PATIENT AGREEMENT AND INFORMED CONSENT
HORMONE REPLACEMENT THERAPY (HRT)

The purpose of this Patient Agreement and Informed Consent to Hormone Replacement Therapy (HRT) (“HRT Consent”) is to inform you about the treatment, medical, or diagnostic procedure that may be recommended by physicians engaged by Broad Health P.A., Adrian Rawlinson, M.D., P.C., and Broad Health of NC, P.C. (collectively “Broad Health”) so that you may make the decision of whether or not to undergo the treatment or procedure after knowing the risks and benefits involved.

1. HRT Treatment; Risks and Benefits

HRT involves the administration of controlled or scheduled medications regulated by the U.S. Drug Enforcement Administration (DEA), as well as non-controlled medications. After reviewing your current symptoms, medical history, medications, lifestyle behaviors (such as diet, exercise, mental and physical stress, sleep), and labs, your Broad Health physician will use their professional judgment to determine if hormone replacement therapy is clinically necessary for you.

Potential Clinical Benefits of HRT

• Testosterone Benefits: Increased libido, energy, sense of well-being, decreased frequency/severity of headaches, decreased hot flashes, increased muscle mass, decreased visceral fat, improved insulin sensitivity, improved lipid panel, decreased risk of dementia, decreased bone loss, improved cognition and memory, better sleep, reduced risk of reproductive cancers, reduced risk of cardiovascular disease.

• Estrogen Benefits: Increased libido, sense of well-being, increased energy, decreased hot flashes/night sweats, decreased vaginal dryness, decreased risk of heart disease and cardiovascular disease when started within 10 years of menopause, decreased risk of dementia, decreased bone loss, improved cognition and memory, better sleep, helps with urinary incontinence.

• Progesterone Benefits: Protection from estrogen’s effects on the uterus and breast, reducing the risk of endometrial (uterine) and breast cancer, treatment of irregular menstruation, improved sleep quality, reduced anxiety.

Contraindications of Testosterone Therapy

• Breast Cancer

• Elevated Hematocrit

• Known Hypersensitivity

• Untreated Obstructive Sleep Apnea

• Class III or IV Heart Failure

• Desired Fertility

• Myocardial Infarction (MI) within the last 6 months

• Pregnancy

• Serious Cardiac, Liver, or Kidney Disease

Risks of Testosterone Replacement
Risks may include, but are not limited to: increased red blood cells (erythrocytosis), reduced insulin requirements in insulin-dependent diabetics, increased estradiol levels, edema (fluid retention), reproductive cancers, and cardiovascular disease.

Side Effects and Risks of Testosterone Replacement
Side effects may include acne, oily skin, facial hair, thinning hair, deeper voice, enlarged clitoris, irritability, increased red blood cells (erythrocytosis), reduced insulin requirements in insulin-dependent diabetics, increased estradiol levels, edema, reproductive cancers, and cardiovascular disease. These side effects are usually dose-related and typically resolve with a reduction in dosage. Premenopausal females must use birth control while undergoing testosterone replacement therapy, as testosterone may masculinize a female fetus.

Contraindications of Estrogen Therapy

• Hypersensitivity to estrogen

• Abnormal uterine bleeding

• DVT or PE (current or history of)

• Active or history of stroke

• Breast cancer

• Liver disease

• Pregnancy

• Known Protein C / S, antithrombin deficiency, or other thrombophilic disorders

Side Effects and Risks of Estrogen Therapy
Side effects may include uterine bleeding, breast swelling/tenderness, fluid retention, increased body fat, bloating, irritability, depression, headache, aggravation of migraines, blood clot formation, stroke, breast cancer, liver disease, gallstones, and uterine fibroids.

Contraindications of Progesterone Therapy

• Hypersensitivity to progesterone

• Abnormal uterine bleeding

• Breast cancer

• DVT or PE (active or history of)

• Stroke (active or history of)

• Liver disease

• Pregnancy

Side Effects and Risks of Progesterone
Side effects may include abdominal pain, bloating, breast tenderness, UTI, depression, headache, dizziness, chest pain, anxiety, fatigue, irritability, and cough. Progesterone has not been shown to increase the risk of thrombosis or breast cancer. However, long-term risks of breast cancer or other medical issues are not definitively proven.

There remains controversy regarding the correlation between the use of bioidentical hormone therapy and the potential risk of cancer in patients with a strong family history of prostate, testicular, breast, or ovarian cancer. HRT may be considered experimental because of the lack of adequate scientific evidence or peer-reviewed publications supporting the underlying premise of HRT, and some medical professionals may consider it unnecessary as it is not aimed at treating a specific disease.

Careful surveillance and close monitoring are required to minimize any possible risk. Your Broad Health physician will monitor your hormone levels and other laboratory values as they pertain to your treatment goals.

If topical hormone replacement treatment (cream, gel, etc.) is prescribed, you must take extreme care to avoid any collateral exposure via direct skin-to-skin contact with the application site or exposure to contaminated bed linens, clothes, etc., for any children, pets, co-habitants, or anyone else who may come into contact with the hormonal treatment. Accidental exposure can significantly impact the hormone levels of those affected.

For a disclosure of indications, usage limitations, contraindications, warnings, precautions, adverse reactions, risk of drug abuse and dependence, and other related patient counseling information, please carefully review the U.S. Food and Drug Administration’s (FDA) warning labels found on their website.

2. Other Screenings and Limitations

Broad Health does not offer primary care and cannot take the place of a Primary Care Provider (PCP). If you do not have a PCP, you are encouraged to establish a relationship with one and communicate your HRT treatment received at Broad Health to your PCP, OB-GYN, endocrinologist, and/or urologist to facilitate physician communication regarding your HRT treatments.

Broad Health’s engaged physicians do not perform in-person physical examinations since their interaction with you will be via telemedicine. You should consult with your PCP or other treating clinicians about these examinations. You will be responsible for providing your Broad Health physician with all appropriate medical records and/or facilitating inter-healthcare practitioner communication regarding such evaluations.

3. Alternative Treatment Methods and Their General Nature

Reasonable alternatives to HRT include:

• Leaving hormone levels as they are

• Treating age-related diseases as they appear

• Using pharmaceutical agents that are not bioidentical (synthetics)

Before taking any medication, consider these important lifestyle changes to improve hormone imbalance:

• Eat a balanced diet rich in fruits, vegetables, whole grains, and lean meats while avoiding processed foods

• Get regular quality sleep (7-9 hours nightly)

• Engage in regular exercise, including aerobic, high-intensity interval training, stretching (yoga), and resistance exercise

• Reduce stress and maintain a healthy weight

• Limit alcohol consumption (no more than one drink daily)

• Avoid tobacco products

• Stay hydrated and maintain good dental hygiene

• Foster quality relationships with family and friends

Each patient’s situation is unique, and it is up to the Broad Health physician to determine if and when medication should be added to lifestyle modifications.

4. Patient’s Obligations and Representations

If prescribed HRT, you will be responsible for self-administering the prescribed hormones. To ensure your safety and compliance with the treatment plan, you acknowledge and represent the following:

1. I will carefully follow instructions, recommended dosage, and methods of administration.

2. I will participate in the initial and subsequent hormone testing, as required to safely monitor and treat my hormone levels.

3. I will be under the regular care of another physician (Primary Care Physician, OB-GYN, Endocrinologist, etc.) for all other medical conditions. I will consult my physician(s) for any other medical services I may require. I understand Broad Health is focused solely on hormone therapy.

4. I understand I may suspend or terminate HRT at any time and will immediately notify my Broad Health physician to do so safely.

5. I understand my Broad Health physician may be assisted by other health professionals, as necessary, and I agree to their participation in my care.

6. I certify that I am 18 years of age or older, competent to sign this HRT Consent, and have done so voluntarily.

7. I will immediately report any adverse side effects related to the use of my medication to my Broad Health physician.

8. I will not share, sell, or trade my medication for money, goods, or services.

9. I will use my medication at the prescribed rate and dosage, keep it in its labeled container, and safeguard it from loss or theft.

10. I will not attempt to obtain scheduled HRT medications illegally or from any other healthcare practitioner without disclosing my current medication usage. I understand it is illegal to do so.

11. I am responsible for staying up to date on all age-appropriate screenings, including but not limited to, yearly mammograms and pap smears.

12. I will notify my Broad Health physician of any changes in my medical history.