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APPENDIX J: 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
BACKGROUND including any FDA-issued warnings.
Unapproved (i.e., “off-label”) uses of FDA-approved products
are extremely common in American medicine and are usually Quality Assurance Monitoring
not subject to any special regulations. However, under Fed- With respect to such off-label uses, DoD procedure is to main-
eral law, in some circumstances, unapproved uses of approved tain a regular system of quality assurance monitoring of out-
drugs are subject to FDA regulations governing “investiga- comes and known potential adverse events. For this reason,
tional new drugs.” These circumstances include such uses as the importance of accurate clinical records is underscored.
part of clinical trials, and in the military context, command
required, unapproved uses. Some command requested unap- Information to Patients
proved uses may also be subject to special regulations. Good clinical practice includes the provision of appropriate
information to patients. Each CPG discussing an unusual
ADDITIONAL INFORMATION REGARDING off- label use will address the issue of information to patients.
OFF-LABEL USES IN CPGs When practicable, consideration will be given to including in
The inclusion in CPGs of off-label uses is not a clinical trial, an appendix an appropriate information sheet for distribution
nor is it a command request or requirement. Further, it does to patients, whether before or after use of the product. Infor-
not imply that the Military Health System requires that use by mation to patients should address in plain language: a) that
DoD health care practitioners or considers it to be the “stan- the use is not approved by the FDA; b) the reasons why a DoD
dard of care.” Rather, the inclusion in CPGs of off-label uses health care practitioner would decide to use the product for
is to inform the clinical judgment of the responsible health this purpose; and c) the potential risks associated with such
care practitioner by providing information regarding poten- use.
tial risks and benefits of treatment alternatives. The decision is
for the clinical judgment of the responsible health care practi-
tioner within the practitioner-patient relationship.

Contributors
SSG Collin Dye, SOCM, USA
COL (Ret) Sean Keenan, MC, USA
CPT Brandon Carius, PA-C, USA
SFC Paul Loos, 18D, USA
MSG Michael Remley, SOCM, USAS
SFC Brandon Mendes, 18D, USA
CPT Jacob L. Arnold, MC, USA
MAJ Ian May, MC, USA
LTC Douglas Powell, MC, USAR
CAPT Joshua M. Tobin, MC, USNR
LTC (P) Jamie Riesberg, MC, USA
Col Stacy Shackelford, USAF, MC

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