The Board proposes the new rule to incorporate the practice standards for the certification of smoking marijuana as a route of administration.

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-9.0181Practice Standards for the Certification of Smoking Marijuana as a Route of Administration

PURPOSE AND EFFECT: The Board proposes the new rule to incorporate the practice standards for the certification of smoking marijuana as a route of administration.

SUMMARY: The proposed new rule incorporates the practice of standards for the certification of smoking marijuana as a route of administration.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: : During discussion of the economic impact of this rule at its Board meeting, the Board concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 381.986(4), 458.309(1) FS.

LAW IMPLEMENTED: 381.986, 458.309(1), 458.331(1)(g), (t) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

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]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

     64B8-9.0181    Practice Standards for the Certification of Smoking Marijuana as a Route of Administration.

     (1)  The standards of practice in this rule do not supersede the level of care, skill, and treatment recognized in general law related to healthcare licensure.  All physicians who are authorized to issue a certification for the medical use of marijuana in a form for smoking as defined in s. 381.986(1), F.S., shall comply with this rule.

     (2) Standards.  The nature and extent of the requirements set forth below will vary depending on the practice setting and circumstances presented to the qualified physician.  In addition to the requirements set forth in s. 381.986(4), F.S., the Board has adopted the following standards for the issuing of certifications by qualified physicians for the medical use of marijuana in a form for smoking:

     (a) Evaluation of the Patient. The qualified physician  must conduct a physical examination while physically present in the same room as the patient and a full assessment of the medical history of the patient, including family and social history with an emphasis on substance use disorder and mental health, and must document this information in the medical record.  The medical record also shall document the presence of one or more qualifying medical conditions for the use of smokable marijuana and document previous treatments, if any.

     (b) Treatment Plan. The written treatment plan shall indicate if any further diagnostic evaluations or other treatments are planned including other medications and therapies if indicated. After treatment begins, the qualified physician shall adjust dosing, if necessary, to the individual medical needs of each patient.

     (c)  Informed consent. The qualified physician will discuss and have the patient complete the “Medical Marijuana Consent Form” (DH-MQA-5026) set forth in Rule 64B8-9.018, F.A.C.  In addition, the qualified physician shall discuss the risks and benefits of the use of smokable marijuana including the risk of abuse and addiction, the negative health risks associated with smoking marijuana as well as physical dependence with the patient, persons designated by the patient, or with the patient’s surrogate or guardian if the patient is incompetent. The discussion shall also include expected benefits, duration, options, and common side effects. Special attention must be given to those patients who are at risk of misuse or diversion of their medications.

     (d) Periodic Reviews. A qualified physician must evaluate an existing qualified patient at least once every 30 weeks before issuing a new physician certification.  Based on the circumstances presented, the qualified physician shall review the course of treatment and any new information about the etiology of the need to utilize smokable marijuana. Continuation or modification of therapy shall depend on the qualified physician’s evaluation of the patient’s progress. If treatment goals are not achieved, despite medication adjustments, the qualified physician shall reevaluate the patient and determine the appropriateness of continued treatment. The qualified physician shall monitor patient compliance of marijuana usage and related treatment plans.

(e) Consultation. The qualified physician shall refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. The management of patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients.

(f)  Medical Records. The qualified physician is required to keep accurate, legible, and complete records to include, but not be limited to:

1. The medical history and a physical examination, including history of drug abuse or dependence, if indicated;

2.  Qualifying medical condition or conditions;

3.  Determination that the medical use of marijuana would likely outweigh the potential health risks for the patient; if the patient is younger than 18, inclusion of concurrence by second physician;

4.  Whether the patient is pregnant;

5.  Diagnostic, therapeutic, and laboratory results if performed by the qualified physician or received from another practitioner;

6. Evaluations and consultations if performed by the qualified physician or received from another practitioner;

7. Treatment objectives;

8. Discussion of risks and benefits;

9. Treatments;

10. Medications (including date, type, dosage, and quantity prescribed);

11. Document that the Prescription Drug Monitoring Program database was reviewed;

12. Instructions and agreements;

13. Informed written consent;

14. Drug testing results if indicated;

15. Periodic reviews. Records must remain current, maintained in an accessible manner, readily available for review, and must be in full compliance with rule 64B8-9.003, F.A.C., ss. 381.986, 456.057, and 458.331(1)(m), F.S.

(g) Compliance with Laws and Rules.  Qualified physicians shall at all times, remain in compliance with this rule and all state laws and regulations addressing the issuance of certifications for the medical use of marijuana in a form for smoking.

Rulemaking Authority 381.986(4), 458.309(1) FS. Law Implemented 381.986, 458.309(1), 458.331(1)(g), (t) FS. History–New                     . 

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Rules/Legislative Committee, Board of Medicine

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: April 9, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 29, 2021