Do you find yourself overwhelmed with the thought of controlled drug requirements? The laws regarding controlled drugs are extensive and always changing, and it is your responsibility to keep up with the requirements.
Have you found yourself asking what special security measures you are required to take storing controlled substances? How about what to do with the unused or expired drugs and how to properly log your substances as they are used? Do you know how to prepare for a Drug Enforcement Agency (DEA) audit? Arming yourself with the knowledge and requirements will help you be current, complete, and accurate in case the DEA shows up at your clinic.
Controlled drugs come in five classes, with CI being the most addictive and CV the least.
- Class CI-CII has different requirements than the CIII-CIV class when it comes to storing, ordering, and logging. First, you should never have a CI substance in your practice because it is not readily available for clinic use and includes drugs such as heroin. CII drugs include hydromorphone and hydrocodones, for example, and those drugs should be stored separately from the CIII-CV class drugs.
- Class CIII-CV include drugs such as Alprazolam, Midazolam, torbugesic, and Tramadol. Regarding the logs, you are required to store them in a locked cabinet separated from the physical drugs and your CII logs should always be stored separately from your class CIII-CV logs. You should have your drugs in a double-locked cabinet secured either to the floor or wall. If you have a refrigerated controlled drug it should be secured in the refrigerator within a locked box.
Essentially, you do not want the box to be easily removable. If you cannot secure a box in the refrigerator, you should not stock those drugs. If you have two keys to the controlled lock box, they should never be in the possession of the same person. They need to be separated between two approved staff members/veterinarians who are on an approved list to handle and fill controlled substances.
Removing unused/expired controlled substances
You should never dispose of your expired or unwanted controlled drugs by flushing or squirting them down the drain. So, what should you do with them then? There are multiple reverse distributors you can send them to where the DEA can properly destroy them, such as:
- Heritage Lifecycle
- RX Return Services
- RX Reverse Distributors, Inc.
- United RX Destroyers
These services will walk you through the return process, step by step. You can also ask the DEA to approve your site for destruction, but this is not recommended. The DEA would then need to come inspect your site—and, trust me, you don’t ever want to invite the DEA to your practice for any reason.
If you have drugs to waste, such as drugs for a canceled surgery, waste them using DEA form 41 with an approved disposal method like RX destroyer or Drug Buster. It essentially neutralizes the medications on contact to render them as non-retrievable.
When filling out form 41 for your records, you need to make sure it is complete and you have a witness going through the process with you. You will keep these forms for a minimum of two years and safely store them in a locked filing cabinet.
Determine which logs you are going to use. The American Animal Hospital Association (AAHA) has some excellent logs with all the essential information required by the DEA.
The necessary information for each log should have the following:
- NDC number
- The date the drug was drawn up
- Client’s first and last name
- Client’s address
- Patient name (client and patient number for additional security)
- Corresponding unique number you assign to each bottle
- The reason for requesting the drug
- Amount drawn up or dispensed
- Balance after dispensing drug
- Employees initials who drew/dispensed the medication
- For added security, make sure the prescribing veterinarian also initials it to confirm the information is correct
Tip: When it comes to liquid drugs, you want to make sure you weigh the bottle when you receive it, weigh it after every draw and again when the bottle is empty. Always make sure you know the difference between a closed log and an opened one! A closed log is for unopened drugs and an opened log is for controlled drugs actively in use.
Be as prepared as possible for a DEA audit
The DEA just showed up at your practice, so now what do you do? Do not panic. You’ve got this.
First, check the agent’s credentials and have another staff member present as a witness. You always want to ensure they are who they say they are prior to showing them client information or giving them access to your controlled drugs.
The items they will ask for include, but are not limited to:
- DVM registration
- Practice security/theft prevention plan
- Background checks
- Order forms and 222s
- Destruction protocol/records
- List of personnel allowed to handle drugs
- Biennial inventory count
- Purchasing records/invoices and waste/theft records
Having all of this readily available in a locked filing cabinet will help the process go much smoother. After all, you do not want to be shuffling through a ton of papers while someone is standing over you, especially knowing they have the ability to invoke hefty fines.
Knowing the security and storage requirements, disposal requirements, making sure your records are complete and having a file prepped with the important information will make the process a lot easier.
When the DEA comes to your practice it can be very intimidating. They can come into your clinic at any time, for any reason, and usually when they arrive they already have a valid reason to be there. Preparing yourself with current complete and accurate records can take a lot of pressure off! After all, proper preparation prevents poor performance!
Rachel Singletary is a practice manager in Lakeland, Fla., working with Family Vet Group who started from the bottom and moved her way up. She has managed many different areas of animal hospitals and her top passion is inventory, staff development, and budgeting. Client satisfaction, growth and inventory are major factors in her daily life because she strives to provide a positive experience for both her clients and staff.