Managing Drug Product Shortages

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A previous Tip discussed some important aspects of purchasing and inventory control. A component of this facet of management regards drug product shortages. Drug product shortages can adversely affect drug therapy, compromise or delay medical procedures, result in medication errors, cause patient harm, frustrate pharmacist-patient relationships, and be costly to the pharmacy organization. These costs can be borne from lack of sales and customer grievances, but also from having to purchase more expensive substitutes. Managing drug shortages is particularly complex in acute care settings because these facilities treat patients with emergent conditions, use a large number of single-source products, and employ high-cost new drugs and technologies. Medication errors are more likely to occur when a pharmacy alters how a product is ordered, prepared, or dispensed, or when prescribing practices change to less-familiar alternative agents. Drug shortages have become more common, with various disruptions in the supply chain, including quality problems particularly for large molecule and other drugs more difficult to manufacture. This is compounded by manufacturer business decisions, shortages of raw material, restricted distribution, and other factors.

Given the ramifications of drug shortages, the American Society of Health Systems Pharmacists (ASHP) developed guidelines to manage them.1 These include having a drug product shortage team of key staff who can make decisions, a resource allocation committee that is proactive in scanning the environment even for potential shortages and contingencies, a process for approving alternative therapies, and a process for addressing ethical considerations. The guidelines further describe how to respond to drug product shortages, conducting operational assessment such as inventory on hand, and conducting therapeutic assessment. The pharmacy team should conduct an impact analysis that includes financial ramifications, develop an action plan, and communicate appropriately to all affected stakeholders.

Pharmacy managers must be proactive to the extent possible in managing drug shortages by having ready-made plans. Failing to do so can compromise relationships with multiple stakeholders and jeopardize patient safety.

Additional information about Purchasing and Inventory Management can be found in Pharmacy Management: Essentials for All Practice Settings, 4e. If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to Pharmacy Management: Essentials for All Practice Settings, 4e. If your institution does not provide access, ask your medical librarian about subscribing.

1Fox ER. ASHP guidelines on managing drug product shortages. Am J Health Syst Pharm. 2018;75:e593-601.

Shane Desselle

Professor of Social and Behavioral Pharmacy, Touro University California

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Shane Desselle over 1 year ago

How has your organization handled the prevailing shortages? Have you seen deterioration of relationships with your patients and clients?