EDU-40-12-00006-EP Administration of Acute Herpes Zoster (Shingles) Vaccinations by Pharmacists

10/3/12 N.Y. St. Reg. EDU-40-12-00006-EP

NEW YORK STATE REGISTER

VOLUME XXXIV, ISSUE 40

October 03, 2012

RULE MAKING ACTIVITIES

EDUCATION DEPARTMENT

EMERGENCY/PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. EDU-40-12-00006-EP

Filing No. 947

Filing Date. Sept. 18, 2012

Effective Date. Sept. 18, 2012

Administration of Acute Herpes Zoster (Shingles) Vaccinations by Pharmacists

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

Proposed Action:

Amendment of section 63.9 of Title 8 NYCRR.

Statutory authority:

Education Law, sections 207 (not subdivided), 6504 (not subdivided), 6506(1), 6507(2)(a), 6527(7), 6801(5), 6802(23) and 6909(7); and L. 2012, ch. 116

Finding of necessity for emergency rule:

Preservation of public health and general welfare.

Specific reasons underlying the finding of necessity:

The proposed amendment to the Regulations of the Commissioner of Education is necessary to implement Chapter 116 of the Laws of 2012, which amends Education Law sections 6527, 6801, 6802 and 6909, to authorize pharmacists who have been certified to administer immunizations to also administer vaccinations to prevent acute herpes zoster.

Because the Board of Regents meets at fixed intervals, the earliest the proposed amendment can be presented for adoption, after expiration of the required 45-day public comment period provided for in State Administrative Procedure Act (SAPA) section 202(1) and (5), would be the December 10-11, 2012 Regents meeting. Furthermore, pursuant to SAPA section 203(1), the earliest effective date of the proposed amendment, if adopted at the December meeting, would be December 26, 2012, the date a Notice of Adoption would be published in the State Register. However, the provisions of Chapter 116 of the Laws of 2012 will become effective on October 16, 2012.

Emergency action is necessary for the preservation of the public health and general welfare in order to enable the State Education Department to immediately establish requirements to timely implement Chapter 116 of the Laws of 2012, so that certified pharmacists can begin to treat patients in need of this vaccination, currently recommended for all patients who have had chicken pox and are now 50 years of age or older. Herpes zoster infection, better known as Shingles, is extremely painful, and only a small number of patients who should be receiving the vaccine have been vaccinated.

It is anticipated that the proposed amendment will be presented for adoption as a permanent rule at the December 10-11, 2012 meeting of the Board of Regents, after publication in the State Register and expiration of the 45-day public comment period on proposed rule makings required by the State Administrative Procedure Act.

Subject:

Administration of acute herpes zoster (Shingles) vaccinations by pharmacists.

Purpose:

To implement chapter 116 of the Laws of 2012 to authorize qualified pharmacists to administer acute herpes zoster vaccinations.

Text of emergency/proposed rule:

Paragraphs (1) and (2) of subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education are amended, effective October 16, 2012, as follows:

(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, [pursuant to either a patient specific order or a non-patient specific order and protocol] provided that:

(i) the pharmacist meets the requirements for a certificate of administration prescribed in paragraph (3) of this subdivision and the order and protocol meet the requirements set forth in paragraph (5) of this subdivision; and

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

(a) the immunization is 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

(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.

(2) Authorized immunization agents. A certified pharmacist who meets the requirements of this section shall be authorized to administer:

(i) immunizing agents to prevent influenza or pneumococcal disease to patients 18 years of age or older, 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.

This notice is intended:

to serve as both a notice of emergency adoption and a notice of proposed rule making. The emergency rule will expire December 16, 2012.

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

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

Data, views or arguments may be submitted to:

Office of the Professions, Office of the Deputy Commissioner, State Education Department, State Education Building 2M, 89 Washington Avenue, Albany, NY 12234, [phone], email: [e-mail]

Public comment will be received until:

45 days after publication of this notice.

This action was not under consideration at the time this agency's regulatory agenda was submitted.

Regulatory Impact Statement

1. STATUTORY AUTHORITY:

Section 207 of the Education Law grants general rule-making authority to the Board of Regents to carry into effect the laws and policies of the State relating to education.

Section 6504 of the Education Law authorizes the Board of Regents to supervise the admission to and regulation of the practice of the professions.

Paragraph (a) of subdivision (2) of section 6507 of the Education Law authorizes the Commissioner to promulgate regulations in administering the admission to the practice of the professions.

Paragraph (b) of subdivision (7) of section 6527 of the Education Law, as added by Chapter 116 of the Laws of 2012, authorizes physicians to issue patient-specific orders for herpes zoster vaccine to pharmacists.

Paragraph (b) of subdivision (7) of section 6909 of the Education Law, as added by Chapter 116 of the Laws of 2012, authorizes nurse practitioners to issue patient-specific orders for herpes zoster vaccine to pharmacists.

Subdivision (22) of section 6802 of the Education Law, as amended by Chapter 116 of the Laws of 2012, adds vaccination to prevent acute herpes zoster to the list of immunizations certified pharmacists may administer.

2. LEGISLATIVE OBJECTIVES:

The proposed amendment carries out the intent of the aforementioned statutes that the Department shall supervise the regulation of the practice of the professions for the benefit of the public. The proposed amendment will conform Regulations of the Commissioner of Education to Chapter 116 of the Laws of 2012 which authorizes certain qualified pharmacists to administer vaccinations to prevent herpes zoster pursuant to patient-specific prescriptions.

3. NEEDS AND BENEFITS:

The proposed amendment is necessary to conform the Regulations of the Commissioner of Education to Chapter 116 of the Laws of 2012. Authorizing qualified pharmacists to administer vaccinations to prevent herpes zoster will expand the availability of such vaccinations.

Section 6802(22) of the Education Law provides that non-patient specific immunization orders authorized to be executed by pharmacists may be issued only by physicians and nurse practitioners with a practice site in the county in which the immunization is administered or, if the population of that county is not more than 75,000, in an adjoining county. It is proposed that section 63.9(b)(1)(ii) of the Regulations of the Commissioner be amended to clarify that such restriction applies only to non-patient specific orders. The current regulation imposes the county limitation on all immunizations by pharmacists. The statutory language, however, appears to place that limitation only on immunizations administered pursuant to non-patient specific orders. The proposed amendment is consistent with the statutory language and would enable patients who have a direct relationship with a physician or nurse practitioner to receive the appropriate immunizations pursuant to patient specific orders without regard to the county limitation.

4. COSTS:

(a) Costs to State government: There are no additional costs to state government.

(b) Costs to local government: There are no additional costs to local government.

(c) Cost to private regulated parties: The proposed amendment will not increase costs, and may provide cost-savings to patients and the health-care system. Therefore, there will be no additional costs to private regulated parties.

(d) Cost to regulating agency for implementation and continued administration of this rule: There are no additional costs to the regulating agency.

5. LOCAL GOVERNMENT MANDATES:

The proposed amendment relates solely to the administration of vaccinations to prevent influenza, pneumococcal disease, and herpes zoster and does not impose any program, service, duty, or responsibility upon local governments.

6. PAPERWORK:

The proposed amendment imposes no new reporting or other paperwork requirements.

7. DUPLICATION:

The proposed amendment does not duplicate other existing state or federal requirements, and is necessary to implement Chapter 116 of the Laws of 2012.

8. ALTERNATIVES:

The proposed amendment is necessary to conform the Regulations of the Commissioner of Education to Chapter 116 of the Laws of 2012. There are no significant alternatives to the proposed amendment and none were considered.

9. FEDERAL STANDARDS:

Since there are no applicable federal standards, the proposed amendment does not exceed any minimum federal standards for the same or similar subject areas.

10. COMPLIANCE SCHEDULE:

The proposed amendment is necessary to conform the Regulations of the Commissioner of Education to Chapter 116 of the Laws of 2012. The proposed amendment will become effective on October 16, 2012, which is also the effective date of Chapter 116. It is anticipated that licensees certified to administer immunizations will be able to comply with the proposed amendments by the effective date.

Regulatory Flexibility Analysis

The proposed amendment to the Regulations of the Commissioner of Education authorizes pharmacists who are certified to administer immunizations against influenza and pneumococcal disease to also administer vaccinations to prevent acute herpes zoster. The proposed amendment also clarifies that the requirement that the issuer of orders for immunizations to be performed by pharmacists have a practice site in the county in which the immunizations are issued (or, if that county has a population of less than 75,000, in an adjoining county) applies only to non-patient specific orders. The amendment will not impose any new reporting, recordkeeping, or other compliance requirements, or have any adverse economic impact, on small businesses or local governments. Because it is evident from the nature of the proposed amendment that it will not adversely affect small businesses or local governments, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a regulatory flexibility analysis for small businesses and local governments is not required, and one has not been prepared.

Rural Area Flexibility Analysis

1. TYPES AND ESTIMATED NUMBER OF RURAL AREAS:

The proposed amendment will apply to the 44 rural counties with less than 200,000 inhabitants and the 71 towns in urban counties with a population density of 150 per square mile or less. Of the 23,314 pharmacists registered by the State Education Department, 2,914 pharmacists report their permanent address of record is in a rural county.

2. REPORTING, RECORDKEEPING AND OTHER COMPLIANCE REQUIREMENTS; AND PROFESSIONAL SERVICES:

The proposed amendment is necessary to conform the Commissioner's Regulations with Education Law sections 6527, 6801, 6802 and 6909, as amended by Chapter 116 of the Laws of 2012. These provisions allow pharmacists, certified to administer immunizations, to also be able to administer vaccinations to prevent acute herpes zoster. The proposed amendment does not impose any additional reporting, recordkeeping or other compliance requirements, or professional services requirements, on entities in rural areas.

3. COSTS:

The proposed amendment does not impose any additional costs on regulated parties, including those in rural areas.

4. MINIMIZING ADVERSE IMPACT:

The proposed amendment is necessary to conform the Commissioner's Regulations with Education Law sections 6527, 6801, 6802 and 6909, as amended by Chapter 116 of the Laws of 2012. Following discussions, including obtaining input from practicing professionals, the State Board of Pharmacy has considered the terms of the proposed amendment to Regulations of the Commissioner of Education and has recommended the change. Additionally, the measures have been shared with educational institutions, professional associations, and practitioners representing the profession of pharmacy. The amendments are supported by representatives of these sectors. The proposals make no exception for individuals who live in rural areas. The Department has determined that such requirements should apply to all pharmacists, no matter their geographic location, to ensure a uniform standard of practice across the State. Because of the nature of the proposed rule, alternative approaches for rural areas were not considered.

5. RURAL AREAS PARTICIPATION:

Comments on the proposed amendment were solicited from statewide organizations representing all parties having an interest in the practice of pharmacy. Included in this group were members of the State Board of Pharmacy, educational institutions and professional associations representing the pharmacy profession, such as the Pharmacists Society of the State of New York and the New York State Council of Health System Pharmacists. These groups, which have representation in rural areas, have been provided notice of the proposed rule making and opportunity to comment on the proposed amendment.

Job Impact Statement

The proposed amendment to the Regulations of the Commissioner of Education authorizes pharmacists who are certified to administer immunizations against influenza and pneumococcal disease to also administer vaccinations to prevent acute herpes zoster. The proposed amendment also clarifies that the requirement that the issuer of orders for immunizations to be performed by pharmacists have a practice site in the county in which the immunizations are issued (or, if that county has a population of less than 75,000, in an adjoining county) applies only to non-patient specific orders. The amendment will not have a substantial adverse impact on jobs and employment opportunities. Because it is evident from the nature of the proposed amendments that they 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.