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 medication. 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 Potential benefits: increased libido, energy and sense of well- being, decreased frequency/severity of headaches, decreased hot flashes, increase in muscle mass and decrease in visceral fat, improved insulin sensitivity, improved lipid panel, decreased risk of dementia, decreased bone loss, improved cognition and memory and help with sleep issues, reduced risk of reproductive cancers, reduced risk of cardiovascular disease.
• Estrogen potential 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 in the first 10 years of menopause, decreased risk of dementia, decreased bone loss, improved cognition and memory, help with sleep issues, helps with urinary incontinence.
• Progesterone potential benefits: protection from estrogens effect on the uterus and breast thereby reducing risk of endometrial (uterine) and breast cancer, treatment of irregular menstruation, improved sleep quality, improved anxiety.

 

Contraindications of Testosterone Therapy:

 

• Breast Cancer
• Elevated Hematocrit
• Know Hypersensitivity
• Untreated Obstructive Sleep Apnea
• Class III or IV Heart Failure
• Desired Fertility
• MI within the last 6 months
• Pregnancy
• Serious Cardiac, Liver, Kidney Disease

 

Risks of testosterone replacement may include, but are not limited to: an increase in 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 therapy may include acne, oily skin, facial hair, thinning hair, deeper voice, enlarged clitoris, irritability,  increase in red blood cells (erythrocytosis), reduced insulin requirements in insulin-dependent diabetics, increased estradiol levels, edema (fluid retention), reproductive cancers, and cardiovascular disease. Side effects may include, but are not limited to: enlarged clitoris, hair loss, temporary water retention, acne, irritability, and voice changes. These side effects are usually dose-related and typically resolve with a reduction in dosage. Premenopausal females are required to use birth control while undergoing testosterone replacement therapy. It is theoretically possible for testosterone to 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 a stroke
• Breast cancer
• Liver disease
• Pregnancy
• Known Protein C / S, antithrombin deficiency or other known thrombophilic disorders

 

Side Effects and Risks of estrogen therapy may include but are not limited to: 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 include but are not limited to: abdominal pain, bloating, breast tenderness, UTI, depression, headache, dizziness, chest pain, anxiety, fatigue, irritability, cough.  Progesterone has not been shown to cause any risks or increase the risk of thrombosis or breast cancer in the medical literature. However, long term risks of breast cancer or other medical problems have not been definitively proven.

 

There remains controversy regarding the correlation between the use of bioidentical hormone therapy and the potential risk of cancer in those patients who have 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 such therapy might even be considered by some medical professionals to be medically unnecessary because it is not aimed at treating a particular disease.

 

Careful surveillance and close monitoring are requirements of all patients to minimize any possible risk. Your Broad Health physician will monitor your hormone levels and various 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 of the home, or anyone else whom may come into contact with the hormonal treatment cream/gel. Accidental collateral exposure may significantly impact the hormone levels of those affected. 

 

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

 

In addition, please see the risks and benefits of all medication here.

 

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 a PCP and communicate your HRT treatment received at Broad Health to your PCP, OB-GYN, endocrinologist, and/or urologist to encourage and 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 to provide your Broad Health physician with all appropriate medical records and/or facilitate inter-health care practitioner communication regarding such evaluations.

 

3. Alternative Treatment Methods and Their General Nature.

 

Reasonable alternatives to HRT include:

1. Leaving hormone levels as they are.
2. Treating age related diseases as they appear.
3. Using pharmaceutical agents that are not bioidentical in nature (synthetics).

Before you take any medication, there are a number of important lifestyle changes you should consider, since they could improve your hormone imbalance:

• Eat a healthy balanced diet rich in fruits, vegetables, whole grains and legumes with lean meat, poultry and fish (grass fed, pasture raised or wild caught).  Avoid processed foods and drink filtered water (stay well hydrated).
• Get regular quality sleep - 7-9 hours of uninterrupted sleep nightly
• Quality exercise, which should include: aerobic exercise, high intensity interval training, stretching (yoga), and resistance exercise.
• Practice stress reduction techniques
• Reach and maintain optimal body weight
• Reduce or stop alcohol consumption (no more than one drink daily).
• Do not consume tobacco products
• Maintain optimal dental hygiene.
• Maintain quality connections with family and friends.
• Take selected supplements to support your diet

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Each patients’ situation is unique (biology, environment, psychology) and it is up to the Broad Health physician to determine if and when a patient should try medication in addition to lifestyle modifications. 

 

4. Patient’s Obligations and Representations.

 

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

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

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

                   iii.     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 a specialized practice focused solely on hormones.

                  iv.     I understand that I may suspend or terminate HRT at any time and hereby agree to immediately notify my Broad Health physician of any desire to suspend or terminate this treatment so that such suspension or termination may be done safely.

                    v.     I understand my Broad Health physician may be assisted by other health professionals, as necessary, and agree to their participation in my care as it relates to the evaluation and treatment of the conditions this HRT Consent covers.

                  vi.     I certify that I am 18 years of age or older, am competent to sign this HRT Consent, and have done so of my own free will.

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

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

                  ix.     I will use my medication at the prescribed rate and dosage and will keep the medications in its respected labeled container and will safeguard my medications from loss or theft.

                    x.     I will not attempt to obtain scheduled HTRT medications illegally or from any other health care practitioner without disclosing my current medication usage. I understand that it is against the law to do so.

                  xi.     I am responsible for remaining up to date on all age-appropriate screenings including, but not limited to, yearly mammogram and pap smear.

                 xii.     I will notify my Broad Health physician of any change in my medical history.