Best practices for logbooks

Photo: Naret/Adobe Stock

Peter Weinstein, DVM, MBA, spoke alongside Kelley Detweiler, an expert on Drug Enforcement Administration (DEA) regulatory compliance, about best practices for maintaining controlled substance logbooks during a session at the Fetch dvm360 Conference in Kansas City, Missouri. In addition to general logbook compliance, the presentation covered how to handle and reconcile discrepancies, and the DEA’s position on hub loss and substance waste.

Maintaining DEA-compliant logbooks

Weinstein and Detweiler began their presentation with a brief section about frequently asked questions (FAQs), addressing some common misconceptions. They explained that, according to Title 21 of the Code of Federal Regulations, logbooks are not required to be bound, but they must be maintained in a manner that does not allow any log sheets to be loose or falling out of order. They also must be secured in consistent chronological order for the current 2-year period, according to Detweiler. Logbooks should also be stored close to where DEA-compliant controlled substances are being used, they are not required to be locked up, and they should never leave the premises.

Perhaps the strongest point of emphasis throughout the pair’s discussion regarding DEA-compliant logbooks was the significance of the entries consistently balancing out to 0. The DEA does not want variances. Similarly, it is their recommendation to never leave blanks in logbooks. If a practice is documenting waste, rather than leaving a field blank as in indication that there was no waste, filling in a "0" as a record that there was no confirmed waste was advised.

“[DEA]-compliant logs should tell the story of the controlled substance usage from the point of acquisition to the point of administration, dispensing, or disposition,” Weinstein said during their session at the Fetch dvm360 conference. “Disposition could be wasting, and/or expiration.”

For more information, Weinstein and Detweiler debunked myths and misconceptions surrounding DEA regulation in a dvm360 exclusive interview.

Conducting DEA biennial inventory

According to DEA regulations, a full inventory of all controlled substances must be conducted biennially at a minimum following the date when the initial DEA inventory was conducted. Though, Weinstein compares waiting until the last minute to complete biennial inventory to getting taxes together each year on April 14, knowing they are due on April 15.

Reconciling controlled substance logs

The speakers discussed conducting controlled substance reconciliations on logbooks, which is the process of comparing the actual amount of physical inventory "on-hand" against the amount of inventory that should be on-hand according to the logbooks, Detweiler noted. They compared to a checkbook of every drug from a specific category. If a practice is not reconciling their controlled substance logs on a regular basis, there would be no way to identify discrepancies or to identify if their logs are consistent with their inventory. Weinstein recommended that reconciliation logs be conducted by an authorized user and a witness, preferably on camera for an extra layer of security.

“So, the more you do a reconciliation, the more likely you are to balance out,” Weinstein said. “Don’t you hate it at the end of the day, when you’re balancing out the drawer, and there’s a penny off? Well, how about if that penny is 1 cc of fentanyl… what do you do to resolve [that]?”

In their session, the pair also recommended that reconciliations be conducted, at minimum, weekly. Although the DEA does not set forth a specific frequency for conducting reconciliations, the more often you reconcile the better. Frequency should be determined based on the size of the practice and volume of controlled substance use. If it's a large practice with higher controlled substance usage, reconciliations should be conducted daily or, if possible, at the end of each shift. In general, the more controlled substances a practice uses, the more often they should reconcile.

Detweiler stressed the urgency of recognizing discrepancies. “Because remember, if something doesn’t jibe, you have 24 hours to make notification to the DEA,” she said. “And that registrant who’s holding the bag needs to know immediately, because it affects their entire license and livelihood.”

What is an acceptable amount of hub loss?

“So, the DEA recognizes that hub loss exists,” Detweiler said during the session. “However, they do not specify a certain amount of hub loss that is allowed, they do not provide how it should be calculated, and they will check how you are accounting for hub loss for things that do not balance out to 0 in your logs.” She explained that, with different substances, often depending on the viscosity, and with different needle gauges, hub loss will vary. Her advice for determining acceptable hub loss is to establish a consistent formula for calculating it. “The DEA wants to know that you’re not predetermining amounts, and that you have a formula,” she said.

She recommended multiplying the number of pokes by whatever amount was determined for hub loss on a specific container or bottle for liquid controlled substances. If the resulting number from your calculations is within 10% of where it’s supposed to be, in most cases that would be considered typical hub loss. Practices should always determine hub loss amounts according to a specific container, and should be prepared to explain those calculations to the DEA with a well-documented formula for how that calculations was determined.

“So, basically, [number of] pokes [multiplied by predetermined amount],” Detweiler clarified. “[If the result is] within 10%, over or under of where you should be, you’re most likely good. If it’s not within 10%, it should be investigated for potential significant loss.”

Key takeaways

Concluding their presentation, Weinstein and Detweiler stressed the importance of documenting waste, even if that means writing “0.” Additionally, Detweiler encouraged the audience to add side comments, because there's no such thing as over-documenting. They also recommended including the date and initials next to any corrections or cross-outs so that everyone knows who to ask if they have questions. Some additional tips for success include:

• Consider using unique bottle identifiers
• Treat every container individually
• Rotate authorized users performing tasks
• Properly account for document, and don’t predetermine, hub loss
• Ensure proper documentation of any discrepancies and make sure the DEA registrant receives a copy of it as soon as possible
• Try to reconcile “at least weekly”

“So, we know that this is not a lot of fun, but it’s really, very important,” Weinstein said, wrapping up the session. “It’s very important for you and your practice, it’s important for your team, it’s important for the profession, and it’s important for the community in which you work.”

Reference

Weinstein P., Detweiler K. Oh My Log! Championing Logbook Success. Presented at: Fetch dvm360 Conference; August 23-25, 2024; Kansas City, MO.