Understanding the Legalities of Off-label Use

The use of pharmaceuticals for treatments that are not specified by the FDA is known as off-label use. This is a very common practice, although many in the medical aesthetic industry may not fully understand the rules that govern off-label use. The fact remains that if physicians use common sense and the medical information that is available, they can avoid legal entanglements. Following are a few details to keep in mind when considering off-label use in a medical aesthetic setting.

Considering Use

In most cases, it is legal for a doctor to use FDA-approved medications in ways that are different from what the label specifically mentions. For example, Botox has been specified by the FDA for use in the treatment of incontinence caused by spinal cord injuries or multiple sclerosis, migraines, upper limb spasticity, pain caused by cervical dystonia, axillary hyperhidrosis (sweating), blepharospasm (eye spasms) in children with dystonia, and strabismus (crossed eyes) in children. The reduction of facial wrinkles was not originally on that list, but it became by far the most prevalent use of the drug, and throughout the past 15 years, Botox has received three indications for cosmetic use. It is typically up to a doctor’s own medical judgment to determine if a medication can be used for other treatments.

Also, it’s worth keeping in mind that the FDA does not govern the practice of medicine; it governs drugs. State medical boards govern the practice of medicine. Therefore, a board-certified doctor can determine how to use a 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 health care and business law firm. “The FDA is not in the business of regulating physicians. If you as a physician want to do something that’s off-label, you don’t need to seek the FDA’s approval.”

In fact, off-label use has led to medical breakthroughs in the past. Aspirin, for example, was originally specified only to treat headaches—after it was introduced, doctors discovered that it thins the blood, and they began using it to treat heart congestion. (It has since been specified by the FDA for use in heart patients.) In the medical aesthetic industry, doctors have been known to try to use fillers and neuromodulators in innovative ways to try to solve unusual problems presented to them by patients.

One in five prescriptions is for off-label use, according to The Agency for Healthcare Research and Quality (ahrq.gov)

Regulatory Issues

Should patients and medical aesthetic staff members worry about their doctor conducting off-label treatment? Generally, the answer is no, because it is up to the doctor’s judgment, and one can reasonably assume that that judgment is informed by thoughtful research and years of experience.

“The physician has the ability to treat patients based on their own medical knowledge, what other peers are doing, what is documented in medical journals that are out there, or experiments they’ve done,” Mr. Adatto says.

However, doctors also have been known to use drugs on patients for more experimental purposes, and when that happens, state medical boards can intervene.

“If a physician is providing off-label treatment that no other physician is administrating, and there are no medical journal articles on the use of this drug for a particular treatment, the physician can quickly fall outside the medical standard of care,” says Mr. Adatto. “This can cause issues with their malpractice insurance and their medical board. It is also important to note that the state where the treating physician is furnishing off-label treatment controls if it is within the medical standard of care. As such, even if physicians in other states are rendering an off-label treatment with the drug, your state must approve the same off-label treatment. Otherwise, the physician could then be in trouble with their medical board for experimental use that’s outside the medical community standard of care. Providers don’t want to be going in a situation where a medical board does not approve of, or believes it is too experimental for a patient.”

If physicians are found to be using pharmaceuticals irresponsibly, they could be censured by the medical board and lose their medical licenses. In addition, they will need to explain their actions to the board.

Reckless Endangerment

In addition to facing sanctions from their state’s medical board, physicians who engage in reckless off-label drug use may be subject to liability issues. If a physician is found to have harmed a patient with his or her off-label pharmaceutical treatments, he or she could be sued for malpractice. If the off-label use resulted in serious injury or death, a doctor can even be subject to criminal prosecution.

You may remember the case of Dr. Conrad Murray, the personal physician for music legend Michael Jackson. Dr. Murray was found complicit in Mr. Jackson’s death because he improperly administered propofol—a drug specified for use as an anesthetic—in order to help the “King of Pop” sleep. He was found guilty of involuntary manslaughter and sentenced to four years in prison.

“Propofol is a drug usually associated with anesthesia, and generally only used for surgery. But Michael Jackson’s physician was using it to help sedate him,” Mr. Adatto says. “This goes back to the main rule, that if not that many doctors were using the drug for an off-label use, like sleep and relaxation outside of a surgery, the physician is subjecting himself to malpractice claims, loss of his medical license, and in this case, jail time.”

A doctor who is administering pharmaceuticals off-label also must be completely forthcoming with the patients being treated and obtain their express consent prior to providing these treatments. Misleading patients as to the specified use of the drugs being administered is another excellent way for a doctor to attract the attention of a state medical board.

“If a provider is telling a patient that this drug has been approved for a particular condition, and the FDA has not approved it for that condition, the state medical board can consider that the doctor is providing false or misleading information,” Mr. Adatto says. “When you’re treating a patient for an off-label use, make sure you provide the proper risk discloses and obtain the applicable consents.”

In order to prove he or she has properly acquired consent for these treatments, the physician should be sure to get it in writing.

“We would always recommend to physicians that if you are going to be using a drug off-label, make sure you have a written consent that then describes the risk, so that a patient can also acknowledge that they received this information both orally and in writing,” Mr. Adatto says. “That’s going to protect the physician, showing that they did tell this particular patient that they were using this drug for an off-label use, and the patient understood that and assumed some of those risks.”

Sensible Solutions

Off-label use can be a particularly tricky issue in medical spas, since non-doctors are sometimes the ones administering these treatments. Everyone in a medical aesthetic practice must understand that off-label use is a medical decision that is to be made only by a doctor. For example, a nurse administering an off-label pharmaceutical must be following a doctor’s order, and the decision needs to be established following proper delegation protocols.

If a doctor uses good judgment backed by research and is forthcoming with patients about why he or she wants to administer that drug in a manner that is not directly approved by the FDA, off-label use should result in no legal issues. However, obtaining patient consent is vitally important in cases such as these, so doctors should consult with their health care attorneys to verify that the consent they obtain will shield them from potential action. (Author’s note: The American Med Spa Association [AmSpa] works with a national law firm that focuses on medical aesthetic legalities and, as a member, along with a number of other great benefits, you receive a discount off of your initial consultation. To learn more, log on to www.americanmedspa.org.)

In many cases, doctors who provide off-label treatments are are doing so in the best interests of their patients. Providing them the leeway to do so has led to important medical breakthroughs and changed countless lives for the better. As long as doctors take the proper precautions, off-label use is perfectly acceptable from a legal standpoint.