Many EMS agencies have sought clarification on handling controlled substances, only to come back with more questions than answers. Much of this is no fault of our own: Until recently the DEA had not specifically addressed EMS agencies' handling of narcotics. Its goal was to prevent diversion, keeping potentially dangerous drugs out of the wrong hands, and its focus was primarily on manufacturers, distributors, researchers, and physicians…until recently.
Before the Protecting Patient Access to Emergency Medications Act of 2017 (PPAEMA) passed, the Controlled Substances Act (CSA) prohibited administration of controlled substances “outside of the physical presence of the agency’s medical director.” This method of administration is simply not practical in our line of work. Many patients suffer from issues and ailments that require immediate administration of narcotics such as fentanyl, ketamine, Versed, morphine, etc. Although the DEA did not strictly enforce this mandate, there it was in black and white, the elephant in the room during many high-level EMS legislative committee meetings.
Prompted by the Controlled Substances Act verbiage, many states took matters into their own hands by incorporating statutory language that would allow EMS workers to administer controlled substances via standing orders from their medical director.
Now that the new PPAEMA is in place, does this leave the door open for the DEA to potentially scrutinize EMS agencies’ handling of narcotics more closely? You bet.
I was tasked by my division chief with enhancing my department’s standards regarding DEA controlled-substance compliance, specifically their destruction. At first I, like many before me, was met with consistent rejection and many more questions. Could it be this difficult to do the right thing? In a word, yes, partially because the answers just weren’t out there yet. Substantial research of codes, laws, and regulations at every level led me to partner my department with our local law enforcement agency. Our area’s police department has an efficient, smooth, systematic way of destroying the tons of narcotics it confiscates on a regular basis. Could we essentially just jump on that bandwagon?
We had expired narcotics that were in need of proper destruction; police had exponentially more (illicit) controlled substances that required the same fate. After months of reaching out to our local DEA office, we received an official letter from our DEA special agent in charge confirming it was permissible to turn our controlled substances over to law enforcement for destruction.
It was a small victory…but what about security? Storage? Distribution? Also, what about all the associated costs regarding narcotics incurred by EMS agencies in providing the elevated level of care to the public we're known for? There are significant costs associated with purchasing, securing, recording, and destroying expired intact vials of controlled substances.
These medications are a necessary part of our job, but they are also expensive. If you choose the route of using a reverse distributor to destroy your expired vials, that can be expensive as well.
It’s a dual cost: The department pays for the medication—perhaps it sits on a slow truck until it expires—and then has to pay for its destruction as well.
Our agency reduces cost by partnering with law enforcement to destroy our expired narcotics, rather than paying a reverse distributor. It took some time to achieve the necessary authorization for this, and its availability to you may vary depending on the DEA special agent in charge for your area.
When purchasing any medication (not only controlled substances), efficient, cost-effective utilization is a priority. Many departments use electronic tracking methods, some with advanced RFID technology, to sort, rotate, and track purchased medications. This method is one many departments use to increase cost savings simply because you can effectively track and monitor your controlled substances, adjusting quantities or rotating stock when needed.
Electronic tracking of narcotics may have the potential to significantly assist with diversion avoidance as well. Many of these electronic-tracking companies offer what they term "cradle to grave” tracking, which allows administrators to easily view useful information on one dashboard.
I quite possibly may have read and sifted through more legislation and statutes than a student in her final year of law school. The DEA is now creating guidance specific to EMS agencies, and it would be prudent to realize this may increase our profile on its radar. Making sure your agency is compliant, well-organized, and knowledgeable about your state’s requirements as well as federal regulations will help lead to a smooth process in the event of an audit from one of EMS’ many governing bodies.
There are other important points to remember about the new Protecting Patient Access to Emergency Medications Act:
EMS agencies are now permitted to receive their own DEA registration. Previously the medical director was the only one authorized to obtain this.
Under their medical director’s supervision, registered EMS agencies are now liable for ensuring the appropriate use, security, and reporting of controlled substances used by the agency.
This was only some of what I discovered on my journey through the world of EMS and controlled substances. I can almost guarantee I am not the only one who faced challenges obtaining information and finding authorization and clarity regarding these necessary, and also highly regulated, medications.
EMS organizations and their governing bodies share the goal of ensuring the public is afforded the best possible medical care and misuse of dangerous substances is avoided. Many questions remain about best practices and compliance. Perhaps this article and others like it will help open the door for more conversation and transparency regarding EMS agencies’ handling of controlled substances.
1. Controlled Substances Act of 1970, www.deadiversion.usdoj.gov/21cfr/21usc/