(2) A pharmacy intern that has completed a training course associated with Doctor of Pharmacy degree pursuant to the requirements in section 63.9(b)(3)(ii).

2. Subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education is amended, as follows:

(b) Immunizations

(1) …

(2) …

(3) …

(4) With the exception of a certified pharmacy intern, a certified pharmacist shall not delegate the administration of immunizations to another person. For purposes of this section, a certified pharmacy intern shall mean a pharmacy intern who is certified to administer immunization as specified in section 6806 of the Education Law and has completed the requirements set forth in subdivision (d) of section 63.4 of this Part. Such a certified pharmacy intern may only administer immunizations under the immediate personal supervision of the certified pharmacist.

[(4)] (5) Standards, procedures and reporting requirements for the administration of immunization agents. Each certified pharmacist shall comply with the following requirements when administering an immunization agent pursuant to either a patient specific order or a non-patient specific order and protocol:

(i) . . .

(ii) . . .

(iii) . . .

(iv) . . .

(v) a certified pharmacist shall not allow a certified pharmacy intern to administer immunizations unless the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, is informed that the pharmacy intern will be administering the immunization and the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, consents to administration of the immunization by the certified pharmacy intern. If the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, does not consent to administration by the certified pharmacy intern, then the option to receive the immunization from a certified pharmacist shall be provided.

[(v)] (vi) a certified pharmacist shall provide written instructions to the recipient regarding the appropriate course of action in the event of contraindications or adverse reactions, which statements are required to be developed by a competent entity knowledgeable about the adverse reactions of the immunization agent which shall be administered, such as the Centers for Disease Control of the U.S. Department of Health and Human Services, which issues vaccine information statements;

[(vi)] (vii) a certified pharmacist, when administering an immunization in a pharmacy, shall provide for an area that provides for the patient’s privacy, such area shall include:

(a) a clearly visible posting of the most current “Recommended Adult Immunization Schedule” published by the advisory committee for immunization practices (ACIP);

(b) education materials on influenza vaccines for children as determined by the commissioner and the commissioner of the department of health.

[(vii)] (viii) a certified pharmacist shall provide a copy of the appropriate vaccine information statement to the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, before administering the immunization;

[viii] (ix) a certified pharmacist shall provide to each recipient or other person legally responsible when the recipient is incapable of consenting to immunization, a signed certificate of immunization with the recipient’s name, date of immunization, address of administration, administering pharmacist, immunization agent, manufacturer and lot number. With the consent of the recipient or a person legally responsible when the recipient is incapable of consenting, the certified pharmacist shall communicate this information to the recipient’s primary health care practitioner, if one exists, within one month of the administration of such immunization, and such communication may be transmitted in electronic format;

[(ix)] (x) a certified pharmacist shall report any adverse outcomes as may be required by Federal law on the vaccine adverse event reporting system form of the Centers for Disease Control of the U.S. Department of Health and Human Services, or on the successor form;

[(x)] (xi) a certified pharmacist shall ensure that a record of all persons immunized including the recipient’s name, date, address of administration, administering pharmacist, immunization agent, manufacturer and lot number is recorded and maintained in accordance with section 29.2(a)(3) of this Title;

[(xi)] (xii) to the extent required by the Public Health Law, the Education Law and/or the New York City Health Code, a certified pharmacist shall report the administration of any immunizations to the New York State Department of Health and/or the New York City Department of Health and Mental Hygiene, in a manner required by the Commissioner of Health of the State of New York or of the City of New York, as applicable. Such report shall not include any individually identifiable health information unless:

(a) such information is otherwise required by law; or

(b) the recipient has consented to the disclosure of such information, in which case the information may be included to the extent permitted by law; and

[(xii)] (xiii) each certified pharmacist shall provide information to recipients on the importance of having a primary health care practitioner, in a form or format developed by the Commissioner of Health;

[(xiii)] (xiv) each certified pharmacist shall, prior to administering the immunization or immunizations, inform the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, of the total cost of the immunization or immunizations, subtracting any health insurance subsidization, if applicable. In the case where the immunization is not covered, the pharmacist shall inform the recipient, or other person legally responsible for the recipient when the patient is incapable of consenting to the immunization, that the immunization may be covered when administered by a primary care physician or health care practitioner; and

[(xiv)] (xv) Reporting of administration of immunizing agent;

(a) when a licensed pharmacist administers an immunizing agent, he or she shall report such administration by electronic transmission or facsimile to the patient’s attending primary health care practitioner or practitioners, if any, unless the patient is unable to communicate the identity of his or her primary health care practitioner, and, to the extent practicable, make himself or herself available to discuss the outcome of such immunization, including any adverse reactions, with the attending primary health care practitioner, or to the statewide immunization registry or the citywide immunization registry, as established pursuant to sections 2168 of the Public Health Law and 11.07 of the New York City Health Code, respectively.

A Notice of Emergency Adoption and Proposed Rulemaking was published in the State Register on January 30, 2019. A second Notice of Emergency Adoption was published in the State Register on April 24, 2019. Technical amendments were made to the proposed rulemaking to correct an error in §§ 63.4(d) and 63.9(b)(4) which incorrectly cited Education Law § 6808 instead of Education Law § 6806. However, no revisions are required to the previously published Regulatory Impact Statement published on April 24, 2019.

A Notice of Emergency Adoption and Proposed Rulemaking was published in the State Register on January 30, 2019. A second Notice of Emergency Adoption was published in the State Register on April 24, 2019. However, no revisions are required to the previously published Regulatory Flexibility Analysis published on April 24, 2019.

A Notice of Emergency Adoption and Proposed Rulemaking was published in the State Register on January 30, 2019. A second Notice of Emergency Adoption was published in the State Register on April 24, 2019. However, no revisions are required to the previously published Rural Area Flexibility Analysis published on April 24, 2019.

A Notice of Emergency Adoption and Proposed Rulemaking was published in the State Register on January 30, 2019. A second Notice of Emergency Adoption was published in the State Register on April 24, 2019. However, no revisions are required to the previously published Job Impact Statement published on April 24, 2019.

As a rule that requires a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2021, which is no later than the 3rd year after the year in which this rule is being adopted.

Since publication of a Notice of Emergency Adoption and Proposed Rule Making in the January 30, 2019 State Register, the State Education Department received the following comments:

1. COMMENT:

A New York State school of pharmacy professor noted that the citations to Education Law § 6808 in §§ 63.4(d) and 63.9(b)(4) of the proposed rule appeared to be incorrect.

This commenter also supported the amendments to § 63.4(d) because they provide schools the opportunity to train student interns in the specifics of becoming competent to administer vaccines under the supervision of a certified pharmacist. Commenter further asserted that New York’s schools of pharmacy are eminently well-qualified to do this. Commenter sought clarification on how the required training courses in the administration of immunizations would be approved by the Commissioner and the Commissioner of Health.

Additionally, commenter asked whether a properly qualified pharmacy intern, under 63.4(d), in the beginning of his/her second year of pharmacy school and engaged clinically (administering vaccines) through the next third year, would need to repeat the required training to become certified to administer immunizations once he/she became a licensed pharmacists Commenter asserted that this would be unnecessarily duplicative and a waste of resources.

DEPARTMENT RESPONSE:

Subsequent to the publication of the proposed rule in the State Register, Department staff discovered that the proposed rule inadvertently cited Education Law § 6808 in two of its provisions, instead of Education Law § 6806. Consequently, non-substantial revisions were made to replace the citations to Education Law § 6808 with citations to Education Law § 6806.

Regarding the approval of training programs, registered pharmacy programs need not obtain separate approval from SED to provide the training required for pharmacy interns to obtain a certificate of administration. Most, if not all, of these registered pharmacy programs presently include immunization administration as part of their respective curriculum and use the American Pharmacists Association (APhA) immunization certification program. Thus, the vaccination administration training that pharmacy interns will be taking has already been approved by SED.

In addition to the APhA immunization certification program, SED currently accepts completion of training in the administration of immunization agents received as part of a Doctor of Pharmacy degree program for licensed pharmacists seeking immunization certification. SED will accept this same training for pharmacy interns seeking immunization certification.

Students that have been engaged in continuous practice in the administration of immunization will not have to repeat this training to become certified to administer immunizations once they become licensed pharmacists. But they will have to submit the pharmacist immunization certification form to SED and attach a copy of an approved course completion certificate in immunization, as well as a copy of a current valid course completion card in Basic Life Support or its equivalent. As stated above, acceptable training for this purpose includes completion of training in the administration of immunization agents received as part of a Doctor of Pharmacy degree program.

In cases where a student has not been engaged in continuous practice in the administration of immunizations, he/she would be required to retake the 20-hour coursework in order to obtain immunization certification once he/she becomes a licensed pharmacist. SED disagrees with the commenter’s position that this retraining issue needs to be explicitly addressed in the final regulations and does not believe amendments are necessary. However, the commenter’s suggestions are noted and may be addressed by the Department in future guidance.