ORAL CHEMOTHERAPY
Misinterpreting the label doubles the dosage
Venclexta (venetoclax) is an oral BCL-2 (B-cell lymphoma 2) inhibitor indicated for treatment of adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or acute myeloid leukemia. Recently, a hospitalized patient was prescribed a 20 mg dose of Venclexta. The drug's manufacturer, AbbVie, provides the tablets in several presentations, one of which is a unit dose package that contains two 10 mg tablets (see photos). As shown, however, the label on the package provides only the single tablet strength, 10 mg. Pharmacy staff, thinking that the two-tablet package contains a total of 10 mg, dispensed two unit-dose packages (four tablets) for the 20 mg dose. A nurse called the pharmacist to question whether all four tablets were to be given for the desired 20 mg dose and was told to administer them all. When nurse scanned the barcode on the package, the system read 10 mg and prompted the nurse to scan the second package. This scan reinforced the erroneous premise that each package contained a total of 10 mg. Thus, the patient received all four tablets, a 40 mg dose, instead of the intended 20 mg dose.
Similar errors related to this type of unit dose packaging have been reported with other products. The FDA should clarify how to safely label products like these with the total amount in the blister pack plus the amount per tablet and number of tablets. Otherwise, two-tablet doses should be discouraged altogether, with only single-tablet unit dose packages allowed. The Institute for Safe Medication Practices has notified AbbVie about this issue.
ENTERAL FEEDING DEVICES
Fit for safety
Misconnections between enteral devices and other medical devices, such as I.V. lines, tracheostomy tubes, and neuraxial access sites, have been associated with serious injuries and death. Under the trade name ENFit, a global standard was established to reduce the risk of enteral feeding set and syringe misconnections with vascular access devices or other clinical tubing connections. To meet this standard, the Global Enteral Device Supplier Association (GEDSA) has announced that member manufacturers will begin phasing out the manufacture of legacy feeding tubes starting July 1, 2020. Also, on January 1, 2021, there will be an industry-wide discontinuation of transition adapters, including those sold singly or now attached to ENFit feeding sets (see photos above) because they will no longer be needed. These moves will essentially force the adoption of ENFit devices. Organizations that have yet to convert to ENFit are urged to develop plans to do so as soon as possible. In addition, this information must be communicated to the broader healthcare community, including nurses, pharmacists, interventional radiologists, and providers who insert gastrointestinal tubes. For additional information, visit the GEDSA Stay Connected website (http://www.gedsa.org).