I acknowledge that I have been fully informed about the nature and purpose of any medications that may be prescribed to me under the care of a Vita Bella practitioner. The following consent forms outline my understanding of the various therapies and treatments provided by Vita Bella.I also understand the importance of taking medication as prescribed as well as the importance of regular follow-up visits with my healthcare provider while participating in various treatments to monitor their effectiveness, adjust the dosage if necessary, and manage any potential side effects.
Preparation
I reviewed the administration protocol with a healthcare provider. Gather all the necessary supplies, including the medication, syringe, needle, alcohol swabs, and a sharps container for safe disposal. Be sure to check the dosage and expiration date of the medication before each administration.
Hand Hygiene
Wash your hands thoroughly with soap and water or use hand sanitizer to ensure cleanliness before working with medication. Gloves should be used when indicated.
Injection Site
Choose an appropriate injection site, based on the administration injection method for the medication - Subcutaneous (administered in the fatty tissue, underneath the skin) or Intramuscular (which is typically the gluteal region (buttock) or the lateral thigh). Use an alcohol swab to clean the skin in a circular motion, starting in the center and moving outward. Allow the area to dry completely.
Medication Prep
Attach a needle to the syringe and remove the protective cap. Clean the top of the vial with an alcohol swab and allow it to dry. Insert the needle into the vial of medication and insert an equal amount of air to the amount of medication to be withdrawn. The prescribed dosage is as directed by your healthcare professional. Make sure there are no air bubbles in the syringe by gently tapping it and pushing out any air. Ensure the needle doesn't touch anything before the medication is administered.
Needle Insertion
Subcutaneous: Hold the syringe like a pencil or dart and using a quick, smooth motion, insert the needle into the cleaned subcutaneous tissue at a 45-degree angle or 90-degree angle, depending on the specific instructions provided by your healthcare professional.
Intramuscular: Hold the syringe like a pencil or dart, and using a quick, smooth motion, insert the needle into the clean injection site at a 90-degree angle. The length of the needle may depend on factors such as an individual's body composition. Pull back slightly on the plunger of the syringe to check if blood appears in the syringe. If blood is present, it may indicate that the needle has entered a blood vessel. In such cases, withdraw the needle slightly and check again.
Injection
If no blood is aspirated, slowly and steadily push the plunger to inject the medication into the muscle. Take your time to avoid injecting too quickly, as it can cause discomfort.
Removal
Once the injection is complete, withdraw the needle gently and quickly. Apply pressure with a clean cotton ball or sterile gauze to the injection site to minimize bleeding.
Disposal
Do not recap the needle. Dispose of the used syringe and needle in a sharps container according to proper disposal guidelines. Sharps containers can be purchased on Amazon, a pharmacy, or medical supply store.
Risk
Instructional Videos
Intramuscular Injection Instruction Video
Subcutaneous Injection Instruction Video
Understanding of Treatment
I acknowledge that I have been fully informed about the potential risks, benefits, and alternatives associated with non-FDA approved medications. Non-FDA approved medications are pharmaceutical drugs that have not undergone the rigorous evaluation and approval process by the U.S. Food and Drug Administration (FDA).
When a drug or substance is "not approved for clinical use," it means that the drug has not received formal authorization from a regulatory body (like the U.S. Food and Drug Administration (FDA) in the United States) to be marketed and prescribed for a specific medical condition. The reasons for a lack of approval can vary:
I also understand the importance of taking any medication as prescribed as well as the importance of regular follow-up visits with my healthcare provider to monitor the effectiveness of the medication, adjust the dosage if necessary, and manage any potential side effects.
Potential Benefits
I understand that potential benefits of the non-FDA approved medication may not be fully understood, and that the efficacy and safety of non-FDA approved medications may not have been fully established through formal clinical trials.
Side Effects
I understand that potential risks and side effects with non-FDA approved medication may not be fully understood. Risks associated with non-FDA approved medication may include, but are not limited to:
Alternative Options
Your healthcare provider may provide you with alternative FDA-approved medications or treatments available for your medical condition. FDA-approved alternatives have undergone more rigorous evaluation and may be considered safer and more effective.
Questions and Concerns
I acknowledge that I have had an opportunity to ask questions about the risks, benefits, and alternatives to non-FDA approved medication, and that all my questions have been answered to my satisfaction.
Purpose and Explanation
This agreement outlines the conditions under which you, the patient, will be prescribed and managed on a Schedule II, III, IV, and V medication.
Schedule II (C-II)
Schedule III (C-III)
Schedule IV (C-IV)
Schedule V (C-V)
Control and regulation of these substances vary by country, and the U.S. schedule might differ from the classification in other countries. In the U.S., prescriptions for Schedule II medications have the most restrictions, such as not being able to get refills without a new prescription, while Schedule III to V drugs may have fewer restrictions, though still controlled.
Keep in mind that while the CSA provides a framework, individual states might also have additional regulations and schedules.
The purpose of this agreement is to ensure appropriate use, minimize the risk of diversion, and promote patient safety.
Compliance
I agree to comply with all aspects of my treatment plan, including taking the medication as prescribed, attending regular follow-up appointments, and informing my healthcare provider of any changes in my health or medication use.
Single Prescribing Provider and Pharmacy
I understand that I should obtain a prescription for specific scheduled medications from only one prescribing healthcare provider and fill them at one designated pharmacy, unless specifically authorized by my primary healthcare provider.
Refills
I acknowledge that Schedule II medications typically do not allow for refills. As a result, I understand that I will need to obtain a new prescription for each medication supply. Schedule III through V can be offered refills if deemed appropriate by the provider.
No Sharing or Diversion
I commit not to share my medication with others or engage in any form of diversion, which includes selling, trading, or giving my medication to anyone else.
Controlled Substance Monitoring
I acknowledge that my healthcare provider may use prescription drug monitoring programs to review my medication history for monitoring and safety purposes.
Follow Up Appointments
I agree to attend all follow-up appointments as scheduled to assess the effectiveness of my treatment, monitor potential side effects, and discuss any concerns related to my medication.
Drug Interactions
I will inform my healthcare provider about all medications, supplements, and over-the-counter drugs I am taking to avoid potential drug interactions.
Abnormal Side Effects
In the event of any unusual or severe side effects, I will immediately contact my healthcare provider or seek medical attention.
Pregnancy and Breastfeeding
I will inform my healthcare provider if I am pregnant, planning to become pregnant, or breastfeeding, as this may impact my treatment plan.
Non-FDA Approved Use
I understand that Schedule II-V medications may be used off-label for certain medical conditions and that my healthcare provider will discuss the rationale for such use.
Medication Discontinuation
If my healthcare provider determines that discontinuing the medication is necessary, I agree to follow their instructions for tapering or stopping the medication.
Agreement Termination
I acknowledge that non-compliance with this agreement or any concerns regarding misuse may lead to the termination of my treatment with controlled medications.
I also understand the importance of taking medication as prescribed as well as the importance of regular follow-up visits with my healthcare provider while participating in androgen hormone therapy to monitor its effectiveness, adjust the dosage if necessary, and manage any potential side effects.
Potential Benefits
I understand that potential benefits of androgen hormone therapy are the return to optimal physiological levels which can decrease fat distribution and improve energy levels, mood, and strength.
Side Effects
I understand that androgen hormone therapy may have side effects, which can include but are not limited to:
Additional Risks or Long Term Effects
Cardiovascular/Cerebrovascular risks: Some studies suggest a potential association between TRT and an increased risk of events such as heart attacks and strokes, although the evidence is not consistent across all studies.
Polycythemia: TRT can cause an increase in the production of red blood cells, which can make the blood more viscous. This condition, called polycythemia, can increase the risk of blood clots, which can lead to conditions like deep vein thrombosis or pulmonary embolism.
Sleep apnea: TRT may worsen sleep apnea in some men, especially those who already have the condition. Sleep apnea can lead to a variety of complications, cardiovascular disease including but not limited to pulmonary hypertension and right heart failure.
Prostate Hypertrophy/Cancer risks: While the relationship between TRT and prostate cancer is still not fully understood there's some concern that TRT might stimulate the growth of prostate tissue and potentially increase risk of cancer in men who already have it but don’t know it. Regular monitoring of prostate-specific antigen (PSA) levels and prostate examinations are recommended for men on TRT.
Infertility: TRT can decrease sperm production by suppressing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This can result in infertility. Men wishing to maintain their fertility or thinking about future childbearing should discuss this risk with their physicians and options to minimize the risk.
Gynecomastia: An increase in breast tissue, known as gynecomastia, can sometimes occur in men taking testosterone, likely due to the conversion of testosterone to estrogen in the body. Increased nipple sensitivity, and tissue growth under or around the nipple should be reported to the provider.
Liver toxicity: Though rare, especially with modern TRT formulations, there's potential for liver toxicity, especially with oral formulations of testosterone that were used in the past.
Dependency: Stopping TRT after long-term use can result in symptoms of low testosterone because the body may reduce its natural production in response to the external supplementation. This can lead to dependency on the therapy for normal testosterone levels.
Potential effect on mood and mental health: While TRT can improve mood in some men with low testosterone, it might exacerbate symptoms in men with existing mental health conditions.
I understand that all the long-term effects of androgen hormone therapy are not fully known and that it is possible that additional risks or complications could become apparent over time.
Alternative Options
Health optimization including diet modification, sleep hygiene, and exercise programs have been shown to increase androgen levels. Alternative medication options to exogenous hormone supplementation include use of Selective Estrogen Receptor Modulators, Human Chorionic Gonadotropin, and Aromatase Inhibitors.
Understanding of Treatment
I acknowledge that I have been fully informed about the nature and purpose of GLP-1 receptor agonist therapy. I understand that this treatment involves the use of medications, which may involve injections or oral medication.
I also understand the importance of taking medication as prescribed as well as the importance of regular follow-up visits with my healthcare provider while participating in GLP-1 receptor agonist therapy to monitor its effectiveness, adjust the dosage if necessary, and manage any potential side effects.
Potential Benefits
I understand that potential benefits of GLP-1 receptor agonist therapy may include improved blood sugar control, potential weight loss, and a decrease in cardiovascular fitness.
Side Effects
I understand that GLP-1 receptor agonist therapy may have side effects, which can include but are not limited to:
Additional Risks or Long Term Effects
I understand that the long-term effects of GLP-1 receptor agonist therapy are not fully known and that it is possible that additional risks or complications could become apparent over time.
Alternative Options
Your healthcare provider may provide you with alternative treatments or therapies available for your medical condition. These alternatives may include lifestyle changes, healthy Diet with caloric-deficit, and exercise program, depending on your specific needs and circumstances.
Understanding of Treatment
I acknowledge that I have been fully informed about the nature and purpose of growth hormone/growth hormone releasing peptides. I understand that this treatment involves the use of medications, which may involve injections or oral medication.
I also understand the importance of taking medication as prescribed as well as the importance of regular follow-up visits with my healthcare provider while taking growth hormone/growth hormone releasing medication to monitor its effectiveness, adjust the dosage if necessary, and manage any potential side effects.
Potential Benefits
I understand that potential benefits of growth hormone/growth hormone releasing peptides may include potential improvement in energy levels and body composition.
Side Effects
Additional Risks or Long Term Effects
These potential risks are part of why it's important for people on growth hormone therapy to have regular check-ups with their healthcare provider. It's also crucial to remember that most people on this therapy do not experience severe side effects, and for many people, the potential benefits in terms of growth and development outweigh the potential risks.
Alternative Options
Your healthcare provider may provide you with alternative therapies or treatments. However, alternative treatments are limited. Lifestyle changes like a healthy diet, sleep hygiene and regular exercise can support overall health but are not a substitute for hormone replacement therapy.
Understanding of Treatment
I acknowledge that I have been fully informed about the nature and purpose of androgen hormone replacement therapy. I understand that this therapy involves the use of hormones, such as testosterone, which may involve injections, skin patches, gels, or oral medication. With the goal to correct a clinical significant deficiency.
I also understand the importance of taking medication as prescribed as well as the importance of regular follow-up visits with my healthcare provider while participating in androgen hormone therapy to monitor its effectiveness, adjust the dosage if necessary, and manage any potential side effects.
Potential Benefits
I understand that potential benefits of androgen hormone therapy are the return to ideal physiological levels which can improve muscle mass, energy levels, mood, and decrease fat distribution.
Side Effects
I understand that androgen hormone therapy may have side effects, which can include but are not limited to:
Additional Risks or Long Term Effects
Cardiovascular/Cerebrovascular risks: Some studies suggest a potential association between TRT and an increased risk of events such as heart attacks and strokes, although the evidence is not consistent across all studies.
Polycythemia: TRT can cause an increase in the production of red blood cells, which can make the blood more viscous. This condition, called polycythemia, can increase the risk of blood clots, which can lead to conditions like deep vein thrombosis or pulmonary embolism.
Sleep apnea: TRT may worsen sleep apnea in some men, especially those who already have the condition. Sleep apnea can lead to a variety of complications, cardiovascular disease including but not limited to pulmonary hypertension and right heart failure.
Prostate Hypertrophy/Cancer risks: While the relationship between TRT and prostate cancer is still not fully understood there's some concern that TRT might stimulate the growth of prostate tissue and potentially increase risk of cancer in men who already have it but don’t know it. Regular monitoring of prostate-specific antigen (PSA) levels and prostate examinations are recommended for men on TRT.
Infertility: TRT can decrease sperm production by suppressing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This can result in infertility. Men wishing to maintain their fertility or thinking about future childbearing should discuss this risk with their physicians and options to minimize the risk.
Gynecomastia: An increase in breast tissue, known as gynecomastia, can sometimes occur in men taking testosterone, likely due to the conversion of testosterone to estrogen in the body. Increased nipple sensitivity, and tissue growth under or around the nipple should be reported to the provider.
Liver toxicity: Though rare, especially with modern TRT formulations, there's potential for liver toxicity, especially with oral formulations of testosterone that were used in the past.
Dependency: Stopping TRT after long-term use can result in symptoms of low testosterone because the body may reduce its natural production in response to the external supplementation. This can lead to dependency on the therapy for normal testosterone levels.
Potential effect on mood and mental health: While TRT can improve mood in some men with low testosterone, it might exacerbate symptoms in men with existing mental health conditions.
I understand that all the long-term effects of androgen hormone therapy are not fully known and that it is possible that additional risks or complications could become apparent over time.
Alternative Options
Health optimization including diet modification, sleep hygiene, and exercise programs have been shown to increase androgen levels. Alternative medication options to exogenous hormone supplementation include use of Selective Estrogen Receptor Modulators, Human Chorionic Gonadotropin, and Aromatase Inhibitors.
Understanding of Treatment
I acknowledge that I have been fully informed about the nature and purpose of PDE5 inhibitor medication. I understand that this treatment involves the use of medications, which may involve injections or oral medication.
I also understand the importance of taking medication as prescribed as well as the importance of regular follow-up visits with my healthcare provider while taking PDE5 medication to monitor its effectiveness, adjust the dosage if necessary, and manage any potential side effects.
Potential Benefits
I understand that potential benefits of PDE5 inhibitor medication may include improved erectile function and the ability to achieve and maintain erections, enhancement of sexual performance and satisfaction, and potential improvement in overall sexual health and quality of life.
Side Effects
I understand that PDE5 inhibitor medication may have side effects, which can include but are not limited to:
Additional Risks or Long Term Effects
Before starting PDE5 inhibitor medication, it is crucial for your healthcare provider to evaluate your cardiovascular health. Inform your healthcare provider of any history of heart problems, stroke, or low blood pressure, as some patients with certain cardiovascular conditions may need to avoid PDE5 inhibitors due to potential risks.
Alternative Options
Your healthcare provider may provide you with alternative treatments or therapies available for your medical condition. These alternatives may include lifestyle changes, counseling, or other medications for erectile dysfunction, depending on your specific needs and circumstances.
Understanding of Treatment
I acknowledge that I have been fully informed about the nature and purpose of psychostimulant medication. I understand that this treatment involves the use of medications.
I also understand the importance of taking medication as prescribed as well as the importance of regular follow-up visits with my healthcare provider while taking psychostimulant medication to monitor its effectiveness, adjust the dosage if necessary, and manage any potential side effects.
Potential Benefits
I understand that potential benefits of psychostimulant medication may include improved attention, focus, and concentration (in the case of ADHD), reduction of hyperactivity and impulsivity (in the case of ADHD), increased wakefulness and alertness (in the case of narcolepsy/shift work disorder), and potential improvements in overall functioning and quality of life.
Side Effects
I understand that psychostimulant medication may have side effects, which can include but are not limited to:
Additional Risks or Long Term Effects
Before starting psychostimulant medication, it is crucial for your healthcare provider to be aware of your full psychiatric and medical history, including any pre-existing conditions, current medications, and substance use. Inform your healthcare provider of any history of heart problems, mental health disorders, or family history of sudden cardiac events.
Alternative Options
Your healthcare provider may provide you with alternative treatments or therapies available for your medical condition. These alternatives may include behavioral interventions, counseling, or non-stimulant medications for ADHD, depending on your specific needs and circumstances.
Right to Withdraw
I understand that I have the right to withdraw my consent and discontinue treatment at any time without prejudice to my future medical care.
Privacy and Confidentiality
I understand that my personal health information will be kept confidential and shared only as required by law or as necessary for my treatment.
Questions and Concerns
I acknowledge that I have had an opportunity to ask questions about my treatment, and that all my questions have been answered to my satisfaction.
I voluntarily consent to participate in a treatment plan involving the above medications as prescribed to me under the supervision of Vita Bella Health Medical Group PA of Florida, a healthcare provider. I also certify that if I have any changes in my medical history, I will notify the provider or care team member who treated me immediately. By signing below, I confirm that I understand and agree to the terms outlined in this form.