On June 9, 2017, members of the South Carolina State Board of Nursing, the State Board of Medical Examiners and the State Board of Dentistry came together to establish uniform guidance for licensees performing injections of neuromodulators, including Botox, for both cosmetic and non-cosmetic purposes. Prior to this meeting, each board had its own guidance on the use of these products. The product of that meeting was a Joint Advisory Opinion, intended to provide guidance to licensees using neuromodulators, including Botox for a wide variety of reasons including but are not limited to, problems with the Temporomandibular joint (TMJ), overactive bladders, cervical dystonia, chronic migraines, muscle spasms and hyperhidrosis. Each board retained its exclusive authority and responsibility to evaluate the conduct of its licensees within the context of individual facts presented in any disciplinary matter to determine whether conduct complained of constitutes a violation of the respective profession’s applicable statutory and regulatory requirements for professional conduct.
First, a practitioner must be actively licensed to practice dentistry, medicine, or nursing in South Carolina in order to inject neuromodulators for either cosmetic or non-cosmetic purposes. Additionally, any licensee must have documented special education and training regarding the pharmacology of injectable neuromodulators, including but not limited to, contraindications, potential side effects, injection techniques and appropriate injection sites for the condition being treated, applicable storage and sterility requirements, and necessary resuscitative techniques and equipment in the event of an unexpected adverse outcome. Continuing education and competency demonstrated for these procedures is ongoing and must be documented.
Second, it is necessary to establish a bona fide physician-practitioner relationship prior to the injection of any neuromodulator for either cosmetic or non-cosmetic purposes. A medical record must be created for each patient and should include, at a minimum, the following information for each injection: informed consent, diagnosis or description of condition to be treated, record of anatomical location of injection site(s) either via photograph or diagram, dosage, and manufacturer’s lot number.
Third, practitioners should adhere to the FDA and manufacturer’s guidelines for storage, reconstitution, administration, and management of unused product to ensure patient safety.
Fourth, neuromodulators should only be injected in an appropriate clinical setting that ensures sterility and resuscitative capabilities. Each facility where neuromodulators will be injected should have written policies and procedures in place governing these procedures.
Fifth, cosmetic use is a delegable act to an appropriately qualified licensed person pursuant to state law and the physician or dentist must be on site and readily available for any problems that may occur. If a physician assistant is performing the injection, it must be done pursuant to the practice guidelines executed by and established with the supervising physician. If an advanced practice registered nurse (APRN) is performing the injection, it must be done pursuant to the written protocol executed by and established with the supervising physician or dentist. If a registered nurse is performing the injection, it must be done with the on-site supervision of a physician or APRN.
Non-cosmetic use is non-delegable and must be performed by either the physician or dentist.
Finally, patient safety is the responsibility and priority for any licensed practitioner engaged in the injection of neuromodulators, whether for cosmetic or non-cosmetic purposes.
If you are uncertain if your practice meets the requirements of the Joint Advisory Opinion or a complaint has been filed against your licensee, call me to see if I can help (803) 470-4490.