[First Reprint]

ASSEMBLY, No. 1025

STATE OF NEW JERSEY

212th LEGISLATURE

 

PRE-FILED FOR INTRODUCTION IN THE 2006 SESSION

 


 

Sponsored by:

Assemblyman JEFF VAN DREW

District 1 (Cape May, Atlantic and Cumberland)

Assemblywoman NILSA CRUZ-PEREZ

District 5 (Camden and Gloucester)

Assemblywoman PAMELA R. LAMPITT

District 6 (Camden)

 

Co-Sponsored by:

Assemblyman Diegnan, Assemblywoman Greenstein, Assemblymen Conaway, Conners, Manzo, Scalera, Moriarty, Gordon, Mayer, Stack and Assemblywoman Vainieri Huttle

 

 

 

 

SYNOPSIS

     "Pharmacy Quality Improvement and Error Prevention Act."

 

CURRENT VERSION OF TEXT

     As reported by the Assembly Consumer Affairs Committee on January 30, 2006, with amendments.

  


An Act concerning prescription drug-related errors and supplementing chapter 14 of Title 45 of the Revised Statutes.

 

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

 

     1.  This act shall be known and may be cited as the "Pharmacy Quality Improvement and Error Prevention Act."

 

     2.  The Legislature finds and declares that:

     a.  The number of complaints filed with the New Jersey Board of Pharmacy concerning prescription errors has more than doubled in the past eight years;

     b.  According to a 1999 report of the Institute of Medicine of the National Academies, more than 7,000 Americans die each year from medication errors, including those that occur in and out of hospitals, as compared with 6,000 deaths annually from workplace injuries; and

     c.  The essential obligation of government to protect the health and well-being of its citizens dictates the need for immediate action by this State to initiate a systematic effort to reduce the possibility of prescription errors that may have serious adverse consequences for the residents of New Jersey.

 

     3.  As used in this act:

     "Board" means the New Jersey Board of Pharmacy in the Division of Consumer Affairs in the Department of Law and Public Safety.

     "Medication-related error" means a preventable event related to a prescription drug, which adversely affects a person who uses that prescription drug and is potentially attributable, in whole or in part, to the procedures, actions or personnel of a pharmacy or to other persons, health care providers, or entities, including, but not limited to, the ordering, labeling; packaging, nomenclature; compounding; dispensing; furnishing; administration; monitoring, or use of, or the provision of information to a person about, that prescription drug.

     "Pharmacy" means a pharmacy practice site as defined in section 2 of P.L.2003, c.280 (C.45:14-41).

     "Prescription" means a prescription as defined in section 2 of P.L.2003, c.280 (C.45:14-41).

     "Task force" means the New Jersey Task Force on Medication Error Prevention as established pursuant to section 4 of P.L.     , c.    (C.    ) (now pending before the Legislature as this bill).


     4.  There is established the "New Jersey Task Force on Medication Error Prevention."

     a.  The task force shall consist of 1[23] 241 members as follows:

     (1) the Director of the Division of Consumer Affairs, 1the Commissioner of Health and Senior Services,1 one representative of the Board of Pharmacy, one representative of the Board of Medical Examiners, one representative of the Board of Nursing, one representative of the Board of Dentistry, and the Dean of the Ernest Mario School of Pharmacy at Rutgers or their designees, who shall serve ex officio; and

     (2) 17 public members, who shall include:

     (a) two persons appointed upon the recommendation of an organization representing pharmacists;

     (b) two persons appointed upon the recommendation of an organization representing independent pharmacies;

     (c) two persons appointed upon the recommendation of an organization representing chain drug stores;

     (d) two persons representing pharmaceutical manufacturers;

     (e) one person appointed upon the recommendation of an organization that represents physicians;

     (f) one person appointed upon the recommendation of an organization that represents dentists;

     (g) one person appointed upon the recommendation of an organization that represents nurses;

     (h) one person appointed upon the recommendation of an organization that represents hospitals;

     (i) one person that represents managed care carriers;

     (j) two persons who represent the interests of health care consumers, and

     (k) two pharmacists representing mail service pharmacy.

     Of the 17 public members, five shall be appointed by the Governor; six shall be appointed by the President of the Senate; and six shall be appointed by the Speaker of the General Assembly.  The Governor, the President of the Senate, and the Speaker of the General Assembly shall consult with each other on the appointment of the public members.

     b.  Vacancies in the membership of the task force shall be filled in the same manner provided for the original appointments.  The public members of the task force shall serve without compensation but may be reimbursed for traveling and other miscellaneous expenses necessary to perform their duties, within the limits of funds made available to the task force for its purposes.

     c.  (1) The task force shall organize as soon as practicable, but no later than the 30th day after the appointment of its members, and shall select a chairperson and vice-chairperson from among the members. The chairperson shall appoint a secretary who need not be a member of the task force.

     (2) The task force may meet at the call of the chairperson and hold hearings at the times and in the places it may deem appropriate and necessary to fulfill its charge.  The task force shall be entitled to call to its assistance, and avail itself of the services of, the employees of any State, county or municipal department, board, bureau, commission or agency as it may require and as may be available to it for its purposes.

     (3) The Division of Consumer Affairs shall provide staff services to the task force.

     d.  The purpose of the task force shall be to provide guidelines for the New Jersey State Board of Pharmacy to utilize in implementing medication error prevention, pharmacy quality improvement, and consumer education programs on this topic.  The guidelines provided by the task force shall address topics including, but not limited to:

     (1) the type of situations a registered pharmacist should be required to report to the board information based upon which the pharmacist concludes that a medication-related error may have occurred.  In examining this issue, the task force shall consider what constitutes serious or significant harm and the types of medication-related errors which may cause or contribute to such harm;

     (2) information which should be required to be included in a report filed by a registered pharmacist indicating that a medication-related error may have occurred;

     (3) appropriate time frames in which a registered pharmacist should be required to file a required report indicating that a medication-related error may have occurred;

     (4) circumstances which should result in pharmacy personnel being required to satisfactorily complete education courses aimed at reducing medication-related error.  In developing this standard, the task force shall consider the merits of requiring personnel whose actions, inactions, or procedures seem to be associated with or contribute to repeated instances of serious medication-related errors to satisfactorily complete such courses; and

     (5) elements which should be included in required education courses for pharmacy personnel, and an acceptable time frame in which they should be completed.

     e.  The task force shall present a report of its findings and recommendations to the Governor and the Legislature no later than 12 months after the date of its initial meeting, and shall be authorized to periodically issue a summary of its deliberations prior to the presentation of its report.

 

     5.  A pharmacy doing business in this State shall establish a continuous quality improvement program no later than 6 months after the date of the rules and regulations required pursuant to section 10 of P.L.     , c.     (C.    ) (now pending before the Legislature as this bill) are adopted by the New Jersey Board of Pharmacy.

     a.  The program shall be designed to document, review and assess medication-related errors in order that the pharmacy may take appropriate action if reasonably necessary to prevent their recurrence.

     b.  The program shall also include measures that are designed to minimize the incidence of medication-related errors if reasonably necessary, including, but not limited to, compliance with the following requirements:

     (1) pharmacy personnel shall verify the accuracy of each prescription before it is dispensed;

     (2) the pharmacy shall adopt procedures for the receipt of electronically transmitted prescriptions as permitted pursuant to pharmacy laws and regulations; and

     (3) the pharmacy shall prominently display, for easily accessible reference by pharmacy personnel, the information provided by the board pursuant to section 6 of P.L.     , c.     (C.    ) (now pending before the Legislature as this bill).

     c.  Records, meetings, determinations, and findings that are generated for, and maintained as a component of, a pharmacy's quality improvement program concerning medication-related errors, pursuant to subsection a. of this section, shall be considered privileged and confidential peer review documents and matters, and shall not be subject to discovery, use, subpoena, or admissible as evidence in any administrative, disciplinary, arbitration, civil or other proceeding; except that the provisions of this subsection shall not be construed to:

     (1) prevent review of a pharmacy's quality improvement program policies and procedures and any records maintained by the pharmacy in connection with the program by the government agency with jurisdiction over the pharmacy as necessary to determine compliance with this section; except that any such review shall not be considered a waiver of any privileges or protections provided under these provisions;

     (2) prohibit a patient from accessing his own prescription drug records; or

     (3) affect the discoverability of any records that are not solely generated for, and maintained as a component of, a pharmacy's quality improvement program concerning medication-related errors, pursuant to subsection a. of this section.

 

     6.  The board shall provide for the periodic distribution, to all licensed pharmacies in the State, of written information about prescription drugs that have been identified by the board, the federal Food and Drug Administration, or any other public or private entity as determined appropriate by the board, as having names that look or sound alike to the extent that they are difficult to differentiate without careful examination.  This information shall be identified by the board as an "ALERT TO PHARMACIES" and formatted in a manner that clearly displays the relevant pairs of prescription drugs, such that pharmacy personnel may display this information for easily accessible reference in the pharmacy.

 

     7.  a.  The board shall prepare an informational brochure that is designed to educate and inform consumers about their role in medication safety and error prevention.  The brochure shall, at a minimum, explain:

     (1) the patient's role in preventing medication-related errors;

     (2) actions that a patient may take to prevent a medication-related error;

     (3) what a patient can do if the patient suspects a medication-related error; and

     (4) the procedure by which a patient may report a medication-related error to the board and what actions the board will take in response to such a report.

     b.  The board shall post the brochure on its Internet web site and make a supply of the brochures available to all pharmacies registered with the board for distribution to the public.

 

     8.  The board shall conduct a study of the feasibility of requiring by a certain date, as determined by the board, that every prescription written in this State be transmitted to a pharmacy by facsimile, telephone or electronically or in typewritten form, and shall determine the most effective means of implementing such a requirement.  The board shall report its findings and recommendations to the Governor and Legislature no later than one year after the effective date of this act.

 

     9.  a.  A registered pharmacist shall file a report with the board whenever required to do so pursuant to the rules and regulations adopted by the New Jersey Board of Pharmacy pursuant to section 10 of P.L.     , c.     (C.    ) (now pending before the Legislature as this bill).

     b.  A registered pharmacist who, without good cause as determined by the board, fails to report information to the board, as required pursuant to subsection a. of this section, is subject to P.L.1978, c.73 (C.45:1-14 et seq.).

     c.  A registered pharmacist who reports information to the board relating to a medication-related error, as required pursuant to subsection a. of this section, shall be immune from liability in a civil action for any injury or damages in connection with that medication-related error.

 

     10.  The Board of Pharmacy shall adopt, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), rules and regulations necessary to implement this act.  These rules and regulations shall be adopted no later than the first day of the seventh month following the presentation of the report by the task force established pursuant to section 4 of P.L.     , c.     (C.    ) (now pending before the Legislature as this bill), and shall be based on the guidelines developed and provided by that task force.  The rules and regulations shall include, but not be limited to:

     a.  an outline of when a registered pharmacist shall file a report with the board regarding medication-related errors;

     b.  guidelines for pharmacies' quality improvement programs; and

     c.  requirements for certain pharmacy personnel to satisfactorily complete education courses aimed at reducing medication-related error.

 

     11.  This act shall take effect immediately, except that sections 6 and 7 of this act shall take effect on the first day of the seventh month following enactment and section 9 of this act shall take effect on the first day of the fourth month following the adoption by the Board of Pharmacy of the rules and regulations required pursuant to section 10 of P.L.     , c.     (C.    ) (now pending before the Legislature as this bill), but the Board of Pharmacy may take such anticipatory administrative action in advance as shall be necessary for the timely implementation of this act.