Standards for the Prescription of Obesity Drugs

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-9.012Standards for the Prescription of Obesity Drugs

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 48 No. 79, April 22, 2022 issue of the Florida Administrative Register.

The changes are in response to written comments submitted by the staff of the Joint Administrative Procedures Committee and discussion and subsequent vote by the board at a public meeting held June 3, 2022. The changes are as follows:

 

64B8-9.012 Standards for the Prescription of Drugs to Treat Obesity.

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) through (3) No change.

(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 an appropriate physical and complete history; appropriate tests related to medical treatment for weight loss; and appropriate 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 an appropriately educated and trained physician’s assistant licensed pursuant to Chapter 458 or 459, F.S., or an appropriately educated and trained 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 an appropriate 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 a re-evaluation at least once every 3 months. The re-evaluation shall include the elements consistent with the standard of care of the initial evaluation and an assessment of the medical effects of the treatment being provided.

(7) through (8) No change.

Rulemaking Authority 458.336 FS. Law Implemented 458.336 FS. History–New 12-4-97, Amended 2-17-98,                          .

 

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Paul Vazquez, J.D., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin #C03, Tallahassee, Florida 32399-3253, [e-mail]