Addressing Shortages With Compounding

Drug shortages continue to challenge healthcare providers and patients across the United States. Shortages come and go, sometimes creating critical gaps in essential medications. Most shortages are due to significant demand or supply delays, such as the current demand for glucagon-like peptide 1 (GLP-1) agonists. Compounding pharmacies are positioned to bridge these gaps through strategic collaboration and innovative approaches. These facilities can create custom drugs and substitute medications to meet the needs of patients. By working together with healthcare providers, regulatory bodies, and supply chains, compounding pharmacies can develop solutions that continue care during shortages.

Building strategic healthcare partnerships

One of the best ways to deal with shortages in a collaborative way is by establishing relationships between compounding pharmacies and healthcare providers. Physicians, nurses, and specialists require reliable pharmacies that can perform compounding in the event of shortages to continue care. The right pharmacy understands the clinical needs of patients and the regulations around compounded medications. Compounding has strict United States Pharmacopeia (USP) requirements. Healthcare providers must feel confident that pharmacies are creating medicines with these rules in mind. Moreover, partnerships allow proactive communication about impending shortages and the development of alternative treatment. Pharmacies can then create effective solutions that continue to serve patients, while healthcare providers can effectively share information about expected outcomes.

Leveraging FDA resources

The food and drug administration (FDA) has guidelines on compounding during shortages. These regulations provide a framework for pharmacies to operate within legal boundaries while addressing critical medication needs. Sections 503A and 503B, which apply to human drug compounding, can be used to effectively respond to drug shortages. Traditional compounding pharmacies can prepare patient-specific prescriptions, while larger outsourcing facilities can produce batches for healthcare facilities. This creates a collaborative network that fills gaps large and small. These compounding pharmacies can also work together to maintain documentation of all issues related to shortages. These requirements include verification for active pharmaceutical ingredients (APIs), stability testing protocols, and reporting. Using drug shortage databases has also become a vital resource for expanding compounding as needed.

Establishing reliable supply chain networks

Managing the supply chain is vital to meeting compounding needs. In many situations, supply issues faced by larger pharmaceutical companies can be the reason for drug shortages in the first place. Diverse supply chain strategies are necessary, especially those that go beyond traditional API suppliers.
Compounding pharmacies may need to collaborate to find and build relationships with a diverse list of multiple FDA-registered suppliers. This may include international sources that meet USP standards. To avoid stock issues, pharmacies can collaborate to order large quantities of commonly used APIs and distribute them according to patient needs. This can prevent excessive stockpiling and waste that could exacerbate shortages and cost pharmacies in the long run.

Sharing quality assurance protocols

During shortages, maintaining quality standards becomes even more critical. Pharmacies may work with unfamiliar suppliers or formulations, but still have the responsibility of ensuring quality. These protocols must align with USP standards and state board requirements. Collaborating on ingredient testing and finished product testing ensures safety and efficacy. Pharmacies can share quality control data on APIs and suppliers, including internal testing results and drug stability testing. When shortages occur, quality checks mean compounding pharmacies have the confidence to serve patients, regardless of the product's form or origin.

Solving shortages with compounding

Successful collaborative strategies require ongoing evaluation and refinement. Compounding pharmacies should build systems for tracking patient outcomes, monitoring adverse events, and gathering feedback from healthcare providers. This, coupled with building partnerships, sharing quality data, and managing the supply chain, can solve the shortage puzzle. Pharmacies can also collaborate with larger facilities in adjacent areas or work with external partners who perform testing and monitor APIs and supply chains. The resulting data even supports the improvement of future formulations and helps identify best practices. Collaborative compounding strategies will help differentiate pharmacies from competitors in future shortages.