Fentanyl for Prehospital EMS Services
| Bureau of EMS Policy Statement | |
|---|---|
| Policy Statement # | 07-02 |
| Date | 06/11/07 |
| Subject | Re: Fentanyl for Prehospital EMS Services |
| Supercedes/Updates: | New |
History
At the request of the State Emergency Medical Advisory Committee (SEMAC) and a number of air medical service physician medical directors, the Department was approached requesting that fentanyl be added to the formulary approved by the controlled substance 3C license. This request was reviewed by the Departments Division of Legal Affairs and the Bureau of Narcotics Enforcement (BNE)
Based on the potency of fentanyl and the serious issues of diversion and abuse, the Department initially approved its use by New York States air medical service providers under specific conditions. At the May 2007 meeting of the SEMAC, the use of fentanyl was approved for all advanced life support (ALS) EMS agencies possessing a current Department of Health EMS Agency Certification and Prehospital Controlled Substance License, under the specific conditions indicated below.
Conditions for Approval:
In order for the Department to approve the addition of fentanyl to an EMS agency with a current Prehospital Controlled Substance License, the following conditions must be met and the Department must review and issue written approvals.
- The Regional Medical Advisory Committee (REMAC) must develop protocols for the administration of fentanyl and a periodic evaluation of its use on the regional level. The protocols must also be approved by the SEMAC.
- The service medical director must approve, in writing, fentanyl for use by the EMS service.
- Only those individuals certified at the critical care or paramedic level may utilize a controlled substance medication.
The EMS agency must submit an amendment to their controlled substance operational plan to include, but not be limited to the following:
- A detailed description of the procurement; inventory process and security of fentanyl.
- A program for 100% quality assurance by the service medical director for instances where fentanyl has been administered.
- The training program used to in-service all appropriate staff on the inventory, security and administration of fentanyl.
- A separate Quarterly Report (attached) for fentanyl stock and administrations.
- Only two (2) - 2ml glass ampules containing 50mcg/ml, totaling 200 mcg may be carried in each sub-stock.
- The program must insure that the formulary includes an appropriate antagonist necessary to reverse the effects of a fentanyl administration.
- FENTANYL MAY ONLY BE ADMINISTERED UNDER DIRECT ON-LINE MEDICAL CONTROL.
As a part of the reporting process, the agency medical director is required to provide a report of the service's use of fentanyl by December 31st of each year. The report should include, but not be limited to the following items:
- The total number of administrations, amount or medication used and dose.
- The amount of fentanyl wasted.
- A summary of the patient presenting problems.
- A narrative summary highlighting the Quality Assurance reviews conducted for each fentanyl administration.
- All instances where a theft, loss or diversion, are suspected MUST BE REPORTED TO THE DEPARTMENT IMMEDIATELY. This report must be made to the BEMS Central Office.
- Prior to including fentanyl in the EMS agency's formulary, the medical director must receive written approval from the Department.
The Department will closely monitor the EMS agencies that maintain a prehospital (3C) controlled substance license to insure that there is the strictest compliance with all of the applicable sections of Public Health Law, the Codes, Rules and Regulations – Part 800 and Part 80.136 as well as the EMS service's approved Controlled Substance Operations Plan.