A request was received for an opinion on the administration of Cytotec by nurses to patients to induce labor. The request reported that the drug is “…not only not Food and Drug Administration (FDA) approved for this use but the drug manufacturer has stern warnings against this in the drug literature…” The request also posed the question as to whether or not a nurse may refuse to administer the medication as prescribed.
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).
Following discussion of the questions posed, statutes governing nursing practice, the advisory opinion statement listed above, 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, is responsible and accountable for the components of medication administration stated in the Kentucky Nursing Laws KRS 314.011(6)(c): "…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."
Since the request indicated that the nurse did not have information to support the use of this drug as prescribed, the nurse could not adequately carry out the responsibilities to administer the drug in a safe manner. Subsequently, until the nurse has acquired the knowledge and skill to safely administer the drug, it is appropriate for the nurse to refuse to administer it; however, the nurse should seek out resources to assist the nurse in gaining the requisite knowledge and skill.
In addition, the facility’s nursing, pharmacy, and medical staffs should serve as resources in providing additional information and potential mechanisms for assisting with the resolution of concerns. The facility should provide policies and procedures addressing the administration of medications to induce labor and patient informed consent.
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.