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VOLUME 46, ISSUE 13
ISSUE DATE: JULY 7, 2014
RULE PROPOSALS

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS


Proposed Amendments: N.J.A.C. 13:35-7.1, 7.1A, and 7.2


Definitions; Examination of Patient's Condition Required Prior to Dispensing Drugs or Issuing a Prescription; Exceptions; Requirements for Issuing Written Prescriptions for Medicines
 
Authorized By: State Board of Medical Examiners, William Roeder, Executive Director.
 
Authority: N.J.S.A. 45:9-2 and P.L. 2013, c. 46.
 
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
 
Proposal Number: PRN 2014-112.
 
Submit written comments by September 5, 2014, to:
 
   William Roeder, Executive Director
   State Board of Medical Examiners
   PO Box 183
   Trenton, New Jersey 08625-0183
   Or electronically at: www.NJConsumerAffairs.gov/proposal/comment/.
 
The agency proposal follows:
 
Summary

P.L. 2013, c. 46 (N.J.S.A. 24:6J-1 et seq.), the Overdose Prevention Act (Act), encourages witnesses and victims of drug overdoses to seek medical assistance without fear of criminal or civil liability and recognizes the benefits of greater availability of opioid antidotes, such as naloxone, which reverse respiratory depression caused by opioid overdoses. Under the Act, opioid antidotes may be administered by a person who is not at risk of an opioid overdose but who may be in the position to assist another individual during an overdose, such as a family member or law enforcement officer. Such a person would have to receive information on overdoses as required by N.J.S.A. 24:6J-5. This statute requires that patient overdose information include at least: opioid overdose prevention and recognition; how to perform rescue breathing and resuscitation; opioid antidote dosage and administration; the importance of calling 911 emergency telephone service for assistance with an opioid overdose; and care for an overdose victim after administration of the opioid antidote.

The Board of Medical Examiners (Board) rules regarding dispensing drugs or issuing a prescription can be seen as prohibiting dispensing or prescribing to a person who is not the end-user of the medication as it is envisioned in the Act. In order to remove these potential impediments, the Board proposes to amend its rules to recognize that physicians may dispense or prescribe opioid antidotes pursuant to the Act.

N.J.A.C. 13:35-7.1A requires a physician to perform an examination of the patient prior to dispensing a drug or issuing a prescription, subject to certain exceptions. In order to ensure that the rule is not seen as an impediment to a physician dispensing or prescribing an opioid antidote, the proposed amendments would add to the exceptions situations when a physician issues a prescription to a person who is not at risk of an opioid overdose, but may be in the position to assist another individual during an overdose. Such a person would have to have received the patient overdose information required by the Act.

N.J.A.C. 13:35-7.2 requires that a physician provide follow-up care when he or she issues a written prescription. The proposed amendments would exempt a physician from the follow-up care requirement when a prescription is issued to a person who is not at risk of an opioid overdose, but may be in the position to assist another individual during an overdose. The proposed amendments also provide an alternative to the information that must be included on a written prescription. When the prescription is for an opioid antidote, the prescription would have to include the name and address of the person to whom the prescription is issued.

The proposed amendments provide a definition for the term "patient," which incorporates the definition of the term from the Act. Under this definition, a "patient" would mean anyone who is the recipient of a professional service rendered by a licensee and includes a person who is not at risk of an opioid overdose, but who may be in the position to assist another individual during an overdose. Such a person would have to have received the patient overdose information required by the Act.

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 proposed amendments will have a positive social impact in that they will remove possible barriers to physicians dispensing or prescribing opioid antidotes to a person, such as a family member or a law enforcement officer, who may be in a position to assist another individual during an overdose pursuant to the Act. This will facilitate the use of opioid antidotes and promote the goals of the Act, saving the lives of individuals who have overdosed.
 
Economic Impact

The Board does not anticipate that the proposed amendments will have any economic impact.
 
Federal Standards Statement

A Federal standards analysis is not required because there are no Federal laws or standards applicable to the proposed amendments.
 
Jobs Impact

The proposed amendments will not increase or decrease the number of jobs in New Jersey.
 
Agriculture Industry Impact

The Board does not believe that the proposed amendments will have any impact on the agriculture industry of this State.
 
Regulatory Flexibility Analysis

Since physicians are individually licensed by the Board, they may be considered "small businesses" under the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq.

The proposed amendments will not impose any costs and the Board does not believe that physicians will need to employ any professional services to comply with the proposed amendments. The proposed amendments do not impose any reporting or recordkeeping requirements, but do impose compliance requirements as detailed in the Summary above.

As the proposed amendments remove possible barriers to physicians dispensing or prescribing opioid antidotes in accordance with the Act, the Board believes that the amendments must be uniformly applied to all physicians and no exemptions are provided based on the size of a business.
 
Housing Affordability Impact Analysis

The proposed amendments will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the proposed amendments would evoke a change in the average costs associated with housing because the proposed amendments concern standards for dispensing and prescribing opioid antidotes.
 
Smart Growth Development Impact Analysis

The proposed amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed amendments 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 amendments concern standards for the dispensing or prescribing opioid antidotes.
 
Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
 
[page=1546] SUBCHAPTER 7.       PRESCRIPTION, ADMINISTRATION, AND DISPENSING OF DRUGS
 
13:35-7.1   Definitions
 
The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
 
. . .
 
"Patient" means any person who is the recipient of a professional service rendered by a licensee for purposes of diagnosis, treatment, or a consultation relating to treatment. "Patient" includes a person who is not at risk of an opioid overdose, but who, in the judgment of a physician, may be in a position to assist another individual during an overdose and who has received patient overdose information on the indications for and administration of an opioid antidote, consistent with N.J.S.A. 24:6J-1 et seq.
 
. . .
 
13:35-7.1A   Examination of patient's condition required prior to dispensing drugs or issuing a prescription; exceptions
 
(a) (No change.)
 
(b) Notwithstanding (a) above, an examination of the patient's condition shall not be required prior to the dispensing of drugs or the issuance of a prescription under the following circumstances:
 
1.-4. (No change.)
 
5. For a patient examined by a healthcare professional who is in collaborative practice with the practitioner; [and]
 
6. When treatment is provided by a practitioner for an emergency medical condition[.]; and
 
7. For a prescription or standing medication order issued to a person who is not at risk of an opioid overdose, but who, in the judgment of a physician, may be in a position to assist another individual during an overdose and who has received patient overdose information on the indications for and administration of an opioid antidote pursuant to N.J.S.A. 24:6J-5.
 
(c) (No change.)
 
13:35-7.2   Requirements for issuing written prescriptions for medicines
 
(a) (No change.)
 
(b) [(Reserved)] Notwithstanding (a) above, follow-up shall not be required for a prescription issued to a person who is not at risk of an opioid overdose, but who, in the judgment of a physician, may be in a position to assist another individual during an overdose and who has received patient overdose information on the indications for and administration of an opioid antidote pursuant to N.J.S.A. 24:6J-5.
 
(c) (No change.)
 
(d) A practitioner shall include the following information on each written prescription:
 
1. (No change.)
 
2. The full name, age, and address of the patient, or in the case of a prescription for an opioid antidote, the name and address of the person to whom the prescription is issued;
 
3.-10. (No change.)
 
(e)-(h) (No change.)

 

If you wish to submit comments about this rule proposal, please fill out the form below. When you have completed the form, click the "Submit Your Comments" button below.

Last Name :

First Name:

Professional Organization, Association or Affiliation, if any:

E-Mail Address:

PRN 2014-112

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