Our EMS enterprise is very proud of our response to COVID-19. Through the most difficult circumstances, we adapted and improvised to care for our patients and serve our communities. We summarize our experiences in several categories, all of which we believe must be addressed in the reauthorization of PAHPA. As former Assistant Secretary of Preparedness and Response Dr. Nicole Lurie often told us “if you can’t do it every day, you can’t do it on game day.” It is with her prescient words in mind that we offer the following experiences and solutions moving forward.
A. Drug Shortages
Shortages of essential EMS medications (EEMSM) we use every day continue to plague our ability to care for patients. EMS agencies across the United States are currently seeing severe restrictions in the availability of IV fluids (essentially sterile salt water), pain medications, anti-nausea medications, sedatives, and airway management medications. Drug shortages are a market failure, not because the cost of drugs is too high, but most often because the cost of generic sterile injectables is too low for manufacturers to be able to produce a stable, sufficient and redundant supply.
A 2019 survey of physician medical directors of EMS agencies, undertaken by NAEMSP®, demonstrated serious and adverse impacts of drug shortages on EMS patients, including errors in drug administration and dosing, and high rates of unavailability of essential medications, many with no suitable substitute. The nature of EMS medical care is such that when drugs or specific concentrations of a drug go into shortage, medical directors must continually revise their protocols based on what drugs and concentrations they may be able to secure. Paramedics must quickly adjust to alternative medications or the same medication but in a different concentrations, greatly increasing the risk of medication errors in a fast-paced environment in which time is of the essence for patients.
We sincerely appreciate the efforts of Congress and the U.S. Food and Drug Administration (FDA) to mitigate this issue over the past several years; in particular, the efforts of the FDA Drug Shortages Office which has utilized all of the tools at its disposal to their maximum effectiveness. Despite these remarkable efforts, we nevertheless find ourselves in a dire situation, only exacerbated by the pandemic, with no clear resolution on the horizon.
NAEMSP® is 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 between all levels of government, the clinicians and entities administering EEMSM, and the manufacturers producing them will be required to bring lasting resolution to this issue.
- NAEMSP has recommend that the ASPR establish an EMS Drug Shortages Collaborative to bring together all stakeholders — EMS medical directors, agencies and clinicians, pharmaceutical manufacturers; wholesaler distributers among others — to collaborate on how to address drug shortages and provide critical advice to the Secretary, FDA Drug Shortage Task Force, and ASPR. The medications used in EMS are critical to saving lives before and during transport to a hospital. We lack the buying power of large hospital systems, especially among smaller and volunteer EMS agencies in rural areas, to receive priority in the distribution of limited drugs. We need different concentrations than hospitals, and we need them consistently to avoid switching medications and doses to prevent medical errors. We are confident that convening all stakeholders to discuss the unique impacts on drug shortages on EMS will help us all to better collaborate on how to ameliorate these shortages.
- NAEMSP is urging the Congress and the Secretary of HHS to establish a list of EEMS to identify which EMS medications are most needed in every day and in the event of a public health emergency. This will help all stakeholders to work together, with the ASPR and FDA Office of Drug Shortages, to maximize the availability of these medications for EMS. Further, we request that the Secretary identify an even shorter list of no more than 20 critical EMS medications (CEMS), and that the Congress provide authority to the Secretary — either through BARDA or the National Stockpile — to utilize funding to purchase these life-saving medications to ensure a stable supply.
B. EMS Medical Direction
The PAHPA statute already requires that the ASPR’s duties include “improving emergency medical services medical direction”. The pandemic produced many challenges for EMS medical directors and the EMS clinicians whose provision of care they oversee. Most significant was the lack of flexibility and statutory/regulatory impediments in many jurisdictions across the nation to enable EMS medical directors to recognize, adjust to and ameliorate shortages of equipment, devices and medications. For example, these EMS physician Medical Directors had to make difficult choices of whether to utilize expired drugs and devices, including PPEs, or go without. Some states and localities quickly enabled the adoption of crisis standards of care, but many did not, and EMS medical directors remained liable for having to deviate from the normal standard of care when faced with shortages of personnel, equipment, medical devices and medications. Much of the operational guidance put out by CDC and other federal agencies was designed for fixed facilities, forcing medical directors to try to adapt this to a mobile environment of care delivered at the scene or in an ambulance.
- NAEMSP is working to establish a EMS Medical Director position within ASPR. The ASPR Physician EMS Medical Director should report directly to the Assistant Secretary of Preparedness and Response and be responsible for advising the Assistant Secretary on the medical aspects of preparedness and response. It is imperative that the ASPR Medical Director be double boarded in both emergency and EMS medicine, as the medical aspects preparedness and response require intimate knowledge of and direct experience both the in-hospital and pre- and out-of-hospital delivery of emergency medical care. The key areas that the ASPR Medical Director would include:
(i) improving medical direction of EMS during public health emergencies by facilitating the flexibilities needed by EMS medical directors at all levels of government including for clinical practice waivers;
(ii) promoting the timely and widespread adoption of crisis standards of care at the state, local levels to enable flexibility and liability protections in response to a public health emergency;
(iii) preventing and managing shortages of equipment, devices and pharmaceuticals, including the utilization of expired drugs and devices; and
(iv) improving the functionality of operational guidance prior to and during public health emergencies for non-facility based EMS agencies and other mobile medical resources.
C. EMS Agency Resources
One of the most critical challenges facing EMS agencies was the lack of sufficient resources — financial and workforce — throughout the pandemic. Put simply, EMS was not viewed (financially) as an essential public service throughout the worst of the pandemic.
There is no federal grant program specifically for EMS and no available mechanism by which to get money quickly to EMS agencies. Among first responders, CARES funding was prioritized to law enforcement and the fire service. Given the already financially strained EMS enterprise and agencies, the lack of such a mechanism was devastating for EMS agencies and severely constrained their ability to fulfill their critical role in providing care and transport during the pandemic. There simply wasn’t sufficient funding to purchase devices and equipment needed to care for highly infectious patients, including N95 masks, disinfectant to clean ambulance vehicles, and viral filters to protect EMS clinicians and patients during intubation as well as to fund the increased personnel costs associated with overtime and backfilling for quarantined and isolated workers. The financial strain was further exacerbated by the workforce shortage that quickly worsened during the pandemic. EMS clinicians got COVID-19 themselves, requiring 10 or more days before being able to resume duty. And hospitals, facing their own nursing shortages, began utilizing paramedics in their ED’s and ICU’s, drawing from the existing strained EMS workforce.
- NAEMSP is working with Rep. Emanuel Cleaver toward introduction of legislation to provide grants for community paramedicne to EMS agencies. The legislation will allow EMS agencies to utilize such funds for medical direction and other important patient care needs.