JAN-FEB 2019

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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24 JANUARY/FEBRUARY 2019 | Med Esthetics must also make every effort to ensure that that the patient understands what is being discussed. "As far as disclosure, there is no legal requirement to put everything in writing," says Reyero. "This can often be accomplished verbally." If there has been a verbal discussion, the patient will need to sign a form stating that the physician has provided the information needed to make a sensible decision. How- ever, going beyond legal requirements and documenting what was discussed provides an extra layer of protection to the provider and facility. "Nothing prevents you from putting more information than is required down on paper, and I would say that is the best-case scenario," says Reyero. "It's very hard to argue that someone did not disclose something to you if it is in writing on a page that the patient signed or initialed." Going Off Label In the medical aesthetics industry, as in all of healthcare, physicians often utilize medications or devices in ways that are not explicitly approved by the U.S. Food and Drug Administration (FDA). This is known as "off-label" use. One might presume that informed consent takes on even greater importance when a product or procedure is used off-label. But there is no current legal requirement to dis- close this information. "There is nothing in the informed consent doctrine that specifi cally requires a physician to say, 'This is an off-label use,'" says Reyero. "Off-label use means that the FDA hasn't approved this particular drug or this particular device for this particular use. But that doesn't mean usage is inherently less safe. This is why there is no specifi c require- ment or duty for a physician to disclose that information." Still, it may be a good idea to include this information when providing informed consent to patients. This added level of transparency will never hurt from a legal stand- point and can add an extra layer of transparency, especially if the disclosure would likely affect a patient's decision to undergo the treatment or procedure. Providers should ask themselves, are these risks that a reasonable person might wish to know about before accepting treatment? If so, disclosure makes sense. In their November 2008 paper "Informed Consent and Shared Decision-Making: A Requirement to Disclose to Patients Off-Label Prescriptions," published in PLoS Medicine, Michael Wilkes and Margaret Johns of the University of Cali- fornia, Davis argue that physicians are required to disclose off-label usage as it amounts to experimental use of a drug or device. They write, "In many ways the patient given an off-label prescription is involved in an 'n of one' research trial and should be required to provide informed consent." Clinical Trials If a physician is conducting clinical research and wishes to use a patient as a participant, the informed consent process is vital and must be handled with the utmost care. "The FDA has a comprehensive set of requirements for in- formed consent with respect to clinical trials or research," says Reyero. These guidelines can be found on the FDA's website under "Informed Consent for Clinical Trials." Additional information on obtaining informed consent for clinical trials is available through the U.S. Department of Health and Human Services' Offi ce of Human Research Protections ( In general, subjects must understand the purpose of the research, the length of the trial, that they may be exposed to unknown risks, that they may not benefi t from the clinical trial, what discomfort they may experience and that participation is a voluntary decision. State Considerations The trend from the early 20 th century to today has been toward stricter informed consent regulations, and informed consent requirements vary from state to state. So practices and providers need to review their informed consent pro- cesses based on both federal and state regulations. "The public and the courts have consistently pushed for more transparency in healthcare, so practices and medspas are wise to err on the side of providing more disclosures than fewer," says Reyero. "My rule of thumb is always to disclose as much information as possible, because it can only protect you." Alex R. Thiersch, JD, is a healthcare attorney who represents medspas and aesthetic medical professionals. He is the founder and director of the American Med Spa Association (AmSpa) and a partner at the ByrdAdatto law fi rm. Contact him at LEGAL ISSUES If a physician is conducting clinical research and wishes to use a patient as a participant, the informed consent process is vital and must be handled with the utmost care.

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