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    Maryland Register

    Issue Date:  June 22, 2018

    Volume 45 • Issue 13 • Pages 675—676


    Title 10 

    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 Reversal Drugs.

    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

    The proposed action has no economic impact.

    Economic Impact on Small Businesses

    The proposed action has minimal or no economic impact on small businesses.

    Impact on Individuals with Disabilities

    The proposed 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 mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through July 23, 2018. A public hearing has not been scheduled.

    .01 Scope.

    This chapter 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:

    (1) Is prescribed opioids;

    (2) Misuses opioids; or

    (3) Has an opioid use disorder.

    .02 Definitions.

    A. In this chapter, the following terms have the meanings indicated.

    B. Terms Defined.

    (1) “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.

    (2) “Department” means the Maryland Department of Health.

    (3) “Monitored 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 Maryland.

    (4) “Opioid overdose reversal drug” means a drug that:

    (a) Rapidly 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.

    (5) “Prescribing licensed health care provider” means an individual who is authorized by law to prescribe a monitored prescription drug.

    (6) “Risk factor” means a characteristic, condition, behavior, or any variable that increases the likelihood of developing a disease or injury.

    (7) “Secretary” means the Secretary of the Maryland Department of Health.

    (8) Targeted Patient Population.

    (a) “Targeted patient population” means an individual likely to experience or witness an opioid overdose.

    (b) “Targeted patient population” includes, but is not limited to, an individual who:

    (i) Is being prescribed opioids for acute, if appropriate, or chronic pain;

    (ii) Is being treated for an opioid use disorder;

    (iii) Is receiving a prescription for an opioid and a benzodiazepine; or

    (iv) Resides or spends time with an individual who is prescribed opioids, misuses opioids, or has an opioid use disorder.

    .03 General Provisions.

    A. When 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 patient population.

    B. Responsibilities of the Prescribing Licensed Health Care Provider.

    (1) Risk Monitoring.

    (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.

    (b) The prescriber may utilize additional sources of information for determining a patient’s opioid overdose risk including, but not limited to:

    (i) Checking the Maryland Prescription Drug Monitoring Program;

    (ii) Reviewing medical records; and

    (iii) Soliciting family input, if appropriate.

    (2) Education. 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.

    (3) 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.

    .04 Additional Guidelines.

    The Secretary may make the following additional clinical guidance available on the Department’s website:

    A. Any 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.

    Secretary of Health