Legal Considerations of Ketamine for Veterinary Practices
Ariel Pleva, DVM, MPH, Grand View University; Des Moines Area Community College, Des Moines, Iowa
Radford G. Davis, DVM, MPH, DACVPM, Iowa State University
ISSUE
Ketamine is a short-acting, dissociative anesthetic used in both human and animal medicine for sedation. It allows for detachment of pain and the environment while providing hallucinogenic effects to the patient.1 In 1999, ketamine became a schedule III non-narcotic substance under the Federal Controlled Substance Act.2
Because ketamine does not suppress breathing or lower blood pressure, it is a common, safe, injectable anesthetic used in veterinary medicine.2 It is crucial that veterinarians have access to this drug, particularly in equine medicine.2 The AVMA has urged the FDA not to restrict ketamine use in veterinary medicine because of its profound importance in practice.3
Ketamine has become widely popular as a recreational drug because of its fast-acting psychotropic effects, duration period, and low cost.4-6 Recreational use of this drug is concerning because of the risk for adverse events, which can include panic attacks, depression, exacerbated mental health conditions, weight loss, and poor appetite.5
In addition, ketamine is one of several drugs with depressant effects, including confusion, bradycardia, vertigo, lethargy, impaired judgment, amnesia, ataxia, loss of consciousness, syncope, nausea, hypotension, and loss of inhibition and is often used to facilitate sexual assault in humans.4
In 2015, the World Health Organization decided that ketamine should not become internationally scheduled, as it does not pose a significant public health threat in terms of illicit use, and that, therefore, it should remain easily accessible to both human and veterinary medical professionals.2 For humans wanting the drug for illicit use, veterinary clinics are a prime target for robbery.7
Veterinarians should be aware of the licit and illicit aspects of ketamine, how to deter and report theft associated with illicit demand and weak regulations, and the legal requirements surrounding the use of this controlled substance.
ANSWER
Federal & State Laws
Federal law for controlled substances mandates that “all applicants and registrants provide effective controls and procedures to guard against theft and diversion of controlled substances”8 and that “controlled substances listed in schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet.”9 A Drug Enforcement Administration (DEA)-registered veterinarian cannot allow access to controlled substances to an employee who has been denied a DEA registration, been convicted of a felony related to controlled substances, or had his or her DEA registration revoked or suspended.8
Every practitioner must maintain separate inventories and records of schedules III, IV, and V controlled substances separate from schedules I and II.10 The DEA requires that all controlled substance inventory records be updated every 2 years and be available for inspection.10
In addition to federal requirements, each state has its own requirements for record keeping, physical security, disposal, and inventory of controlled substances. Veterinarians are encouraged to contact their state’s controlled substance authority (eg, state board of pharmacy) to learn the legal requirements for possessing and using ketamine.
Penalties for violating state and/or federal regulations can result in suspension or revocation of the dispenser’s federal controlled substance registration11 as well as the state controlled substance registration.
Disposal
Veterinarians with unused ketamine stock should check with their supplier about returns for credit or disposal. If those are unavailable, the DEA uses licensed companies to take the drug; contact information for authorized companies is available from local DEA offices. Practitioners should maintain copies of records documenting the transfer and disposal of controlled substances for at least 2 years.10 Individual states may have additional requirements for ketamine disposal.
PREVENTING & REPORTING THEFT
The authors recommend the following steps to prevent theft of ketamine from the clinic:
Keep a perpetual inventory, as well as a detailed record of drug use by each patient and the addition of new inventory to demonstrate exactly how much ketamine should be in inventory.
Perform random checks to ensure inventory records match physical inventory.
Always have at least 2 team members oversee drug ordering and inventory.
Store ketamine in a sturdy locked cabinet or safe.
Dispose of expired ketamine immediately in an approved manner.
Keep only the needed quantity of ketamine on hand; do not order large amounts that may be unused for long periods of time.
Review security protocols regularly, including staff access.
Veterinarians should notify the nearest DEA Field Division Office within one business day of any theft or significant loss of controlled substances,12 as well as immediately report the theft to their state’s controlled substance authority and police.13