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关于肥胖医学协会2023年关于复合肽的立场声明的常见问题:行动呼吁。

Frequently asked questions to the 2023 obesity medicine association position statement on compounded peptides: A call for action.

作者信息

Bays Harold Edward, Fitch Angela, Francavilla Brown Carolynn, Younglove Courtney, Christensen Sandra M, Alexander Lydia C

机构信息

Louisville Metabolic and Atherosclerosis Research Center, University of Louisville School of Medicine, 3288 Illinois Avenue, Louisville, KY, 40213, USA.

Diplomate of American Board of Obesity Medicine, Knownwell, 15 Oak St Suite 3, Needham, MA, 02492, USA.

出版信息

Obes Pillars. 2024 Jul 30;11:100122. doi: 10.1016/j.obpill.2024.100122. eCollection 2024 Sep.

DOI:10.1016/j.obpill.2024.100122
PMID:39228749
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11369382/
Abstract

BACKGROUND

In 2023, the Obesity Medicine Association (OMA) published "Compounded peptides: An Obesity Medicine Association Position Statement." Since this publication, the use of compounded peptides for the treatment of obesity has continued to evolve, leading to additional confusion and questions from obesity medicine clinicians and their patients.

METHODS

This frequently asked questions (FAQ) document and "Call for Action" commentary is based upon the existing evidence and practical clinical experiences of the authors.

RESULTS

This FAQ is intended to provide insights beyond the original 2023 OMA Position Statement regarding the use of "compounded peptides" for treating obesity. Three obstacles impair patient access to highly effective peptide anti-obesity medications: insufficient production especially during times of high demand, high costs, and lack of clarity surrounding the role of compounded peptides. Solutions to enhance patient access to these medications lie within the existing legal and regulatory framework and Food and Drug Administration policies. Implementing these solutions necessitates dispelling misinformation and providing clear guidance on the appropriate prescribing and administration of compounded peptides, particularly during times of acknowledged shortage.

CONCLUSION

Among stakeholders with aligned priorities, challenges can often be overcome by collaboration and communication. Towards the goal of providing patient-centered care, the OMA calls on applicable stakeholders (e.g., pharmaceutical companies, compounding pharmacy organizations, health insurance companies, and the Food and Drug Administration) to work collaboratively to achieve a consensus that improves patient access to safe anti-obesity medications. The purpose of this "Call to Action" is to ask stakeholders to provide clinicians and their patients clarity regarding the role of compounded peptide anti-obesity medications during times of FDA-acknowledged shortages. Finally, this FAQ review provides clinicians with a simple and practical checklist respective to the potential use of compounded peptides.

摘要

背景

2023年,肥胖医学协会(OMA)发表了《复合肽:肥胖医学协会立场声明》。自该声明发布以来,用于治疗肥胖症的复合肽的使用情况持续演变,这给肥胖医学临床医生及其患者带来了更多困惑和疑问。

方法

本常见问题解答(FAQ)文档及“行动呼吁”评论基于作者现有的证据和实际临床经验。

结果

本常见问题解答旨在提供超出2023年OMA关于使用“复合肽”治疗肥胖症的原始立场声明的见解。有三个障碍阻碍了患者获得高效的肽类抗肥胖药物:产量不足,尤其是在需求旺盛时期;成本高昂;以及复合肽的作用缺乏明确性。在现有法律法规框架和美国食品药品监督管理局(FDA)政策范围内,有增强患者获得这些药物的途径的解决方案。实施这些解决方案需要消除错误信息,并就复合肽的适当处方和给药提供明确指导,尤其是在公认的短缺时期。

结论

在优先事项一致的利益相关者中,挑战往往可以通过合作与沟通来克服。为了实现以患者为中心的护理目标,OMA呼吁相关利益者(例如制药公司、配制药房组织、健康保险公司和FDA)共同努力,达成共识,以改善患者获得安全抗肥胖药物的途径。本“行动呼吁”的目的是要求利益相关者就FDA认可的短缺时期复合肽类抗肥胖药物的作用向临床医生及其患者提供明确信息。最后,本常见问题解答回顾为临床医生提供了一份关于复合肽潜在用途的简单实用清单。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48ed/11369382/02d041a158fc/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48ed/11369382/e937cd4cecef/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48ed/11369382/e910a76f3c1f/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48ed/11369382/02d041a158fc/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48ed/11369382/e937cd4cecef/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48ed/11369382/e910a76f3c1f/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48ed/11369382/02d041a158fc/gr2.jpg

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