TITLE 16 OCCUPATIONAL
CHAPTER 21 PODIATRISTS
PART 9 MANAGEMENT OF PAIN WITH
CONTROLLED SUBSTANCES
16.21.9.1 ISSUING AGENCY:
Regulation and Licensing Department, NM Board of Podiatry.
[16.21.9.1 NMAC -
N, 11/1/2013]
16.21.9.2 SCOPE:
This part applies to all New Mexico licensed podiatrists who hold a
federal drug enforcement administration registration.
[16.21.9.2 NMAC -
N, 11/1/2013]
16.21.9.3 STATUTORY AUTHORITY:
These rules are promulgated pursuant to and in accordance with the
Podiatry Act, Sections 61-8-1 through 61-8-17 NMSA 1978 and the Pain Relief
Act, Sections 24-2D-1 NMSA through 24-2D-6.
[16.21.9.3 NMAC -
N, 11/1/2013]
16.21.9.4 DURATION:
Permanent.
[16.21.9.4 NMAC -
N, 11/1/2013]
16.21.9.5 EFFECTIVE DATE: November
1, 2013, unless a later date is cited at the end of a section.
[16.21.9.5 NMAC -
N, 11/1/2013]
16.21.9.6 OBJECTIVE: It
is the position of the board that practitioners have an obligation to treat
chronic pain and that a wide variety of medicines including controlled
substances and other drugs may be prescribed for that purpose. When such
medicines and drugs are used, they should be prescribed in adequate doses and
for appropriate lengths of time after a thorough medical evaluation has been
completed.
[16.21.9.6 NMAC -
N, 11/1/2013]
16.21.9.7 DEFINITIONS:
A. “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.
B. “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.
C. “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.
D. “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.
E. “Drug abuser” means a person who takes a drug or drugs
for other than legitimate medical purposes.
F. “Pain” means acute or chronic pain or both.
G. “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.
H. “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.
I. “Therapeutic purpose” means the use of pharmaceutical
and non-pharmaceutical medical treatment that conforms substantially to
accepted guidelines for pain management.
J. “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.
[16.21.9.7 NMAC -
N, 11/1/2013]
16.21.9.8 HEALTH CARE PRACTITIONER’S
PRESCTIPTIVE PRACTICES: 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) 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 Podiatry Act or board rules.
[16.21.9.8 NMAC -
N, 11/1/2013]
16.21.9.9 PODIATRIC PHYSICIAN TREATED WITH
OPIATES: Podiatric physicians who have chronic pain
and are being treated with opiates shall be evaluated by a pain clinic or, by
an MD or DO 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.
[16.21.9.9 NMAC -
N, 11/1/2013]
16.21.9.10 PRESCRIPTION MONITORING PROGRAM
(PMP) REQUIREMENTS: The intent of the New Mexico board of podiatry
in requiring participation in the PMP is to assist practitioners in balancing
the promotion of the safe use of controlled substances for the provision of
medical care and services with the need to impede illegal and harmful
activities involving these pharmaceuticals.
A. A podiatrist who holds a federal drug enforcement
administration registration and a
B. A podiatrist 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.
F. Upon
review of a prescription monitoring report for a patient, the practitioner
shall identify 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 twelve 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 Subparagraph F of 16.21.9 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 including reporting of health care providers to their licensing board
if prevailing prescribing standards are being deviated from. 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.
[16.21.9.10 NMAC -
N, 11/01/13; A, 12/30/2016]
16.21.9.11 PAIN MANAGEMENT CONTINUING
EDUCATION: This section applies to all New Mexico board
of podiatry licensees.
A. Immediate requirements effective January 2, 2014. Beginning January 2, 2014 and then for each
annual renewal cycle, all New Mexico board of podiatry licensees shall complete
no less than two continuing medical education hours in appropriate courses:
(1) an understanding of the pharmacology and risks on 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 (16.21.9 NMAC); the applicability of
such courses toward fulfillment of the continuing medical education requirement
is subject to New Mexico board of podiatry approval; podiatrists who have taken
CME in these educational elements between January 1, 2013 and December 31, 2014
may apply those hours toward the required two CME described in this section.
B. Requirements for new licensees. All New Mexico board of podiatry licensees,
whether or not the New Mexico license is their first license shall complete two
continuing medical education hours in pain management during the first year of
licensure and then for each annual renewal cycle.
C. The continuing education requirements of this section are
included in the sixteen hours needed for renewal.
[16.21.9.11 NMAC -
N, 11/1/2013]
16.21.9.12 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 the New Mexico podiatry board rule, 16.21.9 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.
[16.21.9.12 NMAC -
N, 11/1/2013]
HISTORY OF 16.21.9
NMAC: [RESERVED]