Informed Consent Form

Transcription

1 Informed Consent Form Botox Cosmetic (onabotulinumtoxin A) Dysport (abobotulinumtoxin A) Xeomin (incobotulinumtoxin A) INSTRUCTIONS This is an informed-consent document that has been prepared to help inform you about BOTOX (Botulina Toxin Type A, Allergan) injections, its risks, as well as alternative treatment(s). It is important that you read this information carefully and completely. Please initial each page, indicating that you have read the page and sign the consent as proposed by your provider and agreed upon by you. GENERAL INFORMATION Clostridia botulina bacteria produce a class of chemical compounds known as toxins. The Botulina Type A Toxin (BOTOX) is processed and purified to produce a sterile product suitable for specific therapeutic uses. Once the diluted toxin is injected, it produces a temporary paralysis (chemodenervation) of muscle by preventing transmission of nerve impulses to muscle. The duration of muscle paralysis generally lasts for approximately three to four months. BOTOX has been approved to treat certain conditions involving crossed eyes (strabismus), eyelid spasm (blepharospasm), cervical dystonia (spastic muscle disorder with the neck) and motor disorders of the facial nerve (VII cranial nerve). As of April 2002, it has been FDA-approved for the cosmetic treatment of forehead wrinkles caused by specific muscle groups and more recently approved for treatment of crow s feet wrinkles as of September Other areas of the face and body such as smoker s lines around the lips and neck bands may be treated in an off-label fashion. BOTOX has also been used to treat migraine headaches, colorectal disorders, excessive perspiration disorders of the armpit and hands, and musculoskeletal pain disorders. BOTOX injections are customized for every patient, depending on his or her particular needs. These can be performed in areas involving the eyelid region, forehead, and neck. BOTOX cannot stop the process of aging. It can however, temporarily diminish the look of wrinkles caused by muscle groups. BOTOX injections may be performed as a singular procedure or as an adjunct to a surgical procedure. INDICATIONS BOTOX (onabotulinumtoxina) is a prescription medicine that is injected into muscles and used: To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who will still have leakage or cannot tolerate the side effects after trying an anticholinergic medication. To prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years and older with upper limb spasticity. To treat increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spascity. To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older. To Treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older. 5/11/15 Patient Initials 1

2 BOTOX is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in 18 years and older. It is not known whether BOTOX is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine). It is not known whether BOTOX is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, and fingers or to treat increased stiffness in lower-limb muscles. BOTOX has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed. It is not known whether BOTOX is safe or effective for severe sweating anywhere other than your armpits. ALTERNATIVE TREATMENTS Alternative forms of management include not treating the skin wrinkles by any means. Improvement of skin wrinkles may be accomplished by other treatments or alternative types of surgery such as a blepharoplasty, face or brow lift when indicated. Other forms of eyelid surgery may be needed should you have intrinsic disorders affecting the function of the eyelid such as drooping eyelids from muscle problems (eyelid ptosis) or looseness between the eyelid and eyeball (ectropion). Minor skin wrinkling may be improved through chemical skin peels, lasers, injection of filling material, or other skin treatments. Risks and potential complications are associated with alternative forms of medical or surgical treatment. INHERENT RISKS OF BOTOX (BOTULINA TYPE A TOXIN) INJECTIONS Every procedure involves a certain amount of risk and it is important that you understand these risks and the possible complications associated with them. In addition, every procedure has limitations. An individual s choice to undergo a surgical procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with your Medical Provider to make sure you understand risks, potential complications, limitations, and consequences of BOTOX injections. Additional information concerning BOTOX may be obtained from the package-insert sheets supplied by Allergan. SPECIFIC RISKS OF BOTOX (BOTULINA TYPE A TOXIN) INJECTIONS Incomplete Block: It is possible to not experience a complete block of desired muscles. Additional injections to reach the desired level of block can be performed until the goal is achieved. Asymmetry: The human face and eyelid region is normally asymmetrical with respect to structural anatomy and function. There can be a variation from one side to the other in terms of the response to BOTOX injection. Drooping Eyelid (Ptosis): Muscles that raise the eyelid may be affected by BOTOX, should this material migrate downward from other injection areas. Pain: Discomfort associated with BOTOX injections is usually of short duration. Migration of BOTOX: BOTOX may migrate from its original injection site to other areas and produce temporary paralysis of other muscle groups or other unintended effects. BOTOX has been reported to cause swallowing problems in patients treated for spastic muscle disorders of the cervical region (cervical dystonia). 5/11/15 Patient Initials 2

3 Bleeding and Bruising: It is possible, though unusual, to have a bleeding episode from a BOTOX injection. Bruising in soft tissues may occur. Serious bleeding around the eyeball during deeper BOTOX injections for crossed eyes (strabismus) has occurred. Should you develop post-injection bleeding, it may require emergency treatment or surgery. Aspirin, anti-inflammatory medications, platelet inhibitors, anticoagulants, Vitamin E, ginkgo biloba, and other herbs / homeopathic remedies may contribute to a greater risk of a bleeding problem. Do not take these for ten days before or after BOTOX injections. Damage to Deeper Structures: Deeper structures such as nerves, blood vessels, and the eyeball may be damaged during the course of injection. Injury to deeper structures may be temporary or permanent. Corneal Exposure Problems: Some patients experience difficulties closing their eyelids after BOTOX injections and problems may occur in the cornea due to dryness. Should this rare complication occur, additional treatments, protective eye drops, contact lenses, or surgery may be necessary. Unknown Risks: The long-term effect of BOTOX on tissue is unknown. The risk and consequences of accidental intravascular injection of BOTOX is unknown and not predictable. There is the possibility that additional risk factors may be discovered. Dry Eye Problems: Individuals who normally have dry eyes may be advised to use special caution in considering BOTOX injections around the eyelid region. Double-Vision: Double-vision may be produced if the BOTOX material migrates into the region of muscles that control movements of the eyeball. Eyelid Ectropion: Abnormal looseness of the lower eyelid can occur following BOTOX injection. Other Eye Disorders: Functional and irritative disorders of eye structures may rarely occur following BOTOX injections. Blindness: Blindness is extremely rare after BOTOX injections. However, it can be caused by internal bleeding around the eyeball or needle stick injury. In a period of 10 years of BOTOX administration, complications of blurred vision, retinal vein occlusion, and glaucoma have been reported in three patients. The occurrence of eye problems appears to be very rare. Allergic Reactions: As with all biologic products, allergic and systemic anaphylactic reactions may occur. Allergic reactions may require additional treatment. Antibodies to BOTOX: Presence of antibodies to BOTOX may reduce the effectiveness of this material in subsequent injections. The health significance of antibodies to BOTOX is unknown. Infection: Infection is extremely rare after BOTOX injection. Should an infection occur, additional treatment including antibiotics may be necessary. Patient Initials 5/11/15 3

4 Skin Disorders: Skin rash, itching, and swelling may rarely occur following BOTOX injection. Neuromuscular Disorders: Patients with peripheral motor neuropathic disorders (amyotrophic lateral sclerosis, myasthenia gravis, and motor neuropathies) may be at greater risk of clinically significant side effects from BOTOX. Migraine Headache Disorders: BOTOX has been used to treat forehead muscle groups that are involved with the migraine headache condition. Patients are advised that results of BOTOX treatment for migraine headaches may be variable and improvement in this disorder may not occur following BOTOX treatments. Unsatisfactory Result: There is the possibility of a poor or inadequate response from BOTOX injection. Additional BOTOX injections may be necessary. Surgical procedures or treatments may be needed to improve skin wrinkles including those caused by muscle activity. Long-Term Effects: Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss, weight gain, sun exposure, pregnancy, menopause, or other circumstances not related to BOTOX injections. BOTOX injection does not arrest the aging process or produce permanent tightening of the eyelid region. Future surgery or other treatments may be necessary. Pregnancy and Nursing Mothers: Animal reproduction studies have not been performed to determine if BOTOX could produce fetal harm. It is not known if BOTOX can be excreted in human milk. It is not recommended that pregnant women or nursing mothers receive BOTOX treatments. Drug Interactions: The effect of BOTOX may be potentiated by aminoglycoside antibiotics or other drugs known to interfere with neuromuscular transmission Off-Label FDA Issues: There are many devices, medications and injectable fillers and botulinum toxins that are approved for specific use by the FDA, but this proposed use is Off-Label, that is not specifically approved by the FDA. It is important that you understand this proposed use is not experimental and your provider believes it to be safe and effective. Authorization (s): I acknowledge that I have been informed about the Off-Label FDA status of BOTOX (Botulina Toxin Type A, Allergan) and I understand it is not experimental and accept its use. Pregnancy and Neurologic disease; I attest that I am not pregnant and I am not breastfeeding (Female patients only), nor that I have any significant neurologic disease. Furthermore, I agree to keep my treatment Provider informed should I become pregnant or become diagnosed with a neurologic disease during the course of treatment. Before and after treatment instructions have been discussed with me. The procedure, potential benefits and risks, and alternative treatment options have been explained to my satisfaction I understand that the procedure is purely elective, that the results may vary with each individual, and multiple treatments may be necessary. 5/11/15 Patient Initials 4

5 I Infection is possibility anytime a skin procedure is performed or the skin surface is disrupted. Keeping the treated area clean is important. If signs of infection develop after your treatment, such as pain, heat, blisters, or surrounding redness, please call our office immediately. If you have ever had, currently have, or develop a cold sore or herpes outbreak during the course of treatment, IT IS YOUR RESPONSIBILITY TO NOTIFY YOUR TREATMENT PROVIDER IMMEDIATELY. Medical History: I have given a complete history of all medical conditions, previous surgeries and treatments, current list of all medications and allergies. I agree to notify my treatment Provider immediately of any changes to my medical history during the course of my treatments. I understand that any failure to do so may affect the results of my treatment and/or increase the likelihood of side effects or post-treatment complications. Post-treatment instructions: I have been advised that treatment results should be seen 4-7 days 4-7 days after the treatment. I have also been advised to maintain an erect posture and that I must refrain from strenuous exercise, nor manipulate the injection sites for at least twelve (12) hours post-treatment. Photographs: Photographic documentation may be taken. I hereby do do not authorize the use of my photographs for teaching purposes. I acknowledge that it has been recommended to avoid anti-inflammatory meds (such as Ibuprofen, Motrin, Advil, green tea, vitamin E, and Ginko Biloba to reduce possible side effects of bruising and swelling in the areas of treatment. Blood thinning meds may also cause these side effects. Anyone who bruises or bleeds easily, as well as bleeds heavily and/or has questions about their meds or their condition may wish to consult your Medical Provider prior to treatment. It is also recommended to avoid alcoholic drinks before receiving Botox A injections (s). have read and understand all information presented to me before consenting to treatment. I have had all my questions answered. I freely consent to the proposed treatment., hereby authorize (provider s name) to perform Botox Cosmetic, Dysport, or Xeomin Injection on me. PATIENT SIGNATURE DATE TIME AND/OR RESPONSIBLE RELATIVE OR GUARDIAN RELATIONSHIP PROVIDER S NAME PROVIDER S SIGNATURE 5/11/15 Patient Initials 5

6 Healthy Connections, Inc. Therapeutic Migraine Financial Policy All patients are required to pay for their responsibility for out of pocket expense not covered by insurance for services performed on the date of service or before. Deposit of $50.00 is required when procedure appointment is made. I understand an insurance pre-authorization is required before the procedure can be performed. Our goal is to provide you with the highest quality care possible. In order to do so, we use an appointment system that allows each patient ample time with the care provider. To be respectful of other patients and our providers, we ask you notify us of an appointment cancellation at least 24 hours in advance. We reserve the right to asses a fee of $50.00 for missed appointments or those not cancelled 24 hours prior. All Healthy Connections, Inc. financial policies still apply for therapeutic migraine services. The financial policy will be enforced by all clinic personnel. By my signature I certify that I have read the sections above, and agree to the above statements. Printed Name of Patient or Responsible Party: Signature: Date:

7 Medications to Avoid Prior to Procedure for Botox Product It is important to avoid certain medications prior to the procedure. The following medications can have effects on bleeding, swelling, increase the risk of blood clots, and cause other problems if taken around the time of the procedure. Please notify your provider if you are taking any vitamins, herbal medications/supplements as these can also cause problems during the procedure and should not be taken for the 7-10 day period before and one week after the procedure. It is extremely important that if you come down with a cold, fever, rash, cold sore ( fever blister ) or any new medical problem close to the procedure date, you should notify your provider immediately. Section One: The following drugs contain aspirin and/or aspirin like effects that may affect the procedure (abnormal bleeding and bruising). These drugs should be avoided for at least 7-10 days prior to the procedure. A.P.C. Doloprin Nuprin A.S.A. Easprin Orudis A.S.A. Enseals Ecotrin Pabalate SF Advil Emprin with Codeine Pamelor Aleve Endep Parnate Alka Seltzer Plus Equagesic Tablets Percodan Alka Seltzer Etrafon Pepto Bismol (all types)anacin Excedrin Persantine Anaprox Feldene Phenteramine Ansaid Fiorinal Phenylbutzone Argesic Flagly Ponstel Arthritis pain formula Four Way Cold Tablets Propoxyphene Arthritis strength Bufferin Gemnisyn Robaxisal Arthropan Liquid Gleprin Rufen AS.A. Goody s S A C Ascriptin Ibuprofen (all types) Saleto Asperbuf Indocin Salocol Aspergum Indomethacin Sine Aid/Sine Off/Sinutab Aspirin (all brands) Lanorinal SK 65 Compound Atromid Lioresal St. Joseph s Cold Tab B.C. Tablets & Powder Magan Sulindac Backache Formula Magsal Synalgos Bayer Children s Marplan Talwin Compound Bufferin Medomen Tenuate Dospan Buffets II Methocarbamol with Aspirin Tolectin Buffinol Micrainin

8 Toradol Buff Tabs Midol Triamincin Butazolidin Mobidin Trigesic Caffergot Mobigesic Trilisate Tablets/Liquid Cama Arthritis Pain Reliever Momentum Muscular Uracel Carisoprodol Motrin Vanquish Clinoril Nalfon Verin Chewable Naprosyn Voltaren Cope Tablets Naproxen Zorpin Damason Nardil Zorprin Darvon Nicobid Disalcid Norgesic Dolobid Norgesic Forte VITAMINS/HERBAL SUPPLEMENTS: The vitamins and herbal supplements can cause abnormal bleeding problems. Below is a list of herbal supplements/vitamins that may affect the procedure outcome and safety. These vitamins/herbal supplements should be avoided for at 7-10 days prior to the procedure. Dong Quai Gingko Biloba St. John s Wort (all types) Echinacea Ginseng Valerian Ephedra Glucosamine Vitamin C (more than 2000mg daily) Feverfew Goldenseal Vitamin E (more than 400mg daily) Fish Oils (Omega 3 Fatty acids) Kava Garlic Licorice NICOTINE PRODUCTS: Nicotine reduces the blood flow to the skin any may impair healing. Quitting smoking drastically improves the body s response to the procedure. Cigarettes Nicotine Gum Cigars Patches I have read and understand all Medications to Avoid Prior to Procedure and have had all my questions answered thoroughly to my satisfaction. Printed Patient Name Patient Signature Date Printed Witness Name Witness Signature Date

9 Therapeutic Migraine Pre-Treatment Instructions Botox Avoid Alcohol Intake One Week Prior to Treatment To reduce increased swelling or bruising to treatment area, for one week prior to treatment avoid Anti-inflammatory Meds (i.e. Motrin, Advil, Ibuprofen), Aspirin and all aspirin containing products; Blood thinner medications such as Coumadin, Pradaxa, Xarelto, Eliquis, etc.; Herbal products such as gingko biloba, ginseng, St. Johns Wart, and Vitamin E, Fish oil or other Omega 3 products. You may use Tylenol and other acetaminophen products. Please Note: Check with your prescribing physician before stopping any prescription medications. I have read and understand all Pre-Treatment Instructions and have had all my questions answered thoroughly to my satisfaction. Printed Patient Name Patient Signature Date Printed Witness Name Witness Signature Date

10 Therapeutic Migraine Post Treatment Instructions Botox Within the first 24 hours, you should avoid strenuous exercise, extensive sun or heat exposure, and alcoholic beverages. Exposure to any of the above may cause temporary redness, swelling and/or itching at the injections sites. Perform Facial Exercise intermittently X 30 minutes, such as smiling and frowning. Do Not massage treatment area for 12 hours following treatment. Do Not lie down or bend over/down for 4 hours following treatment. Avoid wearing a hat or headband for 12 hours. Avoid washing your hair or styling your hair for 12 hours following treatment. Treatment effect may take 5-10 days. The benefits may last 2-6 months the average is 3 months. Touch-up booster injections may be necessary in 2-4 weeks. It is your responsibility to contact us within this period of time if you feel you need repeat touch-up injections. Use Tylenol for mild pain or discomfort. Avoid aspirin and aspirin containing products for at least 24 hours as these products might cause increased bleeding or bruising. I have read and understand all Post Treatment Instructions and have had all my questions answered thoroughly to my satisfaction. Printed Patient Name Patient Signature Date Printed Witness Name Witness Signature Date

11 ADVANCE BENEFICIARY NOTICE (ABN) NOTE: You need to make a choice about receiving these health care items or services. We expect your insurance coverage will not pay for the item(s) or service(s) that are described below. Insurance coverage does not pay for all of your health care costs & only pays for covered items and services when requirements are met. The fact the insurance coverage may not pay for a particular item or service does not mean tyou should not receive it. There may be a good reason your doctor recommended it. Right now, in your case, insurance coverage probably will not pay for Items or Services: Because: The purpose of this form is to help you make an informed choice about whether or not you want to receive these items or services, knowing that you might have to pay for them yourself. Before you make a decision about your options, you should read this entire notice carefully. Ask us to explain, if you don t understand why insurance coverage probably won t pay. Ask us how much these items or services will cost you (Estimated Cost: $ ), in case you have to pay for them yourself or through other insurance. PLEASE CHOOSE ONE OPTION. CHECK ONE BOX. SIGN & DATE YOUR CHOICE. Option 1. YES. I want to receive these items or services. I understand that insurance will not decide whether to pay unless I receive these items or services. Please submit my claim to my insurance coverage. I understand that you may bill me for items or services and that I may have to pay the bill while my insurance coverage is making its decision. If my insurance coverages does pay, you will refund to me any payments I made to you that are due to me. If my insurance coverage denies payment, I agree to be personally and fully responsible for payment. That is, I will pay personally, either out of pocket or through any other insurance that I have. I understand I can appeal my insurance s decision. Option 2. NO. I have decided not to receive these items or services. I will not receive these items or services. I understand that you will not be able to submit a claim to my insurance and that I will not be able to appeal your opinion that my insurance won t pay. Date Signature of patient or person acting on patient s behalf NOTE: Your health information will be kept confidential. Any information that we collect about you on this form will be kept confidential in our offices. If a claim is submitted to your insurance, your health information on this form may be shared with your insurance. Your health information which your insurance sees, will be kept confidential by your insurance.