New
Mexico Register / Volume XXIII, Number 15 / August 15, 2012
This is an
amendment to 16.19.29 NMAC, Sections 7, 8, 9, 12 and 14, effective 8-31-12.
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. “Prescription
monitoring program” (PMP) means a centralized system to collect, monitor, and
analyze electronically, for controlled substances, prescribing and dispensing
data submitted by pharmacies and dispensing practitioners, of which the data is
to be used to support efforts in education, research, enforcement and abuse
prevention.
[E.] F. “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.] G. “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; A, 08-31-12]
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. The executive director shall have the authority to approve
submission schedules that exceed seven days. A record of each controlled substance
prescription dispensed must be transmitted to the boards’ agent [by computer
modem] electronically.
[16.19.29.8 NMAC - N, 07-15-04; A,
06-11-11; A, 08-31-12]
16.19.29.9 ACCESS
TO PRESCRIPTION INFORMATION: Practitioners
registered with the program may designate one delegate per practice site to
register with the program for the purpose of requesting and receiving reports
for the practitioner.
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[.];
(11) the
board shall use de-identified data obtained from the prescription drug
monitoring 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.
(12) the
board shall share prescription drug monitoring database data with the
department of health for the purpose of tracking inappropriate prescribing and
misuse of controlled substances, including drug overdose.
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; A, 08-31-12]
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.
D. All
registrants to the prescription monitoring program will complete a web based
training program approved by the board.
[16.19.29.12 NMAC - N, 07-15-04; 16.19.29.12 NMAC - N, 06-11-11; A,
08-31-12]
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.] Prescription
information submitted to the New Mexico prescription monitoring program (PMP)
is protected health information.
Registrants with access to the PMP are required to 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 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.] Individual
registrants found to be in violation of this section may be subject to one or
more of the following actions.
(1) Termination of access to
the program information.
(2) A complaint may be filed
with appropriate professional regulatory entities.
[16.19.29.14 NMAC - Rn, 16.19.29.12 NMAC, 06-11-11; A, 08-31-12]