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ISMP petitions USP on epinephrine issues

(Article taken from the August 12, 2004 Medication Safety Alert Newsletter)


The recent death of a 16-year-old boy due to an epinephrine overdose (ISMP Medication Safety Alert! July 29, 2004) has further highlighted ongoing serious problems with epinephrine labeling and nomenclature. Two factors that contribute to errors include: (1) lack of understanding of the difference between dose concentrations (such as 1:1,000 or 1 mg/mL and 1:10,000 or 0.1 mg/mL), and (2) the fact that it’s too easy to confuse numbers in the thousands because there are so many zeros. There also is no warning on ampuls of epinephrine reminding practitioners that the more concentrated forms need to be diluted before use. Since the drug is grandfathered under the 1938 Food, Drug and Cosmetic Act, it is not regulated by FDA. However, it is a United States Pharmacopeia (USP) drug. Therefore, ISMP has petitioned the USP asking for the elimination of ratio expressions on labels of epinephrine injection. In its petition, ISMP stressed that the drug should be expressed only in mg, except when mixed with local anesthetics such as lidocaine, as indicated for prolonging duration of local anesthesia. ISMP also asked for changes in nomenclature to prevent epinephrine from being confused with ephedrine, another longstanding problem that was reported again last week. A copy of the petition can be accessed through our website by clicking here.


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