Consent For Nasal Spray Esketamine

Spravato

Please correct the errors described below.

Consent for Nasal Spray Esketamine (Spravato)

1. For the treatment of Treatment-Resistant Depression, I have agreed to receive the following procedure:

Spravato (Esketamine Nasal Spray)

2. My doctor explained to me:

a. The treatment process

b. Potential benefits and risks of this treatment

c. Possible side effects, complications, and contraindications to the use of esketamine.

d. Risks and benefits of other treatment options, including not receiving this treatment.

e. How likely it is that the desired outcome of the procedure will be achieved.

f. I do not have any of the conditions that would prevent me from receiving the procedure.

g. The information contained in this consent form is also described in the Spravato Patient Brochure, Frequently Asked Questions, and Guide to Understanding Treatment-Resistant Depression all of which are included in the Welcome folder and available from your doctor.

3. I understand that;

a. SPRAVATO™ (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant (AD), for the treatment of treatment-resistant depression (TRD) in adults. SPRAVATO™ is not approved as an anesthetic agent. The safety and effectiveness of SPRAVAT™ as an anesthetic agent have not been established.

b. Effectiveness: According to the literature, efficiency emerged within the first 24 hours following administration in about 70% of the cases and the effects typically last for about 2 weeks. Longer or shorter duration of action is possible. Like all medical treatments, I understand that there is no guarantee Spravato Nasal Spray, or any treatment modality, will be successful.

c. Procedure: Use the SPRAVATO™ nasal spray myself under the direct observation of a healthcare provider with a 2-hour monitor after each administration until the healthcare provider determines I am ready to leave the healthcare setting. The Day I starting dose of SPRAVATO™ nasal spray is 56 mg (2 devices). A single-use device delivers a total of 28 mg of SPRAVATO™ (each device contains 2 sprays, 1 spray in each nostril). Day 1 starting dose: 56 mg and Subsequent doses: 56 mg or 84 mg twice a week for 4 weeks, then 56 mg or 84 mg once weekly from week 5 to week 8. From week 9 on, 56 mg or 84 mg every 2 weeks then once a month or as recommended by the prescriber.

d. Complications and side effects may occur. Risk for sedation and dissociation after administration. I agree to receive counseling on the risks and the need for monitoring for resolution of sedation and dissociation, and for any changes in my vital signs. Sedation and dissociation can result from treatment with SPRAVATO™ and I must stay after each treatment until these effects resolve. I may feel: sleepy and/or distortion of time and space and illusions, disconnected from myself, my thoughts, feelings and things around me.), derealization, and depersonalization. My blood pressure may increase and may need to be monitored or treated. DRUG INTERACTIONS CNS depressants (e.g., benzodiazepines, opioids, alcohol): Concomitant use may increase sedation. Psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil)or monoamine oxidase inhibitors (MAOIs): Concomitant use may increase blood pressure.

e. Potential for abuse and misuse.

f. Ulcerative or Interstitial Cystitis: Cases of ulcerative or interstitial cystitis have been reported in individuals with long-term off-label use or misuse/abuse of ketamine. In clinical studies with SPRAVATO™ nasal spray, there was a higher rate of lower urinary tract symptoms (pollakiuria, dysuria, micturition urgency, nocturia, and cystitis) in SPRAVATO™-treated patients than in placebo-treated patients. No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year. Let your healthcare provider know if you experience any urinary tract and bladder symptoms during the course of treatment with SPRAVATO™ and you may be referred to an appropriate healthcare provider as clinically warranted.

g. A single dose of SPRAVATO™ caused cognitive performance to decline 40 minutes post-dose. h. Pregnancy: SPRAVATO™ may cause embryo-fetal harm when administered to a pregnant woman. Let us know if you are pregnant or planning to become pregnant during the treatment course.

h. Pregnancy: SPRAVATO™ may cause embryo-fetal harm when administered to a pregnant woman. Let us know if you are pregnant or planning to become pregnant during the treatment course.

i. Esketamine is contraindicated in Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation or history of intracerebral hemorrhage or hypersensitivity to esketamine, ketamine, or any of the excipients.

j. I should make arrangements to safely leave the healthcare setting and get home.

k. I should not drive or use heavy machinery for the rest of the day on which I receive SPRAVATO™.

I. I should contact my doctor or inform him/her at my next visit if I believe I have a side effect or reaction from SPRAVATO™.

m. In order to receive SPRAVATO™, I am required to be enrolled in the REMS, and my information will be stored in a database of all patients who receive SPRAVATO™ in the United States. Janssen Pharmaceuticals, Inc. and its agents, including trusted vendors, may contact me via phone, mail, fax, or email to support the administration of the REMS. Janssen Pharmaceuticals, Inc. and its agents, including trusted vendors, may use, disclose, and share my personal health information for the purpose of the operations of the REMS, including enrolling me into the REMS and administering the REMS, coordinating the dispensing of SPRAVATO™, and releasing and disclosing my personal health information to the Food and Drug Administration (FDA), as necessary, and as otherwise required by law. Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022.

4. You may refuse the medication. If you consent, you may withdraw it at any time by stating such an intention to any member of the treating staff.

5. Reasonable alternative treatments are available. In general, alternative treatments for depression include antidepressant medication, transcranial magnetic stimulation and/or electroconvulsive therapy.

6. I have understood and am satisfied with my understanding of the risks and benefits of the procedure as well as the risks and benefits of the alternatives as explained to me. Therefore, I give my consent for the procedure. I authorize the above-named clinician(s) and his or her associates to:

a. Perform the above-described procedure as well as any additional services which are considered needed to treat or correct conditions discovered during the treatment.

b. Determine the need for and allow persons, including interns and personnel in the procedure room during my procedure for medical and/or educational purposes.

Intake Form

PERSONAL INFORMATION

Please indicate with an * which phone numbers we may NOT leave as a message.

Relative or friend in case of emergency:

FINANCIAL

I understand that The Injection & Infusion Clinic of vortex Psychiatry does not accept insurance for Ketamine Infusion treatment. Upon request, I will be given a receipt that I may submit to my insurance for possible reimbursement. As well, I understand that if I cancel within 24 hours or do not show up for an appointment, I will be billed the entire amount of the appointment. I have been given the opportunity to ask questions regarding this statement.

INTAKE FORM

27. I certify that I have completed this questionnaire to the best of my knowledge by signing my name below:

Discharge Instructions and Recommendations

Do not drive a car or operate heavy machinery for 12 hours after your infusion.

Do not drink alcohol for 24 hours after your infusion.

Avoid solid food for the next 1 hour, and drink liquids instead.



Your next appointment:

Contact us below with the occurrence of any side effects including nausea/vomiting, anxiety, or any other concerns.

Said A Ibrahim l MD

925-648-2650

4155 Blackhawk Circle Plan

Suite 240

Danville, CA 94506

Practice Policies

You will be evaluated, trained, and by a licensed provider. We wish to take this opportunity ty to welcome you and also to state some basic principles we believe are essential in establishing a good relationship between us. Please read through this information, asking questions as needed.

1. INITIAL INTERVIEW: Your first history and physical is considered an evaluation interview and exam. At the time of this appointment, the following decisions will be made with you:

a) If ketamine is an appropriate treatment option

b) Frequency of ketamlne infusion sessions

c) Goals of therapy (what you hope to gain from this process.)


2. APPOINTMENTS: Each appointment varies in length depending on your chief complaint. Typically, 40 min infusion appointments take just under 2 hours, At the end of each appointment, you can make arrangements for your next appointment, or you may also book all your prescribed appointments at once.

3. CANCELLATIONS: If you find that you need to cancel an appointment, please give as much notice as possible so that we can schedule people that are on our waiting list. You will be personally charged for your appointment if not canceled at least 24 hours in advance other than for emergency reasons.

4. PAYMENTS: We would greatly appreciate payment in full for each office prior to the start of your appointment. If you do not have a charge card. We will accept cash and credit cards.

5. INSURANCE: Insurance is an agreement between you and your Insurance company as to how treatment will be paid for. We will assist you in any way possible by providing receipts and documentation. We currently do not directly participate with Insurance plans for Ketamine Infusion treatment. However, we will assist you by giving you receipt; to submit, and follow-up contacts. Some Insurance companies will pay for a portion of out patient ketamine infusion services. You should check with your Insurance company representative to find out the specific requirements and limitations of this coverage. We will be happy to assist you in the preparation of Insurance forms if you feel there is a chance your Insurance company will pay for these services. The hourly rate will apply. Payments for services received through Vortex Psychiatry are ultimately your responsibility. If your Insurance company requires that outpatient ketamine Infusion services be preauthorized, it is your responsibility to initiate the reauthorization process, i.e. containing your primary care physician, Insurance company, or a third party "gatekeeper". Failure to obtain the required preauthorization for outpatient mental health services will result in you being held 100% responsible for all charges.

6. CONFIDENTIALITY: All Information regarding the specific nature of your treatment is maintained at The Injection & Infusion Clinic of Vortex Psychiatry and is considered confidential within the office unless specified by you in writing. However, each provider at this office reserves the right to use specialty consultation with other medical providers at the office as deemed necessary. We follow HIPAA and maintain confidentiality.

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