Empowerment vs Advocacy: Responsible Stewardship of Patient’s Access to Medicines

29 May 2023 byJoanne G. Blanco, MD

Diabetes mellitus (DM) and obesity are two of the most prevalent chronic health conditions worldwide, affecting millions of individuals globally.1,2 As the landscape of diabetes therapy continues to evolve, it is becoming increasingly clear that a one-size-fits-all approach is no longer sufficient. By considering a range of factors beyond just glucose control, healthcare providers can provide more effective, personalized care that results in better outcomes for patients with diabetes. 



Emerging Role of GLP-1 RAs in Weight Loss
Prescriptions for newer classes of glucose-lowering medications such as glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are becoming more common due to their ability to positively affect not only metabolic outcomes, but cardiovascular and renal outcomes as well.3 Originally developed for the treatment of type 2 DM, GLP-1 RAs have been shown to have beneficial effects not only on glycemic control, but also on weight loss and blood pressure in both diabetic and non-diabetic patients.4

GLP-1 RAs have a unique mechanism of action: simultaneously increasing insulin secretion and inhibiting glucagon only in response to increased glucose levels, making it an ideal target for diabetic individuals with potential use for obese and nondiabetic individuals without the risk of hypoglycemia.5 

Off-Label Prescribing of GLP1 RAs for Diabetes Management: A Growing Concern
While the use of GLP1 RAs for weight loss in non-diabetic patients may seem like a promising solution, it is crucial to note that not all these drugs are approved by regulatory bodies for this purpose. As a result, their use in this context is considered off-label.6  

Off-label use of some GLP1 RAs for weight loss in non-diabetic patients has become popular in the past months, causing intermittent shortages in various dosages.7 This shortage has fueled speculations about who is getting them as they have exploded in popularity.8  

One of the primary ethical concerns associated with the off-label prescription of GLP-1 RAs for weight loss is the potential for harm to patients. While these medications may be effective in promoting weight loss, they may also carry significant risks when used inappropriately.7,8  

This recent trend of off-label use of GLP-1 RA medications for weight loss has created challenges in accessing these drugs for diabetic patients who genuinely need them.8 The popularity of these medications for non-diabetic individuals seeking weight loss has led to potential shortages and restrictions in availability,9 hindering access for diabetic patients who may achieve better glycemic control with these drugs. 

A Call for Responsible Prescriptions of GLP1 RAs
GLP1-RAs have a favorable impact on glycemia, weight, lipids, and blood pressure. Although initial treatment may cause frequent gastrointestinal side effects, they are relatively well-tolerated.4 While these potential benefits hold great promise, it is essential to direct them toward appropriate patients where medicines target real therapeutic needs.  

As healthcare professionals, it is imperative to understand the potential consequences of off-label usage, particularly in terms of patient outcomes. While there may be exceptional circumstances where such usage is warranted, it is important to rely on clinical judgment and prioritize patient well-being by advocating for more research when necessary and informing patients about the potential risks and uncertainties that come with off-label prescribing.10  

It is essential for patients to have access to potentially beneficial off-label treatments but ensuring appropriate access to GLP-1 RA medications for diabetic patients who truly require them is of paramount importance. By providing appropriate access, we can optimize the management of diabetes and potentially improve patient outcomes while minimizing the potential harm that can arise from off-label use. It is crucial for healthcare professionals to exercise clinical judgment, consider individual patient needs, and advocate for appropriate access to GLP-1 RAs in order to promote optimal diabetes care and patient well-being.10



References:
1.       World Health Organization. Diabetes. Available at https://www.who.int/health-topics/diabetes#tab=tab_1. Accessed 04 May 2023.
2.       Powell-Wiley TM, et al. Circulation 2021;143:e984–e1010.
3.       Ng E, et al. Aust J Gen Pract 2022;51(7):513–518.
4.       Ma H, Lin Y-H, Dai LZ, et al. BMJ Open 2023;13:e061807.
5.       Xu D, Nair A, Sigston C, et al. Cardiovasc Ther 2022;2022:6820377.
6.       Wehrwein P. For Weight Loss, Off-Label GLP-1s Are Increasingly the Chosen Ones. Available at https://www.managedhealthcareexecutive.com/view/for-weight-loss-the-glp-1s-are-the-ones-amcp-2023. Accessed 04 May 2023.
7.       Rosen NS. With growing popularity of new weight loss drugs, doctors emphasize potential risks. Available at https://abcnews.go.com/Health/growing-popularity-new-weight-loss-drugs-doctors-emphasize/story?id=96424302. Accessed 15 May 2023.
8.       O’kane C. CBS News. Available at https://www.cbsnews.com/news/ozempic-wegovy-weight-loss-drugs-shortage-prescriptions/. Accessed 15 May 2023.
9.       FDA. FDA Drug Shortages. Available at https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Semaglutide+%28Ozempic%29+Injection&st=c&tab=tabs-4&panels=1. Accessed 16 May 2023.
10.   Dresser R, Frader J. J Law Med Ethics 2009;373:476–396. 

PH-NP-LILLY-TRULIC-NR-HCP-000012 MAY 2023