VOLUME 49, ISSUE 16
ISSUE DATE: AUGUST 21, 2017
RULE PROPOSALS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINER
BOARD OF PHARMACY
Jointly Proposed Amendment: N.J.A.C. 13:35-6.26Jointly Proposed New Rule: N.J.A.C. 13:39-4.21A Click here to view Interested Persons Statement
Procedures for Physician Ordered Immunizations Performed by Licensed Pharmacists; Requirements for Pharmacists to Administer Influenza Vaccine to Patients Under 18 Years of Age Authorized By: Board of Medical Examiners, William Roeder, Executive Director, and Board of Pharmacy, Anthony Rubinaccio, Executive Director.
Authority: N.J.S.A. 45:9-2 and 45:14-47.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2017-203.
Submit comments by October 20, 2017, to:
William Roeder, Executive Director
Board of Medical Examiners
140 East Front Street, 2nd Floor
PO Box 183
Trenton, New Jersey 08625
and to:
Anthony Rubinaccio, Executive Director
Board of Pharmacy
PO Box 45013
Newark, New Jersey 07101
or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.
The joint proposal of the agencies follows:
Summary P.L. 2003, c. 280 (N.J.S.A. 45:14-63) permits licensed pharmacists to administer drugs in immunization programs provided they are qualified pursuant to rules of the Board of Pharmacy (Pharmacy Board) and Board of Medical Examiners (Medical Board). Under P.L. 2003 c. 280, licensed pharmacists were prohibited from administering pediatric immunizations. P.L. 2013, c. 254, amended P.L. 2003, c. 280, to permit licensed pharmacists to administer the influenza vaccine to patients who are at least seven years old. If a patient is under 18 years of age, the patient's parent or legal guardian must consent to a licensed pharmacist administering the vaccine. If a patient is under 12 years of age, a licensed pharmacist may administer the vaccine only if an authorized prescriber has issued a prescription for the vaccine.
The Medical Board proposes to amend N.J.A.C. 13:35-6.26 to correct a mistaken citation to accurately cite N.J.A.C. 13:39-4.21 and to reflect that the Pharmacy Board is proposing new N.J.A.C. 13:39-4.21A, which effectuates P.L. 2013, c. 254. N.J.A.C. 13:35-6.26 requires a licensed pharmacist who is participating in an immunization program to have a standing order from a physician. The standing order must include procedures for reporting adverse events to the physician. The Medical Board proposes to amend N.J.A.C. 13:35-6.26, so that the standing order [page=2747] would have to require that adverse events be reported to the physician within 24 hours of notice of the event.
The Pharmacy Board proposes new N.J.A.C. 13:39-4.21A to effectuate P.L. 2013, c. 254. The proposed new rule permits licensed pharmacists to administer influenza vaccines to patients under 18 years of age if they are authorized to administer vaccines pursuant to N.J.A.C. 13:39-4.21. The proposed new rule requires licensed pharmacists to obtain written consent from a patient's parent or guardian if the patient is under 18 years of age. Additionally, the proposed new rule mandates that if a patient is between seven and 12 years of age, the licensed pharmacist may administer the vaccine only pursuant to a prescription. The proposed new rule also clarifies that pharmacists are not permitted to administer the vaccine to patients under the age of seven.
The Medical Board and the Pharmacy Board have determined that the comment period for this proposal will 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.
Social Impact The Medical Board and Pharmacy Board believe that the proposed amendments and new rule may benefit consumers to the extent that they will now have greater access to influenza immunizations for children. The proposed amendments and new rule will allow such individuals the opportunity to obtain pediatric influenza immunizations at pharmacy practice sites throughout the State.
Economic Impact The Medical Board and the Pharmacy Board do not believe that the proposed amendments and new rule 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 or new rule.
Jobs Impact The Medical Board and the Pharmacy Board do not believe the proposed amendments and new rule will result in the creation or loss of jobs in the State.
Agriculture Industry Impact The proposed amendments and new rule will have no impact on the agriculture industry in the State.
Regulatory Flexibility Analysis Since licensed pharmacists and physicians are individually licensed by the Medical Board and Pharmacy Board, under the Regulatory Flexibility Act (Act), N.J.S.A. 52:14B-16 et seq., they may be considered "small businesses" for the purposes of the Act.
The proposed amendments and new rule will not impose any costs. The Medical Board and Pharmacy Board do not believe that licensed pharmacists or physicians will need to employ any professional services to comply with the requirements of the proposed amendments and new rule. The proposed amendments and new rule impose no recordkeeping or reporting requirements, but impose compliance requirements as detailed in the Summary above.
The proposed amendments and new rule ensure that pediatric influenza vaccines are administered by licensed pharmacists in a safe and effective manner. No differing compliance requirements are imposed upon any licensed pharmacist or physician based upon the size of a business.
Housing Affordability Impact Analysis The proposed amendments and new rule will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the proposed amendments and new rule would evoke a change in the average costs associated with housing because the proposed amendments and new rule concern the administration of pediatric influenza vaccines by licensed pharmacists.
Smart Growth Development Impact Analysis The proposed amendments and new rule will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed amendments and 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 the State because the proposed amendments and new rule concern the administration of pediatric influenza vaccines by licensed pharmacists.
Full text of the proposal follows (additions indicated in boldface
thus; deletions indicated in brackets [thus]):
CHAPTER 35
BOARD OF MEDICAL EXAMINERS
SUBCHAPTER 6. GENERAL RULES OF PRACTICE
13:35-6.26 Procedures for physician ordered immunizations performed by licensed pharmacists
(a) A New Jersey licensed physician may participate in an immunization program with a licensed pharmacist pursuant to N.J.S.A. 45:14-63 of the Pharmacy Practice Act, provided that the pharmacist is authorized to engage in such activities by the Board of Pharmacy pursuant to N.J.A.C. 13:39-[4.20]
4.21 and 4.21A, and provided the pharmacist administers vaccines and related emergency medications, which shall be limited to diphenhydramine and epinephrine, pursuant to:
1.-2. (No change.)
(b) A physician shall supervise a licensed pharmacist who is participating in an immunization program implemented pursuant to the physician's standing order. Supervision by the delegating physician shall be deemed adequate if the delegating physician:
1. Is responsible for formulating or approving a standing order, which shall include compliance with Centers for Disease Control and Prevention (CDC) guidelines for vaccine administrations, set forth in Appendix D of "Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book: Course Textbook)," updated 10th edition, February 2007. The CDC vaccine administration guidelines are incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, [http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/appdx-full-d.pdf]
http://www.cdc.gov/vaccines/pubs/pinkbook/appendix/index.html. The standing order shall also include compliance with the American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (2005). The AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care ([2005]
2010) are incorporated herein by reference, as amended and supplemented, and can be found at the AHA website, www.americanheart.org, specifically, [http://circ.ahajournals.org/content/vol112/24-suppl/]
http://circ.ahajournals.org/content/122/16_suppl_2/S250. The order shall also include procedures [which]
that shall be followed for the reporting of adverse events
, which shall include a requirement that adverse events are reported to the physician within 24 hours of notice of the event. The delegating physician shall annually review the order and the services provided to patients under the order;
2.-4. (No change.)
CHAPTER 39
STATE BOARD OF PHARMACY
SUBCHAPTER 4. PHARMACY PERMIT REQUIREMENTS
13:39-4.21A Requirements for pharmacists to administer influenza vaccine to patients under 18 years of age (a) A licensed pharmacist must be authorized to administer vaccines and related emergency medications pursuant to and to comply with the requirements of N.J.A.C. 13:39-4.21. (b) For a patient who is under 18 years of age, a pharmacist must obtain the written consent of the patient's parent or legal guardian. (c) For a patient who is under 12 years of age, but is at least seven years of age, a pharmacist may administer the influenza vaccine only pursuant to a prescription by a licensed physician. (d) A pharmacist shall not administer an influenza vaccine to a patient who is younger than seven years of age.
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)
|
