MAY-JUN 2018

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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Using pharmaceuticals "off-label"—that is, in ways that are not specifi ed by the United States Food and Drug Admin- istration (FDA)—is technically legal but somewhat contro- versial in aesthetic medicine. Decisions regarding off-label usage should be based on current standards of care, the best interest of the patient, and your own training and expertise within the medical fi eld. Following are some important points to consider when examining the off-label use of pre- scription products in your practice. THE LEGALITY OF OFF-LABEL USAGE Medical boards—not the FDA—govern the practice of medicine. So once the FDA approves a product, it is up to the physician to determine how to use that particular drug. "To be very, very clear, the FDA has no ability—zero ability—to have any control over how a physician practices medicine," says Bradford Adatto, partner for ByrdAdatto, a Dallas-based healthcare and business law fi rm. "The FDA is not in the business of regulating physicians. If you as a physician want to use a product for an off-label indication, you do not need to seek the FDA's approval." In fact, off-label use has led to many medical break- throughs. Aspirin was originally approved to treat head- aches. After it was introduced, doctors discovered that it also thins the blood and began using it to combat heart congestion. (The FDA has since specifi ed aspirin for use in heart patients.) In the medical aesthetics industry, doctors have learned to use botulinum toxins in innovative ways to solve unique problems presented by patients, often leading to new FDA approvals, such as Botox for forehead lines. STANDARD OF CARE CONCERNS While the FDA has no jurisdiction over how a physi- cian practices medicine; medical boards and insurance companies are another story. When examining medical negligence claims involving off-label usage of drugs, medical boards look at the physician's training, knowledge and li- censure, as well as current standards of care. This includes how other physicians use the same products or drugs, what is documented in the medical literature, opinions of colleagues, and ultimately, what is in the best interest of the patient. Reckless off-label use of a drug or drugs can lead to legal liability issues and medical board sanctions. If the off-label treatment results in serious injury or death, the doctor may be subject to criminal prosecution. "If a physician provides off-label treatments that no other physician is administering, and no literature supports the use of this drug for that particular treatment, the physician can quickly fall outside the medical standard of care," says Adatto. "This can cause issues with their malpractice insur- ance and state medical board. Providers do not want to be in a situation where a medical board believes a treatment is too experimental." 26 MAY/JUNE 2018 | Med Esthetics © GETTY IMAGES LEGAL ISSUES | By Alex R. Thiersch, JD Legal, ethical and informed consent considerations when using products off-label. OFF-LABEL USE

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