Page 22 - Journal of Special Operations Medicine - Winter 2015

is used by the United Kingdom, France, Germany, The hemorrhagic shock, especially those with noncompress-
Netherlands, and Israel, 12,36 but there is still no FDA- ible hemorrhage. This study would provide valuable in-
approved dried plasma product available to US Forces. formation about the magnitude of the lifesaving benefit
The US Special Operations Command (USSOCOM) derived from using plasma alone in the prehospital set-
has spearheaded efforts to obtain approval for an FDP ting. To better translate the findings of this study to the
product to be used by SOF medics. The Commander military setting, the study should preferably be done in
of USSOCOM emphasized the urgent need for this ap- emergency medical services systems that have relatively
proval in a letter to the acting Assistant Secretary of De- long prehospital evacuation times. The prehospital re-
fense for Health Affairs in 2010. In the absence of an suscitation fluid choice may be less likely to improve
37
FDA-approved dried plasma product, the French FDP outcomes in trauma patients with only a 10- or 15-min-
product is currently being used by a select few Special ute transport time to the hospital. Surrogate outcome
Operations units under a treatment protocol (Figure 2), measures for survival, such as improvement in coagula-
but the administrative burden and the expense of that tion status, may also be a useful outcome measure in
approach severely limit the benefit of the French FDP studies on prehospital plasma use.
to US Forces.
2. Establish a Military Use Panel as a shared effort be-
Figure 2 Bottle of freeze-dried plasma used by US SOF tween the DoD and the FDA. One purpose of this panel
under a treatment protocol. would be to consider the approval of a military indica-
tion label for medications that are currently labeled for
other indications but have applicability for military use.
Examples include oral transmucosal fentanyl citrate,
ketamine, and tranexamic acid. A second purpose of
the proposed DoD–FDA Military Use Panel would be
to evaluate products that have been approved for use by
North Atlantic Treaty Organization (NATO) allies and
have applications for the US Military but which have
not been approved by the FDA for use in the United
States. The French and German dried plasma products
are examples of such items.

The usefulness of such a panel with respect to blood
products is discussed above. This panel could also help
Photo courtesy of SGM F. Bowling improve combat casualty care through modifications in
the existing regulatory approach to medications of par-
ticular interest to battlefield trauma care.

Obtaining an approved indication for a new drug is a
complex, expensive, and time-consuming process. Fur-
The establishment of an FDA approval process specifi- ther, there is little incentive for pharmaceutical com-
cally designed to meet the needs of US Combat troops— panies to seek new indications when both they and
a Department of Defense (DoD)–FDA Military Use physicians know that it is entirely legal and accepted for
Panel—could greatly expedite the process. At present, physicians to prescribe a medication approved for one
there are mechanisms in place to provide special consid- indication to treat a patient who has another condition
erations for military use in the approval of devices but (so-called off-label use). This has given rise to a number
not for medications or blood products. This topic is dis- of seemingly anomalous labeling and prescribing prac-
cussed further in the second RDT&E priority below. In tices. Off-label use of medications by physicians in the
the absence of an approved dried plasma product, most United States is very common, especially in specialties
US Combat medics are compelled to use colloids (not such as pediatrics and obstetrics, where useful medica-
an optimal choice for resuscitation from hemorrhagic tions often have no approved indication in those pop-
shock) or crystalloids (an even worse choice.) ulations. 38,39 The lack of drugs approved for obstetric
indications in the United States is especially notable. As
Since Combat medics are generally unable to carry blood of 2010, no new medications had been approved for an
components on the battlefield, there is also a significant obstetric indication since 1995. 38
need for a prospective, randomized trial to be initiated
in the US civilian sector to evaluate the use of plasma Although physicians are authorized to use medications
as the sole prehospital resuscitation fluid for patients in for off-label indications as they believe appropriate

10 Journal of Special Operations Medicine Volume 15, Edition 4/Winter 2015