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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_19_библиотеки_им_акад_М_И_Перельмана
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274 Appendix 4
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personally responsible for payment. Payment is due at the time treatment is
rendered. I understand there are no refunds on any services rendered.
I further agree that, in the event of non-payment, I will bear the cost of collections and/or Court costs and reasonable legal fees, should this be required.
Results
I am aware that when small amounts of a purified Neuromodulation is
injected into a muscle it causes weakness/relaxation of that muscle. This
appears in 2–10 days and can last 3–4 months, but can be shorter or longer.
I understand that the length of response may vary from patient to patient and
from one treatment to the next.
Follow up treatments are scheduled on day 14 through 19 after your initial treatment date. At this visit we will evaluate the effect of your treatment.
You can add an additional area or more to the previously treated area if the
provider feels it is safe and necessary. Neuromodulation treatment is not an
exact science and the treatment is unique to the patient desires and goals. It is
common that patients may need more neuromodulation at the follow up
visit. In a very small number of individuals, the injection does not work
as satisfactorily or for as long as usual. Rarely, there are some individuals
who do not respond at all. It is at the discretion of my practitioner as to
whether or not a “touch-up” injection may be needed after the first 14 days
of treatment. I understand, if that is the case, an additional charge may incur.
I understand that I will not be able to “frown” while the injection is effective, but that this will reverse after a period of months at which time
re-treatment is appropriate. Follow up visits are not recommended after
the 19 day period. I understand that I am advised to make a follow up
appointment between day 14 and 19 post treatment. If this appointment
is not made or kept the effectiveness can not be properly assessed therefore
touch ups outside of this time frame may net be permitted and we will wait
till your next 3 month visit. The practice will honor the value of their work
however, the 2 week follow up must be had in order properly asses and diagnose. The neuromodulation will begin to slowly breakdown over the
3 months so it is common to begin to see movement at about 6 weeks time.
I am aware that the practice of medicine is not an exact science, and
I acknowledge that no guarantees have been made to me as to the results
of the procedure.
I understand that the success of the procedure is to some extent dependent upon my closely following my practitioner’s instructions. I must not
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perform any vigorous exercise, and I must not massage or manipulate the
area (s) of the injections for the 3 –4 h post-injection period. I further understand I will not wear a hat or have a facial and or massage for 3 days post
injections.
I understand this is an elective procedure and hereby voluntarily consent
to treatment with neuromodulation injections for the condition known as:
Facial Dynamic Wrinkles. The procedure has been fully explained to me as
well as the areas which are “off label.”
I have read the above information and understand it. My questions have
been answered to my satisfaction.
I accept the risks and complications of the procedure. I understand that
no guarantees are implied as to the outcome of the procedure. I certify that
I am over the age of 18 and am not under the influence of drugs or alcohol.
I have read and understand the pre and post neuromodulation instructions.
I certify if any changes occur in my medical history, I will notify the
office. I hereby give my voluntary consent to this procedure, and release
Surface Medical Esthetics, PLLC medical staff, and specific technicians from
liability associated with the procedure. This consent form is freely and voluntarily executed and shall be binding upon my spouse, relatives, legal
representatives, heirs, administrators, successors and assigns.
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APPENDIX 5
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Neuromodulation pre treatment
instructions
It is prudent to follow some simple guidelines before treatment that can
make all the difference between a fair result or great result, by reducing
some possible side effects associated with the injections. We realize this is not
always possible; however, minimizing these risks is always desirable.
• Avoid alcoholic beverages at least 24 h prior to treatment (alcohol
may thin the blood increasing the risk of bruising).
• Avoid anti-inflammatory/blood thinning medications ideally, for
a period of two (2) weeks before treatment. Medications and
supplements such as Aspirin, Vitamin E, Gingo Biloba, St. John’s Wort,
Ibuprofen, Motrin, Advil, Aleve, Vioxx, and other NSAIDS (non-
steroidal anti-inflammatory drugs) are all blood thinning and can increase
the risk of bruising/swelling after injections.
• Schedule your neuromodulation appointment at least 2 weeks
prior to a special event which may be occurring, i.e., wedding,
vacation, etc. It is not desirable to have a very special event occurring
and be bruised from an injection.
• You will need to reschedule your appointment if you are on antibiotics
for an infection. It is also necessary to reschedule your appointment if
you have a fever or had a fever in the last 48 h.
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APPENDIX 6
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Neuromodulation post treatment
instructions
The guidelines to follow post treatment have been followed for
years, and are still employed today to prevent the possible side effect of pto-
sis. These measures should minimize the possibility of ptosis almost 98%.
• No straining, heavy lifting, vigorous exercise for 3–4 h following treat-
ment. It is now known that it takes the toxin approximately 2 h to bind
itself to the nerve to start its work, and because we do not want to
increase circulation to that area to wash away the neuromodulation from
where it was injected. This waiting period continues to be recommended by
most practitioners.
• Avoid manipulation of area for 3–4 h following treatment. (For the same
reasons listed above.) This includes not doing a facial, peel, or micro-
dermabrasion after treatment with Neuromodulation for 3 days.
A facial, peel, or micro-dermabrasion can be done in same appointment
only if they are done before the Neuromodulation.
• Do not lie down or bend over for 3–4 h following treatment.
(This instruction has been employed for years by some practitioners.)
• Avoid having a facial or massage for 3 days.
• Do not wear a hat or helmet for 3 days.
• It can take 2–10 days to take effect and 2 weeks for full effect. It is recom-
mended that the patient contact office no later than 3 weeks after treat-
ment if desired effect was not achieved and no sooner than 2 weeks to
give toxin time to work.
Makeup may be applied before leaving the office. Some practitioners
recommend avoiding Retin-A, Glycolic acid, Vitamin C, and Kinerase
for 24 h to the treated areas.
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I have been counseled in these pre and post-treatment instructions and
have been given a written copy of these instructions. All my questions have
been answered to my satisfaction.
APPENDIX 7
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Policy and procedure for
neuromodulation administration
Purpose
To ensure safe and effective treatment of patients undergoing Botulinum
Toxin A administration at Surface Medical Esthetics, PLLC the following
policies and procedures have been developed.
Policy
A medical professional such as a Registered Nurse (RN), Doctor (MD),
Advanced Practice Registered Nurse (APRN), Licensed Practical Nurse
(LPN) with current state licensure, shall be able to assess, consult and treat
patients with Botulinum Toxin A for hyperfunctional lines of the upper face,
specifically the forehead, crows feet, and the glabellar region between the
eyebrows, following the guidelines set forth.
Setting
The licensed Medical Professional will perform the Administration of Botulinum Toxin A in multi settings and locations, such as but not limited to:
• Surface Medical Esthetics, PLLC at 822 Lafayette Rd suite 4 Hampton
NH 03842 authorized by the Medical Director or Advanced Registered
Nurse Practitioner as a health care office(s)
All Botulinum Toxin A administration procedures shall be performed in a
professional, clean, safe environment, equipped with proper sharps disposal
system, and Osha and universal precautions in place.
Supervision
The Medical Professional will function under the general supervision of the
Medical Director and/or Advanced Registered Nurse Practitioner who is
immediately available for consultation by telecommunication and is physically available as medically necessary.
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All adverse reactions such as ptosis, diplopia, lower eyelid retraction, and
weakening of the lacrimal pump shall be reported immediately to the Medical Director and/or the Advanced Registered Nurse Practitioner when it
occurs. Adverse events will be documented in the patient’s chart.
Record keeping
The Medical Professional is responsible for maintaining patient records,
including but not limited to patient assessment, signed informed consent
of risks, benefits, and potential adverse effects, treatment #, treatment sites,
# of injections, solution/concentration used, and the patient response to
treatment.
Training/education
The Medical Professional will have specialized training/certification in the
Administration of Botulinum Toxin A. A Medical Doctor, Doctor of
Osteopath, Advanced Registered Nurse Practitioner experienced in this
procedure, or a teaching institution specializing in this procedure, may perform this training/certification. Satisfactory Training will include:
• Mechanism of Action of Botulinum Toxin A
• Basic Theory of Treatment for Cosmetic Purposes
• Facial Anatomy and Muscle Function
• Pharmacokinetics
• Storage, preparation, and dilution of Botulinum Toxin A
• Safety, efficacy, and complication issues
• Contraindications
• Assessment and identification of areas to be treated
• Safe application of injection techniques and return demonstration
Evaluation and competency
Initial evaluation and final determination of satisfactory training and competence shall be by the Medical Director and/or Advanced Registered Nurse
Practitioner. On-going evaluation of the competence of the Medical
Professional will be done, at a minimum, on a yearly basis at the time of
the Medical Professional scheduled company evaluation, and more often,
if needed, i.e. indicated by patient dissatisfaction or efficacy issues.
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This evaluation will be done by the Medical Director and/or Advanced
Registered Nurse Practitioner and shall be documented in the Medical
Professionals file.
Authorized personnel documentation
All Medical Professionals who have successfully completed training and
posses a certificate of completion and have been determined to be competent to perform the Administration of Botulinum Toxin A will be documented on the appropriate form and will be kept on file as part of the
Standardized Procedure Policy in the Administration office.
Limitations
The Medical Professional will not knowingly treat any patients who are
knowingly pregnant, trying to get pregnant, lactating, patients with allergies
to human albumin, any patients with significant autoimmune or neurological diseases, i.e., Amyotrophic Lateral Sclerosis (ALS), Lambert-Easton
Disorder, Mysthenia Gravis, Multiple Sclerosis, and Parkinson’s.
Protocol for administration of Botulinum Toxin A
Medical Professional will:
1. Complete assessment and a medical history questionnaire and take
photos at rest and with animation in all positions with all new patients.
2. Patients with a history of allergies to human albumin, patients with significant neurological and autoimmune diseases, pregnant or lactating
patients will be denied treatment. (See Limitations section.)
3. Upon passing medical screening, patient will be fully informed of risks,
benefits, and potential adverse reactions and an informed consent will
be signed.
4. Botulinum Toxin A will be stored in freezer (5°C or lower) until
ready for use. Once reconstituted, it must be refrigerated, not refrozen.
5. Botulinum Toxin A will only be reconstituted
should be used within the first 4 h, but may be refrigerated up to
30 days.
6.
Vacuum will be released, using a 22 guage needle prior to reconsti-
tution. If no vacuum is present the neuromodulation vial will be sent
just prior to use and
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