Age-related COVID-19 vaccine mix-ups
A National Alert Network alert was issued in December 2021 about mix-ups between the Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11 years and the formulation for individuals 12 years and older. Reported errors include cases wherein the healthcare providers incorrectly thought it was acceptable to give a smaller or diluted dose of the formulation intended for individuals 12 or older to children ages 5 through 11. Vaccine vials for individuals 12 and up (purple cap) should never be used to prepare doses for younger children.
Onpattro requires a 0.45-micron filter for preparation
A hospital recently reported two sterile compounding errors involving the lack of an appropriate filter during the preparation of Onpattro (patisiran) lipid complex injection indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
According to the package insert, the product requires a 0.45-micron filter to be used during compounding, although one is not supplied. Hospitals may not routinely stock the 0.45-micron filter and may need to special order this item, as was the case at the reporting institution.
In one of the cases reported, the pharmacist misread the instructions and gave a 5-micron filter to the compounding technician to prepare the product. In the second case, no filter was used during compounding. The technician misunderstood the directions and assumed that the 0.45-micron filter was required during drug administration since a filter of that size was not commonly used during compounding. The hospital contacted the company to determine if it was possible to filter the medication after it was diluted in 0.9% sodium chloride, and the company said that the lipid complex would be altered if filtered after further dilution. This resulted in wasting the drug.
For other medications that require a specific filter, such as AmBisome (amphotericin B liposome for injection), the manufacturer (Astellas Pharma) provides the filter with the medication. Additional factors that contributed to not filtering the medication included high workload volumes and unfamiliarity with the product. Also, the technicians involved in both cases did not routinely compound sterile products but were assisting due to the increase in workload. The pharmacy staff is working to update the compounding instructions to clarify that filtration with a 0.45-micron filter is necessary for Onpattro. They are also putting the filter together with the drug in a kit for use when needed.
Prasugrel unavailable in unit-dose packaging
In 2021, Eli Lilly discontinued production of unit-dose packaging for the antiplatelet drug, Effient (prasugrel), leaving only 30-count bulk bottles of 5 mg or 10 mg tablets of the branded product for purchase. This is discouraging for hospitals since almost all drugs are dispensed in unit-dose packaging with a bar code on the label "...as a strategy to prevent medication errors." Unit-dose packaging also allows for the medication to be safely loaded in an automated dispensing cabinet (ADC); for example, cardiac catheterization labs often need a 60 mg loading dose (6 x 10 mg tablets) emergently for patients with acute coronary syndromes.
Because prasugrel is prone to oxidative and moisture-based degradation, the medication must be kept in its original container, which has a desiccant. The drug could be dispensed from the pharmacy when needed urgently, such as to cardiac catheterization labs, but this may lead to delays in care when emergent treatment is necessary. The cardiac team would have to contact the pharmacy and wait for the medication to be delivered. Another option would be to load an entire 30-count bottle in an ADC, but this could increase the potential for dosing errors if someone accidentally gives more or less than the recommended dose. One hospital developed a workaround by dispensing the bottle and desiccant after removing 24 tablets (and disposing them since they cannot be repackaged) and leaving 6 x 10 mg (60 mg) in the bottle for the loading dose. The bottle is then labeled with a repackaging barcode that covers the manufacturer's barcode.
The brand, Effient, is now marketed in the US by Daiichi Sankyo, which was acquired from Lilly in early 2022. However, the unit-dose packaging remains unavailable. Most generic manufacturers of prasugrel also do not provide the drug in unit-dose packaging. Aurobindo, however, indicates the unit dose in their packaging of prasugrel.