Drug regulations make drugs safer & raise EMS liability
It was a chilling story. A medical director for a tiny volunteer service in Texas was slapped with a multi-million dollar fine by the Drug Enforcement Agency (DEA) for the theft of narcotics by the service’s director. The fine was based on the loss of 240 ampules of Fentanyl and multiple counts of incorrectly completed forms.
In addition, the medical director, an emergency physician, was immediately threatened with the loss of his medical license by the Texas Board of Medical Examiners.
The paramedic director, who was accused of stealing the narcotics, and his partner were also fined. Interestingly, the DEA argued that the partner should have been aware of the theft.
The paramedic who “diverted” the Fentanyl had been a friend and colleague of the medical director for 20 years. Despite the small size of the organization, the medical director ensured there was a narcotics control policy in place. The narcotics were kept in a secure, double-locked location, per DEA regulations. When the medical director was alerted to a possible problem, he did an audit of the narcotics and was the one who contacted the authorities.
Eventually, the DEA settled with the medical director for $16,000, but only after a grueling and protracted investigation. Including attorney’s fees, the ordeal cost him an estimated $30,000. In the process, he was able to keep his license and gain an important lesson: When it comes to narcotics, trust no one–even a friend.
Recommendations for EMS agencies
Ray Fowler, MD, associate professor of emergency medicine at the University of Texas Southwestern Medical Center and deputy medical director for operations, Dallas Area BioTel (EMS) System, used this cautionary tale to set the stage for an enlightening–and unsettling–session at the 2011 Pinnacle Conference in Miami Beach, Fla., in late July. “It only takes one person with the keys to bring it all down,” he says.
He provided a number of recommendations to help EMS agencies keep out of the DEA’s crosshairs. First and foremost, every agency must have a written, controlled substance policy. “You do your people a favor when you help them stay honest,” he says. “If a paramedic or an EMT gets caught in Texas, he or she will likely suffer difficult consequences. Physicians with substance abuse issues might be allowed to go into rehabilitation, but there really is little second chance for Texas EMS providers,” says Fowler.
Every member of the organization must understand the importance of the policy. “Every ampule, every molecule, every time without exception must be accounted for,” he says.
At the hospital, if a problem is found with a drug count after shift change, the entire previous shift is required to return to work until the problem is resolved. That same level of attention must be established at an EMS agency, Fowler insists. People need to know that they will be called back if there is a discrepancy. “A missing ampule of a scheduled drug can no more be tolerated in the EMS world than it would be in a hospital,” he says.
Do drug screens according to a pre-established policy.
“Document, document, document,” Fowler says.
A strong narcotics policy means some work on the part of the medical director. After all, it’s the medical director who is ultimately responsible for narcotics. Fowler suggests that the medical director personally conduct a periodic inventory check.
According to Fowler, the four essentials of a solid narcotics policy include:
- Initial inventories to provide a baseline.
- Reordering based only upon documented usage, including wastage. Fowler suggests that agencies be cautious when it comes to electronic documentation. Defaults can trip up drug counts. To monitor drug use, he gets an e-mail every time Versed or Fentanyl is used in his system.
- Periodic inventories. Fowler says that daily inventories are a must for all inventories, but not to expect the crews to like it. “I can’t believe how much pushback I get on daily inventories,” he says. Don’t forget about intermediate locations and get signatures coming on and off duty.
- Standard investigation–An ad hoc investigative policy is not recommended, Fowler says. It often leads to a kneejerk reaction that could result in personnel issues. Fowler suggests testing the system by doing a random check on a weekend or having rigs come in for random spot checks. “Be creative!” he says.
Fowler learned that because each of the stations in his system includes a central system used for distributing medical supplies to EMS rigs, the DEA considers the central inventory area to be a “distributor.” Moreover, each of the fire stations must be registered as such with separate DEA numbers. What he has been told is that if drug boxes spend the night on the rigs, they become a separate location also requiring registration with the DEA. Because there is no category for EMS providers, his stations are essentially registered just like doctors’ offices for the purposes of being able to administer scheduled drugs to patients. Although this can be done on the DEA website, it does take some time.
Once registered, Fowler discovered an unfortunate consequence. Blank forms may be mailed to each fire station–the very same forms that got the Texas medical director fined because of signature issues.
He notes that the form–DEA 222–makes multiple copies. The third copy within the set contains an area that is different from the others and needs to be filled out with information regarding the receipt of the medications into inventory. It was this section that tripped up the Texas medical director and caused the $15,000 per form fine.
Evidently, there are many gray areas that are open to interpretation by individual DEA agents. To make sure an agency is in compliance, he suggests inviting the local DEA office to do an audit.
“It’s clearly apparent to me that there’s not a uniform policy at the federal level,” he says. “They want to see that you have a policy and that you are following your own rules.”
Fowler doesn’t know if, in the final analysis, this regulation makes drugs any safer. “All it does is raise our liability,” he says.