TMB Bulletin, July 2014 Page: 2
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FDA Testosterone Therapy Announcement, Con
1t.
men who lack or have low testosterone in connection
with an associated medical condition. Examples of
medical conditions include failure of testicles to pro-
duce testosterone because of reasons such as genetic
problems or chemotherapy. Other examples include
problems with the hypothalamus and pituitary, brain
structures that control the production oftestosterone
by the testicles.
The FDA is urging health care professional and patients
to report side effects involving prescription testos-
terone products to the FDA MedWatch program.The Medical Board wishes to stress that potential disciplinary
issues with testosterone therapy could arise with the "off-
label" use of testosterone if the physician does not provide and
obtain proper informed consent for off-label use or if the physi-
cian does not discuss the benefits weighed against possible
risks of the therapy.
Board rules providing standards for physicians practicing com-
plementary and alternative medicine should be consulted.
Chapter 200 of Board rules requires, in part: patient assess-
ment, disclosure of expected outcomes, risks and benefits of
treatment, a documented treatment plan with periodic review,
adequate medical records, and therapeutic validity.Rules Reminder: Off-line EMS Medical Director
A physician who acts as an off-line medical director for an
EMS service in the state of Texas is required to register as
such with both the Texas Medical Board and the Texas De-
partment of State Health Services (DSHS).
As of July 2014, the TMB registration for off-line medical
directors is part of the physician biennial registration pro-
cess.
An EMS Medical Director is defined in Board rule 197 as: "A
physician licensed by the board who is responsible for all
aspects of the operation of an EMS system concerning pro-
vision of medical care. This physician may also be referred
to as the 'off-line medical director."'
In addition, TMB board rule states that an EMS off-line med-
ical director shall be:
a physician licensed to practice in Texas and who is
registered as an EMS medical director with the Texas
Department of State Health Services;
" familiar with the design and operation of EMS sys-
tems;
" experienced in prehospital emergency care and emer-
gency management of ill and injured patients;
actively involved in:
0 the training and/or continuing education of EMS
personnel, under his or her direct supervision, at
their respective levels of certification;0 the medical audit, review, and critique of the per-
formance of EMS personnel under his or her direct
supervision;
0 the administrative and legislative environments
affecting regional and/or state prehospital EMS or-
ganizations;
knowledgeable about local multi-casualty plans;
familiar with dispatch and communications operations of
prehospital emergency units; and
knowledgeable about laws and regulations affecting local,
regional, and state EMS operations.
Please see Board rule 197 for a complete list of EMS off-line
medical director requirements, including registration excep-
tions by waiver and additional CME requirements.
Information on registration with DSHS as an EMS off-line medi-
cal director is available through the Office of EMS/Trauma Sys-
tems Coordination at the following link: http:/
www.dshs.state.tx.us/emstraumasystems/provfro.shtm
Editor's Note: The preceding articles are intended for general
guidance only and do not replace the text of Board rules and
laws or ensure compliance.2
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Texas Medical Board. TMB Bulletin, July 2014, periodical, July 2014; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth1511173/m1/2/?q=j+w+gardner: accessed June 23, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.