IVERMECTIN

Beware of unproven COVID-19 treatments

Published online ahead of print, a research article described how ivermectin, an anthelmintic drug, inhibits the replication of the SARS-CoV-2 virus in a petri dish. After the article appeared, the FDA's Center for Veterinary Medicine became aware of this medication's increased public visibility, leading the FDA to issue a medical product safety alert warning consumers against taking ivermectin products intended for animals in an effort to prevent or cure COVID-19.1 Ivermectin tablets are approved for human use for treatment of some parasitic worms, and topical formulations are approved for human use for the treatment of head lice and skin conditions such as rosacea. But in the latest study, which describes basic scientific research, no ivermectin was administered to any animals or humans. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat COVID-19.

Medications formulated for animals can seriously injure people. Warn patients not to take any form of ivermectin or any other drug purported to treat COVID-19 unless it has been prescribed by a healthcare provider and is obtained through a legitimate source. Help protect public health by alerting the FDA about any products being promoted as a treatment or cure for COVID-19. Send an email to mailto:[email protected], or call 1-888-InfoFDA (1-888-463-6332).

REFERENCE

1. US Food and Drug Administration. FDA letter to stakeholders: do not use ivermectin intended for animals as treatment for COVID-19 in humans. News release. April 10, 2020. [Context Link]

MISLEADING LABEL

Strength in numbers

Teva's 5 mL haloperidol decanoate injection lists the drug strength, 50 mg/mL, on the outer carton as well as the immediate container label. However, the strength should properly be listed as 250 mg/5 mL (50 mg/mL), as required by USP General Chapter <7> Labeling (USP <7>). Although the label indicates that the product is a 5 mL multiple-dose vial, that information is easily missed because it is located apart from the 50 mg/mL expression in a smaller font, as shown in the photo above. This almost led to a dispensing error at one hospital, when a pharmacy technician was about to refill an automated dispensing cabinet pocket with a 250 mg vial instead of the intended 50 mg vial. In this case, the bar code was scanned, which identified that the vial contained the wrong amount of drug. For safety reasons, if a 250 mg vial is needed, hospitals should purchase it from a different manufacturer until Teva's labeling is updated using the proper format for listing the concentration.

GLUCOMETER READINGS

High-dose ascorbic acid interferes with results

A patient with COVID-19 and diabetes was started on high-dose I.V. ascorbic acid (vitamin C). The patient became hyperglycemic, requiring treatment with an I.V. insulin infusion. The next day, a pharmacist notified the prescriber that high-dose I.V. ascorbic acid interferes with glucometer measurements, elevating the results. The prescriber discontinued the ascorbic acid without adjusting the insulin infusion dose. The patient then became hypoglycemic, requiring treatment with 50% I.V. dextrose.

Interest in the antioxidant properties of ascorbic acid has grown during the novel coronavirus pandemic, and high-dose ascorbic acid is being explored as a treatment for COVID-19. Severe anemia is also common in these critically ill patients. Unfortunately, both anemia and high-dose ascorbic acid impact the accuracy of most glucometer results, leading to falsely elevated glucose levels and the potential for excessive insulin dosing and hypoglycemic events. The hospital where this event happened is considering requiring lab confirmation of glucometer results above 200 mg/dL for patients receiving I.V. ascorbic acid.

Resources for COVID-19

ECRI has launched a COVID-19 Resource Center with a weekly summary of resources, webinars on various COVID-19-related topics, strategies, and tactics to support patient care during the COVID-19 pandemic. Access it at http://www.ismp.org/ext/368.