DAR File No. 42283
This rule was published in the February 15, 2018, issue (Vol. 2018, No. 4) of the Utah State Bulletin.
Health, Disease Control and Prevention, Health Promotion
Rule R384-210
Co-prescription Guidelines -- Reporting
Change in Proposed Rule
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:
HealthDisease 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 [email protected]
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
Additional Information
More information about a Notice of Change in Proposed Rule is available online.
The Portable Document Format (PDF) version of the Bulletin is the official version. The PDF version of this issue is available at https://rules.utah.gov/publicat/bull_pdf/2018/b20180215.pdf. The HTML edition of the Bulletin is a convenience copy. Any discrepancy between the PDF version and HTML version is resolved in favor of the PDF version.
Text to be deleted is struck through and surrounded by brackets ([example]). Text to be added is underlined (example). Older browsers may not depict some or any of these attributes on the screen or when the document is printed.
For questions regarding the content or application of this rule, please contact Anna Fondario at the above address, by phone at 801-538-6201, by FAX at , or by Internet E-mail at [email protected]. For questions about the rulemaking process, please contact the Office of Administrative Rules.