No. 42283 (Change in Proposed Rule): Rule R384-210. Co-prescription Guidelines -- Reporting

DAR File No.: 42283
Filed: 01/31/2018 03:41:34 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this change in proposed rule is to establish scientifically based guidelines for controlled substance prescribers to co-prescribe an opiate antagonist to a patient pursuant to Section 26-55-108. During the public comment period, the Utah Poison Control Center recommended to include on the list of considerations for naloxone to be dispensed/co-prescribed to households where preschool age children live or visit, such as babysitting grandparents, whenever opiate pain medication is prescribed. Intermountain Healthcare provided a coordinated response from primary care, specialists, pharmacists, and behavioral health that included grammatical changes and language clarifications to the rule.

Summary of the rule or change:

This rule establishes scientifically based guidelines for controlled substance prescribers to coprescribe an opiate antagonist to a patient pursuant to Title 26, Chapter 55. (EDITOR'S NOTE: The original proposed new rule upon which this change in proposed rule (CPR) was based was published in the November 15, 2017, issue of the Utah State Bulletin, on page 30. Underlining in the rule below indicates text that has been added since the publication of the proposed new rule mentioned above; strike-out indicates text that has been deleted. You must view the CPR and the proposed new rule together to understand all of the changes that will be enforceable should the agency make this rule effective.)

Statutory or constitutional authorization for this rule:

• Title 26, Chapter 55

Anticipated cost or savings to:

the state budget:

This rule contains scientifically-based guidelines for controlled substance prescribers to co-prescribe an opiate antagonist to a patient, and provides education on overdose prevention to patients and/or the patient's household members when factors that increase risk for opioid overdose are present. There may be savings in preventing individuals from requiring treatment in an emergency department or in hospitalization but those costs are hard to measure.

local governments:

There may be savings in preventing individuals from requiring treatment in an emergency department or in hospitalization but those costs would be hard to measure.

small businesses:

Some small pharmacies may see an increase in sales of naloxone kits due to the co-prescribing guidelines.

persons other than small businesses, businesses, or local governmental entities:

There may be savings in preventing individuals from requiring treatment in an emergency department or in hospitalization costs but those costs would be difficult to measure. Some pharmacies may see an increase in sales of naloxone kits due to the co-prescribing guidelines.

Compliance costs for affected persons:

This rule provides scientifically-based guidelines on co-prescribing an opiate antagonist to a patient established by Title 26, Chapter 55, which will not result in any compliance costs for affected persons. Some pharmacies may see an increase in sales of naloxone kits due to the co-prescribing guidelines.

Comments by the department head on the fiscal impact the rule may have on businesses:

The original version of this rule was published in the November 15, 2017, Utah State Bulletin. This new rule provides guidelines when a provider who prescribes a controlled substance should also co-prescribe an opiate antagonist. This is pursuant to S.B. 258 passed during the 2017 General Session. Due to comments received by the Health Promotion Division, revisions were made to the proposed rule. These revisions were substantive. It adds households where preschool age children live or visit and when opiate medication is prescribed (as opposed to being present). It changes a risk to include known histories and unstable medical conditions, and adds cognitive decline medical conditions.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Disease Control and Prevention, Health Promotion
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Anna Fondario at the above address, by phone at 801-538-6201, by FAX at , or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

03/19/2018

This rule may become effective on:

03/26/2018

Authorized by:

Joseph Miner, Executive Director

RULE TEXT

R384. Health, Disease Control and Prevention; Health Promotion.

R384-210. Co-prescription guidelines -- Reporting.

R384-210-1. Authority and Purpose.

This rule establishes scientifically based guidelines for controlled substance prescribers to co-prescribe an opiate antagonist to a patient pursuant to Section 26-55-108.

 

R384-210-2. Guidelines for the Issuance of a Prescription for an [ Opiate ] Opioid Antagonist Along With a Prescription for an [ Opiate ] Opioid .

(1) Co-prescribing guidelines are applicable when prescribing opioids.

(2) [Clinicians shall consider offering a co-prescription for an opiate antagonist]Prescribers are encouraged to co-prescribe and opioid antagonist, such as naloxone ;[,] and to provide education on how to recognize an opioid overdose [prevention ]to patients , [and the ]patient's household members and/or close contacts, [especially ]when available, if factors exist that increase risk for opioid overdose , and households where preschool age children live or visit, whenever opiate medication is prescribed.[are present. These risk factors ] Risks for opioid overdose include:

(a) a known history of overdose;

(b) a known history of substance use disorder;

(c) a[underlying] mental health condition that could make a patient susceptible to overdose;

(d) a risk for returning to a high dose to which they are no longer tolerant (e.g., patients recently released from prison);

(e) unstable medical conditions, such as respiratory disease, sleep apnea, cognitive decline medical conditions, or other comorbidities that make a patient susceptible to opioid toxicity, respiratory distress or overdose;

(f) higher opioid dosages such as a dose greater than or equal to 50 Morphine Milligram Equivalents[(greater than or equal to 50 MME]/day[)]; and

(g) concurrent benzodiazepine use.[

(3) Clinicians shall consider offering a co-prescription for an opiate antagonist, such as naloxone, and education on overdose to persons in a position to aid someone who is at risk of overdose.]

 

KEY: naloxone, opioid antagonist, co-prescribing

Date of Enactment or Last Substantive Amendment: [2017]2018

Authorizing, and Implemented or Interpreted Law: 26-55