Informed Medical Consent for SPRAVATOTM(esketamine) Treatment
This form is informed consent for treatment with SPRAVATOTM (esketamine) and by reviewing and signing this form, means you have been educated and instructed in the use of this product for treatment-resistant depression and the possible alternatives to treatment and the restrictions surrounding this Procedure and requirements in engaging in this Procedure.
Also by signing this form, you agree with your decision to engage in this Treatment was in no way coerced, pressured or forced upon you and is voluntarily your decision.
Procedure Date:*
Alternatives to Treatment:
Electroconvulsive Therapy, Trans-cranial magnetic stimulation, vagus nerve stimulation, acupuncture, psychotropic medication management.
Purpose of Treatment:
SPRAVATOTM is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults.
SPRAVATOTM is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATOTM is safe or effective as an anesthetic medicine.
It is not known if SPRAVATOTM is safe and effective in children.
SPRAVATOTM Dosing:
SPRAVATOTM is taken with a daily oral antidepressant
You administer SPRAVATOTM nasal spray yourself under the supervision of a healthcare professional at a certified SPRAVATOTM treatment center
SPRAVATOTM is taken twice a week for the first four weeks
After the first four weeks, SPRAVATOTM is taken once a week for a month
After this, SPRAVATOTM is usually taken either once a week or once every two weeks
Indication of Treatment:
If you’ve struggled with depression and tried two or more antidepressants¶ in your current episode without adequate relief, treatment is indicated for treatment-resistant depression.
Education of events after Treatment Exposure:
Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
attempts to commit suicide
thoughts about suicide or dying
worsening depression
other unusual changes in behavior or mood
Possible Adverse events:
Dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting and feeling drunk.
If these common side effects occur, they usually happen right after taking SPRAVATOTM and go away the same day.
SPRAVATOTM may cause serious side effects including:
See “What is the most important information I should know about SPRAVATOTM?”
Increased blood pressure. SPRAVATOTM can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATOTM and for at least 2 hours after you take SPRAVATOTM. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATOTM. Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
WAIVER AND RELEASE OF LIABILITY
In consideration of the risk of injury while participating in (the "Activity"), and as consideration for the right to participate in the Activity, I hereby, for myself, my heirs, executors, administrators, assigns, or personal representatives, knowingly and voluntarily enter into this waiver and release of liability and hereby waive any and all rights, claims or causes of action of any kind whatsoever arising out of my participation in the Activity, and do hereby release and forever discharge , located at , , , their affiliates, managers, members, agents, attorneys, staff, volunteers, heirs, representatives, predecessors, successors and assigns, for any physical or psychological injury, including but not limited to illness, paralysis, death, damages, economic or emotional loss, that I may suffer as a direct result of my participation in the aforementioned Activity, including traveling to and from an event related to this Activity.
I AM VOLUNTARILY PARTICIPATING IN THE AFOREMENTIONED ACTIVITY AND I AM PARTICIPATING IN THE ACTIVITY ENTIRELY AT MY OWN RISK. I AM AWARE OF THE RISKS ASSOCIATED WITH TRAVELING TO AND FROM AS WELL AS PARTICIPATING IN THIS ACTIVITY, WHICH MAY INCLUDE, BUT is NOT LIMITED TO, PHYSICAL OR PSYCHOLOGICAL INJURY, PAIN, SUFFERING, ILLNESS, DISFIGUREMENT, TEMPORARY OR PERMANENT DISABILITY (INCLUDING PARALYSIS), ECONOMIC OR EMOTIONAL LOSS, AND DEATH. I UNDERSTAND THAT THESE INJURIES OR OUTCOMES MAY ARISE FROM MY OWN OR OTHERS' NEGLIGENCE, CONDITIONS RELATED TO TRAVEL, OR THE CONDITION OF THE ACTIVITY LOCATION(S). NONETHELESS, I ASSUME ALL RELATED RISKS, BOTH KNOWN OR UNKNOWN TO ME, OF MY PARTICIPATION IN THIS ACTIVITY, INCLUDING TRAVEL TO, FROM AND DURING THIS ACTIVITY.
I agree to indemnify and hold harmless against any and all claims, suits or actions of any kind whatsoever for liability, damages, compensation or otherwise brought by me or anyone on my behalf, including attorney's fees and any related costs, if litigation arises pursuant to any claims made by me or by anyone else acting on my behalf. If incurs any of these types of expenses, I agree to reimburse.
I acknowledge that and their directors, officers, volunteers, representatives, and agents are not responsible for errors, omissions, acts or failures to act of any party or entity conducting a specific event or activity on behalf of.
I acknowledge that this Activity may involve a test of a person's physical and mental limits and may carry with it the potential for death, serious injury, and property loss. The risks may include, but are not limited to, those caused by terrain, facilities, temperature, weather, lack of hydration, condition of participants, equipment, vehicular traffic and actions of others, including but not limited to, participants, volunteers, spectators, coaches, event officials and event monitors, and/or producers of the event.
I ACKNOWLEDGE THAT I HAVE CAREFULLY READ THIS "WAIVER AND RELEASE" AND FULLY UNDERSTAND THAT IT IS A RELEASE OF LIABILITY. I EXPRESSLY AGREE TO RELEASE AND DISCHARGE AND ALL OF ITS AFFILIATES, MANAGERS, MEMBERS, AGENTS, ATTORNEYS, STAFF, VOLUNTEERS, HEIRS, REPRESENTATIVES, PREDECESSORS, SUCCESSORS AND ASSIGNS, FROM ANY AND ALL CLAIMS OR CAUSES OF ACTION AND I AGREE TO VOLUNTARILY GIVE UP OR WAIVE ANY RIGHT THAT I OTHERWISE HAVE TO BRING A LEGAL ACTION AGAINST FOR PERSONAL INJURY OR PROPERTY DAMAGE.
To the extent that statute or case law does not prohibit releases for negligence, this release is also for negligence on the part of, its agents, and employees.
In the event that I should require medical care or treatment, I agree to be financially responsible for any costs incurred as a result of such treatment. I am aware and understand that I should carry my own health insurance.
In the event that any damage to equipment or facilities occurs as a result of my or my family's willful actions, neglect or recklessness, I acknowledge and agree to be held liable for any and all costs associated with any actions of neglect or recklessness.
Contraindications to Treatment:
Do not take SPRAVATOTM if you:
have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms, and legs)
have an abnormal connection between your veins and arteries (arteriovenous malformation) have a history of bleeding in the brain
are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATOTM.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATOTM.
Details of Procedure:
Patient to self administer medication and to repeat dose after 5 minutes, and must be monitored for a total of 2 hours in the office.
Requirements and documentation of Procedure:
Phq-9 scale for depression to be administered on each treatment day and once prior to treatment. Logbook of medical monitoring to include blood pressure prior and twice during Procedure (duration of treatment 2 hours).
Treatment Plan Adherence:
You will take SPRAVATOTM nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATOTM nasal spray device.
Your healthcare provider will tell you how much SPRAVATOTM you will take and when you will take it.
Follow your SPRAVATOTM treatment schedule exactly as your healthcare provider tells you to. During and after each use of the SPRAVATOTM nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
You will need to plan for a caregiver or family member to drive you home after taking SPRAVATOTM.
If you miss a SPRAVATOTM treatment, your healthcare provider may change your dose and treatment schedule.
Some people taking SPRAVATOTM to get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATOTM and not drink liquids at least 30 minutes before taking SPRAVATOTM.
If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATOTM.
Prohibition to the use of a motor vehicle, Driving or use of heavy mechanical equipment:
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATOTM. Do not take part in these activities until the next day following a restful sleep.
Name of Driver other Than Patient: *
Financial Policy Waiver/Policy
We recommend you call your insurance company prior to rendering services from Faisal Rafiq MD. PC. or Any of its clinicians, to avoid such issues as not being reimbursed for your visits or to all ensure we are a covered and paneled provider under your insurance company. We are committed to providing you the best possible care. If you have medical insurance we are anxious to help you receive your maximum allowable benefits. In order to achieve these goals, we need your assistance and your understanding.We will file your insurance claim with your primary insurance for you, however, we ask that you pay any co-payment or deductible at the time services are rendered and the balance in full if your insurance has not paid in 60 days. For Insurance Co-payment we accept Cash, Money Order and all Major Credit Cards. We do not accept personal checks.We will do all we can to expedite insurance reimbursement, but you must realize that:
1. Your insurance is a contract between you, your employer and the insurance company. If we participate with your insurance plan, we are under contract to the only charge what your company allows. Since each carrier "usual and customary" fees differ, we will take the appropriate discount when your insurance company pays our practice.
2. Not all services are a covered benefit in all contracts. Some insurance companies arbitrarily select certain services they will not cover. These non-covered services are your responsibility. We must emphasize that as Medical Care Providers; while the filing of insurance claims is a
courtesy we extend to our patients, all charges are your responsibility from the date the services are rendered. We realize that temporary financial problems may affect payment of your account. If such problems arise, we encourage you to contact us promptly for assistance in the management of your account. If you have any questions about any of our financial policies or any uncertainty regarding insurance coverage, please do not hesitate to ask. We are here to help you.
ASSIGNMENT OF INSURANCE BENEFITS & ACCEPTANCE OF FINANCIAL RESPONSIBILITY.
I authorize the direct payment of any medical benefits to Faisal Rafiq MD. PC., for services, rendered. I understand I am responsible for any and all usual and customary charges not paid as a result of this assignment. If the account is turned over to a third party, collection agency, or attorney, I understand a 10% service charge (Minimum of $15) will be added to the balance, and I understand I will be responsible to pay all litigation expenses, court costs, and reasonable attorney's fees.
Possible outcomes of Treatment:
The patient should have remission of depression symptoms. Will be monitored by scales and clinical evaluations.