The prescribing of anti-obesity drugs should only be
performed by physicians qualified by training and experience to treat obesity.
All licensees are expected to abide by the following guidelines and standards
in the utilization of any drug, synthetic compound, nutritional supplement, or
herbal treatment, for the purpose of providing medically assisted weight loss.
For purposes of this rule, "anti-obesity drugs" means any drug, synthetic
compound, nutritional supplement, or herbal treatment used for the purpose of
providing medically assisted weight loss.
(1) To justify the use of anti-obesity drugs
as set forth above, the patient must have an initial Body Mass Index (BMI) of
30 or above, or an initial BMI of greater than 27 with at least one comorbidity
factor, or an initial measurable body fat content equal to or greater than 25%
of total body weight for male patients or 30% of total body weight for women.
The treating physician may also take into account other factors such as
ethnicity-specific values and markers such as waist circumference when
justifying the use of anti-obesity drugs. BMI is calculated by use of the
formula BMI = weight(kg)/height(m2).
(2) Physicians in Florida are prohibited from
prescribing, ordering, dispensing, or administering any anti-obesity drug that
is both a serotonergic and anorexic agent unless the drug has been approved by
the Food and Drug Administration (FDA) specifically for use in weight loss
management. Selective serotonin re-uptake inhibitors (SSRIs) that have not been
approved by the FDA for weight loss may not be prescribed, ordered, dispensed,
or administered for such purposes.
(3) Physicians may only prescribe
anti-obesity drugs to children with an initial BMI greater than 120th percent
of the 95th percentile with significant comorbidity or an initial BMI greater
than 140th percent of the 95th percentile.
(4) An initial evaluation of the patient
shall be conducted prior to the prescribing, ordering, dispensing, or
administering of any drug, synthetic compound, nutritional supplement or herbal
treatment and such evaluation shall include physical and complete history;
tests related to medical treatment for weight loss; medical referrals as
indicated by the physical examination, history, and testing; all in accordance
with general medical standards of care. The initial evaluation may be delegated
to physician's assistant licensed pursuant to Chapter 458 or 459, F.S., or an
advanced practice registered nurse licensed pursuant to Chapter 464,
F.S.
(5) Prior to prescribing,
ordering, dispensing, or administering anti-obesity drugs the prescribing
physician must obtain written informed consent from the patient. Such consent
shall discuss potential benefits versus potential risks of weight loss
treatments. A copy of the signed informed consent shall be included in the
patient's medical record.
(6) Each
physician who is prescribing, ordering, or providing anti-obesity drugs to
patients must assure that such patients undergo re-evaluation at least once
every 3 months. The re-evaluation shall include the elements consistent with
the standard of care and an assessment of the medical effects of the treatment
being provided.
(7) Each physician
who prescribes, orders, dispenses, or administers anti-obesity drugs for the
purpose of providing medically assisted weight loss shall provide to each
patient a legible copy of the Weight-Loss Consumer Bill of Rights as set forth
in Sections 501.0575(1)(a) through (e)3., F.S.
(8) Any physician who advertises practice
relating to weight loss that includes the prescribing of anti-obesity drugs or
whose services are advertised by another person or entity shall be responsible
for assuring that such advertising meets the requirements of Rule
64B8-11.001, F.A.C. Advertising
weight loss treatment shall be considered false, deceptive, or misleading if it
contains representations that:
(a) Promise
specific results;
(b) Raise
unreasonable expectations;
(c)
Claim rapid, dramatic, incredible, or safe weight loss;
(d) State or suggest that diets or exercise
are not required, or
(e) Suggest
that weight loss is effortless or magical.
