Requirements for physicians recommending cannabis products to patients
Jul 20, 2016 Doctors
- Holds an active, unrestricted license as a physician under Chapter 458, Florida Statues or is an osteopathic physician under Chapter 459, Florida Statues.
- Has treated the patient for at least three months immediately preceding the patient’s registration in the compassionate use registry.
- Has successfully completed the Florida Medical Association course and examination. Successful completion of the course and examination is required each time such physician renews his or her medical license.
- Has determined that the risks of treating the patient with low-THC cannabis or medical cannabis are reasonable in light of the potential benefit to the patient. If a patient is younger than 18 years of age, a second physician must concur with this determination, and such determination must be documented in the patient’s medical record.
- Registers as the orderer of low-THC cannabis or medical cannabis for the named patient on the Compassionate Use Registry, and updates the registry to reflect the contents of the order, including the amount of low-THC cannabis or medical cannabis that will provide the patient with not more than a 45-day supply and a cannabis delivery device needed by the patient for the medical use of low-THC cannabis or medical cannabis. The physician must also update the registry within seven days after any change is made to the original order to reflect the change. The physician must deactivate the registration of the patient and the patient’s legal representative when treatment is discontinued.
- Maintains a patient treatment plan that includes the dose, route of administration, planned duration, and monitoring of the patient’s symptoms and other indicators of tolerance or reaction to the low-THC cannabis or medical cannabis.
- Submits the patient treatment plan quarterly to the University of Florida College of Pharmacy, for research on the safety and efficacy of low-THC cannabis and medical cannabis on patients.
- If ordering low-THC cannabis, obtains the voluntary, written informed consent of the patient or the patient’s legal representative/guardian to treatment with low-THC cannabis after sufficiently explaining the current state of knowledge in the medical community of the effectiveness of treatment of the patient’s condition with low-THC cannabis, the medically acceptable alternatives, and the potential risks and side effects.
- If ordering medical cannabis, obtains written, informed consent as defined in and required under section 499.0295, Florida Statues, if the physician is ordering medical cannabis for an eligible patient pursuant to that section.
- An explanation of the currently approved products and treatments for the patient’s terminal condition.
- An attestation that the patient concurs with his or her physician in believing that all currently approved products and treatments are unlikely to prolong the patient’s life.
- Identification of the specific investigational drug, biological product, or device that the patient is seeking to use.
- A realistic description of the most likely outcomes of using the investigational drug, biological product, or device. The description shall include the possibility that new, unanticipated, di erent, or worse symptoms might result and death could be hastened by the proposed treatment. The description shall be based on the physician’s knowledge of the proposed treatment for the patient’s terminal condition.
- A statement that the patient’s health plan or third-party administrator and physician are not obligated to pay for care or treatment consequent to the use of the investigational drug, biological product, or device unless required to do so by law or contract.
- A statement that the patient’s eligibility for hospice care may be withdrawn if the patient begins treatment with the investigational drug, biological product, or device and that hospice care may be reinstated if the treatment ends and the patient meets hospice eligibility requirements.
- A statement that the patient understands he or she is liable for all expenses consequent to the use of the investigational drug, biological product, or device and that liability extends to the patient’s estate, unless a contract between the patient and the manufacturer of the investigational drug, biological product, or device states otherwise.
- A physician ordering medical cannabis or low-THC cannabis may not be a medical director employed by a dispensing organization.