You wake up smiling on Monday morning. It’s 75 degrees and sunny outside. You have a full day of cat appointments on the schedule. You oh so love your feline patients because each is cooperative and easy to handle, making your job enjoyable. As you walk into work, the veterinary practice is fully staffed, and you know you’ll have plenty of support to cruise through your appointments and finish in time to make your son’s 4 p.m. soccer game.
“BEEEEEEEEP!” Your alarm clock goes off. It’s wake-up time for real. As your wonderful dream fades into the background, you’re thrust into another Monday, aware that real life is not what you dreamed.
There is a bright side, though. You securely stored a bit of magic in the treatment room. It’s inside a small, inconspicuous vial wrapped with a DIY label and the words “Kitty Magic” in purple marker. You know that a tiny amount of this potion will tame the most fractious feline patients. However, you’re unaware that your patient-focused concerns made you oblivious to a plethora of potential regulatory violations.
Kitty Magic is a clinic-concocted combination of agents mixed for use in feline sedation. The drugs and their amounts can vary from one hospital to the next in an attempt to create the “purrfect” potion.
Kitty Magic essentially combines ketamine, telazol, dexdomitor and buprenorphine (or butorphanol). You might call it Kitty Magic, TTDex, TKD or something else. The name and combination of ingredients aren’t what matters. What does matter is your potion includes at least one controlled substance mixed with something else.
Feline patients are notoriously difficult to handle. A bit of sedation can make a world of difference in examining and treating them effectively and safely. However, a single drug might not be ideal due to the potential side effects and desired duration, so you might use a combination of agents.
Theoretically, you could calculate the amount of each ingredient and draw it up individually. The problem is that some cats are extra small and the doses needed are minuscule, resulting in volumes difficult to measure accurately. In those cases, you could dilute the drugs, but that falls into compounding and creates additional math, leading to an increased risk of overdosing or underdosing a patient. Also, the multiple drugs must be combined into a single syringe, or you’ll need to inject the patient numerous times. All this adds to the opportunity for error.
Kitty Magic is desirable at practices that frequently see feline patients because preparing a mixture in advance is much easier than concocting one on a busy day. However, we don’t have benefits without risk, and we don’t have magic without a dark side.
The Dark Side: Drug Diversion
As all good science fiction readers know, magic has a dark side, and Kitty Magic is no different. Its power comes from mixing substances.
Dexdomitor is not a federally controlled substance, but ketamine, buprenorphine, telazol and butorphanol are. Therefore, the standalone controlled substances used in Kitty Magic, in addition to the mixture itself, are at risk for diversion.
Let’s briefly recap the drugs.
- Ketamine: A Schedule III drug under the Controlled Substance Act, the injectable, short-acting anesthetic is used in people and animals. It is referred to as a dissociative anesthetic because it makes patients feel detached and can induce a state of sedation, immobility, relief from pain and amnesia. For those reasons, ketamine is a highly sought-after controlled substance for illicit use that gained popularity when users discovered it produced effects similar to those associated with PCP.
- Buprenorphine: A Schedule III controlled substance under the CSA, the narcotic analgesic is a long-acting (24 to 72 hours) opioid agonist-antagonist capable of producing significant euphoria. It has gained popularity as a heroin substitute and is a primary drug of abuse.
- Telazol (tiletamine/zolazepam): A Schedule III controlled substance under the CSA, it is a fixed-ratio combination of the dissociative anesthetic tiletamine and the tranquilizer zolazepam. Comparable to ketamine in efficacy, telazol is used for anesthesia and can be abused for recreational purposes.
- Torbugesic (butorphanol): A Schedule IV controlled substance under the CSA, it is a synthetic, centrally acting, agonist-antagonist analgesic. Butorphanol is often used in place of buprenorphine in Kitty Magic compounds for simpler, less painful procedures. While at a lower risk for diversion than ketamine and buprenorphine, butorphanol has misuse and dependence potential, and as with other opioids, it can cause a euphoric high in patients.
Drug diversion is the illegal distribution or abuse of prescription drugs or their use for purposes not intended by the prescriber. Diversion threats are external and internal, and the controlled substances used in Kitty Magic are prime targets. For example, in January 2023, gunmen ordered employees at a St. Louis veterinary clinic to open a controlled substances locker. They specifically demanded ketamine. One month later, a South Carolina veterinarian was booked on charges of stealing controlled substances.
It’s All in Your Wand
Like all magic, controlled substances and their properties can be used for evil or good. A U.S. Drug Enforcement Administration registration allowing you to work with controlled substances is a privilege, not a right. As a veterinarian, you’re responsible for ensuring that controlled substances are used only for the good of your patients and are protected from the evil of misuse and diversion. Diversion can take place in any form, so it’s essential to be aware that Kitty Magic compounds are at risk for diversion individually or in combination. Pay attention to these controlled substances when reconciling logs and investigating discrepancies.
Along those lines, consider that adequate security might mean going beyond the minimum requirements. For example, federal law requires a running log of all Schedule II drugs but doesn’t require one for Schedule III and IV medications. However, if you don’t have a running log, how will you know if a drug is missing? Federal law also requires reporting all loss or theft of controlled substances. Ergo, you must be able to identify such cases.
The Ministry of Magic
Like the Ministry of Magic that served as the magical government responsible for regulating and enforcing laws in the Harry Potter series, compounded and controlled substances have governing authorities. At the federal level, a common misconception is that the Food and Drug Administration or DEA regulates compounding. However, the DEA doesn’t run the compounding show. (It only regulates and oversees the controlled substances in compounded medications.) Furthermore, compounded drugs are not FDA-approved, so the agency doesn’t evaluate their safety, effectiveness or quality. Also, the FDA doesn’t inspect compounding pharmacies unless for cause.
While this article focuses on Kitty Magic as a controlled substance, it is also a compounded substance and therefore, a mention of compounding regulations is necessary.
Traditional compounding is regulated by the states. Every state board of pharmacy has something to say about it, incorporating United States Pharmacopeia standards in some way. However, the most significant variations result from whether a state veterinary board weighs in on compounding by veterinarians and whether a pharmacy board is authorized to oversee veterinarians that compound within their practices.
Veterinarians are empowered to prepare compounds, but they must know their state’s specific regulations.
Your Grimoire (Rules to Follow)
For the non-Hermione Grangers out there scratching your heads over what to do, here are a few key points to direct you toward the light.
1. LABELING
Possessing a random drug vial simply labeled “Kitty Magic” is illegal and unsafe. Considering that the sedation cocktail can mean different things at different practices, you can’t assume that everyone ordering or preparing the medication knows what it contains precisely and how to dose it. According to United States Pharmacopeia compounding standards, your label must identify, at a minimum:
- An internal lot number.
- All active ingredients and the amount or concentration
of each. - A beyond-use date.
- The dosage form.
- The total volume in the vial at the start.
- The route of administration.
- The controlled substance schedule of the most restrictive ingredient.
In addition, check your state’s laws since the veterinary or pharmacy practice acts might be even stricter and require more labeling.
2. STORING
Once you label the vial appropriately, consider its storage. If your concoction contains a controlled substance in any amount, you must treat it like any controlled substance. The storage requirements are those for the highest scheduled drug in the compound. For example, if your version contains butorphanol, ketamine and dexmedetomidine, the first two ingredients are Schedule III drugs, and dexmedetomidine is unscheduled. Therefore, you must treat your Kitty Magic as any other Schedule III drug. If the combination contains a Schedule II substance, you must follow all Schedule II requirements.
3. LOGGING
Once you label and store the medication, you must meet all the requirements for logging a controlled substance. Here are two critical steps:
- Appropriately log the controlled substances used to prepare the compound. For example, if butorphanol and ketamine are involved, you need to record each amount on the log sheets.
- Follow the documentation requirements for preparing a compound, including assigning an internal lot number and recording each ingredient’s lot number and national drug code. When you do this, you can also log the vial number assigned to each controlled substance in your compounding record. You can then reference the internal lot number for your compound on the log entry for the use of butorphanol and ketamine.
Are Your Eyes Spinning Yet?
Before employing the powers of Kitty Magic, remember to take all necessary precautions to avoid stepping into the dark side. It’s quite simple. Know the regulations and relevant laws. Read them again. Follow them. The end!
DID YOU KNOW?
Chapters 795 and 797 of the United States Pharmacopeia (bit.ly/3Loznmn) set forth minimum best practices for compounding nonsterile and sterile medications. However, these are guidelines only, not laws or regulations, and it’s up to the states to incorporate and enforce them.