The State Medical Board of Ohio, the Ohio Board of Pharmacy and the Ohio Board of Nursing (collectively, the “Boards”) have recently issued a Joint Regulatory Statement addressing the operation of retail IV therapy clinics in Ohio. The Boards’ statement comes in response to the rapid growth of the industry and general uncertainty among providers due to the lack of clear, industry-specific guidance from the state.
Industry Growth and Regulatory Risks for Retail IV Therapy Clinics
The provision of wellness services, including intravenous (IV) therapy, has grown significantly in recent years, becoming a prominent feature in the wellness and med spa industry. Retail IV therapy clinics administer IV fluids through drip IV infusion tubing into a patient’s vein for the treatment of various conditions, including dehydration, migraines, hangovers, nausea, and inflammation, and to promote overall wellness. Clinics will often advertise menus of preselected mixtures (“cocktails”) or additives to basic saline.
The growth of this industry has raised concerns among regulators about patient safety and compliance. Many clinics do not realize that diagnosing, prescribing, mixing and administering IV treatments are all highly regulated under Ohio law. These services involve the practice of medicine, nursing, and pharmacy and, thus, require specific licensure and adherence to the scopes of practice established by Ohio law. Improper licensure, administration, handling or storage, along with failure to follow proper medical protocols, can pose serious legal risks and endanger patient safety.
The Boards’ statement highlights several key areas of focus for any practice offering IV therapy services, including:
- Maintaining appropriate licensure;
- Adhering to relevant scopes of practice;
- Complying with the applicable standard of care;
- Following all compounding rules; and
- Ensuring proper supervision of personnel.
Next Steps
If you operate or work at a retail IV therapy clinic, make sure you are complying with the following requirements when administering IVs:
- A licensed prescriber (i.e., a physician, physician assistant (with prescriptive authority), certified nurse practitioner, certified nurse midwife or clinical nurse specialist) must personally evaluate each client, diagnose the client and make the treatment recommendations;
- The recommendation, compounding and administration of IV medications cannot be pursuant to protocols or standing orders;
- The provider must obtain informed consent and document it in the medical record before administering an IV;
- Personnel of the clinic must only provide services within their licensed scope of practice;
- Generally, if drugs or vitamins are added to an IV solution, it is considered compounding under Ohio law, and the clinic must obtain a license as a terminal distributor of dangerous drugs (TDDD) from the Ohio Board of Pharmacy;
- Drugs must be compounded in a safe and sterile environment consistent with state law; and
- Clinics must only purchase drugs from Ohio Board of Pharmacy license holders.
Protect Your Business
Ohio regulators are not trying to shut down IV therapy clinics, but they are making it clear that you must operate within the legal boundaries set forth under Ohio law. Clinics must provide services through qualified providers, using safe practices and appropriate oversight.
Now that the Boards have issued a formal statement, they may increase enforcement of the applicable regulations. Licensees who fail to comply could face disciplinary proceedings and sanctions by their respective boards, including monetary fines, probation of a license, suspension of a license, or even revocation of a license.
Contact
If you’re unsure whether your Wellness Clinic or Med Spa is compliant, please reach out to Andrew Wilber (AJW@kjk.com) and Isra Ghanem (ITG@kjk.com) to review your procedures and advise further.
By aligning with Ohio’s law and regulations, you protect your business, your license and, most importantly, your patients.