Dear Chairman Wyden and Ranking Member Crapo:
Thank you for the opportunity to respond to your recent proposal to provide a long-term solution to drug shortages. We sincerely appreciate the efforts of this Committee, Congress and the U.S. Food and Drug Administration (FDA) to mitigate this arduous issue over the past several years. In particular, we value the efforts of the FDA Drug Shortages Office which has utilized all of the tools at its disposal to their maximum effectiveness. Further, we appreciate the Finance Committee’s approach to address the fundamental market failures creating drug shortages. We write to you as the leading Emergency Medical Services (EMS) organizations representing EMS agencies, physicians, and professionals providing life-saving care, treatment and transport to patients with emergency medical and critical care conditions.
While much of the focus on drug shortages has been on hospitals and oncology specifically, the impact of drug shortages in EMS is just as severe and threatens care for EMS patients when minutes count and medications on the ambulance are unavailable, expired or second tier substitutions. EMS agencies struggle to obtain necessary medications, competing with much larger hospital systems with substantially more purchasing power. EMS physicians face Hobbesian choices in establishing protocols for care of EMS patients whose lives are literally on the line in the face of the never-ending drug shortage crisis including which drug to switch to when the preferred one is unavailable, whether to use expired drugs when there are no available alternatives, how to adjust to a different concentration and dosing and train EMS professionals in making such changes. EMS clinicians face an increased risk of medication dosing errors due to a constantly changing inventory subject to the fluctuations of the marketplace. EMS patients suffer and sometimes die from lack of available emergency medications on ambulances.
Our single most important message to you is that within the drug shortage crisis, EMS is different and requires specifically tailored solutions that will ensure that patients requiring life-saving treatment and transport will be assured of receiving them when minutes count for their survival. In short, ensuring the availability of essential emergency medications (EEMs) and most particularly minutes count medications (MCMs) must be a critical priority of the Congress due to the time-sensitive and mobile nature of the treatment provided by EMS agencies and clinicians. Solutions designed for hospitals and physicians may not assist with medication shortages in EMS. In fact, they could inadvertently hinder our ability to access the EEMs and MCMs needed before reaching the Emergency Department.
We are committed to active participation with our federal, regional, state, and local partners as we collectively work toward a solution. Ultimately, we believe a public/private partnership among all levels of government, clinicians and entities administering EEMs, and manufacturers producing them will be required to bring lasting resolution to this issue. As Congress considers legislative options to address the drug shortage, our organizations stand ready to work with Members of Congress on a range of solutions to help improve the medication supply and mitigate the effects of shortages on patient care. We urge Congress to ensure that any stakeholder consultation process includes representatives of the EMS and critical care transport communities.
We have provided a White Paper discussing the Impact of Drug Shortages on EMS Patients to provide background on the unique challenges faced by EMS agencies in providing life-saving treatment and transport to emergency medical and critical care patients suffering from a time critical condition. We do not have any or all perfect solutions to this complex problem. Our organizations have not endorsed the potential approaches outlined, but rather offer them to begin the dialogue with you on how to ensure a stable, sufficient and redundant supply of EEMs and MCMs in particular.
Whatever solutions the Congress chooses to employ should specifically prioritize medications used for treatment of patients with emergency medical, critical and life-threatening illness or traumatic injury, promote access to life-saving medications where they are most needed by patients, and seek to identify and remove impediments to the ability of providers to compensate for lack of access to a preferred drug in the best interest of their patients.
Sincerely,
American Academy of Emergency Medicine (AAEM)
Association of Air Medical Services (AAMS)
Association of Critical Care Transport (ACCT)
American College of Emergency Physicians (ACEP)
American Medical Physician Association (AMPA)
National Association of EMS Educators (NAEMSE)
National Association of EMS Physicians (NAEMSP)
National Association of Emergency Medical Technicians (NAEMT)
National Association of State EMS Officials (NASEMSO)
National EMS Management Association (NEMSMA)
Download the PDF