Shortage of Prefilled Epinephrine Syringes Raises Dosing Error Risk

July 02, 2010 05:05 pm News Staff

The American Society of Health-System Pharmacists, or ASHP, and the Institute for Safe Medication Practices, or ISMP, issued a joint alert( on June 16 about a shortage of prefilled epinephrine syringes that creates the potential for serious, even fatal, medication errors due to inappropriate dosing.

According to a bulletin( from the ASHP, Hospira Inc. is the only remaining U.S. manufacturer of epinephrine 1 mg/10 mL (0.1 mg/mL) emergency syringes after Amphastar Pharmaceuticals Inc. discontinued its emergency drug syringes in December 2009.

The FDA said in a June 4 entry on its drug shortages Web page that unexpected demand created the shortage and that Hospira was trying to increase production to meet that demand. The manufacturer planned to have product available by the end of June, with additional releases in July. As of July 2, however, no further information had been posted. (Editor's note: The shortage has been resolved, according to a Dec. 22, 2010, posting on the FDA website.)

The Hospira product is used in hospitals, ambulances and other settings for heart attacks, drownings, electrocutions and other emergency situations when a patient's heart is stopped, said Bona Benjamin, director of medication use, quality and improvement for the ASHP.

Benjamin said the shortage does not include self-administered 0.3 and 0.15 mg epinephrine injection products, commonly referred to by the brand name EpiPen, which are used to treat severe allergic reactions to insect bites, foods, medications, latex or other causes.

Although the shortage is expected to resolve this summer, the ASHP and the ISMP said in their joint alert that health care professionals should be aware of the risk for medication errors created by the shortage.

Injectable epinephrine is available as 1 mg/mL in 1-mL vials and as 1 mg/mL in 30-mL
vials, as well as in emergency syringes with intracardiac needles, but the organizations said in their alert that those products may not be safe alternatives for code carts, emergency vehicles or other emergency needs for the following reasons:

  • Epinephrine 0.1 mg/mL in 10-mL syringes have a 3.5-inch needle for intracardiac use that is not removable and not compatible with needleless tubing/systems. Attempting to use this product for intravenous or endotracheal administration with the needle attached or attempting to remove the needle may result in injury to both patient and caregiver.
  • Epinephrine is sensitive to light, air and pH and has a short stability time when extemporaneously prepared, making it unsuitable for bulk compounding by pharmacy departments.
  • Health care workers may not recognize or understand the difference between 1:1,000 (1 mg/mL) and 1:10,000 (0.1 mg/mL) concentrations and may miscalculate doses. The ISMP has received reports of fatal events attributed to such miscalculations.
  • The 30-mL vial more easily facilitates accidental overdose by providing sufficient volume of drug to allow 10-fold overdoses.

The ASHP and the ISMP recommended in their alert that current supplies of epinephrine emergency syringes that health care professionals and facilities have on hand should be reserved for code boxes, emergency response vehicles and other settings where pharmacists would not be present to dilute epinephrine during a code situation.

The two groups also made the following recommendations:

  • Do not stock multiple-dose 30-mL vials of injectable epinephrine 1 mg/mL in code boxes because they look similar to 30-mL vials of topical epinephrine that also may be stocked in code boxes or used in operating rooms.
  • Place auxiliary labels on intracardiac epinephrine that warn against intravenous and endotracheal use, and caution health care personnel about the danger of injury with attempted removal of the fixed needle. If not labeled for intracardiac use only, include this information, as well.
  • If using 1 mg/mL ampules or vials in lieu of emergency syringes, package the vial, diluent and syringe label in a clear plastic bag prominently labeled with the drug name and strength. Include instructions on preparing a dilution equivalent to a prefilled 1 mg/10-mL emergency syringe (i.e., epinephrine 1 mg -- dilute in 9 mL of sodium chloride 0.9%).
  • If substituting ampules or vials labeled as 1:1,000, provide a chart for converting doses in milligrams to milliliters, along with instructions for preparing a dilution in code carts, and post the charts in areas where epinephrine is frequently used.