An Unprecedented Rise Of GLP-1
There is a new medication on the market that is making waves and impacting the pharmaceutical supply chain. Glucagon-like peptide-1 (GLP-1) is a receptor agonist and a class of anorectic drugs that is effective in managing type 2 diabetes (T2D) and obesity. Statistics show that more than 40% of Americans struggle with obesity. Over 9% are diagnosed with diabetes. The high demand for treatment means GLP-1 medications are widely prescribed for on-label and off-label means, such as weight management. Pharmacists are tasked to dispense this growing solution, but manufacturers of brand name options are struggling to meet demand. As a result, patients are frustrated as pharmacies are unable to keep up with this mismatch. As an alternative, pharmacies can use compounding to fill the void.
Compounding in times of shortage
As access to GLP-1 continues to fluctuate, compounding pharmacies can help address this shortage. Compounding is the process of recreating medication using raw ingredients or combining multiple medications to produce a new form. By following a detailed plan and using sterile compounding, pharmacies can meet demand, and patients can continue treatment. The pharmacy produces an effective alternative that can help address diabetes management or weight loss. Pharmacies can produce sufficient amounts by working with bulk active pharmaceutical ingredients (APIs) to find the balance between custom options and retail needs.
Benefits of compounding GLP-1
Compounding helps with on-label and off-label needs while providing custom doses unavailable on the market. This option leads to better adherence and more effective outcomes. More importantly, pharmacies can keep up with demand. For patients, based on demand, compounded GLP-1 medications can be more cost-effective than brand-name options. Compounding pharmacies operating under United States Pharmacopeia (USP) 797 guidelines must maintain stringent quality control processes when preparing GLP-1 analogs. In other words, patients can rest assured that the compounded solution will have similar quality and efficacy.
Risks and considerations
Pharmacies looking to add compounded GLP-1 to any offerings must address the risks and considerations. The pharmacy must know and follow all guidelines surrounding quality, drug stability, and storage. Some requirements include beyond-use dating (BUD) assignments, conducting appropriate sterility testing, and maintaining environmental monitoring programs. Furthermore, product stability in different delivery mechanisms, pH balance, and proper preservation all matter when producing a compounded version of GLP-1. There is also the economic impact. Insurance companies provide resistance with certain forms of compounded GLP-1. The drug must also be used within the Food and Drug Administration (FDA)’s scope. Work closely with patients to ensure proper reimbursement and learn all the parameters to avoid legal challenges in the future.
Innovative ways to address shortages
The effectiveness of GLP-1 drugs has led to a significant boom that shows no signs of slowing down. This supply-demand issue has led to poor accessibility and high costs. Compounding helps pharmacies meet demand by creating a custom solution that produces similar results. Until these supply challenges are under control, pharmacists will play a significant role in supporting patients and manufacturers. Patients will also enjoy doses and forms not available on the market. Pharmacies must maintain high-quality standards. Compounding can bridge the gap between supply and demand in the pharmaceutical market.
