There is a disturbing trend in the medical aesthetic industry. Many cosmetic practices and medspas are turning to various quasi-medical and even non-medical personnel in the delivery of injectables. I categorize injectables in three ways: botulinum toxins, dermal fillers and sclerotherapy. Botulinum toxins are drugs and available only by prescription. Physicians can dispense them in their offices. They are also available via pharmacies. Contrary to popular belief, botulinum toxins—such as Botox Cosmetic and Dysport—are not directly available to non-physicians, including registered nurses. A registered nurse can inject neurotoxins under the supervision of a physician, but she cannot acquire them.
When utilizing these products, it is prudent to remember that they should be treated as any other prescription medicine. The use of Botox Cosmetic, for example, is a medical procedure. Therefore, it should only be provided in a medical setting by an appropriate medical provider, such as a physician, registered nurse, nurse practitioner or physician assistant working within the scope of his license within his state. The medical provider must be properly employed or contracted with the practice and properly licensed to provide medical services in that state and in that particular medical setting.
A medical spa, for example, is a medical setting only if it is owned by a physician. Non-physician-owned medical spas may be an appropriate medical setting under certain, limited guidelines. (Note: Physicians can perform these procedures anywhere, including in a patient’s home, but I have always advocated not injecting neurotoxins in the patient’s home due to OSHA regulations, HIPAA and medical waste concerns. Nurses, NPs and PAs also can perform the treatment anywhere that is appropriate, if they are working under the physician’s license. Again, I would advise them not to offer these services at Botox parties in a patient’s home.)
Injectable dermal fillers are not prescription per se, but they are medical devices. As such, they are delivered pursuant to the practice of medicine and all state and federal guidelines. This is a distinction without difference because, although they are not prescriptive, medical devices—as categorized by the United States Food & Drug Administration (FDA)—can only be utilized in a medical facility and delivered to patients by an appropriate medical provider.
Sclerotherapy is the injection of sclerosing material (saline and others) into a blood vessel to thrombose the vessel. The procedure is commonly applied to the treatment of leg veins but has more recently been utilized in other parts of the body. Most cosmetic medical providers utilize saline as the sclerosing agent. Saline is not a medical device or product. However, some medical providers utilize sclerosant drugs, such as sodium tetradecyl sulfate or polidocanol. These materials are medical products and any sclerotherapy procedure that utilizes these materials must follow medical practice guidelines appropriate for the particular state. In addition, the treatments can be delivered only in a medical setting. Some spas and salons have begun offering treatments. They are exploiting antiquated laws that were developed for the large-scale delivery of vaccines.