ETOPOSIDE INJECTION LABELS
Amount per ML or total amount per container?
Toposar (etoposide injection) is a cytotoxic drug indicated to treat certain neoplasms. The carton and vial labels of Toposar (shown below) and generic etoposide injection from Fresenius Kabi don't comply with the standard for both single- and multiple-dose injectable drug products established by U.S. Pharmacopeial Convention (USP) chapter <7>. The USP requires that the total strength per total volume of the container be the primary and most prominent expression of strength on the principal display panel of the label. The total amount per container must then be immediately followed in less prominent fashion by the strength per mL. This is what healthcare professionals are accustomed to seeing and what they expect. But what appears on the labels for Toposar and generic etoposide injection are exactly the opposite of this standard: These labels express the strength as 20 mg/mL as shown below, even though the drug is available in 5 mL (100 mg), 25 mL (500 mg), and 50 mL (1 g) vials.
When drug labeling prominently displays the amount per mL instead of the total amount per container, it could mislead someone into believing that the total amount per mL is the amount in the entire container. For example, the ISMP National Medication Errors Reporting Program database contains a report of a physician who ordered 100 mg of the drug. Because of vial labeling that expressed the per mL amount more prominently, a pharmacist prepared five 5 mL vials (500 mg total) thinking each contained only 20 mg of the drug. Depending on the cancer being treated, doses up to 120 mg/m2 are typical. Fortunately in this case, an independent double-check was conducted and another pharmacist identified the error before it reached the patient.
The manufacturers have been notified and the FDA is investigating the issue. In facilities that have either the Teva or Fresenius Kabi product, an auxiliary label should be placed prominently on the carton and vial stating the total strength per total volume to be sure no one mistakes the per mL dose as the total amount per vial. Barcode scanning during I.V. drug preparation may also help prevent this type of error.
VINCRISTINE
Extravasation unlikely with minibags
Twelve months of data collected at The Johns Hopkins Hospital found zero cases of extravasation among more than 1,300 minibag administrations of I.V. vinCRIStine, an antineoplastic agent, after a recent change from administering the drug from a syringe. These results were recently presented at the Oncology Nursing Society 42nd Annual Congress.1 ISMP Targeted Medication Safety Best Practice #1 calls for dilution of I.V. vinCRIStine in a minibag rather than dispensing and administering the drug in a syringe. This reduces the risk of an accidental mix-up with intrathecal medications, which are given via syringe. Even though such mix-ups have been uniformly fatal, it's been difficult to make this change at some locations because nurses are so used to administering vesicants (other than continuous infusions) via I.V. push through the side port of a free-flowing I.V. line.
According to the Congress presenters, one barrier to standardizing vinCRIStine administration in minibags is the fact that some nurses believe the risk of extravasation is lower when the drug is manually pushed through the I.V. line. Other barriers noted by the researchers included a lack of understanding of the risk of death associated with central nervous system administration of vinCRIStine and an insufficient understanding of how to properly administer vinca alkaloids such as vinCRIStine via a minibag.
These new data should help convince hospitals that have yet to make the switch to minibags for vinCRIStine. Infusion from a minibag is also supported by The Joint Commission, the World Health Organization, the Oncology Nursing Society, and the National Comprehensive Cancer Network.
REFERENCE