The Growing Concern Over The GLP-1 Shortage
The glucagon-like peptide-1 (GLP-1) receptor agonist class of medications, commonly used for type 2 diabetes (T2DM) and weight management, has recently experienced a significant shortage. Gaining immense popularity through social media influencers and ads has only fueled the GLP-1 demand. This shortage has far-reaching implications for patients, pharmacists, and the overall healthcare system. As demand for these medications continues to rise, having innovative strategies to address shortages and maintain drug availability for patients is paramount. Compound pharmacists are uniquely positioned to meet the demand, fill the GLP-1 void, and create another access point for patients. Market trends revealed that semaglutide made up over 88% of all new prescriptions, and utilization for obesity-related conditions nearly doubled over a 12-year period. About 1.7% of all Americans were prescribed a semaglutide medication.
A window into the problem
The US Food and Drug Administration (FDA) maintains a list of drug shortages on medications that are FDA-approved drugs. This provides valuable insights into the medications experiencing supply constraints that are eligible to be compounded. One of the key factors contributing to the GLP-1 shortage is the lack of manufacturing preparedness to meet the production of active pharmaceutical ingredients (API). The pharmaceutical supply chain is quite complex as GLP-1s require refrigeration and come in different dosages. In the event of FDA-recognized shortages, 503A and 503B compound pharmacies are authorized to make GLP-1s to keep up with demand.
Indications for GLP-1s
Current guidelines for type 2 diabetes management include metformin as first-line treatment. A GLP-1 agonist should be considered in patients if metformin is contraindicated or not tolerated when the Hemoglobin A1c (HbA1c) is greater than 1.5% over the target or 3 months of therapy failed to reach the target. GLP-1s should also be strongly considered for patients with a history of cardiovascular disease or stroke. Some GLP-1s are also cleared for weight loss in obese patients with a body mass index (BMI) of 30 or greater. A GLP-1 can be prescribed for overweight patients with a BMI of 27 or greater with a weight-related comorbidity like hypertension, dyslipidemia, or type 2 diabetes.
Compounding a sustainable solution
The emergence of compounding pharmacies affords viable options for patients to gain access to GLP-1 medications, reducing many barriers such as insurance coverage and cost. Licensed compound pharmacies can often provide GLP-1s at more affordable rates than name-brand drugs. Powdered semaglutide can often be purchased from FDA-registered distributors at reduced rates and passed on to patients. After reconstituting the API, adding preservative agents, and testing for impurities, compounded GLP-1s are sent for third-party independent testing. Patients benefit from accessibility and lower costs.
Is compounded GLP-1 the answer?
The GLP-1 shortage has become a growing concern due to increasing demand driven by social media influencers, advertisements, and celebrity endorsements. This shortage has far-reaching implications for patients who can benefit from taking the drug for weight loss or type 2 diabetes. Big Pharma companies originally manufactured GLP-1s without preparing or anticipating the surge in popularity. Compounding pharmacies offer a sustainable solution by providing access to GLP-1 medications at lower costs, reducing barriers, and ensuring patients receive the many benefits of GLP-1s.
The shortage scene
The pharmaceutical landscape is undergoing a significant shift as the GLP-1 medication shortage reaches a turning point. With the recent removal of tirzepatide from the drug shortage list, a new chapter unfolds in the weight loss and diabetes treatment arena. This development marks the end of widespread compounding, which has become a lifeline for many patients seeking affordable alternatives. As major manufacturers ramp up production to meet soaring demand, the focus now shifts to accessibility and affordability of brand-name medications. The transition poses challenges for patients who have relied on compounded versions, raising concerns about continuity of care and financial implications. Meanwhile, the pharmaceutical industry grapples with legal and regulatory complexities as companies move to protect patents and ensure quality control. This evolving situation highlights the delicate balance between innovation, patient access and regulatory oversight in addressing the obesity epidemic and diabetes management.
