54 N.J.R. 118(a)

VOLUME 54, ISSUE 2, JANUARY 18, 2022
RULE PROPOSALS

Reporter
54 N.J.R. 118(a)
NJ - New Jersey Register  >  2022  >  JANUARY  >  JANUARY 18, 2022  >  RULE PROPOSALS  >  LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS

Interested Persons Statement 

INTERESTED PERSONS 
Interested persons may submit comments, information or arguments concerning any of the rule proposals in this issue until the date indicated in the proposal. Submissions and any inquiries about submissions should be addressed to the agency officer specified for a particular proposal. 
The required minimum period for comment concerning a proposal is 30 days. A proposing agency may extend the 30-day comment period to accommodate public hearings or to elicit greater public response to a proposed new rule or amendment. Most notices of proposal include a 60-day comment period, in order to qualify the notice for an exception to the rulemaking calendar requirements of  N.J.S.A. 52:14B-3. An extended comment deadline will be noted in the heading of a proposal or appear in a subsequent notice in the Register. 
At the close of the period for comments, the proposing agency may thereafter adopt a proposal, without change, or with changes not in violation of the rulemaking procedures at      N.J.A.C. 1:30-6.3. The adoption becomes effective upon publication in the Register of a notice of adoption, unless otherwise indicated in the adoption notice. Promulgation in the New Jersey Register establishes a new or amended rule as an official part of the New Jersey Administrative Code. 
Agency


LAW AND PUBLIC SAFETY > DIVISION OF CONSUMER AFFAIRS > NEW JERSEY STATE BOARD OF OPTOMETRISTS

Administrative Code Citation


Proposed Changes: N.J.A.C. 13:38-2.5
Text

  Notice of Proposed Substantial Changes Upon Adoption to Proposed Amendments
Limitations on Prescribing, Administering, or Dispensing of Controlled Dangerous Substances, and Special Requirements for Management of Acute and Chronic Pain (Co-Prescribing Opioid Antidote)

Proposed: January 19, 2021, at 53 N.J.R. 112(a).

Authorized By: New Jersey State Board of Optometrists, Dr. Gigette Collazo Harfst, Chairperson.
Authority: N.J.S.A. 45:12-4; and P.L. 2017, c. 341 and P.L. 2021, c. 54.

Submit written comments by March 19, 2022, to:

Renee Clark, Executive Director
State Board of Optometrists
124 Halsey Street
PO Box 45012
Newark, New Jersey 07101

or electronically at:   www.NJConsumerAffairs.gov/proposal/comment

Take notice that the State Board of Optometrists (Board) proposed amendments at N.J.A.C. 13:38-2.5 on January 19, 2021, at 53 N.J.R. 112(a), to require prescribers to co-prescribe an opioid antidote (for example, naloxone) under certain circumstances. In addition, the Board proposed to amend N.J.A.C. 13:38-2.5 to implement P.L. 2017, c. 341, amending N.J.S.A. 24:21-15.2, which concerns limitations on prescribing, administering, or dispensing of controlled dangerous substances, with specific limitations for opioid drugs, and establishes special requirements for the management of acute and chronic pain. The revised law and proposed amendments clarified the timing of the requirement to enter into a pain management agreement, amend the definition of "initial prescription," and revise the definition of "chronic pain" consistent with the amended statute. The public comment period closed on March 20, 2021. No comments were received.
On April 19, 2021, P.L. 2021, c. 54 was enacted. This new law further revised N.J.S.A. 24:21-15.2 by requiring a health care practitioner who issues a prescription for an opioid drug to also issue a prescription for an opioid antidote when certain conditions are met. The statutorily enacted circumstances and conditions under which the co-prescription is required differ from the Board's proposed rulemaking. Due to these statutory revisions, the Board is proposing changes to the proposed amendments. A summary of the agency-initiated changes is provided below. This notice of proposed substantial changes is published pursuant to N.J.S.A. 52:14B-4.10.  
Summary of Agency-Initiated Changes:  
The Board is proposing to amend N.J.A.C. 13:38-2.5 to implement P.L. 2021, c. 54, which establishes the circumstances and conditions under which a health care practitioner must issue a prescription for an opioid antidote. In accordance with the new law, a licensed optometrist must co-prescribe an opioid antidote whenever the optometrist issues a prescription for an opioid drug that is a controlled dangerous substance and one of the following conditions exists: the patient has a history of substance use disorder, the prescription for the opioid drug is for a daily dose of more than 90 morphine milligram equivalents, or the patient holds a current, valid prescription for a benzodiazepine that is a Schedule III or Schedule IV controlled dangerous substance. The statutory provisions differ from the Board's notice of proposal by requiring the prescription for an opioid antidote whenever an opioid drug is prescribed, instead of when the licensee continuously prescribes a controlled dangerous substance for the management of chronic pain. Additionally, the new law requires the co-prescribing of an opioid antidote if the patient has a history of substance abuse and modifies the threshold for the morphine milligram equivalents (MME) to require the co-prescribing of an opioid antidote where the MME exceeds--rather than equals or exceeds--90 MME. To implement the new law, the Board proposes to remove proposed new paragraph (f)8 (and the attendant technical change at paragraph (f)7) and to add new subsection (i). In addition, the Board proposes to recodify subsections (i) and (j) as new subsections (j) and (k), and to amend recodified subsection (j) to reflect the addition of subsection (i). The Board also proposes to amend subsection (a) to include a definition for the term "opioid antidote."  
Effect of Proposed Changes on Impact Statements Included in Original Proposal  
The proposed changes will not affect the Social, Economic, Jobs, Agriculture Industry, or Racial and Ethnic Community Criminal Justice and Public Safety Impact statements; the Federal Standards Statement; the Regulatory Flexibility Statement; the Housing Affordability or Smart Growth Development Impact Analyses, as published in the original notice of proposal.  
Full text of the proposed substantial changes to the proposed amendments follows (additions to proposal indicated in italicized boldface   thus; deletions from proposal indicated in italicized cursive brackets    {thus}):  
SUBCHAPTER 2.   GENERAL RULES OF OPTOMETRIC PRACTICE  
13:38-2.5    Limitations on prescribing, dispensing, or administering controlled dangerous substances; special requirements for management of acute and chronic pain   
(a) The following words and terms when used in this section, shall have the following meanings, unless the context clearly indicates otherwise:  
. . .  
    ''Opioid antidote" means any drug, regardless of dosage amount or method of administration, which has been approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose. "Opioid antidote" includes, but is not limited to, naloxone hydrochloride, in any dosage amount, which is administered through nasal spray or any other FDA-approved means or methods. 
. . .  
(b)-(e) (No change from proposal.)  
(f) When controlled dangerous substances are continuously prescribed for management of chronic pain, the licensee shall:  
1.-6. (No change.)  
7. Advise the patient, or the patient's parent or guardian if the patient is under 18 years of age and is not an emancipated minor, of the availability of an opioid antidote; {[}and{]};
{8. Provide a prescription for an opioid antidote if the patient has one or more prescriptions totaling 90 morphine milligram equivalents or more per day, or is concurrently obtaining an opioid and a benzodiazepine, and document within the patient record the action taken; and}
{[}8.{]} {9.} (No change in text.)
(g)-(h) (No change.)
(i) Except as provided at (i)1 below, when a licensee issues a prescription for an opioid drug that is a controlled dangerous substance to a patient, the licensee shall also issue the patient a prescription for an opioid antidote when the patient has a history of substance use disorder, the prescription for the opioid drug is for a daily dose of more than 90 morphine milligram equivalents, or the patient holds a current, valid prescription for a benzodiazepine drug that is a Schedule III or Schedule IV controlled dangerous substance.
1. A licensee shall not be required to issue more than one prescription for an opioid antidote to a patient per year.
[page=119]
2. Nothing at (i)1 above shall be construed to prohibit a licensee from issuing additional prescriptions for an opioid antidote to a patient upon the patient's request or when the licensee determines there is a clinical or practical need for the additional prescription.
{(i)} (j) The requirements for prescribing controlled dangerous substances set forth {in} at (d) through {(h)} (i) above shall not apply to a prescription for a patient who is currently in active treatment for cancer, receiving hospice care from a licensed hospice, receiving palliative care, or is a resident of a long-term care facility or to any medications that are being prescribed for use in the treatment of substance abuse or opioid dependence.
{(j)} (k) (No change in text.)