53 N.J.R. 680(a)

VOLUME 53, ISSUE 9, MAY 3, 2021
RULE PROPOSALS

Reporter
53 N.J.R. 680(a)
NJ - New Jersey Register  >  2021  >  MAY  >  MAY 3, 2021  >  RULE PROPOSALS  >  LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS

Interested Persons Statement 

INTERESTED PERSONS 
Interested persons may submit comments, information or arguments concerning any of the rule proposals in this issue until the date indicated in the proposal. Submissions and any inquiries about submissions should be addressed to the agency officer specified for a particular proposal. 
The required minimum period for comment concerning a proposal is 30 days. A proposing agency may extend the 30-day comment period to accommodate public hearings or to elicit greater public response to a proposed new rule or amendment. Most notices of proposal include a 60-day comment period, in order to qualify the notice for an exception to the rulemaking calendar requirements of  N.J.S.A. 52:14B-3. An extended comment deadline will be noted in the heading of a proposal or appear in a subsequent notice in the Register. 
At the close of the period for comments, the proposing agency may thereafter adopt a proposal, without change, or with changes not in violation of the rulemaking procedures at      N.J.A.C. 1:30-6.3. The adoption becomes effective upon publication in the Register of a notice of adoption, unless otherwise indicated in the adoption notice. Promulgation in the New Jersey Register establishes a new or amended rule as an official part of the New Jersey Administrative Code. 
Agency


LAW AND PUBLIC SAFETY > DIVISION OF CONSUMER AFFAIRS > STATE BOARD OF PHARMACY


Administrative Code Citation


Proposed Amendments: N.J.A.C. 13:39-4.21 and 4.21A


Text

  Procedures for Authorized Prescriber Ordered or Government Sponsored Immunizations Performed by Pharmacists, Pharmacy Interns, or Pharmacy Externs; Requirements for Pharmacists, Pharmacy Interns, or Pharmacy Externs to Administer Influenza Vaccine to Minors
Authorized By: Anthony Rubinaccio, Executive Director, State Board of Pharmacy, and William Roeder, Executive Director, Board of Medical Examiners.
Authority: N.J.S.A. 45:14-47 and P.L. 2018, c. 143.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2021-041.

Submit written comments by July 2, 2021, to:

Anthony Rubinaccio, Executive Director
Board of Pharmacy
124 Halsey Street
PO Box 45013
Newark, New Jersey 07101

or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.

The agency proposal follows:
Summary
The State Board of Pharmacy (Board), in consultation with the Board of Medical Examiners, proposes amendments at N.J.A.C. 13:39-4.21 and 4.21A to implement P.L. 2018, c. 143, amending N.J.S.A. 45:14-63, to allow pharmacy interns and pharmacy externs to administer injectable medications and vaccinations under the direct supervision of a pharmacist. A pharmacy intern is an individual who graduated from a school or college of pharmacy, has applied for licensure by reciprocity and needs to satisfy the Board's practice of pharmacy requirements, or is a graduate student participating in an American Society of Health-System Pharmacists (ASHP) accredited post-graduate pharmacy residency program and who is awaiting licensure. A pharmacy extern is a person who is in the fifth or sixth college year, or the third or fourth professional year, at an American Council of Pharmaceutical Education (ACPE)-approved school or college of pharmacy, who is acquiring practical experience under the supervision of the school or college. As with pharmacists, the pharmacy interns and pharmacy externs must meet the qualifications established by the Board.  
The Board proposes to amend the heading of N.J.A.C. 13:39-4.21 to include reference to pharmacy interns and pharmacy externs. The Board also proposes new subsection (a) to include definitions for the terms "direct supervision" and "supervising pharmacist" that are consistent with the requirements of the new law. N.J.S.A. 45:14-63.b(3) requires that pharmacy externs and pharmacy interns act under the direct supervision of a licensed pharmacist who is pre-approved by the Board to administer vaccines and related emergency medications and complies with the Board's rules at N.J.A.C. 13:39-4.21. Consistent with these statutory requirements, the Board determined that "direct supervision" has the same meaning as the statutory definition of "immediate supervision." Both require that the supervising pharmacist must be physically present at the pharmacy practice site and is responsible for accuracy and safety with respect to the actions of the pharmacy interns and pharmacy externs.  
The Board proposes to amend recodified subsection (b) to reference registered pharmacy interns and pharmacy externs. The Board also proposes to amend recodified subsection (c) to require registered pharmacy interns to obtain Board approval before administering vaccinations and emergency related medications. The process for obtaining Board approval, and the requisite education and training for pharmacy interns are the same as that for pharmacists. The Board proposes to amend recodified paragraph (c)3 to specify that the continuing education requirements are applicable only to licensed pharmacists because pharmacy interns do not have continuing education requirements. Proposed new subsection (d) provides that pharmacy externs must satisfy the same education and training requirements that pharmacy interns do. Because the Board does not register pharmacy externs, proposed subsection (d) also provides that it is the responsibility of the supervising pharmacist to confirm that the pharmacy extern meets the education and training requirements.  
Proposed new subsection (e) provides that a registered pharmacy intern or pharmacy extern who administers vaccines and related emergency medications must act under the direct supervision of the supervising pharmacist.  
The Board proposes to amend recodified subsection (f), which concerns maintaining documentation that evidences the pharmacists meet the required education and training, to reference registered pharmacy interns and pharmacy externs, and to update the cross-references consistent with the proposed recodifications.  
The Board also proposes to amend recodified subsection (g) to provide that the Board's approval granted to licensed pharmacists and registered pharmacy interns to administer vaccines and related emergency medications is valid for two years. If the registered pharmacy intern is eligible to renew, consistent with the Board's rules, as a condition of renewal, the registered pharmacy intern must document current certification in the American Heart Association Basic Life Support (BLS) protocol, the Red Cross Adult Cardiac Pulmonary Resuscitation (CPR) protocol for health care providers, or in a course that complies with guidelines created by the International Liaison Committee on Resuscitation (ILCOR). Consistent with the proposed recodifications, the Board also proposes to update the cross-references at subsection (g).  
The Board proposes to amend recodified subsection (h) to specify that the supervising pharmacist is responsible for maintaining and adhering to a manual of policies and procedures for dealing with acute adverse events, ensuring that a pharmacy intern and pharmacy extern adheres to it, and annually reviewing the policies and procedures manual. The Board also proposes to amend recodified subsection (h) to include reference to pharmacy interns and pharmacy externs.  
The Board proposes to update the cross-references at recodified subsections and paragraph (i), (j)4, (l), (m), and (n). In addition, the Board proposes to amend recodified subsection (j), concerning the required procedures before administering vaccinations, recodified subsection (k), concerning the content of the informed consent, and recodified subsection (l), concerning immunization documentation requirements, to include pharmacy interns and pharmacy externs. The Board also proposes to amend recodified paragraph (l)4 to require documenting the name and address of the supervising pharmacist, as well as that of the registered pharmacy intern or pharmacy extern administering the immunization.  
The Board proposes to amend recodified subsection (m) to require the supervising pharmacist for a registered pharmacy intern or pharmacy extern, to document and report clinically significant adverse events. The Board also proposes to amend recodified subsection (n) to include reference to a registered pharmacy intern or pharmacy extern, and to update the cross-reference, consistent with the proposed recodifications. In addition, the Board proposes to amend recodified subsection (n) to delete reference to reporting to the government reporting system, which is proposed at new subsection (o).  
Proposed new subsection (o) provides that the supervising pharmacist or pharmacist-in-charge shall report an immunization administered to a patient by a pharmacist, pharmacy intern, or pharmacy extern to the New Jersey Immunization Information System established pursuant to N.J.S.A. 26:4-134, as required pursuant to N.J.A.C. 8:57-3.16, for inclusion in the patient's registry. The pharmacist-in-charge or the supervising pharmacist will be required to report to the system, as, and when, required, all immunizations provided by licensed pharmacists, or pharmacy interns and pharmacy externs.  
[page=681] P.L. 2018, c. 143 also amended N.J.S.A. 45:14-63 to change the requirement for a "licensed physician" to "authorized prescriber" to issue a prescription or standing order, as necessary, for a pharmacist, pharmacy intern, or pharmacy extern to administer a vaccine or emergency medication. Consistent with this statutory amendment, the Board proposes to amend all references to "New Jersey licensed physician" or "physician" to "New Jersey authorized prescriber" throughout N.J.A.C. 13:39-4.21 and 4.21A.  
N.J.A.C. 13:39-4.21A concerns the requirements for pharmacists to administer the influenza vaccine to patients under 18 years of age. The Board also proposes to amend N.J.A.C. 13:39-4.21A to include reference to pharmacy interns and pharmacy externs. Consistent with the statutory changes at N.J.S.A. 45:14-63.c(2), the Board proposes to amend subsection (c), such that for patients between seven and 10 years of age, reduced from 12, the influenza vaccine may be administered only pursuant to a prescription.  
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 amendments will have a positive social impact by clearly delineating the parameters for pharmacy interns and pharmacy externs to administer vaccinations and related emergency medications, and the responsibilities of the supervising pharmacists. In addition, the proposed amendments may benefit the public to the extent it expands access to vaccinations at pharmacy practice sites throughout the State.  
Economic Impact  
The Board believes that the proposed amendments may have a minimal economic impact to the extent there are costs associated with the supervision of pharmacy interns and pharmacy externs administering vaccines.  
Federal Standards Statement  
A Federal standards analysis is not required because the proposed amendments are governed by N.J.S.A. 45:14-40 et seq., and there are no Federal laws or standards applicable to the proposed amendments.  
Jobs Impact  
The Board does not anticipate that the proposed amendments will increase or decrease jobs in the State.  
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  
Currently, the Board licenses approximately 18,000 pharmacists. If these pharmacists are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies. Pharmacy interns and pharmacy externs are not considered small businesses because they cannot engage in independent practice.  
The proposed amendments impose new compliance, recordkeeping, and reporting requirements upon those pharmacists who will be responsible for supervising pharmacy externs and pharmacy interns, which are discussed in the Summary above. The costs associated with compliance with the proposed amendments are discussed in the Economic Impact. The Board believes that the proposed amendments should be uniformly applied to all supervising pharmacists, pharmacy externs, and pharmacy interns and, therefore, no differing compliance requirements for any businesses are provided based upon size.  
Housing Affordability Impact Analysis  
The proposed amendments will have an insignificant impact on the affordability 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 the administration of vaccinations and related emergency medications by pharmacy externs and pharmacy interns.  
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 because the proposed amendments concern the administration of vaccinations and related emergency medications by pharmacy externs and pharmacy interns.  
Racial and Ethnic Community Criminal Justice and Public Safety Impact  
The Board has evaluated this rulemaking and determined that it will not have an impact on pretrial detention, sentencing, probation, or parole policies concerning adults and juveniles in the State. Accordingly, no further analysis is required.  
Full text of the proposal follows (additions indicated in boldface  thus; deletions indicated in brackets [thus]):  
SUBCHAPTER 4.   PHARMACY PERMIT REQUIREMENTS  
13:39-4.21  Procedures for [physician]   authorized prescriber ordered or government sponsored immunizations performed by pharmacists, pharmacy interns, or pharmacy externs  
(a) The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.  
"Direct supervision" shall have the same meaning as "immediate supervision" as set forth at N.J.S.A. 45:14-41.  
"Supervising pharmacist" means a licensed pharmacist authorized to administer vaccines and related emergency medications pursuant to the requirements of this section, and who is responsible for the direct supervision of a registered pharmacy intern or pharmacy extern administering immunizations to patients pursuant to this section.  
[(a)]  (b) The provisions of this section set forth the requirements for licensed pharmacists, registered pharmacy interns, and pharmacy externs authorized to administer vaccines and related emergency medications, which shall be limited to diphenhydramine and epinephrine, to eligible patients who are 18 years of age and older, consistent with the requirements [of]   at N.J.S.A. 45:14-63, under the following circumstances:  
1. Pursuant to a prescription by a New Jersey [licensed physician]   authorized prescriber for a vaccine, related emergency medications, and pharmacist, pharmacy intern, or pharmacy extern administration of the vaccine that is patient specific;  
2. In immunization programs implemented pursuant to a New Jersey [licensed physician's]   authorized prescriber's standing order for the vaccine, related emergency medications, and administration instructions that are not patient specific; and/or  
3. (No change.)  
[(b)]   (c) In order to administer vaccines and related emergency medications pursuant to this section, a licensed pharmacist   and registered pharmacy intern shall be pre-approved by the Board to perform such functions. In order to obtain such prior Board approval, a pharmacist   or   pharmacy intern shall submit documentation to the Board that establishes that he or she has satisfied the following education and training requirements:  
1.-2. (No change.)  
3. [At]   For a licensed pharmacist, at least two hours of continuing education in immunizations, consistent with the requirements [of]   at N.J.A.C. 13:39-3A.1, in each biennial renewal period.  
(d)   In order to administer vaccines and related emergency medications pursuant to this section, a pharmacy extern shall satisfy the education and training requirements at (c)1 and 2 above, which shall be confirmed by the supervising pharmacist.  
(e) A registered pharmacy intern or pharmacy extern who administers vaccines and related emergency medications pursuant to this section shall act under the direct supervision of the supervising pharmacist.  
[page=682] [(c)]  (f) Documentation which establishes that a licensed pharmacist, registered pharmacy intern, or pharmacy extern has satisfied the education and training requirements [of (b)]   at   (c) above shall be maintained at the pharmacy practice site. If the immunization program is to take place somewhere other than the pharmacy practice site, the documentation shall be maintained in the licensed pharmacist's, registered pharmacy intern's, or pharmacy extern's, as applicable, possession at the immunization location. Such documentation shall be made available for inspection by the Board.  
[(d)]   (g) Board approval granted   to a licensed pharmacist and registered pharmacy intern pursuant to this section shall be renewed on a biennial basis. A pharmacist seeking such renewal shall submit documentation which establishes that he or she has satisfied the requirements [of (b)2]   at (c)2 and 3 above.   A registered pharmacy intern seeking such renewal shall submit documentation that establishes that he or she has satisfied the requirements at (c)2 above and the number of such renewals shall be consistent with N.J.A.C. 13:39-2.7(d).  
[(e)]   (h) [A physician's]   An authorized prescriber's standing order shall specify the procedures that shall be followed for the reporting of adverse events. The licensed pharmacist   and supervising pharmacist shall maintain and adhere to a manual of policies and procedures for dealing with acute adverse events.   The supervising pharmacist shall ensure that a pharmacy intern and pharmacy extern adheres to the manual of policies and procedures for dealing with acute adverse events. The policies and procedures manual shall require, at a minimum, that the pharmacist, pharmacy intern, or pharmacy extern, as applicable, immediately notify emergency medical personnel and obtain assistance for the patient when an adverse event requiring the administration of emergency medications occurs. The policies and procedures manual shall be reviewed annually by the licensed pharmacist   and supervising pharmacist and such review shall be documented.  
[(f)]   (i) [Physicians']   Authorized prescribers' standing orders shall be maintained in either hard copy or electronic form as provided [in (l)]   at   (p) below, and shall be available for inspection by the Board at the pharmacy practice site and, if applicable, at the immunization location.  
[(g)]   (j) Before administration of a vaccine, the licensed pharmacist, registered pharmacy intern, or pharmacy extern, as applicable, shall:  
1.-3. (No change.)  
4. Obtain a signed informed consent form, which complies with the requirements [of (h)]   at    (k) below, from the patient or the patient's representative, which shall be maintained at the pharmacy practice site. If the immunization program is to take place somewhere other than the pharmacy practice site, the signed informed consent forms shall be maintained in the licensed pharmacist's, registered pharmacy intern's, or pharmacy extern's, as applicable, possession at the immunization location, and then transferred to the pharmacy practice site. The signed informed consent forms shall be maintained in either hard copy or electronic form as provided [in (l)]   at   (p) below.  
[(h)]   (k) The informed consent form provided by a licensed pharmacist, registered pharmacy intern, or pharmacy extern, as applicable, to a patient shall contain a check-off box which authorizes the pharmacist, pharmacy intern, or pharmacy extern, as applicable, to send copies of the patient's vaccine documentation to the patient's primary care provider, and another check-off box which prohibits the pharmacist, pharmacy intern, or pharmacy extern, as applicable, from sending copies of the patient's vaccine documentation to the patient's primary care provider. The informed consent form shall specify that a patient's failure to select one of the two check-off boxes shall result in the patient's vaccine documentation being sent to the patient's primary care provider, if identified.  
[(i)]   (l) The licensed pharmacist, registered pharmacy intern, or pharmacy extern, as applicable, shall document all immunizations he or she performs and such documentation shall be maintained at the pharmacy practice site. If the immunization program is to take place somewhere other than the pharmacy practice site, the documentation shall be maintained in the licensed pharmacist's, registered pharmacy intern's, or pharmacy extern's, as applicable, possession at the immunization location, and then transferred to the pharmacy practice site. Such documentation shall be retained in either hard copy or electronic form, consistent with [(l)]   (p) below, and shall be made available for inspection by the Board. Such documentation shall include:  
1.-3. (No change.)  
4. The name and address of the [delegating physician]   authorized prescriber   and supervising pharmacist, if applicable, and the name and address of the licensed pharmacist, registered pharmacy intern, or pharmacy extern administering the dose, and the immunization location, if different from the pharmacy practice site; and  
5. (No change.)  
[(j)]   (m) The licensed pharmacist   or, as applicable, supervising pharmacist for a registered pharmacy intern or pharmacy extern shall document in detail and immediately report all clinically significant adverse events to the [delegating physician]   authorized prescriber, and to the primary care provider, if identified and if authorized on the informed consent form consistent with [(h)]   (k) above. The licensed pharmacist   or supervising pharmacist, as applicable, shall, within 72 hours, report such events to the appropriate government reporting system.  
[(k)]   (n) The licensed pharmacist, registered pharmacy intern, or pharmacy extern, as applicable, shall provide a copy of all patient related documentation and a copy of the signed informed consent form to each patient receiving an immunization, or to the patient's representative, to the patient's primary care provider, if provided and if authorized on the informed consent form consistent with [(h)]   (k) above[, and if applicable, to the appropriate government reporting system].  
(o)   The supervising pharmacist or pharmacist-in-charge shall report an immunization administered to a patient by a pharmacist, pharmacy intern, or pharmacy extern to the New Jersey Immunization Information System, established pursuant to N.J.S.A. 26:4-134, as required pursuant to N.J.A.C. 8:57-3.16, for inclusion in the patient's registry.  
Recodify existing (l)-(m) as   (p)-  (q) (No change in text.)  
13:39-4.21A  Requirements for pharmacists, pharmacy interns, and pharmacy externs to administer influenza vaccine to patients under 18 years of age  
(a) A licensed pharmacist, registered pharmacy intern, and pharmacy extern must be authorized to administer vaccines and related emergency medications pursuant to and to comply with the requirements [of]   at N.J.A.C. 13:39-4.21.  
(b) For a patient who is under 18 years of age, a   licensed  pharmacist [must], registered pharmacy intern, or pharmacy extern, as applicable,   shall obtain the written consent of the patient's parent or legal guardian.  
(c) For a patient who is under [12]   10  years of age, but is at least seven years of age, a   licensed pharmacist, registered pharmacy intern, or pharmacy extern may administer the influenza vaccine only pursuant to a prescription by [a licensed physician]   an authorized prescriber.  
(d) A   licensed  pharmacist, registered pharmacy intern, or pharmacy extern shall not administer an influenza vaccine to a patient who is younger than seven years of age.