Current through Reg. 50, No. 187; September 24, 2024
(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 Section
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 Section
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
64B15-14.012, 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
64B15-15.004, F.A.C., Sections
381.986,
456.057, and
459.015(1)(o),
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), 459.005(1) FS. Law
Implemented 381.986, 459.015(1)(g) FS.
New 7-13-21.