Informed Consent to Medical Treatment

WHO DO YOU CONTACT ABOUT TREATMENT?


NP2GO

800 W 18th St., Ste. 140
Edmond, Oklahoma 73013
(405) 696-7003
[email protected]

 

KEY INFORMATION ABOUT TREATMENTS

The purpose of this form is to explain your options for treatment by NP2GO. The patient’s treatment may be one or more of the following treatments: general medical treatment, urgent care treatment, intravenous therapy/infusions, off-label medical treatment, general weight reduction treatment or weight reduction treatment using compounded pharmaceutical drugs such as appetite suppressants, fat burning injections, or GLP-1 agonist medication, including but not limited to semaglutide, tirzepatide, or other GLP-1 agonist medications. The U.S. Food and Drug Administration (FDA) has not approved off-label medical treatments or treatments using compounded pharmaceutical drugs. However, the FDA regulates the approval of medications and not the practice of medicine. This consent form describes the treatments available to you and is designed to help you decide if you would like to receive treatment. It provides important information about what you will be asked to do during the treatment, about the risks and benefits of the treatment, and about your rights. By signing this form, you are agreeing to undergo this treatment.

The remaining document will now describe more about the available treatments. This information should be considered before you make your choice. Members of the medical team will talk with you about the information described in this document. Some people have personal, religious, or ethical beliefs that may limit the kinds of medical treatments they would want to receive. Take the time needed to ask any questions and discuss this treatment with  NP2GO staff, and with your family, friends, and personal health care providers.

The term “you” refers to “you and/or your child” throughout the remainder of this document.

If the individual being asked to participate in this treatment is not able to give consent for themselves (such as treatment of a minor child or incapacitated person), you, as the Legally Authorized Representative or Parent/Guardian, will be their decision-maker and you are being asked to give permission for this person to receive this treatment. For the remainder of this document, the term “you” refers to you as the decision-maker and/or you as the individual being asked to participate in this treatment.

 

IT IS YOUR CHOICE TO RECEIVE TREATMENT

You may choose not to receive treatment for any reason. If you decide to receive treatment, you may change your mind and stop treatment at any time and for any reason. If you do choose to stop treatment, please inform your provider to ensure a safe withdrawal from the treatment.

 

ADDITIONAL IMPORTANT TREATMENT INFORMATION:

 

URGENT CARE/GENERAL MEDICAL TREATMENT:

The purpose of this treatment is to provide a range of medical services to adult or child patients, including treatment of non-emergent health conditions, diagnostics, routine items like vaccinations, allergic reactions, cuts, burns, sprains, colds, flu, infections, allergic reactions, lab services, physicals, regular primary care exams, drug screenings, and treatment of symptoms such as rashes, coughing, body and muscle aches, nausea, and headaches. However urgent care treatment DOES NOT include treatment for life-threatening conditions for which emergency services should be contacted. The benefits of this treatment include treating and preventing non-ambulatory medical conditions and improving overall long-term health by preventing unnecessary trips to the hospital. The risks associated with treatment include the possibility of harmful interactions with medicines or supplements and the chance that treatment may not work as expected or the possibility that the treatment may cause additional problems, side-effects, or symptoms up to and including death.

 

INTRAVENOUS THERAPY TREATMENT:

The purpose of this treatment is to use an intravenous line to deliver medications, vitamins, or other fluids to adult or child patients who may benefit from the treatment. The treatment consists of inserting a needle into the patient’s vein or muscle to inject a specific formula. The formula generally consists of fluids, medications, or vitamins that are specifically tailored for each individual patient’s specific medical needs. Alternatives to intravenous therapy are oral supplementation and dietary and lifestyle changes. Risks of intravenous therapy include: 1. Discomfort, bruising and pain at the site of the injection. 2. Inflammation of the vein used for injection (phlebitis). 3. Severe allergic reaction; anaphylaxis, cardiac arrest, death. Benefits of intravenous therapy include: 1. Intravenous fluids are not affected by stomach or intestinal disease. 2. The total amount of infusion is available to the tissues. 3. Nutrients are forced into cells by means of a high concentration gradient. 4. Higher doses of nutrients can be given than is possible by oral administration and is accomplished without intestinal irritation. Contraindications to intravenous therapy include: 1. Absolute contraindications: liver failure, renal failure, Addison’s disease, CHF 2. Relative contraindications: Thallasemia, G6PD deficiency, decreased renal function, drug-nutrient interactions, allergy and/or sensitivity to substances intended for IV administration. 3. Caution: HIV/AIDS, immune-suppression, post splenectomy, recent burns, malnourishment, chemotherapy. The patient should immediately notify NP2GO of any changes regarding the following: liver failure, kidney failure, Addison’s disease or congestive heart failure. The patient is responsible for notifying NP2GO about the patient’s current status of relative and cautionary contraindications mentioned above and should notify the practitioner immediately about any changes regarding the status of contraindications in future.

 

WEIGHT REDUCTION TREATMENT:

The purpose of this treatment is to diagnose and treat obesity in adults and children through intermittent fasting, reduction of caloric intake, regular exercise, behavioral lifestyle changes, and the patient’s use of oral and intravenous weight loss supplements, oral and subcutaneous prescription medications, or oral and subcutaneous compounded pharmaceutical drugs. Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved. Compounded pharmaceutical drugs are customized medications that healthcare professionals formulate for your specific needs. Because the compounding process involves the use of multiple prescription medications outside of the FDA approved use or dosage, the FDA has not assessed the safety, quality, or effectiveness of the compounded pharmaceutical drug, however the pharmacy making the compounded pharmaceutical drug is under the supervision of a licensed pharmacist who may be regulated by state pharmacy boards, the FDA, state law, or federal law.

For more information on drug compounding, please visit: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

Alternatives to intravenous drug therapy are oral supplementation and or dietary and lifestyle changes. Risks and Benefits of intravenous therapy are discussed in the prior section are incorporated here and remain the same when intravenous therapy is incorporated into weight reduction therapy.

Common side effects include, but are not limited to:

  • Gastrointestinal: Nausea/vomiting, abdominal pain, Diarrhea/constipation, dyspepsia, abdominal distension, eructation, flatulence, gastroenteritis, GERD, gastritis, lipase increase, amylase increase;
  • Neurological: Headache, dizziness;
  • Cardiac: Heart rate increase, Hypotension;
  • Endocrine: Fatigue, hypoglycemia (diabetic patients), alopecia;
  • Ophthalmic: Retinal disorder (diabetic patients);
  • Skin: redness or pain at injection site;

Serious Reactions include, but are not limited to:

  • Thyroid C-cell tumor (animal studies);
  • Medullary thyroid cancer;
  • Hypersensitivity reaction;
  • Anaphylaxis;
  • Angioedema;
  • Acute kidney injury;
  • Chronic renal failure exacerbation;
  • Pancreatitis;
  • Cholelithiasis;
  • Cholecystitis;
  • Syncope;

 

OFF-LABEL MEDICAL TREATMENT OR UNAPPROVED MEDICAL TREATMENT:

Any of the above-described treatments may be accomplished through use of off-label or unapproved medicines or supplements. The purpose of this type of treatment is to treat or prevent an adult or child’s medical condition using an FDA-approved medication (or sometimes a medication the FDA has not approved) in a way that has not been approved by the FDA. The FDA regulates the approval of medications and not the practice of medicine. Off-label medical treatment or treatment using non-FDA approved medicine is a legal and common practice. While many off-label uses are well documented and widely used, others may have little to no scientific support. The FDA advises that when prescribing a medication off-label, providers and patients should be well informed about the medication(s) and make sure that the off-label use has scientific support.

 

WHAT IS THE COST OF TREATMENT?

The cost of treatment will be discussed with the patient before or at the time of treatment, and the cost will vary depending on the course and scope of treatment. NP2GO does not accept or bill any health insurance provider. The patient is solely responsible for all upfront costs and full payment is expected at the time of treatment. Prices may vary and change from time to time.

 

WHAT ARE THE ADDITIONAL RISKS OR SIDE EFFECTS OF TREATMENT?

You may experience one or more of the risks indicated below from these treatments. In addition to these, there may be other unknown risks, or risks that we did not anticipate, associated with this treatment. Some risks described in this consent document, if severe, may cause death.

 

WHAT ARE THE RISKS RELATED TO PREGNANCY?

If the patient becomes pregnant or begins trying for pregnancy, the patient must stop taking all medication immediately and consult NP2GO.

 

WHAT OTHER TREATMENT OPTIONS ARE THERE FOR YOU?

Before you decide whether or not to participate in this treatment, if applicable, your healthcare provider will discuss other options that are available to you.

 

WILL YOU RECEIVE NEW INFORMATION ABOUT THE TREATMENT WHILE PARTICIPATING?

If we obtain any new information during this treatment that might affect your willingness to continue receiving the treatment, we’ll promptly provide you with that information.

 

WITHDRAWAL OR DISCONTINUATION OF THE TREATMENT

NP2GO may discontinue treatment or discontinue prescribing my medication for any of the following reasons:

  • Failure to pay NP2GO bills;
  • The patient experiences unfavorable side effects or the prescribed treatment is
    ineffective to treat the patient’s condition;
  • The patient provides false or misleading medical or family history;
  • The patient fails to follow the recommended plan of care;
  • The patient fails to uphold other responsibilities under the Agreement.

The Patient may discontinue treatment at any time, however for safety reasons a withdrawing patient is strongly encouraged to consult NP2GO regarding tapering treatment or a plan for further monitoring after treatment is discontinued. Failure to consult NP2GO regarding planned discontinuation of treatment is considered discontinuation of treatment against medical advice of the healthcare provider.

 

CONFIDENTIALITY PROTECTIONS

We will do our best to make sure that the personal information in your medical record will be kept private.

 

PROBLEMS OR QUESTIONS

If you have any problems or questions about this treatment, or about your rights please contact NP2GO.

 

INFORMED CONSENT & LEGAL AGREEMENT

This document is a legally binding agreement between you and NP2GO.

I voluntarily request that NP2GO (“provider”) treats my medical condition.

I have informed my provider of any known allergies, my medical conditions, medications, social/family history.

I have the right to be informed of any alternative options, side effects, and the risks and benefits.

I understand the mechanism of action for my treatment.

I understand how my treatment is to be administered.

I understand my medication may come from a compounding pharmacy, which is not FDA approved and I further understand that my treatment may be off-label or unapproved by the FDA.

Prices may vary and change. Charges for treatment may include my time with a provider representative (in person and via communication outside of the office), supplies, and medication.

Provider may change the pharmacy based on several factors (availability, shipping time, cost).

It has been explained to me that the medication used for my treatment could be harmful if taken inappropriately or without advice from the provider.

I understand treatment from provider has risks and treatment may cause adverse side-effects. I understand the list of risks and side-effects provided to me in this document is not complete and it describes the most common risks and side-effects, and that death is a possible risk of treatment. I understand symptoms may be worse after there has been a change in medication dose or when starting new medication.

I agree to obtain prescriptions only from provider.

If I am looking to transition to a non-compounding pharmacy or seeking insurance coverage, I will tell provider in advance.

I have disclosed my complete medical history including allergies, medications, medical/surgical/social/family history to provider.

Provider may review my medical history (medications, recent lab results, pertinent imaging results).

I will provide updated health information to provider when it becomes available (medication, allergies, personal medical issues/surgeries/social history, or family history changes).

My provider can discuss my treatment plan with any co-treating pharmacist and/or healthcare provider.

I will disclose to other healthcare providers the treatments I am receiving from NP2GO.

I understand Provider may require additional labs during treatment to ensure safety and efficacy or the treatment.

I will take my medications only as prescribed according to the directions, led by provider.

If I feel my medications are not effective, or are causing undesirable side effects, I will contact provider for further instructions.

I will not adjust my medications without prior instruction from provider.

I understand that some specific medications must be either kept frozen or refrigerated.

I understand some medication may require self-injection in the subcutaneous tissue at prescribed intervals and I will follow the prescribed amounts and intervals for injection.

I will not share needles and will dispose of needles safely.

I understand it is important to keep my medication away from children.

I am the only one who will use my prescribed medication. I will not give or sell my medication to anyone else.

If provider deems it appropriate to taper my medication or transition to maintenance dosing, I will comply.

I understand that these and other risks could be serious or in rare cases life-threatening. I understand that if I develop side effects from the medication, I will discontinue taking the medication and notify the Np2Go staff immediately and in the event the problem is severe, I will go to the nearest Emergency room for immediate care.

I do not have a history of pancreatitis. I do not have a FAMILY history of thyroid cancer or medullary endocrine neoplasia syndrome. I am not trying to become pregnant and agree to stop the medications before trying to conceive for at least 2 months in advance. I agree to use backup birth control methods while on GLP-1 medications.

I agree not to take any other weight loss medications, other than those prescribed by Np2Go and further agree to inform the staff of ANY changes in my medication or medical history.

I certify that all family history and medical information on my intake form is correct to the best of my knowledge.

This Agreement shall be binding upon and inure to the benefit of the Parties, and their respective predecessors, successors, assigns, heirs, executors, administrators, directors, officers, employees, agents, shareholders, members, parents, affiliates, subsidiaries, and related companies. The terms of this Agreement shall be enforceable by the Parties and their respective successors, representatives, and assigns.

This Agreement is made and entered into in the State of Oklahoma and shall in all respects be enforced and governed by and under the laws of said State without regard to its principles of conflicts of law, whether statutory or arising under the common law. The federal and state courts residing in Oklahoma City, Oklahoma, shall have jurisdiction over any claim brought under this Agreement.

In the event that any provision of this Agreement is held to be invalid or void, the same shall be deemed severable from the remainder hereof and shall in no way affect any other covenant or provision herein.

The individuals signing this document represent that they are fully authorized to execute this Agreement and no further actions by other Parties are needed to make this Agreement binding and effective according to its terms and conditions.

This Agreement may be executed electronically or in counterparts, each of which is deemed an original, but all of which constitutes one and the same agreement. Delivery of an executed counterpart of this Agreement electronically or by facsimile shall be effective as delivery of an original executed counterpart of this Agreement.

I have read this form in its entirety. It has been explained to me. I have had the opportunity to ask questions and seek independent legal counsel. I fully understand the above information and have no further questions. By signing this agreement, I voluntarily give my consent for treatment and agree to all risks and the terms of this agreement.

 

Please keep a copy of this document for your records.