Has the IRS ever audited your tax returns? Has your state’s veterinary medical board asked you to respond to a pet owner complaint? Has a disgruntled client sued you for negligence or malpractice? Has an employee accused you of a wage-hour violation or wrongful termination?
If you have experienced any of the above or something similar, the key to defending yourself is having concise, well-organized, detailed, honest records. The same goes for your oversight of controlled substances.
Keeping accurate drug records is time-consuming. It requires organization and ongoing maintenance. When you’re at your veterinary practice for 10 to 12 hours a day and sometimes six or seven days a week, the last thing on your mind when you have a minute to breathe is your controlled substance records. However, they should be uppermost in your mind.
U.S. Drug Enforcement Administration recordkeeping requirements are designed to prevent the illegal diversion of controlled substances. The agency makes random, unannounced visits to investigate how a veterinary practice receives, manages, distributes and stores regulated drugs.
The DEA expects R&R from you or, in other words, “readily and retrievable” records. Your DEA documents must be physically separated from ordinary business records and easily found when an investigator arrives. The last thing you want is to search through files and stacks of paper when the DEA is on-site. You don’t want to appear disorganized and make diversion investigators wait, which can send the initial interaction on a downward spiral. Likewise, saying, “I didn’t have time” to prepare and organize the records won’t go over well. An even worse thing to say is, “I can’t find them.”
Required Records
Which records must be readily retrievable? These:
- Biennial and initial inventory sheets.
- Power of attorney documents.
- Your DEA registration and state license.
- Vendor invoices and verified packing slips.
- Controlled substance logs and transfers.
- DEA Form 106 reports of theft or significant loss.
- Reverse-distributor records and any completed Form 41s documenting spills or breakage.
- Authorized personnel list.
- Employee screening statements.
- DEA distribution Form 222.
A few notes about the required records:
- Power of attorney: Check whether your state requires power of attorney documents to be notarized.
- Transfers: Anytime a controlled substance is transferred, specific records must be kept by both the sending and receiving DEA registrants. (Read Transfer With Care at bit.ly/transfer-TVB for more information.)
- Authorized personnel lists: They are living, breathing documents that must be updated whenever an individual’s authorized status is granted or revoked.
- Screening statements: Individuals working with controlled substances should execute one during onboarding and again annually. (Learn more at bit.ly/407k2Mw.)
- DEA Form 41: If you fill out the document upon the breakage or spillage of a controlled substance during operations, make sure two witnesses sign it. Staple to the form any photos or statements explaining what happened.
The DEA registrant is responsible for maintaining all required records, not the office manager, technicians, suppliers, power of attorney or corporate owner. Records must be stored at the registered location and retained for two years. (Your state might require a longer period.)
Financial Consequences
Violating DEA recordkeeping requirements can subject registrants to a litany of civil and monetary penalties. Under the Controlled Substances Act, a citation can cost upward of $15,040 per violation and can compound into increased sanctions and fines.
Last year, I was called to assist with a DEA matter after an unannounced inspection at a 24/7 emergency hospital. When the DEA requested the hospital’s most recent biennial inventory, an employee responded, “What’s a biennial inventory?” (Note: The DEA requires you to conduct a biennial inventory every two years, at a minimum.)
Needless to say, the hospital’s lack of a biennial inventory (and knowing what it is) led to additional recordkeeping violations, multiple citations and the practice’s temporary closure. Four weeks later, after extensive and costly remediation activities and legal expertise, the hospital reopened with an estimated revenue loss of $920,000.
A Drug’s Biography
I’m often asked, “How do I know if my records are compliant?” The answer is they tell the story of a controlled substance from the moment of acquisition to the point of dispensing, administration or disposition. Or “from womb to tomb,” as Dr. Peter Weinstein, my Simple Solutions 4 Vets business partner, likes to say.
If your records clearly show everything that took place from when a controlled drug was ordered and received to its movement, usage and complete depletion, your paperwork is likely in good shape. If you must search for documents or obtain additional information to understand a drug’s history, you have critical work to do.
Can you see why maintaining records is best done when an event occurs? Think about having to go back almost two years to locate three pills or 1 milliliter. The “tomb” should always end in a zero, meaning a product was used, dispensed, administered, wasted or expired (reverse distributed). Zero is the only number the DEA accepts at the end of life for a controlled substance.
In addition to being readily retrievable, Schedule II controlled substance records must be maintained separately from Schedule III, IV and V records. I recommend using a dedicated binder to store and organize Schedule II documents. For security purposes, keep them in a locked area that only the registrant or designated power of attorney who orders Schedule II drugs can access.
Real-Time Recordkeeping
The DEA does not allow backlogging. When information is missing in log entries or receiving paperwork, someone often responds, “I’ll fix that now.” However, I explain that filling in missing information or changing controlled substance records after a transaction is not fixing the records. It’s falsifying them. (Note: Correcting legitimate errors in records is different).
The administration and dispensing of controlled substances must be logged at the time it occurs. The real-time rule also applies when verifying deliveries being moved into inventory. The DEA cares about the accuracy and completeness of your records, not how busy you are.
Dr. Weinstein told me he sat next to someone on an airplane who was filling out a veterinary practice’s controlled substances logs. The updates went back at least six weeks. Removing the logs from DEA-registered premises is a violation. The traveler didn’t intend to do anything wrong or nefarious but was trying to catch up and was unaware of the multiple violations.
You wouldn’t falsify financial records; that’s a possible crime. Think of your controlled substance records the same way because they’re an accounting of your practice’s drug usage.
QUICK TIPS
- Always use a stapler, not a paperclip, when attaching required controlled substance documents.
- Always log, verify and document in real time.
- Never remove logbooks from a DEA-registered location.
- If you use an automated electronic logging system, keep blank USB flash drives on hand to export records rather than try to print them when the DEA or state authorities are present.