VOLUME 43, ISSUE 21
ISSUE DATE:NOVEMBER 7, 2011
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF PHARMACY
Pre-Proposed New Rule: N.J.A.C. 13:39-4.22
Notice of Pre-Proposal
Remote Processing of Prescriptions
Authorized By: State Board of Pharmacy, Edward G. McGinley, R.Ph, President.
Authority: N.J.S.A. 45:14-47 and 48.
Pre-proposal Number: PPR 2011-002.
Take notice that the State Board of Pharmacy (Board) is considering proposing a new rule to permit pharmacists and pharmacy technicians to perform certain pharmaceutical functions at locations that are not permitted as New Jersey pharmacies. The Board believes that the pre-proposed new rule will provide pharmacies greater flexibility in managing prescription processing operations. The pre-proposed new rule will also help ensure that any prescription processing functions performed remotely, or outside of a permitted pharmacy, are performed by qualified and appropriately trained individuals pursuant to safeguards designed to protect the confidentiality of prescription and patient information.
Comments on the pre-proposed new rule should be sent by January 6, 2012 to:
Lawrence DeMarzo, Deputy Director
Division of Consumer Affairs
P.O. Box 45013
Newark, New Jersey, 07101
Full text of the pre-proposed new rule follows:
13:39-4.22 Remote processing of prescriptions
(a) For purposes of this section, the following words shall have the following meanings, unless the context clearly indicates otherwise:
"Remote location" means a location in New Jersey that is not a New Jersey permitted pharmacy, or a location in another state, territory or possession of the United States, where pharmaceutical functions are performed.
"Remote processing of prescriptions" means the performance of pharmaceutical functions at a location other than a New Jersey permitted pharmacy.
(b) A New Jersey permitted pharmacy may permit a pharmacist at a remote location to perform the following pharmaceutical functions only:
1. Receipt, interpretation and clarification of prescription orders;
2. Data entry of prescription medication information;
3. Prospective drug review;
4. Refill authorizations;
6. Patient counseling;
7. Claims submission; and
8. Claims resolution and adjudication.
(c) A New Jersey permitted pharmacy engaging in the remote processing of prescriptions at a remote location in New Jersey shall ensure that a pharmacist performing pharmaceutical functions at the remote location holds an active New Jersey pharmacist license in good standing. A New Jersey permitted pharmacy engaging in the remote processing of prescriptions at a remote location outside of New Jersey shall ensure that a pharmacist performing pharmaceutical functions at the remote location holds an active pharmacist license or registration in good standing in that jurisdiction, and that the pharmacist is authorized to engage in the remote processing of prescriptions under the pharmacy laws and regulations of that jurisdiction.
(d) A pharmacist performing pharmaceutical functions for a New Jersey permitted pharmacy at a remote location in New Jersey or in another state, territory or possession of the United States shall be an employee of the pharmacy.
(e) A New Jersey permitted pharmacy may permit a New Jersey registered pharmacy technician to perform the pharmaceutical functions set forth in (b) above at a remote location in New Jersey, consistent with the requirements of N.J.A.C. 13:39-6.15. A New Jersey permitted pharmacy engaging in the remote processing of prescriptions at a location outside of New Jersey may permit a pharmacy technician at such location to perform the pharmaceutical functions set forth in (b) above, provided the technician is authorized to perform such functions under the pharmacy laws and regulations of that jurisdiction.
(f) The pharmacist-in-charge shall ensure that all pharmacy technicians engaging in the remote processing of prescriptions have received adequate training relevant to performing pharmaceutical functions at a remote location. All pharmaceutical functions performed by a pharmacy technician at a remote location shall be supervised by a licensed pharmacist.
(g) The pharmacist-in-charge shall ensure that 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 are in place to ensure the confidentiality of all patient information. Security controls shall include at least two factor positive authentication of the authorized user, encryption of all data exchanged between the equipment located at the remote processing site and the remote processing pharmacy, and measures designed to prevent unauthorized storage or transfer of patient information.
(h) 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, PL 104-191.
(i) 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 of N.J.A.C. 13:39-7.6.
(j) The pharmacist-in-charge shall be responsible for all pharmaceutical functions performed in connection with the remote processing of prescriptions.
(k) The remote location shall be considered part of the permitted 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.
(l) No medications shall be stored at, or dispensed from, a remote location.
(m) An out-of-State pharmacy registered with the Board pursuant to N.J.A.C. 13:39-4.20 may engage in the remote processing of prescriptions that are to be shipped, mailed, distributed or delivered into New Jersey, provided that the remote processing of prescriptions is authorized under the pharmacy laws and regulations in the jurisdiction where the out-of-State pharmacy is located, and provided that such functions are performed by licensed or registered pharmacists or pharmacy technicians that have been adequately trained.
(n) A New Jersey permitted pharmacy or a registered out-of-State pharmacy may engage in the remote processing of prescriptions in conjunction with another pharmacy provided the pharmacies are parties to a central prescription handling arrangement for which they have obtained Board approval pursuant to N.J.A.C. 13:39-4.19.