This month, the American Medical Association, American Pharmacist Association, and American Society of Health-System Pharmacists issued a joint release urging prescribers and pharmacists to stop ordering, prescribing, and dispensing ivermectin to prevent or treat Covid-19 outside of clinical trials. The reason for issuing this plea is a 24-fold increase in prescribing and dispensing of ivermectin since before the pandemic. According to the release, calls to poison control centers due to ivermectin ingestion have increased five-fold from their pre-pandemic baseline. The associations reminded the public that (1) ivermectin is not approved by the FDA for human use to prevent or treat Covid-19 and (2) Clinical trials and observational studies to evaluate the use of ivermectin to prevent and treat COVID-19 in humans have yielded insufficient evidence to recommend its use.
What is even more important for retail pharmacies is that many payors consider dispensing ivermectin to treat or prevent covid-19 as clinically inappropriate. Any such dispensing is likely to result in recoupments. To ensure appropriate use, virtually all payors require prior authorization for dispensing products containing ivermectin.
While some pharmacies (such as CVS) refuse to fill ivermectin prescriptions for non-FDA approved uses, others fill these scripts for cash patients.
Keep in mind that if your pharmacy does dispense ivermectin and bills third party payors for it, the prescription must have a diagnosis code showing that the product is used as approved.
But if your pharmacy dispenses ivermectin for the off-label use (to treat/prevent covid) to cash patients, you still have a duty to ensure that the prescription is written for a legitimate medical use. The biggest issue with these prescriptions is that they are often prescribed by “online doctors” for large doses. It is the pharmacist’s responsibility to verify that the prescription is coming from a legitimate source and does not present danger to the patient’s health. For example, currently, ivermectin is approved as a one-time treatment with a follow-up dose several months afterwards. However, some ivermectin prescriptions are for daily intake for a period of a few months. Such extended use may cause serious side effects ranging from nausea to coma and death. Ivermectin can also negatively interact with other medications. So a full review of the patient’s drug regimen is recommended.
Just for your entertainment, here is how some of prescriptions for ivermectin look like (notice the chicken soup and hot lemonade).
In addition to checking the dosage and reviewing patient’s current medication intake, the pharmacist should educate and inform the patient (in writing) of the potential side effects and risks associated with taking ivermectin.
This informed consent should also contain a release of the pharmacy and acknowledgement that the patient understands the risks involved and wishes to proceed with the treatment at their own risk.
While such releases may minimize pharmacy’s exposure to liabilities, they will not shield the pharmacy from any government investigations. For example, some state boards indicate that dispensing ivermectin may constitute unprofessional conduct. Recently, the California Department of Consumer Affairs, the Medical Board of Board of California, and the California State Board of Pharmacy issued a joint statement reminding health care professionals that inappropriately prescribing or dispensing medications constitutes unprofessional conduct in California. The statement specifically addressed improper prescribing and dispensing of medications related to treatment of Covid-19.
Most boards, however, do not prohibit ivermectin dispensing as long as the pharmacists use their professional judgment in dispensing valid prescription while meeting all applicable federal and state laws and regulations.
In addition, the FDA issued several warning letters to companies selling ivermectin to treat/prevent Covid. The most recent warning was issued to RxMedKart for selling “Ziverdo Kit” containing Acetate 50 mg, Doxycycline 100 mg & Ivermectin 12 mg as a treatment/prevention of Covid. The FDA’s warning explained that this company was selling misbranded and unapproved drugs and requested to cease any further activity.
While it is important to accommodate patients and drugs are permitted to be used off-label, remember that you have a right to refuse to fill any prescription if doing so is contrary to your professional judgment. It is better to err on the side of caution and refuse the fill if in your professional judgment there is a question as to the safety for the patient.