Informed Consent
​The purpose of Functional Medicine laboratory testing in our office is to evaluate nutritional, biochemical, or physiological imbalance and to determine any need for medical referral. These lab tests in our office are not intended to diagnose disease. This office may recommend conventional lab tests as well as functional medicine assessments.
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Functional Medicine assessment is designed to assist our doctors and other healthcare providers in finding the underlying causes of your condition. Functional medicine has evolved through the efforts of scientists and clinicians from the fields of clinical nutrition, molecular biology, biochemistry, physiology, conventional medicine, and a wide array of scientific disciplines. Functional Medicine evaluates the body as a whole, with special attention to the relationship of one body system to another and the nutrient imbalances and toxic overload that may adversely affect these relationships.
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Your medical physician may or may not agree with the necessity for—or our interpretation of—these tests. If you have any questions or concerns, please discuss them with our doctor.
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Selling Nutritional and Herbal Supplements
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According to the Federal Food, Drug, and Cosmetic Act, as amended, Section 201(g)(1), the term drug is defined as an “article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Technically, vitamins, minerals, trace elements, amino acids, herbs, or homeopathic remedies are not classified as drugs. However, these substances can have significant effects on physiology and must be used rationally. In this office, we provide nutritional counseling and make individualized recommendations regarding the use of these substances in order to upgrade the quality of foods in a patient’s diet and to supply nutrition to support the physiological and biomechanical processes of the human body. Although these products may also be suggested with a specific therapeutic purpose in mind, their use is chiefly designed to support given aspects of metabolic function. The use of nutritional supplements may be safely recommended for patients already using pharmaceutical medications (drugs), but some potentially harmful interactions may occur. For this reason, it is important to keep all of your healthcare providers fully informed about all medications and nutritional supplements, herbs, or hormones you may be taking.
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Sale of Nutritional Supplements at Telos Functional and Integrative Medicine LLC
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You are under no obligation to purchase nutritional supplements from our clinic.
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As a service to you, we make nutritional supplements available for you to purchase. We endorse only products from manufacturers who have gained our confidence through considerable research and experience. We determine quality by considering: (1) the quality of the science behind the product; (2) the quality of the ingredients themselves; (3) the quality of the manufacturing process; and (4) the synergism among product components. The brands of supplements that we have vetted and approved for use in our clinic are those that meet our high standards and that tend to produce predictable results.
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While these supplements may come at a higher financial cost than those found on the shelves of pharmacies or health food stores, the value must also include assurance of their purity, quality, bioavailability (ability to be properly absorbed and utilized by the body), and effectiveness. The chief reason we make these products available is to ensure quality. You are not guaranteed the same level of quality when you purchase your supplements from the general marketplace. We are not suggesting that such products have no value; however, given the lack of stringent testing requirements for dietary supplements, product quality varies widely.
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Informed Consent for Testosterone or Dehydroepiandrosterone (DHEA) Therapy
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It is important that you understand the potential risks of starting testosterone therapy along with the many benefits we have already discussed. There are many alternatives to testosterone or dehydroepiandrosterone (DHEA) replacement, such as the lifestyle changes that have been discussed with you.
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The following is a list of some common side effects:
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+ Some patients can become more aggressive or have other subtle mental health changes while on testosterone or DHEA replacement.
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+ Small testicles or decreased sperm counts can occur.
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+ Bone marrow can be stimulated with testosterone or DHEA replacement, so blood cell counts must be monitored.
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+ Testosterone or DHEA can make the blood “thicker,” which can increase the risk of blood clots.
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+ If you have prostate cancer that has not yet been diagnosed, it can grow with the use of testosterone or DHEA replacement. Your doctor will need to monitor your PSA levels and perform rectal exams to check for prostate nodules every 6 months while on treatment.
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+ It is possible that testosterone or DHEA replacement can increase prostate size, leading to a condition called benign prostatic hypertrophy (BPH), which can make it hard to urinate.
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+ Testosterone or DHEA can irritate the liver in some people, so your doctor will need to order regular liver function tests.
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+ Some studies hint at increased risk of heart attack and stroke in men on testosterone or DHEA replacement, especially older men and men who already have cardiovascular diseases.
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+ Because testosterone can break down into estrogen, males and females who have breast cancer (or who are at high risk for breast cancer) should not use testosterone. Mammograms for women are recommended while using testosterone, DHEA, or estrogen.
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+ Testosterone replacement has been associated with changes in cholesterol, calcium levels, or kidney function; severe congestive heart failure; severe sleep apnea; swelling; or changes in libido (sex drive). It can cause acne, enlarged or tender breasts, or elevated blood pressure.
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+ Testosterone or DHEA cannot be used during pregnancy or while breastfeeding.
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+ Masculinizing signs, such as facial hair growth, have been seen in women and children exposed to testosterone or DHEA replacement.
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Informed Consent Delegating Physician/Provider and Delegatee Performing Medical Services
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The delegating physician/provider is delegating the following services and is accountable for the performance of these services by the delegate.
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Counseling and patient education related to therapeutic lifestyle changes including:
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1. Perform initial and serial follow up Vitals and/or anthropometry
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2. Perform initial and serial follow up bioimpedance measurements
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3. Assessment/review of a lifestyle-associated health history
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4. Review and serial follow up of a symptom-based health assessment
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5. Provide patient education regarding Dr.’s instructions, lab values, etc
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6. Diet/Menu plan counseling and monitoring
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7. Exercise/activity plan counseling and monitoring
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8. Therapeutic nutritional protocol implementation and monitoring
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9. Stress management counseling and monitoring
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10. Sleep/recuperation/restoration counseling and monitoring
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11. Keeping detailed medical chart records of all counseling/services performed
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These delegated medical services are specific and detailed per physician/provider approved, evidence-based protocols.