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Medispas raise patient safety concerns

People may enjoy the convenience and pampering of having laser hair removal combined with a pedicure, or a chemical peel followed by a massage at a medical spa in the local mall. But do they know their safety could be at risk?

Medical spas, or medispas, offer a range of services including medical and surgical procedures for the purpose of improving one’s well-being and/or appearance in a non-traditional setting. Medical aesthetic procedures commonly performed include laser hair removal, intense pulsed light treatments, microdermabrasion, chemical peels, and filler and botulinum toxin injections. Some medispas even offer laser resurfacing to remove blood vessels, pigmented spots, and tattoos as well as sclerotherapy. These services are often provided by physicians or non-physicians who may have limited or no formal training or education in aesthetic medicine. The non-physicians may be operating with limited or no supervision by a licensed and qualified physician.

“The main concern about medical spas is patient safety because these procedures have inherent risks,” stated Bruce Brod, MD, a dermatologist in Lancaster, Pa., and former chair of the American Academy of Dermatology Association State Policy Committee. Among the potential complications are prolonged erythema, burns, pigmentation problems, and infection. Eye damage can occur if the laser is pointed the wrong way. Permanent problems include scarring and pigmentation loss. Anesthesia reactions have even resulted in patient death. Another concern is that a potentially dangerous skin lesion may be missed, he said. Individuals who are not properly trained or supervised may laser what they think is an unsightly brown spot, which is really an undetected malignant melanoma that becomes masked by the cosmetic procedure.

Nowadays there’s a tendency to commercialize cosmetic treatments, said Amy Derick, MD, a dermatologist based in Barrington, Ill. “The problem is that there is no disclosure about the training and qualifications of the people providing these procedures,” she added. “It could be an aesthetician who is supervised by an out-of-state physician. But the consumer doesn’t know that.”[pagebreak]

Growing market

The growing global market for medical aesthetic procedures is forecast to reach approximately $4 billion in 2017. In 2010, 11.6 million minimally invasive procedures were performed, according to the American Society of Plastic Surgeons. The top five involve the use of botulinum toxins, soft tissue fillers, chemical peels, laser hair removal, and microdermabrasion.

The current market is fueling the proliferation of medical spas. In 2007, there were 976 medical spas in the United States, according to the International SPA Association, but other estimates put that number as high as 2,500. And while annual revenues decreased slightly for the spa industry between 2005 and 2006, the association claims that revenues for medical spas more than doubled to one billion-plus during that same time.

Varying state regulations

Only a handful of states currently address the performance of medical aesthetic services or medical spas. For example, Maryland has the most comprehensive regulations, which took four years to get passed in August 2010, said Rockville, Md., dermatologist Lawrence Green, MD, who worked with the state medical society on their passage. “The longer you wait, the more difficult it is to make changes because the current practice becomes the standard practice in the state,” said Dr. Green, who became involved after seeing a growing number of patients unnecessarily injured as a result of having procedures at medispas. “I’m just one of 250 dermatologists in the D.C. area,” he said. “If I was seeing one to two patients a month with complications, so were other dermatologists.”

“Many states are beginning to explore how to potentially regulate or legislate what goes on in a medical spa,” Dr. Brod said. State medical boards regulate the practice of medicine. But before that can happen, enabling legislation has to be passed giving the board the authority to do so, he explained.

Because the definition of the practice of medicine varies across state lines, medical aesthetic procedures are not considered the practice of medicine in many states, noted Michael Zanolli, MD, a dermatologist in Nashville, Tenn. He was involved in getting the Tennessee Medical Association to pass a resolution this past March to include the “enhancement of the aesthetic appearance of another” in the definition. “That’s the missing piece we needed to have a basic foundation for saying that many of these activities that occur in medical spas are indeed the practice of medicine,” he said. The resolution, which was sponsored by the Tennessee Dermatology Society, will be on the agenda for the 2011-2012 legislative session.

Laser hair removal is not considered the practice of medicine in Virginia, but it is in neighboring Maryland, noted Dr. Green. “If you’re a physician assistant performing laser hair removal in Maryland, the physician has to be on-site and you have to be licensed and properly trained. If no doctor is there, the Board of Physicians can cite you for practicing medicine without a license and your licensing board can reprimand you.”

Like many dermatologists, Dr. Brod would like to see the medical spas themselves regulated. “These facilities are different than ambulatory surgery centers and medical offices and, as such, should have separate licenses to operate,” he said. Licensing medical spas would create the appropriate funding needed to enforce regulations.

Tami Cassis, MD, a dermatologist in Prospect, Ky., who serves on the state medical licensure board, is working to present a bill that will do just that. The legislation will not only require medical spas to be licensed facilities, but will address physician supervision, including training, competency, and delegation. The goal is to present the bill during the 2011-2012 legislative session.[pagebreak]

Scope of practice

The focus of regulatory efforts is to establish scope of practice standards regarding who can perform medical aesthetic procedures and in what setting.

Dr. Brod believes that it is the responsibility of dermatologists, as the skin care experts, to develop these standards. Such standards should include training and education requirements of both physicians and non-physicians performing services, written treatment plans and procedure protocols, and reporting of adverse events.

“Right now, there’s a wide range of individuals who are not physicians and who have little or no formal training offering these medical procedures at medical spas,” Dr. Brod stated. Currently, all minimally invasive cosmetic procedures can be delegated to at least one type of non-physician at the physician’s discretion, according to a recent survey of 31 allopathic medical boards across the country published in the Journal of the American Academy of Dermatology. But medical boards have limited ability to regulate non-physicians. An equal number of boards required general supervision of non-physicians or some type of on-site supervision; a small number permitted off-site supervision. Few states required reporting of incidents involving these procedures. Western states tended to have liberal delegation and supervision requirements whereas Southern states had more stringent requirements.

Certain procedures can be done by trained and licensed individuals, such as aestheticians in Tennessee who require at least one year of training, Dr. Zanolli said. “I think it is okay for them to do superficial chemical peels or laser hair removal with a low energy laser.” But there are procedures that shouldn’t be performed in medical spas or by non-physicians, he added.

Physician supervision

Many dermatologists also take issue with physician supervision, or lack thereof, at medical spas. Most state regulations don’t define the role of medical director. When they do, physician supervision runs the gamut from direct, on-site supervision to being within a specified distance, such as 30 minutes away, in case problems arise, to off-site supervision.

“Many medispas have physicians who aren’t dermatologists or plastic surgeons with little or no training supervising others. They take a one-day course to learn how to do the procedures and even then, they usually just delegate them,” Dr. Green said.

The medical director could be any physician with a state license who may visit the medical spa once a week or once a month, and may live 300 miles away, said Dr. Zanolli, adding, “I’m not nave enough to think just because a physician performs a procedure that there won’t be any side effects, but at least in a doctor’s office there is someone there who is experienced and trained to address them.”

Moreover, the term “board-certified physician” is being deliberately misused by some to confuse the public. “Some of these medical directors market themselves as a board-certified physician specializing in dermatology,’ which is not the same as a board-certified dermatologist,” Dr. Derick said, “but the consumer doesn’t know the difference.”

She advocates for full disclosure regarding the qualifications of the medical director and the individuals performing the procedures. “When you sign up for a hair removal package, for example, you should be told that an aesthetician is providing the service and is being supervised by an out-of-state family practice doctor,” said Dr. Derick, who appears on the AADA’s new patient-focused video about cosmetic treatments. (See sidebar.) “But patients will never get that, and they don’t know to ask. They trust doctors and don’t think that doctors will mislead them.”

Many dermatologists agree that supervising physicians should assess and evaluate patients prior to ordering treatment, prescribe or order medical treatments, demonstrate competency in procedures being performed, and be physically on-site or readily available within a specific time frame. Ultimately, the supervising physician is responsible for patient safety, Dr. Brod noted, regardless of who performs the procedure.[pagebreak]

Common ground

Dermatologists looking to get involved in regulatory efforts should team up with other specialists, such as plastic surgeons, facial plastic surgeons, otolaryngologists, and ophthalmologists. This needs to be made a house of medicine issue, Dr. Brod said the legislators and regulators don’t like to see infighting among the different medical specialties. “If that hurdle is not overcome, it will be much more difficult to adopt higher standards.”

Dr. Green knows firsthand the importance of finding common ground on this issue. He worked with plastic surgeons and otolaryngologists to get regulations passed in Maryland. “You have to find good compromises for everyone involved,” he said. “We can’t do it ourselves as dermatologists. You have to do it as a cohesive group of doctors because that’s what the medical board or state legislature will listen to.”

In addition to working with other specialties and the state dermatology society, Dr. Zanolli stressed the importance of utilizing available resources, such as the AADA’s model legislation/regulation on medical spa standards of practice. The model statute offers the necessary regulations to provide oversight of the medical spa industry and enact important patient safeguards. Additionally, it can be adapted to account for existing state laws.

“The AADA’s resources are very helpful because the Academy knows the type of language that encompasses the concern about patient safety and regulation, and it knows what’s happening in other states,” he said. The American Society for Dermatologic Surgery has published Guidelines for Ethical Patient Safety Practices as well as patient safety tips when considering cosmetic procedures in a spa or salon. The AADA’s Complete State Regulation of Medical Spa Facilities Toolkit will be available online at aad.org this fall. For more information on AADA’s resources to support state regulations of medispas, contact the AADA at (202) 842-3555 or email Kathryn Chandra, the Academy’s assistant director of state policy, at kchandra@aad.org.

“When these types of procedures are performed in a spa-like setting, it creates an air that what’s going on in there is neither dangerous nor life-threatening, and that nothing can go wrong,” Dr. Brod concluded. “That gives a false sense of security to the public.”

Dr. Derick added, “My goal is to build relationships with my patients. But these medical spas go in and out of business. For them, it’s a business transaction at a low price with uncertain outcomes. That’s very different than going to a doctor who you will know for 30 years.”


New video highlights cosmetic treatments

The American Academy of Dermatology recently developed a patient-focused video that addresses the importance of seeking a skilled and experienced physician for cosmetic treatments.

In the video, which features Amy Derick, M.D., consumers are encouraged to ask the following questions:

  • What are the doctor’s credentials?
  • Is he or she board certified?
  • How many of these specific cosmetic surgery procedures has the physician performed?
  • What results can be expected?
  • Are there any risks?

To view the video on the AAD website, go to www.aad.org/skin-care-and-safety/skin-health-tips/who-should-be-providing-your-cosmetic-treatment-faqs.



 

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New video highlights cosmetic treatments