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NEW JERSEY REGISTER
VOLUME 34, NUMBER 17
TUESDAY, SEPTEMBER 3, 2002
RULE PROPOSAL
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF PHARMACY
PRESCRIPTIONS AND MEDICATION ORDERS TRANSMITTED BY TECHNOLOGICAL DEVICES IN AN
INSTITUTION; PRESCRIPTIONS TRANSMITTED BY FACSIMILE; ELECTRONICALLY TRANSMITTED
PRESCRIPTIONS

Proposed Amendment: N.J.A.C. 13:39-5.8

Proposed New Rules: N.J.A.C. 13:39-5.8A and 5.8B

Authorized By: State Board of Pharmacy, Debora Whipple, Executive Director.

Authority: N.J.S.A. 45:14-1 et seq. and 45:1-15.1.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2002-310.

Submit comments by November 2, 2002 to:

Debora Whipple, Executive Director

State Board of Pharmacy

124 Halsey Street

PO Box 45013

Newark, New Jersey 07101

The agency proposal follows:

Summary

Pursuant to its general rulemaking authority set forth at N.J.S.A. 45:14-1 et seq. and 45:1-15.1, the State Board of Pharmacy (the Board) is proposing new rules concerning the filling of prescriptions transmitted by facsimile or by electronic device. The Board is proposing that existing rule N.J.A.C. 13:39- 5.8, which sets forth requirements for prescriptions and medication orders transmitted by technological devices, be amended so that the existing rule, once amended, will apply only to institutions, such as healthcare facilities. The Board notes that the proposed new rules do not encompass procedures for filling facsimile and electronic medication orders in health care facilities but the Board will be proposing separate rules for the filling of medication orders transmitted by facsimile and/or electronic means to such facilities in the future. Until that time when rules are in place to address facsimile and electronic medication orders in healthcare facilities, the proposed amended rule will continue to address the practice. The Board believes that separate rules regarding facsimile and electronic prescriptions for retail pharmacy and health care facility settings are necessary so as to ensure that the Board's rules are responsive to the different needs of pharmacists practicing in these diverse settings.

The Board believes that proposed new rule N.J.A.C. 13:39-5.8A, which sets forth requirements for prescriptions transmitted by facsimile, and N.J.A.C. 13:39-5.8B, which sets forth requirements for prescriptions transmitted electronically, will help to protect the health, safety and welfare of New Jersey consumers by ensuring that proper procedures are followed in the filling of prescriptions received electronically or by facsimile. In addition, the Board believes that the proposed new rules 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 facsimile and electronic prescriptions may result in a decrease in medication errors that are caused by misread or illegible prescriptions.

Proposed new rules N.J.A.C. 13:39-5.8A and 5.8B authorize pharmacists to dispense medications pursuant to facsimile and electronic prescriptions. For clarification purposes, N.J.A.C. 13:39-5.8A(a) and 5.8B(a) provide definitions for the terms "facsimile prescription" and "electronic prescription." To protect against diversion of prescription medications, N.J.A.C. 13:39-5.8A(b) and 5.8B(b) prohibit pharmacists from filling facsimile or electronic prescriptions transmitted by anyone other than an authorized prescriber or the prescriber's authorized agent. If an electronic prescription is transmitted by an authorized agent, N.J.A.C. 13:39-5.8B(b) requires the transmission to include the full name and title of the agent. As an additional safeguard, pharmacists are required, pursuant to N.J.A.C. 13:39-5.8A(c) and 5.8B(d), to ensure that the facsimile machine and/or computer device used to receive facsimile and/or electronic prescriptions are located within the pharmacy prescription area.

Proposed N.J.A.C. 13:39-5.8A(d) requires a pharmacist receiving a facsimile prescription to ensure that the prescription contains certain minimum information. The prescription must contain the prescribing practitioner's name, address, telephone number, license number, academic degree, and handwritten original signature, as well as the name, age and address of the patient. The prescription must also contain the date of the prescription's issuance, the name, strength and quantity of the drug prescribed, and the number of refills permitted or the time limit provided for refills. If the prescription is for a controlled substance, the prescriber's Drug Enforcement Administration (D.E.A.) number must also be provided on the prescription. N.J.A.C. 13:39-5.8A(e) also requires the facsimile transmission of a prescription to contain, at a minimum, the identification number of the facsimile machine used to transmit the prescription, the date and time of the transmission, and if an authorized agent transmits the prescription, the agent's full name and title. If a pharmacist is receiving an electronic prescription, the pharmacy permit holder must ensure that the electronic system utilized in the pharmacy has adequate security and system safeguards designed to prevent and detect unauthorized access to the system, pursuant to the requirements of N.J.A.C. 13:39- 5.8B(c).

Proposed N.J.A.C. 13:39-5.8A(f) and 5.8B(e) require pharmacists to seek verbal verification of facsimile and electronic prescriptions from prescribing practitioners whenever a pharmacist has a question regarding the authenticity, accuracy or appropriateness of the prescription. A pharmacist, however, may accept verbal verification regarding the authenticity or legibility of the prescription from the practitioner's agent. A pharmacist is precluded, however, from filling a facsimile or electronic prescription where the pharmacist's questions regarding authenticity, accuracy or appropriateness have not been answered.

Proposed N.J.A.C. 13:39-5.8A(h) and 5.8B(g) provide that a pharmacist may fill a facsimile or electronic prescription for a Schedule II controlled substance provided that the original signed prescription is presented to the pharmacist prior to dispensing the medication. Furthermore, pursuant to N.J.A.C. 13:39-5.8A(h), a pharmacist may fill and dispense a facsimile prescription for a Schedule II substance prescribed for pain management, as provided in N.J.S.A. 45:14-14, for a resident of a long term care facility (paragraph (h)2) or for a patient receiving services from a hospice, without receiving the original prescription (paragraph (h)3). A pharmacist may also fill and dispense a facsimile prescription for a Schedule II substance prescribed for pain management which is to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion, without receiving the original prescription (paragraph (h)1). Under current Federal law, these options for filling prescriptions for pain management are permitted by facsimile only. In the event the Federal government in the future permits the filling of Schedule II controlled substances electronically, the Board has provided for such eventuality by including a provision in N.J.A.C. 13:39-5.8B(g). N.J.A.C. 13:39-5.8B(g) provides further that if permitted by Federal law in the future, the electronic transmission will serve as the original signed prescription for a Schedule II medication. In addition, under proposed N.J.A.C. 13:39- 5.8A(i), a pharmacist may fill and dispense a facsimile prescription for a Schedule III, IV or V controlled substance without receiving the original prescription. Pursuant to proposed N.J.A.C. 13:39-5.8B(h), a pharmacist may fill and dispense an electronic prescription for a Schedule III, IV or V controlled substance provided the pharmacist obtains the original signed prescription, an oral prescription or a facsimile prescription from the prescriber or the prescriber's agent prior to dispensing. In the event the Federal government adopts changes to otherwise permit the electronic transmission of Schedule III, IV or V controlled substances, the proposed rule provides for such a possibility by the inclusion of a provision in N.J.A.C. 13:39-5.8B(h). If permitted to fill and dispense Schedule III, IV and V prescriptions received electronically, N.J.A.C. 13:39-5.8B(h) also provides that the electronic prescription shall serve as the original signed prescription. The Board proposes N.J.A.C. 13:39-5.8A(h) and (i) and 5.8B(g) and (h) in order to make the Board's rules on dispensing of controlled substances pursuant to facsimile and electronic prescriptions consistent with the Federal requirements set forth in 21 C.F.R. § § 1306.11 and 1306.21.

Proposed new rules N.J.A.C. 13:39-5.8A(j) and 5.8B(i) prohibit pharmacists from entering into any agreement with a prescribing practitioner which requires facsimile or electronic prescriptions to be transmitted to a particular pharmacy. The Board proposes subsections (j) and (i) in order to safeguard a patient's right to have his or her prescription transmitted to a pharmacy of the patient's choice.

The Board has determined that the comment period for this proposal shall be 60 days; therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this proposal is excepted from the rulemaking calendar requirement.

Social Impact

The Board believes that the proposed new rules and amendment will have a positive impact upon licensed pharmacists and retail pharmacy permit holders to the extent that the rules establish guidelines for the dispensing of prescriptions received in facsimile and/or electronic format. The proposed new rules and amendment will provide licensees with direction and guidance as to how such prescriptions must be processed, and how medications prescribed in this manner may be dispensed. The Board also believes that the proposed new rules and amendment will have a positive impact upon consumers to the extent that the increased use of facsimile and 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.

Economic Impact

The Board believes that the proposed new rules and amendment may have an economic impact upon retail pharmacy permit holders who wish to receive facsimile and/or electronic prescriptions, to the extent that such permit holders will have to purchase the necessary equipment, which may include facsimile machines, computer devices and the computer software necessary to run the electronic prescription programs. The costs of complying with the proposed new rules and amendment will vary depending on whether a permit holder chooses to receive such prescriptions, and on what type of equipment the permit holder chooses to purchase.

Federal Standards Statement

A Federal standards analysis is not required because the proposed new rules and amendment are governed by N.J.S.A. 45:14-1 et seq., and, therefore, are not subject to any Federal standards or requirements. The Board notes, however, that the proposed requirements for the facsimile and electronic transmission of prescriptions for controlled substances set forth at N.J.A.C. 13:39-5.8A(h) and (i) and 5.8B(g) and (h) are consistent with the Federal D.E.A. standards articulated at 21 C.F.R. § § 1306.11 and 1306.21.

Jobs Impact

The Board does not believe that the proposed new rules and amendment will result in the creation or the loss of jobs in the State.

Agriculture Industry Impact

The Board does not believe that the proposed new rules and amendment will have any impact upon the agriculture industry in the State.

Regulatory Flexibility Analysis

The Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., requires the Board to provide a description of the types and an estimate of the number of small businesses to which the proposed new rules will apply. Currently, the Board licenses approximately 12,291 pharmacists and 2,061 retail pharmacy permit holders. If, for purposes of the Act, Board licensees and retail pharmacy permit holders are considered "small businesses," then the following analysis applies.

The Act requires the Board to set forth the reporting, recordkeeping and other compliance requirements of the proposed new rules and amendment, including the kinds of professional services likely to be needed to comply with the requirements. The Act further requires the Board to estimate the initial and annual compliance costs of the proposed new rules and amendment, to outline the manner in which it has designed the proposed new rules and amendment to minimize any adverse economic impact upon small businesses, and to set forth whether the proposed new rules establish differing compliance requirements for small businesses.

Proposed new rules N.J.A.C. 13:39-5.8A and 5.8B and the proposed amendment to N.J.A.C. 13:39-5.8 do not impose any reporting requirements upon licensees or permit holders. N.J.A.C. 13:39-5.8A(g) and 5.8B(f) do impose recordkeeping requirements upon pharmacists by requiring all pharmacists to maintain printed copies of facsimile and electronic prescriptions for a period of five years. Pharmacists may comply with these recordkeeping requirements by maintaining electronic reproductions of the facsimile prescriptions or records of the electronic prescriptions that are readily retrievable and printable.

The proposed new rules also impose various compliance requirements upon pharmacists and retail pharmacy permit holders who accept facsimile or electronic prescriptions. N.J.A.C. 13:39-5.8A(a) and 5.8B(a) permit pharmacists to accept facsimile and electronic prescriptions provided all the requirements set forth in the rules are satisfied. N.J.A.C. 13:39-5.8A(b) and 5.8B(b) prohibits pharmacists from filling facsimile or electronic prescriptions transmitted by anyone other than an authorized prescriber or the prescriber's authorized agent. If an electronic prescription is transmitted by an authorized agent, N.J.A.C. 13:39-5.8B(b) requires the transmission to include the full name and title of the agent. In addition, pharmacists must ensure that the facsimile machine used to receive facsimile prescriptions, or the computer device used to receive electronically transmitted prescriptions, are located within the pharmacy prescription area, pursuant to N.J.A.C. 13:39-5.8A(c) and 5.8B(d).

Proposed N.J.A.C. 13:39-5.8A(d) requires pharmacists receiving facsimile prescriptions to ensure that the facsimile prescription contains specific information. At a minimum, the facsimile prescription must contain the prescribing practitioner's name, address, telephone number, license number, academic degree, and handwritten original signature; the name, age and address of the patient; the date of issuance; the name, strength and quantity of the drug prescribed; the number of refills permitted or time limit for refills; and the prescriber's D.E.A. number, if the prescription is for a controlled substance. N.J.A.C. 13:39-5.8A(e) also requires a pharmacist receiving a facsimile prescription to ensure that the transmission contains the identification number of the facsimile machine used to transmit the prescription, the date and time of the transmission, and if an authorized agent transmits the prescription, the agent's full name and title. If a pharmacist is receiving an electronic prescription, the permit holder must ensure that the electronic system utilized in the pharmacy has adequate security and system safeguards designed to prevent and detect unauthorized access, modification or manipulation of the prescriptions, pursuant to N.J.A.C. 13:39-5.8B(c).

N.J.A.C. 13:39-5.8A(f) and 5.8B(e) require pharmacists to seek verbal verification of facsimile or electronic prescriptions from prescribers whenever the pharmacist has a question regarding the authenticity, accuracy or appropriateness of the prescription. A pharmacist, however, may accept verbal verification regarding the authenticity or legibility of a prescription from the practitioner's authorized agent. A pharmacist, however, may not fill a facsimile or electronic prescription where his or her questions regarding authenticity, accuracy or appropriateness have not been addressed.

N.J.A.C. 13:39-5.8A(h) and 5.8B(g) require a pharmacist filling a facsimile or electronic prescription for a Schedule II controlled substance to obtain the original signed prescription prior to dispensing the medication. Pursuant to N.J.A.C. 13:39-5.8A(h), however, a pharmacist may fill a facsimile prescription for a Schedule II substance prescribed for pain management for a resident of a long term care facility or for a patient receiving services from a hospice, without receiving the original prescription prior to dispensing. A pharmacist may also fill and dispense a facsimile or electronic prescription for a Schedule II substance prescribed for pain management which is to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion, without receiving the original prescription. Pursuant to N.J.A.C. 13:39-5.8B(g), if permitted by Federal law, an electronically transmitted prescription for a Schedule II controlled substance shall serve as the original signed prescription.

A pharmacist may fill a facsimile prescription for a Schedule III, IV or V controlled substance without receiving an original prescription prior to dispensing, provided all the requirements associated with facsimile prescriptions are satisfied pursuant to N.J.A.C. 13:39-5.8A(i). In addition, pursuant to N.J.A.C. 13:39-5.8B(h), a pharmacist may fill and dispense a prescription for a Schedule III, IV or V medication transmitted electronically provided that the pharmacist has obtained the original signed prescription, an oral prescription or a facsimile prescription from the prescribing practitioner or the practitioner's authorized agent. If permitted by Federal law, however, the electronic prescription shall serve as the original signed prescription.

Proposed N.J.A.C. 13:39-5.8A(j) and 5.8B(i) prohibit pharmacists from entering into any agreement with a prescribing practitioner which requires that facsimile or electronic prescriptions be transmitted to a particular pharmacy. Pharmacists are also prohibited from entering into any agreement that denies a patient the right to have his or her prescription transmitted to a pharmacy of the patient's choice.

No additional professional services will be needed to comply with the proposed new rules and amendment. The costs of compliance with the proposed new rules and amendment are discussed in the Economic Impact statement above. Since the Board proposes the new rules and amendment in order to promote the health, safety and welfare of New Jersey consumers in obtaining prescription medications, the proposed new rules and amendment will be uniformly applied and, therefore, no differing compliance requirements for any pharmacists and retail pharmacy permit holders are provided based upon the size of the business.

Smart Growth Impact

The Board does not believe that the proposed new rules and amendment will have any impact upon the achievement of smart growth or upon implementation of the State Development and Redevelopment Plan.

Full text of the proposal follows:

<< NJ ADC 13:39-5.8 >>

13:39-5.8 Prescriptions and medication orders transmitted by technological devices <<+in an institution+>>

(a) (No change.)

(b) A registered pharmacist <<-at a retail pharmacy and a registered pharmacist->> filling prescriptions under an institutional permit for employees of the institution and their dependents and for out-patients who are treated by staff members of the institution in their respective clinics, as permitted pursuant to N.J.S.A. 45:14-32, may accept for dispensing prescriptions for all substances other than Schedule II controlled dangerous substances which have been transmitted by technological device, under the following conditions only:

1.-2. (No change.)

(c)-(g) (No change.)

<< NJ ADC 13:39-5.8A >>

<<+13:39-5.8A Prescriptions transmitted by facsimile+>>

<<+(a) A pharmacist may accept for dispensing a facsimile prescription, consistent with the requirements of this section. For purposes of this section, "facsimile prescription" means a prescription which is transmitted by a device which sends an exact image to the receiver.+>>

<<+(b) A pharmacist shall not fill a facsimile prescription transmitted by anyone other than a practitioner authorized to prescribe medications pursuant to N.J.S.A. 45:14-14, or the prescribing practitioner's authorized agent.+>>

<<+(c) The facsimile machine used to receive prescriptions shall be located within the pharmacy prescription area.+>>

<<+(d) A facsimile prescription shall contain the following:+>>

<<+1. The prescribing practitioner's full name, address, telephone number, license number, proper academic degree or identification of professional practice for which licensed, and handwritten original signature;+>>

<<+2. The full name, age, and address of the patient;+>>

<<+3. The date of issuance;+>>

<<+4. The name, strength and quantity of the drug prescribed;+>>

<<+5. The number of refills permitted or time limit for refills, or both; and+>>

<<+6. The prescribing practitioner's D.E.A. number, if the drug prescribed is a controlled substance.+>>

<<+(e) The facsimile transmission of the prescription shall contain the following:+>>

<<+1. The identification number of the facsimile machine which is used to transmit the prescription;+>>

<<+2. The date and time of the prescription transmission;+>>

<<+3. The name, address, telephone number and facsimile number of the pharmacy; and+>>

<<+4. If an authorized agent transmits the facsimile prescription, the full name and title of the transmitting agent.+>>

<<+(f) A pharmacist shall seek verbal verification of a facsimile prescription from the prescribing practitioner whenever the pharmacist has reason to question the authenticity, accuracy or appropriateness of the prescription. A pharmacist may accept verbal verification regarding the authenticity or legibility of a facsimile prescription from a prescribing practitioner's authorized agent. A pharmacist shall not fill a facsimile prescription where there is a question regarding authenticity, accuracy or appropriateness if such verification is not provided.+>>

<<+(g) A pharmacist shall retain a printed copy of a facsimile prescription, or an electronic reproduction of the facsimile prescription that is readily retrievable and printable, for a minimum of five years pursuant to N.J.S.A. 45:14-15. The printed copy shall be of non-fading legibility.+>>

<<+(h) A pharmacist may fill a prescription for a Schedule II controlled substance transmitted by facsimile provided that the original signed prescription is presented to the pharmacist prior to the dispensing of the controlled substance, except as provided in (h)1, 2 and 3 below.+>>

<<+1. A prescription for a Schedule II substance prescribed for pain management to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile shall serve as the original written prescription and shall be maintained pursuant to the requirements of (g) above.+>>

<<+2. A prescription for a Schedule II substance prescribed for pain management for a resident of a long term care facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile shall serve as the original written prescription and shall be maintained pursuant to the requirements of (g) above.+>>

<<+3. A prescription for a Schedule II substance prescribed for pain management for a patient receiving services from a hospice certified by Medicare under Title XVIII or licensed by the State may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent shall note on the facsimile prescription that the patient is a hospice patient. The facsimile shall serve as the original writtenprescription and shall be maintained pursuant to the requirements of (g) above.+>>

<<+(i) A pharmacist may fill a prescription for a Schedule III, IV or V controlled substance transmitted by facsimile consistent with the requirements of this section. The facsimile prescription shall serve as the original written prescription.+>>

<<+(j) A pharmacist shall not enter into any agreement with a prescribing practitioner that requires that facsimile prescriptions be transmitted to a particular pharmacy or in any way denies a patient the right to have his or her prescription transmitted by facsimile to a pharmacy of the patient's choice.+>>

<< NJ ADC 13:39-5.8B >>

<<+13:39-5.8B Electronically transmitted prescriptions+>>

<<+(a) A pharmacist may accept for dispensing an electronic prescription, consistent with the requirements of this section. For purposes of this section, "electronic prescription" means a prescription which is transmitted by a computer device in a secure manner.+>>

<<+(b) A pharmacist shall not fill an electronic prescription transmitted by anyone other than a practitioner authorized to prescribe medications pursuant to N.J.S.A. 45:14-14, or the prescribing practitioner's authorized agent. If the electronic prescription is transmitted by the practitioner's authorized agent, the transmission shall include the full name and title of the agent.+>>

<<+(c) The permitholder shall ensure that the electronic system utilized to receive prescriptions shall have adequate security and system safeguards designed to prevent and detect unauthorized access, modification or manipulation of the prescriptions.+>>

<<+(d) The computer or device used to receive electronically transmitted prescriptions shall be located within the pharmacy prescription area.+>>

<<+(e) A pharmacist shall seek verbal verification of an electronic prescription from the prescribing practitioner whenever the pharmacist has reason to question the authenticity, accuracy or appropriateness of the prescription. A pharmacist may accept verbal verification regarding the authenticity or legibility of an electronic prescription from a prescribing practitioner's authorized agent. A pharmacist shall not fill the electronic prescription where there is a question regarding authenticity, accuracy or appropriateness if such verification is not provided.+>>

<<+(f) A pharmacist shall retain a printed copy of an electronic prescription, or a record of an electronic prescription that is readily retrievable and printable, for a minimum of five years pursuant to N.J.S.A. 45:14-15. The printed copy shall be of non-fading legibility.+>>

<<+(g) A pharmacist may fill a prescription for a Schedule II controlled substance transmitted electronically, 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, an electronic prescription shall serve as the original signed prescription.+>>

<<+(h) A pharmacist may fill a prescription for a Schedule III, IV or V controlled substance transmitted electronically, provided that the pharmacist has obtained the original signed prescription, an oral prescription, or a facsimile prescription from the prescribing practitioner or the prescribing practitioner's authorized agent prior to the dispensing. If permitted by Federal law, and in accordance with Federal requirements, an electronic prescription shall serve as the original signed prescription.+>>

<<+(i) A pharmacist shall not enter into any agreement with a prescribing practitioner 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.+>>

If you have any comments or questions, our e-mail address is:

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Posted September 3, 2002