June 22, 2018
45 • Issue 13 • Pages 675—676
MARYLAND DEPARTMENT OF HEALTH
Subtitle 13 DRUGS
10.13.03 Guidelines for Co-Prescribing
Opioid Overdose Reversal Drugs
Authority: Health-General Article, §§2-104(b),
13-3501, and 13-3502, Annotated Code of Maryland
Notice of Proposed Action
The Secretary of
Health proposes to adopt new Regulations .01—.04 under a new
chapter, COMAR 10.13.03 Guidelines for Co-Prescribing Opioid Overdose
Statement of Purpose
The purpose of
this action is to provide guidance to healthcare practitioners, who are
prescribing opioids to treat a patient’s pain or an opioid use disorder, in
determining the appropriate circumstances in which to consider prescribing an
opioid overdose reversal drug. These guidelines are being promulgated in
accordance with H.B. 1329/S.B. 967 Heroin and Opioid Prevention Effort (HOPE)
and Treatment Act of 2017 (Chs. 571 and 572, Acts of 2017).
Comparison to Federal Standards
There is no
corresponding federal standard to this proposed action.
Estimate of Economic Impact
action has no economic impact.
Economic Impact on Small Businesses
action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be
sent to Michele Phinney, Director, Office of Regulation and Policy
Coordination, Maryland Department of Health, 201 West Preston Street, Room 512,
Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to
email@example.com, or fax to 410-767-6483. Comments will be accepted
through July 23, 2018. A public hearing has not been scheduled.
applies to all licensed health care practitioners who may prescribe an opioid
overdose reversal drug to an individual who:
A. May be at an
elevated risk of experiencing an opioid overdose including, but not limited to,
an individual who:
(1) Is receiving
an opioid for chronic pain;
(2) Is receiving
an opioid and a prescription for a benzodiazepine; or
(3) Has an
opioid use disorder; or
B. Resides or
spends time with an individual who:
(3) Has an
opioid use disorder.
A. In this
chapter, the following terms have the meanings indicated.
“Co–prescribed” means, with respect to an opioid overdose reversal drug, the
practice of prescribing the drug in conjunction with an opioid prescription for
a patient at an elevated risk of overdose.
means the Maryland Department of Health.
prescription drug” means a prescription drug that contains a Schedule II,
Schedule III, Schedule IV, or Schedule V controlled dangerous substance
designated under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of
overdose reversal drug” means a drug that:
reverses the respiratory depressant effects of an opioid medication; and
(b) Is approved
by the federal Food and Drug Administration for the treatment of a known or
suspected opioid overdose.
licensed health care provider” means an individual who is authorized by law to
prescribe a monitored prescription drug.
factor” means a characteristic, condition, behavior, or any variable that
increases the likelihood of developing a disease or injury.
means the Secretary of the Maryland Department of Health.
patient population” means an individual likely to experience or witness an
patient population” includes, but is not limited to, an individual who:
(i) Is being prescribed opioids for acute, if appropriate, or
(ii) Is being
treated for an opioid use disorder;
receiving a prescription for an opioid and a benzodiazepine; or
spends time with an individual who is prescribed opioids, misuses opioids, or
has an opioid use disorder.
determined appropriate by the prescribing licensed health care provider,
targeted patient populations may be co-prescribed an opioid overdose reversal
drug, if the individual is at an elevated risk of experiencing an opioid
overdose by virtue of belonging to one or more categories of the targeted
Responsibilities of the Prescribing Licensed Health Care Provider.
(a) It is
suggested that the licensed health care provider routinely assess patients for
their risk of being likely to experience or witness an opioid overdose.
The prescriber may utilize additional sources of information for determining a
patient’s opioid overdose risk including, but not limited to:
Checking the Maryland Prescription Drug Monitoring Program;
Reviewing medical records; and
Soliciting family input, if appropriate.
If a patient is assessed to be at risk of an opioid overdose, the prescriber
may educate the patient about,, including but not
limited to, the following areas:
(a) The risks
of an opioid overdose; and
(b) How to
identify and respond to an opioid overdose.
Documentation. Licensed health care providers should document education and
clinical services related to the provision of an opioid overdose reversal drug
in their patients’ medical records in accordance with the standard of care.
may make the following additional clinical guidance available on the
available opioid overdose reversal drug formulations, corresponding prescribing
templates, and any standing order for these drugs; and
B. Any other
applicable information deemed necessary by the Secretary.
ROBERT R. NEALL
Secretary of Health
201 W. Preston Street, Baltimore, MD 21201-2399
(410) 767-6500 or 1-877-463-3464