EDU-37-13-00002-P Administration of Meningococcal Disease Vaccinations by Pharmacists

9/11/13 N.Y. St. Reg. EDU-37-13-00002-P

NEW YORK STATE REGISTER

VOLUME XXXV, ISSUE 37

September 11, 2013

RULE MAKING ACTIVITIES

EDUCATION DEPARTMENT

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. EDU-37-13-00002-P

Administration of Meningococcal Disease Vaccinations by Pharmacists

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

Proposed Action:

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)(c), 6802(22) and 6909(7)(c); L. 2013, ch. 274

Subject:

Administration of meningococcal disease vaccinations by pharmacists.

Purpose:

To implement chapter 274 of the Laws of 2013 to authorize qualified pharmacists to administer meningococcal disease vaccinations.

Text of proposed rule:

Paragraph (2) of subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education is amended, effective December 4, 2013, 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, [or] pneumococcal disease or meningococcal disease [to patients 18 years of age or older], pursuant to a patient specific order or a non-patient specific order; and

(ii) …

Text of proposed 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 rule was not under consideration at the time this agency submitted its Regulatory Agenda for publication in the Register.

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 (c) of subdivision (7) of section 6527 of the Education Law, as added by Chapter 274 of the Laws of 2013, authorizes physicians to prescribe and order a non-patient specific regimen to a licensed pharmacist for administering immunizations to prevent meningococcal disease.

Subdivision (22) of section 6802 of the Education Law, as amended by Chapter 274 of the Laws of 2013, adds immunizations to prevent meningococcal disease to the list of immunizations certified pharmacists may administer.

Paragraph (c) of subdivision (7) of section 6909 of the Education Law, as added by Chapter 274 of the Laws of 2013, authorizes nurse practitioners to prescribe and order a non-patient specific regimen to a licensed pharmacist for administering immunizations to prevent meningococcal disease.

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 274 of the Laws of 2013 which authorizes certain qualified pharmacists to administer vaccinations to prevent meningococcal disease pursuant to patient-specific prescriptions or non-patient specific orders.

3. NEEDS AND BENEFITS:

The proposed amendment is necessary to conform the Regulations of the Commissioner of Education to Chapter 274 of the Laws of 2013. Authorizing qualified pharmacists to administer vaccinations to prevent meningococcal disease will expand the availability of such vaccinations.

The proposed amendment also includes a technical revision to clarify that immunizations performed by certified pharmacists may be administered only to adult patients who are 18 years of age or older, in accordance with Education Law section 6802(22).

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 amendments 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, acute herpes zoster, and meningococcal disease, 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 274 of the Laws of 2013.

8. ALTERNATIVES:

The proposed amendment is necessary to conform the Regulations of the Commissioner of Education to Chapter 274 of the Laws of 2013. There are no significant alternatives to the proposed amendments, 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 274 of the Laws of 2013. The proposed amendment will become effective on October 29, 2013, which is also the effective date of Chapter 274. 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, pneumococcal disease and acute herpes zoster to also administer vaccinations to prevent meningococcal disease. The proposed amendment also includes a technical revision to clarify that immunizations performed by certified pharmacists may be administered only to adult patients who are 18 years of age or older, in accordance with Education Law section 6802(22). 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 approximately 24,162 pharmacists registered by the State Education Department, approximately 2,914 pharmacists report that 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 to Education Law sections 6527, 6802 and 6909, as amended by Chapter 274 of the Laws of 2013. These provisions allow pharmacists, certified to administer immunizations, to also be able to administer vaccinations to prevent meningococcal disease. 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, 6802 and 6909, as amended by Chapter 274 of the Laws of 2013. 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 amendment is 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 AREA 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.

6. INITIAL REVIEW OF RULE (SAPA § 207):

Pursuant to State Administrative Procedure Act section 207(1)(b), the State Education Department proposes that the initial review of this rule shall occur in the fifth calendar year after the year in which the rule is adopted, instead of in the third calendar year. The justification for a five year review period is that the proposed amendment is necessary to implement statutory requirements in Chapter 274 of the Laws of 2013 and therefore the substantive provisions of the proposed amendment cannot be repealed or modified unless there is a further statutory change. Accordingly, there is no need for a shorter review period. The Department invites public comment on the proposed five year review period for this rule. Comments should be sent to the agency contact listed in item 10. of the Notice of Proposed Rule Making published herewith, and must be received within 45 days of the State Register publication date of the Notice.

Job Impact Statement

The proposed amendment to the Regulations of the Commissioner of Education authorizes pharmacists who are certified to administer immunizations against influenza, pneumococcal disease and acute herpes zoster to also administer vaccinations to prevent meningococcal disease. The proposed amendment also includes a technical revision to clarify that immunizations performed by certified pharmacists may be administered only to adult patients who are 18 years of age or older, in accordance with Education Law section 6802(22). The amendment will not have a substantial adverse impact on jobs and employment opportunities. Because it is evident from the nature of the proposed amendment 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.