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APPENDIX G: ADDITIONAL INFORMATION REGARDING OFF-LABEL USES IN CPGS

Purpose Additional Procedures
The purpose of this appendix is to ensure an understanding BALANCED DISCUSSION
of DoD policy and practice regarding inclusion in CPGs of Consistent with this purpose, CPG discussions of off-label
“off-label” uses of US Food and Drug Administration (FDA)– uses specifically state that they are uses not approved by the
approved products. This applies to off-label uses with patients FDA. Further, such discussions are balanced in the presenta-
who are armed forces members. tion of appropriate clinical study data, including any such data
that suggest caution in the use of the product and specifically
including any FDA-issued warnings.
Background
Unapproved (i.e., “off-label”) uses of FDA-approved products QUALITY ASSURANCE MONITORING
are extremely common in American medicine and are usually With respect to such off-label uses, DoD procedure is to main-
not subject to any special regulations. However, under Fed- tain a regular system of quality assurance monitoring of out-
eral law, in some circumstances, unapproved uses of approved comes and known potential adverse events. For this reason,
drugs are subject to FDA regulations governing “investiga- the importance of accurate clinical records is underscored.
tional new drugs.” These circumstances include such uses as Information to Patients
part of clinical trials, and in the military context, command
required, unapproved uses. Some command requested unap- Good clinical practice includes the provision of appropriate
proved uses may also be subject to special regulations. information to patients. Each CPG discussing an unusual
off-label use will address the issue of information to patients.
When practicable, consideration will be given to including in
Additional Information Regarding an appendix an appropriate information sheet for distribution
Off-Label Uses in CPGs
to patients, whether before or after use of the product. Infor-
The inclusion in CPGs of off-label uses is not a clinical trial, mation to patients should address in plain language: a) that
nor is it a command request or requirement. Further, it does the use is not approved by the FDA; b) the reasons why a DoD
not imply that the Military Health System requires that use by health care practitioner would decide to use the product for
DoD health care practitioners or considers it to be the “stan- this purpose; and c) the potential risks associated with such
dard of care.” Rather, the inclusion in CPGs of off-label uses use.
is to inform the clinical judgment of the responsible health
care practitioner by providing information regarding poten-
tial risks and benefits of treatment alternatives. The decision is
for the clinical judgment of the responsible health care practi- Keywords: prolonged field care; Tactical Combat Casualty
tioner within the practitioner–patient relationship. Care (TCCC); sepsis; austere environment

*Corresondence to dockeenan95@aol.com or rapp.justin@gmail.com
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1 Mr Rapp is affiliated with SFC, USASOC. COL (Ret) Keenan, USA, is affiliated with the Joint Trauma System. Mr Taylor is affiliated with
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Global Response Management. Ms Rapp is affiliated with Cape Fear Valley Hospital, SGT, 629th Forward Resuscitation and Surgical Team.
5 Mr Turconi is a primary care paramedic, former Italian Special Forces. CAPT Maves, USN, is affiliated with the Naval Medical Center,
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San Diego. CDR Kavanaugh, USN, is affiliated with the Naval Medical Center, San Diego. Dr Makati is a fellow with the Department of
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Nephrology, West Virginia University (WVU). LTC Powell is affiliated with USAR, USASOC/WVU. Mr Loos is affiliated with SFC, USASOC.
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CPT Sarkisian, USA, is a staff emergency physician. Dr Sakhuja is affiliated with the Section of Cardiovascular Critical Care, Department of
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Cardiovascular and Thoracic Surgery, WVU. LTC (Ret) Mosely, USA, is affiliated with the Joint Trauma System. Col Shackelford, USAF, is
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affiliated with the Joint Trauma System.

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