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Form DH-MQA-5026 • 64B8-9.018 / 64B15-14.013 F.A.C.

Medical Marijuana Informed Consent Form

A qualified physician may not delegate the responsibility of obtaining written informed consent to another person. The qualified patient, or the patient's parent or legal guardian if the patient is a minor, must initial each section to indicate that the physician explained the information and, along with the qualified physician, must sign and date the informed consent form. This consent form contains three parts: Part A must be completed by all patients; Part B is only required for patients under 18 with a diagnosed terminal condition who receive a certification for medical marijuana in a smokable form; Part C is the signature block and must be completed by all patients.

Patient Information

Part A: Must be completed for ALL patients

Initial each section (a–h) to confirm the physician explained the information.

a. Federal Classification — Schedule I Controlled Substance

The federal government has classified marijuana as a Schedule I controlled substance. Schedule I substances are defined, in part, as having (1) a high potential for abuse; (2) no currently accepted medical use in treatment in the United States; and (3) a lack of accepted safety for use under medical supervision. Federal law prohibits the manufacture, distribution and possession of marijuana even in states, such as Florida, which have modified their state laws to treat marijuana as a medicine. When in possession of medical marijuana, the patient or the patient's caregiver must have his or her medical marijuana use registry identification card in his or her possession at all times.

b. FDA Approval & Oversight Status

Marijuana has not been approved by the Food and Drug Administration for marketing as a drug. Therefore, the "manufacture" of marijuana for medical use is not subject to any federal standards, quality control, or other federal oversight. Marijuana may contain unknown quantities of active ingredients, which may vary in potency, impurities, contaminants, and substances in addition to THC, which is the primary psychoactive chemical component of marijuana.

c. The Potential for Addiction

Some studies suggest that the use of marijuana by individuals may lead to a tolerance to, dependence on, or addiction to marijuana. I understand that if I require increasingly higher doses to achieve the same benefit or if I think that I may be developing a dependency on marijuana, I should contact my qualified physician.

d. Coordination, Motor Skills & Cognition — Do Not Operate Machinery

The use of marijuana can affect coordination, motor skills and cognition, i.e. the ability to think, judge and reason. Driving under the influence of cannabis can double the risk of vehicular accident, which escalates if alcohol is also influencing the driver. While using medical marijuana, I should not drive, operate heavy machinery or engage in any activities that require me to be alert and/or respond quickly. I understand that if I drive while under the influence of marijuana, I can be arrested for "driving under the influence."

e. Potential Side Effects of Medical Marijuana Use

Potential side effects include, but are not limited to: dizziness, anxiety, confusion, sedation, low blood pressure, impairment of short term memory, euphoria, difficulty in completing complex tasks, suppression of the body's immune system, may affect the production of sex hormones leading to adverse effects, inability to concentrate, impaired motor skills, paranoia, psychotic symptoms, general apathy, depression and/or restlessness. Marijuana may exacerbate schizophrenia in persons predisposed to that disorder. Use may cause talking or eating in excess, alter perception of time and space and impair judgment. Medical authorities claim that use, especially by persons younger than 25, can result in long-term problems with attention, memory, learning, drug abuse, and schizophrenia. There is substantial evidence of a statistical association between long-term cannabis smoking and worsening respiratory symptoms and more frequent chronic bronchitis episodes. I agree to contact my physician if I become depressed or psychotic, have suicidal thoughts, experience crying spells, respiratory problems, changes in normal sleeping patterns, extreme fatigue, increased irritability, or begin to withdraw from family and/or friends.

f. Risks, Benefits & Drug Interactions

Signs of withdrawal can include: feelings of depression, sadness, irritability, insomnia, restlessness, agitation, loss of appetite, trouble concentrating, sleep disturbances and unusual tiredness. Symptoms of marijuana overdose include, but are not limited to, nausea, vomiting, hacking cough, disturbances in heart rhythms, numbness in the hands, feet, arms or legs, anxiety attacks and incapacitation. If I experience these symptoms, I agree to contact my physician immediately or go to the nearest emergency room. Numerous drugs are known to interact with marijuana and not all drug interactions are known. Some mixtures of medications can lead to serious and even fatal consequences. I agree to follow the directions of my physician regarding the use of prescription and non-prescription medication, and I will advise any other treating physician(s) of my use of medical marijuana. Marijuana may increase the risk of bleeding, low blood pressure, elevated blood sugar, liver enzymes, and other bodily systems when taken with herbs and supplements. I understand that medical marijuana may have serious risks and may cause low birthweight or other abnormalities in babies. I will advise my physician if I become pregnant, try to get pregnant, or will be breastfeeding.

g. Current State of Research on Efficacy by Condition

Cancer: There is insufficient evidence to support or refute that cannabinoids are an effective treatment for cancers, including glioma. There is conclusive evidence that oral cannabinoids are effective antiemetics in the treatment of chemotherapy-induced nausea and vomiting. Epilepsy: Insufficient evidence; currently available data consist solely of uncontrolled case series. Glaucoma: Limited evidence that cannabinoids are an ineffective treatment for improving intraocular pressure; studies showing positive effects have shown only short-term benefit. HIV/AIDS: Limited evidence that cannabis and oral cannabinoids are effective in increasing appetite and decreasing weight loss. PTSD: Limited evidence (a single, small fair-quality trial) that nabilone is effective for improving PTSD symptoms. ALS: Insufficient evidence. Crohn's disease: Insufficient evidence; some studies suggest CBD may be beneficial in inflammatory bowel diseases. Parkinson's disease: Insufficient evidence for motor symptoms or levodopa-induced dyskinesia. Multiple sclerosis: Substantial evidence that oral cannabinoids are effective for improving patient-reported MS spasticity symptoms. Chronic nonmalignant pain: Substantial evidence that cannabis is an effective treatment for chronic pain in adults. The physician has provided a summary of the current research on the efficacy of marijuana to treat the patient's medical condition.

h. Use of De-identified Health Information for Research

The Department of Health submits a data set to the Consortium for Medical Marijuana Clinical Outcomes Research for each patient registered in the medical marijuana use registry that includes the patient's qualifying medical condition and the daily dose amount and forms of marijuana certified for the patient. The patient's de-identified health information contained in the physician certification and medical marijuana use registry may be used for research purposes.

Part B: Certification in smokable form for a patient under 18 with a diagnosed terminal condition

Part C: For certification of smoking as an appropriate route of administration

Initial each section below.

Acknowledgement of Contaminant Risks

Smokable marijuana has infectious risks that are not present in processed products. Certain molds and mildews can contaminate marijuana plants during growing, processing, storage in dispensaries and in patient homes. These contaminants can pose health risks, particularly to those who are immunosuppressed due to their disease state and treatments. While the State of Florida requires third party testing you should still inspect your product.

Respiratory Health

Exposures to tobacco smoke and household air pollution consistently rank among the top risk factors for respiratory disease burden and the global burden of disease. Given the known relationships between tobacco smoking and multiple respiratory conditions, one could hypothesize that long-term marijuana smoking leads to similar deleterious effects on respiratory health, and some investigators argue that marijuana smoking may be even more harmful than tobacco smoking.

Health Risks of 2nd & 3rd Hand Smoke to Household Members

You should never smoke medical marijuana around other family members, especially children and any household guests. You should smoke outside to allow adequate ventilation and to mitigate the dangers of secondhand and thirdhand smoke to others. Marijuana should never be smoked inside vehicles or other small spaces that children will occupy even if the children are not present at the time the product is consumed.

Dangers of Smoking Where Oxygen Is in Use

If you use oxygen or have others in your household who use oxygen you should not smoke marijuana or any other combustible material in the vicinity of where the oxygen is in use due to the risk of fire and explosion.

Self-Dosing, If Permitted

I have been given instructions or discussed guidance on self-dosing with my qualified physician if permitted to do so.

Part D: Must be completed for ALL patients

I have had the opportunity to discuss these matters with the physician and to ask questions regarding anything I may not understand. I acknowledge that Dr. Danice Blaise has informed me of the nature of the recommended treatment, including but not limited to, any recommendation regarding medical marijuana. Dr. Danice Blaise also informed me of the risks, complications, and expected benefits of any recommended treatment, including its likelihood of success and failure. I acknowledge that Dr. Danice Blaise informed me of any alternatives to the recommended treatment, including the alternative of no treatment, and the risks and benefits. Dr. Danice Blaise has explained the information in this consent form about the medical use of marijuana.

The qualified physician signature and witness signature will be completed at the clinic during your visit with Dr. Danice Blaise. By submitting, you digitally sign this consent with your typed name and selected date.