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NEW JERSEY REGISTER
VOLUME 39, ISSUE 11
ISSUE DATE: JUNE 4, 2007
RULE PROPOSALS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS
PHYSICIAN ASSISTANT ADVISORY COMMITTEE

39 N.J.R. 2201(a)

Proposed Amendments: N.J.A.C. 13:35-2B.12

Click here to view Interested Persons Statement

Requirements for Issuing Prescriptions for Medications; Special Requirements for Issuance of CDS

Authorized By: State Board of Medical Examiners, William Roeder, Executive Director, in consultation with the Physician Assistant Advisory Committee.

Authority: N.J.S.A. 45:9-27.19.

Calendar Reference: See Summary below for explanation of exemption to calendar requirement.

Proposal Number: PRN 2007-178.

Submit comments by August 3, 2007 to:

Dorcas O'Neal, Executive Director
Physician Assistant Advisory Committee
124 Halsey Street
P.O. Box 45035
Newark, New Jersey 07101

The agency proposal follows:

Summary

The State Board of Medical Examiners (the Board), in consultation with the Physician Assistant Advisory Committee (the Committee), is proposing to amend N.J.A.C. 13:35-2B.12 to establish the requirements for issuing prescriptions for medications and the special requirements for issuing prescriptions for controlled dangerous substances. These requirements are in accordance with P.L. 2005, c. 48, approved on March 21, 2005, which authorizes physician assistants to order or prescribe controlled dangerous substances in certain situations.

The Board is proposing to reorganize N.J.A.C. 13:35-2B.12 so that the rule includes the provisions of P.L. 2005, c. 48. The Board is proposing new N.J.A.C. 13:35-2B.12(b)1 through 11, which sets forth all the information that a physician assistant must provide on all prescription blanks. This information, except for N.J.A.C. 13:35-2B.12(b)11, was previously in N.J.A.C. 13:35-2B.12(a)2 and 3, which are proposed for deletion. Proposed N.J.A.C. 13:35-2B.12(b)11 establishes that the physician assistant's Drug Enforcement Administration registration number must be included on the prescription. In addition, the Board is proposing new N.J.A.C. 13:35-2B.12(c), which sets forth the requirements a physician assistant must comply with when ordering or prescribing controlled dangerous substances. A physician assistant treating a patient in an inpatient or outpatient setting may only order or prescribe Schedule II, III, IV or V controlled dangerous substances when a supervising physician has authorized a physician assistant to: continue or reissue that which the supervising physician had previously ordered or prescribed; and adjust that which a supervising physician had previously ordered, or prescribed only after a consultation with the supervising physician. Initiation of an order or prescription for controlled dangerous substances by a physician assistant may be made only if there is a prior consultation with the supervising physician or if it is part of a treatment plan for a patient with a terminal illness. The physician assistant who chooses to include controlled dangerous substance prescribing as part of his or her scope of practice must, pursuant to new N.J.A.C. 13:32-2B.12(c), register with the appropriate State and Federal authorities and new N.J.A.C. 13:35-2B.12(d) requires consistency with physician prescribing under N.J.A.C. 13:35-7.2(h) that only one controlled dangerous substance shall appear on a prescription blank.

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 rule amendments will have a positive social impact upon licensed physician assistants since they are now authorized in limited, carefully defined circumstances, to order or prescribe controlled dangerous substances. This added scope of practice makes physician assistants more valuable as ancillary care providers. The Board also believes that the proposed rule amendments will have a positive social impact upon the public because appropriate access to controlled dangerous substance medications is increased by delegation of prescribing rights to well trained and supervised ancillary care providers. The public safety is protected because of the oversight provided by the supervising physician and the special conditions under which physician assistants may prescribe controlled dangerous substances.

Economic Impact

The Board anticipates that the proposed rule amendments will impose additional costs upon those licensees who are authorized to issue controlled dangerous substances since they will have the expense of obtaining a Drug Enforcement Administration registration number and any other required registration fees. To the extent that there may be costs involved for a licensee to register, the minimal costs are greatly outweighed by the ability of physician assistants to prescribe controlled dangerous substances.

Federal Standards Statement

A Federal standards analysis is not required because the proposed rule amendments are subject to State statutory requirements and are not subject to any Federal requirements.

Jobs Impact

The Board does not believe that the proposed rule amendments will either increase or decrease jobs in the State.

Agriculture Industry Impact

The proposed amendments will have no impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

If, for the purposes of the Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., the approximately 1,600 licensed physician assistants are considered "small businesses," then the following analysis applies. The proposed rule amendments will not impose reporting or recordkeeping requirements upon licensees; however, they do impose compliance requirements. Proposed N.J.A.C. 13:35-2B.12(b) imposes compliance requirements upon licensees since the rule establishes the information that must be contained on a prescription blank. Proposed rule N.J.A.C. 13:35-2B.12(c) also imposes requirements upon licensees with which they must comply when ordering or prescribing controlled dangerous substances. No additional professional services will be needed to comply with the proposed rule amendments. The Board believes that the proposed rule amendments should be uniformly applied to all licensees in order to ensure the health, welfare and safety of the general public in the practice of medicine; and, therefore, no differing compliance requirements for any licensee are provided.

Smart Growth Impact

The Board does not anticipate that the proposed rule amendments will have any impact on the achievement of smart growth or on implementation of the State Development and Redevelopment Plan, otherwise known as the State Plan.

Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):

13:35-2B.12 Requirements for issuing prescriptions for medications; [memorialization of verbal orders for CDS given by physicians] special requirements for issuance of CDS

(a) A physician assistant may issue prescriptions for medications only in accordance with the [following conditions:] requirements contained in this section.

(b) A physician assistant shall provide the following on all prescription blanks:

1. The physician assistant's full name, professional identification ("PA-C"). license number, address and telephone number. This information shall be printed on all prescription blanks;

2. The supervising physician's full name, printed or stamped;

3. A statement indicating whether the prescription is written pursuant to protocol or specific physician direction. Acceptable abbreviations are "prt" for protocol and "spd" for specific physician direction;

4. The full name, age and address of the patient;

5. The date of issuance of the prescription;

6. The name, strength and quantity of drug or drugs to be dispensed and route of administration;

7. Adequate instruction for the patient. A direction of "p.r.n." or "as directed" alone shall be deemed an insufficient direction;

8. The number of refills permitted or time limit for refills, or both;

9. The signature of the prescriber, hand-written;

10. The words "substitution permissible" and "do not substitute" and shall contain space for the physician assistant's initials next to the chosen option, in addition to the space required for the signature required by (b)9 above; and

11. The physician assistant's Drug Enforcement Administration (DEA) registration number, if the physician assistant is authorized to issue CDS.

[1.] (c) A physician assistant [shall not issue prescriptions for] may order or prescribe controlled dangerous substances[.] (CDS) if:

1. A supervising physician has authorized a physician assistant to order or prescribe Schedule II, III, IV or V controlled dangerous substances in order to:

i. Continue or reissue an order or prescription for a controlled dangerous substance issued by the supervising physician;

ii. Adjust the dosage of an order or prescription for a controlled dangerous substance originally ordered or prescribed by the supervising physician, provided there is prior consultation with the supervising physician;

iii. Initiate an order or prescription for a controlled dangerous substance for a patient, provided there is prior consultation with the supervising physician if the order or prescription is not pursuant to iv below; or

iv. Initiate an order or prescription for a controlled dangerous substance as part of a treatment plan for a patient with a terminal illness, which for the purposes of this subparagraph means a medical condition that results in a patient's life expectancy being 12 months or less as determined by the supervising physician; and

2. The physician assistant has registered with and obtained authorization to order or prescribe controlled dangerous substances from the appropriate State and Federal agencies.

[2. A physician assistant shall provide the following on all prescription blanks:

i. The physician assistant's full name, professional identification ("PA-C"), license number, address and telephone number. This information shall be printed or stamped on all prescription blanks;

ii. The supervising physician's full name, printed or stamped;

iii. A statement indicating whether the prescription is written pursuant to protocol or specific physician direction. Acceptable abbreviations are "prt" for protocol and "spd" for specific physician direction;

iv. The full name, age and address of the patient;

v. The date of issuance of prescription;

vi. The name, strength and quantity of drug or drugs to be dispensed and route of administration;

vii. Adequate instruction for the patient. A direction of "p.r.n." or "as directed" alone shall be deemed an insufficient direction;

viii. The number of refills permitted or time limit for refills, or both;

ix. The signature of the prescriber, hand-written; and

x. Every prescription blank shall be imprinted with the words "substitution permissible" and "do not substitute" and shall contain space for the physician assistant's initials next to the chosen option, in addition to the space required for the signature in (a)3ix above.

3. A physician assistant shall not initiate an order for controlled dangerous substances. However, a physician assistant may memorialize an order for a controlled dangerous substance when the order has been verbally given by the supervising physician or physician designee in a licensed inpatient or outpatient setting, including, but not limited to, hospital emergency departments, licensed ambulatory surgery centers and nursing homes, when the following requirements are met. The controlled dangerous substance order shall be written on the order sheet of the patient's chart with:

i. The letters VO (meaning an order relayed to the physician assistant by the physician in person) or TO (meaning an order relayed to the physician assistant by the physician over the telephone);

ii. The supervising physician's or physician designee's name printed;

iii. The signature of the physician assistant directly under the order for the controlled dangerous substance; and

iv. The supervising physician's or the physician designee's countersignature of the controlled dangerous substance order within 24 hours in the inpatient setting and within 48 hours of the order in the outpatient setting.]

(d) Only one controlled dangerous substance shall appear on a prescription blank.

(e) Written prescriptions shall be issued only on New Jersey Prescription Blanks (NJPB), secured from an approved vendor and subject to the required security mandates of the prescription blank program pursuant to N.J.S.A. 45:14-14.



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