By: Susan St. John
The Board of Medicine and Board of Osteopathic Medicine Joint Committee on Medical Marijuana (the “Committee”) have started the journey to developing rules pursuant to the Medical Marijuana Use Act, Senate Bill 8A, Chapter 2017-232, Laws of Florida, Section 381.986, Florida Statutes). The Committee’s first conference was held July 14, 2017, with a follow-up conference being held August 3rd. A third conference is scheduled for August 25th during the Board of Osteopathic Medicine’s monthly meeting.
Importantly, the Committee has been working on developing patient consent forms that conform to the requirements set forth under the Act. Pursuant to the Act, a patient must sign an informed consent form each time his or her qualified physician issues a physician certification for medical marijuana use. The informed consent form must include information related to: 1) the Federal Government’s classification of marijuana; 2) approval and oversight status of by the FDA (its not approved for medical use by the FDA, therefore is not afforded oversight by the FDA; 3) research status on efficacy of medical marijuana for the conditions listed in the Act; 4) addiction potential; 5) potential effect marijuana has on the body, including coordination, motor skills, and cognition; 6) potential side effects; 7) potential risks, benefits and drug interactions; and 8) that a patient’s de-identified information may be used for research purposes. The Committee’s draft consent form demonstrates the amount of information that will need to be included on the form and provides for a patient to initial each of the eight disclosures that must be included in the form.
With the amount of content required by the Act that must be disclosed to a patient to obtain informed consent, it will be important for physicians to spend an adequate amount of time explaining the form and its contents prior to the patient initialing and signing any part of the form. As a best practice, a copy of the completed and signed consent form, as well as the physician’s notes pertaining to the visit with the patient to go over the form, should be maintained in the patient’s record. The start and end time of the patient visit with respect to explaining the form to the patient should also be included in the patient’s medical record.
Besides the informed consent form to be developed by the Committee, a physician should also consider creating a patient package that contains information regarding Medical Marijuana Use, including information related to tars contained in Medical Marijuana or other undesirable consequences attributable to Medical Marijuana use, and a Patient Agreement form wherein the patient agrees not to seek Medical Marijuana from another qualified physician, that Medical Marijuana will be taken as prescribed, the patient is not currently using illegal drugs or abusing prescription medications, the patient will not attempt to sell or divert Medical Marijuana to others, and other provisions vital to protecting the patient and the practitioner.
The Committee is also working on a form for physicians who must report information concerning a qualified patient and qualifying medical condition to the Board of Medicine or Board of Osteopathic Medicine. This form is being developed to achieve consistency of information that must be reported to the appropriate Board by statute within 14 days of issuing the physician certification. Information that the physician must submit includes: 1) documentation supporting that the patient’s medical condition is a qualifying medical condition; 2) documentation that establishes the efficacy of marijuana as treatment for the patient’s condition; 3) documentation supporting benefits of medical use of marijuana would likely outweigh the risks of use; and 4) any other documentation as required by board rule.
Additionally, the Committee has started drafting rule language for disciplinary actions related to medical marijuana law for MDs and DOs. The first round draft of Rule 64B8-8.001, Disciplinary Guidelines, proposes to add Rule 64B8-8.001(2)(ttt), related to issuing a physician certification as defined by Section 381.986, in a manner out of compliance with the requirements of that section and the rules adopted thereunder. The draft rule recommends a range of penalties, including probation to suspension, revocation, denial of license and administrative fines ranging from $1,000 to $10,000 depending on whether it’s a first or second offense. Further, draft language provides that the Board may deviate from the recommended penalties based on aggravating and mitigating circumstances.
Draft Rule 64B15-19.002(82), is similar to Draft Rule 648-8.001(2)(ttt), and also includes a minimum and maximum range of penalties for first and second offenses. Under Draft Rule 64B15-19.002(82) first offense penalties range from denial or probation and a $1,000 administrative fine to denial or revocation and an administrative fine of $5,000. Second offense penalties range from denial or suspension and an administrative fine of $5,000 to denial or revocation and an administrative fine of $10,000.
MDs and DOs will be held to current practice standards, as well as new practice standards – including new forms and rules as discussed above – once such forms and rules are adopted. It will be vitally important for physicians to be well aware of the law, required forms, and developing rules to maintain compliance with prescribing Medical Marijuana.