THIS INFORMED CONSENT (THE"CONSENT") FOR METHYLCOBALAMIN (B12) INJECTIONS (“B12 INJECTION”)SETS FORTH THE TERMS AND POLICIES FOR THE CLINICAL SERVICES PROVIDED BY SUPERPOWER MEDICAL GROUP OF CA PC, A CALIFORNIA PROFESSIONAL MEDICAL CORPORATION, AND OTHER THIRD-PARTY MEDICAL GROUPS (COLLECTIVELY, THE"MEDICAL GROUPS") THROUGH THE ONLINE TECHNOLOGY PLATFORM("PLATFORM" OR "SUPERPOWER PLATFORM"), WHICH IS OWNED AND OPERATED BY SUPERPOWER HEALTH, INC. ("SUPERPOWER").
The purpose of this consent is to provide you with information about the risks, benefits, and safety considerations associated with B12 injections in order for you to make an informed decision as to whether or not to proceed with treatment, as well as to obtain your agreement to adhere to the treatment protocol as prescribed by yourMedical Group healthcare provider (“Healthcare Provider”). Please read this form carefully and ask any questions you have before signing.
Vitamin B12 is an important water-soluble vitamin involved in red blood cell production, brain health, andDNA synthesis. A deficiency in this key vitamin can cause serious symptoms, including fatigue, nerve damage, digestive issues, and neurological problems like depression and memory loss. Therefore, many people turn to vitamin B12supplements to help meet their needs and prevent a deficiency.
Methyl cobalamin is the active form of B12, and unlike other forms, does not need to be further processed to be utilized by the body’s cells.
B12 is often found in animal foods but not in as many plant foods; therefore, vegans are advised to supplement with B12. Oral supplementation is an option, but it may not be absorbed well if a person has digestive issues.
Additionally, most everyone’s ability to absorb B12 declines with age and supplementation genera rally becomes necessary in older age, especially if the quantity of food consumed decreases.
Many vitamin injections such as Vitamin B12and others can be administered as an intramuscular or subcutaneous injection.The difference between the two is that intramuscular injections are inserted into the muscle, and subcutaneous injections are inserted just below the skin.
Both subcutaneous and intramuscular Injections are a means to deliver vitamins, minerals, and nutrients to the body while avoiding the digestive process. These substances are administered in small amounts(1-3cc). Depending on the compounds injected and where they are injected, they may be absorbed quickly or more gradually.
An intramuscular injection is absorbed faster because the muscle tissue has more blood supply. However, it means that this method may be more painful and may cause swelling and redness. The advantage of subcutaneous injection is that it is easier to learn at home and less painful.Additionally, a subcutaneous injection uses a shorter needle because it does not need to go deep into the tissues.
However, the manner of administering the injection may change depending on the amount of fat under your skin.
Subcutaneous injections are injected into the fatty tissue deeply under the skin. The location of injection is important for subcutaneous injections. Some areas of the body have a more easily accessible layer of tissue, where a needle injected under the skin will not hit muscle, bone, or blood vessels.
The most common injection sites are:
· Abdomen: at or under the level of the belly button, about two inches away from the navel
· Arm: back or side of the upper arm
· Thigh: front of the thigh
Intramuscular (IM) Injections involve the injection of a substance directly into a muscle. IM injections are generally injected into one of two locations: 1) deltoid muscle (shoulder); or 2) gluteal muscle (upper outer buttock).
You will receive a shipment of vitamin injections at your selected shipping address and instructions for how to self-administer the injections. It is important that you follow the instructions carefully. NOTE: This medicine is only for you. Do not share this medicine with others.
· B12 injected subcutaneously or intramuscularly is not affected by stomach or intestinal absorption disturbances and therefore is better absorbed by the body. This can be especially helpful for individuals with conditions such as decreased intestinal absorption of nutrients, achlorhydria, long-term PPI use, and pernicious anemia.
· Higher doses of B12can be given than is possible by oral consumption and without intestinal irritation that can accompany doses given by mouth.
· Discomfort such as pain, redness, bruising, swelling, burning, stinging, tingling, numbness, drainage, prolonged bleeding and/or scar formation at the site of the injection. Bleeding is possible if a blood vessel is pierced.
· For IM Injections:If the injection misses the muscle and is not deposited into fat then some or all of the medicine might be wasted.
· Infection is always a potential risk when the skin is punctured even when sterile procedures are used.
· Injury to nerve and/or muscle at the site of the injection.
· Sensitivities or allergic reactions to the injection solution.
· Mild and temporary metabolic disturbances such as diarrhea, upset stomach, nausea, increased urination, itching, headache, joint pain, racing heart, dizziness, or a feeling of light-headedness after injections depending on the substance(s) in the injection.
· In rare cases, B12can cause diarrhea, peripheral vascular thrombosis, temporary itching of the skin, transitory exanthema, urticaria, feelings of swelling of the whole body.
Oral supplementation of B12; Transdermal application with B12 patches, and Dietary changes (eating foods fortified with B12 and eating animal products such as meat, chicken, fish, dairy and whole eggs including yolk).
B12 Injections are contraindicated if you have any of the following conditions:
· Chronic liver disease, including hepatitis, and/or kidney dysfunction
· Individuals with sensitivity to cobalt and/or cobalamin and those with Leber’s disease, a hereditary optic nerve atrophic condition, as it can lead to blindness.
· Individuals with an allergic reaction to cyanocobalamin, cobalt, other medications, foods, dyes, or preservatives.
· Individuals with severe megaloblastic anemia
· Thrombocytopenia(low platelet counts) and coagulopathy (bleeding tendency) are contraindications for vitamin injections, as they may lead to bruising and/orexcessive bleeding.
· Pregnancy and breastfeeding may be a contraindication depending on the substance injected.Please tell your Medical Group provider immediately if you are pregnant or are breast feeding.
o B12 Interactions with drugs: Chloramphenicol can impede on the red blood cell producing properties of B12.
o Other drugs that decrease or reduce absorption of B12include: antibiotics, cobalt irradiation, colchicine, colestipol, H2-blockers, metformin, nicotine, birth control pills, potassium chloride, proton pump inhibitors such as Prevacid, Losec, Aciphex, Pantaloc, and Zidovudine.
Your Healthcare Provider will determine the appropriate dosage of based on laboratory testing and medical history.
To continue receiving prescriptions, you will be required to complete laboratory testing before initiating treatment, three months after starting treatment, and then annually thereafter, unless otherwise indicated by your clinician in the event of a dose change or the occurrence of side effects.
You understand that all Clinical Services will be provided via telehealth. Telehealth involves the delivery of healthcare services using electronic communications, information technology or other means between a healthcare provider and a patient who are not in the same physical location. Telehealth may be used for diagnosis, treatment, follow-up and/or patient education, and may include, but is not limited to, one or more of the following:
Electronic systems used will incorporate network and software security protocols to protect the confidentiality of customer identification and imaging data and will include measures to safeguard the data and to ensure its integrity against intentional or unintentional corruption.
There are potential risks associated with the use of telehealth. These risks include, but may not be limited to:
Due to state licensure requirements of healthcare providers, you have to physically be in the state that your Medical Group Healthcare Provider is licensed in during your telehealth visit. By agreeing to this Consent, you are confirming that you will only opt in to care when you are in your state of residence or in one of our locations. Furthermore, you are confirming that your state of residence is one in which the Medical Groups are licensed to treat.
You should seek emergency help or follow-up care when recommended by any healthcare provider or when otherwise needed. You should never discontinue medications or stop a course of treatment without first contacting your primary care provider or other medical professionals for advice. You should not delay treatment or advice from your primary care provider or other medical professionals based on information provided by the Medical Group Healthcare Providers via the Superpower Platform.
All laws and protections for in-person medical care also apply to telehealth care. This includes confidentiality of information, access to medical records, and sharing of information that could identify you personally. You may decide that you do not want to use theClinical Services at any time, seek treatment elsewhere and/or with in-person offerings.
Please sign below to acknowledge your understanding and agreement of the following terms in order to proceed with treatment with Methylcobalamin (B12) Injections with a Medical Group Healthcare Provider via the Superpower Platform:
BY SIGNING THIS INFORMED CONSENT,YOU ACKNOWLEDGE THAT YOU HAVE READ AND UNDERSTAND THE INFORMATION PROVIDED ABOUT B12 INJECTION TREATMENT, INCLUDING THE RISKS, BENEFITS, AND SAFETY CONSIDERATIONS. YOU AGREE TO ADHERE TO THE TREATMENT PROTOCOL AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER AND TO REPORT ANY SEVERE SIDE EFFECTS OR CONCERNS TO YOUR HEALTHCARE PROVIDER PROMPTLY.
Take your medication exactly as directed and written on your prescription label. By FDA law, this medication is not for resale, nor can it be returned for refund. Do not let anyone else take your medication. This medication is intended for use solely by the person for whom it is prescribed and should not be shared with any other individuals. Please follow the directions of your prescribing Healthcare Provider and on your prescription label carefully. If you need further explanation or have questions, please ask your prescribing Healthcare Provider to explain any part you do not understand.
You understand that the Healthcare Provider prescribing B12 Injection holds a professional license issued by the professional licensing board or agency in the state where they practice. You can report a complaint relating to the care provided by contacting the appropriate state professional licensing board.
You acknowledge that there are no guarantees or assurances made with respect to the results of taking the B12 Injections prescribed for you, and there are no guarantees that there will not be side effects and complications.
Additionally, you understand and acknowledge that the United States Food and Drug Administration (FDA) has not evaluated or approved the B12 Vitamin Injections to diagnose, treat, cure, or prevent any disease.
You understand that B12 injections may be inappropriate and unsafe if you have certain health conditions, allergies, or take certain medications or supplements, whether prescribed or over-the-counter. For this and other reasons, you understand that it is vital that you truthfully and accurately disclose all health information requested by your prescribing Healthcare Provider including allergies, medications you are taking (both prescription and over the counter), medical/surgical/social/family history, and pertinent lab results, and keep your Medical Group prescribing Healthcare Provider updated as to any changes in your health conditions and history during treatment with B12 Injections, and you agree there shall be no liability on the part of the Medical Groups, the Healthcare Providers orSuperpower if you fail to do so.
BY CLICKING "I AGREE" OR OTHERWISE INDICATING YOUR ACCEPTANCE, YOU ARE PROVIDING YOUR INFORMED CONSENT TO RECEIVE B12 INJECTIONS THROUGH THIS SERVICE. YOU CERTIFY THAT YOU ARE NOT CONSENTING ON BEHALF OF A MINOR CHILD, AS THIS SERVICE DOES NOT PROVIDE TREATMENT TO INDIVIDUALS UNDER THE AGE OF 18.
You confirm and agree that: I have read this entire Informed Consent, and I understand and agree to the information herein. I understand this is an elective treatment. The nature of the therapy, and the potential risks, benefits and alternatives have been explained to me, and I have had the opportunity to ask questions, and all my questions have been answered to my satisfaction. I hereby freely and voluntarily accept all risks associated with B12 Injections and elect and consent to proceed with treatment.
MEMBERNAME:___________________________
SIGNATURE:_____________________________
DATE:__________________________________
