A request was received for an opinion on the administration of Versed (midazolam) via an intranasal route in school settings, if a nurse can refuse to administer this medication, and if the nurse may delegate its administration to unlicensed personnel.
Following discussion of the questions posed, review of the statutes governing nursing practice, and the manufacturer’s drug literature, it was the advisory opinion of the Board that nursing practice should be consistent with the Kentucky Nursing Laws, established standards of practice, and be evidenced based.
A nurse who administers any medication, including a medication prescribed for non-FDA approved uses (such as Intranasal Versed), is responsible and accountable for the components of medication administration stated in the Kentucky Nursing Laws, KRS 314.011(6)(c) as follows: "…Components of medication administration include, but are not limited to:
- Preparing and giving medications in the prescribed dosage, route, and frequency, including dispensing medications only as defined in subsection (17)(b) of this section;
- Observing, recording, and reporting desired effects, untoward reactions, and side effects of drug therapy;
- Intervening when emergency care is required as a result of drug therapy;
- Recognizing accepted prescribing limits and reporting deviations to the prescribing individual;
- Recognizing drug incompatibilities and reporting interactions or potential interactions to the prescribing individual; and
- Instructing an individual regarding medications."
A nurse who does not have the knowledge, skill, or requisite information to support the use of a prescribed medication cannot adequately carry out his/her responsibilities to administer the medication in a safe manner. Subsequently, the nurse should refuse to administer the medication; however, the nurse should seek out resources to gain the
requisite knowledge and skill for potential future practice. The prescriber should be notified of the situation as well.
The Board has issued Advisory Opinion Statement (AOS) #14 entitled Roles of Nurses in the Implementation of Patient Care Orders. Section 5 provides information on the duty of the RN to exercise independent and sound judgment based upon the nurse’s individual educational preparation and experience, nurse responsibility and obligation to question an order that is deemed inappropriate by the nurse according to his/her educational preparation and clinical experience, and reference to KRS 314.021(2).
KRS 314.021(2) holds all nurses individually responsible and accountable for his/her acts based upon the nurse's education and experience. Each nurse must exercise professional and prudent judgment in determining whether the performance of a given act is within the scope of practice for which the nurse is both licensed and clinically competent to perform. The Kentucky Board of Nursing has published Scope of Practice Determination Guidelines that contain a decision tree chart providing guidance to nurses in determining whether a selected act is within an individual nurse's scope of practice.
A school system should determine, in an established written policy and procedure, the drugs that may be administered in a school setting. This determination should be based upon, but not limited to, the training and skill of the nurse, resources available, access to emergency medical services and other interventions that could be instituted.
Intranasal Versed for control of seizures is being prescribed for a non-FDA approved use. In a FDA Information Sheet (1998 Update) on Off-Label Use of Marketed Drugs, Biologics, and Medical Devices, the FDA advises: Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics, and devices according to their best knowledge and judgments. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects. Use of a marketed product in this manner, when the intent is the “practice of medicine,” does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE), or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.
The Practice Committee deferred issuing a recommendation to the Board regarding the delegation of Intranasal Versed administration to unlicensed personnel at this time.