New Mexico Register / Volume XXXIII, Issue 3 / February 8, 2022

This is an amendment to 16.10.11 NMAC, Section 7, 9, 10 and 12 effective 2/8/2022.

16.10.11.7 DEFINITIONS:

A. “Alternate supervising physician” means a physician who holds a current unrestricted license, is a cosignatory on the notification of supervision, and agrees to act as the supervising physician in the supervising physician’s absence with no change to the scope of practice or protocol of the pharmacist clinician. The alternate supervising physician must be approved by the board or designee.

[A.] B. “Consultation” means in person, telephonically, by two-way radio, by e-mail or by other electronic means.

[B. “Alternate supervising physician” means a physician who holds a current unrestricted license, is a cosignatory on the notification of supervision, and agrees to act as the supervising physician in the supervising physician’s absence with no change to the scope of practice or protocol of the pharmacist clinician. The alternate supervising physician must be approved by the board.]

C. “Dangerous drug” means a drug, that because of any potentiality for harmful effect or the methods of its use or the collateral measures necessary to its use, is not safe except under the supervision of a physician licensed by law to direct the use of such drug and the drug prior to dispensing is required by federal law and state law to bear the manufacturer’s legend “Caution: Federal law prohibits dispensing without a prescription”.

D. “Pharmacist clinician” means a pharmacist with additional training required by regulation adopted by the New Mexico board of pharmacy in consultation with the New Mexico medical board and the New Mexico academy of physician assistants, who exercises prescriptive authority in accordance with guidelines or protocol.

[C.] E. “Scope of practice” means duties and limitations of duties placed upon a pharmacist clinician by their supervising physician and/or the alternate supervising physician(s) and the board; includes the limitations implied by the [field of practice] specialty of the supervising physician and/or the alternate supervising physician(s), the training and experience of the pharmacist clinician and the board.

F. “Supervising physician” means a physician, or group of physicians who hold a current unrestricted license and are approved by the board to supervise a pharmacist clinician and includes a physician approved by the board as an alternate supervising physician.

G. “Written Protocol” means a written agreement between a pharmacist clinician or group of pharmacist clinicians and a physician or group of physicians that delegates prescriptive authority.

[4/5/1997, 4/27/2000; 16.10.11.7 NMAC - Rn & A, 16 NMAC 10.11.7, 1/10/2007; A, 2/8/2022]

16.10.11.9 APPROVAL OF SUPERVISING PHYSICIANS: A physician shall only be approved as a pharmacist clinician supervisor after the pharmacist clinician registers with the board by submitting an application for authority to practice under the supervision of a licensed physician. The application shall include:

A. the name, address, phone number of the applicant and his/her proof of current certification as a pharmacist clinician by the board of pharmacy;

B. the name, address, and phone number of the supervising physician;

C. a written protocol agreed to and signed by the pharmacist clinician and the supervising physician that shall include:

(1) a statement identifying the physician authorized to prescribe dangerous drugs and the pharmacist clinician who is a party to the guidelines or protocol;

(2) a statement of the types of prescriptive authority that the pharmacist clinician is authorized to make within his scope of practice which may include:

(a) a statement of the types of diseases, dangerous drugs or dangerous drug categories involved and the type of prescriptive authority authorized in each case; and

(b) a general statement of the procedures, decision criteria or plan the pharmacist clinician is to follow when exercising prescriptive authority;

(c) a statement of the activities the pharmacist clinician is to follow in the course of exercising prescriptive authority, including documentation of decisions made and a plan for communication to and consultation with the supervising physician concerning specific decisions made; documentation may occur on the prescriptive record, patient profile, patient medical chart or in a separate log book; and

(d) a statement that describes appropriate mechanisms for reporting to the physician the pharmacist clinician’s activities in monitoring the patients; and

(e) a statement that describes provisions for immediate communication or consultation between the pharmacist clinician and the supervising physician or alternate supervising physician.

D. The pharmacist clinician may be authorized in the protocol to monitor dangerous drug therapy as follows:

(1) collecting and reviewing patient dangerous drug histories;

(2) measuring and reviewing routine patient vital signs including pulse, temperature, blood pressure and respiration; and

(3) ordering and evaluating the results of laboratory tests relating to dangerous drug therapy, including blood chemistries and cell counts, controlled substance therapy levels, blood, urine, tissue or other body fluids, culture and sensitivity tests when performed in accordance with guidelines or protocols applicable to the practice setting.

E. A pharmacist clinician may only prescribe controlled substances if he/she:

(1) has obtained a New Mexico controlled substances registration and a drug enforcement agency registration, and

(2) prescribes controlled substances within the parameters of written guidelines or protocols established under these regulations and Section 3, A. of the Pharmacist Prescriptive Authority Act.

[ F. The protocol for each pharmacist clinician shall be reviewed by the board as least every two years.]

[G.] F. A pharmacist clinician shall perform only those services that are set forth in the protocol.

[H.] G. Pharmacist clinicians may prescribe only those drugs described in a board approved protocol.

[I.] H. A physician may supervise as many pharmacist clinicians as the physician can effectively supervise and communicate with in the circumstances of their particular practice setting.

[ J. Within thirty days after an employer terminates the employment of a pharmacist clinician, the supervising physician and/or the pharmacist clinician shall submit a written notice to the board providing the date of termination and reason for termination. The pharmacist clinician shall not work as a pharmacist clinician until the board approves another supervising physician.]

[4/5/1997, 4/27/2000; 16.10.11.9 NMAC - Rn & A, 16 NMAC 10.11.9, 1/10/2007; A, 1/2/2008; A, 2/8/2022]

16.10.11.10 THE PHYSICIAN’S REQUIREMENTS OF SUPERVISION:

A. Supervising physicians must provide direction to pharmacist clinicians to specify the pharmacotherapeutic services to be provided under the circumstances in each case. This may be done by written protocol or by oral consultation. It is the responsibility of the supervising physician to assure that the appropriate directions are given and understood.

B. Supervising physicians must establish a quality assurance program for review of medical services provided by the pharmacist clinician.

C. If the supervising physician is of the opinion that circumstances warrant exceptions to the requirements set forth in Subsections A or B above, the supervising physician must specify the circumstances in writing and deliver the same to the board. The board will review, grant or deny requests for exceptions or waivers, at the board’s discretion.

D. Documentation of the supervising physician reviews must be retained by the pharmacist clinician and be available for board inspection for a period of not less than [five (5)] three years from the date of such reviews.

E. The pharmacist clinician must have prompt access to the physician by telephone or other electronic means for advice and direction.

F. If the supervising physician plans to be or is absent from his or her practice for any reason, the supervising physician cannot designate a pharmacist clinician to take over those duties or cover the practice during such absence. The supervising physician may designate an alternate supervising physician, approved by the board, to cover the practice and perform the duties of supervising physician. The alternate supervising physician will then supervise the pharmacist clinician and will be responsible for the pharmacist clinician’s actions or omissions in exercising prescriptive authority or other duties as a pharmacist clinician.

G. [In order to change a supervising physician between biennial renewals of registration, without a change to the pharmacist clinician's scope of practice or protocol, a pharmacist clinician shall submit to the board a change of supervising physician form and the required fee, as specified in 16.10.9.11 NMAC. The new supervising physician may only act after the application is approved by the board.] Supervising physician is required to report any supervised pharmacist clinician who is practicing below accepted standards of care to the board.

[4/5/1997, 4/27/2000; 16.10.11.10 NMAC - Rn & A, 16 NMAC 10.11.10, 1/10/2007; A, 2/8/2022]

16.10.11.12 PHARMACIST CLININCIAN SUPERVISOR APPLICATION, RENEWAL AND TERMINATION:

A. Required documentation. Each applicant for a pharmacist clinician supervisor and alternate pharmacist clinician supervisor must submit the required fees as specified in 16.10.9.8 NMAC and the following documentation:

(1) A completed signed application.

(2) Copy of proof of current certification of the pharmacist clinician by the New Mexico board of pharmacy.

(3) A written protocol signed by the pharmacist clinician and the supervising physician, which includes the requirements in 16.10.11.9 C NMAC.

(4) Physicians who have had previous disciplinary action against them will be subject to further review by the board and may be approved, or approved with limitations, or denied. Physicians who had previous disciplinary action may apply to become a pharmacist clinician supervisor or alternate supervisor, the application will be sent to the board for consideration and decision.

B. License expiration. Pharmacist clinician supervisor licenses shall be renewed on July 1. Initial licenses are issued for two years.

C. Process for written protocol. The protocol for each pharmacist clinician shall be reviewed by the board or designee upon new application, if change of supervising physician occurs, or if a written protocol has been changed or modified.

D. Change of supervising physician. In order to change a supervising physician between biennial renewal of approval, without a change to the pharmacist clinician's scope of practice or protocol, an applicant shall submit to the board a change of supervising physician form and the required fee, as specified in 16.10.9.11 NMAC. The new supervising physician may only act after the application is approved by the board.

E. License issuance. Pharmacist clinician supervisor licenses are issued with the name of the pharmacist clinician who the supervisor is authorized to supervise. A copy of the license will be mailed to both the pharmacist clinician and the pharmacist clinician supervisor.

F. Employment Termination/Change. Within [thirty] 30 days after an employer terminates the employment of a pharmacist clinician, the supervising physician shall submit a written notice to the board providing the date of termination and reason for termination. The pharmacist clinician shall not work as a pharmacist clinician except under a current approved protocol and supervising physician.

[16.10.11.12 NMAC - N, 2/8/2022]