New Mexico
Register / Volume XXXV, Issue 21 / November 5, 2024
This is an amendment to
16.19.4 NMAC, Section 7, and 9 effective 11/05/2024
16.19.4.7 DEFINITIONS:
A. “A
year” begins with the pharmacist’s birth month and ends the last day of the
pharmacist’s birth month the following year.
B. “Accredited Provider” An
institution, organization or agency that has been recognized by the
Accreditation Council for Pharmacy Education, in accord with its policy and
procedures, as having demonstrated compliance with the standards which are
indicative of the Provider's capability to develop and deliver quality
continuing pharmacy education.
C. “Activity” as used in the ACPE criteria
for quality and these regulations, the term refers to an individual educational
experience or program such as a lecture, home study course, workshop, seminar,
symposium, etc.
D. “Alternate
supervising physician” means a physician who holds a current unrestricted
license, is a cosignatory on the notification of supervision, agrees to act as
the supervising physician in the supervising physician’s absence, or expand the
“scope of practice or sites of practice” of the pharmacist clinician and is
approved by the board.
E. “Board”
means the New Mexico board of pharmacy.
F. “Consultation”
means communication in person, telephonically, by two-way radio, by e-mail or
by other electronic means.
G. “Contact
hour” means a unit of measure equivalent to 60 minutes of participation in
an approved organized learning experience or activity.
H. “Continuing
education unit (CEU)” means ten contact hours of participation or it’s equivalent in an organized continuing education
activity sponsored by an accredited provider.
I. “Continuing pharmacy education (CPE)” means a structured education
activity offered by an accredited provider, designed or intended to support the
continuing development of pharmacies or pharmacy technicians to maintain and
enhance their competence. Continuing
pharmacy education should promote problem-solving and critical thinking and be
applicable to the practice of pharmacy.
J. “Continuing professional development (CPD)” means the
responsibility of individual pharmacists for systematic maintenance,
development and broadening of knowledge, skills and attitudes, to ensure
continuing competence as a professional, throughout their careers.
K. “Criteria
for quality” means continuing education provider shall show evidence of
adherence to the criteria adopted by the American council on pharmaceutical
education as indicative of the ability to provide continuing pharmaceutical
education activities; areas include:
administrative and organization; budget and resources; teaching staff;
educational content management of activity; method of delivery; facilities;
evaluation mechanism.
L. “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 provider 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;” or “Caution: federal law
restricts this drug to use by or on the order of a licensed veterinarian.”; or
“Rx only.”
M. “Guidelines
or 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.
N. “Initial
pharmacist licensure” means the license issued shall be valid for no less
than 24 months. The license will expire the last date of his/her birth month that immediately
follows the minimum 24 month time period.
O. “Live
programs” means CPE activities that provide for direct interaction between
faculty and participants and may include lectures, symposia, live
teleconferences, workshops, etc.
P. “Monitor dangerous drug therapy” means
to review the dangerous drug therapy regimen of patients by a pharmacist
clinician for the purpose of evaluating and rendering advice regarding
adjustment of the regimen. “Monitor
dangerous drug therapy” includes:
(1) collecting and reviewing patient dangerous drug histories;
(2) measuring and reviewing routine
patient vital signs including pulse, temperature, blood pressure and
respiration;
(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 and;
(4) evaluating situations that require
the immediate attention of the physician and instituting or modifying treatment
procedures when necessary.
Q. “Oversight committee” means a joint
committee made up of four members to hear issues regarding pharmacist
clinicians’ prescriptive authority activities and supervising physicians’
direction of these activities.
R. “Patient
safety” means the prevention of healthcare errors and the elimination or
mitigation of patient injury caused by healthcare errors.
S. “Pharmaceutical care” means the
provision of drug therapy and other patient care services related to drug
therapy intended to achieve definite outcomes that improve a patient’s quality
of life, including identifying potential and actual drug-related problems,
resolving actual drug-related problems and preventing potential drug-related
problems.
T. “Pharmacist” means a person duly
licensed by the board to engage in the practice of pharmacy pursuant to the
Pharmacy Act, Sections 61-11-1, 61-11-2, 61-11-4 to 61-11-28 NMSA 1978.
U. “Pharmacist clinician” means a
pharmacist with additional training required by regulations adopted by the
board 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.
V. “Pharmacist in charge” means a
pharmacist who accepts responsibility for the operation of a pharmacy in
conformance with all laws and rules pertinent to the practice of pharmacy and
the distribution of drugs and who is personally in full and actual charge of
the pharmacy and its personnel.
W. “Practice of pharmacy” means
continually optimizing medication safety, patient wellness, and quality of
services through the effective use of pharmaceutical care and emerging
technologies and competency-based and performance-based training. The practice of pharmacy may include:
(1) Pharmaceutical dispensing including product
selection.
(2) specialty pharmacy practice including pharmacists working
for licensed pharmaceutical manufacturers or wholesalers;
(3) practice of telepharmacy within
and across state lines;
(4) engaging in health care educational activities;
(5) pharmacy-specific academia;
(6) provision of those acts or services necessary to provide
pharmaceutical care in all areas of patient care including patient counseling,
prescriptive authority, drug administration, primary care, medication therapy
management, collaborative practice, and monitoring dangerous drug therapy;
(7) inspecting on a full time basis to ensure compliance with
the practice of pharmacy;
(8) provision of pharmaceutical and drug information services,
as well as consultant pharmacy services;
(9) engaging in other phases of the pharmaceutical profession
including those with research or investigational or dangerous drugs;
(10) engaging in functions that relate directly to the
administrative, advisory, or executive responsibilities pursuant to the
practice of pharmacy in this state;
(11) the responsibility for compounding and labeling of drugs and
devices;
(12) the proper and safe storage of drugs and devices; and
(13) the maintenance of proper records.
X. “Practitioner” means a health care
provider duly authorized by law in New Mexico to prescribe dangerous drugs
including controlled substances in schedules II through V.
Y. “Prescriptive authority” means the
authority to prescribe, administer, monitor or modify dangerous drug therapy.
Z. “Professional judgment” means a
cognitive process, by alicensed pharmacist, that
takes education, experience and current standards of practice into
consideration when drawing conclusions and reaching decisions.
AA. “Renewal period” means continuing
education programs or activities must be completed during the 24 month time period occurring between the last day of the
pharmacist’s birth month and the last day of his/her birth month 2 years later.
BB. “Scope of practice” means those duties
and limitations of duties placed upon a pharmacist clinician and includes the
limitations implied by the field of practice of the supervising physician
and/or the alternate supervising physician(s) and the board.
CC. “Standard
of care" means care provided by a licensee that is within the accepted
standard of care that would be provided in a same or similar setting by a
reasonably competent and prudent licensee or registrant with similar education,
training, and experience.
[CC.] DD. “Supervising physician” means a doctor, or group of doctors, of
medicine or osteopathy approved by the board to supervise a pharmacist
clinician; and includes a physician approved by the medical board as an
alternate supervising physician.
[2/15/1996; 16.19.4.7 NMAC -
Rn, 16 NMAC 19.4.7, 3/30/2002; A, 1/31/2007; A, 8/16/2010; A, 10/25/2012; A,
11/13/2018; A, 5/07/2024;
A, 11/05/2024]
16.19.4.9 DEFINING UNPROFESSIONAL OR DISHONORABLE CONDUCT:
A. Preamble: In defining "unprofessional
conduct" the definitions of professional conduct and a pharmacist's duty
should be considered.
B. Professional
conduct may be defined as complying with all the laws and regulations that
apply to a given professional activity.
C. Definition: Unprofessional or dishonorable conduct by a
pharmacist shall mean, among other things, but not be limited to:
(1) Violation of any provision of the Pharmacy Act as
determined by the board.
(2) Violation of the board of pharmacy regulations as
determined by the board.
(3) Violation of the Drug and Cosmetic Act as determined by
the board.
(4) Violation of the Controlled Substances Act as determined
by the board.
(5) Failure of the pharmacist to conduct theirself professionally in conformity with all
applicable federal, state and municipal laws and regulations to their
relationship with the public, other health professions and fellow pharmacists.
(6) Failure to keep their pharmacy and/or area of professional
practice clean, orderly, maintained and secured for the proper performance of
their professional duties.
(7) Acquiring prescription stock from unlicensed sources.
(8) Failure to hold on the strictest
confidence all knowledge concerning patrons, their prescriptions, and other
confidence entrusted or acquired of by them; divulging in the interest of the
patron only by proper forms, or where required for proper compliance with legal
authorities.
(9) Participation in a plan or agreement which compromises the
quality or extent of professional services, or facilities at the expense of
public health or welfare.
(10) The solicitation of prescription business by providing
prescribers with prescription blanks with the name of any licensed pharmacy or
pharmacist printed thereon.
(11) The solicitation of prescription business by providing a
prescriber with pre-selected medication on a prescription blank. This does not apply to:
(a) the inpatient, or institutional
setting (i.e. long term care or correctional facility) by an in-house or
contracted pharmacy; or
(b) a request for therapeutic interchange
of a medication prescribed for the patient;
(12) The solicitation of a prescription whereby the initial
prescription request was not initiated by the patient or practitioner. This does not apply to a request for
therapeutic interchange of a medication prescribed for
the patient.
(13) Failure to report a theft or loss of controlled substances
in accordance with 16.19.20.36 NMAC.
(14) Failure to report an impaired licensee in compliance with
Subparagraph (a) of Paragraph (1) of Subsection C of 16.19.4.12 NMAC.
(15) Failure to train or supervise adequately supportive
personnel or the use of supportive personnel in activities outside the scope of
their permitted activities.
(16) Conviction, plea of nolo contendere, or entering into any
other legal agreements for any violation of the Pharmacy Act, Controlled
Substances Act, Drug Device and Cosmetic Act or any similar act of another
state or territory of the United States.
(17) Suspension, revocation, denial, or forfeiture of license to
practice or similar disciplinary action by a licensing agency of another state
or territory of the United States.
(18) Dispensing a prescription for a dangerous drug to a patient
without an established practitioner-patient relationship:
(a) except for the provision of treatment
of partners of patients with sexually transmitted diseases when this treatment
is conducted in accordance with the expedited partner therapy guidelines and
protocol published by the New Mexico department of health;
(b) except for on-call practitioners
providing services for a patient’s established practitioner;
(c) except for delivery of dangerous drug
therapies to patients ordered by a New Mexico department of health physician as
part of a declared public health emergency;
(d) except for dispensing the dangerous
drug naloxone or other opioid antagonist as authorized in Section 24-23-1 NMSA
1978;
(e) except for the prescribing or
dispensing and administering for immunizations programs.
(19) Dispensing a prescription for a dangerous drug to a patient
if the pharmacist has knowledge, or reasonably should know under the
circumstances, that the prescription was issued on the basis
of an internet-based questionnaire or an internet-based consultation
without a valid practitioner-patient relationship.
(20) Failure to perform a prospective drug review as described in
Subsection D of 16.19.4.16 NMAC and document steps taken to resolve potential
problems.
(21) Acts or omissions within the provision of patient care
including prescriptive authority, primary care, medication therapy management,
collaborative practice, and monitoring dangerous drug therapy which fail to
meet the standard of care.
[3/1/1993; 16.19.4.9 NMAC - Rn, 16 NMAC 19.4.9, 3/30/2002; A, 7/15/2002; A,
1/15/2008; A, 9/16/2011; A, 8/31/2012; A, 3/23/2016; A, 10/19/2019; A,
11/13/2018; A, 9/13/2022; A, 5/07/2024; A, 11/05/2024]