Purpose

This document outlines the rules and regulations of the Department of Public Health, Drug Control Program governing the practices and activities of a nurse anesthetist involving controlled substances (i.e., prescription medications, including anesthetics and therapeutics).

Regulatory Background

The practices and activities of a nurse anesthetist involving controlled substances are governed by M.G.L. chapters 112 and 94C, as amended by Chapter 191 of the Acts of 2010, as well as regulations of the Board of Registration in Nursing at 244 CMR 4.00, and the Drug Control Program (DCP) at 105 CMR 700.000 and 105 CMR 721.000. In addition, regulations of the Board of Registration in Medicine at 243 CMR 2.00 govern the practices of the supervising physician for the nurse anesthetist. A statement on physician supervision of nurse anesthetists is available on the Board of Medicine's website at www.mass.gov/massmedboard.

Practices and activities involving the ordering of tests and diagnostics are outside the scope of this guidance and are regulated by the Board of Registration in Nursing for nurse anesthetists and the Board of Registration in Medicine for supervising physicians.

Licensure and Registration

Prior to practicing, a nurse anesthetist is required to have current Registered Nurse licensure and authorization for Advanced Practice by the Board of Registration in Nursing in the category of Nurse Anesthetist. Advanced Practice that involves controlled substances requires a supervising physician pursuant to the Board's regulations at 244 CMR 4.00.

Requirements for nurse anesthetist registration with the DCP for activities involving controlled substances are the same as those for other Advanced Practice Nurses. A nurse anesthetist may perform certain activities without registration, as outlined below, provided such activities are pursuant to the signed order of a health care provider registered with the DCP to prescribe controlled substances in accordance with 105 CMR 700.000 ("registered prescriber"). As provided by Chapter 191 of the Acts of 2010 and regulations at 105 CMR 700.000, a nurse anesthetist may also obtain his/her own registration, the Massachusetts Controlled Substances Registration (MCSR), to conduct additional activities with controlled substances, also outlined below.

Controlled substance means a drug, substance, or immediate precursor in any schedule referred to in M.G.L. c. 94C or 105 CMR 700.000. All prescription drugs are controlled substances in Massachusetts (regardless of federal scheduling), including anesthetics and many therapeutics.

Activities Allowed Without and With Registration

The following sections describe the activities involving controlled substances that are allowed without and with a MCSR.

It should be noted that regulations of the Board of Registration in Nursing state that administration of anesthesia by a nurse anesthetist directly to a patient does not require a written prescription. However, as also stated in the Board's regulations, this provision does not change the requirement in DCP's regulations for a written medication order for a nurse anesthetist without a MCSR to administer anesthesia.

Administration of Medications, including Anesthesia, by a Nurse Anesthetist without a MCSR

A nurse anesthetist without a MCSR may administer a controlled substance only pursuant to the signed order of a registered prescriber The requirement for an anesthesia order signed by a supervising physician or designee may be met by specific anesthesia protocols, which may, in turn, be documented in collaborative guidelines pursuant to Board of Registration in Nursing regulations at 244 CMR 4.25. The required elements of the anesthesia protocols must include, but are not necessarily limited to, date of the orders or protocols, name of the patient, name(s) of the anesthetic(s) that may be used, the protocol for selecting an anesthetic(s), and the protocol for determining the dosage, strength, route of administration and dose interval.

For the element of the anesthesia protocols requiring the "name of patient" it would be sufficient to stipulate in the protocols, "any patient ordered by the supervising physician to receive anesthesia pursuant to these protocols". "Date" would sufficiently be described as the effective dates of the protocols (i.e., the effective date and expiration date). The remaining elements would be in protocol format.

Prescribing, Ordering, Dispensing and Administering Medications by a Nurse Anesthetist with a MCSR

In order to prescribe or issue a medication order for a controlled substance, or dispense or administer a controlled substance, as a registered prescriber, a nurse anesthetist must have current Registered Nurse licensure, Board authorization to practice in the category of Nurse Anesthetist, current registration (i.e., MCSR) with DCP and, where appropriate, registration with the U.S. Drug Enforcement Administration (DEA).

In accordance with regulations of DCP and the Boards of Registration in Nursing and Medicine, provided prescriptive guidelines mutually developed and agreed upon with a supervising physician are in place, a duly registered nurse anesthetist may conduct the following specific activities with a controlled substance during the immediate peri-operative care of a patient:

  • Issue a written prescription for a controlled substance
  • Issue a written or verbal medication order directing an individual licensed and authorized by M.G.L. c. 94C to administer to an ultimate user
  • Administer a controlled substance without the order of a physician
  • Dispense a controlled substance for immediate treatment
  • Dispense a controlled substance sample

With respect to the administration of anesthesia, a nurse anesthetist with a MCSR must have anesthesia protocols documented in collaborative guidelines as noted above for a nurse anesthetist without a MCSR.

Additional Information

This guidance is not intended to be an exhaustive treatment of the rules and regulations governing the practices and activities of a nurse anesthetist relative to controlled substances. For additional information, please consult the statutes and regulations or contact the Drug Control Program at 617-983-6700 or dcp.dph@state.ma.us.

8/26/11


This information is provided by the Drug Control Program within the Department of Public Health.