AMED will need to make up to $40,000 worth of changes to comply with a new national requirement that ambulance services be licensed by the Drug Enforcement Administration, although many of the basic procedures needed to comply are already in place for the local organization.

The necessary adjustments will be more extensive for smaller ambulances services that don’t have many of those basic procedures already in place, according to AMED Executive Director Gary Watters.

The new “final rule” based on the Protecting Patient Access to Emergency Medications Act of 2017 will require “oodles of paperwork,” installations at station houses and in vehicles and site inspections, according to Watters and online sources.

Under the new rules, AMED workers will not be able to restock ambulances with narcotics directly received from hospitals where they deliver patients on whom they used those narcotics, but will instead need to restock from AMED stations, according to Watters.

AMED will no longer be able to keep narcotics in a locked cabinet within a regular storeroom but must create a locked stockroom accessible only by personalized electronic fobs, with a safe within the storeroom in which the narcotics will be kept, according to Watters.

And the ambulances themselves will need to be equipped with safes for the narcotics, according to Watters.

The new safe room in the agency’s headquarters station in Lakemont will be created from an office that was recently vacated due to a transition, Watters said.

AMED already has the tracking software needed to work with the new setup, according to Watters.

The new rules are designed to combat drug “diversion,” according to online sources.

AMED has never had a diversion incident, although other ambulance agencies have had such incidents, Watters said.

Prior to the new rules, ambulance agencies “operated in a regulatory environment that was functional but imperfect,” according to a Feb. 26 post by the staff of the American Ambulance Association on the association’s website.

“Controlled substances were often handled under the DEA registration of a hospital, pharmacy, or medical director,” the article states. “While this approach allowed EMS agencies to deliver critical medications in the field, it left gaps in regulatory clarity and accountability.”

The new rules make ambulance agencies themselves responsible “for controlled substance compliance, documentation and chain-of-custody tracking,” the post states.

The old rules for the law were written to jibe with operations in fixed facilities like hospitals, clinics and pharmacies, according to the article.

The environment for those operations contrasts with the “highly mobile environments” in which “controlled substances move across vehicles, stations, shifts and personnel on a daily basis” for ambulance services, according to the post.

There is clearly a backlog in processing license requests, given that AMED’s application wasn’t even acknowledged by email until five days had elapsed, Watters told his board Monday.

“They’re inundated and overwhelmed,” he said.

The new rules will generate costs and force operational changes for AMED, but won’t “necessarily change our world,” Watters said.

To some degree, it will create inconveniences for AMED workers, who might need to go back out from caring for a patient in a house to retrieve narcotics from a safe in their ambulance, Watters said.

However, he expects there will be “workarounds” created to minimize such inconvenience, while staying within the new rules, he said.

For small ambulance agencies, the new rules will require significant investment and will likely be “world-changing,” Watters said.