TITLE 16 OCCUPATIONAL AND PROFESSIONAL
LICENSING
CHAPTER 10 MEDICINE AND SURGERY PRACTITIONERS
PART 14 MANAGEMENT OF PAIN AND OTHER
CONDITIONS WITH CONTROLLED SUBSTANCES
16.10.14.1 ISSUING
AGENCY: New Mexico Medical Board, hereafter called
the board.
[16.10.14.1 NMAC - N, 1/20/2003;
A, 4/3/2005]
16.10.14.2 SCOPE: This part
applies to all New Mexico medical board licensees who hold a federal drug
enforcement administration registration.
[16.10.14.2 NMAC - N, 1/20/2003;
A, 9/28/2012]
16.10.14.3 STATUTORY AUTHORITY: These rules are promulgated pursuant to and in accordance with the Medical Practice Act, Sections 61-6-1 through 61-6-35 NMSA 1978 and the Pain Relief Act, Sections 24-2D-1 through 24-2D-6 NMSA 1978.
[16.10.14.3 NMAC - N, 1/20/2003;
A, 9/28/2012]
16.10.14.4 DURATION: Permanent.
[16.10.14.4 NMAC - N, 1/20/2003]
16.10.14.5 EFFECTIVE DATE: January 20,
2003, unless a later date is cited at the end of a section.
[16.10.14.5 NMAC - N, 1/20/2003]
16.10.14.6 OBJECTIVE: This part governs the prescribing of
controlled substances in the treatment of pain and other conditions to ensure
that they are prescribed for appropriate doses and durations and after a
thorough medical evaluation.
[16.10.14.6 NMAC - N, 1/20/2003;
A, 4/3/2005; A, 11/30/2016]
16.10.14.7 DEFINITIONS:
A. “Acute pain” means the normal, predicted
physiological response to a noxious chemical or thermal or mechanical stimulus,
typically associated with invasive procedures, trauma or disease and is
generally time-limited.
B. “Addiction” is a neurobehavioral
syndrome with genetic and environmental influences that results in
psychological dependence on the use of substances for their psychic
effects. It is characterized by
behaviors that include one or more of the following: impaired control over drug
use; compulsive use; continued use despite harm; and, craving. Physical dependence and tolerance are normal
physiological consequences of extended opioid therapy for pain and should not
by themselves be considered addiction.
C. “Benzodiazepine” means any controlled substance referenced
at Subsection A of 16.19.20.68 NMAC, as
may be amended from time to time.
D. “Chronic
pain” means pain that persists after reasonable medical efforts have been
made to relieve the pain or its cause and that continues, either continuously
or episodically, for longer than three consecutive months. “Chronic pain” does not, for purpose of the
Pain Relief Act requirements, include pain associated with a terminal condition
or with a progressive disease that, in the normal course of progression, may reasonably
be expected to result in a terminal condition.
E. “Clinical
expert” means a person who, by reason of specialized education or
substantial relevant experience in pain management, has knowledge regarding
current standards, practices and guidelines.
F. “Controlled
Substance” means a drug or substance listed in schedules I through V of the
Controlled Substances Act or regulations adopted thereto.
G. “Delegate” means a person
designated by a practitioner pursuant to 16.19.29.9 NMAC for the purpose of
requesting and receiving prescription monitoring program (PMP) reports for that
practitioner.
H. “Opioid” means the class of
drugs that includes the natural derivatives of opium, which are morphine and
codeine, and related synthetic and semi-synthetic compounds that act upon
opioid receptors.
I. “Opioid
antagonist” means a drug approved by the federal food and drug
administration that when administered negates or neutralizes in whole or in
part the pharmacological effects of an opioid analgesic in the body, including naloxone
and such other medications approved by the board of pharmacy for the reversal
of opioid analgesic overdoses.
J. “Pain” means acute or chronic pain or both.
K. “Physical
dependence” means a state of adaptation that is manifested by a
drug-specific withdrawal syndrome that can be produced by abrupt cessation,
rapid dose reduction, decreasing blood level of the drug, administration of an
antagonist, or a combination of these.
L. “Practitioner”
means a New Mexico medical board licensee maintaining licensure pursuant to
state law that allows that individual to prescribe, order, administer or
dispense controlled substances to patients (see 16.19.29.7 NMAC).
M. “Prescription
monitoring program” means a centralized system to collect, monitor, and
analyze electronically, for controlled substances, prescribing and dispensing
data submitted by pharmacies and dispensing practitioners. The data are used to support efforts in
education, research, enforcement and abuse prevention.
N. “Schedule
II-V” refers to any controlled substance listed in schedule II, III, IV, or
V of the Controlled Substances Act found at Chapter 30, Article 31 NMSA 1978,
regulations promulgated by the New Mexico board of pharmacy found at 16.19.20
NMAC, or federal controlled substances regulations promulgated pursuant to 21
U.S.C. 812.
O. “Stimulant” means any controlled
substance referenced in Subsection C of 16.19.20.66 NMAC, Subsection A of
16.19.20.67 NMAC, Subsection D of 16.19.20.68 NMAC, or Subsection B of
16.19.20.69 NMAC, as may be amended from time to time.
P. “Therapeutic
purpose” means the use of pharmaceutical and non-pharmaceutical medical
treatment that conforms substantially to accepted guidelines for pain
management and other conditions.
Q “Tolerance” means a state of adaptation
in which exposure to a drug induces changes that result in a diminution of one
or more of the drug’s effects over time.
[16.10.14.7 NMAC - N, 1/20/2003;
A, 9/28/2012; A, 11/30/2016; A, 3/24/2020]
16.10.14.8 PRESCRIPTION MONITORING PROGRAM (PMP)
REQUIREMENTS: The intent of the New Mexico medical board in
requiring participation in the PMP is to assist practitioners in balancing the
safe use of controlled substances with the need to impede harmful and illegal activities
involving these pharmaceuticals.
A. Any practitioner
who holds a federal drug enforcement administration registration and a New
Mexico controlled substance registration shall register with the board of
pharmacy to become a regular participant in PMP inquiry and reporting.
B. A practitioner
may authorize delegate(s) to access the prescription monitoring report
consistent with board of pharmacy regulation 16.19.29 NMAC. While a practitioner’s delegate may obtain a
report from the state’s prescription monitoring program, the practitioner is
solely responsible for reviewing the prescription monitoring report and
documenting the receipt and review of a report in the patient’s medical record.
C. Before a
practitioner prescribes or dispenses for the first time, a controlled substance
in schedule II, III, IV or V 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 practitioner shall review a prescription monitoring report for the
patient for the preceding 12 months.
When available, the practitioner shall review similar reports from
adjacent states. The practitioner shall
document the receipt and review of such reports in the patient’s medical
record.
D. A prescription
monitoring report shall be reviewed a minimum of once every three months during
the continuous use of a controlled substance in schedule II, III, IV or V for
each patient. The practitioner shall
document the review of these reports in the patient’s medical record. Nothing in this section shall be construed as
preventing a practitioner from reviewing prescription monitoring reports with
greater frequency than that required by this section.
E. A practitioner
does not have to obtain and review a prescription monitoring report before
prescribing, ordering, or dispensing a controlled substance in schedule II,
III, IV or V:
(1) for
a period of four days or less; or
(2) to
a patient in a nursing facility; or
(3) to
a patient in hospice care; or
(4) when
prescribing , dispensing or administering of:
(a) testosterone;
or
(b) pregabalin;
or
(c) lacosamide;
or
(d) ezogabine;
or
(e) stimulant
therapy for pediatric patients less than age 14.
F. Upon review of a
prescription monitoring report for a patient, the practitioner shall identify,
document and be aware of a patient currently:
(1) receiving
opioids from multiple prescribers;
(2) receiving
opioids and benzodiazepines concurrently;
(3) receiving
opioids for more than 12 consecutive weeks;
(4) receiving
more than one controlled substance analgesic;
(5) receiving
opioids totaling more than 90 morphine milligram equivalents per day;
(6) 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 Subsection F of 16.10.14.8 NMAC, the
practitioner, 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, or offering or arranging treatment for opioid or
substance use disorder. The practitioner
shall document actions taken to prevent, mitigate, or resolve the potential
problems or risks.
H. Practitioners
licensed to practice in an opioid treatment program, as defined in 7.32.8 NMAC,
shall review a prescription monitoring report upon a patient’s initial
enrollment into the opioid treatment program and every three months thereafter
while prescribing, ordering, administering, or dispensing opioid treatment
medications in schedule II, III, IV or V for the purpose of treating opioid use
disorder. The practitioner shall
document the receipt and review of a report in the patient’s medical record.
[16.10.14.8 NMAC - N, 1/20/2003;
A, 4/3/2005; A, 9/28/2012; A, 2/14/13; 16.10.14.8 NMAC - Rp, 16.10.14.10 NMAC, 11/30/2016]
16.10.14.9 REGULATIONS FOR THE APPROPRIATE
TREATMENT OF PAIN WITH CONTROLLED SUBSTANCES: The following regulations shall be used by the board
to determine whether a health care practitioner’s prescriptive practices are
consistent with the appropriate treatment of pain.
A. The treatment of pain with various
medicines or controlled substances is a legitimate medical practice when
accomplished in the usual course of professional practice. It does not preclude treatment of patients
with addiction, physical dependence or tolerance who have legitimate pain. However, such patients do require very close
monitoring and precise documentation.
B. The prescribing, ordering,
administering or dispensing of controlled substances to meet the individual
needs of the patient for management of chronic pain is appropriate if
prescribed, ordered, administered or dispensed in compliance with the
following.
(1) A practitioner shall complete a
physical examination and include an evaluation of the patient's psychological
and pain status. The medical history
shall include any previous history of significant pain, past history of
alternate treatments for pain, potential for substance abuse, coexisting
disease or medical conditions, and the presence of a medical indication or
contra-indication against the use of controlled substances.
(2) A practitioner shall be familiar with
and employ screening tools as appropriate, as well as the spectrum of available
modalities, in the evaluation and management of pain. The practitioner shall consider an
integrative approach to pain management.
(3) A written treatment plan shall be
developed and tailored to the individual needs of the patient, taking age,
gender, culture, and ethnicity into consideration, with stated objectives by
which treatment can be evaluated, e.g. by degree of pain relief, improved
physical and psychological function, or other accepted measure. Such a plan shall include a statement of the
need for further testing, consultation, referral or use of other treatment
modalities.
(4) The practitioner shall discuss the
risks and benefits of using controlled substances with the patient or surrogate
or guardian, and shall document this discussion in the record.
(5) Complete and accurate records of care
provided and drugs prescribed shall be maintained. When controlled substances are prescribed,
the name of the drug, quantity, prescribed dosage and number of refills
authorized shall be recorded.
Prescriptions for opioids shall include indications for use. For chronic pain patients treated with
controlled substance analgesic(s), the prescribing practitioner shall use a
written agreement for treatment with the patient outlining patient responsibilities. As part of a written agreement, chronic pain
patients shall receive all chronic pain management prescriptions from one
practitioner and one pharmacy whenever possible.
(6) The management of patients needing
chronic pain control requires monitoring by the attending or the consulting
practitioner. The practitioner shall
periodically review the course of treatment for chronic pain, the patient’s
state of health, and any new information about the etiology of the chronic pain
at least every six months. In addition,
a practitioner shall consult, when indicated by the patient’s condition, with
health care professionals who are experienced by the length and type of their
practice in the area of chronic pain control; such professionals need not be
those who specialize in pain control.
(7) When prescribing opioids for chronic pain, practitioners shall require
urine drug testing when starting opioid therapy and shall use urine drug testing
at least every six months to assess for prescribed medications as well as other
controlled prescription drugs and illicit drugs.
(8) If, in a practitioner’s medical
opinion, a patient is seeking pain medication for reasons that are not
medically justified, the practitioner is not required to prescribe controlled
substances for the patient.
C. Pain management for patients with
substance use disorders shall include:
(1) a contractual agreement;
(2) appropriate consultation;
(3) drug screening when other factors
suggest an elevated risk of misuse or diversion; and
(4) a schedule for re-evaluation at
appropriate time intervals at least every six months.
D. The board will evaluate the quality
of care on the following basis: appropriate diagnosis and evaluation;
appropriate medical indication for the treatment prescribed; documented change
or persistence of the recognized medical indication; and, follow-up evaluation
with appropriate continuity of care. The
board will judge the validity of prescribing based on the practitioner’s
treatment of the patient and on available documentation, rather than on the
quantity and chronicity of prescribing.
The goal is to control the patient’s pain for its duration while
effectively addressing other aspects of the patient’s functioning, including
physical, psychological, social, and work-related factors.
E. The board will review both
over-prescription and under-prescription of pain medications using the same
standard of patient protection.
F. A practitioner who appropriately
prescribes controlled substances and who follows this section would be
considered to be in compliance with this rule and not be subject to discipline
by the board, unless there is some violation of the Medical Practice Act or
board rules.
[16.10.14.9 NMAC - N, 4/3/2005;
A, 9/28/2012; 16.10.14.9 NMAC - Rp, 16.10.14.8 NMAC, 11/30/2016]
16.10.14.10 PHYSICIAN, PHYSICIAN ASSISTANTS AND
ANESTHESIOLOGIST ASSISTANTS TREATED WITH OPIATES: Physicians,
physician assistants or anesthesiologist assistants who have chronic pain and
are being treated with opiates shall be evaluated by a pain clinic or, by a
physician pain specialist, and must have a complete, independent
neuropsychological evaluation, as well as clearance from their physician,
before returning to or continuing in practice.
In addition, they must remain under the care of a physician for as long
as they remain on opiates while continuing to practice.
[16.10.14.10 NMAC - N,
9/28/2012; A, 2/14/13; 16.10.14.10 NMAC - Rp, 16.10.14.9 NMAC, 11/30/2016; A, 2/8/2022]
16.10.14.11 CONTINUING
EDUCATION FOR THE PRESCRIBING OF CONTROLLED SUBSTANCES: This section
applies to all New Mexico medical board licensees who hold a federal drug
enforcement administration registration and a New Mexico controlled substances
registration. Pursuant to the Pain
Relief Act, in order to ensure that all such health care practitioners safely
prescribe for pain management and harm reduction, the following rules shall
apply.
A. Immediate requirements effective
November 1, 2012: Between November
1, 2012 and no later than June 30, 2014, all New Mexico medical board licensees
who hold a federal drug enforcement administration registration and a New
Mexico controlled substances registration, shall complete no less than five
continuing medical education hours in appropriate courses that shall include:
(1) an understanding of the pharmacology
and risks of controlled substances;
(2) a basic awareness of the problems of
abuse, addiction and diversion;
(3) awareness of state and federal
regulations for the prescription of controlled substances;
(4) management of the treatment of pain;
and
(5) courses may also include a review of
this rule 16.10.14 NMAC the applicability of such courses toward fulfillment of
the continuing medical education requirement is subject to medical board
approval. Practitioners who have taken
continuing medical education hours in these educational elements between July
1, 2011 and November 1, 2012, may apply those hours toward the required five
continuing medical education hours described in Subsection A of 16.10.14.11
NMAC.
B. Triennial
requirements for physicians:
Beginning with the July 1, 2014 triennial renewal date, pursuant to
16.10.4.8 NMAC, as part of the 75 continuing medical education hours required
during each triennial renewal cycle, all New Mexico medical board physician
licensees who hold a federal drug enforcement administration registration and a
New Mexico controlled substances registration, shall be required to complete
and submit five continuing medical education hours. Appropriate courses shall include all of the
educational elements described in Paragraph (1) through (5) of Subsection A of 16.10.14.11
NMAC. A licensee may request prior board approval of the applicability of any
courses may be requested. These hours
may be earned at any time during the three-year period immediately preceding
the triennial renewal date. The five
continuing medical education hours completed prior to July 1, 2014, as defined
in Subsection A of 16.10.14.11 above, may be included as part of the required
continuing medical education hours in pain management in either the triennial
cycle in which these hours are completed, or the triennial cycle immediately
thereafter.
C. Biennial
requirements for physician assistants:
Beginning with the July 1, 2014 biennial renewal date, 16.10.15.16 NMAC,
in addition to the national commission on certification of physician assistants
(NCCPA) certification required during each biennial renewal cycle pursuant to
16.10.15.16 NMAC, all New Mexico medical board physician assistant licensees
who hold a federal drug enforcement administration registration and a New
Mexico controlled substances registration, shall be required to complete and
submit three continuing medical education hours. Appropriate courses shall include all of the
educational elements described in Paragraph (1) through (5) of Subsection A of
16.10.14.11 NMAC, or other courses in pain management with controlled
substances. A licensee may request prior
board approval of the applicability of any courses may be requested. These hours may be earned at any time during
the two-year period immediately preceding the renewal date. Three of the five continuing medical
education hours completed prior to July 1, 2014, as defined in Subsection A of
16.10.14.11 NMAC above, may be included as part of these required three
continuing medical education hours in pain management in either the biennial
cycle in which these hours are completed, or the biennial cycle immediately
thereafter. Any or all three of these
hours may also be applied to satisfy NCCPA requirements for certification.
D. Biennial
requirements for anesthesiologist assistants: Beginning with the July 1, 2014 biennial
renewal date, 16.10.19.15 NMAC, all New Mexico medical board anesthesiologist
assistant licensees who hold a federal drug enforcement administration
registration and a New Mexico controlled substances registration, shall be
required to complete and submit three continuing medical education hours. Appropriate courses shall include all of the
educational elements described in Paragraph (1) through (5) of Subsection A of
16.10.14.11 NMAC, or other courses in pain management with controlled substances. A licensee may request prior board approval
of the applicability of any courses may be requested. These hours may be earned at any time during
the two-year period immediately preceding the renewal date. Three of the five continuing medical
education hours completed prior to July 1, 2014, as defined in Subsection A of
16.10.14.11 NMAC above, may be included as part of these required three
continuing medical education hours in pain management in either the biennial
cycle in which these hours are completed, or the biennial cycle immediately
thereafter.
E. Requirements
for new licensees: All New Mexico
medical board licensees, whether or not the New Mexico license is their first
license, who hold a federal drug enforcement administration registration and a
New Mexico controlled substances registration, shall complete five continuing
medical education hours in pain management during the first year of
licensure. These continuing medical
education hours completed prior to the first renewal may be included as part of
the hours required in Subsections B, C or D of 16.10.11.14.11 NMAC.
[16.10.14.11 NMAC - N, 9/28/2012;
A, 2/14/2013; A, 11/30/2016]
16.10.14.12 NOTIFICATION: In addition to the notice of procedures set
forth in the State Rules Act, Section 14-4-1 et seq NMSA 1978, the board shall
separately notify the following persons of the Pain Relief Act and Part 14 of
the New Mexico medical board rule, 16.10.14 NMAC;
A. health care practitioners under its
jurisdiction; and
B. a health care practitioner being
investigated by the board in relation to the practitioner’s pain management
services.
[16.10.14.12 NMAC - N, 9/28/2012]
16.10.14.13 REQUIREMENTS FOR LICENSEES OF THE NEW
MEXICO MEDICAL BOARD
WHO PRESCRIBE, DISTRIBUTE
OR DISPENSE OPIOID ANALGESICS:
A. A health care provider who prescribes, distributes or
dispenses an opioid analgesic for the first
time to a patient shall
advise the patient on the risks of overdose and inform the patient of the
availability of an
opioid antagonist. With respect to a patient to whom an opioid
analgesic has previously been prescribed, distributed
or dispensed by the health
care provider, the health care provider shall advise the patient on the risks
of overdose
and inform the patient of the
availability of an opioid antagonist on the first occasion that the health care
provider prescribes,
distributes or dispenses an opioid analgesic each calendar year.
B. A health care provider who
prescribes an opioid analgesic for a patient shall co-prescribe an opioid antagonist
if the amount of opioid analgesic being prescribed is at least a five-day
supply. The prescription for the opioid
antagonist shall be accompanied by written information regarding the temporary
effects of the opioid antagonist and techniques for administering the opioid
antagonist. That written information
shall contain a warning that a person administering the opioid antagonist
should call 911immediately after administering the opioid antagonist.
[16.10.14.13 NMAC - N,
3/24/2020]
HISTORY OF 16.10.14 NMAC: [RESERVED]