The Washington Pharmacy Quality Assurance Commission (PQAC) sent out a communication to pharmacists this week with a reminder that the U.S. Food and Drug Administration (FDA) has not approved ivermectin for use in treating or preventing COVID-19 in humans and it has not been proven safe or effective for this indication. PQAC advised pharmacists receiving prescriptions for ivermectin for the treatment of prevention of COVID-19 should use their professional judgment in determining whether to fill them and if they have concerns related to the prescribing practices of a practitioner, it may be appropriate to reach out to the corresponding licensing board or commission.
Human-grade ivermectin products differ from those for animals. Ivermectin tablets are FDA-approved to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. There are also some topical forms of the medication that are approved to treat head lice and for skin conditions such as rosacea. The drug is not approved to treat or prevent COVID-19 in people.
Side effects from ivermectin may include but are not limited to, skin rash, nausea, vomiting, diarrhea, stomach pain, facial or limb swelling, dizziness, seizures, confusion, a sudden drop in blood pressure, and liver injury (hepatitis). Drugs prescribed for animals are often highly concentrated because they are used for large animals and therefore may be toxic to humans. The FDA has received multiple reports of people who were hospitalized after self-medicating with ivermectin intended for horses. In July 2021, poison control centers across the country reported a five-fold increase in the number of calls for human exposure to ivermectin.
Despite the dangers, nationwide the CDC has seen a sharp increase in both providers prescribing and patients requesting ivermectin for COVID-19. According to the CDC, during the second week of August more than 88,000 prescriptions were reported nationwide, which is 24-times higher than the number of prescriptions written before the pandemic and more than double the previous peak of prescriptions written in early January 2021. The FDA has established a cross-agency task force that closely monitors for fraudulent COVID-19 products that claim to prevent, diagnose, treat, or cure COVID-19.
The FDA has also set up a resource page with FAQs on ivermectin and COVID-19. Rules for pharmacists relevant to providing appropriate medication therapy can be found in WAC 246-945-415 and WAC 246-945-305.
Source: Washington State Department of Health
Posted August 27, 2021