A recent, severe increase in the number of drug shortages has become a significant part of our national health care crisis. Which drugs are short, and why? The answers are unexpectedly complex. Gundy Sweet, Pharm.D., director of drug information and medication use policy for the U-M Health System, unravels some of the tangled factors behind the drug shortage crisis and shares the impact shortages are having on U.S. health systems and the national health care budget.
Q: What is the scope of the drug shortage problem in the U.S.?
A: Drug shortages have been around for more than a decade. There were roughly 70 newly identified shortages annually through 2006. Then the numbers started to skyrocket, with 267 shortages in 2011 — up from 211 in 2010 and 166 in 2009. The American Society of Hospital Pharmacists (ASHP) lists 283 active drug shortages as of this interview. Ten percent of those were newly identified in 2012, with the other roughly 250 being carry-overs — shortages are not resolving as quickly as they did in the past. Also concerning are shortages of related drugs, making identification of alternative therapies challenging.
Q: What kinds of drugs are involved?
A: Virtually every therapeutic drug class has been touched. Most are generic; the vast majority are parenteral (drugs administered by injection). FDA data on shortages classified as “medically necessary” show that 80 percent of shortages are for parenteral products.
Q: What’s causing this crisis?
A: Many factors come into play. When brands go generic, more companies come to market. Competition drives the price down and eventually there is no good return on investment. Manufacturers pull out of the market and those that remain are unable to supply the market demand. The FDA reports that the top three generic injectable manufacturers hold 71 percent of the market volume. Most sterile injectables have one manufacturer that produces at least 90 percent of the product’s market share. It doesn’t take much to tip the apple cart.
Law requires that the FDA approve the active pharmaceutical ingredient (API) source and the production line for any drug product. If the API source dries up, the FDA must approve a secondary source prior to use. Any needed equipment recalibration can cause further delays. It’s a domino effect. I suspect there’s also production equipment that’s dated or in need of repair. Lines shut down either voluntarily or at the request of the FDA when they’re not able to produce a quality product that meets good manufacturing practice requirements. When that involves one of just three major U.S. suppliers, it’s a bad situation.
A global market complicates the situation further. Many active ingredients come from foreign sources whose plants also need to be inspected and approved. In addition, nearly everyone in the product supply chain has moved to just-in-time inventory. It’s not uncommon for us to have a one-week inventory on-hand for a given drug, and the same is often true for our suppliers. There are good reasons for this, but it leaves no cushion in the market — the entire supply chain becomes reactionary.
It’s important to remember that the FDA must work within what’s defined in the law. It literally will take an act of Congress to allow the FDA to do some things that could help, although no one quick fix will solve this very complicated problem.