Are your controlled substance records DEA compliant?
Recently, several hospitals in the West have been unsure about whether AAHA Controlled Substance Logs were in recordkeeping compliance with both DEA and state regulations.
So AAHA put the question to the experts: Jack Teitelman, retired Drug Enforcement Administration (DEA) supervisory agent and chief executive officer of DEA compliance experts Titan Group. Teitelman and his colleagues looked into the matter.
Their answer: “Your logs are DEA compliant,” said Teitelman.
After an investigation into what prompted the concerns, Teitelman and his team discovered that parties in both states had either misunderstood or misinterpreted some of the language in the DEA’s Code of Federal Regulations (CFR) Title 21, which governs food and drugs within the US for the Food and Drug Administration, the DEA, and the Office of National Drug Control Policy. The CFR includes protocols for reporting the use and distribution of controlled substances in veterinary hospitals and pharmacies.
Titan’s findings? The concerns were groundless: AAHA Controlled Substance Logs are DEA compliant nationwide.
Teitelman wrote in a statement: “The use of bound controlled substance logbooks such as the AAHA Unopened and Opened Container Logs meet the minimum requirements for use in all 50 states.” You can read the full statement here.
NEWStat talked to Teitelman to find out what caused the concerns in Arizona and California.
In Arizona, the problem boiled down to a confusion over methods of recordkeeping and the question, “is one method ‘more compliant’ than another?” “No,” said Teitelman. As long as you’ve accurately recorded the required information in such a way that it can be tracked and audited, “you’re compliant.”
In California, it was a question of running balances.
Teitelman said, “The State was telling everybody you should not be showing a running balance.” Teitelman said that makes no sense at all, and compares it to filling out a checkbook register: It’s like constantly recording deposits and withdrawals but never balancing the checkbook. “If I can’t show a balance, how do I know how much money I really have?”
Titan contacted the California State Veterinary Board (CVMB) and asked them what their reasoning was.
“They said ‘The laws state you only have to do an inventory once every two years, so that’s when you can get your balance.’ [However,] we have to have [running] balances. You have to think about what is best practice. Best practice is accurately tracking your inventory.” And you can’t do that if you don’t keep a running balance.
Eventually, the CVMB conceded the point and told Titan that if hospitals wanted to keep a running balance, they could go ahead: “They said logbooks such as AAHA’s are not a problem because having a balance row is actually increased compliance.”
In the end, Teitelman said, “States just want accurate and complete records. It’s very basic. All they want to know is how much have you ordered, how much have you used/dispensed, and [that you can] show us those logbooks.”
Photo credit: © iStock/Canan turan