Informed Consent for Hormone Replacement Therapy
I, the undersigned, authorize and give my informed consent to Hybrid Advanced Medical Solution, for the administration of hormone replacement therapy.
Expected Benefits of Hormone Replacement Therapy
- Control of symptoms associated with declining hormone levels.
- Potential to prevent, reduce, or control physical diseases and dysfunction associated with declining hormone levels.
- I have been fully informed, and I am satisfied with my understanding, that this treatment may be viewed by the medical community as new, controversial, and unnecessary by the Food and Drug Administration.
- I understand that my healthcare provider cannot guarantee any health benefits or that there will be no harm from the use of hormone replacement therapy.
Risks and Side Effects of Hormone Replacement Therapy
Some of the following risks/adverse reactions are derived from the Food and Drug Administration (FDA) labeling requirements for these drugs as therapeutic drug levels in the bloodstream. My healthcare provider may prescribe these medications at dosages designed to achieve physiologic levels of hormones in my bloodstream or urine generally associated with that of a 25-35-year-old person and would be within the "normal" or "average" blood concentrations of that age group.
- I understand that there are risks (both known and unknown) to any medical procedure, treatment, and therapy; and, that it is not possible to guarantee or give assurance of a successful result. I acknowledge and accept these known and unknown general risks.
- I understand that the general risks of this proposed therapy may include, but are not limited to, bruising, soreness or pain, and possible infection by hormones administered via injection.
- Risks of estrogen replacement include, but are not limited to:
- Heart attack
- Blood clot formation
- Increased risk of breast cancer
- Increased risk of uterine cancer (if progesterone is not administered concurrently)
- Increased risk of prostate cancer
- Fibroid tumors
- I understand that the Women's health Initiative study demonstrated increased risk of the aforementioned when estrogen replacement is initiated 10 or more years after menopause
- Estrogen replacement is not recommended for women with a history of the following:
- Breast or uterine cancer
- Blood Clots
- Gallbladder Disease
- Uterine Fibroma
- Liver Disease
- Side effects of estrogen replacement therapy include, but are not limited to:
- Increased body fat
- Fluid retention
- Uterine bleeding
- Impaired glucose tolerance
- Aggravation of migraines
- Risks of progestin progesterone replacement (not natural progesterone) include, but are not limited to:
- Birth Defects
- Damage to nerve cells
- Blood clots
- Breast cancer
- Side effects progesterone replacement therapy include, but are not limited to:
- Nipple or breast tenderness
- Fluid retention
- Difficulty sleeping
- Hot flashes
- Appetite increase/weight gain
- I understand that occasionally there are complications with Testosterone Replacement therapy including, but not limited to:
- Fat Loss
- Increased Estrogen
- I understand the risks associated with estrogen as previously described
- Abscess (intramuscular injections only)
- Fluid Retention
- I understand this may negatively affect my chronic conditions, such as heart disease, kidney disease, or liver disease
- Reduced Luteinizing Hormone & Follicle Stimulating Hormone
- I understand that this can affect my fertility, and I am not currently attempting to have a child
- Dyslipidemia (change in cholesterol levels)
- Secondary erythrocytosis (thickening of the blood)
- PSA elevation
- Liver enzyme elevation
My Compliance Obligation While Receiving Hormone Replacement Therapy:
- I agree to comply with the proposed treatment and therapy as prescribed. I understand that I may be responsible for administering the hormones prescribed to me via the following methods: injection, oral consumption, or application to my skin.
- I understand that I will only receive my prescription as long as I am up to date with preventative screenings; therefore, I consent to the following:
- Laboratory monitoring of blood chemistry, complete blood cell count, and hormone levels every 3 months; including a PSA for men.
- Physical examination and screening evaluation every 3 months.
- Mammogram annually (once a year) for women.
- Bone density scan bi-annually (every 2 years).
- Pap smear per recommended guidelines.
- I will notify my healthcare provider of all signs or symptoms of possible reactions to my therapy.
- I agree to comply with all other healthy lifestyle activities that have been individually prescribed for me.
- I have disclosed the following to my healthcare provider: complete medical history, current medications (prescription, non-prescription, and supplements), and social history (alcohol, smoking, illicit substances).
- I agree to consult my healthcare provider prior to stopping my prescribed therapy and prior to starting additional supplements that have not been recommended by my healthcare provider.
I certify that I have been given the opportunity to ask any and all questions regarding the proposed treatment. I received all the information requested. I fully understand that I have the right to not consent to hormone replacement therapy. I have adequate knowledge upon which to provide informed consent.
I attest to reading and fully understanding this form's content and clinical meaning. I attest that I discussed the aforementioned with my healthcare provider, and I consent to this treatment. I hereby affix my signature to this authorization for this proposed long-term treatment. I have been given a copy of this consent form, and I understand fully any and all of the possibly represented implications and meanings of its writing and expectations.