New Joint Advisory Opinion Re: IV Therapy

Some level of basic health screening generally occurs prior to the selection and administration of an IV therapy cocktail. 

Generally, “wellness” IV therapy is self-paid by the person seeking treatment.

While some IV therapy clinics are provider-owned medical corporations, there is a national trend of business ownership by individuals who are not clinicians, or whose scope of practice does not include the authorization to establish a provider-patient relationship, evaluate a patient for IV therapy, and order the IV cocktail for the patient.   

Best Practices for the Provision of IV (Hydration) Therapy in West Virginia

The Boards encourage all providers of retail IV therapy to conform with the following best practices when offering IV therapy to persons in West Virginia. 

1.  IV therapy, including IV hydration therapy, is the practice of medicine.

2.  The administration of IV therapy pursuant to an appropriate, legal order, is a common intervention in nursing practice.

3.  IV therapy requires the insertion of a needle into a patient’s vein for the intravenous administration of fluid into a patient’s bloodstream, monitoring the patient during and at the conclusion of treatment, and removal of the IV catheter thereafter. This is a medical procedure which requires supervision by licensed health professionals.  

4.  A person who receives IV hydration therapy is a patient, and an appropriate medical record for the patient must be created and maintained. The record should be available to the patient and other treating providers and should be maintained in a manner that is HIPAA compliant and comports with the medical record retention and confidentiality requirements of West Virginia law.

5.  To provide IV therapy, a provider must first establish a provider-patient relationship with the patient.  A provider-patient relationship is formed when a provider serves a patient’s medical needs, examines, diagnoses, or treats a patient, or agrees to examine, diagnose, or treat a patient.[5] 

6.  Physicians may assess patients for IV therapy.  Physician assistants (“PAs”) and advance practice registered nurses (“APRNs”) who are practicing within their education, training, and experience (and within the scope of their respective professions) may also assess patients for IV therapy.  The provider assessment requires the provider to personally evaluate the patient, diagnose the patient, and make treatment recommendations. 

7.  A provider should obtain and document informed consent in the medical record prior to the delivery of care. 

8.  IV saline, and any after-market additives are drugs which require a prescription (or order) to administer.  IV therapy cannot be administered without a valid prescription (or order).

9.  Physicians, PAs and APRNs should only order IV therapy if they, as the assessing provider, determine it would be beneficial to the patient. The prescription or order must be part of a medically prescribed plan of care that includes a personal examination and a bona fide patient relationship.

10.  Physicians, PAs and APRNs should not issue “standing orders” for a retail IV therapy business, or its employees, to provide IV therapy to patients.  A standing order does not create an independent provider-patient relationship between individual persons and the provider or the IV therapy business.   IV therapy should not be administered based upon a standing order.    

11.  The administering of IV therapy requires a professional license. A licensed person other than the physician, PA or APRN may administer IV therapy only if the administration of IVs is within that licensee’s scope of practice. 

12.  Registered nurses (“RNs”) may participate as part of the care team at an IV hydration clinic.

13.  RNs may insert and remove IV catheters and monitor patients before, during and after IV therapy is administered.  The on-site presence of a physician, PA, or APRN is not required for an RN to administer the prescribed/ordered IV hydration; however, the RN must have the knowledge, skill, and competency necessary to carry out the administration procedures and monitor the client in a safe manner. The RN should perform a nursing evaluation and  monitor the patient for such things as side effects, toxic effects, allergic reactions, unusual and unexpected effects, changes in a patient’s condition that contraindicate continued administration of the pharmaceutical or treatment regimen, and effects that may rapidly endanger a client’s life or well-being. An RN should be prepared to make judgments and decisions concerning actions to take in the event such effects occur and should document all nursing acts performed by the RN in carrying out the IV administration and noted during the monitoring of the patient during administration.

14.  In the practice of IV therapy, physicians and advanced practice providers may not delegate or authorize RNs to:

a.  Prescribe or order IV therapy.

b.  Independently recommend or approve the patient’s “selection” of a specific IV hydration cocktail.

c.  Administer IV therapy without a valid prescription order from the prescribing provider who has an established a provider-patient relationship with the patient and has determined that a specific IV therapy would be beneficial to the patient.

d.  Compound IV therapy cocktails.   

15.  The term “compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug or device. The FDA has cautioned that patients can be significantly harmed when drugs are compounded in a way that does not assure sterility and quality.

16.  IV therapy cocktails are compounded drugs.  Adding vitamins, minerals, or prescription drugs to a bag of saline solution is compounding. 

17.  Drug compounding must follow specific safety, stability, and sterility guidelines (as defined by USP 797, 2023 revised standard for immediate use only compounds), and may only be undertaken by licensed pharmacists and, in certain circumstances, legally qualified practitioners of medicine.  

18.  Providers who order IV therapy and who do not receive compounded end-use cocktails from a licensed pharmacy should only compound IV therapy cocktails if they have the education, training, and experience to ensure the safety, stability, and sterility of the final product.

19.  Legally qualified providers of medicine who elect to engage in the compounding of IV therapy cocktails should personally compound the cocktails they order for their patients. Providers should only delegate the compounding of IV therapy cocktails to other legally qualified members of the treatment team. 

20.  Treatment provided to a patient pursuant to a provider’s order for IV therapy falls within the supervision and professional responsibility of the ordering provider. 

21.  Retail IV hydration clinics which are not owned by providers with prescriptive authority shall not exercise influence or control over the provider’s independent exercise of medical judgment in the treatment of any patient. 

If a licensed provider has questions concerning any of the guidelines set forth herein, the licensee should contact their licensing board for additional information. If a non-licensed retail IV therapy business owner has questions about these guidelines, the owner should contact any of the Boards responsible for this Joint Advisory Opinion.