Compound When Manufacturing Is Delayed

Pharmaceutical compounding represents the intricate process of combining, mixing, or altering ingredients to create medications tailored to individual patient needs. A compound pharmacy is essential when commercially available drugs are shortlisted, unique dosages are required, allergies to specific compounds exist, and alternative routes of administration are desired. Approximately 7,500 compounding pharmacies operate within the US, filling approximately 1% to 3% of all prescriptions written by providers. Traditional compounding pharmacies are 503A authorized entities regulated to utilize active pharmaceutical ingredients (API) acquired from a Food and Drug Administration (FDA) registered manufacturer or wholesale distributor. Careful consideration of API is required to ensure purity, stability, and quality to derive the intended therapeutic effect. This field requires rigor, expertise, and a deep understanding of pharmacology. In the absence of compounding, many patients would lack access to necessary medications, leading to compromised health and well-being.

The ripple effect

Drug shortages create significant challenges for patients and healthcare providers, disrupting ongoing treatment protocols, conventions, and patient care. In 2024, the top 5 drug classes experiencing drug shortages included antimicrobials, chemotherapy, central nervous system (CNS), fluids and electrolytes, and hormone agents. The rationale for drug shortages falls into categories involving manufacturing, hurricanes, business decisions, supply and demand, and the largest, at 55%, unknown. Delays and interruptions in medication access create a downstream cascade of negative consequences, impacting both the physical and mental well-being of patients. For instance, a cancer patient facing shortages in critical chemotherapy agents may not only suffer emotionally from anxiety and frustration but also may experience reduced survival rates.

Navigating scarcity: The FDA shortage list

The FDA shortage list identifies medications experiencing supply disruptions, signaling a heightened need for alternative solutions. One notable example includes GLP-1 receptor agonists, often prescribed for type 2 diabetes mellitus and weight management. Reports indicate that shortages, secondary to the increased popularity of numerous health benefits often perpetuated by social media and other outlets. A US study involving 1 million new GLP-1 users revealed that these agents doubled among individuals without diabetes who were seeking weight loss management. Another study of over 4 million GLP-1 prescriptions demonstrated that 16.2% were for weight loss and 83.8% for diabetes treatment. Again, compounding pharmacies play a central role in mitigating the impact of critical drug shortages, offering invaluable alternatives to standard pharmaceutical options.

Adaptive compounding solutions

Compounding pharmacies are nimble and able to adapt to fluctuating market demands by creating medications customized to individual needs, sensitivities, and unique requirements. This permits closing gaps in the market where typical pharmaceutical inventory may not be suitable. Compounding employs flexibility and efficiency by integrating technology to monitor emerging trends and market needs, identifying opportunities for proactive responses to improve access and distribution. Additionally, compounding can provide essential medications when commercial manufacturers discontinue drugs that decline in usage but are important for specific patient populations with niche medical needs.

Meeting unmet needs through compounding

Traditional pharmaceutical manufacturing can often leave gaps that compound pharmacies can address through personalized formulations and alternate delivery methods. Oftentimes, compounding can mitigate the impact of drug shortages that lead to disruptions in patient treatment plans, improving the burden of healthcare delivery. Compound pharmacies are integral in maintaining access to high-demand medications like GLP-1s, ensuring continuity of care for patients during periods of manufacturing constraints. This flexibility allows for rapid response to evolving patient needs, especially when traditional supply chains are strained. Safeguarding public health necessitates continuous monitoring of drug shortages and proactive approaches by compounding pharmacies to ensure and prevent patient treatment interruptions.