TITLE 16 OCCUPATIONAL
AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 29 CONTROLLED
SUBSTANCE PRESCRIPTION MONITORING PROGRAM
16.19.29.1 ISSUING
AGENCY: Regulation and Licensing Department - Board
of Pharmacy.
[16.19.29.1 NMAC - N,
7/15/2004]
16.19.29.2 SCOPE: All
persons that dispense controlled substances and drugs of concern pursuant to prescriptions from practitioners
and practitioners who dispense controlled substances and drug(s) of
concern directly to a patient under
their care. All persons authorized to
receive disclosure of prescription monitoring program prescription information.
[16.19.29.2 NMAC -
N, 7/15/2004; A, 3/22/2015; A, 11/27/2016; A, 2/28/2023]
16.19.29.3 STATUTORY AUTHORITY:
Sections 30-31-1 through 30-31-41 of the Controlled Substance Act NMSA
1978, authorizes the board of pharmacy to promulgate rules and charge
reasonable fees regarding controlled substances. Section 30-31-16 of the Controlled Substance
Act NMSA 1978 authorizes the board to collect information regarding controlled
substances. Paragraph (1) of
Subsection A of Section 61-11-6 NMSA, 1978 authorizes the board of pharmacy to
promulgate rules to carry out the provisions of the Pharmacy Act, Paragraph
(18) of Subsection A of Section 61-11-6 NMSA 1978 authorizes the Board to
promulgate rules that prescribe the activities and duties of pharmacy owners
and pharmacists in each practice setting.
Section 61-11-8 NMSA requires drug records to be kept for all dangerous
drugs pursuant to the Pharmacy Act.
[16.19.29.3 NMAC -
N, 7/15/2004, A, 3/22/2015; A, 2/28/2023]
16.19.29.4 DURATION:
Permanent.
[16.19.29.4 NMAC -
N, 7/15/2004]
16.19.29.5 EFFECTIVE
DATE: July 15, 2004, unless a later date is cited
at the end of a section.
[16.19.29.5 NMAC -
N, 7/15/2004]
16.19.29.6 OBJECTIVE: The
objective of Part 29 of Chapter 19 is to promote the public health and welfare
by detecting and preventing substance abuse and misuse, and encouraging
appropriate treatment of pain and other conditions for which controlled
substances are prescribed. The purpose of the program is to improve access to
controlled substances prescription information for legitimate medical needs by
allowing a practitioner or a pharmacist to obtain a patient's pharmaceutical
history related to controlled substances and drug(s) of concern. The
program's objectives will include education of the public and health care
professionals regarding the nature and extent of the problem of drug abuse, and
appropriate prescribing and use of controlled substances and drug(s) of
concern
[16.19.29.6 NMAC -
N, 7/15/2004; A, 3/22/2015; A, 9/25/2018; A, 2/28/2023]
16.19.29.7 DEFINITIONS:
A. “Audit trail information” means any query based information resulting
from an authorized prescription monitoring program user’s request for a
prescription monitoring program report, which could include the user’s name,
date and time of the query or other related information.
B. “Board” means the New Mexico board of pharmacy,
herein referred to as the board.
C. “Controlled substance”
has the meaning given such term in Section 30-31-2 NMSA 1978.
D. “Delegate”
means an individual authorized as an agent of a practitioner or pharmacist for
the purpose of obtaining data from the PMP for review by the practitioner or
pharmacist. The delegate must report
directly to said practitioner or pharmacist and the practitioner or pharmacist
shall be accountable for the delegate’s actions:
(1) a
pharmacist’s delegate must be a certified pharmacy technician or a registered
intern;
(2) a
pharmacy technician or pharmacist intern may access information to the extent
the information relates specifically to a current patient to whom the
pharmacist is dispensing or considering dispensing any controlled substance or
drug(s) of concern, or for the purposes
of a pharmacist providing pharmaceutical care as defined in law.
E. “Dispenser” means
the person who delivers a schedule II - V controlled substance or
drug(s) of concern to the ultimate user,
but does not include the following:
(1) a
licensed hospital pharmacy that distributes such substances for the purpose of
inpatient hospital care;
(2) a
practitioner, or other authorized person who administers such a substance; or
(3) a
practitioner who dispenses to the patient no more than 12 dosage units or 72
hours’ worth (whichever is less) of such a substance or;
(4) a
wholesale distributor of a schedule II - V controlled substance or
drug(s) of concern;
(5) clinics,
urgent care or emergency departments dispensing to the patient no more than 12
dosage units or 72 hours’ worth (whichever is less) of such a substance or;
(6) a
veterinarians or veterinary clinics dispensing to non-human patients.
F. “Drug of concern” means a non-controlled dangerous drug that the Board has by rule determined to require dispenser PMP reporting of in the same manner as controlled substance prescription dispensing, when required reporting is expected to protect patients due to interaction of the drug of concern with controlled substances or other compelling issue. Gabapentin is a drug of concern, except when dispensed pursuant to a prescription issued by a veterinarian.
G. “Patient” means the ultimate user of a drug for whom
a prescription is issued and for whom a drug is dispensed.
H. “Person” means
an individual, corporation, business trust, estate, trust, partnership, limited
liability company, association, joint venture or any legal or commercial
entity.
I. “PMP director” means the individual authorized by the board
to administer the prescription monitoring program (PMP).
J. “PMP report” means a compilation of data generated from
the PMP concerning a patient, a dispenser, a practitioner, or a schedule II - V controlled substance or
drug(s) of concern.
K. “Practitioner” means a person maintaining licensure
pursuant to state law that allows him or her to prescribe controlled substance
medications in accordance with that licensure.
L. “Prescription monitoring program” (PMP)
means a program as described in 16.19.29.6 NMAC which includes a centralized
system to collect, monitor, and analyze electronically, for schedules II - V
controlled substances and drug(s) of concern, prescribing and dispensing data submitted by dispensers of which the
data is to be used to support efforts in education, research, enforcement and
abuse prevention.
M. “Schedule II - V controlled
substance” means a substance
listed in schedules II, III, IV, and V as set forth in the Controlled Substance
Act, Sections 30-31-5 through 30-31-10 NMSA 1978 or the federal Controlled
Substances Regulation (21 U.S.C. 812).
N. “State” means
the state of New Mexico.
[16.19.29.7 NMAC - N, 7/15/2004; A, 6/11/2011; A, 8/31/2012; A, 10/24/2014;
A, 3/22/2015; A, 11/27/2016; A, 9/25/2018; A, 2/28/2023; A 10/10/2023]
16.19.29.8 MANDATORY
REPORTING OF PRESCRIPTION INFORMATION TO THE PMP:
A. The board shall
monitor the dispensing of all schedule II - V controlled substances and
drug(s) of concern by all dispensers
licensed to dispense such substances to patients in this state.
B. Each dispenser
shall submit to the board by electronic means information regarding each
prescription dispensed for a drug included under Subsection A of this
section. Information to be submitted for
each prescription as well as the standards for how this information shall be
formatted, not contrary to law, is defined in the PMP data reporting manual
available on the state PMP website at http://nmpmp.info shall include at a
minimum:
(1) dispenser
NPI number;
(2) dispenser
NCPDP number;
(3) dispenser
DEA number (unless no controlled substances are dispensed
and dispenser has no DEA number);
(4) patient
name;
(5) patient
address;
(6) patient
date of birth;
(7) patient
gender;
(8) reporting
status (new, revised, void);
(9) prescription
number;
(10) date
prescription written;
(11) refills
authorized;
(12) date
prescription filled;
(13) refill
number;
(14) product
ID (NDC) + product ID qualifier;
(15) quantity
dispensed;
(16) days’
supply;
(17) drug
dosage units;
(18) transmission
form of Rx origin;
(19) payment
type;
(20) prescriber
NPI number; (except veterinarians)
(21) prescriber
DEA number (unless prescriber is prescribing a drug of concern and has
no DEA number)
C. Dispenser
reporting:
(1) each
dispenser shall submit the information required under Subsection B of this
section in accordance with transmission methods and frequency established by
the board; but shall report within one business day of the prescription being
filled.
(2) if
a dispenser pharmacy did not dispense any
schedule II – V controlled substances or drug(s) of concern during an operating business day, the dispenser
shall submit a “zero report” within one business day. Information to be submitted with each zero
report as well as the standards for how this information shall be formatted,
not contrary to law, is defined in the PMP data reporting manual available on
the state PMP website at http://nmpmp.org shall include at a minimum:
(a) dispenser
DEA number;
(b) reporting
start date; and
(c) reporting
end date.
(3) the
PMP director shall have the authority to approve submission schedules that
exceed one business day.
D. Corrections to information submitted to the PMP must be addressed
including:
(1) file
upload or “outstanding uncorrected errors” as defined in the PMP data reporting
manual;
(2) prescriptions
that were not dispensed to the patient must be voided from the PMP;
(3) incorrect
information in prescriptions records submitted to the PMP must be submitted to
the PMP database within five business days once the dispenser has been notified
or becomes aware of the incorrect information.
[16.19.29.8 NMAC - N, 7/15/2004; A, 6/11/2011; A, 8/31/2012; A, 3/22/2015;
A, 3/23/2016; A, 9/25/2018; A, 2/28/2023; A 10/10/2023]
16.19.29.9 DISCLOSURE
OF PRESCRIPTION INFORMATION:
A. Prescription
information submitted to the board shall not be subject to the Inspection of
the Public Records Act, Sections 14-2-1 through 14-2-12 NMSA 1978 and shall be
confidential except as provided in Subsections C through G of 16.19.29.9 NMAC.
B. The board shall
maintain procedures to ensure that the privacy and confidentiality of patients
and patient information collected, recorded, transmitted, and maintained in the
PMP is not disclosed to persons except as provided in Subsection C through G of
16.19.29.9 NMAC.
C. Board inspectors
may review prescription information after receiving complaints, and in the course of their enforcement of board administered
statutes and regulations.
D. The board shall be authorized to provide PMP information to the
following persons:
(1) persons
authorized to prescribe or dispense controlled substances, for the purpose of
providing medical or pharmaceutical care for their patients;
(2) a
consultant pharmacist for the purpose of providing pharmaceutical care for a
facility’s patients; and in ensuring that facility records appropriately
account for controlled substance receipt, administration and disposition;
(3) a
delegate designated by a practitioner; or pharmacist; who must also maintain an
active account, can designate one or more (up to four) delegates for the
purpose of requesting and receiving PMP reports for the practitioner or
pharmacist; the practitioner or pharmacist shall be responsible for terminating
the delegate’s access to the PMP within five business days of a delegate’s
authorization ending;
(4) state
practitioner licensing boards whose licensees have prescriptive authority for
controlled substances, including the medical board, board of nursing, board of
veterinarian medicine, board of dental health care, board of examiners in
optometry, board of osteopathic medicine, board of acupuncture and oriental
medicine, and board of podiatry, as the PMP information relates to their
licensees;
(5) practitioner licensing
authorities of other states if their licensees practice in this state or
prescriptions provided by their licensees are dispensed in this state;
(6) local,
state and federal law enforcement or prosecutorial officials engaged in an ongoing investigation of an individual in the enforcement of
the laws governing licit drugs;
(7) the
state human services department regarding medicaid
program recipients;
(8) a
state metropolitan, magistrate and district, or federal court as required by a
grand jury subpoena or criminal court order;
(9) state drug court personnel as authorized by the PMP director;
(10) personnel
of the board for purposes of administration and enforcement of this rule or of
16.19.20 NMAC;
(11) the
prescription monitoring program of another state or group of states with whom
the state has established an interoperability agreement;
(12) a living individual who request’s his or her own PMP report in
accordance with procedures established under the Pharmacy Act, Subsection D of
Section 61-11-2 NMSA 1978 and Subsection H of 16.19.6.23 NMAC, or an agent
authorized by the living individual along with a valid HIPAA release form or
court issued subpoena, or;
(13) a
parent to have access to the prescription records about his or her minor child,
as his or her minor child’s personal representative when such access is not
inconsistent with state or other laws;
(14) licensed healthcare professionals (nurses, pharmacists and
practitioners) from Medicare, health insurers, workers compensation
program/insurers and pharmacy benefit managers for persons enrolled in or
covered by their programs, as part of patient care for those persons.
E. The board shall
use de-identified data obtained from the PMP database to identify and report to
state and local public health authorities the geographic areas of the state
where anomalous prescribing dispensing or use of controlled substances is
occurring.
F. The board shall share PMP database data with the department of health
for the purpose of tracking inappropriate prescribing and misuse of controlled
substances or drug(s) of concern,
including drug overdose.
G. The board shall provide data to public or private
entities for statistical, research, or educational purposes after removing
information that could be used to identify individual patients and persons who
have received prescriptions from dispensers.
H. PMP information gained from other states’ prescription monitoring
programs shall not be subject to civil subpoena, nor shall such information be
disclosed, discoverable, or compelled to be produced in any civil proceeding,
nor shall such records be deemed admissible as evidence in any civil proceeding
for any reason.
[16.19.29.9 NMAC - N, 7/15/2004; A, 6/11/2011; A, 8/31/2012; A, 3/22/2015;
A, 11/27/2016; A, 9/25/2018; A, 2/28/2023]
16.19.29.10 DISCLOSURE
OF AUDIT TRAIL INFORMATION:
A. Audit trail
information maintained by the board shall not be subject to the Inspection of
Public Records Act, Sections 14-2-1 through 14-2-12 NMSA 1978, and shall be
confidential except as provided in Subsection C and D of 16.19.29.10 NMAC.
B. The board shall
maintain procedures to ensure that the privacy and confidentiality of patients
and patient information collected, recorded, transmitted, and maintained in the
PMP is not disclosed to persons except as provided in Subsection C and D of
16.19.29.10 NMAC.
C. Board inspectors
may review audit trail information after receiving complaints, and in the course of their enforcement of board administered
statutes and regulations.
D. The board shall
be authorized to provide audit trail information to the following persons:
(1) state
practitioner licensing boards whose licensees have prescriptive authority for
controlled substances, including the medical board, board of nursing, board of
veterinary medicine, board of dental health care, board of optometry, board of
osteopathic medicine, board of acupuncture and oriental medicine, and board of
podiatry, as the audit trail information relates to their licensees for the
purposes of reviewing compliance with PMP utilization;
(2) practitioner
licensing authorities of other states if their licensees practice in this state
or prescriptions provided by their licensees are dispensed in this state as the
audit trail information relates to their licensees for the purposes of
reviewing compliance with PMP utilization requirements;
(3) personnel
of the board for purposes of administration and enforcement of this rule or of
16.19.20 NMAC;
(4) the
board shall share PMP database data with the department of health for the
purpose of tracking inappropriate prescribing and misuse of controlled substances
or drug(s) of concern, including
drug overdose.
E. Audit trail
information shall not be subject to civil subpoena, nor shall such information
be disclosed, discoverable, or compelled to be produced in any civil
proceeding, nor shall such records be deemed admissible as evidence in any
civil proceeding for any reason.
[16.19.29.10 NMAC -
N, 7/15/2004; A, 6/11/2011; Repealed, 3/22/2015; A, 9/25/2018; A, 2/28/2023]
16.19.29.11 AUTHORITY
TO CONTRACT: The board may contract with another agency of
this state or with a private vendor, as necessary, to ensure the effective
operation of the PMP. A contractor shall
comply with the provisions regarding confidentiality of prescription
information in 16.19.29.9 NMAC and shall be subject to the penalties specified
in 16.19.29.14 NMAC.
[16.19.29.11 NMAC - N, 7/15/2004; A,
3/22/2015]
16.19.29.12 REGISTRATION FOR ACCESS TO PRESCRIPTION INFORMATION:
A. Persons
authorized for access to PMP information as listed in Paragraphs (1) through
(10) and (14) of Subsection D of 16.19.29.9 NMAC must apply for access as
described at the PMP website located at http://nmpmp.org or as otherwise
indicated. Persons granted access must
maintain individual accounts and shall not share access information with other
persons.
B. All persons
authorized for access to PMP information and applying for such access to the
PMP shall successfully complete a web based training program as determined by
the PMP director.
C. Persons
reporting prescription information to the PMP, but not authorized for access to
PMP information must also apply for access as described at the PMP website
located at http://nmpmp.org or as otherwise indicated.
D. The PMP director
shall have the authority to set account access and registration renewal
requirements necessary for accounts to be considered active and shall also have
authority to cancel inactive accounts.
[16.19.29.12 NMAC - N,
7/15/2004; 16.19.29.12 NMAC - N, 6/11/2011; A, 8/31/2012; A, 3/22/2015; A,
11/27/2016; A, 9/25/2018]
16.19.29.13 INFORMATION EXCHANGE WITH OTHER PRESCRIPTION MONITORING PROGRAMS:
A. The board may
provide PMP information to other states’ prescription monitoring programs and
such information may be used by those programs consistent with the provisions
of this rule.
B. The board may
request and receive PMP information from other states’ prescription monitoring
programs and may use such information under provisions
of this rule.
C. The board may
develop the capability to transmit information to and receive information from
other prescription monitoring programs employing the standards of
interoperability.
D. The board may
enter into written agreements with other states’ prescription monitoring
programs or other persons hosting compatible information sharing technologies
for the purpose of describing the terms and conditions for sharing of PMP
information under this section.
[16.19.29.13 NMAC - N, 7/15/2004; 16.19.29.13 NMAC - N, 6/11/2011; A,
3/22/2015]
16.19.29.14 PENALTIES:
A. A dispenser who
knowingly fails to submit prescription monitoring information to the board as
required by this rule or knowingly submits incorrect prescription information
shall be subject to disciplinary proceedings as defined in Section 61-11-20 of
the Pharmacy Act NMSA 1978.
B. Prescription
information submitted to the PMP is protected health information. Persons with access to the PMP shall exercise
due diligence in protecting this information and access it only as necessary in the course of legitimate professional regulatory, or law
enforcement duties.
C. A person found
to be in violation of this section may be subject to one or more of the
following actions.
(1) Termination
of access to PMP information.
(2) A
complaint may be filed with his or her appropriate professional licensing
entities.
[16.19.29.14 NMAC -
Rn, 16.19.29.12 NMAC, 6/11/2011; A, 8/31/2012; A, 3/22/2015]
16.19.29.15 SEVERABILITY: If any
provisions of this rule or its application to any person or circumstance is
held invalid or unenforceable, the remainder of this rule shall not be affected
and shall be valid and enforceable.
[16.19.29.15 NMAC - Rn, 16.19.29.13
NMAC, 6/11/2011; A, 3/22/2015]
HISTORY OF
16.19.29 NMAC: [RESERVED]