Toward a new best practice for controlled substance monitoring
Of all the things we do in EMS, there aren’t all that many opportunities to make a difference each day. Many of our patients need little more than transport to an ED, whether for primary care or chronic medical problems.
Thus, when any of us gets the chance to administer morphine or fentanyl to a patient with third-degree burns, or to push midazolam in a case of status epilepticus, or to use an induction agent like ketamine for a difficult airway, we may just get to make a difference. We may feel a sense of gratitude, too, for our ability to use those controlled substances—opioids, benzodiazepines and anesthetic induction agents—that we go through a lot of trouble to carry.
This trouble stems from the fact that substance abuse affects not only our patients, but many of our colleagues as well—often tragically. As a result, it’s our responsibility to track the use of these drugs, both to ensure their appropriate and safe administration, and to prevent their potential diversion.
Diversion refers to the act of diverting a controlled substance from its intended purpose, whether at the time of administration or the time of wasting.
Our ability to effectively manage the problem of diversion may be traced to the lack of EMS-specific regulations in the original Controlled Substances Act of 1970. Since very little guidance was provided regarding EMS interpretation of the law, a kind of Wild West approach has characterized our handling of controlled substances for the last half-century. Some agencies require online medical control, while others prescribe these drugs under standing order medical protocols.
To the dismay of EMS medical directors, system executives and their legal counsels, the U.S Drug Enforcement Agency (DEA) has more recently interpreted this law as stating that “… dispensing of a controlled substance in response to a standing order would … not be valid.”1
This has opened the door to potential medicolegal exposure for systems that administer controlled substances under standing orders and has, therefore, been one of the driving forces behind the recent introduction of the Protecting Patient Access to Emergency Medications Act of 2016. Recently passed by the U.S. House of Representatives, this bill is still under review in the Senate. Among other things, it removes the requirement for real-time medical control and individual prescriptions.2
Although we may be on the verge of a collective sigh of relief in anticipation of the passage of this new law, it may be a false hope to think that it will truly solve the problem of diversion.
EMS systems may track controlled substances, butthe processes they use are often rudimentary, whether relying on paper forms, signatures and manual drug counts or some form of technology and software. Nevertheless, substantial time, effort and financial resources are spent to make these foolproof, and to eliminate the possibility for error.
Policies on the handling of controlled substances typically regulate distribution, resupply and wasting of unused drugs. There are processes for recognizing and addressing tampering, as well as policies for dealing with expired medications.
These processes are designed to track vials and, to a lesser extent, the medication within them. Specific tracking numbers are used to account for vials from the minute they leave the pharmacy to the time they’re returned. There are rules about where they’re stored, how they’re secured while in the possession of paramedics and how the medications should be wasted. There are mountains of policies, procedures and foolproof standard operating procedures/ standard operating guidelines (SOPs/SOGs) to ensure that what goes out and what comes back in all add up.
The question, though, is whether “foolproof” actually means that we’re fooling ourselves. It may be that all these processes really do is keep us off the radar of our state regulatory agencies and the DEA-and do little to address the underlying problem. Although amounts of drugs administered and wasted are carefully documented and empty vials are returned for resupply, what happens to a drug once it’s drawn up in a syringe is a lot harder to track.
Measuring the Problem
In a recent survey of large metropolitan 9-1-1 EMS systems around the country, medical directors were asked how many instances of diversion they’ve had. Nineteen of the 23 responses reported no cases in recent memory. Of four agencies that reported diversions, there were a total of six individual cases.3
This means that at some of the largest EMS agencies in the country, there have only been six instances of diversion among millions of patient encounters and tens of thousands of controlled substance utilizations.
Here in Texas, there were 15 investigations into suspected controlled substance diversions in 2016 alone, three of which were reported by our organization, MedStar Mobile Healthcare.4
The only reason these cases were discovered by MedStar is because the system measures each paramedic’s controlled substance use and waste, and then compares these metrics monthly to every other paramedic in the system. To benchmark potential outliers, we set the threshold for abnormally high use or waste as three times the system average.
An example of what such a spike might look like is shown in Figure 1. For the months of October, November and December, provider A (blue) has typical use compared to the system average (green). In January and February, we begin to see an increase in use but it’s still not over the threshold. Finally, in March and April, there’s a dramatic increase in use.
Figure 1: Monthly controlled substance administration (Provider A vs. system average)
At this point, the individual’s use is evaluated for drug administrations that don’t seem appropriate to the clinical circumstances. This information is typically picked up from several locations on the electronic patient care report (ePCR), including the narrative, physical exam, vital signs, oxygen saturation (SpO2), and end-tidal carbon dioxide (EtCO2).
In our protocol, the use of the narcotic fentanyl isn’t indicated for chest pain due to suspected acute coronary syndromes (ACS), nor is it indicated for any patient with pain documented as less than or equal to 6 out of 10 on a pain scale. We also wouldn’t expect fentanyl to be administered to a patient with inadequate respiratory status, severely diminished mental status, or with a potentially significant head injury. An example of one such individual’s possible out-of-protocol administrations is illustrated in Table 1.
Each individual’s pattern of drug wasting is also compared to monthly system averages. As illustrated in Figures 2 and 3, provider B (green) administers does of fentanyl that don’t exceed the system threshold-but their monthly pattern of wasting does.
Figure 2: Monthly controlled substance administration (Provider B vs. system average)
To put this in better perspective, a paramedic may use fentanyl in doses of no more than 100 mcg several times a month and never exceed the threshold. If, however, several of these cases included drug administrations where only 25 mcg of fentanyl are given to patients and the remaining 75 mcg wasted, the total might exceed the threshold.
Figure 3: Monthly controlled substance waste (Provider B vs. system average)
Looking at all of this from the system perspective, Figure 4 illustrates the total number of above threshold notifications for the three controlled substances currently utilized at MedStar-fentanyl, midazolam and ketamine-representing a total of approximately 10 to 25 cases each month that require individual QA and ePCR review.
Figure 4: Monthly controlled substance administrations /wastes & providers who exceeded thresholds
What Happens Next?
In those instances where paramedics not only exceed the system threshold, but their pattern of use or waste appears to be clinically inappropriate, two things happen:
- Paramedics are brought in for face-to-face QA reviews to better understand their critical thinking and clinical decision- making. Although they may be educated or remediated, the process is entirely non-disciplinary and nonpunitive in nature.
- Individual cases are also independently reviewed by the system compliance officer to determine whether drug testing is required, including urine or hair follicle evaluation for either recent or remote substance use. If either of these tests are positive, the results are evaluated by an independent occupational health physician to correlate them with the individual’s personal prescriptions and medical record.
Diversion can be subtle and the devil is often in the details. Most EMS providers typically have a “style” to their treatment, and the rate at which they administer controlled substances doesn’t vary greatly from month to month. When reviewing their cases, we get a feel for this style and a reasonable sense of the types of calls for which they administer these drugs.
Since protocols are also meant to be guidelines, there will always be exceptions. Thus, the QA process doesn’t seek to identify a single out-of-protocol violation so much as it looks for multiple instances, especially those where inappropriately high doses are used.
There are times when paramedics have high administration rates but, regardless of the results of drug testing, we find that they may not have good understanding of pain management protocol, whether with regard to dosing,indications or contraindications.
As a result, the process provides an opportunity to educate not only the provider, but sometimes the entire system as well.
Is There a Downside?
Although systems should take pride in controlled substance tracking processes that might point to suspected instances of diversion, reporting these cases can also raise some eyebrows. They may lead to the perception that something is wrong with an agency’s processes, and that they may be increasing the opportunities for misuse of drugs.
It’s also worth recognizing that the commitment to a philosophy which critically evaluates controlled substance use also often leads to further investigation at the state level, not to mention potential fines, DEA involvement and a mountain of paperwork. It doesn’t take a great leap of understanding then to imagine how all this might not encourage self-reporting or the development of tracking processes that might uncover such cases in the first place.
System executives and managers may be inclined to take a “hear no evil, see no evil” approach, especially if they believe they have the best tracking systems already in place and don’t understand how diversions might be occurring right under their noses.
The way this often plays out is that, even when the limited processes identify a suspected diversion, personnel may resign and move on to the next agency in lieu of taking drug tests. In those instances where drug tests actually “pop” positive, individuals may be fired-but not always reported to the state.
It’s no surprise that, with the potential for complicated and time-consuming state investigations, fines and possible media attention, termination of employment without a report to regulatory authorities may just simply be an easier and less messy option.
Finally, it’s worth noting that, in addition to any other system QA initiatives for which there may already be limited personnel and technology available, a critical approach to controlled substance monitoring requires a nontrivial commitment of both human and technical resources.
Diversion is a difficult problem because it deals with our friends and EMS family, and the inherent difficulty of our jobs. It’s unlikely that someone begins a career in EMS because they want to divert controlled substances.
The nature of our job places us in stressful situations every day. We work long hours, get little sleep and rarely have sufficient time to decompress. This can lead to stress and anxiety and, in some cases, symptoms of post-traumatic stress disorder. Providers often self-medicate with alcohol, drugs, tobacco and caffeine, and rarely do they seek professional help.
The typical response to diversion is often termination of employment or suspension of licensure or certification. However, if the employee resigns in lieu of termination (as is often the case), the deeper issues aren’t addressed.
Most organizations have programs through which providers can self-report substance abuse and seek treatment without fear of punitive action, but how many of our colleagues have availed themselves of this service? And how many can recognize their addiction, or overcome the sense of shame or humiliation that prevents them from doing so?
A New Best Practice
Controlled substance abuse and diversion are embedded in a complex mix of societal and cultural influences and biases. The following principles are based on our experience and offered here to help navigate toward a new best practice for addressing this complicated problem.
- EMS providers face extremely stressful situations every day. To manage this stress, many providers self-medicate. If we can’t get a handle on the pace and content of our jobs and our own mental health, we probably won’t correct the problem of controlled substance diversion.
- Don’t rely on vial tracking systems as the sole means to prevent diversion. Even the most advanced technology and software can’t identify subtle trends in the administration and wasting of drugs-something that may require a human eye to detect.
- Although the reporting of controlled substance violations may appear punitive and even get an organization some unwanted attention, it’s important to do more than “kick the can” to the next system.
- Systems should consider programs through which personnel may self-report problems with substance abuse, and then be provided the opportunity for treatment without negative consequence.
1. Partridge JW. (Dec. 19, 2011.) Correspondence from DEA to Anchorage Fire & Ambulance Districts. NASEMSO.org. Retrieved Sept. 19, 2017, from www.nasemso.org/Projects/GovernmentAffairs/documents/DEA_Letter120911.pdf.
2. Hudson R. (Jan. 12, 2016.) H.R.4365: Protecting patient access to emergency medications act of 2016. Congress.gov. Retrieved Sept. 19, 2017, from www.congress.gov/bill/114th-congress/house-bill/4365.
3. U.S. Metropolitan Municipalities EMS Medical Director Consortium. (2017.) Email listserv survey.
4. Texas Department of State Health Services. (December 2016.) Report on emergency medical services. Retrieved Sept. 19, 2017, from www.dshs.texas.gov/legislative/2016-Reports/SB8-HB3556-EMS-Report.pdf.