March 1, 2012
To: Ohio EMS agencies, EMS medical directors, hospitals, and hospital pharmacists From: Ohio Department of Public Safety, Division of Emergency Medical Services Subject: The February 22, 2012 announcement of drug shortages from the FDA. In light of recent events, your prompt attention is requested to review practices by your agency for substituting drugs that are unavailable or in limited supply that are used by EMS agencies.
The recent announcement of drug shortages from the FDA has impacted on hospitals and may have a negative impact on the ability of EMS professionals to provide the traditional standard of care in the prehospital environment for some patients, as about half of the medications on the FDA’s list are commonly stocked and administered by EMS agencies.
RATIONALE FOR REVIEW
The following suggestions for alternative drugs are solely based upon the February 22, 2012 drug shortage report from the FDA; therefore, continuous communication with the pharmacists and frequent reassessment of the FDA drug shortage list is imperative. The ongoing drug shortage situation is a dynamic one and the medications in short supply may change on a daily basis. The highest priority must be given to maintaining patient care while at the same time following Ohio law. All transitions to alternative medications must be done in compliance with Ohio’s State Board of Pharmacy and the DEA’s regulations. It is also imperative that EMS medical directors serve as the party to initiate the transition to and implementation of alternative medications for EMS agencies. The addition of any alternative medication to an EMS protocol must be paired with training, continuing education, competency assessment, and continuous performance improvement measures. The National Association of State EMS Officials (NASEMSO) Medical Directors Council has discussed this issue as well as the increased risk of potential conflict with DEA regulations when EMS professionals and EMS medical directors may contemplate administration of expired scheduled medications. Temporary waivers of drug expiration dates are currently being explored for potential viability as an avenue of relief.
The NASEMSO Medical Directors Council acts in an advisory role to NASEMSO and does not have the authority to grant states the ability to waive the expiration dates of medications for EMS agencies or emergency care facilities nor does it have the authority to create policies for the FDA or DEA. Nevertheless, we are committed to be a lead partner with EMS organizations and other stakeholders within our emergency care system to definitively address this dilemma that we believe that the incidences of drug shortages will be ongoing for some time. The FDA has ultimate authority of approval for the administration of medications beyond the expiration dates. An additional consideration is that the FDA’s list of drug shortages includes scheduled medications. For these medications, approval from the DEA, in addition to the FDA, may be required to waive the expiration date of a scheduled medication. The presence of active and involved EMS medical direction is critical and required. EMS medical directors may wish to create and/or implement “just in time” protocols for alternative medications to ensure seamless quality patient care and to maintain patient safety in the pre-hospital setting.
Dr. Carol Cunningham,
State Medical Director
Ohio Department of Public Safety, Division of EMS