Drug Shortages Affect Everyone
With at least 68% of Americans using prescription drugs at some point, drug shortages at different points in time are possible. High demand and supply issues are often the cause of typical drug shortages. Not only do patients struggle to receive consistent care, but pharmacies are also unable to supply consistent medicine, which impacts revenue and the patient experience. When a drug shortage occurs, compounding pharmacies step in as a critical resource to ensure patients can access medication. Compounding is the process of creating, mixing, or altering custom medication using raw ingredients to meet the individual needs of patients. To provide safe, effective medication, compounding pharmacies must follow strict United States Pharmacopeia (USP) standards. Understanding these rules is essential to running a thriving compounding pharmacy.
Why USP standards matter
The role of a compounding pharmacy goes beyond simply filling a prescription during drug shortages. Compounding pharmacies must provide safe, quality-controlled alternatives that patients can trust. The USP provides the foundational standards that guide this crucial work. Following standards ensures compounded preparations are reliable, even during shortages. The pharmacy can provide consistent medication that aligns with the ingredients and efficacy of mass-produced equivalents. By adhering to these standards, a pharmacy reinforces a commitment to patient safety and becomes a vital part of the healthcare system.
The blueprint for action
Navigating a drug shortage requires an understanding of both the Food and Drug Administration (FDA) and the USP regulations. From time to time, the FDA allows compounding pharmacies to duplicate commercially available drugs that are on the official FDA drug shortage list. However, this permission is not a license to bypass quality standards. Compounding pharmacies must still comply with all other regulations, state laws, and USP standards. USP general chapter 795 is the blueprint for non-sterile preparations. These guidelines cover everything from ingredient quality to labeling and beyond-use dates (BUDs) guidelines. For sterile preparations, such as injectable glucagon-like peptide-1 (GLP-1) agonists, USP General Chapter 797 is the key guide. There are strict requirements for environmental controls, personnel training, and product sterility. Adhering to these standards, especially during a shortage, is non-negotiable.
Quality control is your competitive advantage
During a drug shortage, there is a temptation to cut corners to meet demand. However, a compounding pharmacy's long-term success depends on a reputation for quality. A great way to maintain quality is to source and test the active pharmaceutical ingredients (APIs) required for compounding. According to USP guidelines, all ingredients must be sourced from reliable, FDA-registered suppliers. These ingredients must undergo rigorous testing for identity, purity, and potency. Compounding pharmacies may need to use new suppliers during a shortage. Ensuring the suppliers have FDA-approved APIs is non-negotiable. Both suppliers and compounding pharmacies should invest in 3rd party testing to further ensure quality. This additional step not only ensures safety but also builds confidence and trust with patients.
Get proactive with compounding
Maintaining communication is vital during a drug shortage. Best practices dictate that prescribers and other healthcare professionals should be informed about which drugs are in short supply and what compounded options are available. A pharmacy can provide clear, concise information about the compounded preparation, including the formulation, any differences from the commercial product, and the rationale for the assigned beyond-use date. This transparency extends to the patient as well. The pharmacist must counsel on how to properly use the compounded medication, particularly if the dosage or administration method differs from what the patient is accustomed to. Providing written instructions that are easy for a layperson to understand can prevent confusion and potential errors.
Mastering inventory and supply
Another USP standard relates to storage and documentation. These steps ensure preparations are free of contamination while meeting potency. Shortages highlight the need for a resilient and well-managed supply chain. While commercial pharmacies may struggle with empty shelves, a compounding pharmacy can maintain a buffer by sourcing from different, vetted suppliers. The pharmacy can then proactively manage inventory. Implementing a robust risk management plan can help a pharmacy prepare and anticipate future shortages. Compounding pharmacies can also use these standards to produce batches of medication in short supply, as well as individual drugs in different forms. The team can then move to conserving existing stock, identifying alternative APIs, and establishing a network of reliable partners.
A path to lasting improvement
Drug shortages can occur at any time. Once the FDA approves compound alternatives, pharmacies must be ready. Systems must be put in place to follow USP standards for sterile and non-sterile medications. The focus should be on quality control, communication, and supply chain management, especially during a crisis. Providing effective, trustworthy medication can lead to improved pharmacy operations, increased patient volume, and a better patient experience. Using USP standards as a guide, the protocols developed to navigate drug shortages can be integrated into daily practice. This creates a more resilient, efficient, and more trusted compounding practice.
