Although many ACEP members have forgotten about times when medications were consistently plentiful, it’s really been just a little longer than a decade that never-ending shortages have plagued patients and physicians alike. Since 2010, clinicians have been facing more than 150 active shortages at any given time. In fact, 10 of the most basic medicines have combined for more than 50 shortages in the past decade: dextrose, diazepam, epinephrine, fentanyl, lorazepam, morphine, ondansetron, nalbuphine, naloxone, and promethazine.

There are solutions beyond just tracking shortages. Although the U.S. Food and Drug Administration (FDA) is taking interest, many emergency physicians sometimes wonder if the government is problem solver, problem creator, or perhaps both. Emergency physicians may be unaware of these facts:

• The FDA has a drug-shortage team, further empowered by Congress’s passage of the FDA Safety and Innovation Act (FDASIA) of 2012.
• Pharmaceutical companies are now required to let the FDA know as soon as possible if actual or potential shortages are noted or expected.
• The FDA drug-shortage team has a “prevention tool kit” ranging from prioritizing manufacturing approvals to asking additional pharmaceutical companies to join in a particular generic medication’s production.
• The FDA can allow imports of foreign products to alleviate shortages. Recent examples of imports include propofol and normal saline.
• All of these points considered, the FDA and Congress can’t compel any company to supply a medication, no matter how critical or lifesaving it may be. Pharmaceutical manufacturing is a business; companies choose to make products or not.

While the cause of most shortages is some kind of manufacturing deficit, either in quality or capacity, the root cause of how those deficits come about is often unclear. Many of these products are generic and inexpensive in both wholesale and retail markets. When profit margins are slim, manufacturers may not have cash on hand or incentive to invest in manufacturing equipment dedicated to that product. Many companies have chosen to add more products to manufacturing schedules without corresponding additions in capacity. Overall, we’re left with a combination of economics, infrastructure, and business-model conflicts that is at the root cause of most shortages.

ACEP’s Emergency Medical Services (EMS) Committee leaders, Craig Manifold, DO, FACEP, and I, recently consulted with Erin Fox, PharmD, adjunct associate professor at the University of Utah School of Medicine in Salt Lake City, about these shortages. If you haven’t heard of Dr. Fox’s passion about the shortage of emergency medications in the United States, you should know we have a real ally.

Dr. Fox has been intricately involved in tracking shortages for more than 15 years. The American Society of Health-System Pharmacists (ASHP) maintains a very useful resource at www.ashp.org/shortage. Dr. Fox leads a team at the University of Utah Drug Information Service in close partnership with ASHP. She works on contingency strategies continuously and takes a particular interest in shortages impacting critical patient encounters, the encounters we face daily in EMS and emergency medicine.

Ten of the most basic medicines have combined for more than 50 shortages in the past decade: dextrose, diazepam, epinephrine, fentanyl, lorazepam, morphine, ondansetron, nalbuphine, naloxone, and promethazine.

For example, how is it that, with saltwater being so abundant on Earth, we can be in short supply of normal saline? Dr. Fox shares that it’s actually quite complicated to take large amounts of saltwater, make it sterile and particle free, and package it. This shortage comes down to capacity. With only three suppliers of fluids in the United States, there simply isn’t capacity to make up shortfalls in case of even a small recall or when a manufacturer needs to close a facility for cleaning. We also have other issues straining the supply of fluids, such as new medications that need dilution. Finally, companies increasingly manufacture on a just-in-time basis. When even a small glitch occurs, the supply chain is so fragile that it results in a shortage in your ED.

Dr. Fox predicts ongoing shortages of generic injectable medicines. She admits that predictions are particularly difficult as drug manufacturers do not disclose exactly which medicines are manufactured in specific facilities. Even if you follow the quality data that the FDA provides about a facility’s inspection, the medicines manufactured there remain secret.

Dr. Fox advises us of the benefits in partnering with pharmacists in both EMS and ED settings to help emergency physicians remain up to date about what shortages will be affecting their practices. The University of Utah Drug Information Service contacts manufacturers directly to verify contents of the ASHP Drug Shortages Resource Center. Emergency physicians can consider the alternatives and management suggestions made available on that Web site. The shortages considered particularly serious can be found by filtering on the “No Commercially Available Preparations” tab.

Dr. Fox encourages emergency physicians to do the following:

• Talk to the media about the impact of medication shortages in their individual practices.
• Remember that working around the shortages but not talking openly about them paradoxically makes the shortages invisible to policy makers and the public alike.
• Advocate that Congress create and pass legislation to mandate that pharmaceutical manufacturers disclose the location and the actual company that manufactures their products. Increased transparency in labeling helps identify shortage causes and helps in making quality purchasing decisions.

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Dr. Goodloe is medical director, medical control board, for the EMS system for Metropolitan Oklahoma City and Tulsa and professor and EMS section chief in the department of emergency medicine at the University of Oklahoma School of Community Medicine in Tulsa.