2020 Florida Regulations 64B15-14.004: Standards for the Prescription of Obesity Drugs
Current as of: 2020 | Check for updates
|
Other versions
The prescription of medication for the purpose of enhancing weight loss should only be performed by osteopathic physicians with training and experience to treat obesity. All licensees are expected to abide by the following guidelines and standards in the utilization of any drug or synthetic compound 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 25 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 osteopathic 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. The osteopathic physician may deviate from these guidelines in individual cases where two or more comorbidity factors are present.
(2) An initial evaluation of the patient shall be conducted prior to the prescribing, ordering, dispensing or administering of any drug or synthetic compound 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 osteopathic physician assistant licensed pursuant to Florida Statutes Chapter 459, or an appropriately educated and trained advanced registered nurse practitioner licensed pursuant to Florida Statutes Chapter 464
(b) If the initial evaluation required above is delegated to an osteopathic physician assistant or to an advanced registered nurse practitioner, then the delegating osteopathic physician must personally review the resulting medical records prior to the issuance of an initial prescription, order or dosage.
(3) Prescriptions or orders for any drug or synthetic compound for the purpose of assisting in weight loss must be in writing and signed by the prescribing osteopathic physician. Initial prescriptions or orders of this type shall not be called into a pharmacy by the osteopathic physician or by an agent of the osteopathic physician.
(4) At the time of delivering the initial prescription or providing the initial supply of such drugs to a patient, the prescribing osteopathic 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.
(5) Each osteopathic 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 or synthetic compound assisted weight loss program shall be re-evaluated at least once every 3 months.
(6) Each osteopathic physician who prescribes, orders, dispenses or administers any drug or synthetic compound for the purpose of assisting a patient in weight loss shall maintain medical records in compliance with Rule Fla. Admin. Code R. 64B15-15.004, and must also reflect compliance with all requirements of this rule.
(7) Each osteopathic 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.
(8) Any osteopathic 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 Fla. Admin. Code R. 64B15-14.001 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.
Rulemaking Authority 459.005, 459.0135 FS. Law Implemented Florida Statutes § 459.0135. History—New 3-29-98, Amended 9-18-02.
(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 25 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 osteopathic 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. The osteopathic physician may deviate from these guidelines in individual cases where two or more comorbidity factors are present.
(2) An initial evaluation of the patient shall be conducted prior to the prescribing, ordering, dispensing or administering of any drug or synthetic compound 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 osteopathic physician assistant licensed pursuant to Florida Statutes Chapter 459, or an appropriately educated and trained advanced registered nurse practitioner licensed pursuant to Florida Statutes Chapter 464
(b) If the initial evaluation required above is delegated to an osteopathic physician assistant or to an advanced registered nurse practitioner, then the delegating osteopathic physician must personally review the resulting medical records prior to the issuance of an initial prescription, order or dosage.
(3) Prescriptions or orders for any drug or synthetic compound for the purpose of assisting in weight loss must be in writing and signed by the prescribing osteopathic physician. Initial prescriptions or orders of this type shall not be called into a pharmacy by the osteopathic physician or by an agent of the osteopathic physician.
(4) At the time of delivering the initial prescription or providing the initial supply of such drugs to a patient, the prescribing osteopathic 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.
(5) Each osteopathic 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 or synthetic compound assisted weight loss program shall be re-evaluated at least once every 3 months.
(6) Each osteopathic physician who prescribes, orders, dispenses or administers any drug or synthetic compound for the purpose of assisting a patient in weight loss shall maintain medical records in compliance with Rule Fla. Admin. Code R. 64B15-15.004, and must also reflect compliance with all requirements of this rule.
(7) Each osteopathic 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.
(8) Any osteopathic 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 Fla. Admin. Code R. 64B15-14.001 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.
Rulemaking Authority 459.005, 459.0135 FS. Law Implemented Florida Statutes § 459.0135. History—New 3-29-98, Amended 9-18-02.