TITLE 7 HEALTH
CHAPTER 32 ALCOHOL
AND DRUG ABUSE
PART 7 OVERDOSE
PREVENTION AND EDUCATION PROGRAM AUTHORIZATION FOR
OPIOID
ANTAGONISTS
7.32.7.1 ISSUING
AGENCY: Department of
Health; Public Health Division; Infectious Disease Prevention and Control
Bureau.
[7.32.7.1 NMAC - Rp, 7.32.7.1 NMAC, 7/15/2016]
7.32.7.2 SCOPE: This rule
applies to all New Mexico department of health registered overdose prevention
and education programs that obtain, prescribe, dispense, distribute, or
administer an opioid antagonist.
[7.32.7.2 NMAC - Rp 7.32.7.2 NMAC, 7/15/2016]
7.32.7.3 STATUTORY
AUTHORITY: The statutory
authority for adopting these rules is found in Subsection E of Section 9-7-6
NMSA 1978 (Department of Health Act) and Subsection J of Section 24-23-1 NMSA
1978 which requires the secretary of health to “promulgate rules relating to
overdose prevention and education programs.”
[7.32.7.3 NMAC - Rp 7.32.7.3 NMAC, 7/15/2016]
7.32.7.4 DURATION: Permanent.
[7.32.7.4 NMAC - Rp, 7.32.7.4 NMAC, 7/15/2016]
7.32.7.5 EFFECTIVE
DATE: July 15, 2016,
unless a later date is cited at the end of a section.
[7.32.7.5 NMAC - Rp, 7.32.7.5 NMAC, 7/15/2016]
7.32.7.6 OBJECTIVE: The objective of
these regulations is to reduce mortality due to opioid overdose by increasing
the administration, distribution, prescription and dispensation of opioid
antagonists to individuals who are at risk of opioid overdose and to
individuals, such as family members, friends or other persons, who may be in a
position to assist individuals who are experiencing an overdose. These regulations shall set standards for the
establishment of standing orders to obtain, store, distribute and administer an
opioid antagonist; the establishment of overdose prevention and education
programs and standards for them to register, obtain, store, and distribute naloxone;
the establishment of standards for overdose prevention curricula, training and
the certification of individuals to store and distribute opioid antagonists for
the overdose prevention and education programs.
[7.32.7.6 NMAC - Rp, 7.32.7.6 NMAC, 7/15/2016]
7.32.7.7 DEFINITIONS:
A. “Administration of opioid
antagonist” means the direct application
of an opioid antagonist to the body of an individual by injection, inhalation,
ingestion or any other means.
B. “Department” means the New Mexico department of health.
C. “Dispense” means to evaluate and implement a prescription
for an opioid antagonist, including the preparation and the delivery of a drug
or device to a patient or patient’s agent;
D. “Distribute”
means to deliver an opioid antagonist drug or opioid antagonist device by
means other than by administering or dispensing;
E. “Enrollment form” means the form approved by the department to register
an individual as a trained targeted responder.
F. “Licensed prescriber” means any individual who is authorized by law to
prescribe an opioid antagonist in the state.
G. “Medication log” means the form used to track the storage and
distribution of the opioid antagonist.
H. “Opioid” means any substance containing or derived from opium including, but
not limited to morphine and heroin, and any morphine-like synthetic narcotic
that produces the same effects as substances derived from the opium poppy.
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 in the body. "Opioid
antagonist" shall be limited to naloxone or other like medications that
are indicated for use in reversing an opioid overdose and are approved by the
department for such purpose.
J. “Overdose prevention and education program (OPE)” means
any community-based organization, law enforcement agency, detention facility or
school that has registered with the department in accordance with department
rules and uses an approved department curriculum to teach overdose prevention
and opioid antagonist administration.
K. “Overdose response educator” means any staff or volunteer who is registered with an overdose prevention and education program
who are trained and certified by the department in the overdose response education curriculum.
L. “Overdose response educator
curriculum” means a department approved
curriculum to train and certify overdose response educators, which must be
repeated every two years.
M. “Possess”
means to have physical control or custody of an opioid antagonist.
N. “Record of use form” means the department designated report for the use or
loss of an opioid antagonist, the response to a suspected opioid overdose or
the re-issuance of an opioid antagonist to a trained targeted responder.
O. “Standing
order” means a licensed prescriber’s instruction or
prescribed procedure that is either patient specific or non-patient specific
that can be exercised by other persons until changed or canceled by a licensed
prescriber.
P. “Storage”
means possession of an opioid antagonist with the intent to dispense or
distribute it.
Q. “Trained
targeted responder” means a person who is trained by overdose response
educators to possess and administer an opioid antagonist to a person who is
experiencing an opioid overdose, and has completed the trained targeted responder curriculum.
R. “Trained
targeted responder curriculum” means a department approved curriculum for
trained targeted responders.
[7.32.7.7 NMAC - Rp, 7.32.7.7 NMAC, 7/15/2016]
7.32.7.8 REQUIREMENTS
FOR OVERDOSE PREVENTION AND EDUCATION PROGRAMS, OVERDOSE RESPONSE EDUCATORS AND
TRAINED TARGETED RESPONDERS:
A. Overdose prevention and education
program requirements: An overdose
prevention and education program is a program which facilitates the distribution
of opioid antagonists and provides education related to overdoses, overdose
prevention and the administration of opioid antagonists. An overdose
prevention and education program shall:
(1) register
with the department using the form approved by the department which shall
include at a minimum:
(a) date
of registration;
(b) overdose prevention and education program name; and
(c) name, address, e-mail and telephone number of overdose prevention and education program contact;
(2) identify
who will be overdose response educators;
(3) train
or verify overdose response educators have successfully completed and
maintained a current certification in the overdose
response educator curriculum;
(4) enroll
trained targeted responders using the enrollment form;
(5) train
or verify trained targeted responders have completed the trained targeted
responder curriculum;
(6) identify
and maintain a secure location for the storage of the opioid antagonists
designated for distribution in accordance with these regulations;
(7) label
the opioid antagonist in accordance with these regulations;
(8) utilize
the record of use form to report all known uses or losses of an opioid
antagonist, responses to a suspected opioid overdose, or the re-issuance of an
opioid antagonist to a trained targeted responder;
(9) maintain
personal protective equipment and response equipment at training locations;
(10) provide
trained targeted responders with necessary response equipment; and
(11) be
prepared for scheduled and unscheduled site visits by the department where the
department may review the maintenance of enrollment forms, record of use forms,
medication logs and any other information required to be maintained pursuant to
these rules.
B. Overdoes response educators shall:
(1) successfully complete the overdose
response educator curriculum and
maintain this certification;
(2) comply
with the terms of a standing order issued by a licensed prescriber, which may
include possession of opioid antagonists and distribution of the opioid
antagonist to trained targeted responders;
(3) teach trained targeted responders the
trained targeted responder curriculum;
and
(4) complete
medication log, enrollment forms and record of use forms for trained targeted
responders.
C. Trained
targeted responders:
(1) are trained in the trained
targeted responder curriculum; and
(2) shall
report all known responses to suspected opioid overdoses to an overdose prevention and education program
using the record of use form.
[7.32.7.8 NMAC - Rp, 7.32.7.9 & 10 NMAC, 7/15/2016]
7.32.7.9 REQUIREMENTS
FOR DISTRIBUTION OF OPIOID ANTAGONIST:
A. The New Mexico department of health public health
division pharmacy warehouse can distribute the opioid antagonist to any
registered overdose prevention and
education program.
B. Standing orders from a department licensed prescriber for
the distribution of an opioid antagonist shall include at a minimum:
(1) authorization to maintain supplies of opioid
antagonists for the purposes of distributing them as part of the department’s
overdose prevention efforts;
(2) authorization for
overdose response educators to possess and distribute the opioid antagonist to
trained targeted responders;
(3) instructions for
overdose response educators to educate and advise clients of overdose
prevention methods, recognizing an overdose, and potential contraindications
and precautions.
C. Medication log, enrollment forms and record of use forms shall be
utilized by an overdose prevention and
education program in order to document the distribution and administration
of opioid antagonists.
[7.32.7.9 NMAC - Rp, 7.32.7.10
NMAC, 7/15/2016]
7.32.7.10 REQUIREMENTS
FOR STORAGE OF THE OPIOID ANTAGONIST:
A. Any opioid antagonist designated for distribution by an overdose prevention and education program
must be stored in a secure designated location.
(1) The location must be locked with
entry limited to overdose response educators and other individuals as
designated by the overdose prevention and
education program.
(2) A medication log of the opioid
antagonist must be maintained, and include the following information, at
minimum:
(a) lot
numbers of the opioid antagonist;
(b) expiration dates of the opioid antagonist;
(c) date, quantity of opioid antagonist doses and
the name of the individual who is removing the opioid antagonist from the
secured location for distribution;
(d) date, quantity of opioid antagonist
doses and the name of the individual who is returning doses of the opioid
antagonist to the secured location if they have not been distributed; and
(e) for doses of the opioid antagonist
distributed, the medication log must also include the name and date of birth of
the trained targeted responder, the date of distribution, lot number of each
opioid antagonist dose and the expiration date of each opioid antagonist dose.
B. Any registered overdose prevention and education program, may make an opioid
antagonist available for use in response to a possible overdose incident. The opioid antagonist designated for use at an
overdose prevention and education program
for a possible overdose response shall be stored in a secure but accessible
location.
[7.32.7.10 NMAC - Rp, 7.32.7.10 NMAC, 7/15/2016]
7.32.7.11 LABELING
OF THE OPIOID ANTAGONIST:
A. The overdose
prevention and education program shall label the opioid antagonist prior to
it leaving the designated secure storage location which shall include:
(1) the name and address of the overdose prevention and education program
distributing the opioid antagonist; and
(2) the text “use as directed.”
B. At the time of distribution of an opioid
antagonist to a trained targeted responder, the overdose response educator
shall complete the following information on the label:
(1) name of the trained targeted responder;
(2) date of distribution of the opioid antagonist;
and
C. At the time of distribution of an opioid
antagonist to a trained targeted responder, the overdose response educator will
provide directions for use of the opioid antagonist.
[7.32.7.11 NMAC - N, 7/15/2016]
7.32.7.12 MINIMUM
REQUIREMENTS FOR ENROLLMENT AND RECORD OF USE FORMS:
A. The enrollment form shall include at a
minimum:
(1) name of the overdose prevention
and education program;
(2) department designated code of the trained
targeted responder; and
(3) the quantity of the opioid antagonist
distributed.
B. The record of use form shall contain
at a minimum:
(1) the
name of the overdose prevention and
education program recording the report;
(2) the department designated code of the
reporting trained targeted responder;
(3) the quantity of the opioid antagonist
administered, lost, or expired;
(4) the date or approximate date of the overdose
incident, if there is one being reported;
(5) the disposition of the person who was
administered the opioid antagonist; and
(6) the
quantity of the opioid antagonist distributed.
[7.32.7.12 NMAC-N, 7/15/2016]
7.32.7.13 APPLICABILITY
OF REGULATIONS: In the event an approved opioid antagonist is classified
as an “over the counter” (OTC) medication the following portions of these
regulations shall no longer be applicable: 7.32.7.9, 7.32.7.10, 7.32.7.11 NMAC.
Department protocols will remain in
effect.
[7.32.7.13 NMAC-N, 7/15/2016]
History of 7.32.7 NMAC:
Pre - NMAC History: None.
History of Repealed Material:
7.32.7 NMAC, Authorization to Administer Opioid
Antagonists, filed 6/1/2001.
7.32.7 NMAC, Authorization to Administer Opioid
Antagonists, filed 8/30/2001 - Repealed effective 7/15/2016. Part name changed to Overdose Prevention and Education Program Authorization for Opioid
Antagonists.