Page 44 - JSOM Summer 2020

APPENDIX B:
ADDITIONAL INFORMATION REGARDING OFF-LABEL USES IN CLINICAL PRACTICE GUIDELINES

Purpose the clinical judgment of the responsible healthcare practitioner
within the practitioner-patient relationship.
The purpose of this Appendix is to ensure an understanding of
Department of Defense (DoD) policy and practice regarding
inclusion in clinical practice guidelines (CPGs) of “off-label” Additional Procedures
uses of US Food and Drug Administration (FDA)-approved
products. This applies to off-label uses with patients who are Balanced Discussion
Armed Forces Members. Consistent with this purpose, CPG discussions of off-label
uses specifically state they are uses not approved by the FDA.
Furthermore, such discussions are balanced in the presenta-
Background tion of appropriate clinical study data, including any such data
Unapproved (i.e., “off-label”) uses of FDA-approved products that suggest caution in the use of the product and specifically
are extremely common in US medicine and are usually not including any FDA-issued warnings.
subject to any special regulations. However, under federal law,
in some circumstances, unapproved uses of approved drugs Quality Assurance Monitoring
are subject to FDA regulations governing investigational new With respect to such off-label uses, DoD procedure is to main-
drugs. These circumstances include such uses as part of clinical tain a regular system of quality assurance monitoring of out-
trials and, in the military context, command required, unap- comes and known potential adverse events. For this reason,
proved uses. Some command-requested unapproved uses may the importance of accurate clinical records is underscored.
also be subject to special regulations.
Information to Patients
Good clinical practice includes the provision of appropriate
Additional Information Regarding information to patients. Each CPG discussing an unusual
Off-Label Uses In CPGS off-label use will address the issue of information to patients.
The inclusion in CPGs of off-label uses is not a clinical trial nor When practicable, consideration will be given to including in
is it a command request or requirement. Furthermore, it does an appendix an appropriate information sheet for distribution
not imply that the Military Health System requires that use to patients, whether before or after use of the product. Infor-
by DoD healthcare practitioners or considers it to be the stan- mation to patients should address in plain language: (1) that
dard of care. Rather, the inclusion in CPGs of off-label uses the use is not approved by the FDA; (2) the reasons why a
is to inform the clinical judgment of the responsible health- DoD healthcare practitioner would decide to use the product
care practitioner by providing information regarding potential for this purpose; and (3) the potential risks associated with
risks and benefits of treatment alternatives. The decision is for such use.

42 | JSOM Volume 20, Edition 2 / Summer 2020