Ketamine for Prehospital EMS Services

Bureau of EMS Policy Statement
Policy Statement # 10-04
Date 05/24/2010
Subject Ketamine for Prehospital EMS Services
Supercedes/Updates New

This Policy Statement establishes the State Emergency Medical Advisory Committee (SEMAC) and the Department's criteria for including ketamine in an EMS agency's controlled substance formulary. Please take the time to read and understand this Policy Statement. Each individual EMS agency, its controlled substances agent and the medical director are responsible for adhering to all applicable laws, regulations and policies.

History:

In June of 2009, the SEMAC approved ketamine to be added to the State EMS Drug Formulary. As this requires a change to the prehospital use of controlled substances formulary, the Department must review and approve the medication, the process for inventory, security and training. Once done, the Commissioner makes a final ruling. This request was reviewed by the Department's Division of Legal Affairs, the Bureau of Narcotic Enforcement (BNE), the Bureau of Emergency Medical Services (BEMS) and given final approval by the Commissioner of Health.

Based on the potency of ketamine and the potential for serious issues of diversion and abuse, the Department is extremely concerned about its applications in the prehospital environment.

Conditions for Approval:

In order for the Department to approve the addition of ketamine to an EMS agency with a current Class 3C controlled substance license, the following conditions must be met and the Department must review and issue written approvals.

  1. The Regional Medical Advisory Committee (REMAC) must develop protocols for the administration of ketamine and a quarterly evaluation of its use on the regional level.
  2. The protocols must also be approved by the SEMAC and then by the Department.
  3. The service medical director must approve, in writing, ketamine for use by the EMS service.
  4. Only those individuals certified at the paramedic level may administer ketamine.
  5. The EMS agency must submit an amendment to their Controlled Substance Operations Plan to include, but not be limited to the following:
    • A detailed description of the procurement; inventory process and security of ketamine.
    • A program for 100% quality assurance by the service medical director for instances where ketamine has been administered.
    • A separate Quarterly Report (attached) for ketamine stock and administrations. This must be received by the Department within 30 days of the end each quarter.
  6. The EMS agency must submit for review and approval by the Department, the training program developed to in-service personnel. The program must include, but not be limited to training on the updated controlled substance plan, inventory, security, patient administration and reporting policies and procedures. The curriculum format must follow the BEMS required curriculum addition format.
  7. Each substock (the controlled substance medications carried on each vehicle) is limited to a MAXIMUM of 1,000 mg.
  8. KETAMINE MAY ONLY BE ADMINISTERED TO A PATIENT UNDER A DIRECT ON-LINE ORDER FROM A MEDICAL CONTROL PHYSICIAN.
  9. There are two (2) components of the reporting process:
    1. The EMS agency must submit a Ketamine Quarterly Report form (attached) within 30 days of the end of each quarter.
    2. The EMS agency medical director is required to provide a written report of the service's use of ketamine in the prior year no later than January 31st of each year. It must include, but not be limited to the following items:
      • The total number of administrations, amount or medication used and dose.
      • The amount of ketamine wasted.
      • A summary of the patient presenting problems.
      • A narrative summary highlighting the Quality Assurance reviews conducted for each ketamine administration.
  10. 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 using the Loss of Controlled Substances Report form (DOH-2094).
  11. Prior to including ketamine in the EMS agency's formulary, the medical director and the agent must receive written approval from the Department.
  12. If the agency makes any changes or updates to the Controlled Substance Operations Plan, it must provide the specific changes to the Department in writing prior to implementation.

The Department continues to closely monitor the EMS agencies that maintain a Class 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 Section 80.136 of the Part 80 Rules and Regulations on Controlled Substances in New York State, as well as the EMS service's approved Controlled Substance Operations Plan.