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, 07-15-04]
16.19.29.2 SCOPE: All
persons or entities that dispense controlled substances pursuant to
prescriptions from practitioners.
[16.19.29.2 NMAC -
N, 07-15-04]
16.19.29.3 STATUTORY AUTHORITY: Section
30-31-16 of the Controlled Substance Act.
30-31-1 through 30-31-42 NMSA 1978, authorizes the board of pharmacy to
promulgate regulations and charge reasonable fees regarding controlled
substances. 30-31-16 authorizes the
board to collect information regarding controlled substances.
[16.19.29.3 NMAC -
N, 07-15-04]
16.19.29.4 DURATION:
Permanent.
[16.19.29.4 NMAC -
N, 07-15-04]
16.19.29.5 EFFECTIVE
DATE: 07-15-04, unless a later date is cited at the
end of a section.
[16.19.29.5 NMAC -
N, 07-15-04]
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 encouraging appropriate
treatment of pain and other conditions for which controlled substances are
prescribed. The purpose of the system is to improve access to controlled
substances for legitimate medical needs by allowing a practitioner or a
pharmacist to obtain a patient's pharmaceutical history related to controlled
substances. 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, appropriate prescribing and
use of controlled substances, and the medical treatment options for abusers of
controlled substances and pain management.
[16.19.29.6 NMAC -
N, 07-15-04]
16.19.29.7 DEFINITIONS:
A. “Controlled
substance” has the meaning given such term in 30-31-2 NMSA.
B. “Board of pharmacy”
means the state agency responsible for the functions listed in 16.19.29.8
NMAC.
C. “Patient” means
the person or animal who is the ultimate user of a drug for whom a prescription
is issued and for whom a drug is dispensed.
D. “Dispenser” means
the person who delivers a schedule II - V controlled substance as defined in Subsection
E 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 wholesale distributor of a schedule II - V controlled substance;
(4) clinics, urgent care or emergency
departments dispensing no more than 12 dosage units to an individual patient
within a 72 hour period.
E. “Schedule II, III, IV and V
controlled substance” means
substances that are listed in schedules II, III, IV, and V of the schedules
provided under 30-31-5 to 30-31-10 of NMSA or the federal controlled substances
regulation (21 U.S.C. 812).
F. “Report” means a compilation of data concerning a
patient, a dispenser, a practitioner, or a controlled substance.
[16.19.29.7 NMAC -
N, 07-15-04; A, 06-11-11]
16.19.29.8 REQUIREMENTS
FOR THE PRESCRIPTION MONITORING PROGRAM:
A. The board shall
monitor the dispensing of all schedule II, III, IV and V controlled substances
by all pharmacies 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 reported
shall conform to the standards developed by the American society for automation
in pharmacy (ASAP) and published in the “ASAP
telecommunications format for controlled substances”, 2009 4.1
edition. Information submitted for each
prescription shall include:
(1) dispenser DEA number;
(2) date prescription filled;
(3) prescription number;
(4) whether the prescription is new or a refill;
(5) NDC code for drug dispensed;
(6) quantity dispensed;
(7) patient name;
(8) patient address;
(9)
patient date of birth;
(10) prescriber DEA number;
(11) date prescription issued by prescriber;
(12) and payment classification.
C. Each dispenser
shall submit the information in accordance with transmission methods and
frequency established by the board; but shall report at least every seven days. A record of each controlled substance prescription
dispensed must be transmitted to the boards’ agent by computer modem.
[16.19.29.8 NMAC -
N, 07-15-04; A, 06-11-11]
16.19.29.9 ACCESS
TO PRESCRIPTION INFORMATION:
A. Prescription
information submitted to the board shall be confidential and not subject to
public or open records laws, except as provided in Subsections C, D and E 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 is not
disclosed to persons except as in Subsection C, D, and E of this 16.19.29.9
NMAC.
C. After receiving a complaint, the board
inspectors shall review the relevant prescription information. If
there is reasonable cause to believe a violation of law or breach of
professional standards may have occurred, the board shall notify the
appropriate law enforcement or professional licensing, certification or
regulatory agency or entity, and provide prescription information required for
an investigation.
D. The board will establish written protocols
for reviewing the prescription data reported.
These protocols will be reviewed and approved by the board as needed but
at least once every calendar year. These
protocols will define information to be screened, frequency and thresholds for
screening and the parameters for using the data. Data will be used to notify providers,
patients and pharmacies to educate, provide for patient management and
treatment options.
E. The board shall be authorized to provide data in the prescription
monitoring program 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) an individual who request's their own
prescription monitoring information in accordance with procedures established
under 61-11-2.D NMSA, 1978 and Subsection G of 16.19.6.23 NMAC;
(3) New Mexico medical board, New Mexico board
of nursing, New Mexico board of veterinary medicine, New Mexico board of dental
health care, board of examiners in optometry, osteopathic examiners board,
acupuncture & oriental medicine board, and podiatry board for their
licensees;
(4) professional licensing authorities of
other states if their licensees practice in the state or prescriptions provided
by their licensees are dispensed in the state;
(5) 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;
(6) human services department regarding
medicaid program recipients;
(7) metropolitan, district, state or federal
court(s) under grand jury subpoena or criminal court order;
(8) personnel of the board for purposes of
administration and enforcement of this regulation, or 16.19.20 NMAC or;
(9) the controlled substance monitoring
program of another state or group of states with whom the state has established
an interoperability agreement;
(10) 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.
F. 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.
[16.19.29.9 NMAC -
N, 07-15-04; A, 06-11-11]
16.19.29.10 REPORTS: A
written request will be filed with the board prior to release of a report.
A. Persons listed
in Paragraphs (1) through (10) of Subsection E of 16.19.29.9 NMAC must submit a
written request listing the information for the report.
B. Reports will be
prepared and delivered to the requesting person via U.S. mail, facsimile, or
other electronic means.
C. Reports may be
provided by secured electronic means after verification of electronic request.
D. The program will produce
reports for the board that evaluate the effectiveness of the program and assist
in identifying diversion of controlled substances. The program will produce statistical reports
to evaluate the dispensing of controlled substances and utilization of the
program. These reports will be able to
provide data on:
(1) number of solicited reports from
prescribers for a specified time period;
(2)
number of solicited reports from a specified prescriber for a specified
time period;
(3) number of solicited reports from
pharmacies for a specified time period;
(4) number of solicited reports from a
specified pharmacy for a specific time period;
(5) number of solicited reports from other
unauthorized individuals for a specified time period;
(6) number of individuals receiving a
prescription for a specified schedule for a specified time period;
(7) threshold report of number of individuals
receiving a prescription for a specified schedule from 6 or more prescribers or
6 or more pharmacies within a specified time period;
(8) number of solid dosage units for a
specified schedule for pain relievers, tranquilizers, stimulants and sedatives
for a specified time period;
(9) list of individual prescriptions for a
specified zip-code or state code;
(10) number of prescriptions for a specified
zip-code;
(11) number of dosage units for a specified
drug and specified zip-code.
E. The board shall receive a quarterly
program outcomes report from staff or contractors. A statistical analysis of the data that does
not include protected information should be reported on the web site or in the
newsletter.
[16.19.29.10 NMAC - N, 07-15-04; A, 06-11-11]
16.19.29.11 AUTHORITY
TO CONTRACT: The board is authorized to contract with
another agency of this state or with a private vendor, as necessary, to ensure
the effective operation of the prescription monitoring program. Any contract shall be bound to comply with the
provisions regarding confidentiality of prescription information in 16.19.29.9
NMAC of this regulation and shall be subject to the penalties specified in
16.19.29.12 NMAC of this regulation for unlawful regulations.
[16.19.29.11 NMAC - N, 07-15-04]
16.19.29.12 REGISTRATION FOR ACCESS TO PRESCRIPTION INFORMATION:
A. Practitioners
with individual drug enforcement administration (DEA) issued numbers will
complete and submit a hard copy written, signed and notarized application. After verification of submitted information,
a username and password will be issued to the practitioner. One subaccount per practitioner account is
authorized for an agent of the practitioner.
The agent designated by the practitioner will complete and submit a hard
copy written, signed and notarized application.
After verification of submitted information, a username and password
will be issued to the agent.
B. Pharmacies with
DEA issued numbers will complete and submit a hard copy written, signed and
notarized application. After
verification of submitted information, a username and password will be issued. Pharmacies will designate one individual who
will complete and submit a hard copy written, signed and notarized
application. After verification of
submitted information, a username and password will be issued to the
individual. Pharmacies will not be
permitted to obtain a subaccount.
C. All
registrations will be renewed every three years by completing and submitting a new
application.
[16.19.29.12 NMAC - N, 07-15-04;
16.19.29.12 NMAC - N, 06-11-11]
16.19.29.13 INFORMATION EXCHANGE WITH OTHER PRESCRIPTION MONITORING PROGRAMS:
A. The New Mexico
board of pharmacy may provide prescription monitoring information to other
states’ prescription monitoring programs and such information may be used by
those programs consistent with the provisions of the rule.
B. The New Mexico
board of pharmacy may request and receive prescription monitoring information
from other states’ prescription monitoring programs and may use such
information under provisions of this rule.
C. The New Mexico
board of pharmacy may develop the capability to transmit information to and
receive information from other prescription monitoring programs employing the
standards of interoperability.
D. The New Mexico
board of pharmacy is authorized to enter into written agreements with other
states’ prescription monitoring programs or other entities hosting compatible
information sharing technologies for the purpose of describing the terms and
conditions for sharing of prescription information under this section.
[16.19.29.13 NMAC -
N, 07-15-04; 16.19.29.13 NMAC - N, 06-11-11]
16.19.29.14 PENALTIES:
A. A dispenser who
knowingly fails to submit prescription monitoring information to the board as
required by this regulation or knowingly submits incorrect prescription
information shall be subject to disciplinary proceedings as defined in 61-11-20
NMSA.
B. A person
authorized to have prescription monitoring information pursuant to this
regulation who knowingly discloses such information in violation of this regulation
shall be subject to criminal proceedings as described in 26-1-16.D and 26-1-26
NMSA.
C. A person
authorized to have prescription monitoring information pursuant to this
regulation who uses such information in a manner or for a purpose in violation
of this regulation shall be subject to criminal proceedings as described in
26-1-16.D and 26-1-26 NMSA.
[16.19.29.14 NMAC -
Rn, 16.19.29.12 NMAC, 06-11-11]
16.19.29.15 SEVERABILITY: If
any provisions of this regulation or application thereof to any person or
circumstance is held invalid, the invalidity does not affect other provisions
or applications of the regulation which can be given effect without the invalid
provisions or applications, and to this end the provisions of this regulation
are severable.
[16.19.29.15 NMAC - Rn, 16.19.29.13
NMAC, 06-11-11]
HISTORY OF
16.19.29 NMAC: [RESERVED]