HUMAN USE OF VETERINARY PHARMACEUTICALS

To oppose human use of pharmaceuticals approved only for veterinary use; further,

To support use of veterinary pharmaceuticals only under the supervision of a licensed veterinarian in compliance with the Animal Medicinal Drug Use Clarification Act of 1994; further,

To encourage state and federal regulatory bodies as well as other stakeholders to monitor the misuse of veterinary pharmaceuticals and, when appropriate, limit the public availability of those pharmaceuticals; further,

To educate healthcare professionals and the public about the adverse effects of human consumption of veterinary pharmaceuticals; further,

To encourage research, monitoring, and reporting on the adverse effects of human consumption of veterinary pharmaceuticals to define the public health impact of and to quantify the strain these agents place on the healthcare system.

Rationale

Medications that are formulated for veterinary use are often supplied at higher concentrations, contain compounds not safe for human use, and require specialized knowledge to administer. The prevalence of drug misuse in the veterinary setting is not well documented, but surveys of veterinarians by the Idaho Board of Veterinary Medicine, Colorado Veterinarians, and Veterinary Hospitals in Pennsylvania found that they suspect 23% of animal owners misuse veterinary medicines on themselves, their children, or friends, and that the most-documented misused drugs are opioids, benzodiazepines, and ketamine. These findings are concerning because animals often require a more potent dose of controlled substances, which can be appealing for individuals with substance use disorders, and medications are often dispensed directly to the animal owner, bypassing pharmacists, who are critical players in prescription drug misuse risk mitigation.

In the in United States, licensed veterinarians can prescribe, administer, carry, stock, and dispense medications, including veterinary-only drugs, drug compounds, and FDA-approved over-the-counter veterinary drugs. These drugs are typically veterinary formulations that are not tested for human safety or approved for human use, and the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) permits veterinarians to prescribe those drugs in an “extralabel” manner. Under AMDUCA regulations, “extralabel use” means the actual or intended use of a drug, by or on the order of a veterinarian, in a manner that is not in accordance with approved labeling (similar to off-label use in human medicine). Any deviation from labeled use, by veterinarians or lay persons, is an illegal use unless it meets all the requirements of FDA's extralabel drug-use rules. Deviations from the label include use in a species or production class not on the label and use of a different route of administration.

More recently, the COVID-19 pandemic has exacerbated human consumption of veterinary compounds, as some medications being studied for efficacy against the virus produce promising or equivocal preliminary results that are seized upon by the public and some prescribers, leading to inappropriate prescribing. For example, ASHP, APhA, and AMA have called for an immediate end to the prescribing, dispensing, and use of ivermectin for treatment of COVID-19 outside of a clinical trial. Due to the response of the medical community, many physicians and pharmacies are not writing or filling prescriptions for this medication, driving patients to purchase the animal formulation of ivermectin for human consumption. Earlier in the pandemic, a patient in Arizona consumed chloroquine phosphate meant for fish as a treatment for COVID-19 and died. The FDA, aware of the misuse of chloroquine products, issued a cautionary letter to stakeholders and worked with online marketplaces to remove the products from the market.

Finally, some veterinary compounds produce mild to life-threatening human adverse effects upon accidental or intentional exposure or ingestion. Patients exposed to or ingesting these products present to the emergency department with symptoms that range from bronchospasm, central nervous system stimulation, and miscarriage to sudden death, which demonstrates the need for timely reporting of abuses, misuses, or accidental exposures of these agents.