Administration of immunization agents by certified pharmacists.
Purpose:
Establish criteria for the certification of licensed pharmacists and requirements for the administration of immunizations.
Substance of revised rule:
The Board of Regents proposes to amend the Regulations of the Commissioner of Education by adding a new section 63.9, effective December 3, 2008. Section 63.9 of the Regulations of the Commissioner of Education is added to establish requirements relating to the administration of immunizations for the prevention of influenza and pneumococcal disease and medications for the emergency treatment of anaphylaxis by certified pharmacists.
Section 63.9(a) defines the applicability of the provision, authorizing certified pharmacists to administer certain immunization agents and medications for the emergency treatment of anaphylaxis only to the extent that the applicable provisions in Education Law sections 6527, 6801, 6802, 6828 and 6909 have not expired or been repealed.
Sections 63.9(b)(1) and (b)(2) provide that a pharmacist with a certificate of administration issued by the Department is authorized to administer immunization agents to prevent influenza or pneumoccoccal disease to patients over the age of 18, pursuant to either a patient specific order or non-patient specific order and protocol ordered by a licensed physician or certified nurse practitioner with a practice site in the county in which the immunization is administered. 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.
Section 63.9(b)(3) establishes the requirements that a licensed pharmacist must meet in order to obtain a certificate to administer immunizations from the Department. The licensed pharmacist shall submit an application with the required fee and present satisfactory evidence of completion of one of the following: (1) a training course in the administration of immunizations acceptable to the Commissioner and the Commissioner of Health; (2) a training course associated with a Doctor of Pharmacy degree; or (3) possession of a current certificate of administration issued by another jurisdiction and continuous practice in the administration of immunizing agents since the pharmacist received such training or completion of a retraining program in the administration of immunization agents.
Section 63.9(b)(4) establishes the standards, procedures and reporting requirements for the administration of immunizing agents.
Section 63.9(b)(5)(i) provides that certified pharmacists shall maintain or ensure the maintenance of a copy of the patient specific order or the non-patient specific order and protocol prescribed by a licensed physician or a certified nurse practitioner which authorizes the certified pharmacist to administer immunization agents. This section prescribes the information required to be included in patient specific orders and non-patient specific orders and protocol. Such orders and protocol shall be considered a record of the patient. The pharmacist shall maintain a record of the patient in either: (a) a patient medication profile, or (b) in instances where a patient medication profile is not required, on a separate form that is retained by the pharmacist who administered the immunization.
Section 63.9(b)(5)(ii) establishes the contents of patient specific orders and non-patient specific orders.
Section 63.9(b)(5)(iii) specifies additional provisions required to be included in non-patient specific orders, including the incorporation of a protocol.
Section 63.9(b)(5)(iv) requires the protocol, incorporated into the non-patient specific order, to include the standards, procedures and reporting requirements set forth in section 63.9(b)(4).
Section 63.9(c)(1) authorizes certified pharmacists to administer medications for the emergency treatment of anaphylaxis.
Section 63.9(c)(2) establishes the standards, procedures and reporting requirements for the administration of anaphylaxis treatment agents by certified pharmacists.
Section 63.9(c)(3)(i) requires a certified pharmacist to maintain or ensure the maintenance of a copy of the non-patient specific order and protocol prescribed by a licensed physician or a certified nurse practitioner that authorizes such pharmacist to administer medications for the emergency treatment of anaphylaxis. This section requires a record of each patient to be maintained in either a patient medication profile, or in instances where a patient medication profile does not exist, on a separate form that is retained by the pharmacist who has administered the immunization.
Section 63.9(c)(3)(ii) provides that the non-patient specific order shall authorize one or more named pharmacists, or certified pharmacists who are not individually named but are identified as employed or under contract with an entity that is legally authorized to employ or contract with pharmacists to provide pharmaceutical services, to administer specified anaphylaxis treatment agents in specified circumstances for a prescribed period of time. This subparagraph also prescribes the content for such non-patient specific orders.
Section 63.9(c)(3)(iii) requires that the protocol to be incorporated into the non-patient specific order include the requirements set forth in section 63.9(c)(2).
Revised rule compared with proposed rule:
Substantial revisions were made in section 63.9(b)(4)(x).
Text of revised proposed rule and any required statements and analyses may be obtained from
Lisa Struffolino, New York State Education Department, 89 Washington Avenue, Room 148, Albany, NY 12234, (518) 473-4921, email: lstruffo@mail.nysed.gov
Data, views or arguments may be submitted to:
Frank Munoz, New York State Education Department, 2nd Floor, West Wing, Education Building, Albany, NY 12234, (518) 486-1965, email: opopr@mail.nysed.gov
Public comment will be received until:
30 days after publication of this notice.
Revised Regulatory Impact Statement
Since publication of a Notice of Proposed Rule Making in the State Register on November 19, 2008, the following substantial revisions were made to the proposed rule:
Section 63.9(b)(4)(x) has been revised to clarify that a certified pharmacist shall report the administration of any immunizations to the New York State Department of Health and/or to the New York City Department of Health and Mental Hygiene, in a manner required by either the Commissioner of Health of the State of New York or of the City of New York, as applicable.
The above revisions to the proposed rule do not require any revisions to the previously published Regulatory Impact Statement.
Revised Regulatory Flexibility Analysis
Since publication of a Notice of Proposed Rule Making in the State Register on November 19, 2008, the proposed rule was revised as set forth in Statement Concerning the Regulatory Impact Statement filed herewith.
The above revisions to the proposed rule do not require any revisions to the previously published Regulatory Flexibility Analysis.
Revised Rural Area Flexibility Analysis
Since publication of a Notice of Proposed Rule Making in the State Register on November 19, 2008, the proposed rule was revised as set forth in the Revised Regulatory Impact Statement filed herewith.
The above revisions to the proposed rule do not require any revisions to the previously published Rural Area Flexibility Analysis.
Revised Job Impact Statement
Since publication of the Notice of Proposed Rule Making in the State Register on November 19, 2008, the proposed rule was revised as set forth in the Statement Concerning the Regulatory Impact Statement filed herewith.
The proposed rule, as so revised, requires certified pharmacists to report the administration of any immunizations to the New York State Department of Health and/or to the New York City Department of Health and Mental Hygiene, in a manner required by either the Commissioner of Health of the State of New York or of the City of New York. The revised rule will not have a substantial adverse impact on job or employment opportunities. Because it is evident from the nature of the revised rule that it will have no impact on jobs or employment opportunities, no further measures were taken. Accordingly, a job impact statement is not required and one has not been prepared.
Assessment of Public Comment
A Notice of Proposed Rule Making was published in the State Register on November 19, 2008. Below is a summary of written comments received by the State Education Department (SED) and SED's assessment of issues raised.
1. COMMENT: Section 63.9(b)(4)(x) of the proposed amendment relates to the reporting requirements for both the New York State Department of Health and the New York City Department of Health and Mental Hygiene. However, this section only refers to the Commissioner of Health, which could be interpreted to mean only the Commissioner of Health of the State of New York and not the New York City Commissioner of Health, as was originally intended.
DEPARTMENT RESPONSE: SED agrees with this comment and has revised the proposed rule to refer to the "Commissioner of Health of the State of New York or of New York City, as applicable.
2. COMMENT: One commenter indicated that the proposed amendment is inconsistent because it refers to the individuals receiving immunizations as both "patients" and "recipients."
DEPARTMENT RESPONSE: SED agrees that both terms are used interchangeably throughout the proposed amendment. However, SED believes the terms are used appropriately and will not result in confusion to the regulated parties.
