Virginia Regulatory Town Hall
Agency
Department of Health Professions
 
Board
Board of Pharmacy
 
Guidance Document Change: Guidance on Emergency Medical Services Drug Kits

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10/25/21  9:50 am
Commenter: Anonymous

Storage
 

From the document "The drug kit must remain secured in the ambulance at appropriate temperatures at all times. These kits are not intended to be stored within the EMS facility."

There is a practical need to store medication kits in a secured manner when a vehicle is out of service for repair etc. Allowing a properly secured and monitored storage location in a facility (such as the Fire-EMS station where the vehicle is typically located) should be considered. 
CommentID: 116552
 

10/25/21  9:56 am
Commenter: Anonymous

Storage of IV solutions in facility
 

From the document:

"If (intravenous) solutions must be stored within the EMS facility, the agency must first obtain a CSR for the purpose of storing these solutions in the EMS facility at the address on the application."

Unclear why IV solutions would be specifically called out to address in-station storage when there is a long list of regulated medical equipment (such as needles, IV catheters etc) that require similar protections for secure storage. Additionally, requiring a separate CSR for the sole purpose of storing these medical supplies creates a high regulatory burden for larger EMS agencies with multiple stations under a single agency umbrella. 

 

CommentID: 116553
 

10/25/21  10:16 am
Commenter: Anonymous

Pending DEA guidance
 

Several aspects of the proposed BOP guidance seem out of step with The DEA's proposed rules on the amended Controlled Substances Act. Perhaps waiting for the DEA's rules to be finalized prior to writing the BOP guidance document should be considered to prevent having differing guidance published.  

Some examples:

DEA rules have proposed:

-permitting storage in facilities without requiring a separate registration for each individual site (e.g. firehouse)

-allowing one for one medication exchange with a hospital following a patient care episode even if the EMS agency's primary routine means of medication handling is agency-based.

In section II of the BOP document, EMS Preparation of its Own Kits Model:
Storage of Schedule II-VI Drugs within EMS Facility for Preparation of Drug Kits:

"Under this model, the EMS facility is solely responsible for preparing and securely storing drug kits for its own use, and replacing drugs within the kits as used for patient administration. The EMS agency does not exchange kits or drugs with a hospital pharmacy."

This prohibition of 1 for 1 exchange at the hospital appears out of step with what DEA is proposing (establishing routine handling of medications by EMS agency but still allowing one for one after an emergency incident with  transfer of custody).

From the DEA's proposed rules amended Controlled Substances Act:

Section E.1.a. Restocking

"Following an emergency response where controlled substances were administered, EMS personnel may not have enough time to return to their stationhouse to restock their EMS vehicle with controlled substances. Depending on the circumstances, the stationhouse may be a considerable distance from the hospital where the EMS personnel brought a patient, or the volume of emergencies may be so great that the ambulance does not have time to return to the stationhouse. Rural EMS systems in the United States may face transport distances of 20 to 100 miles to the nearest hospital. Thus, the Act allows non hospital-based EMS agencies to receive controlled substances from a hospital for the purpose of restocking an EMS vehicle following an emergency response."

 

 

CommentID: 116555
 

11/1/21  3:11 pm
Commenter: Anonymous

Exchange of the kit in the emergency department...
 
CommentID: 116585
 

11/1/21  3:14 pm
Commenter: Anonymous

Exchange of the kit in the emergency department...
 

Exchange of the kit in the emergency department must only be performed by a pharmacist, nurse, or prescriber if the kit contents include Schedule II, III, IV, or V drugs: 

Why can't ALS providers remove their own narcotics/medications from a pyxis system? What problem are we trying to solve here? What if the ED is staffed with Paramedics? Can they replace the scheduled medications? This will create more of a problem by requiring overworked nurses to complete one more unneeded step. 

CommentID: 116586
 

11/1/21  3:17 pm
Commenter: Anonymous

Drug kit storage only in an ambulance
 

The drug kit must remain secured in the ambulance at appropriate temperatures at all times. These kits are not intended to be stored within the EMS facility.:

Why can't these kits be stored inside of an EMS facility? Why would it be prohibited for us to secure the medications in a locked supply room while a unit is out of service for maintenance? This is simply not practical.

CommentID: 116587
 

11/1/21  3:18 pm
Commenter: Anonymous

One-for-one narcotic exchange
 

A one-to-one exchange of drugs in Schedules II-V is not allowed:

Why? We need to allow the one-to-one exchange of narcotics as several different agencies carry different narcotics per their protocols. This would make restocking much easier at outlying hospitals and also would return ambulances to service more quickly. 

CommentID: 116588
 

11/1/21  3:20 pm
Commenter: Anonymous

Typo?
 

An initial inventory of all stocks on hand of Schedules II through V drugs must be taken and at least every two years.

At least every two years, what?

CommentID: 116589