52 N.J.R. 676(a)
VOLUME 52, ISSUE 7, APRIL 6, 2020
52 N.J.R. 676(a)
NJ - New Jersey Register > 2020 > APRIL > APRIL 6, 2020 > RULE PROPOSALS > LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS
Interested Persons Statement
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.
LAW AND PUBLIC SAFETY > DIVISION OF CONSUMER AFFAIRS > STATE BOARD OF MEDICAL EXAMINERS
Administrative Code Citation
Proposed Amendment: N.J.A.C. 13:35-7.6
Limitations on Prescribing, Administering, or Dispensing of Controlled Dangerous Substances, and Special Requirements for Management of Acute and Chronic Pain: Physicians, Podiatrists, Physician Assistants, and Certified Nurse Midwives
Authorized By: State Board of Medical Examiners, William V. Roeder, Executive Director.
Authority: N.J.S.A. 45:9-2 and P.L. 2017, c. 341.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2020-033.
Submit written comments by June 5, 2020, to:
William V. Roeder, Executive Director
State Board of Medical Examiners
PO Box 183
Trenton, New Jersey 08625-0183
Or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx
The agency proposal follows:
The United States is in the midst of an opioid overdose epidemic, and prescription opioid abuse and misuse continue to be a national public health concern. From 1999 to 2017, more than 700,000 people nationally died from drug overdoses. In 2017 alone, more than 70,200 Americans died from drug overdoses involving illicit drugs and prescription opioids. New Jersey has been hit especially hard, with drug overdose deaths climbing steadily from 1,304 deaths in 2014, to 3,118 suspected drug overdose deaths in 2018. And the death toll from opioids would be even higher without the availability of the overdose-reversal drug, naloxone. During the same 2014-2018 period, the number of annual naloxone administrations by New Jersey law enforcement and emergency medical services first responders rose from 5,174 to 16,082. Even these staggering statistics do not reflect the number of naloxone administrations by other healthcare professionals or by the friends and family of overdose victims--a number that likely grew as New Jersey State agencies have worked together to increase access to naloxone for members of the public.
To address this ongoing epidemic and further increase the public availability of naloxone, the State Board of Medical Examiners (Board) proposes to amend N.J.A.C. 13:35-7.6 to require prescribers to co-prescribe an opioid antidote (for example, naloxone) under certain circumstances. In addition, the Board proposes to amend N.J.A.C. 13:35-7.6 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. These limitations and requirements apply to the following licensees under the jurisdiction of the Board: physicians, podiatrists, physician assistants, and certified nurse midwives. The revised law and proposed amendments clarify 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" in the rule consistent with the amended statute.
In accordance with P.L. 2017, c. 341, the Board proposes to amend the definitions of "chronic pain" and "initial prescription" at N.J.A.C. 13:35-7.6 to be consistent with the statutory definition. "Chronic pain" is now defined as pain that persists or recurs for more than three months. Thus, the Board proposes to bring the rules into alignment with the statutory definition of chronic pain, which is pain that persists "or recurs" for more than three months. Similarly, the term "initial prescription" clarifies that the five-day limit for opioid prescriptions for acute pain would not be triggered if the patient had "used or was administered" a pharmaceutical equivalent of the prescribed medication within the last year.
The Board proposes to amend paragraph (c)2 to update a reference from "practitioner" to "physician" to be consistent with N.J.S.A. 45:9-22.19 and the Division of Consumer Affair's Controlled Dangerous Substance rules at N.J.A.C. 13:45H-7.5, which state that only "physicians" licensed by the Board are permitted to issue multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of a Schedule II controlled dangerous substance.
The Board also proposes to amend subsection (d) to specify that the subsection's discussion requirements are triggered when a Schedule II controlled dangerous substance or any opioid drug are used to treat acute pain. The Board also proposes to amend the topics of discussion to include that opioids are highly addictive, even when taken as prescribed and used as directed.
P.L. 2017, c. 341 also cleared up confusion engendered by the original statute pertaining to the timing of the requirement to enter into a pain management agreement by removing reference to the "third prescription." Because prescribers are to issue prescriptions for opioids for an amount appropriate to the patients' treatment needs, the prescriber is encouraged to issue small amounts and, therefore, may issue three prescriptions in a short period of time, while the patient is still experiencing acute pain. Consistent with the statutory changes, the Board proposes to amend N.J.A.C. 13:35-7.6(d)2 and (e) to remove reference to the "third prescription," and replace it with references to "the outset of treatment of chronic pain." In accordance with the definition of "chronic pain," the obligation to enter into a pain management agreement, set forth in subsection (e), will not commence until the third month, regardless of the number of prescriptions that may have issued over the three-month period.
In addition, the Board proposes new paragraph (f)8 to require the co-prescribing of an opioid antidote (for example, naloxone) if, as part of the treatment of chronic pain, 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. The Board believes that mandating the co-prescribing of an opioid antidote under these circumstances will help reduce the risk of overdose deaths. The Board's decision to co-prescribe an opioid antidote is consistent with guidance issued by the U.S. Department of Health and Human Services and the American Medical Association's Opioid Task Force. This amendment is also consistent with initiatives undertaken in a number of other states, equally concerned about the rising overdose deaths in their jurisdictions. For example, in Vermont, the rule governing prescribing of opioids for pain requires that prescribers co-prescribe naloxone for all patients who receive one or more opioid prescriptions totaling a Morphine Milligram Equivalent (MME) Daily Dose of 90 or more--a standard also followed by California and Arizona. Some states adhere to differing standards by which co-prescription of naloxone becomes mandatory. Virginia has a threshold limit of 120 MME per day, Ohio has a threshold limit of 80 MME per day, and Rhode Island has a threshold limit of only 50 MME per day. Washington State requires that physicians assess whether the patient is "high risk" based on a number of factors, such as medical or behavioral co-morbidities, polypharmacy, dosages of opioids, or use of concurrent central nervous system depressants. While the Board's proposed amendment cannot impose a requirement on patients to fill a prescription, regular issuance of a naloxone prescription to individuals at risk will facilitate broader awareness of this life-saving medication. The co-prescribing requirement is in addition to the existing requirement to 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.
Mandatory co-prescribing of naloxone for higher-risk opioid patients finds support in the recommendations of national public health authorities, whether or not those authorities have specifically recommended that co-prescription be made mandatory in particular circumstances. The U.S. Department of Health and Human Services has issued guidance advising that "clinicians should strongly consider prescribing or co-prescribing naloxone, and providing education about its use" to certain patients who are at risk of opioid overdose, including but not limited to those receiving [page=677] opioids at a dosage of 50 or more MME per day. See Naloxone: The Opioid Reversal Drug that Saves Lives (Dec. 19, 2018), available at http://www.hhs.gov/opioids/sites/default/files/2018-12/naloxone-coprescribing-guidance.pdf. An Advisory Committee of the U.S. Food and Drug Administration (FDA) has concluded that labeling language that recommends co-prescription of naloxone for all or some patients prescribed opioids, or more targeted prescribing for patients otherwise at high risk for death from opioid overdose would be an effective method for expanding access to naloxone and improving public health. See FDA Center for Drug Evaluation and Research, Final Summary Minutes of the Joint Meeting of the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committee at 8 (Dec. 17-18, 2018), available at http://www.fda.gov/media/121173/download. The Centers for Disease Control and Prevention (CDC) has recommended that "clinicians should evaluate risk factors for opioid-related harms" before starting and periodically during continuation of opioid therapy, and should "incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present." D. Dowell et al., CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016 (Mar. 18, 2016), available at http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm?CDC_AA_refVal= https%3A%2F%2Fwww.cdc.gov%2Fmmwr%2Fvolumes%2F65%2Frr%2Frr6501e1er.htm. The Surgeon General recommends that prescribers prescribe naloxone to individuals who are at elevated risk for opioid overdose. See U.S. Surgeon General's Advisory on Naloxone and Opioid Overdose (Apr. 5, 2018), available at http://www.hhs.gov/surgeongeneral/priorities/opioids-and-addiction/naloxone-advisory/index.html. And a Task Force of the American Medical Association has called for expanding access to naloxone through co-prescribing and urges physicians to co-prescribe naloxone to patients at risk of overdose when clinically indicated. See American Medical Association, Help Save Lives: Co-prescribe Naloxone to Patients at Risk of Overdose (Aug. 2017), available at http://www.end-opioid-epidemic.org/wp-content/uploads/2017/08/AMA-Opioid-Task-Force-naloxone-one-pager-updated-August-2017-FINAL-1.pdf.
In addition, research indicates that mandating the co-prescription of naloxone for at-risk patients can substantially increase the rates at which naloxone is dispensed. See M. Sohn, et al., Association of Naloxone Coprescription Laws with Naloxone Prescription Dispensing in the United States, JAMA Netw Open. (July 21, 2019) (finding that "having a legal mandate for naloxone coprescription was associated with approximately 7.75 times more dispensed naloxone prescriptions compared to not having the requirements"), available at: http://jamanetwork.com/journals/jamanetworkopen/fullarticle/2736179.
The Board also proposes to amend subparagraphs (b)3 and (f)4 to simply refer to the codified statutory citation for the Prescription Monitoring Program, instead of the initial Public Law, which has since been amended.
As the Board has provided as 60-day comment period on this notice of proposal, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
The Board believes that the proposed amendments will have a positive impact on the consumers of New Jersey by reducing the risk of overdose deaths. In addition, the proposed amendments update and clarify the standards for practitioners who prescribe, dispense, or administer controlled dangerous substances. Specifically, among other things, the proposed amendments clarify the situations in which physicians and patients must enter into pain management agreements.
The proposed amendments are unlikely to have a direct economic impact on patients because they do not incur costs when they receive prescriptions, nor are they required to fill opioid antidote prescriptions. Similarly, the proposed amendments are unlikely to have a direct economic impact on prescribers because they do not incur costs when they write prescriptions. Patients and/or their insurers will bear costs when patients fill opioid antidote prescriptions, and these costs may eventually be passed on to the public. It is difficult to estimate these costs, however, and the Board believes the benefits accruing from lives saved will outweigh the costs involved.
Federal Standards Statement
A Federal standards analysis is not required because there are no Federal laws or standards applicable to the proposed amendments are governed by N.J.S.A. 45:9-1 et seq., and 24:21-15.2.
The Board does not believe that the proposed amendments will result in the creation or the loss of jobs in the State.
Agriculture Industry Impact
The Board does not believe that the proposed amendments will have any impact on the agriculture industry of the State.
Regulatory Flexibility Analysis
Currently, the Board licenses approximately 38,340 physicians, 1,290 podiatrists, 3,820 physician assistants, and 370 certified nurse midwives. If these licensees are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.
Proposed N.J.A.C. 13:35-7.6(f)8 will impose new recordkeeping and compliance requirements upon a practitioner who has a patient that has one or more prescriptions totaling 90 morphine milligram equivalents or more per day or is concurrently obtaining an opioid and a benzodiazepine. These requirements are discussed in the Summary above. No additional professional services will be needed to comply with the proposed amendments. The costs of compliance are discussed in the Economic Impact statement above. The proposed amendments should be uniformly applied to all licensed practitioners who are authorized to prescribe drugs in order to ensure the health, safety, and welfare of the general public. Therefore, no additional compliance requirements for any licensed practitioner are provided based upon the size of the business.
Housing Affordability Impact Analysis
The proposed amendments will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed amendments concern the prescribing, administering, or dispensing of controlled dangerous substances.
Smart Growth Development Impact Analysis
The proposed amendments will have an insignificant impact on smart growth development and there is an extreme unlikelihood that the proposed amendments would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed amendments concern the prescribing, administering, or dispensing of controlled dangerous substances.
Racial and Ethnic Community Criminal Justice and Public Safety Impact
The Board has evaluated this rulemaking and determined that it will not have an impact on pretrial detention, sentencing, probation, or parole policies concerning adults and juveniles in the State. Accordingly, no further analysis is required.
Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
SUBCHAPTER 7. PRESCRIPTION, ADMINISTRATION, AND DISPENSING OF DRUGS
13:35-7.6 Limitations on prescribing, administering, or dispensing of 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:
"Chronic pain" means pain that persists [for three or more consecutive months and after reasonable medical efforts have been made to relieve the [page=678] pain or its cause, it continues, either continuously or episodically] or recurs for more than three months.
"Initial prescription" means a prescription issued to a patient who:
1. (No change.)
2. Was previously issued a prescription for, or used or was administered the drug or its pharmaceutical equivalent, and the date on which the current prescription is being issued is more than one year after the date the patient last used or was administered the drug or its equivalent. When determining whether a patient was previously issued a prescription for, or used or was administered a drug or its pharmaceutical equivalent, the practitioner shall consult with the patient, review prescription monitoring information, and, to the extent it is available to the practitioner, review the patient's medical record.
(b) When prescribing, dispensing, or administering controlled dangerous substances, a practitioner shall:
1.-2. (No change.)
3. Access relevant prescription monitoring information as maintained by the Prescription Monitoring Program (PMP) pursuant to [section 8 of P.L. 2015, c. 74 (]N.J.S.A. 45:1-46.1[)] and consider that information in accordance with N.J.A.C. 13:45A-35;
4.-5. (No change.)
(c) With respect to Schedule II controlled dangerous substances, unless the requirements of this subsection are met or the prescribing of opioids is subject to limitations as set forth in (g) below, a practitioner may authorize a quantity, not to exceed a 30-day supply, which shall be at the lowest effective dose as determined by the directed dosage and frequency of dosage. The prescribing of opioids in any schedule is subject to limitations as set forth in (g) below.
1. (No change.)
2. Notwithstanding the 30-day supply limitation, a [practitioner] physician may prescribe multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of a Schedule II controlled dangerous substance provided that:
i.-iv. (No change.)
(d) Prior to issuing an initial prescription for a Schedule II controlled dangerous substance [for pain] or any opioid drug in the course of treatment for acute pain, a practitioner shall discuss with the patient, or the patient's parent or guardian if the patient is under 18 years of age and is not an emancipated minor, the reasons why the medication is being prescribed, the possible alternative treatments, and the risks associated with the medication. With respect to opioid drugs, the discussion shall include, but not be limited to, the risks of addiction, including that opioids are highly addictive, even when taken as prescribed and used as directed, physical or psychological dependence, and overdose associated with opioid drugs and the danger of taking opioid drugs with alcohol, benzodiazepines, and other central nervous system depressants, and requirements for proper storage and disposal.
1. (No change.)
2. The practitioner shall reiterate the discussion required in (d) above prior to issuing [the third] a prescription at the outset of [the] a course of treatment for chronic pain for a Schedule II controlled dangerous substance [for pain] or any opioid drug.
3. (No change.)
(e) [At the time of, or prior to, issuance of the third prescription for] Prior to the commencement of an ongoing course of treatment for chronic pain with a Schedule II controlled dangerous substance [for pain] or any opioid [drug], the practitioner shall enter into a pain management agreement with the patient. The pain management agreement shall be a written contract or agreement that is executed between a practitioner and a patient, that is signed and dated prior [to the issuance of the third prescription for the ongoing] to the commencement of an ongoing course of treatment [of] for chronic pain using a Schedule II controlled dangerous substance or any opioid drug, and which shall:
1.-5. (No change.)
(f) When controlled dangerous substances are continuously prescribed for management of chronic pain, the practitioner shall:
1.-3. (No change.)
4. Access relevant prescription monitoring information as maintained by the Prescription Monitoring Program (PMP) pursuant to [section 8 of P.L. 2015, c. 74 (]N.J.S.A. 45:1-46.1[)] and consider that information in accordance with N.J.A.C. 13:45A-35;
5.-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 to text.)
(g)-(j) (No change.)
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