By Vanessa Orr

Semiglutide, an antidiabetic medication used for the treatment of type 2 diabetes, has recently become very popular as a weight loss drug. Endorsed by celebrities like Oprah Winfrey, the drug’s increasing popularity has created shortages in the market, and practices are having a difficult time finding it for their patients.

As a result, medical providers are going to compounding pharmacies to get the drugs made. Unfortunately, the resulting products are not FDA approved, resulting in risks for both patients and the practitioners who prescribe them.

“The only drug approved by the FDA for weight-loss use is Wegovy®. Ozempic® and Rybelsus® are only approved by the FDA for Type 2 diabetes use,” explained Kyla Murphy, AVP National Healthcare Practice, Risk Strategies. “As with any new drug, no one knows what the risks are and what will happen long-term; in fact, several state governments have already stepped in to stop practitioners from using these compounded drugs.”

Novo Nordisk, which manufactures Wegovy®, Ozempic® and Rybelsus®, has filed suit against a number of compounding pharmacies and medical spas using compounded drugs, claiming false advertising, trademark infringement, and unlawful sales of an off-label compound.

Patients have also begun suing practitioners who have prescribed these medications after suffering negative events or after taking the drugs for a specified period of time and undergoing serious side effects when they stop.

“This has created an issue with providers trying to secure insurance. Since these compounded drugs are not FDA-approved and companies are being sued by Novo Nordisk for providing them, insurance companies that provide professional liability insurance do not want to insure any doctors using these compounded drugs,” said Tom Murphy, SVP National Healthcare Practice, Risk Strategies. “We’ve already been approached by a number of doctors who have opened medspas and are providing weight loss drugs, and the majority are using compounding pharmacies because there is such a demand for it.”

Part of the attraction of providing these compounded products is that it is an all-cash business, as health insurance, Medicare and Medicaid are not paying for it at this time. While that may change in the future, if insurers can be convinced that an obese person using one of these products can lose weight and in turn, improve their overall health, the fact that it is now being used aesthetically is causing pushback from health insurance carriers.

As with any drug or prescription, doctors prescribing these types of medications need to perform a good faith exam and look into the weight loss needs and family history of any patient who may use them. “They also need to have a good legal team behind them to write up consent forms and make sure that a specific treatment plan is in place,” said Kyla Murphy. “And they need to be honest with patients about the risks and regulations for using semiglutides.”

As patients continue to demand these products and doctors continue to provide them, it’s especially important that doctors, nurse practitioners and other medical professionals measure whether the risks outweigh the rewards.

“Everyone wants a quick fix,” said Tom Murphy, “and if it works, and the person has no side effects or health issues, more power to them. But providers need to know the pitfalls associated with them, and also realize that we don’t know the long-term effects of these medications at this point.

“If a doctor prescribes a medication that is not FDA-approved, and the patient has a bad outcome and sues for damages, the defense will have a hard time explaining why the doctor is using a non-FDA approved drug,” he added. “That’s why insurance companies don’t want to cover them. While it is not illegal to provide off-brand drugs, it is much harder to find insurance coverage for doctors who prescribe them.”

He adds that even if a doctor already has insurance, if they did not disclose their use of non-FDA approved drugs on the application, the insurance company may not cover them in a lawsuit.

For more information, contact Kyla Murphy at Kyla.murphy@risk-strategies.com or Tom Murphy at tmurphy@risk-strategies.com or call 800-966-2120.