Pharmacy
CiteScore
4.70
自引率
9.50%
发文量
81
审稿时长
14 weeks
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