RUFINAMIDE ORAL SUSPENSION
Discard within 90 days of opening the bottle
Rufinamide (40 mg/mL) oral suspension, a generic antiepileptic drug from Hikma, should be discarded within 90 days after the bottle is opened. This is noted in the product's package insert but not on the bottle or the outer carton. The carton and bottle label for the brand-name rufinamide product, Banzel (40 mg/mL) oral suspension from Eisai, mentions this important warning. The problem has been reported to Hikma, which reports that it has initiated a revision of the carton and bottle labeling that will be implemented in the next production cycle. For now, the facility that reported the problem is attaching auxiliary labels to the bottle. Educate patients who have been prescribed rufinamide oral suspension about the 90-day limit.
CHEMOTHERAPY
Piqray labeling sows confusion
Piqray (alpelisib), a kinase inhibitor, is prescribed with fulvestrant to treat specific forms of advanced or metastatic breast cancer. It is available as 50 mg, 150 mg, and 200 mg oral tablets. The standard dose is 300 mg (two 150 mg tablets) daily. The product is packaged in a carton with a principal display panel that reads, "Two 14-day blister packs each containing 28 tablets." As shown above, the label also states that this is a "28-day supply," but it fails to note the total number of tablets inside the carton, which is 56. In one reported case, this led to an extra carton being dispensed during monthly refills for two patients. Apparently pharmacy staff saw "28-day supply" on the carton and assumed they would need two boxes to reach the intended quantity of 56 tablets. The staff member did not understand that "Two 14-day blister packs each containing 28 tablets" meant that each carton contained 56 tablets. In fact, some computer listings erroneously indicate "28" as the quantity.
An inpatient pharmacist reported that the facility's electronic health record (EHR) displays Piqray as "Unit strength: 300 mg, quantity: 56 tablets, days supply: 28," which led staff to believe the tablet strength was 300 mg, 2 tablets daily, or 600 mg per day. This resulted in an inpatient order for an incorrect dose of 600 mg per day.
This type of confusion extends to the 250 mg daily dose but not to the 200 mg daily dose because a 200 mg strength tablet is available. If a patient needs only one 200 mg tablet daily and the carton contains 28 tablets, there is no risk of confusion.
Facilities that stock Piqray must ensure that the EHR and pharmacy software correctly indicate the tablet strength, daily dose, and quantity per box. In addition, staff should be educated about potential confusion surrounding the correct quantity and dose. For the 300 mg and 250 mg daily dose cartons, affix flags or reminders to indicate that one box contains 56 tablets and that only one box is needed for a 28-day supply.
The Institute for Safe Medication Practices (ISMP) has contacted Novartis, the manufacturer of Piqray, to recommend updating the label. Novartis agreed to follow up on these issues.
COVID-19 VACCINATIONS
USP vaccine handling toolkit available
The US Pharmacopeia (USP) has published a free COVID-19 Vaccine Handling Toolkit for healthcare professionals. It was developed by over 40 independent expert volunteers led by USP's Healthcare Safety and Quality Expert Committee with representation from several other Expert Committees, including representatives from the CDC and FDA. ISMP was also a participating organization. The Toolkit, which will be updated as new information and more vaccines become available, will eventually include operational strategies in three key areas: preparation and labeling; storage, handling, and transport; and waste and disposal. Access it at http://www.ismp.org/ext/634.