Drug Shortages Harming Patients

By Mike McEvoy
EMS Editor

Patients are suffering and even dying as a result of a series of never-before-seen medication shortages. During 2010 in the U.S., a record 211 drugs became scarce; 2011 shortages will likely top that figure. Hospitals, clinics, pharmacies, and EMS have been forced to ration critical medications, postpone treatments and surgeries, and find alternatives or substitutes when medications become scarce. The results are placing patients at increased risk of harm.

The most serious shortages are affecting emergency medicine, critical care, and oncology. Lack of medications such as epinephrine, norepinephrine, propofol, morphine, and cytarabine (a leukemia drug) has seriously affected patient care. Workarounds requiring recalculation of doses, dilution of more concentrated drug forms, and substitution of other agents during resuscitation have cost precious time, under and over-dosed patients, and led to a multitude of adverse outcomes. Inability to obtain medications has resulted in calamities such as a 16-year-old left with brain damage from a shortage of muscle relaxant needed after jaw surgery and a middle-aged woman who remains comatose when epinephrine was not available after her heart surgery. At least two deaths from hydromorphone have been reported when the drug was substituted for shortages of morphine.

Unfortunately, no one organization systematically tracks drug shortages and little, if any, warnings exist when shortages are about to occur. Causes are varied, ranging from lack of raw materials, increased regulation by the Food and Drug Administration (FDA), manufacturing equipment breakdowns, to consolidation of manufacturers. In some cases, increased oversight from the FDA has caused suppliers to just drop out of manufacturing medications, as happened during 2010 with propofol and pre-loaded syringes of epinephrine. Most medication shortages involve sterile injectable generics with slim profit margins and high propensity for manufacturing problems because of their complexity to produce. Consolidation in the pharmaceutical industry has resulted in a more global raw material supply chain with many materials coming from outside the United States. Problems with manufacturing or obtaining raw materials in other countries quickly lead to supply problems in the U.S. Compounding the problem are several smaller distributors who have been quick to take advantage of shortages, buying up and reselling existing supplies at exorbitant profit.

Solutions most likely need to be multifaceted. Manufacturers and regulators need to start coordinating supply and demand needs in a more organized fashion and work to assure that regulatory issues don’t unnecessarily interfere with production. Legislation has been proposed that would obligate manufacturers to notify the FDA whenever events occur that could lead to drug shortages. The FDA would also be give additional authority to address manufacturing obstacles that result in shortages. Last year, for example, the FDA was able to alleviate the propofol shortage by quickly authorizing foreign import.

Nonetheless, the current situation is a crisis. No clear solutions are in sight and frustrated providers will continue to experience abrupt and seemingly unpredictable shortages of critical medications. Patient harm will continue until effective solutions are implemented by both manufacturers and the FDA.

 
References
  1. FDA Web site on medication shortages: www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.
  2. Institute for Safe Medication Practices (ISMP): www.ismp.org.
  3. American Society of Health-System Pharmacists (ASHP): www.ashp.org
  4. Stein R. Shortages of Key Drugs Endanger Patients. Washington Post, May 1, 2011. Accessed on line: www.washingtonpost.com/national/shortages-of-key-drugs-endanger-patients/2011/04/26/AF1aJJVF_story.html.

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