N.J. Admin. Code § 13:39-4.21

Current through Register Vol. 56, No. 9, May 6, 2024

Section 13:39-4.21 - Procedures for 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.

(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 at N.J.S.A. 45:14-63, under the following circumstances:

1. Pursuant to a prescription by a New Jersey 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 authorized prescriber's standing order for the vaccine, related emergency medications, and administration instructions that are not patient specific; and/or

3. In immunization programs sponsored by government agencies that are not patient specific.

(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. Completion of an academic and practical curriculum that includes instruction in Centers for Disease Control and Prevention (CDC) guidelines for vaccine administrations, set forth in Chapter 6, Vaccine Administration, of "Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book: Course Textbook)," updated 13th edition, 2015. 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/vac-admin.html. The instruction shall be offered by a provider accredited by the Accreditation Council for Pharmacy Education (ACPE). The curriculum shall include the following subjects:

i. The Occupational Exposure to Bloodborne Pathogens standard of the Occupational Health and Safety Administration (OSHA), set forth at 29 C.F.R. § 1910.1030, and the New Jersey Public Employees Occupational Safety and Health (PEOSH) Act, set forth at N.J.S.A. 34:6A-25" et seq., incorporated herein by reference;

ii. CDC Guideline for Infection Control in Health Care Personnel (1998). The CDC Guideline for Infection Control in Health Care Personnel (1998) 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/hicpac/pdf/infectcontrol98.pdf;

iii. Basic immunology;

iv. Communicable or vaccine preventable disease epidemiology;

v. Vaccine characteristics, contraindications, monitoring, proper storage and proper handling;

vi. Informed consent;

vii. Pre- and post-vaccine assessment and counseling;

viii. Immunization record management;

ix. Immunization schedules established pursuant to "General Recommendations on Immunization" of the CDC Advisory Committee on Immunization Practices (ACIP) (December 1, 2006), incorporated herein by reference, as amended and supplemented. The ACIP recommendations can be found at the CDC website, www.cdc.gov, specifically, http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5515a1.htm;

x. Injection techniques;

xi. Emergency responses to adverse events;

xii. Medical waste disposal; and

xiii. Reporting adverse events;

2. 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). The ILCOR guidelines, 2010 International Consensus on Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC) Science with Treatment Recommendations, are incorporated herein by reference, as amended and supplemented, and can be found at the American Heart Association website, http://americanheart.org/presenter.jhtml?identifier=3022512, specifically, http://circ.ahajournals.org/content/122/16_suppl_2/S250; and

3. For a licensed pharmacist, at least two hours of continuing education in immunizations, consistent with the requirements 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.

(f) Documentation which establishes that a licensed pharmacist, registered pharmacy intern, or pharmacy extern has satisfied the education and training requirements 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.

(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 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).

(h) 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.

(i) Authorized prescribers' standing orders shall be maintained in either hard copy or electronic form as provided at (p) below, and shall be available for inspection by the Board at the pharmacy practice site and, if applicable, at the immunization location.

(j) Before administration of a vaccine, the licensed pharmacist, registered pharmacy intern, or pharmacy extern, as applicable, shall:

1. Screen the patient using CDC established criteria for each specific vaccine to be administered;

2. Counsel the patient and/or the patient's representative about contraindications, proper care of the injection site, and instructions to contact a physician or emergency care facility in the event of any adverse reaction;

3. Inform the patient and/or the patient's representative in writing, in specific and readily understood terms, about the risks and benefits of the vaccine and provide the patient with a vaccine information sheet published by the CDC; and

4. Obtain a signed informed consent form, which complies with the requirements 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 at (p) below.

(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.

(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 (p) below, and shall be made available for inspection by the Board. Such documentation shall include:

1. The patient's name, address, telephone number, date of birth, allergies and gender;

2. The vaccine administered, the manufacturer, expiration date, lot number, site of administration, and dose administered;

3. The date of original order and the date of administration(s);

4. The name and address of the 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. The name and address of the patient's primary care provider, if provided.

(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 authorized prescriber, and to the primary care provider, if identified and if authorized on the informed consent form consistent with (k) above. The licensed pharmacist or supervising pharmacist, as applicable, shall, within 72 hours, report such events to the appropriate government reporting system.

(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 (k) above.

(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.

(p) All documentation and records required to be maintained by this section shall be maintained in either hard copy or electronic form for a period of not less than seven years from the date of most recent entry and shall be supplied to any physician or health care provider upon receipt of a signed patient release of health information form. All records shall be made available to persons authorized to inspect them under State and Federal statutes and regulations. The oldest six years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but the storage facilities shall be secure. Patient records shall be kept confidential.

(q) In the case of immunization programs implemented pursuant to a physician's standing order, a licensed pharmacist shall be supervised by the delegating physician. Supervision by the delegating physician shall be deemed adequate if the delegating physician:

1. Is responsible for formulating or approving a standing order, periodically reviewing the order and the services provided to patients under the order;

2. Is geographically located to be easily accessible to the pharmacy practice site and, if applicable, to the immunization location.

3. Is available through direct telecommunication for consultation, assistance, and direction; and

4. Receives annual status reports on the immunization program as administered by the pharmacist.

N.J. Admin. Code § 13:39-4.21

Amended by 49 N.J.R. 3761(a), effective 12/4/2017

Amended by 54 N.J.R. 449(a), effective 3/7/2022