COVID-19 vaccine package concerns
Concerns regarding inconsistencies in the labels of the COVID-19 vaccines for young children have been reported. According to the Pfizer-BioNTech Fact Sheet for Healthcare Providers Administering Vaccine (http://www.ismp.org/ext/936) for children ages 6 months through 4 years, the vial labels may state either "Age 2y to < 5y" or "Age 6m to < 5y," and carton labels may state either "For age 2 years to < 5 years" or "For age 6 months to < 5 years." However, these products can all be used for children 6 months through 4 years. Facilities that receive these vials may find the labels confusing and mistakenly believe the vaccine labeled "2y to < 5y" cannot be used for children younger than 2 years. Also, some labels may state the vaccine should be discarded 6 hours after dilution, while the Fact Sheet states it should be discarded 12 hours after dilution. This could lead to unnecessary waste of vaccines.
In addition, the vial label and the box of the Moderna vaccine with the purple border specify "BOOSTER DOSES ONLY" (see Moderna COVID-19 vaccine label with a purple border). However, according to Moderna vaccine information (http://www.ismp.org/ext/935), this product is currently the only primary series vaccine available for use in children 6 through 11 years old.
Clinicians and parents are likely to become confused by these mislabeled products, resulting in missed opportunities to vaccinate more eligible patients. Manufacturers need to modify the labels to reflect the approved age range (Pfizer-BioNTech), the actual time the vial can be used before discarding it (Pfizer-BioNTech), and the primary series indication (Moderna). Meanwhile, organizations that use these products should familiarize themselves with these discrepancies and consider posting clarifying information for staff to review (http://www.ismp.org/ext/937, http://www.ismp.org/ext/935).
Potassium chloride for injection concentrate 250 mL bags reaching organizations
As the supply of potassium chloride for injection concentrate in 250 mL glass bottles is being depleted, more organizations are now receiving B. Braun's new pharmacy bulk package presentation of potassium chloride for injection concentrate (2 mEq/mL) in a 250 mL EXCEL container plastic bag.
Like several B. Braun I.V. infusion bags, this pharmacy bulk package has blue and red labeling, so a mix-up with other look-alike infusion bags could result in the potassium chloride for injection concentrate being accidentally dispensed and administered undiluted.
Ensure that only the pharmacy can purchase, store, and utilize this product. After purchase and upon receipt of the bags in the pharmacy, open the case and affix large, bold auxiliary warning labels to the overwrap on both sides of all bags. When using this product to prepare compounded sterile preparations, bar code scanning is imperative.
Pharmacists can now prescribe Paxlovid and need to be aware of error risks
The FDA has authorized state-licensed pharmacists to prescribe PAXLOVID (nirmatrelvir and ritonavir) to eligible patients (http://www.ismp.org/ext/947). However, certain limitations are outlined in this authorization to ensure the patient is assessed and the medication is appropriately prescribed.
Pharmacists should refer patients for a clinical evaluation with a healthcare provider licensed or authorized to prescribe medications if any of the following conditions apply:
* Sufficient information is not available to assess renal and hepatic function.
* Sufficient information is not available to assess potential drug-drug interactions.
* Modification of other medications is needed due to a potential drug-drug interaction.
* Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers (http://www.ismp.org/ext/827) or potential drug-drug interactions for which recommended monitoring would not be feasible.
Pharmacists and practitioners who prescribe Paxlovid should review previously reported errors and associated safe practice recommendations (http://www.ismp.org/node/32452, http://www.ismp.org/node/29033).