1. Cohen, Michael R. ScD, MS, RPh

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Labeling omits key information

Earlier this year, the FDA approved Par Pharmaceutical's 1 mL and 30 mL vials of Adrenalin (EPINEPHrine) 1 mg/mL for I.V. use. The product was formerly labeled for I.M. and subcutaneous use; as shown in the photo below, the package label now also includes I.V. infusion. The labeling does not contain instructions for I.V. push administration, which is a common use for treating cardiac arrest. The only I.V. indication in the approved labeling is for hypotension associated with septic shock. Labeling for that indication calls for diluting 1 mL (1 mg) of EPINEPHrine from the vial in 1,000 mL of a 5% dextrose or 5% dextrose and sodium chloride solution. No mention of the typical dilution of 1 mg in 10 mL (0.1 mg/mL) for I.V. use is found in the labeling, probably because the company did not submit data about I.V. push use during cardiac arrest.


Another FDA-approved vial of EPINEPHrine by Belcher Pharmaceuticals has the same indication for hypotension associated with septic shock. Prefilled emergency syringes (1 mg/10 mL) available from Amphastar Pharmaceuticals and Pfizer, which are labeled with instructions for use in treating cardiac arrest, have been subject to shortages.

Figure. This product... - Click to enlarge in new windowFigure. This product is now approved for I.V. use, but the labeling does not specifically include instructions for administration via I.V. push.

Keep in mind that because the Par EPINEPHrine product contains tartaric acid as a preservative, it is not for use during intraocular surgery. At one time, Par Pharmaceutical's 1 mL Adrenalin vials (but not the 30 mL vials) had no preservative, and induction and maintenance of mydriasis during intraocular surgery was one of the listed indications. Now, the only EPINEPHrine product that can be used in eye surgery is Belcher Pharmaceuticals' EPINEPHrine product, which has no preservative.



These drug vials are hard to tell apart

As shown below, the labels for several injectable Alvogen products have the same distinct mustard-yellow background color; in addition, a color band that highlights the product strength distracts the eye from the drug name. Near-miss errors related to these look-alike labels have been reported. In one case, for example, a nurse discovered a vial of rocuronium 50 mg/5 mL in an automated dispensing cabinet drawer that normally holds vials of metoprolol tartrate 5 mg/5 mL. Rocuronium is a nondepolarizing neuromuscular blocking agent; metoprolol is a beta-blocker used to manage hypertension. Warnings about rocuronium being a paralyzing agent are included on the label's side panel, but this critical information could be missed if the drug is stocked in error and thought to be another drug. Fortunately, the nurse in this case recognized the mix-up before the medication was used. The Institute for Safe Medication Practices has alerted the company to this issue.



Warning statement open to misinterpretation

To prevent incidents in which a single insulin pen is used for multiple patients, the FDA requires pen manufacturers to include the statement, "For single patient use only," on all pens and outer cartons. A patient who was newly started on NOVOLOG Mix 70/30 (insulin aspart protamine and insulin aspart) read the statement and thought "single patient use" meant to administer the entire contents at once. It is unknown if the patient received 60 units (the maximum that can be dialed as a single dose) or the entire 300 units in the pen. The patient became unresponsive and was brought to the hospital with a blood glucose level below 30 mg/dL. Placed on a 10% dextrose infusion, the patient responded to treatment and recovered.


The patient in this case had received no education about administration technique or dosing. Never underestimate the value of patient teaching or make assumptions about the patient's level of knowledge. When educating a patient about the use of insulin pens, be sure to discuss the meaning of "For single patient use only."