Re: Proposed rule to add WAC Nonsurgical medical cosmetic procedures

Transcription

1 Ms. Susan Gragg Board of Naturopathy State of Washington P.O. Box Olympia, WA Re: Proposed rule to add WAC Nonsurgical medical cosmetic procedures Dear Ms. Gragg: On behalf of the Washington State Dermatology Association and the 13,800 U.S. members of the American Academy of Dermatology Association ( Academy ), we are writing to urge you to reject the July 2018 proposal of the Board of Naturopathy authorizing naturopaths to perform nonsurgical cosmetic medical procedures, such as botulinum toxin and inert substances used for cosmetic purposes. The proposal would also create training and practice requirements for such aesthetic injectable techniques set forth in WAC We believe these procedures are outside the scope of naturopathy, inconsistent with the practice of naturopathy, and can represent a significant risk to patient safety when not administered by licensed and qualified medical doctors or under the direct supervision of a medical doctor. Further, a scope of practice expansion should be authorized by statute rather than administrative procedure. For the reasons detailed below, we urge you to reject this dangerous proposal. Use of Injectable Products Constitutes the Practice of Medicine The use of injectable products, such as those allowed in the proposal, constitutes the practice of medicine within the scope of dermatology. According to the AADA Position Statement on Medical Spa Standards of Practice: Procedures by any means, methods, devices, or instruments that can alter or cause biologic change or damage the skin and subcutaneous tissue constitute the practice of medicine and surgery. These include but are not limited to the use of: scalpels; all lasers and light sources, microwave energy, electrical impulses, and all other energy emitting devices; thermal

2 Page 2 of 5 destruction; chemical application; particle sanding; and other foreign or natural substances by injection or insertion. Any procedure that constitutes the practice of medicine, including but not limited to any procedure using a Food and Drug Administration (FDA)- regulated device that can alter or cause biologic change or damage, should be performed only by an appropriately trained physician or appropriately-trained non-physician personnel under the direct, onsite supervision of an appropriately-trained physician in accordance with applicable local, state, and/or federal laws and regulations. With the growing public demand and appreciation for facial filler and neuromodulators, establishing uniform educational requirements and scope of practice standards concerning who can administer these products is critically important. In addition to the obvious cosmetic applications of these products, it is crucial that we emphasize their importance as treatment for scarring from injury and surgery, as well as for medical conditions, such as cystic acne; other applications include correcting facial asymmetries resulting from congenital, accidental, or medical conditions. Our utmost concern is to ensure that these products are safely administered by licensed and qualified medical doctors or under the direct, on-site supervision of a licensed and qualified medical doctor. Further, Washington law defines naturopathy as the art and science of the diagnosis, prevention, and treatment of disorders of the body by stimulation or support, or both, of the natural processes of the human body. Authorizing naturopaths to perform nonsurgical cosmetic medical procedures is inconsistent with this definition. Short-Term Training is Not Adequate to Protect Patient Safety Properly performing procedures using botulinum toxin or dermal fillers requires specific, long-term training, including as part of a medical residency in cutaneous dermatologic procedures. The education for naturopaths does not include the appropriate training to use these products, and a short-term training program offered by manufacturers of these products is insufficient and does not adequately promote patient safety. Washington law requires a naturopath to graduate from a naturopathic college approved by the board which teaches adequate courses in all subjects necessary to the practice of naturopathic medicine. The focus of their education is on emphasizing prevention, treatment, and optimal health through the use of

3 Page 3 of 5 therapeutic methods and substances that encourage individuals inherent selfhealing process, 1 rather than the skin and facial tissue. Naturopaths complete four years of graduate level education but are not required to complete a residency or fellowship. Naturopaths are also not required to demonstrate competency in procedures involving skin and soft tissue augmentation involving products that can alter or damage such living tissue, nor does their training include a detailed medical knowledge of anatomy and possible adverse events associated with fillers and neuromodulators including sensitivity, infection, and necrosis. In comparison, following eight years of college and medical school and a oneyear internship, board-certified dermatologists and dermatologic surgeons complete at least a three-year dermatology residency program. Additionally, board-certified dermatologists are required to have registered 12,000-16,000 patient care hours during this process, as opposed to the naturopaths 720-1,200 hours. We receive in-depth education in anatomy and surgical and cosmetic procedures involving the skin and adjacent structures, which prepares dermatologists to safely and effectively perform cosmetic medical procedures using injectables and botulinum toxin. Included in this training is proper technique, producing optimal outcomes and the management of adverse events. In a 2007 paper, Drs. Hayes Gladstone and Joel Cohen note, As with other cutaneous procedures, it is necessary to receive adequate training before using soft-tissue augmentation agents. In our opinion, physician injectors should first be made to demonstrate a detailed knowledge of anatomy and possible adverse events (such as sensitivity, infection and necrosis) through passing an American Board of Medical Specialties examination in one of the CORE aesthetic specialties after residency training in one of these disciplines. (See Exhibit A attached). The Proposed Rule Endangers Patient Safety As dermatologists, our utmost concerns are quality patient care and patient safety. Quality patient care includes evaluating a patient s needs and current condition(s), selecting an appropriate course of treatment in accordance with their medical history, and providing adequate information and follow-up care. As stated above, short-term, basic training on how to use a product is in no way equivalent to a medical doctor s training and understanding of a medical 1 Definition of Naturopathic Medicine. American Association of Naturopathic Physicians. Retrieved from

4 Page 4 of 5 procedure and its implications for each patient. Ultimately, patient safety and quality of care are seriously compromised. An analysis by the U.S. Food and Drug Administration s (FDA) General and Plastic Surgery Devices Panel of six years of adverse event reports associated with the use of injectable dermal fillers concluded: There are a number of adverse events that are serious and unexpected such as facial, lip, and eye palsy, disfigurement, retinal vascular occlusion, blindness, as well as rare but life-threatening events such as severe allergic reactions and anaphylactic shock. Some of the common adverse events that are expected to occur shortly after injection and resolve quickly can have a delayed onset and/or remain for a long period of time and turn into more serious problems. A number of the adverse events reported to the FDA and the device manufacturers imply that, in these cases, the administration of injectables were performed by untrained personnel or in settings other than health clinics or doctors offices 2. Further, a survey conducted by the Physicians Coalition for Injectable Safety found that 84 percent of physician respondents had seen at least one patient with complications from cosmetic injectables and 38 percent had seen complications arising from cosmetic injections administered by an unqualified or untrained provider. 3 Injectable fillers that are approved for injection in the dermis or mid-todeep dermis require extensive knowledge of facial anatomy to ensure proper placement of the injections. Understanding which injectable product is appropriate for each anatomic site and its particular limitations is fundamental to avoiding adverse effects. Numerous studies have cautioned medical doctors on the use of dermal fillers, noting, a physician's selection of facial filler(s) should be based on a solid understanding of the various filler products, appropriate patient selection, and the physician's proficiency in injection techniques. (See Exhibit B attached). Moreover, in discussing these devices, the FDA s Consumer Health Information materials suggest that patients should discuss fillers with a 2 FDA General and Plastic Surgery Devices Panel. Dermal Filler Devices. November 11, Retrieved from %20FDA%20Executive%20Summary%20Dermal%20Fillers.pdf 3 New Data Finds Greater Measures Needed For Consumer Safety And Education On Injectable Therapies. August Retrieved from

5 Page 5 of 5 doctor who can refer the patient to a specialist in the fields of dermatology or aesthetic plastic surgery 4. Expanding Scope of Practice is Role of Legislature The Washington legislature did not consider the administration of fillers for cosmetic purposes when it established naturopaths scope of practice in The statute indicates that the practice of naturopathy expressly includes many things but fails to include any reference to application of botulinum toxin and fillers for cosmetic purposes. The Washington legislature has not granted an expansion of scope for practice to include use of these products, though under the principles of statutory construction, this responsibility lies with them. A scope expansion of this nature is more appropriately addressed through the legislative process rather than administrative, as is done with questions of scope for other health care professions. In order to protect the citizens of Washington from adverse events and ensure quality patient care, we urge you to reject the proposed language. Naturopaths do not receive the comprehensive education and training that is required to identify and respond to potential complications resulting from the cosmetic medical administration of botulinum toxin and inert substances. We appreciate the opportunity to provide written comments on this issue. For further information, please contact Lisa Albany, director, state policy for the American Academy of Dermatology Association, at lalbany@aad.org (202) Sincerely, Suzanne Olbricht, M.D., FAAD President American Academy of Dermatology Association Andrea Kalus, MD, FAAD President Washington State Dermatology Association 4 Filling in Wrinkles Safely. Retrieved from