A Critical Compounding Role: Alleviating Drug Shortages at Hospitals

Drug shortages have become an increasingly common issue in the healthcare system, presenting significant challenges for both patients and providers. These shortages occur when the demand for a medication exceeds its supply and can result from various factors, including manufacturing problems, supply chain disruptions, regulatory issues, and sudden spikes in demand. During such crises, compounding pharmacies play a vital role in providing relief. By creating customized medications, compounders can bridge the gap when commercial drugs are unavailable. They ensure that patients receive the necessary treatments, preventing interruptions in care that could have severe consequences. The adaptability and responsiveness of compounding pharmacies underscores their essential contribution to patient care, especially in times of drug shortages.

When hospitals are unable to access life-saving medications, compounding pharmacies play a vital role in bridging the gap. 503A compounding pharmacies, which are licensed and inspected by their state boards of pharmacy, specialize in creating individualized, patient-specific medications prescribed by healthcare providers. This is especially important for rare diseases or situations where precision dosing and formulations must be customized, such as chemotherapy. Meanwhile, 503B outsourcing facilities—who are registered with and inspected by the FDA—serve a different role, producing larger batches of medications to support hospitals during widespread shortages. These facilities step in when essential drugs like lidocaine or IV fluids are on backorder, helping maintain continuity of care during national or regional supply disruptions.

If you are someone who reads through all the fine print in any documents you sign, you have probably come across a consent section in any hospital paperwork that included "consent to medication not yet FDA approved and/or medication prepared/repacked by outsourcing or compounding pharmacy." This statement highlights the complex reality that certain medications, which have not yet received FDA approval, are sometimes necessary for patient care. Additionally, the consent section usually includes another important clause: "certain medication for which there are no alternatives or which your physician recommends may be necessary for potentially life-saving treatment." This underscores the vital role that compounded medications can play in situations where no FDA-approved alternatives exist, or where a physician deems them essential for treatment. It's important to recognize the essential and sometimes life-saving role that compounding pharmacies can fulfill in the medical field.

As access to critical medications becomes increasingly strained in traditional healthcare settings in the United States, hospitals are turning more often to high-quality, licensed compounding pharmacies and outsourcing facilities to fill the gaps. These partnerships are not just convenient, they are essential to delivering timely, effective care and ensuring patients receive the treatments they need, exactly when they need them. Compounding pharmacies respond swiftly during shortages and play an essential role in supporting improved patient outcomes and hospitals. 

By Matthew Johnson, Pharma Source Direct and Emily Durham, Revelation Pharma