By Dr. Natalie Young, PharmD, BCSCP, FACVP
In this VETgirl online veterinary continuing education blog, Dr. Natalie Young, PharmD, BCSCP, FACVP reviews the use of controlled substances in veterinary medicine. Read on to find out best practices and legal compliance with prescribing and dispensing controlled substances to animals. What are the current rules and regulations? How should possible drug diversion in the clinic or with clients be dealt with? What can we do as a veterinary community to support current efforts against the opioid crisis? You can also check out Dr. Natalie Young’s webinar on February 7, 2023 entitled Use of Controlled Substances in Veterinary Medicine: A Refresher.
The misuse of prescription drugs, particularly opioids, is not a new issue in our country. After years of battling this epidemic, the drug crisis continues to decimate communities and families. Federal and state governments and other vested parties continue to implement policies and regulations for clinicians to follow in hopes of reducing prescription drug misuse. These include the creation of state-run prescription drug monitoring programs (PDMPs) and mandating continuing education programs. Despite these efforts, ongoing confusion remains high in our profession.
It is critical that our veterinary community familiarize itself with legal compliance, best practices, and tips for preventing diversion. Although the veterinary setting is not a conventional source of prescription medications for drug deviants, certain drugs of interest remain the mainstay of treatment for several conditions animal patients encounter. This article is geared towards some of the most asked questions I receive and addresses the current recommendations for prescribing, dispensing, and handling of controlled substances.
Prescribing
All veterinarians must follow the rules outlined in the Controlled Substance Act (CSA) enforced by the Drug Enforcement Administration (DEA), register with the DEA, and have a DEA number to prescribe controlled substances. According to state and federal laws, all veterinarians in a single practice may share a collective DEA number to order, administer and dispense controlled substances but must have an individual DEA number in order to prescribe.
When prescribing a controlled substance, all the following elements are required:
· Patient name, date of birth (if known), client name, and home address (no P.O. boxes)
· Prescriber full legal name, DEA registration number, and office address (no P.O. boxes)
· Medication name, strength, dosage form, quantity, directions, and refills (if applicable)
The method for delivering or transmitting the prescription to the pharmacy depends on the drug schedule. I must emphasize that, at the time of this writing, I am not aware of any electronic system used in veterinary medicine that is DEA-approved. That means that electronic transmission of controlled substances is currently not an option for veterinary prescribers.
Schedule II prescriptions may be submitted electronically. Again, the system must be DEA-approved or handwritten. The pharmacy must receive the handwritten prescription prior to dispensing the medication and the prescription must be signed by the prescribing veterinarian. Verbal prescriptions are allowed in emergency situations only and the proper prescriptions must be presented to the pharmacy within 7 days.
Schedule III-V prescriptions maybe be submitted electronically through a DEA-approved system, handwritten, faxed, or verbally communicated to the pharmacy. The handwritten and faxed prescriptions must contain the prescribing veterinarian’s signature.
Some federal and state regulations may differ, making it imperative to stay up to date with your local legislation regarding, but not limited to, quantity and refill limits.
For Schedule II substances, there is no federal limit to the quantity that may be prescribed but this can vary state-by-state. Three sequential 30-day prescriptions may be given to the client at the same time provided that the issue date (date written) is the same for all three prescriptions. They cannot be post-dated. Applicable prescriptions must also include the earliest fill date (“Do not fill until…”). No refills are allowed.
A Schedule III-IV prescription can be approved for up to five refills within six months. Most Schedule V prescriptions follow this same rule although it does vary by state.
Gabapentin isn’t considered a controlled substance at a federal level. But several states have passed their own laws classifying gabapentin as a Schedule V substance. At the time of this writing, these states are Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia, and West Virginia.
Lastly, as a good steward, I recommend limiting prescribing of controlled substances to use only when necessary. It is important to prescribe at the lowest effective dose for the shortest time needed, and if possible, after trying non-controlled drugs.
Storing, Dispensing, and Record Keeping
It’s customary for veterinary clinics to stock controlled substances, administer the medications onsite, and dispense these medications to clients.
When managing controlled substance stock, there are things that the clinic can do to actively prevent diversion within the practice. These recommendations include, but are not limited to:
• Double-count controlled substances when filling controlled substances. Counting should be done by different employees, if possible.
• Ensure that the same employee is not responsible for both ordering and inventorying controlled substances.
• Inventory controlled substances on a regular basis (not just every 2 years, which is required by federal law).
• Audit all orders of controlled substances.
• Lock controlled substances in a safe with 24/7 security surveillance. Installing security cameras is an excellent idea!
When dispensing controlled substances, some states may require reporting to the state prescription drug monitoring program (PDMP). PDMPs are important risk mitigation tools to monitor “doctor shopping” or “pharmacy hopping.” Beyond dispensing, a minority of states mandate that veterinarians check PDMPs before prescribing controlled substances.
Disposal, Theft, and Loss
Any theft of “significant loss” of a controlled substance should be immediately reported to the local police department and to the DEA using Form 106 within one business day of discovery. Note that the DEA does not define “significant loss”, and this will be up to your professional judgement based on your operations.
The breakage, damage, or spillage of a controlled substance is not a “loss.” If recoverable, the disposal must follow DEA requirements. DEA Form 41 should be used to document the disposal. If not recoverable or is drug wastage (e.g., remnants in a vial or syringe), the incident should be properly documented in a logbook or electronic record keeping system. Have two witnesses’ sign. DEA Form 41 does not need to be filled out in this case.
For disposal, a licensed reverse distributor is the most appropriate way to dispose of unused controlled substance office stock.
It is not appropriate to accept unused controlled substances from clients. Encourage them to dispose of these medications safely via permanent drug take back locations or utilizing local law enforcement “take back days.” The DEA has published guidance for more information on this topic at www.deadiversion.usdoj.gov/drug_disposal.
Drug Diversion
Several reputable research studies have shown that healthcare providers are concerned about drug diversion and that a significant amount of diversion does go undetected. As a veterinary community, we do have an obligation to recognize signs that a staff member or client may be diverting controlled substances. Those behaviors include, but are not limited to:
Staff
• Excessive/frequent questions about controlled substances
• Unusual expertise in pain management
• Spending unnecessary time near controlled substances
• Discrepancies with ordering/inventory of controlled substances
• Erratic behavior
• Unexplainable absences
Clients
• Vet shopping
• Reporting injuries of suspicious origin or incomplete history
• Claim medications were lost
• Request specific drugs or refills and not return for follow-ups
• Become hostile when controlled drugs are refused
Concluding Comments
It is important to remember that substance abuse is not indicative of one’s moral character. It is a medically recognized mental disorder that effects millions of people. We must approach these individuals with care and compassion when attempting to help.
It is equally important to recognize that we, as healthcare providers, are not responsible for the opioid epidemic but clearly have a leading role to play in the fight against it. I have provided numerous references and resources to supplement this article but please feel free to reach out with further questions.
