TITLE 16 OCCUPATIONAL
AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 4 PHARMACIST
16.19.4.1 ISSUING
AGENCY: Board of Pharmacy.
[2/15/1996; 16.19.4.1 NMAC -
Rn, 16 NMAC 19.4.1, 3/30/2002; A, 12/15/2002; A, 8/16/2010; A, 9/14/2021]
16.19.4.2 SCOPE: All
designations of pharmacists subject to licensure and regulation by the Board of
Pharmacy.
[2/15/1996; 16.19.4.2 NMAC -
Rn, 16 NMAC 19.4.2, 3/30/2002]
16.19.4.3 STATUTORY
AUTHORITY: Paragraph (1) of
Subsection A of Section 61-11-6 NMSA, 1978 authorizes the board of pharmacy to
adopt, regularly review and revise rules and regulations necessary to carry out
the provisions of the Pharmacy Act, Sections 61-11-1, 61-11-2, 61-11-4 to
61-11-28 NMSA 1978. Those provisions
include the authority to:
A. deny
or take disciplinary action with respect to any certificate of registration or
license held or applied for under the Pharmacy Act, Section 61-11-20 NMSA 1978;
B. require and establish criteria for
continuing education as a condition of renewal of a pharmacist license,
Paragraph (4) of Subsection A of Section 61-11-6 NMSA 1978;
C. issue permits or licenses, as
defined and limited by board regulation, to nursing homes, industrial and
public health clinics and home care services, Paragraph (6) of Subsection A of
Section 61-11-6 and 61-11-14 NMSA 1978;
D. provide for the issuance and renewal
of licenses for pharmacists, Paragraph (3) of Subsection A of Section 61-11-6,
and 61-11-13 NMSA 1978;
E. provide for the registration of pharmacist
interns, their certification, annual renewal of certification, training,
supervision, and discipline, Paragraph (5) of Subsection A of Section 61-11-6
NMSA 1978; and
F. adopt rules and regulations that
establish patient counseling requirements,
Paragraph (18) of Subsection A of 61-11-6 NMSA 1978. Under the Pharmacist Prescriptive Authority
Act, Sections 61-11B-1 to 61-11B-3 NMSA 1978, the board is required to
establish regulations governing certification as a pharmacist clinician. The Impaired Pharmacists Act, Sections
61-11A-1 to 61-11A-8 NMSA 1978, requires the establishment by the board of a
plan for treatment and rehabilitation of impaired pharmacists. Subsection B of Section 61-1-36 NMSA 1978
authorizes the board of pharmacy to promulgate rules relating to listing
specific criminal convictions that could disqualify an applicant from receiving
a license on the basis of a previous felony conviction. Subsection B of Section 28-2-3 NMSA 1978
prohibits the board of pharmacy from considering certain criminal records to be
used, distributed or disseminated in connection with an application for a
license. Section 28-2-4 NMSA 1978
authorizes the board of pharmacy the power to refuse to grant or renew, or
suspend or revoke a license where the applicant or licensee has been convicted
of a felony and the criminal conviction directly relates to the particular
profession and other convictions specified.
[3/14/1998; 16.19.4.3 NMAC -
Rn, 16 NMAC 19.4.3, 3/30/2002; A, 9/14/2021; A, 11/30/2021]
16.19.4.4 DURATION: Permanent
[2/15/1996; 16.19.4.4 NMAC - Rn, 16 NMAC 19.4.4, 3/30/2002]
16.19.4.5 EFFECTIVE
DATE: February 15, 1996, unless a different
date is cited at the end of a Section or Paragraph. This Part reformatted for inclusion into the
New Mexico Administrative Code (NMAC) effective 2/15/1996.
[3/14/1998; 16.19.4.5 NMAC -
Rn, 16 NMAC 19.4.5, 3/30/2002]
16.19.4.6 OBJECTIVE: The
objective of Part 4 of Chapter 19 is to promote the delivery of quality
pharmaceutical services by establishing comprehensive regulations governing
pharmacists, conduct, continuing education and requirements, criteria for
specialized certification, and duties and responsibilities.
[2/15/1996; 16.19.4.6 NMAC -
Rn, 16 NMAC 19.4.6, 3/30/2002]
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. “Supervising physician” means a doctor,
or group of doctors, of medicine or osteopathy approved by the respective 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]
16.19.4.8 DEFINING
GROSS IMMORALITY: Gross immorality
shall constitute a felony conviction of a crime involving a disqualifying
criminal conviction. “Conviction” means
either a plea of guilty or nolo contendere, or any other full adjudication on
the merits by a court of competent jurisdiction, including but not limited to a
trial. A copy of the record of
conviction certified by the clerk of the court entering the conviction is
conclusive evidence.
A. Convictions for any of the following
offenses, or their equivalents in any other jurisdiction, are disqualifying
criminal convictions that may result in license suspension, or disqualify a
licensee or applicant from receiving or retaining a license issued by the
board:
(1) Section
30-2-1 NMSA 1978 “Murder”;
(2) Sections 30-9-1 and 30-9-11 to
30-9-13 NMSA 1978, Criminal sexual offenses, including of a minor and
enticement of a child;
(3) Sections 30-37-2 to 30-37-3.3 NMSA
1978, Sexually oriented material harmful to minors, including child
solicitation by electronic communication device and criminal sexual
communication with a child;
(4) Sections 30-6A-3 to 30-6A-4 NMSA
1978, Sexual exploitation of children, including prostitution;
(5) Section 30-16-2 NMSA 1978 “Robbery”;
(6) Section 30-16-6 NMSA 1978 “Fraud”;
(7) Section 30-16-8 NMSA 1978
“Embezzlement”;
(8) Section 30-16-9 NMSA 1978
“Extortion”;
(9) Section 30-16-10 NMSA 1978 “Forgery”;
(10) Section 30-16-11 NMSA
1978 “Receiving stolen property”;
(11) Section 30-16-24.1
NMSA 1978 “Theft of identity; obtaining identity by electronic fraud”;
(12) Section 30-16-30 NMSA
1978 “Dealing in credit cards of another”;
(13) Section 30-16-31 NMSA
1978 “Forgery of a credit card”;
(14) Section 30-16-33 NMSA
1978 “Fraudulent use of a credit card”;
(15) Section 30-28-3 NMSA
1978 “Criminal solicitation”;
(16) Section 30-42-4 NMSA
1978 “Engaging in a pattern of racketeering activity”;
(17) Sections 30-44-4 to
30-44-7 NMSA 1978, Offenses related to Medicaid Fraud;
(18) Sections 30-47-4 to
30-47-6 NMSA 1978, Abuse or neglect of a care facility resident, exploitation
of a care facility resident’s property;
(19) Section 30-51-4 NMSA
1978 “Money laundering”;
(20) Section 30-52-1 NMSA
1978 “Human trafficking”;
(21) Section 24-26-12 NMSA
1978 “Intentionally hampering, obstructing, tampering with or destroying a
monitoring device or a recording made by a monitoring device installed in a
facility pursuant to the Patient Care Monitoring Act” (Sections 24-26-1 to
24-26-12 NMSA 1978);
(22) Section 27-5-12 NMSA
1978 Making false statement in claim for payment under Indigent Hospital and
County Health Care Act (Chapter 27, Article 5 NMSA 1978);
(23) Section 66-8-102 NMSA
1978 “Fourth or subsequent conviction for driving under the influence of
intoxicating liquor or drugs”;
B. Unless
otherwise specified by law, the board shall not consider a criminal conviction
as part of an application for licensure unless the conviction in question is
one of the disqualifying criminal convictions listed in Subsection A of this
Section 16.19.4.8 NMAC. Any decision by
the Board to take action against an applicant or licensee on the basis of a
disqualifying criminal conviction shall occur in conformance with the Uniform
Licensing Act.
C. Nothing in this section prevents the
board from denying an application or disciplining a licensee on the basis of
the licensee or applicant’s conduct to the extent that such conduct violated
the Pharmacy Act (Chapter 61, Article 11 NMSA 1978), the Drug Device and
Cosmetic Act (Chapter 26, Article 1 NMSA 1978), the Controlled Substances Act
(Chapter 30, Article 31 NMSA 1978), the Imitation Controlled Substances Act
(Chapter 30, Article 31A NMSA 1978), or the Drug Precursor Act (Chapter 30,
Article 31B NMSA 1978), or similar act of another state or of the United
States, or pursuant to the Impaired Health Care Provider Act (Chapter 61,
Article 7 NMSA 1978), or the Impaired Pharmacists Act (Chapter 61, Article 11
NMSA 1978), regardless of whether the individual was convicted of a crime for
such conduct or whether the crime for which the individual was convicted is
listed as one of the disqualifying criminal convictions listed in Subsection A
of this rule. Proceedings shall occur in
conformance with the Uniform Licensing Act (Chapter 61, Article 1 NMSA 1978).
D. Notwithstanding
Subsection C of this Section, in connection with an application for licensure,
the board shall not use, distribute, disseminate, or admit into evidence at an
adjudicatory proceeding criminal records of any of the following:
(1) an arrest not followed by a valid
conviction;
(2) a conviction that has been sealed,
dismissed, expunged or pardoned;
(3) a juvenile adjudication; or
(4) a conviction for any crime other than
the disqualifying criminal convictions listed in Subsection A of this section.
[3/1/1993; 16.19.4.8 NMAC -
Rn, 16 NMAC 19.4.8, 3/30/2002; A, 11/30/2021]
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.
[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]
16.19.4.10 CONTINUING PHARMACY EDUCATION REQUIREMENTS:
A. Continuing pharmacy education (CPE)
shall include study in one or more of the general areas of socioeconomic and
legal aspects of health care; the properties and actions of drugs and dosage
forms; etiology; characteristics and therapeutics of the disease state, or such
other subjects as the board may from time to time approve. Continuing pharmacy education approved in New
Mexico shall be limited to programs and activities offered by the accreditation
council for pharmacy education (ACPE), accredited provider, programs or courses
approved by the board or other state boards of pharmacy and pharmacy law
programs offered by the board.
B. Continuing
pharmacy education, certified as completed by an approved provider will be
required of a registered pharmacist who applies for renewal of New Mexico
registration as follows: 3.0 CEU (30 contact hours) every two
years. Effective January 1, 2013,
pharmacist and pharmacist clinician renewal applications shall document.
(1) A minimum of 1.0 CEU (10 contact
hours) excluding the law requirement, per renewal period shall be obtained
through “live programs” that are approved as such by the ACPE or the
accreditation council for continuing medical education (ACCME). Live programs provided by other providers
(such as continuing nursing education) may be acceptable based on review and
approval of the board.
(2) A minimum of 0.2 CEU (two contact
hours) per renewal period shall be in the area of patient safety as applicable
to the practice of pharmacy.
(3) A minimum of 0.2 CEU (two contact
hours) per renewal period shall be in the subject area of pharmacy law offered
by the New Mexico board of pharmacy.
(4) Effective January 1, 2015, a minimum
of 0.2 CEU (two contact hours) per renewal period shall be in the area of safe
and appropriate use of opioids. An
educational program consisting of a minimum of 0.2 CEU (2 contact hours) that
addresses both patient safety as applicable to the practice of pharmacy and the
safe and appropriate use of opioids will satisfy requirements of Paragraphs (2)
and (4) of Subsection B of this
section.
C. The number of CEU's to be awarded
for successful completion shall be determined by the accredited provider in
advance of the offering of the activity.
D. The
board will accept CPE education units for programs or activities completed
outside the state; provided, the provider has been approved by the ACPE under
its' criteria for quality at the time the program was offered.
E. Continuing
pharmacy education will be required of all registrants holding an in-state
status and out-of-state active status license. (61-11-13D). Pharmacists granted New Mexico initial
licensure are exempt from CPE requirements.
Inactive status licensees will be required to furnish CPE for the
current licensing period, 1.5 CEU for
each year the licensee was inactive, only for the purpose of reinstating
to active status.
F. Not
less than ten percent of the registrants will be randomly selected each year by
the board for audit of certificates by the state drug inspectors. Pharmacists and pharmacist clinicians without
sufficient documentation of completion of CPE requirements shall.
(1) Be subject to a fine of not less that $1000.00.
(2) Be required to complete the deficient CPE in a
satisfactory time period as determined by the board.
G. In
the event a pharmacist makes an application for renewal and does not furnish
necessary proof of compliance upon
request, the board will afford the applicant opportunity for hearing
pursuant to the Uniform Licensing Act.
H. [RESERVED]
I. [RESERVED]
J. Pharmacy
law requirement:
(1) Active status: A minimum of 0.2 CEU (two contact hours) of the 3.0 CEU (30 contact hours) required for registration renewal, shall be in
the subject area pharmacy law as offered by the board. In
lieu of a board program, pharmacists not residing and not practicing pharmacy
in New Mexico, may complete an ACPE accredited course, in the subject area
pharmacy law, meeting the CEU requirements of this paragraph.
(2) Licensees
may obtain 0.1 CEU (one contact hour) per year, in the subject area pharmacy
law, by attending one full day of a regularly scheduled New Mexico board of
pharmacy board meeting or serving on a board approved committee.
K. Board of pharmacy law programs shall
offer 0.2 CEU and be two contact hours in length.
[02/26/1995; 16.19.4.10 NMAC
- Rn, 16 NMAC 19.4.10, 3/30/2002; A, 12/15/2002; A, 1/31/2007; A, 8/16/2010; A,
3/23/2013; A, 8/12/2013; A, 5/07/2024]
16.19.4.11 CONSULTANT PHARMACIST:
A. Duties and responsibilities:
(1) To abide by the code of ethics of the
American Society of Consultant Pharmacists. Must be qualified to practice as a consultant
pharmacist and is to be aware of all federal and state drug laws, rules and
regulations related to pharmacy services, and to provide the facility with
current information pertaining to drug service.
(2) Ensure that drugs are handled in the
facility in which he/she is the consultant pharmacist, in a manner that protects
the safety and welfare of the patient.
(3) Set the policies and procedures in
the facility as related to all facets of drug handling and distribution; these
policies and procedures to be reviewed and updated on an annual basis.
(4) To visit the facility, commensurate
with their duties, as specified by board regulations relative to the facility
or by written contract with the administration of the facility not inconsistent
with board regulations.
(5) His/her primary goal and objective
shall be the health and safety of the patient, and he/she shall make every
effort to assure the maximum level of safety and efficacy in the provision of
pharmaceutical services.
(6) The consultant pharmacist shall not
condone or participate in any transaction with any practitioner of another
health profession, or any other persons whosoever under which fees are divided,
or rebates or kickbacks paid or caused to be paid, or which may result in
financial exploitation of patients or their families in connection with the
provision of drugs and medication or supplies or pharmaceutical services.
B. Consultant pharmacist serving skilled
nursing facilities and intermediate care facilities - upper level care - long
term care facilities by any other title:
(1) The consultant pharmacist's agreement
with the facility shall include but is not limited to the following duties and
responsibilities.
(a) Serve as a member of appropriate
committees, and attend these meetings.
(b) Development of
the drug control procedures manual.
(c) Monitor on a
routine basis all aspects of the total drug distribution system - to be
accomplished in a manner designed to monitor and safeguard all areas of the
drug distribution system.
(d) Maintain active
pharmacist status registration in the state.
(e) Assume
responsibility for the destruction or removal of unwanted dangerous drugs and
any controlled substances as prescribed by law and regulations.
(f) Maintain a log
of all visits and activities in the facility indicating dates and other
pertinent data; such logs are to be available to inspection by state drug
inspectors upon request.
(g) Furnish and
replenish emergency drug supply in acceptable containers. Maintain a log of use and replacement of
drugs in the emergency tray.
(h) Make routine
inspections of drug storage areas, patient health records, and review drug
regimen of each patient at least once a month.
Report irregularities, contraindication, drug interactions, etc., to the
medical staff.
(i) Provide or make
arrangements for provision of pharmacy services to the facility on a 24-hour,
seven days a week basis, including stat orders.
(j) Provide
in-service training of staff personnel as outlined in the procedures manual.
(k) Meet all other
responsibilities of a consultant pharmacist as set forth in the board
regulations and federal or state laws and which are consistent with quality
patient care.
(l) The contract
consultant pharmacist to a SNF or ICF facility, that is required to review
patients' drug regimen as set forth in Subparagraph h of Paragraph (1) of
Subsection B of 16.19.4.11 NMAC, who is under contract as sole supplier of
unit-doses/state of the art medications, shall be exempt from charges of
unprofessional conduct under Paragraph (10) of Subsection B of 16.19.4.9 NMAC.
(m) The consultant
pharmacist to a SNF or ICF facility who delivers drugs in a unit-dose system,
approved by an agent of the board, which is a tightly sealed, unopened,
individual dose, shall be exempt from the requirements of 16.19.6.14 NMAC. The regulation shall not prohibit the return
to the pharmacy stock, where partial credit may be given in accordance with any
federal or state law or regulation, to the patient for such medication, when
the physician discontinues the drug therapy, the patient expires or for any
other reason, other than an outdated drug.
(n) Customized patient medication packages: In lieu of dispensing one, two, or more
prescribed drug products in separate containers or standard vial containers, a
pharmacist may, with the consent of the patient, the patient's care-giver, the
prescriber, or the institution caring for the patient, provide a customized
patient medication package. The
pharmacist preparing a patient medication package must abide by the guidelines
as set forth in the current edition of the United States Pharmacopoeia for
labeling, packaging and record keeping.
(o) Repackaging of patient medication packages: In the event a drug is added to or
discontinued from a patient's drug regimen, when a container within the patient
medication package has more than one drug within it, the pharmacist may
repackage the patient's patient medication package and either add to or remove
from the patient medication packaged as ordered by the physician. The same drugs returned by the patient for
repackaging must be reused by the pharmacist in the design of the new patient
medication package for the new regimen, and any drug removed must either be
destroyed, returned to the DEA or returned to the patient properly labeled.
(p) Return of patient medication package drugs.
(i) Patient
medication packages with more than one drug within a container may not under
any circumstances be returned to a pharmacy stock.
(ii) Patient
medication packages with only one drug within a container: 1 Non-Institutional: A patient medication package stored in a
non-institutional setting where there is no assurance of storage standards may
not be returned to pharmacy stock. 2
Institutional: A patient
medication package stored in an institutional setting where the storage and
handling of the drugs are assured and are consistent with the compendia
standards may be returned to the pharmacy stock provided the following
guidelines are followed: (1) the drug is
to be kept within the patient medication package and it is to remain sealed and
labeled until dispensed; (2) the expiration date of drug shall become fifty
percent of the time left of the expiration for the drug; and (3) no schedule II
- V drugs may be returned to inventory; and (4) proper record keeping for the
addition of drugs into inventory must be done.
(2) When a consultant pharmacist enters
into a written contractual agreement with a facility to which he/she will
provide service.
(a) The consultant
pharmacist whose practice is not in the immediate vicinity of the facility for
which he has entered into a written service agreement, shall have a written
agreement with a local pharmacist to be available on any emergency basis. The consultant pharmacist shall be
responsible for the proper training and instruction of such local
pharmacist. Said local pharmacist shall
be known as a "co-consultant".
The vendor shall be responsible for the safety and efficacy of back-up
pharmaceutical services he provides.
(b) A copy of these
agreements must be filed with the facility and a copy maintained by the
consultant pharmacist. Any termination
of such agreement shall be reported in writing, within 10 days, of termination
to the administrator.
(c) Should a local
pharmacist (co-consultant) not be available, the consultant pharmacist must
provide an alternative procedure approved by the board. If the consultant is also the vendor, then
such alternative procedure must reasonably assure rapid delivery of drugs;
medical supplies and pharmacy service to the facility.
C. Consultant pharmacist - clinic facility:
(1) The consultant pharmacist providing
services to a clinic shall.
(a) Assume overall
responsibility for clinic pharmaceutical services, for clinic facility supportive
personnel, and for procedures as outlined in the procedures manual, including
all records of drugs procured, administered, transferred, distributed,
repackaged or dispensed from the clinic.
(b) Assume
responsibility for the destruction or removal of unwanted or outdated dangerous
drugs, including controlled substances, as required by laws and regulations.
(c) Develop the pharmaceutical
services procedures manual for the clinic establishing the system for control
and accountability of pharmaceuticals.
(d) Provide
in-service education and training to clinic staff, as applicable.
(e) Report in
writing to the board within 10 days, any termination of services to the
clinic.
(f) Comply with all
other provisions of Part 10, limited drug clinics, as applicable to the
individual clinic facility.
(g) The consultant
pharmacist shall personally visit the clinic on the minimum basis described in
Items (i) through (v) of this Subparagraph to ensure that the clinic is
following set policies and procedures.
Visitation schedules are as follows.
(i) Class
A clinics shall have the on-site services of a consultant pharmacist for the
dispensing or distribution of dangerous drugs.
The consultant pharmacist shall comply with Paragraphs (4), (5) and (7)
of Subsection A of 16.19.4.16 NMAC of this regulation.
(ii) Class
B clinics shall have the services of a consultant pharmacist as listed
below: 1. Category 1 clinics shall be visited by the
consultant pharmacist at least every other month. 2.
Category 2 clinics shall be visited by the consultant pharmacist at
least monthly. 3. Category 3 clinics shall be visited by the
consultant pharmacist at least every other week.
(iii) Class
C clinics shall be visited by the consultant pharmacist at least every three
months.
(iv) Class
D clinic shall be reviewed at least once yearly during school session.
(v) Class
E clinic shall be visited by the
consultant pharmacist at least weekly for a clinic with a patient census of 150
or more or with a mobile narcotic treatment program, and at least every other
week for a clinic with a patient census of less than 150.
(h) The consultant
pharmacist shall review the medical records of not less than five percent of a
Class B clinics patients who have received dangerous drugs (as determined by
the dispensing or distribution records) since the consultant pharmacist's last
visit. Such review shall be for the
purpose of promoting therapeutic appropriateness, eliminating unnecessary
drugs, and establishing the medical necessity of drug therapy, by identifying
over-utilization or under-utilization, therapeutic duplication, drug-disease
contraindications, drug-drug contraindications, incorrect drug dosage or
duration of drug treatment, drug-allergy interactions, appropriate medication
indication, and/or clinical abuse/misuse.
Upon recognizing any of the above, the consultant pharmacist shall take
appropriate steps to avoid or resolve the problem which shall, if necessary,
include consultation with the prescriber.
(i) The consultant
pharmacist shall maintain a log or record of all visits and activities in the
clinic. Such record shall include a log
of all medical records reviewed, along with a record of all consultant
pharmacist interventions and/or consultations.
This log or record shall be available for inspection by state drug
inspectors upon request.
(j) Consultant
pharmacist serving a Class D school based emergency medicine clinic shall:
(i) review
records at least annually; this review shall include a review of the self-assessment form, receipt and
disposition records, and storage records; this annual review does not require
an on-site visit by the consultant pharmacist;
(ii) oversee the
removal of expired or unwanted dangerous drugs; removal options are transfer to
another licensed location, return to the legitimate source of supply or to a
reverse distributor; remaining portions of used dangerous drugs may be
destroyed by the consultant pharmacist;
(iii) review dangerous
drug administration records within 72 hours of administration; this review
shall be documented and available for inspection at the licensed location for
three years; review shall include verification of compliance with procedures
and protocols, including administration by properly trained personnel.
(iv) ensure required
records are available for inspection at the licensed location for three years,
including a log of comments and activities of consultant pharmacist;
(v) verify a current
list of trained staff, in accordance with New Mexico department of health
requirements, is maintained at the licensed location and available for
inspection;
(vi) approve a policy
and procedures manual outlining procedures for the receipt, storage, record
keeping, administration and accountability of all dangerous drugs; this
includes policies and procedures for the removal and destruction of unwanted,
unused, outdated or recalled dangerous drugs; must verify compliance with all
training and protocols required by the New Mexico department of health.
(k) The consultant
pharmacist of a Class E clinic shall review dispensing, distribution, and
supplying records since the consultant pharmacist’s last visit, to ensure
records are maintained accurately and in proper form. The consultant pharmacist shall also review
the medical records of all clinic patients prior to initiation of take home
dosing, and medical records of not less than five percent of clinic patients
who have received dangerous drugs (as determined by the dispensing,
distribution, or supplying records) since the consultant pharmacist's last
visit. Such review shall be for the
purpose of promoting therapeutic appropriateness, eliminating unnecessary
drugs, and establishing the medical necessity of drug therapy, by identifying
over-utilization or under-utilization, therapeutic duplication, drug-disease
contraindications, drug-drug contraindications, incorrect drug dosage or
duration of drug treatment, drug-allergy interactions, appropriate medication
indication, and/or clinical abuse/misuse.
Upon recognizing any of the above, the consultant pharmacist shall take
appropriate steps to avoid or resolve the problem which shall, if necessary,
include consultation with the prescriber.
A log or record will be maintained in accordance with Subparagraph (i)
of Paragraph (1) of Subsection (C) of 16.19.4.11 NMAC.
(2) A
clinic may petition the board for an alternative visitation schedule as set
forth in Subsection R of 16.19.10.11 NMAC
D. Consultant pharmacists serving custodial
care facilities:
(1) Custodial care facility as used in
this regulation includes: Any facility
which provides care and services on a continuing basis, for two or more
in-house residents, not related to the operator, and which maintains custody of
the residents' drugs.
(2) Any facility which meets the
requirements outlined in Paragraph (1) of Subsection D of 16.19.4.11 NMAC shall
be licensed by the board, engage a consultant pharmacist, whose duties and
responsibilities are indicated in 16.19.4 and 16.19.11 NMAC.
(3) Procurement of drugs or medications
for residents will be on the prescription order of a licensed practitioner. Refills shall be as authorized by the practitioner. When refill authorization is indicated on the
original prescription, a refill for a resident may be requested by the
administrator of the licensed facility or his designee to the providing
pharmacy.
(4) The administrator or a designated
employee of the facility will sign a receipt for prescription drugs upon
delivery.
(5) All prescription drugs will be stored
in a locked cabinet or room and the key will be assigned to a designated
employee or the administrator as indicated in the procedures manual.
(6) Proper storage as stipulated in the
official compendium USP/NF will be the responsibility of the licensed facility.
(7) Records - the consultant pharmacist
shall be responsible for the following records:
(a) incoming
medications - including refills;
(b) record of
administration;
(c) waste or
loss; This accountability record shall
be maintained on a patient log, on forms meeting requirements of the board of
pharmacy.
(8) All prescription containers shall be
properly labeled as required in 16.19.11 NMAC.
No bulk containers of legend drugs will be kept on the premises, except
in a facility with a 24-hour per day and 365 day per year on-site licensed
nurse. Only the following stock
dangerous drugs may be kept:
(a) tuberculin
testing solution; and
(b) vaccines as
recommended by the centers for disease control (CDC) and prevention’s advisory
committee on immunization practices and appropriate for the facility population
served; and
(c) naloxone for opioid overdose.
(9) Consultant pharmacist shall include
in the procedures manual the name of individual(s) responsible for the
assistance with medications.
(10) It shall be the responsibility of the
pharmacist to give proper training/instruction to the person(s) at the facility
who have day-to-day responsibility for receipt and administration of
medications to resident when adverse reactions, special diet, or any other
information relative to the administration of a drug is needed by the staff.
(11) The consultant pharmacist shall be
required to maintain a patient profile on each individual, if applicable to the
facility and individual.
(12) The consultant pharmacist shall visit
the facility no less than once a quarter or more often, commensurate with
patient drug regimen review and shall be available in emergencies, when
needed. A log shall be maintained
indicating all visits to the facility and noting any activities or
irregularities to be recorded or reported.
This log shall be available for state drug inspectors' review upon
request.
(13) The consultant shall be responsible for
the preparation of a procedures manual outlining procedures for the receipt,
storage, record keeping, maintenance of patient profiles, administration and
accountability of all legend drugs and procedures for the removal and
destruction of unwanted, unused, outdated or recalled drugs - controlled
substances shall be handled pursuant to state and federal regulations.
E. No
drug that has been dispensed pursuant to a prescription and has left the
physical premises of the facility licensed by the board shall be dispensed or
reused again except the re-labeling and reuse of pharmaceuticals may be
permitted in the following situations:
in a correctional facility, licensed by the board, under the following
circumstances dangerous drugs, excluding controlled substances, may be re-used:
(1) the patients must reside in the same
facility;
(2) the reused medication must have been
discontinued from the original patient’s drug regimen;
(3) the drug was never out of the
possession of the licensee “keep on person” pharmaceuticals may never be
reused;
(4) the drugs were originally dispensed
in packaging that is unopened, single-dose or tamper-evident containers;
(5) the patient receiving the re-labeled
medication must have a valid prescription/order for the medication that is to
be reused;
(6) repackaging and re-labeling may only
be completed on site by the consultant pharmacist designated for that facility.
F. The
consultant pharmacist must maintain records at the facility for three years
containing the following information:
(1) date when the re-labeling occurred;
(2) the name and ID of the patient for
whom the medication was originally intended for and the date in which it was
discontinued from his or her drug regimen;
(3) the name and ID of the patient who
will receive the reused medication;
(4) the name, strength and amount of the
medication being reused;
(5) the name of pharmacist re-labeling
the medication;
(6) pursuant to 16.19.10.11 NMAC the
pharmacist must label the reused pharmaceutical and maintain a dispensing log
for all such re-issued pharmaceuticals and the expiration date for such
re-issued drugs shall be no greater than fifty percent of the time remaining
from the date of repackaging until the expiration date indicated on the
original dispensing label or container.
[8/27/1990; 16.19.4.11 NMAC -
Rn, 16 NMAC 19.4.11, 3/30/2002; A, 6/30/2006; A, 10/24/2014; A, 15/07/2015; A, 11/30/2021; A, 9/13/2022; A, 5/07/2024]
16.19.4.12 IMPAIRED LICENSEE OR REGISTRANT:
A. Definitions; For the purpose of this section:
(1) Chemical dependence - repeated use of alcohol or drugs
culminating in a pattern of chemical need.
(2) Disciplinary authority - the board which may discipline
pharmacists.
(3) Diversion - illicit dispensing, distribution or
administration of a scheduled controlled substance not in the normal course of
professional practice.
(4) Drug - a chemical substance alone or in combination
including alcohol.
(5) Drug abuse - improper or excessive use of a drug to the
detriment of the individual and/or society.
(6) Impaired pharmacist - a pharmacist who is unable to
practice pharmacy with reasonable skill, competence or safety to the public
because of drug abuse, physical illness, mental illness, the aging process or
loss of motor skills, sight or hearing.
(7) Licensing authority - authority that licenses/registers
pharmacists.
(8) Recovering - a term used to describe an impaired
pharmacist who has successfully completed the approved treatment program and is
being rehabilitated in accordance with a professionally prescribed aftercare
treatment. (Use of
"recovering" rather than "recovered" is intended to
indicate that recovery is a continuous process with no finite end point).
(9) Reinstatement - the process whereby the recovering
impaired pharmacist is permitted to resume the practice of pharmacy.
(10) Treatment - the therapeutic interruption of the disease
process by competent and skilled professional resources.
B. Applicability: This section is applicable to all
licensed/registered externs, interns, pharmacists, and any other board
licensee/registrant, and applicants for licensure or registration. For the purpose of this section, the word
"licensee" shall include all persons licensed/registered by the board
of pharmacy and applicants for license or registration.
C. Procedures:
(1) Impaired licensee reporting:
(a) If any person knows that a licensee
is impaired, that person shall report any relevant information either to the
board-contracted treatment program or to the board.
(b) When the board receives an initial
report relating to an alleged impaired board licensee, the board may:
(i) refer the licensee to the examining
committee who may require evaluation by the board-contracted program and
require enrollment if recommended; or
(ii) refer the licensee to the
board-contracted program with required enrollment if recommended; or
(iii) file a complaint to initiate
disciplinary action.
(2) Disciplinary
sanctions: board referral to the
board-contracted program - when a licensee whose license or registration is
suspended or revoked successfully completes a board approved treatment program,
that licensee must appear before the board as a condition of consideration for
reinstatement. The licensee must provide
documentary evidence from the contracted treatment program, stating that the
licensee has reached recovery and may be allowed to practice without
endangering the public.
(3) Confidentiality: The names of voluntary participants in the
program and records relating to their referral and treatment are confidential
provided, however, that this information may be disclosed:
(a) in a disciplinary hearing before the
board and in court proceedings arising therefrom;
(b) to the board and to the pharmacist's
licensing/disciplinary authorities of other jurisdictions in accordance with
law;
(c) pursuant to an order of a court of
competent jurisdiction;
(d) in injunctive proceedings brought by
the board; and
(e) as otherwise provided by law.
(4) Civil
immunity: No member of the board or the
committee or any board-approved intervenor shall be liable for any civil
damages because of acts or omissions which may occur while acting in good faith
pursuant to the Impaired Health Care Provider Act 61-7-1 to 61-7-12 NMSA 1978.
[8/27/1990; 16.19.4.12 NMAC -
Rn, 16 NMAC 19.4.12, 3/30/2002; A, 9/13/2022; A, 5/07/2024]
16.19.4.13 CHANGE
OF ADDRESS: Any registrant or
licensee shall report in writing any change of address or employment to the
board within 10 days.
[8/27/1990; 16.19.4.13 NMAC -
Rn, 16 NMAC 19.4.13, 3/30/2002]
16.19.4.14 ACTIVE
STATUS: Any pharmacist who maintains
competency through the development and maintenance of knowledge, skill and
aptitude, to ensure continuing competence as a pharmacy professional, and is
able to demonstrate to the board said competence in the practice of pharmacy
shall be issued an active license. Records
of continuing education or continuous professional development shall be
maintained and available for inspection by the board or the board’s agent. A pharmacist shall be issued an active status
license upon proper application and payment of fees.
[8/27/1990; 16.19.4.14 NMAC -
Rn, 16 NMAC 19.4.14, 3/30/2002; A, 12/15/2002; A, 10/25/2012]
16.19.4.15 INACTIVE STATUS:
A. A pharmacist not engaged or ceasing
to be engaged in the practice of pharmacy for two or more years shall be issued
an inactive status license upon proper application and payment of fees.
B. Pursuant
to Section 61-11-13.B, an inactive status pharmacist applying for an active
status license, who has not been actively engaged in pharmacy for two or more
years, may be required to serve an internship training program and submit
evidence of continuing education relating to the practice of pharmacy, as
required by Section 61-11-6 and Section 61-11-13 and the board regulations.
[8/27/1990; 16.19.4.15 NMAC -
Rn, 16 NMAC 19.4.15, 3/30/2002; Repealed, 12/15/2002; 16.19.4.15 NMAC - Rn,
16.19.4.16 NMAC, 12/15/2002; A, 5/07/2024]
16.19.4.16 RESPONSIBILITIES OF PHARMACIST AND PHARMACIST INTERN:
A. The following responsibilities
require the use of professional judgment and therefore shall be performed only
by a pharmacist or pharmacist intern:
(1) receipt of all new verbal prescription orders and
reduction to writing;
(2) initial identification, evaluation and interpretation of
the prescription order and any necessary clinical clarification prior to dispensing;
(3) professional consultation with a patient or his agent
regarding a prescription;
(4) evaluation of available clinical data in patient
medication record system;
(5) oral communication with
the patient or patient's agent of information, as defined in this section under
patient counseling, in order to improve therapy by ensuring proper use of drugs
and devices;
(6) professional consultation with the prescriber, the
prescriber's agent, or any other health care professional or authorized agent
regarding a patient and any medical information pertaining to the prescription;
(7) drug regimen review, as defined in Section 61-11-2L NMSA
1978;
(8) professional consultation, without dispensing, will
require that the patient be provided with the identification of the pharmacist
or pharmacy intern providing the service.
B. Only
a pharmacist shall perform the following duties:
(1) final check on all aspects of the completed prescription
including sterile products and cytotoxic preparations, and assumption of the
responsibility for the filled prescription, including, but not limited to,
appropriateness of dose, accuracy of drug, strength, labeling, verification of
ingredients and proper container;
(2) evaluation of pharmaceuticals for formulary selection
within the facility;
(3) supervision of all supportive personnel activities
including preparation, mixing, assembling, packaging, labeling and storage of
medications;
(4) ensure that supportive personnel have been properly
trained for the duties they may perform;
(5) any verbal communication with a patient or patient's
representative regarding a change in drug therapy or performing therapeutic
interchanges (i.e. drugs with similar effects in specific therapeutic
categories); this does not apply to substitution of generic equivalents;
(6) any other duty required of a pharmacist by any federal or
state law.
C. Patient
records.
(1) A reasonable effort must be made to obtain, record and
maintain at least the following information:
(a) name, address, telephone number, date
of birth (or age) and gender of the patient;
(b) individual medical history, if
significant, including disease state or states, known allergies and drug
reactions and a comprehensive list of medications and relevant devices; and
(c) pharmacist’s comments relevant to the
individuals drug therapy.
(2) Such information contained in the patient record should be
considered by the pharmacist or pharmacist intern in the exercise of their
professional judgment concerning both the offer to counsel and the content of
counseling.
D. Prospective
drug regimen review.
(1) Prior to dispensing any prescription, a pharmacist shall
review the patient profile for the purpose of identifying:
(a) clinical abuse/misuse;
(b) therapeutic duplication;
(c) drug-disease contraindications;
(d) drug-drug interactions;
(e) incorrect drug dosage;
(f) incorrect duration of drug
treatment;
(g) drug-allergy interactions;
(h) appropriate medication indication.
(2) Upon recognizing any of the above, a pharmacist, using
professional judgment, shall take appropriate steps to avoid or resolve the
potential problem. These steps may
include requesting and reviewing a controlled substance prescription monitoring
report or another states’ reports if applicable and available, and consulting
with the prescriber and counseling the patient.
The pharmacist shall document steps taken to resolve the potential
problem.
E. Prescription
monitoring program (PMP) report for opioid prescriptions. When presented with an opioid prescription
for a patient, obtaining and reviewing a PMP report for that patient can be an
important tool that assists the pharmacist in identifying issues or problems
that put his or her patient at risk of prescription drug abuse, overdose, or
diversion. A pharmacist shall use
professional judgment based on prevailing standards of practice in determining
whether to obtain and review a PMP report before dispensing an opioid
prescription to that patient, and shall document his or her action regarding
such reports.
(1) A pharmacist shall request and review a PMP report
covering at least a one year time period and another states’ report, where
applicable and available if;
(a) a pharmacist becomes aware of a
person currently exhibiting potential abuse or misuse of opioids (i.e.
over-utilization, early refills, multiple prescribers, appears sedated or
intoxicated upon presenting a prescription for an opioid or an unfamiliar
patient requesting an opioid by specific name, street name, color, or
identifying marks, or paying cash when the patient has prescription insurance);
(b) a pharmacist receives an opioid
prescription issued by a prescriber with whom the pharmacist is unfamiliar
(i.e. prescriber is located out-of-state or prescriber is outside the usual
pharmacy geographic prescriber care area);
(c) a pharmacist receives an opioid
prescription for an unfamiliar patient who resides outside the usual pharmacy
geographic patient population area;
(d) a pharmacist receives an initial
prescription for any long-acting opioid formulations, including oral and
transdermal dosage forms (e.g fentanyl or methadone);
(e) a pharmacist becomes aware of a
patient receiving an opioid concurrently with a benzodiazepine or carisoprodol;
(2) The pharmacist shall document the review of these PMP
reports.
(3) Upon recognizing any of the above conditions described in
Paragraph (1 ) of Subsection E of 16.19.4.16 NMAC, a pharmacist, using
professional judgment, shall take appropriate steps to avoid or resolve the
potential problem. These steps may
include consulting with the prescriber and counseling the patient. The pharmacist shall document steps taken to
resolve the potential problem.
(4) After obtaining an initial PMP report on a patient, a
pharmacist shall use professional judgment based on prevailing standards of
practice, in deciding the frequency of requesting and reviewing further
prescription monitoring reports and other states’ reports for that
patient. Except that PMP reports shall
be reviewed a minimum of once every three months during the continuous use of
opioids for each established patient.
The pharmacist shall document the review of these reports.
(5) In the event a report is not immediately available, the
pharmacist shall use professional judgment in determining whether it is
appropriate and in the patient’s best interest to dispense the prescription
prior to receiving a report.
(6) A prescription for an opioid written for a patient in a
long term care facility (LTCF) or for a patient with a medical diagnosis
documenting a terminal illness is exempt from Subsection E of 16.19.4.16
NMAC. If there is any question whether a
patient may be classified as having a terminal illness, the pharmacist shall
contact the practitioner. The pharmacist
shall document whether the patient is “terminally ill” or an “LTCF patient”.
F. Counseling.
(1) Upon receipt of a new prescription drug order and
following a review of the patient's record, a pharmacist or pharmacist intern
shall personally offer to counsel on matters which will enhance or optimize
drug therapy with each patient or the patient's agent. Upon receipt of a refill prescription drug
order a pharmacy technician may query the patient or patient's agent regarding
counseling by the pharmacist or pharmacist intern concerning drug therapy. Such counseling shall be in person, whenever
practicable, or by telephone, and shall include appropriate elements of patient
counseling which may include, in their professional judgment, one or more of
the following:
(a) the name and description of the drug;
(b) the dosage form, dosage, route of
administration, and duration of drug therapy;
(c) intended use of the drug and expected
action;
(d) special directions and precautions
for preparation, administration and use by the patient;
(e) common severe side or adverse effects
or interactions and therapeutic contraindications that may be encountered,
including their avoidance and the action required if they occur;
(f) techniques for self-monitoring drug
therapy;
(g) proper storage;
(h) prescription’s refill information;
(i) action to be taken in the event of a
missed dose;
(j) the need to check with the
pharmacist or practitioner before taking other medication; and
(k) pharmacist comments relevant to the
individual's drug therapy, including any other information peculiar to the
specific patient or drug.
(2) [REPEALED]
(3) Alternative forms of patient information may be used to
supplement patient counseling when appropriate.
Examples include, but not limited to, written information leaflets,
pictogram labels and video programs.
(4) Patient counseling, as described above and defined in this
regulation shall not be required for in-patients of a hospital or institution
where other licensed health care professionals are authorized to administer the
drug(s).
(5) A pharmacist shall in no way attempt to circumvent or
willfully discourage a patient or patient's agent from receiving
counseling. However, a pharmacist shall
not be required to counsel a patient or patient's agent when the patient or
patient's agent refuses such consultation.
(6) When the patient or agent is not present when the
prescription is dispensed including, but not limited to, a prescription that
was shipped by the mail, the pharmacist shall ensure that the patient receives
written notice of available counseling.
Such notice shall include days and hours of availability, and: (a) of his or her right to request
counseling; and (b) a toll-free telephone number in which the patient or
patient's agent may obtain oral counseling from a pharmacist who has ready
access to the patient's record. For
pharmacies delivering more than fifty percent of their prescriptions by mail or
other common carrier, the hours of availability shall be a minimum of 60 hours
per week and not less than six days per week.
The facility must have sufficient toll-free phone lines and personnel to
provide counseling within 15 minutes.
(7) In every pharmacy there shall be prominently posted in a
place conspicuous to and readable by prescription drug consumers a notice
concerning available counseling.
G. [REPEALED]
H. Regulatory assessment. Profiles, either electronic or hard copy,
shall be available for inspection, and shall provide the capability of storing
the described historical information.
The profiles must demonstrate that an effort is being made to fulfill
the requirements by the completion of the detail required. A patient record shall be maintained for a
period of not less than three years from the date of the last entry in the
profile record.
[8/27/1990; 16.19.4.16 NMAC -
Rn, 16 NMAC 19.4.16, 3/30/2002; 16.19.4.16 NMAC - Rn, 16.19.4.17 NMAC,
12/15/2002; A, 2/1/2004; A, 11/30/2004; A, 1/15/2005; A, 1/31/2007; A,
8/31/2012; A, 10/25/2012; A, 10/19/2019; A, 9/13/2022; A, 05/07/2024]
16.19.4.17 PHARMACIST CLINICIAN:
A. Purpose: The purpose of these regulations is to
implement the Pharmacist Prescriptive Authority Act, Sections 61-11B-1 through
61-11B-3 NMSA 1978 by providing minimum standards, terms and conditions for the
certification, registration, practice, and supervision of pharmacist
clinicians. These regulations are
adopted pursuant to Section 61-11B-3 NMSA 1978 of the Pharmacist Prescriptive
Authority Act.
B. Initial
certification and registrants.
(1) The board may certify and register a pharmacist as a pharmacist clinician upon
completion of an application for certification and satisfaction of the
requirements set forth in these regulations.
(2) A pharmacist who applies for certification and registration as a pharmacist
clinician shall complete application forms as required by the board and shall
pay a fee. The fee shall be set by the
board to defray the cost of processing the application, which fee is not
returnable.
(3) To obtain initial certification and registration as a pharmacist clinician, the following must be
submitted:
(a) proof of
completion of 60 hour board approved physical assessment course, followed by a
150 hour, 300 patient contact preceptorship supervised by a physician or other
practitioner with prescriptive authority, with hours counted only during direct
patient interactions;
(b) the applicant
will submit a log of patient encounters as part of the application;
(c) patient
encounters must be initiated and completed within two years of the application;
(d) a pharmacist
clinician requesting a controlled substance registration to prescribe
controlled substance in schedule II or schedule III shall be trained in
responsible opioid prescribing practices.
Educational programs shall include an understanding of the pharmacology
and risks of controlled substances, a basic awareness of the problems of abuse,
addiction, and diversion, and awareness of the state and federal regulations of
the prescribing of controlled substances.
(4) The board shall register each
pharmacist certified as a pharmacist clinician.
(5) Upon certification and
registration by the board, the name and address of the pharmacist
clinician, (name of the
supervising physician if applicable), and other pertinent
information shall be enrolled by the board on a roster of pharmacist
clinicians.
C. Biennial renewal of registration.
(1) Renewal applications shall be
submitted prior to the license expiration.
(2) Applications for renewal must
include:
(a) documentation of
continuing education hours, including proof of completion of 2.0 CEU 20 contact hours, at least 10 of which will be live
CPE or continuing medical education (CME) approved by (ACPE) or ACCME (live
programs provided by other continuing education providers may be submitted for
review and approval to the board), beyond the required hours in 16.19.4.10 NMAC
(as amended), as required by the board; and
(b) a pharmacist
clinician with a controlled substance registration to prescribe controlled
substances listed in schedule II or schedule III shall complete a minimum of
0.2 CEU (two contact hours) per renewal period in the subject area of
responsible opioid prescribing practices, and
(c) a current
protocol of collaborative practice signed by the supervising physician (if
prescriptive authority is sought); and
(d) a copy of the
pharmacist clinician’s registration with the supervising physicians board (if
prescriptive authority is sought); and
(e) other additional
information as requested by the board.
D. Prescriptive
authority, guidelines or protocol.
(1) Only a registered pharmacist
clinician with current protocols, registered with the New Mexico medical board
may exercise prescriptive authority.
(2) A pharmacist clinician seeking to
exercise prescriptive authority shall submit an application to the board. The application must include the supervising
physicians’ name and current medical license, protocol of collaborative
practice and other information requested by the board. A pharmacist may submit the application with
the initial application for certification or as a separate application after
becoming certified and registered as a pharmacist clinician.
(3) The protocol will be established and approved by the
supervising physician as set
forth in these regulations and will be kept on file at each practice site of
the pharmacist clinician and with the board.
(4) The protocol must include:
(a) name of the physician(s) authorized to prescribe dangerous drugs and name of
the pharmacist clinician;
(b) statement of the types of
prescriptive authority decisions the pharmacist clinician is authorized to
make, including, but not limited to:
(i) types of diseases, dangerous drugs
or dangerous drug categories involved and the type of prescriptive authority
authorized in each case;
(ii) ordering lab tests and other tests
appropriate for monitoring of drug therapy;
(iii) procedures, decision criteria or plan
the pharmacist clinician is to follow when exercising prescriptive authority;
(c) activities to be followed by the
pharmacist clinician while exercising prescriptive authority, including
documentation of feedback to the authorizing physician concerning specific decisions made; documentation may be
made on the prescriptive record, patient profile, patient medical chart or in a
separate log book;
(d) description of
appropriate mechanisms for consulting with the supervising physician, including
a quality assurance program for review of medical services provided by the
pharmacist clinician, (this quality assurance program will be available for
board review); and
(e) description of
the scope of practice of the pharmacist clinician.
(5) Pharmacist clinicians shall not prescribe dangerous drugs
including controlled substances for self-treatment or treatment of immediate
family members, except under emergency situations. This will not apply to medications that may
be prescribed under 16.19.26 NMAC.
E. Scope
of practice.
(1) A pharmacist clinician shall perform only those services
that are delineated in the protocol and are within the scope of practice of the
supervising physician or alternate supervising physician(s).
(2) A pharmacist clinician may practice in a health care
institution within the policies of that institution.
(3) A pharmacist clinician may prescribe controlled substances
provided that the pharmacist clinician:
(a) has obtained a New Mexico controlled
substances registration and a drug enforcement agency registration, and
(b) prescribes controlled substances
within the parameters of written guidelines or protocols established under
these regulations and Subsection A of 61-11B-3 NMSA 1978 of the Pharmacist
Prescriptive Authority Act.
(4) The board may, in its discretion after investigation and
evaluation, place limitations on the tasks a pharmacist clinician may perform
under the authority and direction of a supervising physician or alternate
supervising physician(s).
F. Prescription monitoring program:
(1) A pharmacist clinician exercising
prescriptive authority in the prescribing of a controlled substance;
(a) shall register
with the board to become a regular participant in PMP inquiry and reporting;
(b) may authorize
delegate(s) to access the PMP report consistent with 16.19.29 NMAC; while a
pharmacist clinician’s delegate may obtain a report from the states’ PMP, the pharmacist
clinician is solely responsible for reviewing the PMP report and documenting
the receipt and review of a report in the patient’s medical record;
(c) before a
pharmacist clinician prescribes for the first time, a controlled substance in
schedule II, III or IV to a patient for a period greater than four days, or if
there is a gap in prescribing the controlled substance for 30 days or more, the
pharmacist clinician shall review a PMP report for the patient for the preceding
12 months; when available, the pharmacist clinician shall review similar
reports from adjacent states; the pharmacist clinician shall document the
receipt and review of such reports in the patient’s medical record;
(d) a PMP report
shall be;
(i) reviewed
a minimum of once every three months during the continuous use of an opioid,
benzodiazepine, or carisoprodol for each patient; and
(ii) reviewed
a minimum of once every six months during the continuous use of a controlled
substance in schedule II, III or IV which is not an opioid, benzodiazepine, or
carisoprodol for each patient; and
(iii) the
pharmacist clinician shall document the review of these reports in the
patient’s medical record; nothing in this section shall be construed as
preventing a pharmacist clinician from reviewing PMP reports with greater
frequency than that required by this section;
(e) a pharmacist
clinician does not have to obtain and review a PMP report before prescribing,
ordering, or dispensing a controlled substance in schedule II, III or IV;
(i) to
a patient in a nursing facility; or
(ii) to
a patient in hospice care.
(f) upon review of
a PMP report for a patient, the pharmacist clinician shall identify and be
aware of a patient currently receiving:
(i) opioids
from multiple prescribers;
(ii) opioids
and benzodiazepines concurrently;
(iii) opioids
for more than 12 consecutive weeks;
(iv) more
than one controlled substance analgesic;
(v) opioids
totaling more than 90 morphine milligram equivalents per day;
(vi) exhibiting
potential for abuse or misuse of opioids and other controlled substances, such
as over-utilization, requests to fill early, requests for specific opioids,
requests to pay cash when insurance is available, receiving opioids from
multiple pharmacies.
(g) upon recognizing
any of the above conditions described in Subparagraph (f) of Paragraph (1) of
Subsection F of 16.19.4.17 NMAC, the pharmacist clinician using professional
judgment based on prevailing standards of practice, shall take action as
appropriate to prevent, mitigate, or resolve any potential problems or risks
that may result in opioid misuse, abuse, or overdose; these steps may involve
counseling the patient on known risks and realistic benefits of opioid therapy,
prescription and training for naloxone, consultation with or referral to a pain
management specialist, offering or arranging treatment for opioid or substance
use disorder; the pharmacist clinician shall document actions taken to prevent,
mitigate, or resolve the potential problems or risks.
(2) Pharmacist clinicians licensed to practice in an opioid
treatment program, shall review a PMP report upon a patients’ initial
enrollment into the opioid treatment program and every three months thereafter
while prescribing, ordering, administering, or dispensing opioid treatment
medications in schedule II or III for the purpose of treating opioid use
disorder. The pharmacist clinician shall
document the receipt and review of a report in the patients’ medical record.
G. Complaints and appeals.
(1) The chair of the board will appoint
two members of the board, and the chair of the supervising physician board will
appoint two members of the board to the oversight committee; the oversight
committee will review complaints concerning the pharmacist clinician practice;
the oversight committee will make a report that may include non-binding
recommendations to the board regarding disciplinary action. The board can accept or reject the
recommendations.
(2) Any applicant for certification or
any pharmacist clinician may appeal a decision of the board in accordance with
the provisions of the Uniform Licensing Act, Sections 61-1-1 to 61-1-37 NMSA
1978.
[3/14/1998; 16.19.4.17 NMAC -
Rn, 16 NMAC 19.4.17, 3/30/2002; 16.19.4.17 NMAC - Rn, 16.19.4.18 NMAC,
12/15/2002; A, 9/30/2003; A, 1/31/2007; A, 5/14/2010; A, 8/16/2010; A,
10/25/2012; A, 3/23/2013; A, 6/29/2013; A, 8/12/2013; A, 10/19/2019; A
9/14/2021; A, 9/13/2022; A, 5/07/2024]
16.19.4.18 [Reserved]
[3/14/1998; 16.19.4.18 NMAC -
Rn, 16 NMAC 19.4.18, 3/30/2002; Reserved, 12/15/2002]
HISTORY OF 16.19.4 NMAC:
Pre-NMAC History: The material
in this part was derived from that previously filed with the State Records
Center and Archives:
BOP 69-2, Rules and
Regulations of the State Board of Pharmacy, 6/13/1969.
BOP 69-3, New Mexico Laws and
Regulations, Pharmacy Act, Drug and Cosmetic Act, Narcotic Drug Act, Poisons
Act, Board of Pharmacy Rules and Regulations, 8/15/1969.
BOP 72-1, New Mexico Board of
Pharmacy Rules and Regulations Promulgated Pursuant to New Mexico Drug and
Cosmetic Act, Pharmacy Act, Controlled Substances Act, 7/31/1972.
Regulation No. 4, Pharmacist,
2/7/1980.
Regulation No. 4, Pharmacist,
10/23/1985.
Regulation No. 4, Pharmacist,
2/2/1987.
Regulation No. 4, Pharmacist,
7/27/1990.
History of Repealed
Material:
BOP 72-1, New Mexico Board of
Pharmacy Rules and Regulations Promulgated Pursuant to New Mexico Drug and
Cosmetic Act, Pharmacy Act, Controlled Substances Act - Repealed, 10/29/1985.
Other History:
16 NMAC 19.4, Pharmacists -
Pharmacist, filed 2/2/1996; 16 NMAC 19.4, Pharmacists - Pharmacist, filed 5/2/1996;
16 NMAC 19.4, Pharmacists - Pharmacist, filed 2/25/1998, reformatted and
renumbered to 16.19.4 NMAC, Pharmacist, effective 3/30/2002.