Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B8 - Board of Medicine › Chapter 64B8-9 - STANDARDS OF PRACTICE FOR MEDICAL DOCTORS › Section 64B8-9.012 - 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 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.