Attn: Mr. President, there is a drug shortage

In a recent letter dated April 15, 2012 to the President of the United States from the EMS Labor Alliance, the IAEMSC, IAFC, NAEMSM and NAEMSP share a startling statistic about the shortage of drugs available for use in the field for paramedics.  Although the reasons for the shortage appear to be an ongoing debate, what are your thoughts on this situation?  The letter to the President is below.

 

 

April 15, 2012

To: The Honorable Barack Obama-President of the United States

 

CC: The Honorable Joseph Biden-Vice President of the United States

The Honorable Kathleen Sebelius-Secretary, United States Department of Health and Human Services

The Honorable Janet Napolitano-Secretary, United States Department of Homeland Security

 

Presently, a situation with great national safety and security importance exists which is diminishing Emergency Medical Services (EMS) capabilities on a routine basis and moreover, negatively influencing the overall level of national preparedness. This prevailing circumstance is an expanding national medication shortage-­‐ a supply chain disruption involving many of the potentially lifesaving medications EMS requires to provide pre-­‐hospital treatment to patients in their times of need. This situation is a national shortage of many of the medications EMS delivers to patients in the pre-­‐hospital environment. These include medications for resuscitating victims of cardiac arrest, stopping seizures, managing violent patients, treating unconscious diabetics, and many other potentially life-­‐threatening conditions. Further, this problem is also preventing EMS organizations from gaining access to medications needed to manage patients’ pain. The existential scope of this continuing and escalating problem is a national one in the broadest sense.

As a result of conventional pharmaceutical industry production and the contemporary Federal regulations governing the same, many of the drugs that EMS relies on to provide life-­‐saving intervention and comfort to our patients are currently unavailable to many EMS services. The exact origins of this problem are the subject of ongoing debate. The industry refutes the claims of the Food and Drug Administration (FDA) that production and quality issues are significant contributors with assertions that Federal regulation is to blame. While reality most certainly exists somewhere between these opposing views, the only current effort toward resolution seems to be the voluntary reporting system monitored by FDA. From a front-­‐line perspective, the FDA’s drug shortages list simply chronicles the facets of this growing problem in a running order.

Despite the challenges presented by the current situation, EMS services across the nation must continue to respond to 911 emergency calls every day to treat patients. Some EMS services have obtained, or are attempting to obtain these medications through “compound pharmacies” in an effort to work around these shortages and to continue to deliver their communities’ standards of care in the face of the current critical national shortage. While these compound pharmacies are able to mix the raw elements of these drugs into dispensable products, the absence of the economies of scale afforded by mass production leads to unit prices that can be up to ten times higher than normal. Exacerbating the cost problem is the fact that compounded medications have dramatically reduced shelf lives, requiring a more frequent inventory turnover. These additional costs are not reimbursable. Today’s difficult economic times leave some EMS services unable to afford this option at all, and subsequently unable to appropriately treat patients requiring these interventions. The consequence is a marked reduction in EMS patient care capabilities for entire geographic regions of our nation on a day-­‐ to-­‐day basis. For individual patients, the one thing they may need may not be available at the time of greatest need, with potentially fatal consequences.

Some EMS services have been able to continue providing care, but are operating on an inventory of these products that is below par levels, levels that would be considered prudent during normal times. The availability of these medications becomes the limiting factor in the number of patients that individual EMS services could treat, relegating the EMS standard of care to a necessary first come, first served basis.
In the context of the critical EMS medication shortage and the inability to maintain community standards of care for patients on a day-­‐to-­‐day basis, the ability to manage national level disasters or events is substantially degraded. The first come, first served basis will be almost instantly necessary, magnifying the disparate pre-­‐hospital care from community to community that Americans are already receiving. Once the limited supply of pain control medications are exhausted, all other patients will needlessly suffer. Those in need of other medications in a disaster area will be forced to wait for a supply chain to be established and for it to be functional, which could take days. This assumes that medications are stockpiled and available to be pushed to these affected areas at all. The concept of local EMS systems purchasing medications from compounding pharmacies in exponentially higher quantities is not an option, both from a financial and practical perspective. EMS services do not have the economic resources available to stockpile to this degree, nor do compounding pharmacies necessarily have the surge capacity to meet such an increase in demand. While it may sound dramatic, the disruption in normal EMS operations posed by large-­‐scale events will have significant negative affects on an already tenuous day-­‐to-­‐day EMS landscape.

EMS is particularly vulnerable to the current volatility in supply, due in large part to the specific drugs on the shortage list. According to a recent report by the IMS Institute for Healthcare Informatics; “Drug products on the shortage list are highly concentrated: 63% are in five disease areas: oncology, anti-­‐infectives, cardiovascular, central nervous system and pain management and 80% are generic injectables.” Medications commonly administered by EMS include several in the categories of cardiovascular, central nervous system and pain management medications. A truly alarming finding is that there are shortages in entire classes of medications, making substitutions of one similar medication for another difficult or impossible.
Overall, multiple manufacturers supply the full formulary of EMS medications. Most of the individual drugs, however, have only one or two suppliers. Despite the existence of over 100 suppliers for what could be considered the full EMS pharmacopeia, fifty products have only one supplier, and two-­‐thirds of the drugs have three or fewer suppliers.

Several national EMS organizations are currently collaborating on legislative options to address the issues on an industry-­‐wide level. The complexity of the problem, however, will require a protracted effort that includes discussions of areas of law such as patents and licensing agreements. We are hopeful that these efforts will result in an eventual solution, but they will certainly take quite some time and face many political, economic and legal challenges. More immediate solutions are necessary, as time is a luxury that neither EMS services nor the citizens they serve, have.

We believe that the federal collaborative framework, responsibilities, and authorities necessary to evaluate and resolve this issue currently exist. A consolidated federal approach to this EMS issue, using the framework outlined in the Homeland Security Act of 2002 and subsequent amendments in the Post-­‐Katrina Emergency Management Reform Act (PKEMRA), appears to be the only option for a timely resolution to this present threat.

The Department of Homeland Security (DHS) is the federal agency responsible for Critical Infrastructure Protection in this nation. “Critical infrastructure” is defined by federal law as “…systems and assets, whether physical or virtual, so vital to the United States that the incapacity or destruction of such systems and assets would have a debilitating impact on security, national economic security, national public health or safety, or any combination of those matters.”

DHS, as the Sector Specific Agency (SSA) of the Emergency Services Sector (ESS) of critical infrastructure and key resources (CIKR), is responsible for the protecting the ESS, the sector that includes law enforcement, firefighting, EMS and emergency management.
1 IMS Institute for Healthcare Informatics, Drug Shortages: A closer look at products, suppliers and volume 2 Department of Homeland Security, http://www.dhs.gov/files/programs/critical.shtm

The term “Sector-­‐Specific Agency” refers to the Federal department or agency responsible for infrastructure protection activities in a designated critical infrastructure sector or key resources category. Sector-­‐Specific Agencies conduct their activities under this directive in accordance with guidance provided by the Secretary.3
The ESS is uniquely tasked with the protection of all other critical infrastructure sectors.4 Compromise of the ESS, as is the case with the EMS element in this instance, has an impact on all CIKR elements.
The Homeland Security Act of 2002, as amended by the PKEMRA, establishes the position of Chief Medical Officer (CMO) of the Department of Homeland Security, whose responsibilities include “…serving as the Department’s primary point of contact for State, local, tribal governments, the medical community, and others, within and outside the Department, with respect to medical and public health matters.”5 The CMO’s responsibilities include evaluating situations and issues consistent with his or her responsibilities and as the principal advisor to the Secretary of DHS and the Administrator of the Federal Emergency Management Agency (FEMA), reporting to the Secretary as necessary.6 The Secretary could then bring the issue to the National Security Council, consistent with Presidential Policy Directive-­‐1, for interagency collaboration and resolution.

It is our belief that the integrated all-­‐of-­‐nation approach outlined in Presidential Policy Directive 8 (PPD-­‐8), coupled with consolidated federal leadership for EMS would produce positive results on the drug shortage issue and its impact on the patients that we serve. The issue currently facing EMS is one firmly within the purview and the responsibility of the Secretary of DHS as the SSA for the emergency services sector, and an issue of national security and preparedness. Consistent with the existing legislated authorities of the Secretary of DHS and the Administrator of FEMA from the Homeland Security Act of 2002 and subsequent amendments under PKEMRA, we believe that the Department of Homeland Security and the Department of Health and Human Services have joint responsibility to address the issue of drug shortage for EMS in some manner more timely than through congressional legislative action. The collaborative effort necessary to do so is a legislated relationship in the aforementioned laws.

3 Homeland Security Presidential Directive 7, http://www.dhs.gov/files/programs/gc_1189168948944.shtm 4 Department of Homeland Security, Emergency Services Sector Specific Plan-­‐ An Annex to the National Infrastructure Protection Plan (2010), http://www.dhs.gov/xlibrary/assets/nipp-­‐ssp-­‐emergency-­‐services.pdf 5 Public Law 109-­‐295, Section 516 Chief Medical Officer, sub-­‐sections (a) “In General” and (c) ((5) “Responsibilities.”
6 Public Law 109-­‐295, Section 516 Chief Medical Officer, sub-­‐section (c) (1).

We are seeking your collective leadership, guidance and effort to produce a timely and meaningful resolution to this present national security issue. We are available at any time for
your comments, suggestions or questions.

 

Sincerely,

James Orsino, President EMS Labor Alliance 9-­‐11 Shetland Street Boston, MA 02119 JOrsino@BPPA.org

Al H. Gillespie, EFO, CFSO, MIFireE President and Chairman of the Board International Association of Fire Chiefs

Ronald G. Pirrallo, MD, MHSA President
National Association of EMS Physicians

All of which would be greatly appreciated.
William H. Sugiyama, President International Association of EMS Chiefs 2300 M Street NW, Suite 800 Washington, D.C. 20037 william.sugiyama@iaemsc.org

Skip Kirkwood, M.S., J.D., NREMT-­‐P, EFO, CMO President
National EMS Management Association

Cc: The Honorable Craig Fugate
Administrator, Federal Emergency Management Agency

The Honorable Alexander Garza
Assistant Secretary for Health Affairs, United States Department of Homeland Security

The Honorable Nicole Lurie
Assistant Secretary for Preparedness and Response, United States Department of Health and Human Services

The Honorable Richard Serino
Deputy Administrator, Federal Emergency Management Agency

The Honorable Joseph Servidio
Special Advisor for Homeland Security to the Vice President

The Honorable Brian Kamoie
Senior Director for Preparedness Policy, White House National Security Staff

The Honorable David Bibo
Director for Preparedness Policy, White House National Security Staff

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