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Running on Empty: Navigating the GLP-1 and GIP/GLP-1 Receptor Agonist Drug Shortage

Updated: 17 hours ago

By Sydnie Twillmann, PharmD


Glucagon-like peptide 1 (GLP-1) receptor agonists and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonists have been making the headlines recently, for more reasons than one.  Over the past few years, due to both appropriate and inappropriate use, the demand for and use of GLP-1 and GIP/GLP-1 receptor agonists have increased substantially, leaving drug manufacturers struggling to keep their supply sufficient to meet these increased needs.  According to the 2024 American Diabetes Association Standards of Care, GLP-1 receptor agonists have become first line pharmacotherapy for most patients with type 2 diabetes mellitus (T2DM), including those with concomitant atherosclerotic cardiovascular disease (ASCVD), indicators of high ASCVD risk, or chronic kidney disease.  For patients without the aforementioned comorbidities with the primary goal of glycemic and weight management, GLP-1 and GIP/GLP-1 receptor agonists are recommended.(1)  GLP-1 receptor agonists are not only efficacious for glucose lowering and achieving diabetes treatment goals, but have also demonstrated several added benefits in recent studies.  For instance, liraglutide (Victoza), dulaglutide (Trulicity), and subcutaneous semaglutide (Ozempic) have data supporting risk reduction of major adverse cardiovascular events as well as preserving kidney function in patients with T2DM.(2)(3)(4)   Another benefit of GLP-1 and GIP/GLP-1 receptor agonists is significant weight loss, specifically seen with liraglutide, semaglutide, and tirzepatide, which are now available as FDA approved products for weight management with the brand names Saxenda, Wegovy, and Zepbond respectively.(5)(6)(7) 


While these products have great glycemic, weight, and cardiovascular outcomes, the benefits have resulted in some detrimental repercussions.  Specific to weight management, there has been an increase in inappropriate prescribing of GLP-1 and GIP/GLP-1 receptor agonists for weight loss in patients who do not truly meet criteria for the use of these medications.  For example, pharmacists were seeing Saxenda, Wegovy, and Zepbound being prescribed for patients who did not have a body mass index (BMI) of ≥ 30 kg/m2 or a BMI of ≥ 27 kg/m2 with at least one weight associated comorbidity.  Also, brand name products only FDA approved for the treatment of T2DM, Ozempic and Mounjaro for example, were being prescribed for weight loss in the absence of a T2DM diagnosis.  A quick online search for semaglutide (Ozempic) and tirzepatide (Mounjaro) reveals numerous headlines from popular news networks explaining the weight loss benefits, famous celebrities who have successfully used these medications for weight loss, and even advertisements for weight loss clinics compounding their own GLP-1 and GIP/GLP-1 receptor agonists.


Due to the increased use of GLP-1 and GIP/GLP-1 receptor agonists in the treatment of T2DM and obesity, paired with increased inappropriate prescribing for weight loss, drug manufactures are simply unable to maintain a supply that is sufficient to meet this increased demand.  As a result, we are facing severe drug shortages.  The FDA officially announced semaglutide on shortage in March 2022, followed by tirzepatide and dulaglutide in December 2022, and liraglutide in July 2023.(8)   Even today, two years later, the supply of these medications remains sparse.  Therefore, patients who need these medications to treat their chronic conditions, whether T2DM or obesity, are unable to obtain these medications and are taking a hit to their treatment goals. 


Within my health system and at my practice site, primary care providers and ambulatory care pharmacists have been working to come up with strategies to help patients overcome these shortage and supply issues.  For the treatment of T2DM in particular, some strategies include transferring prescriptions to different community pharmacies that have the medication in stock, titration of current GLP-1 or GIP/GLP-1 to an available dose, switching to other once weekly, once daily, or oral GLP-1 and GIP/GLP-1 products, or holding the GLP-1 or GIP/GLP-1 product and either adjusting their other T2DM medications or initiating other medications for the treatment of T2DM.  However, even with these treatment strategies, patients are still negatively impacted by these shortages.  From personal experience, the majority of patients whom I manage their T2DM treatment on these medications have expressed issues obtaining their product.  Around half of these patients have seen an increase in their hemoglobin A1c, which occurs regardless of the strategies used to combat the shortage issues stated above. 


As ambulatory care pharmacists, there are a few things we can do in addition to the strategies above to help our patients through these shortage issues.  Encourage patients to request refills of their GLP-1 and GIP/GLP-1 receptor agonists early and pick up refills as soon as possible to ensure their medication can be ordered and obtained prior to having to skip doses.  Speak with the patients’ pharmacies to determine which medications and strengths are currently available if changes must be made.  Ensure close follow-up when titrating or initiating other medications and insulin products.  Confirm appropriate documentation of approved indications.  Work with the medical team to help facilitate prior authorizations if needed.  Attempt to re-start the GLP-1 or GIP/GLP-1 receptor agonist as quickly as they are available.  Overall, provide patients with the support and encouragement that together, we will get through this shortage!        

 

1. American Diabetes Association Professional Practice Committee. 9. Pharmacologic approaches to glycemic treatment: Standards of Care in Diabetes-2024. Diabetes Care 2024;47(Suppl 1):S158-S178.

2. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016;375(4):311-322. doi:10.1056/NEJMoa1603827.

3. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121-130. doi:10.1016/S0140-6736(19)31149-3.

4. Marso SP, Bain SC, Consoli A, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375(19):1834-1844. doi:10.1056/NEJMoa1607141.

5. Pi-Sunyer X, Astrup A, Fujioka K, et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015;373(1):11-22. doi:10.1056/NEJMoa1411892.

6. Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021;384(11):989-1002. doi:10.1056/NEJMoa2032183.

7. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022;387(3):205-216. doi:10.1056/NEJMoa2206038.

8. U.S. Food and Drug Administration. FDA Drug Shortages. Updated April 1, 2024. Accessed April 11, 2024. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.

 

Sydnie Twillmann, PharmD

Clinical Assistant Professor

Southern Illinois University Edwardsville School of Pharmacy

Edwardsville, IL


Ambulatory Care Clinical Pharmacist

HSHS Medical Group

Shiloh & O’Fallon, IL

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