A5243

An Act concerning prescription monitoring information and amending P.L.2015, c.74.

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

1. Section 8 of P.L.2015, c.74 (C.45:1-46.1) is amended to read as follows:

8. a. (1) Except as provided in subsection b. of this section, a practitioner or other person who is authorized by a practitioner to access prescription monitoring information pursuant to subsection h. of section 26 of P.L.2007, c.244 (C.45:1-46) shall access prescription monitoring information the first time the practitioner or other person prescribes a Schedule II or Schedule III controlled dangerous substance or a benzodiazepine drug that is a Schedule IV controlled dangerous substance to a new patient [for acute or chronic pain]. In addition, for any prescription of a Schedule II or Schedule III controlled dangerous substance or a benzodiazepine drug that is a Schedule IV controlled dangerous substance for a new or current patient [for acute or chronic pain] which is written on or after the effective date of [P.L.2015, c.74 (C.45:1-46.1 et al.)] P.L. , c. (C. ) (pending before the Legislature as this bill) a practitioner or other authorized person shall access prescription monitoring information on a quarterly basis during the period of time the patient continues to receive such prescriptions.

(2) (a) A pharmacist shall not dispense a Schedule II or Schedule III controlled dangerous substance or a benzodiazepine drug that is a Schedule IV controlled dangerous substance to any person without first accessing the prescription monitoring information, as authorized pursuant to subsection h. of section 26 of P.L.2007, c.244 (C.45:1-46), to determine if the person has received other prescriptions that indicate misuse, abuse, or diversion, if the pharmacist has a reasonable belief that the person may be seeking a controlled dangerous substance, in whole or in part, for any purpose other than the treatment of an existing medical condition, such as for purposes of misuse, abuse, or diversion.

(b) A pharmacist shall not dispense a prescription to a person other than the patient for whom the prescription is intended, unless the person picking up the prescription provides personal identification to the pharmacist, and the pharmacist, as required by subsection b. of section 25 of P.L.2007, c.244 (C.45:1-45), inputs that identifying information into the Prescription Monitoring Program if the pharmacist has a reasonable belief that the person may be seeking a controlled dangerous substance, in whole or in part, for any reason other than delivering the substance to the patient for the treatment of an existing medical condition. The provisions of this subparagraph shall not take effect until the director determines that the Prescription Monitoring Program has the technical capacity to accept such information.

b. The provisions of subsection a. of this section shall not apply to:

(1) a veterinarian;

(2) a practitioner or the practitioner's agent administering methadone, or another controlled dangerous substance designated by the director as appropriate for treatment of a patient with a substance abuse disorder, as interim treatment for a patient on a waiting list for admission to an authorized substance abuse treatment program;

(3) a practitioner administering a controlled dangerous substance directly to a patient;

(4) a practitioner prescribing a controlled dangerous substance to be dispensed by an institutional pharmacy, as defined in N.J.A.C.13:39-9.2;

(5) a practitioner prescribing a controlled dangerous substance in the emergency department of a general hospital, provided that the quantity prescribed does not exceed a five-day supply of the substance;

(6) a practitioner prescribing a controlled dangerous substance to a patient under the care of a hospice;

(7) a situation in which it is not reasonably possible for the practitioner or pharmacist to access the Prescription Monitoring Program in a timely manner, no other individual authorized to access the Prescription Monitoring Program is reasonably available, and the quantity of controlled dangerous substance prescribed or dispensed does not exceed a five-day supply of the substance;

(8) a practitioner or pharmacist acting in compliance with regulations promulgated by the director as to circumstances under which consultation of the Prescription Monitoring Program would result in a patient's inability to obtain a prescription in a timely manner, thereby adversely impacting the medical condition of the patient;

(9) a situation in which the Prescription Monitoring Program is not operational as determined by the division or where it cannot be accessed by the practitioner due to a temporary technological or electrical failure, as set forth in regulation;

(10) a practitioner or pharmacist who has been granted a waiver due to technological limitations that are not reasonably within the control of the practitioner or pharmacist, or other exceptional circumstances demonstrated by the practitioner or pharmacist, pursuant to a process established in regulation, and in the discretion of the director; or

(11) a practitioner who is prescribing a controlled dangerous substance to a patient immediately after the patient has undergone an operation, procedure, or treatment for acute trauma, when less than a 30-day supply is prescribed.

c. The Board of Pharmacy shall evaluate each drug which is newly classified by the federal Drug Enforcement Administration or by the director as a Schedule IV or Schedule V controlled dangerous substance to determine: the actual or relative potential for abuse; scientific evidence of its pharmacological effect, if known; the state of current scientific knowledge regarding the drug; its history and current pattern of abuse; the scope, duration, and significance of abuse; what, if any, risk to the public health; and its physic or physiological dependence liability. Based on that evaluation, the Board of Pharmacy may recommend to the director that the director adopt a regulation to include the drug in the mandatory prescription monitoring information access requirements set forth in subsection a. of this section. Nothing in this subsection shall be deemed to limit the director’s authority to adopt a regulation to include any drug in the mandatory prescription monitoring information access requirements set forth in subsection a. of this section, regardless of whether the Board of Pharmacy has recommended inclusion, or to limit the director’s authority under section 27 of P.L.2007, c.244 (C.45:1-47) to expand the program to include information about prescriptions for drugs that are not controlled dangerous substances.

(cf: P.L.2015, c.74, s.8)

2. The Director of the Division of Consumer Affairs in the Department of Law and Public Safety may adopt, pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), such rules and regulations as may be necessary to implement the provisions of this act.

3. This act shall take effect on the first day of the fourth month next following the date of enactment, except that the Director of the Division of Consumer Affairs in the Department of Law and Public Safety may take any advance administrative action as may be necessary to implement the provisions of this act.

STATEMENT

This bill expands the requirements concerning mandatory checks of prescription monitoring information to include all Schedule II and Schedule III controlled dangerous substances and Schedule IV benzodiazepine drugs, which are a class of drugs that act on the neurotransmitters in the brain to suppress nerve activity. Benzodiazepines, which are most commonly used to treat anxiety, seizures, panic disorders, muscle spasms, alcohol withdrawal, and insomnia, are known to be habit forming and susceptible to abuse.

Specifically, the bill requires prescribers to access prescription monitoring information prior to issuing a first prescription to a new patient for any Schedule II or Schedule III controlled dangerous substance and for any benzodiazepine drug that is a Schedule IV controlled dangerous substance, and to access prescription monitoring information on a quarterly basis for ongoing prescriptions for such drugs issued to new or current patients. Pharmacists will be required to access prescription monitoring information prior to dispensing any prescription for a Schedule II or Schedule III controlled dangerous substance or a benzodiazepine drug that is a Schedule IV controlled dangerous substance. Under current law, only Schedule II controlled dangerous substances prescribed to treat acute or chronic pain are subject to the mandatory access requirements.

The bill additionally requires the Board of Pharmacy to evaluate any controlled dangerous substance that is newly classified as a Schedule IV or Schedule V controlled dangerous substance to determine: the actual or relative potential for abuse; scientific evidence of its pharmacological effect, if known; the state of current scientific knowledge regarding the drug; its history and current pattern of abuse; the scope, duration, and significance of abuse; what, if any, risk to the public health; and its physic or physiological dependence liability. The Board of Pharmacy may recommend that the Director of the Division of Consumer Affairs in the Department of Law and Public Safety adopt a regulation subjecting the drug to the mandatory prescription monitoring information access requirements. Nothing in the bill will limit the director’s authority to adopt a regulation making any drug subject to the mandatory access requirements, regardless of whether the Board of Pharmacy has recommended it, or limit the director’s authority under current law to expand the Prescription Monitoring Program to include information about prescriptions for drugs that are not controlled dangerous substances.

This bill implements a recommendation included in the September 2017 report issued by the Governor’s Task Force on Drug Abuse Control.