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by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services
Drug shortages continueto make headlines across North America on a regular basis. These shortages occur for a variety of reasons. The FDA cites manufacturing quality issues as the major cause. The FDA also notes production delays in manufacturing the final drug product, delays in receiving components and discontinuations of drug products as additional causes that contribute to shortages.1Most recently, spikes in demand also created shortages, as occurred with amoxicillin suspension.
Health Canada describes shortages as when the drug manufacturer is unable to meet the demand for the drug and drug discontinuations, as when the drug manufacturer permanently ceases the sale of the drug.2
When shortages strike, compounders may step in to ensure patients retain access to their therapies and avoid interruptions in their current treatment regimen. For example, at the start of the COVID-19 pandemic, the FDA recognized the need for 503A pharmacies to compound drugs that were in shortage due to the extraordinary influx of hospitalized patients.3Without the contributions of 503A pharmacies, a vast number of patients would have been left without medications critical to their care.
Understanding how the FDA or Health Canada perceives and handles shortages can provide compounders with the ability to know how to help fill the unmet needs of patients while remaining in compliance with the FDA or Health Canada regulatory framework.
You may have noticed challenges arising when ordering some manufactured drug products or received calls on whether or not you can compound a drug because the commercially available product is difficult to find. However, does the FDA consider drugs that are hard to locate part of a drug shortage?
The quick answer is no. The FDA’s official recognition of a drug shortage occurs when a specific drug product appears on the FDA’s Drug Shortages List. A drug must meet many qualifiers, however, before it’s added to that list.
For example, the FDA limits inclusion to drugs they consider as medically necessary — which means that some drug products are disqualified, even if those drugs are in short or limited supply. In addition, the FDA determines if a specific drug qualifies as a drug shortage by dividing the total supply of the drug’s availability throughout the country by the expected demand of that drug.1
While this might appear reasonable to the FDA, the method does not recognize issues such as regional drug shortages, or the fact that community pharmacies and hospitals cannot be contracted with all drug wholesalers. If a regional shortage occurs or if a wholesaler has limited to no supply of a manufactured drug product, then the local pharmacy will not be able to meet the needs of their patients.
Health Canada’s Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051) states that when there is a shortage or no supply of a commercially available product and the healthcare professional has determined a medical need for this product, the product may be compounded during the period of shortage or no supply only. It is also advisable to understand any additional requirements that may exist from your college when it comes to shortages in Canada.
You may also be aware of the American Society of Health- System Pharmacists® (ASHP) Drug Shortages List. Compared to the FDA list, the ASHP Drug Shortages List consistently contains a significantly larger number of drug products.
In addition, the ASHP Drug Shortages List does not limit inclusion based on drugs deemed medically necessary. ASHP also accepts and receives input from practitioners; practitioner input is further substantiated by a team that contacts drug manufacturers about possible shortages.
Currently, the FDA has not recognized the ASHP Drug Shortages List as an official method of documenting shortages; however, a bill now before Congress, HR 167, would do exactly that.4
Look for Drug Shortages: Regulation, Impact & Opportunity, Part 2, on June 14 to learn what the FDA says about duplicating drugs during drug shortages and additional information.
A version of this article originally appeared entirely in PCCA’s members-only magazine, the Apothagram.
References
FDA. (current as of 02.28.2023) Frequently Asked Questions about Drug Shortages. Accessed 03.06.2023 at https://www.fda.gov/drugs/drug-shortages/ frequently-asked-questions-about-drug-shortages
Drug Shortages Canada. Accessed 03.15.23 at https://www. drugshortagescanada.ca
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Compliance. (2020 April, updated 21 May 2020) Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency (Revised) Guidance for Industry. Accessed 03.06.2023 at https://www.fda.gov/media/137125/download
Griffith, H. Morgan (Rep.-R-VA-9) (Introduced 2023 09 January). Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. Accessed 03.06.2023 at https:// www.congress.gov/118/bills/hr167/BILLS-118hr167ih.pdf