Patty, a certified veterinary technician, rushes into the surgery suite with a syringe in hand. “Hey, Doc! We didn’t need all of the euthanasia solution we drew up for the Great Dane. What should I do with it?” In the middle of spaying a dog, the veterinarian responds: “Just put the syringe on my desk, and I’ll get to it later.” Later comes, and Doc is busy again. The syringe is buried under bills and records. It resurfaces a few days later. What to do?
- Return the leftover euthanasia solution to its bottle?
- Put the syringe on a shelf in the treatment area for use another time?
- Inject the solution into one of the animals in the freezer?
The list of how not to do it goes on. Long gone are the days when controlled substances could be flushed down a toilet, poured into a sink or expelled into cat litter. Controlled substance waste is subject to rules and regulations at the federal, state and, in certain areas, municipal levels. What are the requirements, and does the process you use matter? In short, yes.
Back to Basics
In this case, waste refers to any leftover, excess or unusable controlled substances that result from patient administration, dispensing, breakage or spillage. For example, a controlled substance remaining in a syringe, container or tubing after patient administration cannot be repurposed or discarded into the trash or a biohazardous waste container. You must waste it properly. Similarly, if a controlled substance container breaks or spillage occurs, the resulting waste must be appropriately disposed of and documented on DEA Form 41.
Expired controlled substances and controlled substance waste are not the same thing. While both require proper destruction, the steps performed and the documentation are different. Expired controlled substances do not get wasted the same way that leftover, excess or unusable controlled substances do. The destruction of expired controlled substances in a veterinary hospital’s inventory requires submitting official paperwork to the DEA (Form 41 and, for Schedule II drugs, Form 222). If expired controlled substances are wasted without completing, submitting and retaining the required paperwork, their actual destruction isn’t proven. DEA-registered reverse distributors typically complete the destruction process on behalf of customers, but that’s for another article.
Nonretrievable Wasting
Disposing of controlled substances in the trash or a biohazardous waste container is illegal. The DEA requires that such waste be permanently altered physically, leaving it unusable before disposal. A controlled substance is considered legally nonretrievable when it cannot be transformed into a state that would allow it to be used again as a controlled substance.
Proper nonretrievable wasting requires the use of a compliant system. Unfortunately, cat litter is not one.
Among the common customer mistakes that Jordan Brown, the director of strategic partnerships at RX Destroyer, encounters involve improper and illegal controlled substance disposal. Failure to render controlled substance waste nonretrievable before disposal is a DEA violation subject to potential citations and fines of up to $15,691 per violation.
Sewers? No.
Dumping controlled substances into a sink or flushing them down a toilet also is illegal. In 2019, the U.S. Environmental Protection Agency passed a so-called “sewer ban,” which prohibits veterinary practices, other health care facilities and reverse distributors from disposing of controlled substances into a drain or toilet. The ban fulfilled another goal of the Disposal Act: to decrease the amount of pharmaceutical controlled substances introduced into the environment, particularly water supplies. Violations can result in penalties, fines and state and local citations.
Depending on where you practice, you might be subject to additional state regulations concerning controlled substance waste. Examples include California, Oregon and Washington. Brown noted that customers in those states cannot place full RX Destroyer containers into the trash. The waste must undergo specific destruction processes. Therefore, engage a pickup service or mail-back program and obtain and save the certificate of destruction.
Recordkeeping Obligations
Failing to document controlled substance waste properly is another common mistake. That means indicating the amount of waste in your logbooks. For example, if you draw 10 milliliters of ketamine but administer only 7 milliliters, the corresponding log entry should indicate the amounts drawn and administered and the amount wasted (3 milliliters), resulting in a zero balance.
Not surprisingly, RX Destroyer customers experience the same problems with controlled substance waste that I see with my clients. Topping the list is forgetting to complete or retain DEA Form 41. When controlled substance containers break or spillage occurs, the incident must be documented on Form 41 and executed by two authorized witnesses. You do not have to send the form to the DEA, but you must retain completed Form 41s with other DEA-required records for at least two years.
Selecting a Wasting System
Ensure the wasting system you choose meets DEA requirements for rendering controlled substances nonretrievable. Veterinary professionals who provide ambulatory services should use a product that is easy to transport.
While you can purchase controlled substance-wasting systems on websites like Amazon, I recommend using an authorized distributor that has a strong relationship with the manufacturer. Brown noted that RX Destroyer customers who are just starting out aren’t always familiar with their needs and frequently end up purchasing either the wrong product or one that is too small or too large. Human-to-human interaction is essential for buying the appropriate product and ensuring a reliable resource to help with any issues and answer questions.
Pet Owner Waste
Anyone who has worked in the veterinary industry long enough likely encountered a pet owner who didn’t pick up dispensed medication or wanted to return unused portions. Remember that once you dispense controlled substances to an end user, you cannot return the drugs to your inventory. Period! Veterinary professionals should educate clients about properly wasting and disposing of unused controlled substances. The end user, not the veterinary practice, is responsible for adequately wasting unused controlled substances. Clinics that take back dispensed controlled substances create discrepancies in their inventory and recordkeeping and commit a regulatory violation.
Direct the client to an approved collection site if you run into such a request. The DEA offers an online search tool at bit.ly/3GxnsiT.
Six Months Later
Patty rushes into the surgery suite. “Hey, Doc! We didn’t need all of the euthanasia solution we drew up for the golden retriever. I’m so happy we came up with a solution for excess drugs that meets the guidelines and makes us feel better knowing these drugs aren’t getting into the wrong hands.”
Doc, in the middle of a cat neuter, responds: “Patty, I appreciate you finding a safe, legal and simple solution.”
With apologies to singer George Strait (“All My Ex’s Live in Texas”), all your excess lives in an appropriate wasting product. Given the increased demand for controlled substances on the street and sometimes by people working with you, a paper trail, standard operating procedures and the right products will protect you and your practice.
ONLINE RESOURCES
- Disposal of Controlled Substances final rule: bit.ly/3Gyt7W2
- DEA Form 41: bit.ly/3ReKjV8