S2652

An Act concerning opioid antidotes, amending various parts of the statutory law, and supplementing Title 24 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. Section 3 of P.L.2013, c.46 (C.24:6J-3) is amended to read as follows:

3. As used in this [act] chapter:

"Commissioner" means the Commissioner of Human Services.

“Community hub” means a place of social connection and congregation, including, but not limited to, a restaurant, bar, retail store, shopping mall, barber shop, beauty parlor, theater, sporting or event center, inn, hotel, or motel.

"Drug overdose" means an acute condition including, but not limited to, physical illness, coma, mania, hysteria, diminished consciousness, respiratory depression, or death resulting from the consumption or use of a controlled dangerous substance or another substance with which a controlled dangerous substance was combined and that a layperson would reasonably believe to require medical assistance.

"Emergency medical response entity" means an organization, company, governmental entity, community-based program, or healthcare system that provides pre-hospital emergency medical services and assistance. "Emergency medical response entity" includes, but is not limited to, a first aid, rescue and ambulance squad or other basic life support (BLS) ambulance provider; a mobile intensive care provider or other advanced life support (ALS) ambulance provider; an air medical service provider; or a fire-fighting company or organization, which squad, provider, company, or organization is qualified to send paid or volunteer emergency medical responders to the scene of an emergency.

"Emergency medical responder" means a person, other than a health care practitioner, who is employed on a paid or volunteer basis in the area of emergency response, including, but not limited to, an emergency medical technician, a mobile intensive care paramedic, or a fire fighter, acting in that person's professional capacity.

"Health care practitioner" means any individual who is licensed or certified to provide health care services pursuant to Title 45 of the Revised Statutes.

"Institution of higher education" means any public or private university, college, technical college or community college located in New Jersey.

"Law enforcement agency" means a department, division, bureau, commission, board or other authority of the State or of any political subdivision thereof which employs law enforcement officers.

"Law enforcement officer" means a person whose public duties include the power to act as an officer for the detection, apprehension, arrest and conviction of offenders against the laws of this State.

"Medical assistance" means professional medical services that are provided to a person experiencing a drug overdose by a health care practitioner, acting within the practitioner's scope of professional practice, including professional medical services that are mobilized through telephone contact with the 911 telephone emergency service.

"Occupational school" means a business, trade, technical, or other school approved by a nationally-recognized accrediting agency.

"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.

“Pharmacist” means a pharmacist licensed pursuant to P.L.2003, c.280 (C.45:14-40 et seq.).

"Prescriber" means a health care practitioner authorized by law to prescribe medications. "Prescriber" includes, but shall not be limited to, physicians, physician assistants, and advanced practice nurses.

"Public library" means a library that serves, free of charge, all residents of an area without discrimination and that receives its financial support, in whole or in part, from public funds.

"Public transportation hub" means a passenger station, terminal, or other facility, as designated by the Commissioner of Transportation, where public transportation services are made available.

"Recipient" means any individual who or entity that is prescribed or dispensed an opioid antidote in accordance with section 4 of P.L.2013, c.46 (C.24:6J-4) [or] , section 1 of P.L.2017, c.88 (C.45:14-67.2) , or section 4 of P.L. , c (C. ) (pending before the Legislature as this bill). The term "recipient" shall include, but shall not be limited to, private citizens, emergency medical responders, emergency medical response entities, law enforcement officers, law enforcement agencies, recognized places of public access, employees and volunteers providing services at, through, or on behalf of a recognized place of public access, public and nonpublic schools, school nurses and other staff at a public or nonpublic school, sterile syringe access programs, and staff and employees of a sterile syringe access program. The term "recipient" shall not include a prescriber or a licensed pharmacist acting within a professional capacity.

"Recognized place of public access" means a public library, institution of higher education, occupational school, or public transportation hub.

“School” means a public or non-public elementary or secondary school.

"Sterile syringe access program" means a program established pursuant to the provisions of P.L.2006, c.99 (C.26:5C-25 et al.).

(cf: P.L.2021, c.152, s.2)

2. (New section) a. There is established in the Department of Health a program to prevent opioid overdose. It shall be the duty of the Commissioner of Health to establish standards to prevent opioid overdose including, but not limited to, opioid antidote prescribing, dispensing, distribution, possession, and administration pursuant to P.L. , c. (C. ) (pending before the Legislature as this bill) which may include, but not be limited to, standards for prescribing and dispensing opioid antidotes under the Overdose Prevention Act, P.L.2013, c.46 and P.L.2021, c.152; program directors of entities that access, acquire, and maintain opioid antidotes under the Overdose Prevention Act, P.L.2013, c.46 and P.L.2021, c.152; appropriate clinical oversight; training; and record-keeping and reporting. In addition to the rules and regulations promulgated pursuant to this section, a prescriber or other health care practitioner shall also prescribe an opioid antidote with the first prescription in a calendar year of an opioid to a particular patient when any of the following risk factors are present:

(1) the patient has a history of substance use disorder;

(2) the patient has a high dose prescription or cumulative prescriptions that result in 90 morphine milligram equivalents or higher per day; or

(3) the patient is concurrently using opioids and benzodiazepine or nonbenzodiazepine sedative hypnotics.

b. Notwithstanding any rules or regulations to the contrary, the purchase, acquisition, possession, or use of an opioid antidote pursuant to P.L. , c. (C. ) (pending before the Legislature as this bill) shall not constitute the unlawful practice of a profession licensed to practice medicine pursuant to Title 45.

c. The Commissioner of Health, pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), and within 180 days following the effective date of P.L. , c. (C. ) (pending before the Legislature as this bill) shall promulgate rules and regulations to effectuate the purposes of this section.

3. Section 4 of P.L.2013, c.46 (C.24:6J-4) is amended to read as follows:

4. a. (1) A prescriber or other health care practitioner, as appropriate, may prescribe or dispense an opioid antidote directly or through a standing order to any person or entity. Any person or entity may be dispensed an opioid antidote pursuant to an individual prescription or a standing order issued by a prescriber, and any person or entity may be dispensed an opioid antidote by a pharmacy as provided in section 1 of P.L.2017, c.88 (C.45:14-67.2).

(2) Nothing in P.L.2013, c.46 (C.24:6J-1 et al.) shall be construed to restrict in any way the ability of any individual or entity to be dispensed an opioid antidote. The persons and entities to whom an opioid antidote may be prescribed and dispensed shall include private citizens, individuals who are dispensed an opioid antidote for administration or distribution to others in either a private or professional capacity, entities that are dispensed opioid antidotes on behalf of individuals who administer or distribute opioid antidotes to others in the course of their professional duties, and entities other than a prescriber or pharmacist that maintain a stock of opioid antidotes for distribution or administration to others.

(3) (Deleted by amendment, P.L.2021, c.152).

(4) (Deleted by amendment, P.L.2021, c.152).

b. (1) A recipient in possession of an opioid antidote may administer the opioid antidote to any other person, without fee, in any situation in which the recipient reasonably believes the other person to be experiencing an opioid overdose.

(2) A recipient in possession of an opioid antidote may distribute the opioid antidote, without fee, to any other person who the recipient reasonably believes to be at risk of experiencing an opioid overdose or who the recipient reasonably believes will be in a position to administer the opioid antidote to a person experiencing an opioid overdose. A recipient distributing an opioid antidote to another person pursuant to this paragraph shall make reasonable efforts to furnish the person with the overdose prevention information described in section 5 of P.L.2013, c.46 (C.24:6J-5). The Commissioner of Health, or, if the commissioner is not a duly licensed physician, the Deputy Commissioner for Public Health Services, shall issue a standing order authorizing the distribution of opioid antidotes pursuant to this paragraph.

c. (1) A prescriber or other health care practitioner who prescribes or dispenses an opioid antidote in good faith, and in accordance with the provisions of this section, shall not, as a result of the practitioner's acts or omissions, be subject to any criminal or civil liability, or any professional disciplinary action under Title 45 of the Revised Statutes, for prescribing or dispensing the opioid antidote. A pharmacist that dispenses an opioid antidote in good faith, in accordance with the provisions of this section or section 1 of P.L.2017, c.88 (C.45:14-67.2), shall not, as a result of the pharmacist's acts or omissions, be subject to any criminal or civil liability, or any professional disciplinary action under Title 45 of the Revised Statutes, for dispensing the opioid antidote.

(2) A recipient who administers or distributes an opioid antidote in good faith as provided in subsection b. of this section shall not, as a result of any of the recipient's acts or omissions, be subject to any criminal or civil liability, or any professional disciplinary action, for administering or distributing the opioid antidote. Use of an opioid antidote pursuant to P.L.2021, c.152 and P.L. , c. (pending before the Legislature as this bill) shall be considered first aid or emergency treatment for the purpose of any statute relating to liability.

d. (Deleted by amendment, P.L.2021, c.152).

e. The immunity provided by this section for persons who are engaged in prescribing, dispensing, distributing, or administering an opioid antidote shall be coextensive with the immunity provided under sections 7 and 8 of P.L.2013, c.46 (C.2C:35-30 and C.2C:35-31), to the extent that the provisions of those sections apply.

f. (Deleted by amendment, P.L.2021, c.152).

g. (Deleted by amendment, P.L.2021, c.152).

h. (Deleted by amendment, P.L.2021, c.152).

i. Nothing in this section or in P.L.2017, c.88 (C.45:14-67.2) shall be deemed to limit the authority of a prescriber or other health care practitioner to prescribe, dispense, or distribute, or of a pharmacist to dispense, an opioid antagonist under any other provision of law.

(cf: P.L.2021, c.152, s.3)

4. Section 1 of P.L.2017, c.88 (C.45:14-67.2) is amended to read as follows:

1. a. Notwithstanding any other law or regulation to the contrary, a pharmacist may dispense an opioid antidote to any person or entity, regardless of whether the person or entity holds an individual prescription for the opioid antidote, pursuant to a standing order issued by a prescriber or pursuant to the standing order issued pursuant to subsection b. of this section. A pharmacist who dispenses an opioid antidote pursuant to this section shall comply with the provisions of the "Overdose Prevention Act," P.L.2013, c.46 (C.24:6J-1 et al.).

b. The Commissioner of Health, or, if the commissioner is not a duly licensed physician, the Deputy Commissioner for Public Health Services, shall issue a standing order authorizing all licensed pharmacists in the State to dispense an opioid antidote to any individual or entity, regardless of whether the individual or entity holds an individual prescription for the opioid antidote. The Commissioner of Health shall provide a copy of the standing order to the Board of Pharmacy, which shall post a copy of the standing order on the board's Internet website and transmit a copy of the standing order to all licensed pharmacists in such a manner as the board deems appropriate.

c. A pharmacy with 20 or more locations in the State shall either: (1) pursue or maintain a non-patient specific prescription with an authorized health care professional to dispense an opioid antidote to a recipient upon request; or (2) register with the Department of Health as an opioid overdose prevention program.

[c] d. As used in this section:

"Opioid antidote" means naloxone hydrochloride or any other drug approved by the United States Food and Drug Administration for the treatment of an opioid overdose.

"Prescriber" means the same as that term is defined in section 3 of P.L.2013, c.46 (C.24:6J-3).

(cf: P.L.2021, c.152, s.10)

5. Section 5 of P.L.2013, c.46 (C.24:6J-5) is amended to read as follows:

5. a. (1) A prescriber or other health care practitioner who prescribes or dispenses an opioid antidote in accordance with subsection a. of section 4 of P.L.2013, c.46 (C.24:6J-4), and a pharmacist who dispenses an opioid antidote pursuant to subsection a. of section 4 of P.L.2013, c.46 (C.24:6J-4) or section 1 of P.L.2017, c.88 (C.45:14-67.2), shall ensure that overdose prevention information is provided to the recipient. The overdose prevention information shall include, but need not be limited to: information on opioid overdose prevention and recognition; instructions on how to perform rescue breathing and resuscitation; information on opioid antidote dosage and instructions on opioid antidote administration; information describing the importance of calling the 911 emergency telephone service for assistance with an opioid overdose; [and] instructions for appropriate care of a person believed to be experiencing an opioid overdose after administration of the opioid antidote ; the number for the toll-free hotline REACHNJ; instructions on how to access the Department of Human Services’ Division of Mental Health and Addiction Services website; information on fentanyl testing strips and its uses; and any other information deemed relevant by the Commissioners of Health and of Human Services.

(2) (Deleted by amendment, P.L.2021, c.152).

b. (1) (Deleted by amendment, P.L.2021, c.152).

(2) The dissemination of overdose prevention information shall be documented by the prescribing or dispensing health care practitioner or dispensing pharmacist in the patient's medical record or another appropriate record, log or other similar recordkeeping location.

c. In order to facilitate the dissemination of overdose prevention information in accordance with this section, the Commissioner of Human Services, in consultation with the Department of Health and Statewide organizations representing physicians, advanced practice nurses, or physician assistants, and organizations operating community-based programs, sterile syringe access programs, or other programs which address medical or social issues related to substance use disorders, may develop training materials in video, electronic, or other appropriate formats, and disseminate these materials to health care practitioners. The Commissioner of Human Services may make the materials available to the general public through the Internet website of the Department of Human Services, with such modifications as may be appropriate to adapt the materials for use by persons who are not health care practitioners. The commissioner shall ensure the materials are available in English, Spanish, and any other language that the commissioner determines is the first language of a significant number of people who are likely to be prescribed or dispensed an opioid antidote in accordance with subsection a. of section 4 of P.L.2013, c.46 (C.24:6J-4) or dispensed an opioid antidote pursuant to section 1 of P.L.2017, c.88 (C.45:14-67.2).

(cf: P.L.2021, c.152, s.4)

6. Section 6 of P.L.2021, c.152 (C.24:6J-7) is amended to read as follows:

6. a. To the extent funds are made available by the State for this purpose, a community hub, school, or recognized place of public access shall obtain a supply of opioid antidotes pursuant to a standing order issued pursuant to section 4 of P.L.2013, c.46 (C.24:6J-4) or section 1 of P.L.2017, c.88 (C.45:14-67.2), which opioid antidotes shall be maintained in one or more secure and easily accessible locations for the purpose of administering the opioid antidote to any person who is reasonably believed to be experiencing an opioid overdose. Nothing in this section shall be construed to limit, restrict, or otherwise prohibit any other person or entity from obtaining, maintaining, distributing, or administering opioid antidotes as authorized under section 4 of P.L.2013, c.46 (C.24:6J-4) or any other provision of law.

b. A community hub, school, or recognized place of public access that acquires and maintains a supply of opioid antidotes pursuant to subsection a. of this section shall ensure that at least one employee or volunteer who regularly provides services at, through, or on behalf of the community hub, school, or recognized place of public access has received training on the standardized protocols for the administration of an opioid antidote to a person who is reasonably believed to be experiencing an opioid overdose, the requirements for which training shall be established by the Commissioner of Human Services. The training and protocols shall follow best practices for low-threshold community use of opioid antidotes in community hubs, schools, and recognized places of public access, and shall include the overdose prevention information described in subsection a. of section 5 of P.L.2013, c.46 (C.24:6J-5). The commissioner may require by regulation that more than one employee or volunteer at a recognized place of public access complete the training required pursuant to this subsection.

c. A community hub, school, or recognized place of public access may, to the extent not otherwise prohibited by State or federal law, enter into an agreement with a community-based organization to distribute opioid antidotes on the premises of the community hub, school, or recognized place of public access.

(cf: P.L.2021, c.152, s.6)

7. (New section) a. The Commissioner of Health shall publish on the Department of Health’s Internet website data on opioid-related overdose death rates and other information related to fatal opioid overdoses. The report shall be submitted annually, on or before October 1st, to the Governor, and pursuant to section 2 of P.L.1991, c.164 (C.52:14-19.1), to the Legislature. The report shall also be made publicly available and published on the Opioid Data Dashboard webpage of the Department of Health’s website. The report shall include, at a minimum, the following information on a county basis:

(1) the number of opioid overdoses and opioid overdose deaths, including a breakdown by age, gender, ethnicity, and geographic location;

(2) data on emergency room utilization for the treatment of an opioid overdose;

(3) data on the utilization of pre-hospital services for the treatment of an opioid overdose;

(4) data on the dispensation and administration of opioid antidotes; and

(5) any other information necessary to ascertain the success of the program, areas of the State experiencing particularly high rates of opioid overdose, processes to determine if the services, resources, and responses to an opioid overdose are successful and have a positive impact on reducing the opioid overdose rate, and ways to further reduce the rates of opioid overdose.

b. The Commissioner of Health shall provide the above information by each type of opioid antidote available. The commissioner shall provide the data listed in subsection a. of this section to each local county health board in the State once every three months.

c. The Department of Health shall be authorized to call upon the Department of Human Services to support the work of P.L. , c. (C. ) (pending before the Legislature as this bill) to supply such data, or such other information as the Department of Health deems necessary to effectuate the provisions of P.L. , c. (C. ) (pending before the Legislature as this bill). The Department of Human Services shall, to the extent possible and not inconsistent with any other law of this State, cooperate with the Department of Health and shall furnish the Department of Health with such data and information as may be necessary to effectuate the purposes of P.L. , c. (C. ) (pending before the Legislature as this bill).

8. This act shall take effect immediately.

STATEMENT

Under this bill, community hubs and schools would be able to acquire opioid antidotes for distribution and administration to any recipient believed to be experiencing an opioid overdose.

This bill amends the Overdose Prevention Act to add community hub and school to those entities that can access, acquire, and maintain a supply of opioid antidotes on the premises for the benefit of a person reasonably believed to be experiencing an overdose. Under this bill, a “community hub” means a place of social connection and congregation, including but not limited to, a restaurant, bar, retail store, shopping mall, barber shop, beauty parlor, theater, sporting or event center, inn, hotel, and motel. And, “school” means any public or non-public elementary or secondary school.

Additionally, this bill establishes a program within the Department of Health to prevent opioid overdose. The Department of Health would be required to submit a yearly report to the Governor and the Legislature on the following information on a county basis:

· the number of opioid overdoses and opioid overdose deaths, including a breakdown by age, gender, ethnicity, and geographic location;

· data on emergency room utilization for the treatment of an opioid overdose;

· data on the utilization of pre-hospital services for the treatment of an opioid overdose;

· data on the dispensation and administration of opioid antidotes; and

· any other information necessary to ascertain the success of the program, areas of the State experiencing particularly high rates of opioid overdose, processes to determine if the services, resources, and responses to an opioid overdose are successful and have a positive impact on reducing the opioid overdose rate, and ways to further reduce the rates of opioid overdose.

This bill also requires prescribers and pharmacists who prescribe and dispense opioid antidotes to provide additional information, such as the number for the toll-free hotline REACHNJ; instructions on how to access the Department of Human Services’ Division of Mental Health and Addiction Services website; information on fentanyl testing strips and its uses; and any other information deemed relevant by the Commissioners of Health and of Human Services, to the recipient of the antidote.

With this bill, a pharmacy with 20 or more locations in the State would be required to either: maintain a non-patient specific prescription with an authorized health care professional to dispense an opioid antidote to a recipient upon request; or, register with the Department as an opioid overdose prevention program.

Additionally, this bill strengthens the liability protections for prescribers and pharmacists who prescribe or dispense an opioid antidote pursuant to the provisions of this bill.

Lastly, this bill adds a definition of “pharmacist,” to mean a pharmacist licensed pursuant to the provisions of P.L.2003, c.280 (C.45:14-40 et seq.).