COVID-19 MONOCLONAL ANTIBODY

Infusion rate confusion

The FDA granted bamlanivimab, a monoclonal antibody marketed by Eli Lilly, Emergency Use Authorization for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and children (12 years or older weighing 40 kg or more) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. The dose should be administered as soon as possible after a positive viral test and within 10 days of symptom onset. Bamlanivimab is indicated for patients who are at high risk for progressing to severe COVID-19 and/or hospitalization, but not for patients who are already hospitalized.

Table 1 in the Fact Sheet for bamlanivimab provides confusing administration rate information. The drug is available as a concentrated solution and must be diluted before administration by I.V. infusion. Table 1 mentions that the final prepared product of 700 mg/200 mL should infuse at a minimum infusion rate of 200 mL/h; however, it also states that the prepared 200 mL volume must be infused over at least 60 minutes. The specified infusion rate is actually the maximum infusion rate, as the Institute for Safe Medication Practices (ISMP) has confirmed with Eli Lilly. If 200 mL/h is considered the minimum infusion rate, then bamlanivimab could be administered at a faster rate than recommended and the dose would be given in less than 60 minutes.

The hospital that reported this infusion rate discrepancy has created a hard stop within its smart infusion pump software that prevents infusion rates greater than 200 mL/h for bamlanivimab. Also, administration instructions state to administer the dose over at least 60 minutes.

This issue was reported to the FDA and to Eli Lilly. Both have indicated that the Fact Sheet will be revised.

CLOSE CALLS

Heparin-hypertonic saline mix-ups

As shown in the photo, B. Braun 500 mL bags of heparin 25,000 units in D₅W and hypertonic sodium chloride 3% look similar while in their overwraps. In a recent close call, the similar-looking bags were stored next to each other on open shelving in the stockroom due to the large bag size and the wrong product was selected. Thanks to pharmacy dispensing safety checks, the error did not reach the patient.

In another case involving heparin 20,000 units in D₅W 500 mL and hypertonic sodium chloride 3% 500 mL, the similar clear plastic overwraps, along with visual similarities in the labeling (such as the same red and blue text and similar location of product name and strength) led a pharmacy technician to attempt to restock an automated dispensing cabinet (ADC) with the wrong solution. While trying to restock the ADC with the heparin product, the technician kept getting an incorrect bar code scan for the ADC location. The technician then realized that hypertonic saline, not heparin, was in hand.

Figure. B. Braun 500 mL bags of 3% sodium chloride (left) and 25,000 units of heparin (right) look very similar in their overwraps.

ISMP has contacted B. Braun about these packaging similarities and asked the company to consider making changes to at least one of the products to help prevent mix-ups in the future. ISMP has also asked the company to review their other heparin products to minimize the potential for look-alike confusion.

An actual mix-up between heparin and hypertonic saline could prove serious. Bar code scanning should catch an error; however, ISMP has received complaints about the difficulty of scanning a bar code printed in white, as with the bar code on these products.