* This material is provided to Beverly Hills Rejuvenation Center for Franchisees’ use in training their employees. Franchisees may use the material and modify it as they wish so long as they are able to deliver services to meet brand standards. Franchisees are required to align these instructions with current federal, state, and local regulations related to aesthetics practices.
STANDARDIZED PROCEDURE AND PROTOCOL FOR:
Botulinum Toxin A
(Botox / Dysport /Xeomin / Jeuveau)
To ensure safe and effective treatment of clients undergoing Botulinum Toxin A product administration at Beverly HillsRejuvenation Center, the following policies and procedures have been developed.
Policy:
A Physician, Nurse Practitioner (PA), PhysicianAssistant (PA), or Registered Nurse (RN) with current state licensure, herein referred to as AUTHORIZED LICENSED MEDICAL PERSONNEL, shall be able to assess, consult, and treat patients with Botulinum Toxin A products following the guidelines set herein. In the state of CALIFORNIA the MedicalDirector, Nurse Practitioner, or Physician Assistant must perform a good faith examination prior to the use of Botulinum Toxin A products.
Setting:
The AUTHORIZED LICENSED MEDICAL PERSONNEL can perform the administration of Botulinum Toxin A products in various settings and locations, such as but not limited to:
- Physician Office
- Satellite Clinic / Health Care Office(s)
- Medical Spa Setting medically zoned and authorized by the Medical Director or supervising physician at [your locations address]
All Botulinum Toxin A product administration procedures shall be performed in a clean, safe environment, equipped with proper sharps disposal system, and have universal precautions in place.
Supervision:
The AUTHORIZED LICENSED MEDICAL PERSONNEL shall function under the general supervision of the Medical Director, who is immediately available for consultation by telecommunication and is physically available as medically necessary.
All adverse reactions such as ptosis, diplopia, lower eyelid retraction, and weakening of the lacrimal pump shall be reported immediately to the Medical Director. Adverse reaction(s) shall be documented in the client’s chart.
Patient Conditions:
The AUTHORIZED LICENSED MEDICAL PERSONNEL will not knowingly treat any clients with:
- Allergies or hypersensitivity to any BotulinumToxin or any of its ingredients
- Significant autoimmune or neurological diseases
- Pregnant or breast-feeding clients
- History of allergic reaction to any BotulinumToxin
- Skin infection at the planned injection site
- History of hypersensitivity to any BotulinumToxin or its ingredients
Caution with the following drugs for Potential Drug Interactions (BTA effect may be potentiated).
- Aminoglycosides (gentamicin etc.) and other agents interfering with neuromuscular transmission
- Anticolinergic drugs
- Muscle relaxants
Procedure for Product Reconstitution:
- Wash hands
- Cleanse the work surface with a germicidal cleaner
- Identify product, remove from packaging, verify and chart lot # and expiration date of un-reconstituted product
- Cleanse vial tops with an alcohol-impregnated pad
- Reconstitute injectables according to office policy regarding sterile technique and planned concentration of the reconstituted product
- Dispose of syringes/needles in sharps disposal container medical waste box
- Label vial and box:
- Concentration of reconstituted injectable
- Date of reconstitution
- Date of expiration
- Complete the log form to document: lot #, reconstitution date, concentration, and expiration date
- Utilize injectable products according to labeling or off-label, and discard unused/expired products and vials as medical waste
Botulinum Toxin A Treatment Procedure:
The AUTHORIZED LICENSED MEDICAL PERSONNEL will:
- Complete assessment and a medical history questionnaire with all new clients.
- Ensure that informed consent is reviewed and signed by the patient.
- Clients with a history of allergies to human albumin, clients with significant neurological and autoimmune diseases, or pregnant or breastfeeding clients will be denied treatment.
- Good Faith exams are done as required by the Physician, Nurse Practitioner, or Physician Assistant before treatment with a Botulinum Toxin A.
- Upon passing a medical screening, the client will be fully informed of risks, benefits, and potential adverse reactions.
- Develop a treatment plan. If repeat injection, make an assessment of the effect and duration of earlier injection treatments, with adjustments/fine-tuning as needed./li>
- Photographic documentation pre/post-injection, including animated views.
- Botulinum Toxin A product shall be stored in a freezer (-5 degrees C or lower) until ready for use. Once reconstituted, it must be refrigerated (2-8 degrees C), not refrozen. Reconstituted Botulinum Toxin A product should be clear, colorless, and free of particulate matter.
- Botulinum Toxin A product shall only be reconstituted just prior to use and should be used within the first 24 hours, according to the manufacturer. However, medical papers suggest it can be refrigerated for up to 30 days without any loss of efficacy. Gently rotate the vial and record the date of reconstitution on the label.
- Vacuum will be released using a 21/22-gauge, 2.5-inch length needle prior to reconstitution. If no vacuum is present, the Botulinum Toxin A vial will be sent back to the manufacturer, and a new vial shall be used following the same procedure.
- Botulinum Toxin A product should be reconstituted using 2.5 ml to 3.0 ml of preserved saline or non-preserved saline [0.9%] as a diluent, resulting in a 2.5–3.3 units per 0.1cc. A 3-5cc syringe containing non-preserved saline is attached to the 21/22-gauge needle (at a 45° angle) and SLOWLY injected into the vial. Allow the saline to flow down the sides of the vial, thus minimizing air bubble formation and not damaging the delicate Botulinum Toxin A product. Do not shake vigorously. Gently swirl the vial.
- Xeomin – After reconstituting with 0.9% sodium chloride, gently swirl to mix, invert by flipping the vial upside down, and wait 5 minutes before injecting. Do Not Shake!
- If Botox, Dysport, or Xeomin is used for axillary hyperhidrosis, a dilution of 4ml may be used for a larger spread.
Dilution Table For Botox
(Preservative-free 0.9% sodium chloride injection, USP only) |
_ |
Resulting Dose (Units per 0.1 mL) |
100-Unit vial |
2.50 mL |
4.00 Units |
50-Unit vial |
1.25 mL |
4.00 Units |
Dilution Table For Dysport
Dilution for 300-U vial |
Concentration |
1.5 mL |
10 U/0.05 mL |
2.5 mL |
10 U/0.08 mL |
3.0 mL |
10 U/0.1mL |
Diluent Volumes For Xeomin Reconstitution
Volume of preservative-free 0.9% sodium chloride |
50-unit vial: Resulting dose in units per 0.1 mL |
100-unit vial: Resulting dose in units per 0.1 mL |
200-unit vial: Resulting dose in units per 0.1 mL |
0.25 mL |
20 units |
- |
- |
0.5 mL |
10 units |
20 units |
40 units |
1 mL |
5 units |
10 units |
20 units |
1.25 mL |
4 units |
8 units |
16 units |
2 mL |
2.5 units |
5 units |
10 units |
2.5 mL |
2 units |
4 units |
8 units |
4 mL |
1.25 units |
2.5 units |
5 units |
5 mL |
1 unit |
2 units |
4 units |
Dilution Table for Jeuveau Cosmetic
(Preservative-free 0.9% sodium chloride injection, USP only) |
_ |
Resulting Dose (Units per 0.1 mL) |
100-Unit vial |
2.50 mL |
4.00 Units |
- Botulinum Toxin A product is gently drawn up into a 1ml tuberculin syringe using a 21/22-gauge needle. Switch the needle to a 30-33 gauge needle for injection. 31-gauge insulin syringes may also be used to draw up products for injection when the bottle top is removed.
- Clients are injected for facial Botulinum Toxin A product application while in a seated position and in the supine position for Botulinum Toxin A application to axillary for hyperhidrosis.
- Clients are asked to demonstrate dynamically the function of the muscle groups to be injected.
- Prior to administration, the AUTHORIZED LICENSED MEDICAL PERSONNEL will map out points of injection according to landmarks and location of the muscle belly. Note: Increased toxin dose may be necessary for older and male clients.
- In an effort to reduce the complications of ptosis, the following steps should be adhered to:
- Administer at least 1cm above the central eyebrow and 1.5 cm-2 cm from the lateral canthus.
- Ensure the injected volume/dose is accurate and kept to a minimum.
- Avoid injection near the levator superioris, particularly in patients with larger brows.
- Medial corrugator injections should be placed 1cm above the bony supraorbital ridge.
If the patient has a history of ptosis or appears they might be at risk for ptosis, i.e., small forehead, consider using Dysport with 1.5cc NS dilution.
If mild ptosis should occur, the health care provider will instruct the client that this will resolve within a few weeks and in the use of (over-the-counter) Vasocon to assist in alleviating the ptosis. Ptosis or any other complications shall be immediately reported to the Medical Director and documented in the client record.
- Syringe is inserted perpendicular or to the skin and completed at a depth just beneath the dermis in the muscle; 0.1cc of Botulinum Toxin A product is injected into each site varies on each patient. (If performed to axilla for hyperhidrosis, 2mm depth intradermally with bevel up. Injecting 0.1-0.2ml 1-2cm apart and a minimum of 50u of Botox or Xeomin and 100-150 units of Dysport will be injected into EACH axilla).
- After each injection, a cold compress or ice can be applied to the injection site.
- When the procedure is completed, the client will be educated to perform the dynamic facial expressions for the next hour, not to rub or manipulate the injection sites, not to lie down for a period of 4 hours, and to report any problems or complications to the office immediately.
- Typically, the initial doses of reconstituted Botulinum Toxin A product induces chemical denervation of the injected muscles one to two days after the procedure, increasing in intensity during the first week.
Safety Procedures:
In order to reduce the complication of eyelid ptosis, the following steps should be taken:
- All new patients to BTA must have a Good Faith exam done by a BHRC Physician, Nurse Practitioner, or Physician Assistant prior to receiving treatment.
- Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
- Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
- Ensure the injected volume/dose is accurate and, where feasible kept to a minimum.
- Avoid injecting toxin closer than 1 centimeter above the central eyebrow.
Patients with the following cannot be treated with Botulinum Toxin A:
- Active neuromuscular diseases
- Currently pregnant or breast-feeding
- Undiagnosed recent shooting eye pain
Important Safety Information for all Botulinum Toxin A Products
Postmarketing reports indicate that the effects of all Botulinum Toxin A products may spread from the area of injection to produce symptoms consistent with Botulinum Toxin A effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
Record Keeping:
The AUTHORIZED LICENSED MEDICAL PERSONNEL shall be responsible for maintaining client records and inputting them into EMR, including but not limited to client assessment; Good Faith Exam; signed informed consent of risks, benefits, and potential adverse effects; the number of treatments; treatment sites; the number of injections; and client response to treatment.
Requirements for the Authorized Licensed Medical Personnel
I) TRAINING/EDUCATION
The AUTHORIZED LICENSED MEDICAL PERSONNEL shall receive specialized training (and be certified) in the administration of Botulinum toxins Dysport®, Botox®, and Xeomin®. A Physician, Doctor of Osteopath, Advanced Practice Nurse experienced in this procedure, or a teaching institution specializing in this procedure may perform this training and certification. Competencies to successfully demonstrate shall include:
- Mechanism of action of Dysport®, Botox®, and Xeomin®
- Basic theory of treatment for cosmetic purposes
- Facial anatomy
- Storage, preparation, and dilution of Botulinum Toxin A
- Safety, efficacy, and complication issues
- Assessment and identification of areas to be treated
- Safe application of injection techniques (minimum 8 hours hands-on training)
II) COMPETENCIES & DOCUMENTATION:
The Beverly Hills Rejuvenation Center LOS ANGELES Medical Director shall:
- Evaluate the competence of the AUTHORIZED LICENSED MEDICAL PERSONNEL on an annual or as-needed basis if indicated by client dissatisfaction or efficacy issues.
- The Beverly Hills Rejuvenation Center Administrator shall maintain a record of medical staff's training and certifications. Medical Director shall periodically evaluate the competencies of the medical staff.
- Review 10% of all Botulinum Toxin A charts to ensure the safety and efficacy of treatments.
Development & Approval of Standardized Procedure:
The Standardized Procedure and Protocol for the Administration of Botulinum Toxin A products have been developed jointly by the Medical Director, Administrator, and Nurse Practitioner at Beverly Hills Rejuvenation Center [location address], and the official package insert from DISTRIBUTOR. This procedure shall be reviewed on an annual and as-needed basis, and documentation pertinent to that review shall be kept on file in the designated administrative office.