By Mike McEvoy
EMS Editor
A recent change in U S Food and Drug Administration (FDA) requirements resulted in multiple manufacturers discontinuing production of medications, especially certain preloaded medication syringes in common use by Prehospital and hospital emergency responders. Drugs affected include calcium chloride, dextrose 50%, epinephrine (preloaded 1mg/10 ml syringes), haloperidol, and pancuronium. The FDA maintains a Web site with updates on each drug shortage at www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm. EMS Chiefs can sign up to receive email notices of current and resolved drug shortages directly from the FDA at www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.
Only one manufacturer, Hospira, is currently approved and producing preload emergency medications in the US. The good news, announced recently, is that Amphastar Pharmaceuticals subsidiary, IMS (International Medications Systems) who ceased production of emergency meds in December 2009 has received FDA approval to resume manufacture of several emergency medications. Shipments are expected to begin late August 2010 and should help reduce some of the backlog currently shouldered by Hospira.
Alternatives for some meds are available and in use by many EMS. Dextrose 50%, for example, can be substituted with a 250 ml bag of dextrose 10% with the added benefit of reducing potential for tissue injury from extravasation (a serious complication associated with D50%), and ability to more carefully titrate dosing that produces a state of wakefulness without rebound hyperglycemia.
Epinephrine substitution is fraught with potential for error resulting in patient harm. The FDA strongly suggests that substitution follow guidelines of the American Society of Health-System Pharmacists (ASHP) for managing drug shortages. ASHP maintains a drug shortage web page at www.ashp.org/shortages?WT.ac=hp%5FPopLinks%5FDrug%5FShortages with links to specific substitution guidelines for particularly dangerous medications. Epinephrine guidelines are located at www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/GettingStarted/CurrentShortages/Bulletin.aspx?id=640.
