Will Medication Shortages Be The New Normal?

Drug shortages continue despite the FDA approving more medications and tightening the reins on manufacturers.

Perhaps it is a bit ironic, but just when new drug approvals by the U.S. Food and Drug Administration (FDA) hit a 7-year high, we seem to be battling record numbers of medication shortages. A report by the University of Utah Drug Information Service revealed that 267 medications were subject to shortages in 2011, 56 more than in 2010.

The news could have been worse—the FDA took steps in 2011 to prevent some supply shortfalls by requiring manufacturers to report potential shortages in advance to the FDA. According to the University of Utah, the FDA’s actions may have prevented up to 100 additional shortages.

The shortage that occurred recently that gained the most media coverage had been the Gaucher disease medication imiglucerase (Cerezyme). Genzyme’s key plant producing this agent was closed for viral decontamination in 2009, and Cerezyme had only been removed from the FDA’s list of medication supply problems in 2010 before being replaced on the list in September 2011.

Here’s a sampling of other drugs (that begin only with the letter D) currently on the FDA’s Drug Shortage List (http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm):

  • Daunorubicin injection (manufacturing delays)
  • Deferoxamine mesylate injection (manufacturing delays and increased demand at other manufacturers)
  • Desmopressin injection (manufacturing delays and increased demand at other manufacturers)
  • Dexamethasone injection (manufacturing issues and increased demand at other manufacturers)
  • Denileukin Diftitox Injection (awaiting FDA approval of batches, sole manufacturer)
  • Dextroamphetamine tablets (ingredient shortage, sole manufacturer
  • Diltiazem injection (ingredient shortage)
  • Digoxin injection (manufacturing delays and increased demand at the other manufacturer)
  • Diphenhydramine injection (manufacturing delays and increased demand at other manufacturers)
  • Doxorubicin and doxorubicin liposomal injections (manufacturing delays)
  • Droperidol injection (manufacturing delays and increased demand at other manufacturer)

This sampling is representative of pretty much all of the letters in the alphabet. Sterile injectable products seem to be hardest hit.

According to an interview with the Associated Press, Erin Fox, PharmD, Director of the University’s Drug Information Service, the supply issues are caused by the need for manufacturers to shut down key production plants because of quality control problems, and consolidation of the generic drug industry has resulted in fewer manufacturers producing generic versions of similar products. The revenue generated by these medications may not be enough to retain manufacturers’ interest in expending resources on their production. This is particularly true of injectable agents for which generic versions have long been available. Where there used to be six manufacturers producing a generic of these medications, there may only be 1 or 2 today who have difficulty meeting the demand caused by another manufacturer’s plant problems.

Hospitals have been especially hard hit. Dr. Fox pointed out that current shortages in sedatives like diazepam, midazolam, lorazepam, often used in surgery, along with shortages of the pain medication fentanyl, have put special strains on hospitals' departments from maternity units to intensive care units. Metronidazole, the mainstay of treatment for Clostridium difficile infection, also is on the shortage list.

The problem seems to be worsening, as the number of drugs on the shortage list has increased each of the last 5 years. In 2004, only 58 drug shortages were recorded—roughly one-fifth the number today. It has been reported that these shortages have disrupted chemotherapy regimens for cancer, surgical care, and infectious disease and pain management. The FDA may have to work harder at providing incentives for manufacturers to meet demand on these products, which generally offer lower profit margins.

Fortunately, suitable and available alternatives exist for a great many of these at-risk medications. However, managed care organizations and other payers should be concerned that these medications—some of which are still highly useful despite being introduced decades ago—may cost them a great deal more in the future: This may be the price for meeting demand from an industry that has moved on to newer, more profitable drugs.