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NEW JERSEY REGISTER
VOLUME 34, NUMBER 19
TUESDAY, OCTOBER 7, 2002
RULE PROPOSAL

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS
LIMITATIONS ON PRESCRIBING, ADMINISTERING OR DISPENSING OF CONTROLLED SUBSTANCES;
SPECIAL EXCEPTIONS FOR MANAGEMENT OF PAIN IMPLANTABLE INFUSION PUMPS


Proposed Amendment: N.J.A.C. 13:35-7.6

Authorized By: State Board of Medical Examiners, William Roeder, Executive Director.

Authority: N.J.S.A. 45:9-2.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2002-355.

Submit comments by December 6, 2002 to:

William Roeder, Executive Director
State Board of Medical Examiners
PO Box 183
Trenton, NJ 08625-0183

The agency proposal follows:

Summary

Pursuant to its rulemaking powers found in N.J.S.A. 45:9-2, the State Board of Medical Examiners (the Board) proposes to amend N.J.A.C. 13:35-7.6, concerning limitations on prescribing, administering or dispensing controlled substances. The proposed amendments to N.J.A.C. 13:35-7.6(c) revise the subsection so that, in addition to the existing exemption which allows a practitioner to exceed the 120 dosages limitations for Schedule II controlled substances, a practitioner could exceed the 30-day supply limitation for Schedule II controlled substances. The proposed exemption would allow practitioners to prescribe a 90-day supply for medications delivered through an implantable infusion pump which is used to provide pain management for patients suffering from cancer, intractable pain or terminal illness. A practitioner who authorizes a 90-day supply must evaluate and document the patient's continued need for the prescription at least every 30 days.

As the Board has provided a 60-day comment period on this notice of proposal, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Board believes that the proposed amendment will have a positive impact. The amendment will permit practitioners to prescribe a 90-day supply for medications delivered through an implantable infusion pump for pain management. Without this exemption, patients would need to have such pumps filled every 30 days which is more burdensome and inconvenient. The 90-day supply of medication is a more practical and reasonable administration for such patients. Requiring that the practitioner review the need for the prescription every 30 days ensures that the patient safety concerns envisioned by N.J.A.C. 13:35-7.6 are achieved while still providing an accommodation to those patients who use infusion pumps.

Economic Impact

The Board believes that the proposed amendment may have a beneficial economic impact on those members of the public who receive pain management from implantable infusion pumps due to cancer, intractable pain or terminal illness. These individuals will need to make less doctors visits to refill these pumps and will correspondingly incur less costs due to the fewer amounts of visits. The Board does not believe that the proposed amendment will have any other economic impact.

Federal Standards Statement

A Federal standards analysis is not required because there are no Federal standards or requirements applicable to the proposed amendment.

Jobs Impact

The Board does not believe that the proposed amendment will affect jobs in the State, including the generation or loss of jobs.

Agriculture Industry Impact

The Board does not believe that the proposed amendment will have any impact on the agriculture industry of this 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 amendment will apply. If, for purposes of the Act, Board licensees are considered "small businesses" within the meaning of the statute, then the following analysis applies.

The Act requires the Board to set forth the reporting, recordkeeping and other compliance requirements of the proposed 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 amendment with an indication of the varying impact on small businesses of differing types and sizes and to outline the manner in which it has designed the rules to minimize any adverse economic impact upon small businesses.

The costs imposed on small businesses by the proposed amendment are the same costs that are imposed on all businesses as outlined in the Economic Impact statement above.

The Board does not believe that licensees will need to employ any professional services to comply with the requirements of the proposed amendment.

The proposed amendment does not impose any reporting or recordkeeping requirements. The amendment does impose compliance requirements in that licensees who prescribe a 90-day supply of pain medication delivered through an implantable infusion pump must review the need for the prescription at least every 30 days.

The Board believes that since the proposed amendment provides for the safe prescription of pain medications delivered through implantable infusion pumps, the rule should be applied uniformly to all licensees regardless of size.

Smart Growth Impact

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

Full text of the proposal follows:

<< NJ ADC 13:35-7.6 >>

13:35-7.6 Limitations on prescribing, administering or dispensing of controlled substances; special exceptions for management of pain

(a)-(b) (No change.)

(c) <<-A practitioner may exceed the 120 dosage unit limitation for Schedule II controlled substances in (b) above, if the practitioner follows a treatment plan designed to achieve effective pain management which has been tailored to the needs of a patient who is suffering pain from cancer, intractable pain or terminal illness. The treatment plan shall state objectives by which treatment success is to be evaluated, such as pain relief and improved physical and psychological function, and shall indicate if any further diagnostic evaluations or other treatments are planned. The practitioner shall discuss the risks and benefits of the use of controlled substances with the patient, guardian or authorized representative.->> <<+A practitioner may exceed the 120 dosage unit or 30-day supply limitations for Schedule II controlled substances in (b) above in the following circumstances:+>>

<<+1. For the 120 dosage unit limitation, the practitioner follows a treatment plan designed to achieve effective pain management which has been tailored to the needs of a patient who is suffering pain from cancer, intractable pain or terminal illness. The treatment plan shall state objectives by which treatment success is to be evaluated, such as pain relief and improved physical and psychological function, and shall indicate if any further diagnostic evaluations or other treatments are planned. The practitioner shall discuss the risks and benefits of the use of controlled substances with the patient, guardian or authorized representative; and+>>

<<+2. With regards to the 30-day supply limitation, a practitioner may prescribe the use of an implantable infusion pump which is utilized to achieve pain management for patients suffering from cancer, intractable pain or terminal illness. A prescription for such an implantable infusion pump may provide up to a 90-day supply as long as the physician evaluates and documents the patient's continued need at least every 30 days.+>>

(d)-(g) (No change.)

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Posted October 7, 2002