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The clock is ticking for emergency medical service agencies, in Charlotte County and across the region. They have four months to adjust to upcoming federal regulation changes that will upend the way they obtain and distribute medications for use on their ambulances.

The ODEMSA Regional Medication Box Exchange System worked for decades and agencies say it was mutually beneficial for them, as well as hospitals and patients. But it is going away in November thanks to new federal regulations that made the system untenable.

We’ve covered that part before. But now we’re checking in with different agencies to see if, with a few months left, they’ve been able to adjust.

HOW DID THE DRUG BOX EXCHANGE PROGRAM WORK?

The ODEMSA (Old Dominion EMS Alliance) Regional Medication Box Exchange System, informally known as the drug box exchange, allowed agencies providing emergency medical services to obtain their medications from hospitals and use hospital facilities to store them until they were stocked on the ambulances.

Each of the medication kits carried the same commonly used drugs — for example, medications that relieve pain, help mitigate seizures and cardiac episodes, and more.

When a patient needed one or more of the drugs during an ambulance ride, the EMS agency exchanged the partially emptied box at the hospital after handing off the patient. The agency received a fully stocked box, and the previous box was restocked with the used medications and handed off to the next EMS agency.

It’s a system that has worked for more than 40 years, and it all took place at no cost to the EMS agencies.

WHY IS THE PROGRAM BEING DISCONTINUED?

The Drug Supply Chain Security Act by the U.S. Food and Drug Administration is impacting the regional medication kit systems. It goes into effect on Nov. 27, 2024.

“We’ve tried all kinds of ways to make it work so we could have the same system, but there was just no possible way with the law we would be able to do it,” said Heidi Hooker, executive director of the Old Dominion EMS Alliance.

Because of the nature of how the drug box exchange works, it’s near impossible to track medications after they go into the first box. Each medication may be in the hands of several different hospitals and EMS agencies before it is used for a patient.

The new federal regulations implement more stringent regulations on drug security and tracking, which would be very difficult to meet if the drug box exchange program stayed in effect.

“The law wants the medication tracked from the manufacturer until it gets into a patient,” Hooker said.

Walt Bailey wears multiple hats in the realm of public safety. He is president of ODEMSA, fire chief in the Town of Phenix and a member of the Board of Supervisors here in Charlotte County. He believes the unfunded mandate will have a negative impact on the citizens.

“We don’t have the ability to bill for the drugs. We’re going to do whatever we have to do to save the person, but the burden is being put on the locality and the agency.”

Bailey said some agencies may have to spend as much as $100,000 on upgrades to their buildings as well as the added cost in medications. It’s difficult to predict the future cost, as it depends on call volume and any medications that may expire before they’re used.

“It’s going to be negative for the people, and it’s going to mean a somewhat degrade in our ability to provide the service we’ve been able to provide in the past,” he said. “It’s another burden localities have to bear without any hope of recovering that cost.”

Bailey said citizens should reach out to their state and federal lawmakers and ask for better support for fire and EMS, especially in rural areas.

“A new fire truck today exceeds $600,000; a new ambulance — not equipped — is $450,000,” Bailey said. “You can’t sell enough raffle tickets or cook enough stews to support keeping current with the equipment.”

WHAT PROGRESS HAS BEEN MADE?

And now with all that in mind, we come to the big question. What progress has been made in preparing for the switch?

ODEMSA has agreed to surrender its current stock of medication boxes to local EMS agencies, so each agency will retain the boxes it currently has. In addition, the hospitals in the region have agreed to relinquish the medications currently in those boxes, allowing agencies to have some stocked medication as a buffer for when the transition occurs.

Many agencies have acquired needed licensures known as a Controlled Substance Registration (CSR) from the state as well as a license from the U.S. Drug Enforcement Administration.

The state Board of Pharmacy adopted a raft of emergency regulations at its May 2 meeting to streamline certain parts of the process for EMS agencies. For example, all EMS agencies within a jurisdiction can be served by just one agency with a CSR and a DEA license, and likewise for all within a region to be served by the regional EMS council with a single CSR.

In addition, the regional councils would be allowed to purchase the needed medications and distribute them to the agencies if an agency chooses to go that route.

Cody Davis, chief of the Department of Emergency Services in Buckingham County, said his department has obtained its CSR and DEA license. Davis has also increased the medical supplies line item in his budget by $40,000, which he said is a guesstimate on the medication cost.

“We didn’t need to do any sort of structural renovations to create a pharmacy area, because we got approved with what we already had,” Davis said, calling that a “luxury.”

He has already decided what medications his agency will carry and the bags they will use to transport them to calls. A department-wide training is planned for August, and he plans to roll out the changes in September, allowing a buffer prior to the November implementation date in case anything goes wrong.

Andy Aigner, chief of fire and EMS for Cumberland County, said “Cumberland is taking the appropriate steps to ensure there is no lapse in services to our citizens and visitors.”

For his part, Davis believes the changes will ultimately be a good thing in Buckingham County.

“I honestly believe this is going to be a good thing for patient care, because it allows us to create a more tailored care system,” he said. Some of the medications carried before were not useful for the demographics or response times seen by his agency; now, “it gives them a more customized Buckingham County service,” he said.

He’s optimistic some funding may eventually come through to help agencies absorb the cost, naming off several grant programs he plans to apply for.

“Some money now, or already, would’ve been pretty nice,” he said.

THE BIGGEST PROBLEM IS FUNDING

Even with the concessions made by the state board, responding to the changes has been costly.

“The biggest struggle for us is funding,” said Brandon Jenkins of the Nottoway County Emergency Squad Inc. “It’s one of the largest, if not the largest, changes in the Office of EMS history.”

Jenkins said EMS agencies will now have to buy their own medications, obtain their own licenses, and potentially make structural improvements to their buildings to comply with safety and security requirements.

“We’re looking at $27,000 for licensure renewal and medication costs,” Jenkins said, adding that his agency had spent about $9,000 on security cameras, an alarm system, a safe and more. “That might not sound like a lot, but that’s because our members and volunteers came together and probably saved about $4,000 to $5,000 on labor by doing it ourselves. We were fortunate; we already had a room that we didn’t have to do any construction to. Some agencies have to build this from scratch, so it could be much more expensive for other agencies.”

There’s also an invisible cost — additional workload on volunteers that already spend vast amounts of time on duties that aren’t directly related to patient care.

“The call isn’t over when we hand the patient off at the hospital,” Jenkins said. “It’s when we get back to the station and complete documentation and fill a medication bag now and restock our truck and clean our truck.”

Despite the hardships of complying with the new regulations, some believe patient care is unlikely to be impacted.

“Medications are not cheap,” Jenkins said. “If there is a cardiac arrest, we can very easily use $300 to $500 worth of medications on that one patient. But at the end of the day, we’re going to provide the best possible care regardless of the financial constraints that have been put upon us.”

HOW IS ONE LOCAL AGENCY HELPING OTHERS?

Jenkins said he felt compelled to share what his agency had done once they went through the process.

“We went through the process and made some mistakes,” said Jenkins, who is executive director, sits on the executive board, and is agency secretary, all volunteer positions. “There were a ton of other agencies struggling.”

Jenkins decided to put together a class for other agencies detailing how Nottoway County Emergency Squad Inc. had coped with the upcoming changes. He held one class for nearly 200 people in May and another class for nearly 150 people in June. In all, about 95% of all EMS agencies in the state were represented at one of the classes.

“There was so much response that I had to cut off the registration,” he said. “I just kind of walked them through that process and what worked for us.”

Jenkins said that although the new regulations had put a strain on many agencies, it was gratifying to him to be able to help them navigate the changes.

“I could not sit there happy and proud of something we put together and not share it with the rest of the commonwealth,” he said of the classes he offered, which were free to the other agencies. “I have not met one person that did not leave with something good and something valuable.”