51 N.J.R. 923(a)
VOLUME 51, ISSUE 12, JUNE 17, 2019
51 N.J.R. 923(a)
NJ - New Jersey Register > 2019 > JUNE > JUNE 17, 2019 > RULE PROPOSALS > LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS
Interested Persons Statement
Interested persons may submit comments, information or arguments concerning any of the rule proposals in this issue until the date indicated in the proposal. Submissions and any inquiries about submissions should be addressed to the agency officer specified for a particular proposal.
The required minimum period for comment concerning a proposal is 30 days. A proposing agency may extend the 30-day comment period to accommodate public hearings or to elicit greater public response to a proposed new rule or amendment. Most notices of proposal include a 60-day comment period, in order to qualify the notice for an exception to the rulemaking calendar requirements of N.J.S.A. 52:14B-3. An extended comment deadline will be noted in the heading of a proposal or appear in a subsequent notice in the Register.
At the close of the period for comments, the proposing agency may thereafter adopt a proposal, without change, or with changes not in violation of the rulemaking procedures at N.J.A.C. 1:30-6.3. The adoption becomes effective upon publication in the Register of a notice of adoption, unless otherwise indicated in the adoption notice. Promulgation in the New Jersey Register establishes a new or amended rule as an official part of the New Jersey Administrative Code.
LAW AND PUBLIC SAFETY > DIVISION OF CONSUMER AFFAIRS > STATE BOARD OF NURSING
Administrative Code Citation
Proposed New Rule: N.J.A.C. 13:37-7.9B
Electronically Transmitted Prescriptions
Authorized By: State Board of Nursing, Joanne Leone, and Executive Director.
Authority: N.J.S.A. 45:11-24.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2019-091.
Submit written comments by August 16, 2019, to:
Joanne Leone, Executive Director
State Board of Nursing
PO Box 45010
Newark, New Jersey 07101
or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.
The agency proposal follows:
The Board of Nursing (Board) is proposing a new rule that regulates the transmission of electronic prescriptions by advanced practice nurses to licensed pharmacies. Proposed new N.J.A.C. 13:37-7.9B will help to protect the health, safety, and welfare of New Jersey consumers by ensuring that proper procedures are followed in the transmission of such prescriptions. In addition, the Board believes that the proposed new rule will benefit consumers by promoting the filling of prescriptions in a more efficient and timely manner. Moreover, the Board believes that the increased use of electronic prescriptions may result in a decrease in medication errors that are caused by misread or illegible prescriptions.
The proposed new rule authorizes an advanced practice nurse, or an authorized agent, to transmit an electronic prescription to a pharmacy. Such a prescription must contain the information required pursuant to N.J.A.C. 13:37-7.9(d), except that an electronic prescription need not contain a handwritten original signature. The electronic system used to transmit electronic prescriptions must have security safeguards to prevent unauthorized access, modification, or manipulation of prescriptions. The proposed new rule permits an advanced practice nurse to authorize an agent to transmit an electronic prescription. An advanced practice nurse is required to provide verbal verification of an electronic prescription to a pharmacy upon request.
The proposed new rule imposes additional requirements when an advanced practice nurse transmits electronic prescriptions for Schedule II, III, IV, or V controlled substances. When an electronic prescription for a Schedule II controlled substance is transmitted, a pharmacist will only dispense the substance upon the presentation of an original signed prescription. When an electronic prescription for a Schedule III, IV, or V controlled substance is transmitted, a pharmacist will only dispense the substance upon the presentation of an original signed prescription, an oral prescription, or a facsimile prescription. If it is permitted by Federal law, an electronic prescription can serve as an original signed prescription. In such a situation, an advanced practice nurse shall not provide a patient with a signed, written prescription. The proposed new rule prohibits an advanced practice nurse from entering into an agreement that requires the advanced practice nurse to transmit electronic prescriptions to a particular pharmacy.
The Board has determined that the comment period for this notice of proposal shall be 60 days; therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this notice is excepted from the rulemaking calendar requirement.
The Board believes that the rulemaking will have a positive impact upon advanced practice nurses, certified by the Board, to the extent that the proposed new rule will provide advanced practice nurses with direction and guidance as to how electronic prescriptions must be transmitted. The Board also believes that the proposed new rule will have a positive impact upon consumers, to the extent that the increased use of electronic prescriptions may increase the efficiency and accuracy with which prescription medications are prepared and dispensed, and may also lead to a decrease in the number of medication errors which occur as a result of illegible prescriptions.
The Board believes that the rulemaking may have an economic impact upon advanced practice nurses, certified by the Board, who wish to transmit electronic prescriptions, to the extent that such advanced practice nurses will have to purchase electronic prescription computer software. The costs of complying with the proposed new rule will vary depending on whether an advanced practice nurse chooses to transmit such prescriptions, and on the type of software an advanced practice nurse chooses to purchase.
Federal Standards Statement
A Federal standards analysis is not required because the proposed new rule is governed by N.J.S.A. 45:11-24 et seq., and is not subject to any Federal standards or requirements. The Board notes, however, that the proposed requirements for electronic transmission of prescriptions for controlled substances set forth at N.J.A.C. 13:37-7.9B(g) and (h) are consistent with the Federal Drug Enforcement Agency (DEA) standards articulated at 21 CFR 1306.11 and 1306.21.
The Board does not believe that the proposed new rule will increase or decrease the number of jobs in New Jersey.
Agriculture Industry Impact
The Board does not believe that the proposed new rule will have any impact on the agriculture industry of this State.
[page=924] Regulatory Flexibility Analysis
Since advanced practice nurses are individually certified by the Board under the Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., they may be considered "small businesses" for the purposes of the Act.
The costs imposed on small businesses are the same as those imposed on all businesses, as set forth in the Economic Impact statement above. The Board does not believe that advanced practice nurses will need to employ any professional services to comply with the requirements of the proposed new rule. The proposed new rule imposes no reporting or recordkeeping requirements but imposes compliance requirements, as detailed in the Summary above.
As the proposed new rule promotes the health, safety, and welfare of consumers in obtaining prescription medications, the Board believes that the proposed new rule must be uniformly applied. No differing compliance requirements are imposed upon any advance practice nurse based upon the size of a business.
Housing Affordability Impact Analysis
The proposed new rule will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the proposed new rule would evoke a change in the average costs associated with housing because the proposed new rule concerns electronic prescriptions.
Smart Growth Development Impact Analysis
The proposed new rule will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed new rule would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed new rule concerns electronic prescriptions.
Racial and Ethnic Community Criminal Justice and Public Safety Impact
The Board has evaluated this rulemaking and determined that it will not have an impact on pretrial detention, sentencing, probation, or parole policies concerning adults and juveniles in the State. Accordingly, no further analysis is required.
Full text of the proposed new rule follows (additions indicated in boldface thus):
SUBCHAPTER 7. CERTIFICATION OF ADVANCED PRACTICE NURSES
13:37-7.9B Electronically transmitted prescriptions
(a) An advanced practice nurse may transmit, or have an authorized agent transmit, an electronic prescription to a pharmacy that has been approved by a patient, a patient's guardian, or a patient's authorized representative, consistent with the requirements of this section. For purposes of this section, "electronic prescription" means a prescription that is transmitted by a computer or other electronic data processing device in a secure manner, including computer-to-computer and computer-to-facsimile transmissions.
(b) An advanced practice nurse shall comply with all requirements set forth in N.J.A.C. 13:37-7.9 and shall ensure that all information required to be included on a written prescription pursuant to N.J.A.C. 13:37-7.9(d) is provided in each electronic prescription, except that a handwritten original signature shall not be required for the prescription.
(c) An advanced practice nurse's electronic signature, or other secure method of validation, shall be provided with the electronic prescription.
(d) To maintain confidentiality of electronic prescriptions, the advanced practice nurse shall ensure that the electronic system used to transmit the electronic prescription has adequate security and system safeguards designed to prevent and detect unauthorized access, modification, or manipulation of such records, and shall include, at a minimum, electronic encryption.
(e) An advanced practice nurse may authorize an agent to electronically transmit a prescription, provided that the full name and title of the transmitting agent is included on the transmission, and provided that the advanced practice nurse's agent does not sign the electronic prescription.
(f) An advanced practice nurse shall provide verbal verification of an electronic prescription upon request of the pharmacy when the pharmacist has a question regarding the authenticity, accuracy, or appropriateness of the prescription. An advanced practice nurse's authorized agent may provide verbal verification of the electronic prescription to the pharmacy when the pharmacist has a question regarding the authenticity or legibility of the prescription.
(g) An advanced practice nurse or the advanced practice nurse's authorized agent may transmit an electronic prescription to a pharmacy for a Schedule II controlled substance, provided that the original signed prescription is presented to the pharmacist prior to the dispensing of the controlled substance. If permitted by Federal law, and in accordance with Federal requirements, the electronic prescription shall serve as the original signed prescription and the advanced practice nurse shall not provide the patient, the patient's guardian, or the patient's authorized representative with a signed, written prescription.
(h) An advanced practice nurse or the advanced practice nurse's authorized agent may transmit an electronic prescription to a pharmacy for a Schedule III, IV, or V controlled substance, provided that the original signed prescription for presentation at the pharmacy, an oral prescription, or a facsimile prescription is provided. If permitted by Federal law, and in accordance with Federal requirements, the electronic prescription shall serve as the original signed prescription and the advanced practice nurse shall not provide the patient, the patient's guardian, or the patient's authorized representative with a signed, written prescription.
(i) An advanced practice nurse shall not enter into any agreement with a pharmacy that requires that electronic prescriptions be transmitted to a particular pharmacy or in any way denies a patient the right to have his or her prescription transmitted electronically to a pharmacy of the patient's choice.
In order to ensure your comments are received, please send your comments concerning any rule proposals
via email to DCAProposal@dca.lps.state.nj.us.
Please include the following in your email:
Email Subject Line: Rule Proposal Subject
Email Body: Comments to the Rule Proposal, Name, Affiliation
and Contact Information (email address and telephone number)