N.J. Admin. Code § 13:39-4A.2

Current through Register Vol. 56, No. 11, June 3, 2024

Section 13:39-4A.2 - Remote processing of prescriptions by a New Jersey pharmacy

(a) A pharmacy may engage in the remote processing of prescriptions, provided that the pharmacy complies with the requirements of this subchapter.

(b) A pharmacy that engages in the remote processing of prescriptions shall notify the Board that it is engaging in the remote processing of prescriptions and shall provide the name of the pharmacist-in-charge who shall be responsible for ensuring and attesting to compliance with the requirements of this subchapter. Such notification shall be made on a form supplied by the Board.

(c) As part of the permit renewal process pursuant to N.J.A.C. 13:39-4.2, a pharmacy engaging in the remote processing of prescriptions, on an annual basis, shall have the permit holder and pharmacist-in-charge attest to compliance with the provisions of this subchapter.

(d) A pharmacy using remote processing of prescriptions shall ensure that:

1. A pharmacist performing pharmaceutical functions at the remote location holds an active New Jersey pharmacist license in good standing;

2. A pharmacy technician performing pharmaceutical functions at the remote location holds an active New Jersey pharmacy technician registration in good standing; and

3. All pharmaceutical functions performed by a pharmacy technician at a remote location are reviewed and approved by a licensed pharmacist.

(e) A pharmacist or pharmacy technician performing pharmaceutical functions for a pharmacy at a remote location shall be an employee of the pharmacy.

(f) A pharmacy engaging in remote processing of prescriptions shall have the following:

1. A written policy and procedures manual maintained pursuant to this section;

2. A certification by the pharmacist-in-charge that all pharmacy technicians performing pharmaceutical functions at a remote location are registered with the Board pursuant to N.J.A.C. 13:39-6.6;

3. The address of the remote location(s) and a description of the work environment consistent with the requirements at (l) below;

4. The security controls to ensure the confidentiality of all patient information consistent with the requirements at (m) below;

5. The names and license or registration numbers of all personnel performing pharmaceutical functions at the remote location(s); and

6. A certification from each person performing pharmaceutical functions at the remote location(s) that the training described at (i)2 and 3 below has been completed.

(g) A pharmacy may allow a pharmacist at a remote location to perform only the following pharmaceutical functions using technology consistent with (k) below:

1. Receipt, interpretation, and clarification of prescription orders received from a prescriber.

i. Prescriptions shall only be in electronic format subject to the security requirements set forth at (k) below. Prescriptions or other health care information shall not be utilized, maintained, or stored in hard copy format at the remote location;

2. Data entry of prescription medication information;

3. Prospective drug utilization review; 4. Refill authorizations;

5. Product verification provided that there is compliance with the restrictions set forth at (p) below;

6. Interventions;

7. Patient counseling;

8. Claims submission; and

9. Claims resolution and adjudication.

(h) A pharmacy may allow a registered pharmacy technician to perform only the following pharmaceutical functions at a remote location using technology consistent with (k) below:

1. Data entry of prescription medication information;

2. Refill authorizations consistent with the requirements at N.J.A.C. 13:39-6.15(a)7;

3. Claims submission; and

4. Claims resolution and adjudication.

(i) The pharmacist-in-charge shall be responsible for all pharmaceutical functions performed in connection with the remote processing of prescriptions. The pharmacist-in-charge shall be responsible, at a minimum, for ensuring that:

1. No medications are stored at, or dispensed from, a remote location;

2. Prior to performing any services in connection with remote processing, all pharmacists and pharmacy technicians engaged in the remote processing of prescriptions have received adequate training relevant to performing pharmaceutical functions at a remote location;

3. Prior to performing any services in connection with remote processing, all pharmacists and pharmacy technicians are trained in the pharmacy's policy and procedures manual with regard to remote processing of prescriptions;

4. All pharmaceutical functions performed by a pharmacy technician at a remote location are reviewed and approved by a New Jersey licensed pharmacist;

5. The pharmacist or pharmacy technician performing pharmaceutical functions at a remote location has access to the pharmacy's electronic prescription files and that adequate security controls as described at (k) below are in place to ensure the confidentiality of all patient information; and

6. There is a policy and procedures manual with regard to the remote processing of prescriptions that meets the requirements at (j) below.

(j) A pharmacy engaging in the remote processing of prescriptions shall operate according to the pharmacy's written policy and procedures manual.

1. The policy and procedures manual shall include, at a minimum, policies and procedures governing the following:

i. Security controls, including measures to ensure that patient information cannot be captured, copied, downloaded, printed, reproduced, retained, or stored at a remote location;

ii. Work environment for the remote location;

iii. Responsibilities of the pharmacist-in-charge;

iv. Reporting to the Board within seven days of the violations of (m) below and any incidents of other compliance issues with this subchapter that negatively impact patient safety;

v. Methods to ensure that a New Jersey licensed pharmacist reviews and approves all pharmaceutical functions performed by a pharmacy technician at a remote location;

vi. Methods to ensure that access to the records of medications and other medical information of the patients maintained by the pharmacy is limited to New Jersey licensed pharmacists or registered pharmacy technicians approved to have access to the records, for the purpose of complying with N.J.A.C. 13:39-7.19;

vii. Criteria for selecting employees to engage in the remote processing of prescriptions; and

viii. Training of all pharmacists and pharmacy technicians engaging in the remote processing of prescriptions.

2. The policy and procedures manual shall set forth methods that shall ensure retention of each amendment, addition, deletion, or other change to the policies and procedures of operation for at least two years after the change is made. Each change shall be signed or initialed by the pharmacist-in-charge and shall include the date on which the pharmacist-in-charge approved the change.

3. The policy and procedures manual shall be reviewed, at least annually, and updated, if necessary.

4. A copy of the written policy and procedures manual adopted pursuant to this section shall be available and immediately accessible at the pharmacy and each remote location. Upon request, the pharmacy shall provide to the Board a copy of the written policy and procedures manual for inspection and review.

(k) Security controls to ensure the confidentiality of all patient information shall include at least a two-factor positive authentication of the authorized user, encryption of all data exchanged between the equipment located at the remote location and the pharmacy, and measures designed to prevent unauthorized storage or transfer of patient information. The security controls must include measures designed to ensure that patient information cannot be captured, copied, downloaded, printed, reproduced, retained, or stored at a remote location.

(l) Remote processing of prescriptions shall be conducted in a work environment that is conducive to providing quality patient treatment decisions, private counseling, or other pharmaceutical functions permissible pursuant to this section. Individuals who engage in the remote processing of prescriptions out of a home environment shall perform the work in a designated space and, when performing this work, access to the space shall be limited and not actively used as their primary living, household, or family space. This space shall be open and accessible for Board inspection. When not in use, process-related documentation or materials and work equipment shall be properly secured.

(m) All pharmacists and pharmacy technicians participating in the remote processing of prescriptions shall ensure the confidentiality of patient information in compliance with all Federal and State laws, rules, and regulations, including the Federal Health Insurance Portability and Accountability Act of 1996, P.L. 104-191.

(n) A pharmacy engaging in the remote processing of prescriptions shall maintain an audit trail that records and documents all pharmaceutical functions performed by a pharmacist or pharmacy technician at a remote location, consistent with the requirements at N.J.A.C. 13:39-7.6.

(o) The remote location shall be considered part of the pharmacy. The remote location and any equipment and/or devices used in connection with the remote processing of prescriptions shall be subject to Board inspection.

(p) No medications shall be stored at, or dispensed from, a remote location.

N.J. Admin. Code § 13:39-4A.2

Adopted by 55 N.J.R. 954(b), effective 5/1/2023