Iam writing this comment because Iam Rescue Captain of Bolar Volunteer Rescue Squad in Bolar Virginia. We cover Southeren Highland and Northern Bath Counties. I live 14 minutes from on Station. I keep a VAOEMS Certified First Responder Unit at my house locked up and shore line plugged in. Where we live we have no cellular service and our radios are limited on the power that our repeaters can transmit on because of the NARO over in Greenbank, WVA. We are trying to get the board to realize the importance of saving lives, if our First Responder Unit could be equipped with a BLS Schedule 6 box. We have the temperature controlled unit, on Responder 9. When it is 45 minutes to 60 minutes before an epipen can be administered to a patient, and yes I have been in this situation before this ruling could save countless lives. Please help us help our community

Matthew Ratcliffe

Bolar  Volunteer Rescue Squad Chief

The transition away from hospital-supplied sealed drug kits (and especially sealed narcotics kits) is a great challenge but also may have some benefits going forward.  My own experience has been that sealing all the controlled medications in one catch-all bag has had some unintended negative consequences due to the inevitable out of sight/out of mind effect.  Clinicians were not able to handle and inspect the vials, and there were measurable decreases in pain medication use based on the less accessible nature (and increased restocking time) of the multiple-medicine kits.   

18VAC110-20-591 section 6H refers to keeping Schedules II-V drugs in "sealed, secured kit or device" but does not provide further detail and the terms are not in the Definitions section.  Our goal is to track at the individual vial level, and also make sure the medications are easy to account for (to identify any problems as soon as possible).  Under the old system when we carried all our controlled meds in a single sealed bag provided by the hospital, it prevented us from tracking except at the bag level, and also made close examination of each vial difficult if not impossible.

We consulted a DEA Diversion Investigator and a pharmacist and proposed storing all medications in a single box, with each Sched II-V drug vial separately sealed in its own individual bar-coded tamper-evident bag (clear so we can monitor each vial), with the entire drug box locked in our access-controlled compartment in the EMS vehicle?  We were trying to set up functional controlled medication kits, i.e. seizure kit, sedation kit, pain kit, to help our clinicians and increase medication accountability, and for regulatory purposes each kit would be both sealed and secured.  Both the DEA Investigator and the pharmacist agreed these were compliant and secure solutions (although not the same as the traditional all-in-one solution).   Our goal was to keep the controlled medications secure but easier to visually access, inspect, and verify/account for by sealing and storing them individually, which would also coincidentally reduce barriers to use to benefit patients, and reduce medication error potential by separating the often very similar vials.   Could the language in the regulations be revised to provide more clarity on this aspect of storage?

The Highland County Volunteer Rescue Squad ("HCVRS") has been operating two Quick Response Vehicles ("QRV's") in Highland County for a number of years to try to speed response times in our rural and very mountainous county.  The County is one of the largest counties in Virginia by land mass, but is the least populated county, with a population of around 2000 residents. Additionally, the County has several mountain ranges with valleys in between, making cross-county transport time-consuming and difficult. Accordingly, it poses a great challenge to HCVRS and the Highland Emergency Medical Service ("HEMS") to reach remote citizens with challenging medical needs.  Each of our QRV's is equipped with full drug boxes to address the most critical patients.  Each QRV has the full capability of our ambulance units, with the single exception of the ability to transport patients.  The QRV's are located in Blue Grass and in McDowell, and the main transport units are located in Monterey, the county seat.

It has come to our attention that the Board of Pharmacy has expressed concern about the storage of drug boxes on the QRV units.  With respect, if the Board of Pharmacy disallows the drug boxes on our QRV units, it will significantly increase response times and puts patients' lives in danger.  

The QRV units are locked at all times, and are equipped with auxiliary power connections to maintain the temperature of the drug boxes on the QRV units.  The drug boxes within the QRV units are also locked.  Accordingly, the units are double-locked and secured with power connections, as they would be in any of our EMS bays.

HCVRS is prepared to register the locations of the QRV units as contemplated by the proposed regulations, but wishes to convey how critical these QRV units are to the response times in our rural area, and for our ability to meet the emergency medical needs of our community.

I recommend reducing the stringent security requirements for the storage of Schedule II-V controlled substances by updating regulations to explicitly allow DEA-compliant storage systems, such as Automated Dispensing Machines (ADM). Including ADM and other DEA-compliant technologies in the approved methods for storage and exchange would streamline operations, enhance efficiency, and maintain the necessary safeguards to prevent diversion and unauthorized access. The current security requirements for SII-V are cost prohibitive for agencies and reduce EMS access for medication exchange in both urban and rural communities. 

Highland County is 416 square miles of rugged mountainous terrain with a ridge and valley topography.  A location five miles away can easily be a thirty-minute drive.  

Our volunteer rescue squad has developed a fleet of Quick Response Vehicles parked at a volunteer home.   Each unit has the same equipment as an ambulance, with the exception of a stretcher.  These units, all equipped with a drug box, respond locally while an ambulance responds from a more distant central location.

A trained volunteer arriving quickly on scene can provide lifesaving/stabilizing medications...IF THEY HAVE A DRUG BOX IN THE UNIT.  Removing the drug box from our QRV units will completely undo years of hard work creating a best result Emergency Services System and will result in a significantly elevated risk of death, serious injury, or complications for our local residents and visitors.  This is unacceptable.

One size does not fit all.  We are well over an hour to the nearest suitable hospital.  Our QRV fleet allows our providers to stabilize a patient earlier in the process while the ambulance is on the way.

Our county has a small population and cannot afford to fund and staff Emergency Services stations throughout the county.  Instead, we utilize volunteers and FULLY EQUIPPED QRV's to produce good outcomes for our residents.