It’s been the same process for nearly 50 years:
A paramedic responds to an emergency and administers a medication pulled from a red lock box emblazoned with a number.
After driving the patient to a hospital, the paramedic swaps out the opened box with another box bearing a different number before returning to duty.
Then, a hospital pharmacy employee replaces the medication from the original box in preparation for the next paramedic.
That process now has to change under new federal drug rules, and EMS agencies around the Commonwealth are working fast to adjust ahead of when they go into effect in November.
Some agencies, though, might not be able to move fast enough.
Regional drug and IV box exchange programs were the norm for Virginia’s emergency medical service agencies since the 1970s.
“It was just a way in which the hospitals felt they were supporting the EMS agencies and the EMS system in the community,” said Michael Player, executive director of the Peninsulas EMS Council. “I think it has worked very, very well over the years.”
Agencies like Suffolk Fire & Rescue work with nine hospitals in the Tidewater region. That means on any given day, a box that started on a Suffolk EMS vehicle could end up with a different agency.
“We might have a box on Suffolk Medic 1 that was on Norfolk Engine 6 yesterday,” said Suffolk Fire Chief Michael Barakey. “Norfolk Engine 6’s box that was on Suffolk Medic 4 could have been on Newport News [the day before].”
The fluidity of the exchange program left a lot of the accounting leg work to pharmacy staff. It also left a hazy chain of custody of drugs from Lorazepam to morphine.
“[The hospital] who purchased that drug has no way to track that thing from the very cradle to the very end when it hits a patient,” said Suffolk Battalion Chief Keith Johnson.
A 2013 law intended to improve “cradle to grave” drug tracking is just now going into effect, also bringing to an end the five-decade old exchange programs.
Included in the Drug Supply Chain Security Act are requirements for pharmacies to employ electronic systems and procedures that track drugs at the package level. This would allow for greater ease in finding drugs that were recalled, contaminated or expired.
“The FDA is concerned about the quality of the medication,” Player said. “If there’s a bad medication, they want to be able to track who made that medication and be able to know where all that medication is so that they can remove it from the market.”
It wasn’t until November 2023 that EMS agencies were made aware that the exchange programs as they currently exist would not be possible under the new traceability requirements.
It was also then that they were made aware that enforcement of the Drug Supply Chain Security Act starts in November 2024.
“This was a big surprise,” Player said.
EMS agencies had to quickly set up alternative systems for stocking paramedics with the medications they need to respond to emergencies.
For many, it’s still a work in progress.
Suffolk Fire & Rescue plans to order and store its own stock of drugs and IV materials.
“Suffolk Fire & Rescue will be our own pharmacy,” said Johnson.
The department is acquiring secure vaults for central and on-truck storage and logistics software to track inventory. Radio frequency identification technology will help Suffolk track medications down to the vial. A combination of keycards and codes will record who retrieved drugs from any of Suffolk’s vaults.
“We’re able to track all the meds – the meds that we’re given, the meds that are going to expire, the meds that have a recall on them, the meds that are heavily utilized,” Barakey said.
Barakey sees potential efficiencies for Suffolk gained by the change in process. The ability to only replace one drug in a kit rather than the entire exchange box can reduce the amount of time a paramedic is out of service.
But any efficiencies come at a price. Suffolk City Council in May approved $454,000 in traffic enforcement funds to cover Fire & Rescue’s startup costs.
“We’re embracing the change,” Barakey said. “The problem is that some departments … won’t be able to embrace the change because it’d be financially a burden on the community to get set up.”
The costs and tight time frame has led to concern for what could happen if EMS agencies in the state cannot get an alternative system in place before exchange programs end.
According to Player, regional EMS councils are working to keep those concerns from becoming reality.
“Some agencies, they’re large agencies [that are] well-resourced and very capable of doing this on their own,” he said. “Others, small organizations or volunteer organizations, may have difficulty.”
A statewide work group convened to develop tools, resources and recommendations for EMS agencies as they plan their transitions. Teams within the work group focused on different areas, from registry and licensure requirements to drug purchasing procedures.
“The regional councils are developing their own processes for how they’re going to meet or assist the agencies,” Player said.
What that help will look like will vary by region and agency need.
“There’s as many different ways of skinning this cat as there are cats,” Player said.
His Peninsulas region’s council is exploring how it can assist its agencies with drug purchasing and even installing and stocking automated dispensing cabinets at area hospitals.
“We worked with the Board of Pharmacy … they actually passed emergency amendments to the regulations affecting emergency medical services,” said Player. “There’s a lot of tools now with these new regulations that allow one agency to help another agency, regional councils to help all the agencies or a struggling agency so nobody’s going to be left behind.”
In some cases, new-look exchange programs could arise under the management of regional councils if they abide by the new drug tracking requirements. While “more cumbersome and more difficult, it can still be done” according to Player.
“It just needs to be resourced and logistically created for whatever that agency would be and where they were within the council.”
For agencies like Suffolk, councils are offering tools for developing in-house pharmacies, holding vendor fairs and sharing lessons learned by agencies as they work toward self-sufficiency before November.
“The good thing about it is if everything goes like it is right now [for Suffolk] … the end user will see no changes and that’s the most important thing,” said Barakey. “No disruption of services.”
