Handling National Drug Shortages

Anaheim—Though the rate of national drug shortages has decreased over time since hitting a high in 2011, the ongoing shortages are not being resolved and continue to impact patients, clinicians, and health systems. During a session at the ASHP meeting, strategies to manage drug shortages and monitoring patient safety were discussed.

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The top 5 active shortages by drug class include antimicrobials, chemotherapy, cardiovascular conditions, central nervous system disorders, and electrolytes/nutrition, according to the presentation.

In addition, a 2014 report from the Government Accountability Office (GAO) found that although reports of new drug shortages declined in 2012, the total number of shortages active during a given year has increased since 2007 [GAO-14-194; 2014]. GAO indicated that drug shortages may force providers to ration care or rely on less effective drugs, according to provider association representatives.
In the GAO report, various reasons were implicated for causes of drug shortages, specifically:

40% quality problems
• 30% manufacturing delays and
capacity issues
• 12% product discontinuation
• 9% active pharmaceutical ingredient (API) or non-API component issue
• 6% increased demand
• 3% loss of manufacturing site or site change

The GAO report concluded by recommending that the “FDA strengthen its internal controls over its drug shortage data and conduct periodic analyses to routinely and systematically assess drug shortage information, using this information to proactively identify drug shortage risk factors.”

According to the FDA Web site, “shortages of drugs and biologics pose a significant public health threat, delaying, and, in some cases, even denying, critically needed care for patients.”

During the ASHP presentation, the management of drug shortages was discussed, including implementation of a team-based approach. “Managing drug shortages well begins with an established plan,” according to the presentation. A team “checklist” should include:

• Management of data and monitoring of shortages
• Purchasing decision-maker
• Storage, preparation, and dispensing change decision-maker
• Rationing decision-maker
• Change in technology options
• Communicator of information

 The presentation segued into assessments and strategies for the team to consider. The initial assessment should include questions, including which medications are facing a shortage, how much inventory of a medication is currently available, and how long the remaining inventory will last. The clinical assessment should include questions such as how patients will be impacted by the shortage, any evidence-based alternative treatments, and which clinicians and services are most impaired by this. An operations assessment should include questions such as how the pharmacy and technology will be impacted, what the communication strategy will be, and how patients will be managed in the meantime. Lastly, the management strategy should include assessing rationing, alternative medication options, postponement of treatment, or customized alternatives.

According to the presentation, 10 medications have faced shortages more than 50 times between 2001 and 2013, including dextrose, diazepam, epinephrine, fentanyl, lorazepam, morphine, ondansetron, nalbuphine, naloxone, and promethazine.—Kerri Fitzgerald