Fla. Admin. Code Ann. R. 64B8-9.012 - Standards for the Prescription of Obesity Drugs
Current through Reg. 47, No. 249; December 28, 2021
The prescription of medication for the purpose of enhancing weight loss 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, any synthetic compound, any nutritional supplement, or herbal treatment, for the purpose of providing medically assisted weight loss.
(1) To justify the use of weight loss
enhancers as set forth above, the patient must have a Body Mass Index (BMI) of
30 or above, or a BMI of greater than 27 with at least one comorbidity factor,
or a 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
prescription of such weight loss enhancers is not generally appropriate for
children. Any time such prescriptions are made for children, the prescribing
physician must obtain a written informed consent from the parent or legal
guardian of the minor patient in addition to complying with the other
guidelines and standards set forth in this rule. BMI is calculated by use of
the formula BMI = kg/m2.
(2) Physicians in Florida are prohibited from
prescribing, ordering, dispensing, or administering any weight loss enhancer
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) 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 an appropriate physical and
complete history; appropriate tests related to medical treatment for weight
loss; and appropriate medical referrals as indicated by the physical, history,
and testing; all in accordance with general medical standards of care.
(a) The initial evaluation may be delegated
to an appropriately educated and trained physician's assistant licensed
pursuant to Chapter 458, F.S., or an appropriately educated and trained
advanced registered nurse practitioner licensed pursuant to Chapter 464,
F.S.
(b) If the initial evaluation
required above is delegated to a physician's assistant or to an advanced
registered nurse practitioner, then the delegating physician must personally
review the resulting medical records prior to the issuance of an initial
prescription, order, or dosage.
(4) Prescriptions or orders for any drug,
synthetic compound, nutritional supplement or herbal treatment for the purpose
of assisting in weight loss must be in writing and signed by the prescribing
physician. Initial prescriptions or orders of this type shall not be called
into a pharmacy by the physician or by an agent of the physician. Even if the
physician is registered as a dispensing physician, a hard copy of the written
prescription must be maintained in the patient's medical records for each time
such weight loss enhancers are prescribed, ordered, dispensed, or
administered.
(5) At the time of
delivering the initial prescription or providing the initial supply of such
drugs to a patient, the prescribing physician must personally meet with the
patient and personally obtain an appropriate written informed consent from the
patient. Such consent must state that there is a lack of scientific data
regarding the potential danger of long term use of combination weight loss
treatments, and shall discuss potential benefits versus potential risks of
weight loss treatments. The written consent must also clearly state the need
for dietary intervention and physical exercise as a part of any weight loss
regimen. A copy of the signed informed consent shall be included in the
patient's permanent medical record.
(6) Each physician who is prescribing,
ordering, or providing weight loss enhancers to patients must assure that such
patients undergo an in-person re-evaluation within 2 to 4 weeks of receiving a
prescription, order, or dosage. The re-evaluation shall include the elements of
the initial evaluation and an assessment of the medical effects of the
treatment being provided. Any patient that continues on a drug, synthetic
compound, nutritional supplement or herbal treatment assisted weight loss
program shall be re-evaluated at least once every 3 months.
(7) Each physician who prescribes, orders,
dispenses, or administers any drug, synthetic compound, nutritional supplement
or herbal treatment for the purpose of assisting a patient in weight loss shall
maintain medical records in compliance with Rule
64B8-9.003,
F.A.C., and must also reflect compliance with all requirements of this
rule.
(8) Each physician who
prescribes, orders, dispenses, or administers weight loss enhancers 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. The physician shall also
conspicuously post said document in those rooms wherein patients are evaluated
for weight loss treatment.
(9) Any
physician who advertises practice relating to weight loss or whose services are
advertised by another person or entity shall be responsible for assuring that
such advertising meets the requirements of Rule
64B8-8.001,
F.A.C. In addition advertising of 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.
Notes
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