Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B15 - Board of Osteopathic Medicine › Chapter 64B15-14 - PRACTICE REQUIREMENTS › Section 64B15-14.004 - Standards for the Prescription of Drugs to Treat Obesity

Current through Reg. 50, No. 138; July 16, 2024
The prescribing of anti-obesity drugs should only be
				  performed by osteopathic physicians quilified 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 25 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 U.S. 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 history, physical examination, and testing; all in
				accordance with general medical standards of care. The initial evaluation may
				be delegated to an educated and trained 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 osteopathic 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 osteopathic physician who is
				prescribing, ordering, or providing anti-obesity drugs to patients must assure
				that such patients undergo a re-evaluation at least once every 3 months. The
				re-evaluation shall include the elements of the initial evaluation and an
				assessment of the medical effects of the treatment being provided.
(7) Each osteopathic 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 501.0573 and 501.0575(1)(a) through (e)3., F.S.
(8) Any osteopathic 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
				 64B15-14.001, 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.