S295

An Act concerning overdose prevention and the dispensation of opioid antidotes, supplementing P.L.2003, c.280 (C.45:14-40 et seq.), and amending P.L.2013, c.46.

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

1. (New section) a. Notwithstanding any other law or regulation to the contrary, a pharmacist may dispense or otherwise supply an opioid antidote to any patient, regardless of whether the patient holds an individual prescription therefor; provided that the pharmacist complies with the provisions of the “Overdose Prevention Act,” P.L.2013, c.46 (C.24:6J-1 et seq.) and, if applicable, the standardized protocols established by the Board of Pharmacy pursuant to this section.

b. (1) Within 90 days after the effective date of P.L. , c. (C. ) (pending before the Legislature as this bill), the Board of Pharmacy shall adopt standardized protocols for licensed pharmacists to supply opioid antidotes to patients who do not present an individual prescription therefor.

(2) The standardized protocols established pursuant to this subsection shall be consistent with the provisions of the “Overdose Prevention Act,” P.L.2013, c.46 (C.24:6J-1 et seq.), and shall require a licensed pharmacist to determine, in accordance with the provisions of subsection a. of section 4 of the “Overdose Prevention Act,” P.L.2013, c.46 (C.24:6J-4), and prior to supplying an opioid antidote to a patient without a prescription therefor, that the patient is capable of administering the opioid antidote to an overdose victim in an emergency.

c. As used in this section:

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

“Patient” means a person who is at risk of an opioid overdose or a person who is not at risk of an opioid overdose who, in the person’s individual capacity, obtains an opioid antidote from a pharmacist for the purpose of administering that antidote to another person in an emergency, in accordance with the provisions of subsection d. of section 4 of the “Overdose Prevention Act,” P.L.2013, c.46 (C.24:6J-4).

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

3. As used in this act:

"Commissioner" means the Commissioner of Human Services.

"Drug overdose" means an acute condition including, but not limited to, physical illness, coma, mania, hysteria, 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 to opioid [or heroin addicts or abusers] users in the event of an overdose.

"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 acting in that person's professional capacity.

"Health care practitioner" means a prescriber, pharmacist, or other individual whose professional practice is regulated pursuant to Title 45 of the Revised Statutes, and who, in accordance with the practitioner's scope of professional practice, prescribes or dispenses an opioid antidote.

"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.

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

"Patient" means a person who is at risk of an opioid overdose or a person who is not at risk of an opioid overdose who, in the person's individual capacity, obtains an opioid antidote from a health care practitioner, professional, or professional entity for the purpose of administering that antidote to another person in an emergency, in accordance with subsection [c.] d. of section 4 of P.L.2013, c.46 (C.24:6J-4). "Patient" includes a professional who is acting in that professional's individual capacity, but does not include a professional who is acting in a professional capacity.

"Prescriber" means a health care practitioner authorized by law to prescribe medications who, acting within the practitioner's scope of professional practice, prescribes an opioid antidote. "Prescriber" includes, but is not limited to, a physician, physician assistant, or advanced practice nurse.

"Professional" means a person, other than a health care practitioner, who is employed on a paid basis or is engaged on a volunteer basis in the areas of substance abuse treatment or therapy, criminal justice, or a related area, and who, acting in that person's professional or volunteer capacity, obtains an opioid antidote from a health care practitioner for the purposes of dispensing or administering that antidote to other parties in the course of business or volunteer activities. "Professional" includes, but is not limited to, a sterile syringe access program employee, or a law enforcement official.

"Professional entity" means an organization, company, governmental entity, community-based program, sterile syringe access program, or any other organized group that employs two or more professionals who engage, during the regular course of business or volunteer activities, in direct interactions with opioid [or heroin addicts or abusers] users or other persons susceptible to opioid overdose, or with other persons who are in a position to provide direct medical assistance to opioid [or heroin addicts or abusers] users in the event of an overdose.

"Recipient" means a patient, professional, professional entity, emergency medical responder, or emergency medical response entity who is prescribed [or] , dispensed , or otherwise supplied, an opioid antidote in accordance with section 4 of P.L.2013, c.46 (C.24:6J-4).

(cf: P.L.2015, c.10, s.1)

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:

(a) directly or through a standing order, to any recipient who is deemed by the health care practitioner to be capable of administering the opioid antidote to an overdose victim in an emergency;

(b) through a standing order, to any professional or emergency medical responder who is not acting in a professional or volunteer capacity for a professional entity, or an emergency medical response entity, but who is deemed by the health care practitioner to be capable of administering opioid antidotes to overdose victims, as part of the professional's regular course of business or volunteer activities;

(c) through a standing order, to any professional who is not acting in a professional or volunteer capacity for a professional entity, but who is deemed by the health care practitioner to be capable of dispensing opioid antidotes to recipients, for administration thereby, as part of the professional's regular course of business or volunteer activities;

(d) through a standing order, to any professional entity or any emergency medical response entity, which is deemed by the health care practitioner to employ professionals or emergency medical responders, as appropriate, who are capable of administering opioid antidotes to overdose victims as part of the entity's regular course of business or volunteer activities; or

(e) through a standing order, to any professional entity which is deemed by the health care practitioner to employ professionals who are capable of dispensing opioid antidotes to recipients, for administration thereby, as part of the entity's regular course of business or volunteer activities.

(2) Notwithstanding any other law or regulation to the contrary, a licensed pharmacist who is authorized to dispense an opioid antidote pursuant to this subsection may dispense or otherwise supply an opioid antidote to any patient, regardless of whether the patient has an individual prescription therefor; provided that the patient is deemed to be capable of administering the opioid antidote to an overdose victim in an emergency, and provided, further, that the pharmacist acts in compliance with the standardized protocols established by the Board of Pharmacy, pursuant to section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill), when supplying an opioid antidote to a patient who lacks a prescription therefor.

(3) (a) For the purposes of this subsection, whenever the law expressly authorizes or requires a certain type of professional or professional entity to obtain a standing order for opioid antidotes pursuant to this section, such professional, or the professionals employed or engaged by such professional entity, as the case may be, shall be presumed by the prescribing or dispensing health care practitioner to be capable of administering or dispensing the opioid antidote, consistent with the express statutory requirement.

(b) For the purposes of this subsection, whenever the law expressly requires a certain type of emergency medical responder or emergency medical response entity to obtain a standing order for opioid antidotes pursuant to this section, such emergency medical responder, or the emergency medical responders employed or engaged by such emergency medical response entity, as the case may be, shall be presumed by the prescribing or dispensing health care practitioner to be capable of administering the opioid antidote, consistent with the express statutory requirement.

[(3)] (4) (a) Whenever a prescriber or other health care practitioner prescribes or dispenses an opioid antidote to a professional or professional entity pursuant to a standing order issued under paragraph (1) of this subsection, the standing order shall specify whether the professional or professional entity is authorized thereby to directly administer the opioid antidote to overdose victims; to dispense the opioid antidote to recipients, for their administration to third parties; or to both administer and dispense the opioid antidote. If a standing order does not include a specification in this regard, it shall be deemed to authorize the professional or professional entity only to administer the opioid antidote with immunity, as provided by subsection [c.] d. of this section, and it shall not be deemed to authorize the professional or professional entity to engage in the further dispensing of the antidote to recipients, unless such authority has been granted by law, as provided by subparagraph (b) of this paragraph.

(b) Notwithstanding the provisions of this paragraph to the contrary, if the law expressly authorizes or requires a certain type of professional, professional entity, emergency medical responder, or emergency medical response entity to administer or dispense opioid antidotes pursuant to a standing order issued hereunder, the standing order issued pursuant to this section shall be deemed to grant the authority specified by the law, even if such authority is not expressly indicated on the face of the standing order.

[(4)] (5) Any prescriber or other health care practitioner who prescribes [or] , dispenses , or otherwise supplies, an opioid antidote in good faith, and in accordance with the provisions of this subsection, 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 , or otherwise supplying, an opioid antidote in accordance with P.L.2013, c.46 (C.24:6J-1 et seq.).

b. (1) Any professional or professional entity that has obtained a standing order, pursuant to subsection a. of this section, for the dispensing of opioid antidotes, may dispense or otherwise supply an opioid antidote to any recipient who is deemed by the professional or professional entity to be capable of administering the opioid antidote to an overdose victim in an emergency.

(2) Any professional or professional entity that dispenses or otherwise supplies an opioid antidote in accordance with paragraph (1) of this subsection, in good faith, and pursuant to a standing order issued under subsection a. of this section, shall not, as a result of any acts or omissions, be subject to any criminal or civil liability , or any professional disciplinary action , for dispensing or otherwise supplying an opioid antidote in accordance with P.L.2013, c.46 (C.24:6J-1 et seq.).

c. (1) Any emergency medical responder or emergency medical response entity that has obtained a standing order, pursuant to subsection a. of this section, for the administration of opioid antidotes, may administer an opioid antidote to overdose victims.

(2) Any emergency medical responder or emergency medical response entity that administers an opioid antidote, in good faith, in accordance with paragraph (1) of this subsection, and pursuant to a standing order issued under subsection a. of this section, shall not, as a result of any acts or omissions, be subject to any criminal or civil liability, or any professional disciplinary action, for administering the opioid antidote in accordance with P.L.2013, c.46 (C.24:6J-1 et seq.)

d. (1) Any person who is the recipient of an opioid antidote, which has been prescribed [or] , dispensed , or otherwise supplied, thereto for administration purposes pursuant to subsection a. or b. of this section, and who has received overdose prevention information pursuant to section 5 of P.L.2013, c.46 (C.24:6J-5), may administer the opioid antidote to another person in an emergency, without fee, if the antidote recipient believes, in good faith, that the other person is experiencing an opioid overdose.

(2) Any person who administers an opioid antidote pursuant to paragraph (1) of this subsection shall not, as a result of the person's acts or omissions, be subject to any criminal or civil liability , or any professional disciplinary action, for administering the opioid antidote in accordance with P.L.2013, c.46 (C.24:6J-1 et seq.).

e. In addition to the immunity that is provided by this section for authorized persons who are engaged in the prescribing, dispensing, or administering of an opioid antidote, the immunity provided by section 7 or section 8 of P.L.2013, c.46 (C.2C:35-30 or C.2C:35-31) shall apply to a person who acts in accordance with this section, provided that the requirements of those sections, as applicable, have been met.

(cf: P.L.2015, c.10, s.2)

4. This act shall take effect immediately.

STATEMENT

This bill would expand public access to opioid antidotes, such as naloxone hydrochloride, by supplementing the “New Jersey Pharmacy Practice Act,” P.L.2003, c.280 (C.45:14-40 et seq.) and amending the provisions of the “Overdose Prevention Act,” (OPA) P.L.2013, c.46 (C.24:6J-1 et seq.), in order to authorize pharmacists to supply opioid antidotes to patients without prescriptions under standardized protocols that are to be adopted by the Board of Pharmacy in accordance with the bill’s provisions. The authority granted by the bill would be in addition to the existing authority of pharmacists to supply opioid antidotes to patients without prescriptions under a standing order issued by a physician.

The bill would define the term “patient” – consistent with the OPA – to mean a person who is at risk of an opioid overdose or a person who is not at risk of an opioid overdose who, in the person’s individual capacity, obtains an opioid antidote from a pharmacist for the purpose of administering that antidote to another person in an emergency, in accordance with the provisions of the OPA.

The bill would provide, in particular, that a licensed pharmacist may dispense or otherwise supply an opioid antidote to any patient who is deemed to be capable of administering the same, regardless of whether that patient presents an individual prescription for the antidote. The bill would require the Board of Pharmacy, within 90 days after the bill’s effective date, to adopt standardized protocols to be used by licensed pharmacists when furnishing an opioid antidote to a patient who does not present a prescription therefor. The protocols must be consistent with the provisions of the OPA, and must require a pharmacist to determine that the patient seeking the antidote is capable of administering the same to an overdose victim in an emergency. This is the same determination that must be made under the OPA before a pharmacist may dispense an opioid antidote to any person or entity under a standing order. Any pharmacist who acts in good faith, and in accordance with the bill’s requirements, in supplying an opioid antidote to a patient without a prescription, would be immune under the OPA from any civil or criminal liability or any professional disciplinary action stemming from such act.

The bill would also make minor technical and clarifying corrections to the OPA, in order to correct citations, ensure internal consistency, remove pejorative language, and clarify imprecise language therein.