Pharmacists Play a Role in Responding to Drug Shortages

As of September 2018, there were 139 new national drug shortages during this year alone, and a total of 238 overall, according to University of Utah (UA) Drug Information Service data.

"It’s a lot,” Erin R. Fox, PharmD, BCPS, FASHP, Senior Director for Drug Information and Support Services at UA Health, told an audience at a satellite symposium at the 2018 American Society of Health-Systems Pharmacists (ASHP) Midyear Clinical Meeting in Anaheim, CA, this week. The session, which was supported by an educational grant from Baxter Healthcare Corporation, centered on best practices pharmacists can utilize to respond to ongoing drug shortage issues.

Drug shortages have a tremendous impact on the health care system; in the United States, $209 million was spent in 2013 for the purchase of more expensive substitutes, according to ASHP estimates. That estimate does not include other significant costs, such as the added labor required to identify available alternative products and to ensure operational changes to accommodate the product changes.

Data from the Drug Information Service, which provides drug shortage content to ASHP, show the top 5 drug classes with active shortages on September 30, 2018 were antimicrobials, chemotherapy products, cardiovascular and central nervous system medications, and E-lytes, nutrition and fluids. The data presented by Fox showed that many of these active shortages were injectable, including 34 of the 36 items in the E-Lytes, nutrition and fluids category.

In her presentation, Fox said some of most basic products required for patient care are often subject to shortage. She noted bupivacaine, lidocaine, hydromorphone, morphine, fentanyl, ketamine, ondansetron, saline, and sterile water as examples.

Many drug shortages have been related to quality issues at manufacturing facilities, Fox said. While most factories are running at capacity, some also are utilizing aging facilities or producing medications ‘just in time.’ In addition, business decisions impact drug availability, she explained.

“Over the years, manufacturing has become more lean,” said Fox. “It’s expensive to add manufacturing lines, and it takes time. It may not be worth the money to keep those factories up to date.”

Meanwhile, a lack of transparency can pose a problem for ensuring quality, Fox told the audience. Often, companies hire other companies to make their products, and "they just put a label on it,” said Fox.

For injectables, there is also is a fragile supply chain to consider, Fox said. Often, a single firm is producing 90% of the total supply and it is common for that firm to have a sole source of raw materials, she added. Competition for manufacturing these drugs is low, especially when companies consider a low return on investment for certain products.

During her presentation, Fox acknowledged challenges pharmacists face with drug shortages, but said the goal of these health care professionals should be to minimize the impact of drug shortages on patients. These shortages may be not be seen by other professionals on a patient’s health care team, she emphasized, so it is imperative that pharmacists take on this role.

Citing ASHP Guidelines on Managing Drug Product Shortages, which she developed, Fox said a key strategy for pharmacists is to plan for drug availability challenges. “Do as much work ahead as you can,” said Fox. “If you can be well-prepared and make your checklist, you’re already ahead of the game."

Planning ahead includes having a team in place, assessing operational and therapeutic needs, conducting impact analysis, and devising an action plan, Fox said. Having that plan in place extends to disaster response, such as preparedness and recovery.

Gathering data and monitoring a shortage and maintaining contact with local representatives of the manufacturer are part of the pharmacy team's work to mitigate the impact of less drug availability, Fox said. Making decisions for purchasing and rationing drugs; storing, preparing and dispensing these products; and communicating the information to patients also are crucial for managing a drug shortage.

In situations when there is not enough product, Fox urged pharmacists not to ration alone and suggested having a resource allocation committee in place to make those decisions. “There might be days where you lose your entire supply. You have to have a plan for dealing with that,” she said.

Overall, coping with drug shortages comes down to communication. Every team member should know his or her role and be proactive in sharing that information.