TITLE 16 OCCUPATIONAL
AND PROFESSIONAL LICENSING
CHAPTER 17 OSTEOPATHIC
MEDICINE
PART 4 PRESCRIBING AND DISTRIBUTION OF
CONTROLLED SUBSTANCES
16.17.4.1 ISSUING AGENCY:
Regulation and Licensing Department - New Mexico Board of Osteopathic
Medicine.
[16.17.4.1 NMAC - N, 6-11-2018]
16.17.4.2 SCOPE:
This part applies to all licensed osteopathic physicians and osteopathic
physician assistants.
[16.17.4.2 NMAC - N, 6-11-2018]
16.17.4.3 STATUTORY AUTHORITY:
These rules of practice and procedure govern the practice of osteopathic
medicine in New Mexico and are promulgated pursuant to and in accordance with
the Osteopathic Medicine Act, Sections 61-10-5 NMSA 1978 and the Pain Relief
Act, Subsections D of Sections 24-2-1 thru 24-2-6 NMSA 1978.
[16.17.4.3 NMAC - N, 6-11-2018]
16.17.4.4 DURATION:
Permanent.
[16.17.4.4
NMAC - N, 6-11-2018]
16.17.4.5 EFFECTIVE
DATE: June 11, 2018, unless a later
date is cited at the end of a section.
[16.17.4.5 NMAC - N, 6-11-2018]
16.17.4.6 OBJECTIVE: It is the position of the board that
osteopathic physicians and osteopathic physician assistants have an obligation
to treat 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.
[16.17.4.6 NMAC - N, 6-11-2018]
16.17.4.7 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. “Administer” means to apply a prepackaged drug directly
to the body of a patient by any means.
D. “Chronic pain”
means a pain that persists after reasonable 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 the
purpose of the Pain Relief Act requirements, include pain associated with a
terminal condition.
E. “Clinical pain 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. “Delegate” means a person designated by a
practitioner for the purpose of requesting and receiving prescription
monitoring program (PMP) reports for that practitioner.
G. “Dispense” means to deliver a drug directly
to a patient and includes the compounding, labeling and repackaging of a drug
from a bulk or original container.
H. “Distribute” means to administer or supply to a patient under the direct care
of the distributing physician or physician assistant one or more doses of drugs
prepackaged by a licensed pharmacist and excludes the compounding or
repackaging from a bulk or original container.
I. “Drug abuser”
means a person who takes a drug or drugs for other than legitimate medical
purposes.
J. “Established practitioner-patient
relationship” means a relationship between a physician or a physician
assistant and a patient that is for the purpose of maintaining the patient’s
well-being. At a minimum, this relationship is established by an interactive
encounter between patient and physician or a physician assistant involving an
appropriate history and physical or mental status examination sufficient to
make a diagnosis and to provide, prescribe or recommend treatment, with the
informed consent from the patient and availability of the physician or
physician assistant or coverage for the patient for appropriate follow-up care.
A medical record must be generated by the encounter.
K. “Formulary” means any dangerous drugs; including schedule
II-V controlled substances, physicians may use in the care of patients where
there is an established physician-patient relationship.
L. “Licensed osteopathic physician”
means an osteopathic
physician licensed by the New Mexico board of osteopathic medicine in New
Mexico.
M. “Pain” means acute or chronic pain or
both.
N. “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.
O. “Practitioner” means a New Mexico
osteopathic physician or osteopathic physician assistant maintaining licensure
pursuant to state law that allows that individual to prescribe, order,
administer or dispense controlled substances to patients.
P. “Prescribe” means to issue an order individually for the person for whom
prescribed, either directly from the prescriber to the pharmacist or indirectly
by means of a written order signed by the prescriber bearing the name and
address of the prescriber, license classification, the name and address of the
patient, the name of the drug prescribed, direction for use and the date of
issue.
Q. “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.
R. “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.
[16.17.4.7 NMAC - N, 6-11-2018]
16.17.4.8 GUIDELINES: The following regulations shall be used by the board to determine
whether an osteopathic physician's or osteopathic physician assistant’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
should be recorded. Prescriptions for opioids shall include indications for
use. For chronic non-cancer pain patients
treated with controlled substance and 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
non-cancer 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 non-cancer pain, the patient’s state of health, and any
new information about the etiology of the chronic non-cancer pain at least
every six months. In addition, a
practitioner shall consult, when indicated by the patient’s condition, with a
clinical pain expert. Consultation
should occur early in the course of long-term treatment and at reasonable
intervals during continued long-term treatment for assessment of benefit and
need a minimum of once every six months.
(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 abuse disorders shall include:
(1) a contractual agreement;
(2) appropriate consultation;
(3) urine or hair or salivary or blood
drug screening shall be considered 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 as a guiding principle.
F. Any physician or
physician assistant that prescribes opiate based pain medication, shall obtain
at least six CME credits in pain management over a three year period.
G. Any physician or
physician assistant that prescribes opiate based pain medication shall utilize
the state based prescription monitoring program at the initial office visit
which results in a prescription for an opiate based pain medication, and at
least at every three months intervals and at critical turning points in patient
care.
H. 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 Osteopathic
Medicine Act or board rules.
[16.17.3.1 NMAC - N, 6-11-2018]
16.17.4.9 PHYSICIANS
OR PHYSICIAN ASISSTANTS TREATED WITH OPIATES: Physicians or
physician assistants who have chronic pain and are being treated with opiates
shall be evaluated by a pain clinic or, by an M.D. or D.O. 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.
[16.17.4.9 NMAC - N, 6-11-2018]
16.17.4.10 PRESCRIPTION MONITORING PROGRAM
(PMP) REQUIREMENTS: The intent of the New Mexico board of osteopathic medicine 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.
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 12
consecutive weeks;
(4) receiving more than one controlled
substance analgesic;
(5) receiving opioids totaling more than
90 morphine milligram equivalents per day; or
(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 Paragraph F, 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.
[16.17.4.10 NMAC - N, 6-11-2018]
16.17.4.11 NON-CANCER PAIN MANAGEMENT
CONTINUING EDUCATION: This section applies to all New Mexico board of osteopathic medicine
licensed physicians and osteopathic physician assistants who hold a federal
drug enforcement administration registration and licensure to prescribe
opioids. 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. On or before July
1, 2014 all New
Mexico board of osteopathic medicine licensees who hold a federal drug
enforcement administration registration and licensure to prescribe opioids,
shall complete no less than two continuing medical education hours in
appropriate courses that include a review of 16.17.5 NMAC, management of the
treatment of pain, an understanding of the pharmacology and risks of controlled
substances, a basic awareness of the problems of abuse, addiction and
diversion, and awareness of state and federal regulations for the prescription
of controlled substances. All such
courses are subject to board approval.
Practitioners who have taken continuing education hours in these
educational elements in the two years prior to July 1, 2014 may apply those
hours toward the required two continuing education hours described in this
subsection.
B. Beginning with the July 1, 2014 triennial
renewal date, as part of the 75 continuing medical education hours required
during each triennial renewal cycle, all New Mexico board of osteopathic
medicine licensees, who hold a federal drug enforcement administration
registration and license to prescribe opioids, shall be required to complete
and submit six continuing education hours.
Appropriate courses shall include all of the educational elements
described in Subsection A of this section. All such courses are subject to
board approval. These hours may be earned at any time during the three-year
period immediately preceding the triennial renewal date. The two continuing medical
education hours completed prior to July 1, 2014, as defined in Subsection A
above, may be included as part of the required continuing medical education
hours in pain management.
[16.17.4.11 NMAC - N, 6-11-2018]
16.17.4.12 NOTIFICATION: In
addition to the notice of procedures set forth in the State Rules Act Chapter
14, Article 14, NMSA 1978, the board shall separately notify the following
persons of the Pain Relief Act and Part 17 of the New Mexico board of
osteopathic medicine rule;
A. health
care practitioners under its jurisdiction; and
B. health
care practitioners being investigated by the board in relation to the
practitioner’s pain management services.
[16.17.4.12 NMAC - N, 6-11-2018]
HISTORY OF 16.17.4
NMAC:
Pre-NMAC
History: The
material in this part was derived from that previously filed with the state
records center and archives:
BOSE
69-1, Practice Guide for Osteopathic Physicians and Surgeons in New Mexico,
filed 06-05-69;
BOSE
72-1, Regulations for Continuing Medical Education of the New Mexico State
Board of Osteopathic Examination and Registration, filed 06-27-72;
Rule 7,
Annual Renewal of Certificate, filed 12-07-88;
Rule
11, Continuing Medical Education, filed 09-22-89.
History
of Repealed Material: Rule
7, Annual Renewal of Certificate (filed 12-07-88) and Rule 11, Continuing
Medical Education (filed 09-22-89) were both repealed 10-29-2004.
16.17.4
NMAC, Renewal and Continuing Education Requirements repealed effective
6-11-2018.
Other History:
Rule 7, Annual Renewal
of Certificate (filed 12-07-88) and Rule 11, Continuing Medical Education
(filed 09-22-89) replaced by 16.17.4NMAC, Renewal and Continuing Education
Requirements, effective 10-29-2004.