Atlanta Dermatology Association Response

Atlanta Dermatological Association Response

January 19, 2006

To: The State Composite Board of Medical Examiners

Re: Proposed rules for lasers

Fr: The Atlanta Dermatological Association

Dear Board Members,

The first rule of medicine is,” Primum non nocere,” above all, do no harm. This tenet along with informed consent is the basis of modern medical practice and underlies the basis of the physician-patient relationship.

The unchecked and unregulated, marked expansion of cosmetic and laser centers in the state of Georgia, has created a potential unsafe environment for the citizens of Georgia. The Atlanta Dermatological Association seeks to remedy this situation.

We strongly endorse the State Composite Board of Medical Examiners efforts to regulate this area. At this time, we propose additional recommendations which both ensure patient safety and deliver the highest quality patient care.

There exists a deficiency in the ‘direct supervision’ amendment with respect to rule 360-11-02 (Main Features). The proposed rule allows for the supervising physician to be offsite, “at a location within 20 miles, but no more than 30 minutes of the location where the supervised physician’s assistant or nurse authorized by the Georgia Board of Nursing to engage in advance practice nursing,” is located.

The American Academy of Dermatology and the Atlanta Dermatological Association strongly oppose the proposed off site provision. We propose that the supervising physician must be physically present on the premises, at all times, during the laser utilization by non-physician designated personnel, and not located at a distant site

The use of lasers for medical and cosmetic purposes was pioneered and advanced by dermatology departments, most notably, the department of dermatology at the Harvard Medical School. Furthermore, many of the current procedures for laser hair removal and photo-rejuvenation techniques were devised and refined by dermatologists. As a result of our advanced training in medical and surgical dermatology, we feel preeminently qualified to address the issues regarding laser usage.

The use of lasers is a surgical procedure where the skin and its supporting structures are physically altered. With any surgical procedures, complications can arise. With respect to lasers, the most common complications are immediate (burning and blistering) or delayed (infection, scarring, and pigment alteration).

Direct on site supervision allows for the physician to deal with immediate potential complications. The first few minutes of any thermal injury are crucial with respect to functional and cosmetic outcome. For example, the immediate application of ice and the oral administration of ibuprofen can decrease the inflammatory response dramatically thereby minimizing potential injury. The use of steroids, administered either intralesional or systemic can also decrease inflammatory reactions. The use of advance wound healing substrates such as vigilon can also reduce the inflammatory response and reduce injury. The immediate institution of these protocols by the attending physician is critical, and can have major consequences. Non physician personnel lack the experience and training to deal with these issues, hence the need for direct on site supervision. Even a 30 minute delay is too long. Patient safety dictates that the supervising physician be present on site.

A major issue regarding laser centers is the lack of a history and physical by a licensed physician. At hair salons, day spas, and even laser centers, patients can walk in and request chemical peels, laser hair removal, and IPL treatments without a physician consult. In this setting, patients are at severe risk for adverse outcomes.

For example, many of the medications used to treat infection, hypertension, and hyperlipidemia are markedly photosensitive and can impact the response to laser energy. Severe burns may occur. In addition, patients with latent herpes simplex viral infections are at increased risk of reactivation leading to a severe facial infection which is potentially life threatening. These patients require appropriate viral prophylaxes prior to laser surgery. Hence the need for consultation, by a physician, prior to any laser procedure. A consultation is best obtained by the physician at the site of the laser procedure. This consultation will aid in identifying potential complications and allow for “true” informed consent with a discussion emphasizing risk versus benefits.

Evaluation by the supervising physician is necessary to prevent scarring and pigmentation alteration. Many of the sales representatives of laser companies maintain that certain types of lasers are safe for all skin types. A naïve, poorly trained technician with little experience will fail to realize the potential danger. Although FDA approved for skin types I – VI, these devices may cause severe burns, scarring and pigmentation alteration in patients of color (skin types IV – VI) or those patients who have recently tanned. These patients are at greatest risk of injury. Their welfare is best protected by a physician consultation prior to any laser procedure to determine the appropriateness of the procedure as well as the inherent risks. Once again, the patient’s best interest is served by a supervising physician, who is directly on site.

Critics will attempt to undermine our proposals by stating these complications are theoretical. Think again! All of these complications are real, have occurred, and will occur again, unless the rules for laser procedures are tightened. Laser surgical procedures, whether medical or cosmetic, require the on site presence of the supervising physician to maintain the highest level of patient safety and quality care.

With respect to the issue regarding the use of non-physician personnel for laser procedures, the Atlanta Dermatological Association favors the guidelines advanced by the American Academy of Dermatology. The position statement is provided below (see attachment).

With respect to provision 360-11-03 section 4, the Atlanta Dermatological Association would like to expand the definition of ‘qualified personnel’ to include medical assistants and certified aestheticians that have completed extensive training of at least 24 hours in either a Board-approved course, or equivalent training emphasizing laser safety, physics, and applications of the specific laser/IPL to be utilized. Equivalent training may include a preceptorship as well as certified courses instituted by laser manufacturers. Furthermore, qualified personnel must document a minimum of 10 procedures under direct physician supervision which includes an evaluation of performance. The supervising physician must also provide written protocols for the operation of said device. Qualified personnel shall not act independently or exercise independent judgment in performing a laser procedure. The attending physician shall provide direct supervision and is responsible for the safety of the patient, regardless of who performed the laser procedure.

The key to successful use of qualified non-physician personnel is appropriate training and supervision. Such supervision requires direct on site presence of the physician. Our primary obligation is to the patient. The use of lasers, even for cosmetic purposes is a surgical procedure. The above recommendations ensure patient safety and quality care. As the Composite Board of Medical Examiners deliberates on the proposed changes, please consider and adopt our recommendations.

Sincerely,

Mack Rachal, MD/PhD

President, The Atlanta Dermatological Association

Position Statement

The Use of Non-Physician Office Personnel

(Approved by the Board of Directors February 22, 2002;

Amended by the Board of Directors November 23, 2002;

Amended by the Board of Directors July 31, 2004;

Amended by the Board of Directors July 23, 2005)

The guiding principle for all dermatologists is to practice ethical medicine with the highest possible standards. Physicians should be properly trained in all procedures and services performed to ensure the highest level of patient care and safety. A physician should be fully qualified by residency training and preceptorship or appropriate course work. Training should include an extensive understanding of cutaneous medicine and surgery. It is the position of the AADA that only active and properly licensed doctors of medicine and osteopathy shall engage in the practice of medicine.

Under appropriate circumstances, a physician may delegate certain procedures and services to appropriately trained non-physician office personnel. Specifically, the physician must directly supervise the non-physician office personnel to protect the interests and welfare of each patient. Except in exceptional circumstances, the supervising physician shall be physically present on-site, immediately available and able to respond promptly to any question or problem that may occur while the procedure or service is being performed. It is the physician's obligation to ensure and document that, with respect to each procedure and service performed, the non-physician office personnel have received the proper training, All new patients and significant new problems in established patients should be seen by dermatologists in a face to face manner.

This Position Statement is intended to offer physicians guidelines regarding the delegation of performance of medical procedures and services, but is not intended to establish a legal standard of care. Physicians should use their personal and professional judgment in interpreting these guidelines and applying them to the particular circumstances of their individual practice arrangements.