TITLE 16 OCCUPATIONAL
AND PROFESSIONAL LICENSING
CHAPTER 10 MEDICINE
AND SURGERY PRACTITIONERS
PART 11 PHYSICIANS
SUPERVISING PHARMACIST CLINICIANS
16.10.11.1 ISSUING
AGENCY: New Mexico Medical Board, hereafter called the
board.
[4/5/1997,
4/27/2000; 16.10.11.1 NMAC - Rn & A, 16 NMAC 10.11.1, 1/10/2007]
16.10.11.2 SCOPE: This
applies to physicians who supervise pharmacist clinicians.
[4/5/1997,
4/27/2000; 16.10.11.2 NMAC - Rn, 16 NMAC 10.11.2, 1/10/2007]
16.10.11.3 STATUTORY
AUTHORITY: These rules of practice and procedure govern
the practice of medicine in New Mexico and are promulgated pursuant to and in
accordance with the Medical Practice Act, sections 61-6-1 through 61-6-35 NMSA
1978, the Uniform Licensing Act, section 61-1-1 through 61-1-33 NMSA 1978, and
the Impaired Physician Act, section 61-7-1 through 61-7-12 NMSA 1978.
[4/5/1997;
16.10.11.3 NMAC - Rn, 16 NMAC 10.11.3, 1/10/2007]
16.10.11.4 DURATION:
Permanent.
[4/5/1997;
16.10.11.4 NMAC - Rn, 16 NMAC 10.11.4, 1/10/2007]
16.10.11.5 EFFECTIVE
DATE: June 15, 1995, unless a later date is cited
at the end of a section.
[4/5/1997;
16.10.11.5 NMAC - Rn & A, 16 NMAC 10.11.5, 1/10/2007]
16.10.11.6 OBJECTIVE: These
rules and regulations are adopted to carry out the boards' responsibilities set
forth in Sections 61-11B to 61-11B-3, NMSA 1978, the “Pharmacist Prescriptive
Authority Act.”
[4/5/1997;
16.10.11.6 NMAC - Rn & A, 16 NMAC 10.11.6, 1/10/2007]
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.
B. “Consultation” means in person,
telephonically, by two-way radio, by e-mail or by other electronic means.
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.
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 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]
16.10.11.8 INTRODUCTION: These
rules and regulations are adopted to carry out the boards' responsibilities set
forth in Sections 61-11B to 61-11B-3, NMSA 1978, the “Pharmacist Prescriptive
Authority Act.”
[4/5/1997;
16.10.11.8 NMAC - Rn & A, 16 NMAC 10.11.8, 1/10/2007]
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. A pharmacist clinician
shall perform only those services that are set forth in the protocol.
G. Pharmacist
clinicians may prescribe only those drugs described in a board approved
protocol.
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.
[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 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. 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]
16.10.11.11 REPORT
AND COMMITTEE: The chair of the board shall appoint two (2)
members of the board, or a member and an agent of the board to an oversight
committee that shall also include two members appointed by the board of
pharmacy. The oversight committee will
make a report that may include non-binding recommendations to both the board of
pharmacy and the medical board regarding disciplinary action. Each board can accept or reject the
recommendations.
[4/5/1997;
16.10.11.11 NMAC - Rn & A, 16 NMAC 10.11.11, 1/10/2007]
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
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]
HISTORY OF 16.10.11 NMAC:
Pre-NMAC History: The
material in this part was derived from that previously filed with State Records
Center and Archives under:
Rule 25, Physicians
Supervising Pharmacist Clinicians, filed 6/15/1995.
History of Repealed Material: [RESERVED]