N.J. Admin. Code § 13:39-9.19

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:39-9.19 - Records and reports

(a) Records of the pharmaceutical services of the provider pharmacy for the facility shall be the responsibility of the pharmacist-in-charge. A pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or extern(s) performing the component functions of intake, processing, fulfillment, and dispensing of prescriptions as defined in N.J.A.C. 13:39-4.19, which are required to be performed by a pharmacist, pharmacy technician, intern, or extern pursuant to the requirements of this chapter. The collection of demographic information for the patient profile as provided for in N.J.A.C. 13:39-6.15(a)2 i is not required to be, but may be, recorded in the audit trail. All entries to the audit trail made by a pharmacy technician, intern, or extern shall be reviewed and approved by the pharmacist. The pharmacist shall be responsible for the accuracy and appropriateness of the filled prescription. When more than one pharmacist is involved in the component functions of prescription handling, each pharmacist shall be responsible for the accuracy and appropriateness of each component function he or she performed or reviewed and approved, and his or her unique and secure user identifier(s) shall be recorded in an audit trail. Audit trail documentation shall be generated at the time the component function(s) is performed. All audit trail and medication order information 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. The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of 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.

(b) The pharmacy shall maintain a patient profile record for each patient receiving drug therapy in accordance with N.J.A.C. 13:39-7.19 and as follows:

1. The profile records for inpatients shall contain: the date of each entry; the name; sex; age or birthdate; location of the patient; the drug name, dose, route of administration and quantity dispensed; the reported diagnosis, allergies and chronic condition(s) of the patient.

2. All notations made on the inpatients' profile records by pharmacy technicians, interns and externs shall be verified and countersigned, either manually or electronically, by the supervising pharmacist.

3. The inpatient profile record shall be filed and stored for five years following patient discharge. The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day.

(c) All outpatient prescriptions dispensed and outpatient profile records in the institutional pharmacy shall conform to the requirements set forth in N.J.A.C. 13:39-7.6.

(d) Records for receipt, use and final disposition of controlled dangerous substances shall be maintained by the institutional pharmacy in compliance with the requirements of Federal and State controlled dangerous substances laws and regulations. Nursing administration and audit records for controlled dangerous substances shall be available for review by the pharmacy.

(e) Records of the receipt, dispensing and disposal of investigational drugs shall be maintained by the institutional pharmacy in compliance with Federal and State laws and regulations.

(f) The pharmacist-in-charge shall be responsible for maintaining a system by which all reported adverse drug reactions are recorded and reviewed by the Pharmacy and Therapeutics Committee, where applicable, and are submitted to all appropriate State and local agencies consistent with State and local laws and regulations.

N.J. Admin. Code § 13:39-9.19

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