It takes less time than you think and pays dividends to your practice.
Ever wish there was an “easy” button for DEA compliance? Let’s be honest. You’re really good at caring for your animal patients and their owners, but when it comes to keeping up with state and federal controlled substance regulations, well, that’s a different story.
If you’re like most veterinary professionals, understanding today’s complex DEA regulations is a challenge. A lot of practices are concerned they’re not keeping up with DEA rules, but they’re too busy running a practice to navigate the complex nuances of DEA compliance. Oh, and have you tried contacting the DEA with questions? Unfortunately, they aren’t always the best at giving you the information you need to be compliant with their rules and regulations.
Whether you use one or many controlled substances, federal requirements are the same. Unfortunately, failure to meet even one requirement can have significant financial and legal consequences. As a veterinarian you may think the DEA is not showing up at your doorstep, but the truth is the DEA, as well as state regulatory bodies, have dramatically stepped up compliance requirements. This has led to an increased number of unannounced inspections in veterinary practices handling controlled substances. You don’t want to be on the DEA’s hit list.
For additional information, see the October 2019 article DEA Issues New Marching Orders in the War Against Opioid Addiction.
While there is no magical fix for controlled substance compliance, there are ways to simplify the process and make adherence easier. The hardest part is getting started.
So, where do you start? With so many requirements at the state and federal levels, many healthcare professionals have a hard time answering that question. So, let’s focus on the key areas that a DEA Investigator will review when on-site:
Controlled substance compliance starts with recordkeeping. Recordkeeping is the backbone of DEA compliance, and good recordkeeping should tell a complete story from the time controlled substances are ordered and enter to your facility, to the time they are dispensed and/or disposed of. Your chances of having a positive interaction with the DEA are greatly increased if you have consistent and accurate recordkeeping.
Tip: Do not cross-contaminate controlled substance inventory records. Remember that Schedule II controlled substances must be kept separate from all other substances, and this includes corresponding records and invoices.
For those unaware, your biennial inventory is a documented, physical inventory taken of all controlled substances on hand at your facility. The Controlled Substances Act (CSA) requires inventory of controlled substances to be conducted initially (when your DEA registration has been issued) and biennially thereafter. According to DEA regulations, a biennial inventory must be completed every two years, on any date within two years of the previous biennial inventory date. [21 CFR 1304.11(c)].1
Your biennial inventory must include all controlled substances on hand, their form (i.e., liquid, tablet, diskette or powder), quantity and strength.
Tip: Conduct your biennial inventory every year at the same time you conduct your annual inventory to ensure that your biennial inventory is always up to date. If you can conduct a biennial inventory quarterly, even better. The goal is to keep the DEA at bay by always having a three- to six-month time frame available, so there’s no reason for them to go back any further.
Once you’ve completed your biennial inventory, resolve any discrepancies identified between your biennial count and controlled substance logbook records. Discrepancies that cannot be reconciled must be investigated further to determine the cause of the discrepancy. Remember that any significant loss or confirmed theft must be reported on a DEA Form-106, as well as to the appropriate state regulatory authorities and local law enforcement.
“Remember that any significant loss or confirmed theft must be reported on a DEA Form-106, as well as to the appropriate state regulatory authorities and local law enforcement.”
Reconciliation. Most of us dread the task (if we do it at all); but when it comes to compliance oversight, you are required to maintain an accurate, running balance of your controlled substance inventories. Once discrepancies have been resolved, this is your chance to implement a schedule for conducting regular inventory reconciliations. The minimum reconciliation standard for veterinary facilities should be weekly; however, as a best practice, we recommend all facilities routinely conduct reconciliations at the end of every shift.
To simplify the reconciliation process, you can also routinely conduct “cycle counts” by placing controlled substances into categories (according to schedule works well) and reconcile one category at a time. Also referred to as “streamlining inventory reconciliation through cycle counting,” this allows you to systematically count controlled substances on a continuous basis and prioritize reconciliation by breaking the larger process into smaller, manageable tasks that are easier to complete. Remember, unexpected circumstances such as a fire or break-in would warrant the need for additional reconciliations to be conducted.
Tip: Streamline inventory reconciliation by conducting routine cycle counts that allow you to systematically count controlled substance on a continuous basis and prioritize reconciliation by breaking the larger process into smaller, manageable tasks that are easier to complete.
Equally important are your controlled substance security measures. When it comes to security, most individuals automatically think of alarms, cameras and access control, etc. (In fact, many of our veterinarian clients haven’t thought of this at all.) Controlled substance security measures are two-fold:
- Physical security. First, and most obvious, is your facility’s physical security. Does your facility have an alarm system? Are surveillance cameras installed throughout the building, and are they properly positioned to monitor areas where controlled substances are stored, accessed and disposed of? Are your controlled substances stored in a DEA-compliant, locked storage unit? If so, how many individuals have keys and/or access codes?
- Personnel security. Less obvious when it comes to controlled substance security are the measures you should be taking regarding the individuals who work for you. How well do you know your employees, really? If you aren’t conducting routine background checks on your employees, there’s a good chance you may not know the individuals working for you as well as you think you do. Many of the headlines regarding veterinary drug diversion that have popped up recently could have been averted if employees were properly vetted from the start.
Once an employee has been vetted and qualified to work with controlled substances, they still need to be properly authorized to do so by the DEA registrant. Make sure you have Authorized User forms in place that have been executed by both the DEA registrant and the authorized user on file and stored onsite in a secure location. Also, to comply with DEA requirements, all authorized users must also complete an employee screening on a yearly basis (21 CFR 1301.90).2
Due diligence begins with the hiring process. Implement a company-wide policy that mandates background checks for all new and any existing employees, along with random drug testing and annual employee screening statements. By implementing a company-wide policy, you create a standard of compliance that clearly defines expectations and will also protect you from potential claims for discrimination.
If you’ve been procrastinating on controlled substance compliance because it is overwhelming or seems too hard, don’t worry. Hit the “easy” button and take control of your DEA compliance today by doing the following:
- Conduct a biennial inventory
- Resolve any discrepancies identified
- Implement a regular reconciliation schedule
- Review security measures
- Know your employees
- Have a backup plan
Need help? We’re on your side.
Still not sure where to start? The TITAN Group is here to assist. Depending on your unique circumstances, we offer virtual and on-site services to evaluate and remediate any issues/discrepancies so that, if the DEA does show up, you are prepared.
We know that achieving compliance in your practice is easier said than done, even with a DEA compliance checklist at your fingertips. If you are ready to fast-track compliance, we can tailor a plan for your unique circumstances.
Get started today with our convenient and cost-effective virtual DEA compliance services, and immediately begin putting your practice on the right track, without any disruptions to your normal operations.
Ready to take action?
TITAN Group DEA Compliance Analysis™
A TITAN Group DEA Compliance Analysis is perfect for getting a better understanding of where your practice is today, and where it can be moving forward. This virtual analysis puts the power of TITAN in the palm of your hand and gives you the opportunity to assess the level of compliance in your practice. No matter what stage your practice is in, it is essential to operate with the confidence of knowing there are no risks to your invaluable DEA registration.
Am I at risk?
Not sure if your compliance program could pass a DEA audit or inspection? Find out in 60 seconds or less with using TITAN’s online risk assessment.
I must make a disclaimer: I have been using drugs, buying drugs, investigating drugs, studying drugs for the past 32 years. I am a self-professed expert in all things drugs. 26 years with the DEA, combined with personal experience taking pain pills for a bad back gives me a perspective that is quite unique. Nothing in books or on TV can prepare one to deal with the devastating issues that surround drug addiction. TITAN’s mission is to educate not only doctors and pharmacists, but the other side as well, in hopes that together we can end the story of opioid addiction once and for all.