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.