Dr. R. Moulton-Barrett 2-05 STANDARD PROCEDURE FOR PHYSICIAN”S ASSISTANTS REGISTERED NURSES PERFORMING BOTOX® COSMETIC INJECTIONS _____________________________________________________________________ I. POLICY A. Circumstances under which the PA, RN may perform BOTOX® COSMETIC injections. 1. Setting: a. Brentwood or Alameda Medical Offices of Dr. Rex MoultonBarrett 2. Supervision: a. The Physician(MD), Physician’s Assistant( PA) or Registered Nurse(RN) who is trained and qualified will assess the patient prior to treatment to ensure the patient is a candidate for BOTOX® COSMETIC. The patient’s Medical History Questionnaire will be discussed in-depth with patient. (Questionnaire attached). b. The MD, PA or RN will then treat the patient with Bo Tox ( Allergan ), providing that the patient meets patient criteria, and Medical History Questionnaire has been completed. c. The physician will review the treatment rendered and sign the chart upon review 3. Patient Conditions: a. Consultation regarding patient’s chief complaint completed. b. Ensure patient is a candidate for BOTOX® COSMETIC treatment by discussing the Medical History Questionnaire with the patient (please see attached questionnaire). c. Caution must be exercised if patient is taking *aminoglycoside antibiotics, as this may potentate the effects of BOTOX® COSMETIC. d. Patient is aware of potential adverse events following injection of BOTOX® COSMETIC . These are headache, respiratory infection, flu syndrome, blepharoptosis and nausea. e. Patient must be at least 18 years of age, or parent/legal guardian may authorize treatment by filing out medical questionnaire and signing consent form. f. Patient is ≤65 years of age. g. Informed consent given and consent form completed. 4. Contraindications: a. Pregnancy. ADDEND-F-BOTOX-PROCEDURE STANDARD PROCEDURE FOR REGISTERED NURSES PERFORMING BOTOX® COSMETIC INJECTIONS BOTOX® COSMETIC can not be used if there is an infection at the proposed injection site(s). 5. Precautions: a. General: Epinephrine should be available or other precautionary methods taken as necessary should an anaphylactic reaction occur. *aminoglycoside antibiotics (e.g., streptomycin and gentamicin) are derived from various species of Streptomyces, which interfere with the function of bacterial ribosomes.) b. II. PROTOCOL A. B. C. Definition: The administration of the BOTOX® COSMETIC is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients ≤65 years of age. Assessment: 1. Subjective: The above patient conditions have been met. 2. Objective: The patient present with moderate to severe glabellar lines as indicated in Definition A. above. Plan: 1. Storage: Unopened vials of BOTOX® COSMETIC should be stored in a refrigerator (2º - 8º C) for up to 24 months. Do not use after expiration date on the vial. Administer BOTOX® COSMETIC within 4 hours of reconstitution; during this period store in refrigerator. Order BOTOX® COSMETIC per patient scheduled requirements. 2. Treatment: a. BOTOX® COSMETIC dilution technique: Reconstituted vacuum-dried BOTOX® COSMETIC with preservative free 0.9% Sodium Chloride. Diluent 1.0 ml = 2.0 ml = 4.0 ml = 8.0 ml = b. c. d. e. BOTOX-PROCEDURE Resulting dose 10.0 units per 0.1 ml 5.0 units per 0.1 ml 2.5 units per 0.1 ml 1.25 units per 0.1 ml Prep treatment site with alcohol. Decrease discomfort and minimize the risk of ecchymosis by application of cool compress for five minutes. All muscles must be contracted prior to injection. Inject accurate medication into the belly of the appropriate muscle, not to exceed 25 units per muscle. 2 STANDARD PROCEDURE FOR REGISTERED NURSES PERFORMING BOTOX® COSMETIC INJECTIONS f. g. 3. 4. 5. III. Apply pressure directly after injection. No rubbing or massaging of skin after BOTOX® COSMETIC injection. Post treatment - cleanse site with alcohol. Patient Education: a. Instruct patient not to exercise for at least 8 hours post treatment. b. Patient not to recline for 4 hours. c. Instruct patient not to massage treatment sites for 4 days. d. Advise patient not to have microdermabration treatment for 7 days after receiving BOTOX® COSMETIC. e. Inform patient bruising may occur and last 7-10 days. f. Inform patient redness and slight swelling may occur at the injection site. g. Inform patient that a temporary eyelid droop (blepharoptosis) may occur. Note: Prescription eye medication (drops) may be ordered by physician to treat blepharoptosis condition. h. Patient to notify should any concerns or questions arise. Follow-up: a. Patient to return in two weeks for assessment of treatment. b. Subsequent treatment scheduled upon re-innervations of muscles, approximately 2-6 months. Documentation: The following information must be recorded in patient’s chart with each treatment. a. Amount of dilution and units injected per muscle. b. Muscle treated. c. Syringe lot numbers. d. Specific areas treated. e. Patient response to treatment. f. Procure physician review and sign-off on patient charts within 7 days post procedure. REQUIREMENTS FOR RN A. Education: Graduate of PA, RN program with current California PA, RN license. B. Training: 1.Training by MD specific to product knowledge and proper technique. BOTOX-PROCEDURE 3 STANDARD PROCEDURE FOR REGISTERED NURSES PERFORMING BOTOX® COSMETIC INJECTIONS 2. 3. 4. 5. 6. a. b. BOTOX-PROCEDURE Formal education from BOTOX® COSMETIC product representative to increase knowledge, experience and proficiency in the proper administration of the product. Experience: a. No previous experience necessary. Initial Evaluation: Successful completion of BOTOX® COSMETIC education, training and demonstration of competency to MD. Physician will review and sign-off all patient charts within 7 days post procedure. On-going evaluation: Random MD visits during treatment sessions. MD will observe at least 3 treatments quarterly. Annual performance evaluation by Program Manager. 4