Obtaining Patient Consent

Low-THC Cannabis Patient Consent

Section 381.986, F.S. requires physicians obtain voluntary, written informed consent from the patient, or the patient’s legal representative, 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;

• The potential risks and side effects.

 

Terminal Patient Consent

For terminal patients ordered cannabis pursuant so section 381.96, F.S. and section 499.0295, F.S., Florida law requires physicians must obtain written informed consent as defined in section 499.0295, F.S. from the patient, or the patient’s legal representative, to treatment with medical cannabis. This consent must include:

• 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 must include the possibility that new, unanticipated, different, or worse symptoms might result and death could be hastened by the proposed treatment. The description must 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• A statement that the patient’s eligibility for hospice care may be withdrawn if the patient begins treatment with the investigational drug, biological product, or device and that hospice care may be reinstated if the treatment ends and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