The mission of the Texas Board of Nursing (BON or Board) is to protect and promote the welfare of the people of Texas by ensuring that each person holding a license as a nurse in the State of Texas is competent to practice safely. The Nursing Practice Act or NPA (Texas Occupations Code, Chapter 301) and Board Rules are written broadly so they can be applied by every nurse to all of the many different practice settings and specialty areas in nursing across Texas. The BON does not have a list of tasks that nurses can perform because each nurse has a different background, knowledge and level of competence. Determinations of a nurse’s scope of practice are often complex and it is up to the individual nurse to utilize sound professional judgment in accepting any given assignment and/or performing any given procedure.
Ketamine is a schedule three controlled substance1 that has been approved by the U. S. Food and Drug Administration (FDA) as an anesthetic agent2 and has been in use for a relatively long period of time. Ketamine is being used in additional ways for which FDA approval was granted, or in an “off-label” manner. This type of action may be supported by research and literature that addresses the necessary knowledge, required safeguards and risks associated with off-label use of Ketamine. Nurses in Texas are being asked to administer Ketamine off-label for pain management.
When a nurse is considering a specific question, such as “can I administer Ketamine off-label for pain management?” there are documents available on the BON website in Nursing Practice then in Scope of Practice to assist the nurse in arriving at a decision. The Board’s Six-Step Decision-Making Model for Determining Nursing Scope of Practice guides a nurse in deciding if a task is within the nurse's scope of practice. When making these decisions, the model encourages a nurse to consider the six reflective questions using a yes or no answer. If a yes answer is reached on any step, the nurse should proceed to the next step of the decision making model. If the nurse reaches step six with yes answers then the task is most likely within the nurse’s scope of practice. However, if a nurse reaches a no answer on any step the activity is most likely not within the nurse’s scope of practice and the nurse should not proceed with the task. Keep in mind, the answer may not be the same for each nurse.
In the Six-Step Model, step one includes references to documents and information on the BON website, including statutes, rules, and position statements While there is nothing specific in the Nursing Practice Act or Board Rules and Regulations that allows or prohibits the off-label administration of Ketamine for pain management, there are laws and rules that licensed vocational nurses (LVN) and registered nurses (RN) should consider in this decision. For example, the LVN has a directed scope of practice under the supervision of a registered nurse, physician, physician assistant, dentist or podiatrist3. The LVN cares for patients whose healthcare needs are predictable4. When considering the administration of a medication, such as off-label Ketamine for pain management, the predictability of the patient, the patient’s response and the nurse’s skill set required to address the needs of the patient must be considered. If any of these cannot be addressed by the LVN, then it would be beyond the scope of practice of the LVN to administer off-label Ketamine for pain management. Position Statement 15.25, Administration of Medication & Treatments by LVNs, addresses medication administration; however, if the route of Ketamine administration is intravenous (IV), then Position Statement 15.3, LVNs Engaging in Intravenous Therapy, Venipuncture, or PICC Lines, must also be considered.
One of the main rules applicable to a nurse's practice is Board Rule 217.11, Standards of Nursing Practice. When a nurse is considering performing a task, such as the off-label administration of Ketamine for pain management, several standards in section one of this rule, will apply to all LVNs and RNs. Patient safety must be considered in every assignment a nurse accepts5. A nurse must know about the medication, why it is being used, what effects can be expected, and how to administer the medication correctly in order to administer it safely6. Some medications, such as off-label administration of Ketamine for pain management, require an assessment, vital signs, and a pain description and level provided by the patient7. Certain medications require the presence of equipment or monitoring during and following the medication administration due to the potential or known effects of the medication8. Some medications require the nurse administering the medication to have specific skills and current competencies to include emergency interventions should adverse outcomes occur9. Last, but not least, medication administration is not complete without accurate documentation10.
There are several Position Statements that might apply to administration of a medication, such as off-label administration of Ketamine. Position Statement 15.14, Duty of a Nurse in Any Practice Setting, utilizes a landmark court case to illustrate the responsibility a nurse has to advocate for the patient, thus emphasizing the nurse’s critical role in patient safety. Some medication administration is initiated through physician standing orders as addressed in Position Statement 15.5, Nurses with Responsibility for Initiating Physician Standing Orders. Occasionally, a physician delegated act includes medication administration; see Position Statement 15.11, Delegated Medical Acts. There are two position statements that specifically address either the RN or LVN scope of practice in broad terms. These are Position Statements 15.27, The Licensed Vocational Nurse Scope of Practice and 15.28, The Registered Nurse Scope of Practice. While there is a position statement related to moderate sedation that specifically addresses Ketamine, there is not a position statement related to the off-label use of Ketamine for pain management.
Step two of the Six-Step Model directs nurses to look for a valid order and facility policy support. Facility policy may identify specific levels of licensure for the administration of Ketamine, or specific areas or units within the facility where the administration of Ketamine may occur. There may be specific requirements related to current competencies of the personnel who will be administering Ketamine, and for monitoring the patient after the administration of Ketamine. There may be a policy distinction between label uses and off-label uses of Ketamine. When a nurse identifies the safety issues involved in administering off-label Ketamine correctly, looking for an employer’s policy support of the safety measures required may assist a nurse in determining if off-label administration of Ketamine will be safe in a specific setting.
Since nurses are required to administer medications correctly11, what evidence exists to support or refute giving a medication in a way other than approved by the FDA? Step three of the Six-Step Model requires "positive and conclusive data from nursing literature, nursing research, and/or research from a health-related field" and does not negate the requirement for nurses to administer medications correctly. The typical drug reference available to nurses may not include Ketamine, but when Ketamine is included in drug references, it is identified as an anesthetic agent with a specification that IV administration of Ketamine is to be administered by or under the direction of anesthetic personnel. However, there is a growing body of literature related to the use of Ketamine for pain management. One consideration for the nurse is the dosing schedule. Some of the literature indicates pain doses that are significantly lower than the doses used for induction or maintenance of anesthesia, but other literature sources list pain doses up to the lowest anesthetic dosages. A distinct separation between the pain management dose and the anesthetic dose provides a measure of assurance that the medication administration will not venture into the anesthetic usage which is beyond the scope of practice for a nurse. BON staff recommends that the distinction between the pain management dose and the anesthetic dose be clearly defined in a facility’s policies and procedures.
Assuming the dosing schedule for the off-label use of Ketamine in pain management is less than the anesthetic range, and that there is literature support for safe off-label administration of Ketamine for pain management, a nurse should consider steps four, five and six of the Six-Step Model. Step four asks if the nurse has the current competencies to perform the task. If a medication is being given via the IV route, having current skills to assess and intervene are important. If a pump is being used to administer the IV medication, then being familiar with the pump is essential. Step five is for the nurse to consider whether a reasonable and prudent nurse of the same or similar education and similar circumstance would administer off-label Ketamine for pain management. Finally, step six is a personal reflective question and asks the nurse to accept accountability for the actions the nurse takes.
Both the mission of the Board and the nurse's duty to the patient align in favor of patient safety. Therefore, a nurse is obligated to make the safest decision for the patient and using the six-step decision making model for determining scope of practice is one tool to help nurses with this decision whether to accept or refuse12 an assignment related to off-label administration of Ketamine for pain management.
April 2013
1 Texas Department of State Health Services January 2012 Schedules,
http://www.dshs.state.tx.us/Layouts/ContentPage.aspx?PageID=35821&id=3847&terms=controlled+substances+schedule
2 Ketalar Label from FDA website:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016812s039lbl.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=Ketamine&utm_content=17 accessed 5/30/2012
3 Tex. Occ. Code 301.002 (5) & 301.353; and 22 Tex. Admin. Code § 217.11 (2)
4 22 Tex. Admin. Code § 217.11 (2)
5 22 Tex. Admin. Code § 217.11 (1) (B) & (1) (T)
6 22 Tex. Admin. Code § 217.11 (1) (C)
7 22 Tex. Admin. Code § 217.11 (2) & (3)
8 22 Tex. Admin. Code § 217.11 (1) (M)
9 22 Tex. Admin. Code § 217.11 (1) (G), (1) (H), (1) (R), & (1) (T)
10 22 Tex. Admin. Code § 217.11 (1) (D)
11 22 Tex. Admin. Code § 217.11 (1) (C)
12 22 Tex. Admin. Code § 217.20 and Tex. Occ. Code, Sec. 301.352