ASSEMBLY COMMITTEE SUBSTITUTE FOR

 

ASSEMBLY, No. 2797

 

STATE OF NEW JERSEY

 

211th LEGISLATURE

 

ADOPTED JANUARY 10, 2005

 

 

Sponsored by:

Assemblyman HERBERT CONAWAY, JR.

District 7 (Burlington and Camden)

Assemblyman ROBERT J. SMITH

District 4 (Camden and Gloucester)

 

 

 

 

SYNOPSIS

      Establishes Prescription Monitoring Program in Division of Consumer Affairs.

 

CURRENT VERSION OF TEXT

      Substitute as adopted by the Assembly Health and Human Services Committee.

 

 

 

 

 


An Act establishing a prescription monitoring program and supplementing Title 45 of the Revised Statutes.

 

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

 

      1. As used in this act:

      "Controlled dangerous substance" means any substance that is listed in Schedules II, III, IV and V of the schedules provided under the "New Jersey Controlled Dangerous Substances Act," P.L.1970, c.226 (C.24:21-1 et seq.).

      "Director" means the Director of the Division of Consumer Affairs in the Department of Law and Public Safety.

      "Division" means the Division of Consumer Affairs in the Department of Law and Public Safety.

      "Practitioner" means an individual currently licensed, registered or otherwise authorized by the State to prescribe drugs in the course of professional practice.

      "Program" means the Prescription Monitoring Program established under section 2 of this act.

 

      2. a. There is established in the Division of Consumer Affairs in the Department of Law and Public Safety a Prescription Monitoring Program, which shall consist of an electronic system for monitoring controlled dangerous substances that are dispensed in the State by a pharmacist in an outpatient setting.  

      b. Each pharmacy permit holder shall submit to the division, by electronic means, at such intervals as are specified by the director, information about each prescription for a controlled dangerous substance dispensed by the pharmacy that includes:

      (1) The surname and the first name of the patient for whom the medication is intended;

      (2) The street address and telephone number of the patient;

      (3) The original or refill date that the medication is dispensed and the initials of the dispensing pharmacist, if those initials and date are not recorded on the original prescription or in any other record approved by the New Jersey State Board of Pharmacy;

      (4) The number or designation identifying the prescription and the National Drug Code of the drug dispensed;

      (5) The prescribing practitioner's name, license number and Drug Enforcement Administration registration number;

      (6) The name, strength and quantity of the drug dispensed;

      (7) Any additional comments relevant to the patient's drug use, which may include any failure to accept the pharmacist's offer to counsel;

      (8) the date that the prescription was issued by the practitioner; and

      (9) such other information as the director determines necessary.

      The pharmacy permit holder shall submit the information to the division no less than 30 days after dispensing the prescription, or according to a schedule to be determined by the director.

      c. The division may grant a waiver of electronic submission to any pharmacy permit holder for good cause, including financial hardship, as determined by the director. The waiver shall state the format in which the pharmacy permit holder shall submit the required information.

      d. The requirements of this act shall not apply to the dispensing of controlled dangerous substances to inpatients in a hospital or long-term care facility or at the time of discharge from the hospital or facility.

 

      3. a. The division shall maintain procedures to ensure that the privacy and confidentiality of patients and patient information collected, recorded, transmitted and maintained is not disclosed, except as permitted in subsections c. and d. of this section.

      b. The prescription monitoring information submitted to the division shall be confidential and not be subject to public disclosure under P.L.1963, c.73 (C.47:1A-1 et seq.), or P.L.2001, c.404 (C.47:1A-5 et al.).

      c. The division shall review the prescription monitoring information provided by a pharmacy permit holder pursuant to this act. If there is reasonable cause to believe that a violation of law or regulations, or a breach of professional standards, may have occurred, the division shall notify the appropriate law enforcement agency and professional licensing board, and provide prescription monitoring information required for an investigation.

      d. The division may provide prescription monitoring information to the following persons:

      (1) a practitioner authorized to prescribe, dispense or administer controlled dangerous substances who certifies that the request is for the purpose of providing health care to a current patient of the practitioner. Nothing in this act shall be construed to require or obligate a practitioner to access or check the prescription monitoring information prior to prescribing, dispensing or administering medications or as part of the practitioner's professional practice;

      (2) a pharmacist authorized to dispense controlled dangerous substances who certifies that the request is for the purpose of providing health care to a current patient. Nothing in this act shall be construed to require or obligate a pharmacist to access or check the prescription monitoring information prior to dispensing medications or as part of the pharmacist's professional practice;

      (3) a designated representative of the State Board of Medical Examiners, New Jersey State Board of Dentistry, New Jersey Board of Nursing, New Jersey State Board of Pharmacy or State Board of Veterinary Medical Examiners, as applicable, who certifies that he is engaged in a bona fide specific investigation of a designated practitioner whose professional practice was or is regulated by that board;

      (4) a State, federal or municipal law enforcement officer who is acting pursuant to a court order and certifies that the officer is engaged in a bona fide specific investigation of a designated practitioner or patient;

      (5) a designated representative of a State Medicaid program who certifies that he is engaged in a bona fide investigation of a designated practitioner or patient;

      (6) a properly convened grand jury pursuant to a subpoena properly issued for the records; and

      (7) authorized personnel of the division or vendor or contractor responsible for establishing and maintaining the program.

      e. The director may provide nonidentifying prescription drug monitoring information to public or private entities for statistical, research or educational purposes.

 

      4. The division shall be immune from civil liability arising from inaccuracy of any of the information submitted to it pursuant to this act.

 

      5. a. A pharmacy permit holder who (1) knowingly fails to report data as required by this act, or (2) discloses data to a person or entity in violation of section 3 of this act shall be subject to disciplinary action pursuant to section 8 of P.L.1978, c.73 (C.45:1-21) and to a civil penalty in an amount not to exceed $1,000.

      b. A person or other entity other than a pharmacy permit holder who knowingly discloses data to a person or entity in violation of section 3 of this act shall be subject to a civil penalty in an amount not to exceed $10,000.

      c. A penalty imposed under this section shall be collected by the director pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.).

 

      6. The division may contract with one or more vendors to establish and maintain the Prescription Monitoring Program pursuant to guidelines established by the director.

 

      7. There is created in the Department of the Treasury a nonlapsing fund to be known as the "Prescription Drug Monitoring Program Fund." The fund shall be the depository for penalties collected pursuant to section 5 of this act. Monies deposited into the fund and the interest earned thereon shall be used for the operation and administration of the Prescription Monitoring Program established pursuant to this act.

 

      8. Pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), the Director of the Division of Consumer Affairs shall adopt rules and regulations necessary to implement the provisions of this act.

 

      9. This act shall take effect 18 months after enactment, but the Director of the Division of Consumer Affairs may take such anticipatory administrative action in advance as shall be necessary for the implementation of the act.