Among the top 10 lists you want to be on are best-selling writer, most popular Instagram influencer and world-renowned veterinarian. What you don’t want is to be on the FBI’s most-wanted list, on ESPN’s “Not Top 10 Plays” — check it out for a laugh — or in the news as the veterinary practice with a considerable number of DEA violations.
In working with and assessing over 600 veterinary facilities, I predict the average clinic is committing 11 violations that a U.S. Drug Enforcement Administration agent would identify as worthy of fines. Each could earn a $15,691 penalty, or over $172,000 total. If only the practice manager and DEA registrants had read the Code of Federal Regulations and the Controlled Substances Act and adhered to the guidelines.
So, what are the 10 most common DEA violations that I’ve seen? Let’s explore each.
1. Inability to Provide a Biennial Inventory
The DEA requires that all required records, forms and documents, starting with the biennial controlled substance inventory, be available for inspection upon request at the location matching the registration. The inability to produce a biennial inventory is an easy way to get an automatic fail.
The DEA requires a biennial inventory every two years, at a minimum. While many states follow the DEA’s lead, certain ones have additional rules. For example, New York requires a biennial inventory to be performed on May 1 in odd-numbered years. On the other hand, Illinois demands an annual inventory and that the proof be kept for at least five years.
Remember that a biennial inventory is an official record. Therefore, the DEA registrant or power of attorney designee must complete it alongside an authorized witness.
TIPS
- Drugs of concern: Non-DEA schedule “drugs of concern,” such as propofol, xylazine and gabapentin, cannot be inventoried with DEA controlled substances, even if your state schedules them.
- Splitting schedules: Schedule II controlled substance records must be separate from schedules III, IV and V.
2. Records Are Not Readily Retrievable
According to the Controlled Substances Act, the DEA may randomly check registrants for the “correctness of records, reports or other documents required to be kept or made.” If the DEA inspects your practice, you must have everything readily available and organized. The last thing you want is to have to search files and stacks of papers while the DEA is on-site. Diversion investigators forced to wait can become frustrated at having to spend even more time at your practice.
Compliant recordkeeping documents the life cycle of controlled substances from the moment of acquisition to the point of dispensing, administering or disposing. If you want your records to tell the complete story, start with a dedicated binder in which you can properly organize and maintain DEA-required records. Also, keep a separate binder for Schedule II records and store it securely.
TIPS
- Logs: If you use an electronic logging system, keep blank USB drives on hand so you can upload records instead of printing pages of documents when the DEA requests a copy of your logs.
- Maintenance: Designate an authorized individual to “own” maintenance of the DEA binders to make sure all required records are consistently updated over the current two-year period.
- State records: If your state says you must keep records longer than the DEA’s two-year mandate, place older documents in separate binders. Don’t combine them with your DEA records. After all, you don’t want to give the DEA more things to review.
3. Registration and License Issues
Do you have all the registrations and licenses required for working with controlled substances, and are they valid and consistent across all entities of the practice? While that’s a seemingly obvious question, overlooking the requirement can lead to violations and other problems. If your location changes, go online and update your address with all applicable state licensing boards first and then with the DEA.
The renewal time for a practitioner’s DEA registration is every three years. State licensing renewals vary. The DEA allows practitioners to renew their registration online within 60 days of its scheduled expiration. The agency also allows the reinstatement of an expired registration for up to one calendar month after the expiration date. You must submit a new application if you don’t renew within that period. If that happens, you lose your current DEA number. Don’t wait to renew!
TIPS
- Address changes: When updating online, print and keep the confirmation page until official documents show the change.
- State comes first: State licensing must be in place before you apply for a DEA registration. A DEA registration is linked to the existence of a legitimate state license.
- Renewals: Make sure to update your email address on the DEA website to get notifications and renewal reminders.
4. Inaccurate Logging and Infrequent Reconciliations
Keeping up with drug logging is challenging when you work 12-hour shifts and see patients back to back. However, controlled substance recordkeeping can spiral out of control and, if left unattended long enough, pass the point of no return.
Think of your DEA binder as a book and your logs as the main chapters. They reflect every action involving a controlled substance after its acquisition. When log entries are error-strewn (missing information, multiple cross-outs, not accounting for waste), pieces of the story are missing. Logs must be completed in real time by the individual who accessed a controlled substance for a patient. You cannot take logs home or fill them in after your shift. The goal is to ensure your entries maintain a zero balance, indicating the amount drawn, how much was administered or dispensed, and anything wasted.
Discrepancies are bound to happen, sometimes from innocent math errors, manufacturer overfills, leaky vials and forgetting to account for pending client pickups. Other times, differences can indicate something more nefarious. The more frequently you conduct reconciliations, the better you’ll identify and resolve discrepancies before they escalate. Reconcile at least weekly.
TIPS
- Reconciliations: Do them at least weekly in an area covered by security cameras, and utilize two authorized individuals.
- Discrepancies: Have a process for investigating and resolving discrepancies and, as a best practice, use a form to document each step.
5. Poor Employee Vetting
How well do you really know your employees? The family aspect of veterinary practice draws people to the industry, but it can become a problem when you ignore employee vetting and ongoing due diligence.
Preventing drug diversion starts with knowing who works for you. Employee background checks and drug testing are strongly recommended, but not specifically required, by the DEA. At a minimum, team members authorized to work with controlled substances should attest whether they were convicted of a crime or knowingly used narcotics, amphetamines or barbiturates other than those prescribed by a physician. Employees should complete screening statements during the hiring process and again annually.
Once you’ve vetted employees, don’t forget to educate them about the proper handling of controlled substances.
TIPS
- Job candidate references: Ask for and check them.
- Background checks: Conduct them for all new employees and every three to five years for everyone.
- Drug testing: Speak with your HR attorney to ensure drug testing is correctly incorporated into company policies.
6. Noncompliant Storage
The DEA requires that controlled substance storage units weighing under 750 pounds be either:
- Bolted to the floor.
- Affixed or mounted to a wall.
- Secured to an immovable object.
The regulation applies to primary storage units and wherever you might keep controlled substances. Also, don’t forget to secure refrigerated controlled substances.
Controlled substances transported off the premises for patient treatment must be appropriately secured during transit, and any unused drugs must immediately be returned to primary storage at the registered location. You may not take home controlled substances or leave them in a mobile vehicle. Instead, you must log and return them to primary storage after patient use.
Veterinary facilities may also be cited if they don’t properly separate stored controlled substances.
TIPS
- Commingling: Store Schedule II controlled substances separately from Schedule III, IV and V drugs. Do not commingle non-DEA schedule drugs with controlled substances in storage, even if they are scheduled at the state level.
- Old medications: Expired controlled substances must
be securely stored and adequately separated until destruction.
7. Insufficient Physical Security
The Code of Federal Regulations states, “All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances.”
Some of those controls are explicitly laid out, but others are not. For example, facilities that store and use controlled substances must have an electric alarm system and self-closing, self-locking doors. You’d be surprised how many veterinary facilities do not install an alarm or have an inactive one. The same goes for exterior doors. Numerous practices I’ve visited had manual locks on exterior doors. Often, these doors are unlocked, used by employees upon entering or leaving, or propped open for airflow.
Not properly implementing physical security in a facility that stores and works with controlled substances can lead to citations for failing to prevent drug diversion. Worse yet, permitting unauthorized access to your practice by someone seeking to divert drugs puts you and your staff in harm’s way.
TIP
- Security cameras: Make sure to position them correctly. A best practice is to have at least 60 to 90 days of security footage on DVR storage.
8. Inadequate Receiving Processes
After you order drugs from a manufacturer or distributor, it’s not uncommon for multiple shipments to be delivered in the middle of a chaotic day. Controlled substance shipments cannot be left unsecured under any circumstance. The DEA doesn’t care how busy you are. If you cannot place the order into inventory immediately, secure it in a locked cabinet temporarily.
While unpacking controlled substance shipments, keep the packing slip (receipt of invoice). An authorized receiver and witness must date and sign (don’t just initial) the receipt of invoice. With Schedule II controlled substances, provide the verified receipt of invoice to the individual who placed the order so that DEA Form 222/222e can be completed.
TIPS
- Verification: Sign and date the receipt of invoice packing slip.
- Schedule II: Match and attach the verified receipt of invoice and vendor invoice to DEA Form 222 (or 222e if using CSOS).
- Attachment: Use a stapler, not a paperclip, to keep the documents together.
9. Not Accounting for Hub Loss
While the DEA recognizes that syringe hub loss happens when drawing drugs, there is no formal allowance. However, the DEA wants to see that you have a consistent accounting process. Hub loss will vary depending on the substance — for example, 0.05 ml of midazolam and 0.7 ml of ketamine might be considered normal. You cannot pre-determine hub loss, but you must use a formula and be consistent.
The DEA accepts a “reasonable level” of hub loss. If a significant loss occurs, you must notify your local DEA divisional office within 24 hours.
TIPS
- Use a formula: Remember that every controlled substance differs, so you cannot pre-determine a practice-wide hub loss.
- Reporting: If you think a loss is significant, document it and advise the DEA registrant immediately.
10. Noncompliant Wasting and Disposing
Waste, disposal and destruction are separate processes that veterinary practices often confuse. Waste refers to controlled substances not fully expelled during patient administration. It’s an opportunity for diversion, so make sure to render all leftover amounts non-retrievable before disposal.
A controlled substance is deemed non-retrievable when it cannot be accessed or repurposed as a drug or listed chemical. Emptying it into cat litter is not acceptable. Instead, you must use a product such as Rx Destroyer or Cactus Sink before placing controlled substances in a biohazard container. Waste handling should be conducted by an authorized individual. As a best practice, utilize a witness in an area covered by a security camera.
Expired controlled substances must be destroyed appropriately using reverse distribution and incineration. Until expired controlled substances leave your facility for destruction, they must be securely stored and included in inventory counts.
TIPS
- Logging: Track expired controlled substances awaiting destruction.
- Frequency: Send expired controlled substances for reverse distribution quarterly and before conducting a biennial inventory.
If you address all 10 problem areas, you and your veterinary practice will end up among the Top 10 Happiest and Safest Places to Work. That’s a list you want to be on.
LEARN MORE
- DEA Diversion Control Division: bit.ly/401Y4ux
- Inventory requirements: bit.ly/3Qqb2z7
- Employee screening procedures: bit.ly/407k2Mw
- Physical security controls: bit.ly/46T7riZ
- Executing DEA Form 222: bit.ly/3QpBIjf
STORY ARCHIVE
Earn free CE credit by reading Kelley Detweiler’s recent article, “Don’t Fumble the Handoff,” and completing a quiz. The article addresses the proper handling of controlled substances during a veterinary practice merger or acquisition. Check it out at bit.ly/handoff-TVB.