EDU-40-15-00005-A Administration of Vaccinations by Pharmacists, Including Immunizations to Prevent Tetanus, Diphtheria or Pertussis Disease

12/30/15 N.Y. St. Reg. EDU-40-15-00005-A

NEW YORK STATE REGISTER

VOLUME XXXVII, ISSUE 52

December 30, 2015

RULE MAKING ACTIVITIES

EDUCATION DEPARTMENT

NOTICE OF ADOPTION

 

I.D No. EDU-40-15-00005-A

Filing No. 1098

Filing Date. Dec. 15, 2015

Effective Date. Dec. 30, 2015

Administration of Vaccinations by Pharmacists, Including Immunizations to Prevent Tetanus, Diphtheria or Pertussis Disease

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:

Action taken:

Amendment of section 63.9 of Title 8 NYCRR.

Statutory authority:

Education Law, sections 207 (not subdivided), 6504 (not subdivided), 6507(2)(a), 6527(7), 6801(2), (4), 6802(22) and 6909(7); L. 2015, ch. 46

Subject:

Administration of vaccinations by pharmacists, including immunizations to prevent tetanus, diphtheria or pertussis disease.

Purpose:

To implement chapter 46 of the Laws of 2015 to authorize pharmacists to administer tetanus, diphtheria or pertussis vaccinations.

Text of final rule:

1. Paragraph (1) of subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education is amended, effective December 30, 2015, as follows:

(b) Immunizations.

(1) Pursuant to section 6801 of the Education Law, a pharmacist with a certificate of administration issued by the department pursuant to paragraph (3) of this subdivision shall be authorized to administer immunization agents prescribed in paragraph (2) of this subdivision to patients therein specified, provided that:

(i) . . .

(ii) with respect to non-patient specific orders:

(a) the immunization is prescribed or ordered by a licensed physician or a certified nurse practitioner with a practice site in the county or adjoining county in which the immunization is administered; [or] and

(b) [if the immunization is administered in a county with a population of 75,000 or less, the immunization shall be prescribed or ordered by a licensed physician or certified nurse practitioner with a practice site in the county in which the immunization is administered or in an adjoining county.] if the commissioner of health determines that there is an outbreak of disease, or that there is the imminent threat of an outbreak of disease, then the commissioner of health may issue a non-patient specific regimen applicable statewide.

2. Paragraph (2) of subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education is amended, effective December 30, 2015, as follows:

(2) Authorized immunization agents. A certified pharmacist who meets the requirements of this section shall be authorized to administer to patients 18 years of age or older,[:

(i)] immunizing agents to prevent influenza, pneumococcal, [disease or] acute herpes zoster, meningococcal, tetanus, diphtheria or pertussis disease, pursuant to a patient specific order or a non-patient specific order.[; and

(ii) immunizing agents to prevent acute herpes zoster, pursuant to a patient specific order.]

3. Paragraph (4) of subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education is amended, effective December 30, 2015, as follows:

(4) 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) a certified pharmacist shall inform each recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, of potential side effects and adverse reactions, orally and in writing, prior to immunization and shall administer the immunization or immunizations according to the most current recommendations by the advisory committee for immunization practices (ACIP), provided, however, that a pharmacist may administer any immunization authorized when specified by a patient specific prescription;

(iv) . . .

(v) . . .

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

(vii) . . .

(viii) . . .

(ix) . . .

(x) . . .

(xi) 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[.];

(xii) 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

(xiii) Reporting of administration of immunizing agent.

(a) For administrations prior to December 27, 2015, when a licensed pharmacist administers an immunizing agent, he or she shall report such administration 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.

(b) For administrations on or after December 27, 2015, 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.

Final rule as compared with last published rule:

Nonsubstantive changes were made in section 63.9(b)(4)(xiii)(b).

Text of rule and any required statements and analyses may be obtained from:

Kirti Goswami, State Education Department, Office of Counsel, State Education Building, Room 148, 89 Washington Ave., Albany, NY 12234, [phone], email: [e-mail]

Revised Regulatory Impact Statement

Since the publication of a Notice of Emergency Adoption and Proposed Rule Making in the State Register on October 7, 2015, a nonsubstantial revision was made in order to clarify the text of the proposed regulation as follows:

Clause (b) of subparagraph (xiii) of paragraph (4) of subdivision (b) of section 63.9, was revised to add a citation to section “11.07 of the New York City Health Code” to clarify the requirement that pharmacists administering immunizations shall report such administration to the patient’s attending primary health care practitioner or practitioners, 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.

The above nonsubstantial revision does not require any changes to the previously published Regulatory Impact Statement.

Revised Regulatory Flexibility Analysis

Since the publication of a Notice of Emergency Adoption and Proposed Rule Making in the State Register on October 7, 2015, a nonsubstantial revision was made to the proposed regulation as set forth in the Statement Concerning the Regulatory Impact Statement submitted herewith.

The above nonsubstantial revision does not require any changes to the previously published Statement in Lieu of Regulatory Flexibility Analysis for Small Businesses and Local Governments.

Revised Rural Area Flexibility Analysis

Since the publication of a Notice of Emergency Adoption and Proposed Rule Making in the State Register on October 7, 2015, a nonsubstantial revision was made to the proposed regulation as set forth in the Statement Concerning the Regulatory Impact Statement submitted herewith.

The above nonsubstantial revision does not require any changes to the previously published Rural Area Flexibility Analysis.

Revised Job Impact Statement

Since the publication of a Notice of Emergency Adoption and Proposed Rule Making in the State Register on October 7, 2015, a nonsubstantial revision was made to the proposed regulation as set forth in the Statement Concerning the Regulatory Impact Statement submitted herewith.

The revised proposed amendment is necessary to implement Chapter 46 of the Laws of 2015 relating to the administration of immunizations by certified pharmacists.

The revised proposed amendment will not have a substantial impact on jobs and employment opportunities. Because it is evident from the nature of the revised proposed rule that it will not affect job and employment opportunities, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a job impact statement is not required, and one has not been prepared.

Initial Review of Rule

As a rule that requires a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2020, which is the 4th or 5th year after the year in which this rule is being adopted. This review period, justification for proposing same, and invitation for public comment thereon, were contained in a RFA, RAFA or JIS.

An assessment of public comment on the 4 or 5-year initial review period is not attached because no comments were received on the issue.

Assessment of Public Comment

Since publication of a Notice of Emergency Adoption and Proposed Rule Making in the October 7, 2015 State Register, the State Education Department received the following comment:

COMMENT:

The New York City Department of Health and Mental Hygiene requested an additional citation for the reporting requirement to the citywide immunization registry, by pharmacists, to reflect section 11.07 of the New York City Health Code.

DEPARTMENT RESPONSE:

The Department concurs with this nonsubstantial change, which is consistent with regulation and practice, and has amended the proposed rule accordingly.