Consent (Truthfulness)
Please attest to the following confirming that all information you have provided to us is true
and
complete.
I verify that I am the patient and that I have answered the questions asked in this intake form.
I
confirm that I have reviewed and understood all the questions asked of me. I attest that the
answers
and information I have provided in this questionnaire is true and complete to the best of my
knowledge. I understand that it is critical to my health to share complete health information
with
my doctor. I will not hold the doctor or affiliated medical practice responsible for any
oversights
or omissions, whether intentional or not, in the information that I provided
Informed Consent for Compounded GLP-1 Therapy
You are requesting treatment with a compounded GLP-1 receptor agonist or GIP/GLP-1 receptor
agonist
medication, such as semaglutide, tirzepatide, or liraglutide, as part of a medical weight
management
or obesity treatment plan. These medications work by mimicking incretin hormones that regulate
appetite, slow gastric emptying, promote fullness, and improve metabolic health.
Compounded medications are custom-prepared by licensed pharmacists. These formulations may allow
for
alternative dosing schedules, titration strategies, dosing frequencies, routes of
administration, or
the addition of ingredients intended to improve tolerability or reduce side effects. Compounded
medications are not reviewed or approved by the U.S. Food and Drug Administration (FDA) and are
not
subject to the same testing, clinical trials, or manufacturing oversight as FDA-approved
brand-name
products. As a result, compounded medications may differ from FDA-approved products in
consistency,
potency, efficacy, and safety.
Weight loss medications are typically prescribed for individuals who are obese, or for
individuals
who are overweight with related medical conditions. Use of these medications in individuals who
are
overweight without an associated medical condition is considered off-label, meaning the
medication
is prescribed in a manner not specifically approved by the FDA. Off-label prescribing is a
common
and accepted medical practice when clinically appropriate and based on medical judgment.
Potential benefits of treatment may include weight loss or weight management, improved blood
glucose
control, reduced cardiovascular risk, and overall improvement in metabolic health. While many
patients tolerate these medications well, they may cause side effects and, in rare cases,
serious
adverse events including emergency room visits, hospitalization, or death. Common side effects
include nausea, vomiting, diarrhea, constipation, decreased appetite, and indigestion. Serious
or
less common risks include pancreatitis, low blood sugar, gallbladder disease, kidney injury or
worsening kidney function, allergic reactions, and gastrointestinal motility disorders such as
gastroparesis.
These medications are not safe for use during pregnancy or while breastfeeding, as they may pose
risks to a developing baby. The FDA advises the use of additional contraception because these
medications may reduce the effectiveness of oral contraceptives. If you use oral birth control,
you
must continue it with a barrier method, such as condoms, for the first month after starting
treatment and for one month after any dose increase. You may choose to switch to a non-oral
contraceptive method, such as an intrauterine device or implant, prior to starting treatment.
After
stopping the medication, you should continue using effective contraception for at least two
months
to ensure the medication has fully cleared from your system before attempting to conceive.
Ongoing follow-up is required to monitor your response to treatment and to assess for side
effects.
Medication doses may be adjusted based on tolerability and clinical response.
By proceeding with treatment, you acknowledge that compounded medications are not FDA-approved
and
may differ from FDA-approved products in safety and effectiveness. You understand the potential
benefits, risks, side effects, and pregnancy-related precautions associated with GLP-1 and
GIP/GLP-1
receptor agonist therapy, including possible off-label use, and agree to follow prescribed
instructions, attend required follow-up, and promptly report any concerns or side effects.