PPAEMA: Six Months In — What We’ve Learned
PPAEMA: Six Months In — What We’ve Learned
By Clive Savacool, Fire Chief (Ret.), EMT-P
It has been six months since the DEA’s final rule implementing the Protecting Patient Access to Emergency Medications Act (PPAEMA) took effect.
When the rule came out, there was a lot of scrambling. Agencies were trying to understand what had changed, whether they needed their own DEA registration, what their states were going to require, and what they needed to change internally. Even at LogRx, a software company founded on tracking controlled substances, we scrambled to ensure our program was compliant with the new regulations.
Six months later, some of those questions have been answered. Others haven’t.
I recently sat down with retired DEA Special Agent Dennis Wichern for a webinar looking specifically at what we’ve learned during the first six months. Dennis spent 30 years with the DEA, including serving as Special Agent in Charge of the Chicago Field Division. I’ve spent more than 30 years in fire and EMS, including as both a paramedic and a fire chief, so we come at this from two very different directions.
PPAEMA isn’t about changing the way paramedics practice medicine. It’s about accountability. To put it simply, the rules finally caught up with EMS.
The Rules Finally Caught Up With EMS
The Controlled Substances Act was written more than 50 years ago. EMS didn’t fit particularly well into the regulatory framework that developed around it.
Dennis described the purpose of the new rule as formalizing EMS regulations within the Code of Federal Regulations. For decades, the federal rules focused primarily on prescribers, hospitals, pharmacies and other traditional registrants. EMS was never addressed particularly well.
PPAEMA changed that. The new rule provides much clearer direction on how EMS agencies can register, store controlled substances at multiple locations, carry medications aboard EMS vehicles and administer them under standing or verbal orders. All of which is a good thing.
One of the early misconceptions was that the DEA was suddenly cracking down on EMS. The reality is that this legislation helps EMS agencies. It finally gives us some structure around how we’re supposed to operate. And if you’ve spent any time in fire or EMS, you know we tend to like structure.
Registration Has Been Harder Than It Should Be
If there is one issue we’ve consistently heard about during the first six months, it’s registration. Some agencies have had difficulty determining what their state requires before they can obtain a federal DEA registration. Others have struggled simply getting someone at DEA to return a call. Part of the problem is that federal and state requirements have to work together.
As Dennis explained, DEA generally isn’t going to issue a registration until the applicant has whatever authorization is required by the state. That becomes a problem when the federal regulation changes before a state has established a clear process for EMS agencies to follow.
We’ve seen that play out differently across the country. My advice to agencies running into this problem is simple: document what you’re doing. If you’ve called DEA, follow up with an email. Keep the dates. Keep the names. Keep copies of your correspondence. If someone later asks why your registration hasn’t been completed, you should be able to demonstrate that you’ve been actively trying to resolve it.
It’s not that the folks at the DEA don’t want to help. Often the reality is that, like most of us, they’ve got a full workload, and frankly, EMS isn’t at the top of their problem list. Good in some ways, bad in others. In my experience, when I’ve spoken with DEA representatives, they’ve been more than willing to help and are passionate about improving our industry. They just don’t always have the bandwidth to give us the attention we’d like.
The 11 Data Points Are Where the Details Matter
One of the more significant operational changes involves the information agencies need to maintain when controlled substances are administered. There are now 11 required and welldefined data points associated with those records.
Most agencies were already capturing much of this information. But there are details that have caused some confusion. One example is documenting whether a medication was administered pursuant to a standing or verbal order and identifying the appropriate medical authority associated with that administration.
Those may seem like small details until you are asked to produce the records.
As I explained during the webinar, if DEA audits your agency, those records need to be readily retrievable. If demonstrating compliance requires searching through several software systems, paper records and patient care reports just to reconstruct a single administration, you’re making the process much harder than it needs to be and starting off on the wrong foot with a DEA audit.
This is one of the areas we had to focus on at LogRx: not just ensuring compliance, but making sure all records, including DEA Form 222s and Form 41s, could be “readily retrievable” along with all 11 data points for every drug administration. When you’re sitting across from an inspector, it needs to be that easy.
Dennis boiled the DEA’s role down even further: “It’s all about counting beans… can you track the medication from the time it hits your station till when you use it?” That’s probably one of the simplest explanations of controlled-substance accountability I’ve heard.
One issue that actually isn’t new, but still isn’t fully understood, is the difference between waste and destruction. This continues to generate questions.
Waste and Destruction Are Not the Same Thing
In normal EMS operations, we often use the words waste, destruction and disposal interchangeably. DEA doesn’t necessarily look at them that way.
If a paramedic administers part of a syringe and properly wastes the remainder, that waste is documented as part of the administration record.
Destruction is different. Expired medication, damaged inventory and other controlled substances being removed from inventory may require a DEA Form 41 and the appropriate destruction process. Dennis admitted that even when he first joined DEA, the distinction seemed strange:
“When I first heard about the differences between wasting and destruction, I thought, who invented this? Aren’t they the same?” But from a recordkeeping standpoint, the distinction makes sense. One documents what happened to medication associated with a patient administration. The other accounts for controlled substances being removed from inventory. Agencies need to make sure their policies and tracking systems recognize the difference. And again, readily retrievable.
“Good Luck Reinforces Bad Habits”
This may be the biggest lesson from the first six months. EMS has been managing controlled substances for decades. Many agencies have processes that have existed almost as long. That doesn’t necessarily mean those processes are compliant. During the webinar I used an expression I’ve always liked: “Good luck reinforces bad habits.”
If you’ve driven the same stretch of highway at 70 mph every day for years and never received a ticket, eventually 70 starts to feel like the speed limit. Controlled-substance practices can work the same way. We’ve always thrown the remainder in a sharps container. We’ve always kept that record over here. We’ve always transferred narcotics this way at shift change. Nobody has ever questioned it.
That doesn’t necessarily mean it’s right.
PPAEMA gives agencies a good reason to go back and look at practices that may have been passed from one generation of paramedics to another without anyone stopping to ask why they’re doing it that way.
Don’t Confuse Best Practice With a DEA Requirement
This is another area where I think the six-month conversation has become more nuanced.
There are things an agency must do under DEA regulations, and there are things a well-run agency probably should do. Those aren’t always the same thing. Shift-change chain-of-custody documentation is a good example.
Dennis explained that maintaining a log showing that drugs remain intact during shift changes is smart practice, but that level of shift-to-shift documentation is not itself one of DEA’s core federal recordkeeping requirements. That distinction matters.
The goal shouldn’t be to attribute every good narcotics-control practice to DEA. Agencies should understand what federal law actually requires, what their state requires, and what additional controls make sense operationally. There is nothing wrong with exceeding the minimum. In many cases, I think you should, and it sets the right tone for your organization’s culture.
What Happens if DEA Walks in Tomorrow?
This is probably the question I would ask every EMS chief or administrator responsible for controlled substances: If DEA walked through your door tomorrow, could you produce your records without having to search multiple locations? Would you have to call around to different staff members for reports? Could you produce them in ten minutes or less? Or would you be sweating and wishing you’d called in sick?
Dennis identified three areas he would expect an agency to have readily available: its required inventory records, acquisition records such as DEA Form 222s and invoices, and the records associated with controlled-substance administrations. And “readily available” matters.
As Dennis put it during the webinar, “You want one person in charge of the records, and you want he or she to know what they’re talking about.” That doesn’t mean one person needs to handle every controlled substance in the organization. It means somebody owns the process. If an inspector walks in, there shouldn’t be five people standing around trying to figure out who knows where the records are.
Use PPAEMA as a Reset Button
If I were running an EMS agency today, I’d do three things.
First, conduct a self-assessment. Look at how controlled substances move through your organization from the moment they’re received until they’re administered, wasted, destroyed or otherwise leave your inventory. Identify the gaps.
Second, update your policies.
Your policy needs to bring together the federal requirements, your state’s requirements, your local EMS requirements, your medical director’s protocols and your organization’s own procedures.
And third — probably the hardest one — work on the culture. You can have a perfect policy sitting in a binder and still have a terrible controlled-substance program.
Use the new regulations as a reset button. Tell your people why procedures are changing. Train them. Then train them again. Make narcotics accountability part of how your organization operates rather than something everyone thinks about only when there’s a discrepancy.
As I said during the webinar, “The staff is going to take it as serious as you do.” That’s ultimately a leadership issue.
Six Months In
Six months into PPAEMA, I don’t think EMS agencies should look at these regulations as something to fear. They should look at them as an opportunity to clean things up.
The DEA now has regulations that better recognize how EMS actually operates. Agencies have clearer rules for registration, storage, administration and recordkeeping than they had before. It’s almost like they’ve recognized us as an industry. In a way, we should be flattered.
There are still problems, however. Registration remains frustrating in some states. Some of the terminology isn’t intuitive. And there will continue to be questions as agencies put the rule into practice. But the basic test isn’t complicated.
Pick a vial of fentanyl in your system. Can you tell me where it came from? Where it went? Who had it? What happened to it? And can you show me the documentation? If you can do that quickly, you’re probably on the right track. If you can’t, six months into PPAEMA is a pretty good time to figure out why. There are a lot of resources out there to help you get on track; the key is finding the right one to get your agency heading in the right direction, so you can focus on why we exist: to help our patients.
By Clive Savacool, Fire Chief (Ret.), EMT-P
Clive Savacool is a retired fire chief and paramedic with more than 30 years in fire and EMS. He is cofounder and CEO of LogRx, a controlled-substance tracking platform built for EMS and fire agencies. [Watch the full PPAEMA six-month webinar with retired DEA Special Agent in Charge Dennis Wichern here.]
