N.J. Admin. Code § 13:39-7.19

Current through Register Vol. 56, No. 21, November 4, 2024

Section 13:39-7.19 - Patient profile record system

(a) An electronic patient profile system shall be maintained by all pharmacies for persons for whom prescriptions are dispensed. The Patient Profile Record System (PPRS) shall be devised, so as to enable the immediate retrieval of current clinical information necessary to enable the dispensing pharmacist to identify previously dispensed medication and patient specific information at the time a prescription is presented for dispensing.

(b) The following information shall be recorded in the PPRS:

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

2. The address and telephone number of the patient;

3. Indication of the patient's age, birth date or age group (infant, child, adult) and gender;

4. The original or refill date the medication is dispensed;

5. The number or designation identifying the prescription;

6. The practitioner's name;

7. The name, strength and quantity of the drug dispensed;

8. Pharmacist's comments relevant to the patient's drug therapy; and

9. Any allergies and idiosyncrasies of the patient and any medical conditions that may relate to drug utilization, as communicated by the patient or the patient's representative.

i. If there are no patient allergies, idiosyncrasies or medical conditions that may relate to drug utilization, such information shall be documented in the patient profile record system.

(c) The pharmacist shall use professional judgment to review and monitor the patient profile, determine if there should be any adjustment in the original patient information and so indicate the appropriate change in the patient profile record.

(d) All prescription patients who patronize a pharmacy shall have a profile record as specified by this section, and the pharmacist shall inquire as to whether other prescription drugs are being concomitantly utilized in order to establish a current drug history for the patient.

(e) A patient profile record shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for a period of not less than five years from the date of the last entry in the profile record. In using an electronic data processing system, the system shall have the capability of producing retrievable and readable documents of all original and refilled prescription data for a period of not less than five years, including the number of refills authorized by the practitioner. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of record information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.

(f) If the pharmacy uses an electronic data processing system, an auxiliary recordkeeping system shall be established when the electronic data processing system is inoperative for any reason. When the electronic data processing system is restored to operation, the patient profile information and number of refills authorized during the time the electronic system was inoperative shall be entered into the electronic data processing system within 72 hours.

(g) If an electronic data processing system is used, the system shall provide adequate safeguards against manipulation and alteration of records and to protect confidentiality of the information contained in the data bank.

(h) The holder of the pharmacy permit shall make arrangements with the supplier of data processing services or materials to ensure that the pharmacy will continue to have adequate and complete prescription and dispensing records if the relationship with such supplier terminates for any reason.

N.J. Admin. Code § 13:39-7.19

Amended by 49 N.J.R. 3761(a), effective 12/4/2017