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

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No refills please

An Eliquis (apixaban, a factor Xa inhibitor) starter pack was prescribed for a patient to treat deep vein thrombosis and pulmonary embolism. The starter pack indicates that the patient should take two 5 mg tablets (10 mg) twice daily for 7 days, followed by one 5 mg tablet twice daily. The default setting in the electronic health record (EHR) was zero refills for the starter pack. However, a provider modified this field and sent the prescription to a pharmacy with authorization for refills. The outpatient pharmacy did not catch the error, and several months of refills were dispensed to the patient. Thankfully, the patient did not follow the directions on the starter pack each time it was refilled and was taking just one 5 mg tablet twice daily as intended.


Upon investigation, the reporting institution found additional instances in which the starter pack had been prescribed with refills. In each case, the dispensing pharmacy caught the error and corrected the prescription.


Facilities should check the default settings for refills in their EHR for all drug starter packs. If possible, the default should be set to zero without an option permitting a prescriber to modify this field. Other medications with starter packs include Xarelto (rivaroxaban), Chantix (varenicline), Lamictal (lamoTRIgine), and Otezla (apremilast).


Educate patients about why a starter pack has been prescribed for them. Explain that the pack is to be used only for the beginning of therapy and should not be refilled after the initial use. Also review the prescribed maintenance dosage following completion of the starter pack.


If two prescriptions (one for the starter pack and one for the maintenance dose following initial therapy) are sent together to the dispensing pharmacy, the prescriber should instruct the pharmacist to put the maintenance dose prescription on hold until the starter pack has been completed and instruct the patient to complete the starter pack first. The statement, "Begin taking only after the starter pack has been completed," should be included in the maintenance dose directions.



Nonstandard labeling creates confusion

The Institute for Safe Medication Practices (ISMP) continues to receive error reports related to the lack of standardized labeling of prefilled syringes and premixed I.V. infusion products prepared by compounding pharmacies and outsourcers. The FDA does not hold outsourcing facilities to the same labeling standards as commercial manufacturers. For example, under certain conditions, federal law exempts compounded drugs from the requirement for labeling with adequate directions for use. In addition, some compounders deviate from USP container labeling standards, which can contribute to errors.


A recent error report involved syringes of ketamine (a nonbarbiturate general anesthetic) compounded by QuVa Pharma. As shown in the first photo above, they are properly labeled with the concentration per total volume (50 mg/5 mL [10 mg/mL]), but they also contain the unnecessary statement, "5 mL in 5 mL Syringe" located below the concentration. This led to confusion and an error by a nurse who removed a ketamine syringe from an automated dispensing cabinet. The nurse misunderstood the volume statement to mean the concentration was 5 mg/5 mL and withdrew 5.7 mL (instead of 0.57 mL) for a 5.7 mg dose-a 10-fold overdose. The error was not caught until after administration. The patient was observed for hypotension and his vital signs remained stable.


QuVa also provides fentaNYL (a synthetic opioid) in a premixed I.V. bag (see photo below) with a similar unnecessary volume statement, "100 mL in 150 mL Bag." This appears in a slightly larger font than the statement about the total amount per bag, "1000 mcg/100 mL (10 mcg/mL)." The bag size is irrelevant but has the potential to be misinterpreted as the product strength.

Figure. The volume s... - Click to enlarge in new windowFigure. The volume statement, "5 mL in 5 mL Syringe," on this ketamine syringe compounded by QuVa Pharma is unnecessary and potentially confusing.

Standardized labeling should be established for compounders to avoid medication errors. ISMP encourages the FDA to publish guidance for outsourcers to establish specific standards for this industry.

Figure. Similarly, t... - Click to enlarge in new windowFigure. Similarly, the unnecessary volume statement, "100 mL in 150 mL Bag," on this compounded fentaNYL I.V. bag is misleading.