KARNES COUNTY – Smaller Emergency Medical Services around the country have been feeling effects from the 2013 Drug Supply Chain Security Act, but a new change directly effects Karnes County.
KC EMS Assistant Director Casey Ebrom presented to the commissioner court Dec. 31 his concerns and how it relates to the fiscal impact that will be placed on Karnes County.
“In a nutshell, what has occurred was back in 2013 the Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act) went into effect,” Ebrom said.
“In that legislation, there was an established time line. The dates ranged from 2013 to 2023.
“The intention (based upon my interpretation) of the FDA was to establish an effective method to track the production, purchase, distribution and dispensing of pharmaceuticals. At face value, I cannot disagree with the intent of that statement. I do however do not think they (federal government) understood the impact that this will have on the end user(s) (i.e., EMS).”
Nearly five years ago, Karnes County EMS noticed a difference, according to Ebrom.
“In July of 2015 we (EMS) saw a slight change as a result of this with the purchase of pharmaceuticals,” he said.
“The manufacturers and wholesale distributors now had to provide a ‘transaction report’ for every medication that we purchased.
“We in turn have to retain those documents for five years. That ‘new change’ went into effect and is still effective today.”
Roughly two years after its first experience with the drug supply law, Karnes County EMS had to abide by another set of standards.
“Fast forwarding to Nov. 27, 2017, all drug manufacturers were required to begin placing a unique product identifier (aka serial number) with a 2D barcode onto the ‘smallest unit of measure’ they sell (i.e., box of 10 or box of 25),” Ebrom said.
“This was again in an attempt to have uniformity in the product traceability standards across the country.”
With the last implementation of the drug supply law Nov. 27, 2019, Ebrom is now concerned with the future.
“The big change (based upon the original established timeline from 2013) went into effect Nov. 27, 2019,” he said.
“This change was to the quantity of medications that the wholesale distributors can receive and sell to the end user.
“In the past, the wholesale distributors would buy large box quantities of medications from the manufacturers and then resell them in ‘each’ or ‘box’ quantity to the end user.
“Now they can only sell the ‘smallest unit of measure’ from the manufacturer that has a ‘unique product identifier’ affixed to it.
“Simply put, we are forced to purchase a box or case at a time.”
A direct result is an increase in the budget, according to Ebrom.
“This has and will continue to significantly increase the annual cost of stocking and/or replacing pharmaceuticals on our ambulances,” he said.
“The biggest issue(s) I see with this new implementation is that this will place a significant financial burden on smaller EMS agencies across the country as well as continue to exacerbate the never-ending medication shortage.
“We have been fighting medication shortages and back orders for at least the past five to eight years.
“Attempts were made to fix it at the manufacturers’ end; however, there were a lot of EMS agencies that would practice the act of ‘self-policing’, meaning they would only order what they needed because every other person/agency is waiting in line for that same medication.
“That act of ‘being frugal’ has now been eliminated with the implementation of the unit of measure changes from the wholesale distributors.”
Not only will Karnes County continue to witness fiscal increases with the new drug supply change, but EMS departments around the country, according to Ebrom.
As we continue to move forward, I forecast many small and/or volunteer EMS agencies will begin to feel the pain and pressure related to this financial burden,” he said.
“As I said in court, there are some EMS agencies that can barely afford to pay their staff and put fuel in their vehicles; now they will have to deal with this additional challenge related to medications.
Despite any changes, Karnes County EMS wants the public to know the level of care will continue, Ebrom said.
“I do however want to clarify: Karnes County EMS will not alter our services and/or capabilities as a result of this,” he said.
“Dennis and I (along with our staff) are committed to providing the highest level of care to the taxpayers and citizens of Karnes County. This ‘issue’ will be managed appropriately with good budgetary planning and evaluation by our administrative staff (to include our physician medical directors).”