Consent to Ketamine Therapy

(if prescribed by a Provider)

I, the (“Patient”) hereby give my consent to Peak Medical Group, P.C. and its licensed healthcare providers (individually, a “Provider”) to treat my depression, anxiety, PTSD, OCD, drug or alcohol abuse with administration of the drug, ketamine, if my Provider determines such treatment is appropriate. I acknowledge that treatment of depression, anxiety, PTSD, OCD, drug or alcohol abuse is an off-label use for ketamine, which means that such use has not been approved by the U.S. Food & Drug Administration (“FDA”).

About Ketamine

Ketamine is a synthetic pharmaceutical compound consisting of a mixture of two mirror image molecules, R- and S- ketamine. Ketamine is classified as a Scheduled III controlled substance by the U.S. Drug Enforcement Administration (DEA) and is approved by the FDA in injectable forms for induction and maintenance of general anesthesia. The S-form of ketamine (called “esketamine”) is also a Schedule III controlled substance and was approved by the FDA in 2019 in nasal spray form for use with an oral antidepressant to treat adults with treatment-resistant depression and depressive symptoms in adults with major depressive disorder with suicidal thoughts or actions. The FDA has not approved any oral form of ketamine for any use.

Off-Label Use

If you accept these conditions, and if your Provider prescribes ketamine for your, you are consenting to being treated with ketamine for your depression, anxiety, PTSD, OCD, drug or alcohol abuse, which is an off-label use.

“Off-label” use means the use of a drug in a way that has not been approved by the FDA (i.e., the FDA has not made a determination on the safety or effectiveness of the drug for such use). Off-label uses of a drug include:

• Using the drug for a disease or medical condition that differs from the disease or condition it is FDA-approved to treat;
• Prescribing the drug for use at a different dose or dosing schedule than has been approved by the FDA (such as when a drug is approved to be given at a dose of one tablet every day, but a patient is prescribed to take two tablets every day); and/or
• Using the drug in a patient population that has not been approved by the FDA.

Physicians and other authorized prescribers may prescribe a medication for an off-label use as part of the practice of medicine or other applicable profession. In doing so, the prescriber is exercising her/his professional knowledge and judgment to determine that the off-label use of a drug serves the best interests of the patient and is based on sound medical and/or scientific evidence.

Potential Risks

Risks of oral ketamine vary depending on the dose and the duration and intensity of its effects can vary highly from person to person. Below is a list of common, uncommon, and rare side effects. This list is not exhaustive and is not intended to be a comprehensive list of all possible side effects.

Common side effects: Out of body experience; hallucinations; vivid dreams and nightmares; change in motor skills; nausea and vomiting; dizziness; blurred vision; increased saliva production; increased heart rate and blood pressure; and risk of falling when walking.

Uncommon side effects: Rash; double vision; increased pressure in the eye; jerky arm movements; and cognitive issues, including memory problems and verbal processing.

Rare side effects: Severe allergic reaction; irregular or slow heart rate; arrhythmia; low blood pressure; laryngospasm (a spasm of vocal cords); cystitis: inflammation of the bladder, ulcers, and fibrosis; cholecystitis: gallbladder disease; and elevation in liver enzymes.

Even more severe side effects, up to and including death, are possible but extremely rare, such as in the event of a fatal allergic reaction to the medication.

Some patients may experience a state of severe agitation, confusion, or become combative, which may cause threat of severe harm or bodily injury to both themselves and those around them. The risk of such a reaction to the medication may be reduced by avoiding loud noises and disturbing external stimuli. It is recommended that you take ketamine only if you are in a calm and relaxed emotional state.

In addition, ketamine can cause various emotional and psychological conditions, including but not limited to flashbacks, hallucinations, feelings of unhappiness, restlessness, anxiety, insomnia and disorientation.

Dosing Error and Drug Interactions and Other Risks

SEVERE MEDICATION INTERACTIONS ARE POSSIBLE SO PLEASE TELL YOUR PROVIDER ALL OF THE MEDICATIONS, SUPPLEMENTS AND SUBSTANCES YOU ARE TAKING OR HAVE RECENTLY TAKEN PRIOR TO TAKING KETAMINE.

Dosing errors or other unknown drug interaction may require emergent medical intervention or hospitalization. In addition, there is a risk of other medications interacting with ketamine. It is very important that you disclose to your provider all medications (both prescription and over the counter) and supplements that you are taking.

You must abstain from any or all illicit substances for a minimum of 6 weeks prior to your ketamine treatment. Additionally, not adhering to the prescribed dosing may result in injury, illness or death.

It is possible that ketamine may not help your depression, anxiety, PTSD, OCD, drug or alcohol abuse, or other indications.

Ketamine can be dangerous to children, animals, and people for whom it is not specifically prescribed. Upon receipt of your prescribed ketamine product, you must secure a safe place to store the product out of reach of anyone other than you, the patient for whom it was prescribed.

Potential for Ketamine Abuse and Physical Dependence

Ketamine belongs to the same group of chemicals as phencyclidine (Sernyl, PCP, “Angel dust”). This group of chemical compounds is known chemically as arylcyclohexylamines and is classified as hallucinogens (also known as psychedelics). Ketamine is a controlled substance and is subject to Schedule III rules under the Controlled Substance Act of 1970. Medical evidence regarding the issue of drug abuse and dependence suggests that ketamine’s abuse potential is equivalent to that of phencyclidine and other hallucinogenic substances.

Phencyclidine and other hallucinogenic compounds do not meet criteria for chemical dependence, since they do not cause tolerance and withdrawal symptoms. However, cravings have been reported by individuals with the history of heavy use of psychedelic drugs. In addition, ketamine can have effects on mood (feelings), cognition (thinking), and perception (imagery) that may make some people want to use it repeatedly.

Compounded Drugs

The ketamine you will be receiving may be a compounded drug. Compounding is a practice in which a licensed pharmacist, physician, or an outsourcing facility combines, mixes, or alters ingredients of a drug to create a medication. Compounded drugs are not FDA-approved, which means the FDA has not evaluated their safety, effectiveness, or quality. Compounded drugs that are contaminated or otherwise of poor quality have been associated with serious patient illnesses and deaths.

Potential Benefits

The use of ketamine has been associated with a rapid decrease in depression, bipolar disorder, and PTSD symptoms in some patients. While the goal is improvement of symptoms, results cannot be guaranteed, and there is no way to predict how any individual will respond to ketamine therapy. These effects may not be long lasting, and will most likely require further treatments.

Alternatives

Psychotherapy without ketamine is available and can be effective. Major Depression (MDD), PTSD and Bipolar Disorders are usually treated with antidepressant medications, tranquilizers, mood stabilizers and psychotherapy. PTSD is often also treated with Eye Movement Desensitization and Reprocessing (EMDR). Electroconvulsive therapy (ECT) and the recently introduced Transcranial Magnetic Stimulation (TMS) also may be used for treatment-resistant depression.

Patient Consent

Before I undergo ketamine treatment:

I agree and acknowledge that a Provider has discussed with me the above treatment, the potential benefits, likelihood of success, potential risks, and side effects. Alternatives and their risks, benefits and side effects have also been discussed.

I understand that no guarantees have been made to me regarding the results of this treatment, that it may or may not improve my condition, and that the safety or long-term effects of ketamine are unknown. I have had sufficient opportunity to discuss my condition and treatment with my Provider and all of my questions have been answered to my satisfaction. I believe I have been given sufficient information and adequate knowledge upon which to make an informed decision about undergoing the proposed treatment. I have read and fully understand this form and I voluntarily authorize and consent to this treatment.

I understand that other problems/conditions may develop during the course of treatment that cannot be reasonably foreseen.