EDU-47-08-00007-P Administration of Immunization Agents by Certified Pharmacists

11/19/08 N.Y. St. Reg. EDU-47-08-00007-P

NEW YORK STATE REGISTER

VOLUME XXX, ISSUE 47

November 19, 2008

RULE MAKING ACTIVITIES

EDUCATION DEPARTMENT

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. EDU-47-08-00007-P

Administration of Immunization Agents by Certified Pharmacists

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

Proposed Action:

Addition of section 63.9 to Title 8 NYCRR.

Statutory authority:

Education Law, sections 207(not subdivided), 6504(not subdivided), 6507(2)(a), 6527(7), 6801(1),(2), (3), 6802(22), 6828(1), (2), and 6909(7); and L. 2008, ch. 563

Subject:

Administration of immunization agents by certified pharmacists.

Purpose:

Establish criteria for the certification of licensed pharmacists and requirements for the administration of immunization agents.

Substance of proposed rule (Full text is posted at the following State website:www.op.nysed.gov):

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that the applicable provisions in Education Law sections 6527, 6801, 6802, 6828 and 6909 have not expired or been repealed.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).

Text of 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, New York 12234, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Frank Munoz, Office of the Professions, New York State Education Department, 2nd Floor, West Wing, Education Bldg., Albany, New York 12257, [phone], email: [e-mail]

Public comment will be received until:

45 days after publication of this notice.

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.

Subparagraph (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.

Subdivision (1) of section 6508 of the Education Law provides that state boards for the professions shall assist the Board of Regents and Department on matters of professional licensing.

Subdivision 7 of section 6527 of the Education Law authorizes physicians to order non-patient specific regimens for the administration of immunizing agents by pharmacists.

Section 6801 of the Education Law authorizes certified pharmacists to administer immunizing agents and authorizes the Commissioner of Education to promulgate regulations regarding training and reporting requirements.

Subdivision 7 of section 6909 of the Education Law authorizes nurse practitioners to order non-patient specific regimens for the administration of immunizing agents by pharmacists.

Section 6828 of the Education Law authorizes the Commissioner to promulgate regulations relating to the issuance of a certificate of administration to a qualifying pharmacist.

2. LEGISLATIVE OBJECTIVES:

The proposed amendment carries out the intent of the aforementioned statutes by expanding access to immunizations to residents of the State of New York. The proposed amendment establishes procedures for the Department to certify licensed pharmacists to administer immunizing agents and anaphylactic treatments; prescribes standards, procedures, reporting and record keeping requirements for the administration of immunizations and anaphylactic treatments and sets forth the requirements for orders and protocols for the administration of immunizations and anaphylactic treatments.

3. NEEDS AND BENEFITS:

Chapter 563 of the Laws of 2008, effective December 3, 2008, authorizes licensed pharmacists that are certified by the State Education Department to administer immunizations to prevent influenza or pneumococcal disease and medications required for emergency treatment of anaphylaxis. Section 6801(2) of the Education Law, as added by Chapter 563 of the Laws of 2008, directs the Commissioner of Education to promulgate regulations concerning a licensed pharmacist's execution of non-patient specific orders prescribed or ordered by a licensed physician or certified nurse practitioner. Section 6801(3) prohibits a pharmacist from administering immunizing agents without receiving training satisfactory to the Commissioner and the Commissioner of Health.

In order to timely implement the requirements of Chapter 563 of the Laws of 2008, the proposed amendment establishes procedures for the certification of licensed pharmacists to administer immunizations. Specifically, the proposed amendment requires a licensed pharmacist to submit an application, with the required fee, to the Department and present satisfactory evidence of one of the following: (1) completion of a training course in the administration of immunizations acceptable to the Commissioner and the Commissioner of Health, within the three years immediately preceding application for a certificate of administration; (2) a Doctor in Pharmacy Degree and completion of training in the administration of immunization agents received as part of his/her pharmacy degree that is satisfactory to the Department; 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.

The proposed amendment also establishes uniform requirements for certified pharmacists to meet when executing orders to administer immunizations and medications for the emergency treatment of anaphylaxis. For instance, the proposed amendment defines what information should be included in the non-patient specific order and the requirements that must be set forth in the protocol, for a certified pharmacist to follow when administering immunizations through a non-patient specific order. The proposed amendment also establishes uniform reporting requirements. Specifically, the proposed amendment requires a certified pharmacist (1) to inform the recipient, in writing, of potential side effects and adverse reactions prior to the administration of an immunization; (2) to provide written instructions to the recipient regarding the appropriate course of action in the event of contraindications or adverse reactions; and (3) to provide a signed certificate of immunization to the recipient containing certain prescribed information.

With the enactment of Chapter 563 of the Laws of 2008, New York State joins 48 other states and the District of Columbia in authorizing pharmacists to administer immunizations. The proposed amendment is needed to expand access to immunizations, which is expected to reduce morbidity and mortality caused by influenza and pneumococcal disease and any related complications. At the present time, there are approximately 20,000 pharmacists licensed to practice in New York State. Consequently, a significant number of individuals will be affected by the proposed amendment.

The proposed amendment is not expected to cause regulated parties to have to hire additional professional services in order to comply.

4. COSTS:

(a) There are no additional costs to state government beyond those imposed by statute.

(b) There are no additional costs to local government beyond those imposed by statute.

(c) Cost to private regulated parties: The amendment is likely to result in only nominal costs to entities that employ certified pharmacists to execute the non-patient specific orders to administer immunizations. These entities will likely have to bear a small additional cost to provide prescribed written information and issue a certificate of immunization to each recipient who requests such a certificate. The State Education Department estimates that the nominal cost of providing this information and issuing the certificate will be approximately $.75 per recipient. The other paperwork requirements relate to maintenance of patient records, which are already subject to the requirements of section 29.2(a)(3) of the Regents Rules, and consequently will not result in additional costs.

(d) Cost to the regulatory agency. As stated above in "Costs to State Government", the proposed amendment does not impose additional costs on the State Education Department.

5. LOCAL GOVERNMENT MANDATES:

The proposed amendment does not impose any program, service, duty, or responsibility upon local governments.

6. PAPERWORK:

The proposed amendment defines what information should be included in the orders and the requirements that must be set forth in the protocol, for a certified pharmacist to follow when administering immunizations through a non-patient specific order. The proposed amendment also establishes uniform reporting requirements. Specifically, the proposed amendment requires a certified pharmacist (1) to inform the recipient, in writing, of potential side effects and adverse reactions to prior to administration of the immunization; (2) to provide written instructions to the recipient regarding the appropriate course of action in the event of contraindications or adverse reactions; and (3) to provide a signed certificate of immunization to the recipient containing certain prescribed information.

7. DUPLICATION:

The proposed amendment does not duplicate other existing state or federal requirements.

8. ALTERNATIVES:

There are no viable alternatives to the proposed amendment and none were considered because of the nature of the amendment, which implements statutory requirements.

9. FEDERAL STANDARDS:

There are no Federal standards that establish requirements that certified professional nurses must meet to administer immunizations, pursuant to non-patient specific orders and protocol.

10. COMPLIANCE SCHEDULE:

The proposed amendment implements and clarifies statutory requirements. Regulated parties must comply with the proposed amendment on its stated effective date. No additional period of time is necessary to enable regulated parties to comply.

Regulatory Flexibility Analysis

In order to implement the requirements of Chapter 563 of the Laws of 2008, the proposed amendment establishes requirements for the certification of pharmacists to administer immunizations to prevent influenza or pneumococcal disease and medications required for emergency treatment of anaphylaxis. The proposed amendment also establishes requirements relating to the execution of patient specific and non-patient specific orders prescribed by licensed physicians or certified nurse practitioners for the administration of such immunizations. The proposed amendment does not regulate small businesses or local governments. Accordingly, a regulatory flexibility analysis is not required and one has not been prepared.

Because it is evident from the nature of the proposed amendment that it does not 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 applies 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. At the present time, there are approximately 20,303 licensed pharmacists that will be subject to the requirements of the proposed amendment. Of these licensed pharmacists, approximately 2,613 licensed pharmacists report their permanent address of record in a rural county of New York State.

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

Chapter 563 of the Laws of 2008, effective December 3, 2008, authorizes licensed pharmacists that are certified by the State Education Department to administer immunizations to prevent influenza or pneumococcal disease and medications required for emergency treatment of anaphylaxis. Section 6801(2) of the Education Law, as added by Chapter 563 of the Laws of 2008, directs the Commissioner of Education to promulgate regulations concerning a licensed pharmacist's execution of non-patient specific orders prescribed or ordered by a licensed physician or certified nurse practitioner. Section 6801(3) prohibits a pharmacist from administering immunizing agents without receiving training satisfactory to the Commissioner and the Commissioner of Health.

In order to timely implement the requirements of Chapter 563 of the Laws of 2008, the proposed amendment establishes procedures for the certification of licensed pharmacists to administer immunizations. Specifically, the proposed amendment requires a licensed pharmacist to submit an application, with the required fee, to the Department and present satisfactory evidence of one of the following: (1) completion of a training course in the administration of immunizations acceptable to the Commissioner and the Commissioner of Health, within the three years immediately preceding application for a certificate of administration; (2) a Doctor in Pharmacy Degree and completion of training in the administration of immunization agents received as part of his/her pharmacy degree that is satisfactory to the Department; 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 immunizing agents.

The proposed amendment also establishes uniform requirements for certified pharmacists to meet when executing orders to administer immunizations and medications for the emergency treatment of anaphylaxis. For instance, the proposed amendment defines what information should be included in the non-patient specific order and the requirements that must be set forth in the protocol, for a certified pharmacist to follow when administering immunizations through a non-patient specific order. The proposed amendment also establishes uniform reporting requirements. Specifically, the proposed amendment requires a certified pharmacist: (1) to inform the recipient, in writing, of potential side effects and adverse reactions prior to the administration of an immunization; (2) to provide written instructions to the recipient regarding the appropriate course of action in the event of contraindications or adverse reactions; and (3) to provide a signed certificate of immunization to the recipient containing certain prescribed information.

With the enactment of Chapter 563 of the Laws of 2008, New York State joins 48 other states and the District of Columbia in authorizing pharmacists to administer immunizations. The proposed amendment is needed to expand access to immunizations, which is expected to reduce morbidity and mortality caused by influenza and pneumococcal disease and any related complications. At the present time, there are approximately 20,000 pharmacists licensed to practice in New York State. Consequently, a significant number of individuals will be affected by the proposed amendment.

The proposed amendment is not expected to cause regulated parties to have to hire additional professional services in order to comply.

3. COSTS:

The proposed amendment is likely to result in only nominal costs to entities that employ certified pharmacists to execute orders to administer immunizations, including those that are located in rural areas of the State. These entities will likely have to bear a small additional cost to provide prescribed written information and issue a certificate of immunization to each recipient. The State Education Department estimates that the nominal cost of providing this information and issuing the certificate will be approximately $.75 per recipient. The other paperwork requirements relate to maintenance of patient records, that are already subject to the requirements of section 29.2(a)(3) of the Regents Rules, and consequently will not result in additional costs.

4. MINIMIZING ADVERSE IMPACT:

The proposed amendment implements statutory directives to establish requirements for certified pharmacists to execute orders prescribed by licensed physicians or certified nurse practitioners for the administration of immunizations and makes no exception for licensed registered professional nurses who live or work in rural areas. In any event, consistent practice requirements should apply no matter the geographic origin of the licensee to ensure a uniform high standard of competency across the State and that the administration of immunizations is performed safely in all areas of the State. Because of the nature of the proposed amendment, establishing different standards for licensed registered professional nurses in rural areas of New York State is inappropriate.

5. RURAL AREAS PARTICIPATION:

Comments on the proposed rule were solicited from statewide organizations representing all parties having an interest in promoting expanded access to important immunizations. Included in this group were members of the State Board of Pharmacy; educational institutions which currently offer professional pharmacy programs; professional associations representing the pharmacy profession, such as the Pharmacists Society of the State of New York, the New York State Council of Health System Pharmacists and the New York State Chain Drug Association; the State Board for Nursing; the New York State Department of Health; the New York City Department of Health and Mental Hygiene; and many other interested parties. These groups, which have representation in rural areas, have been provided notice of the proposed rule making and an opportunity to comment on the proposed amendment.

Job Impact Statement

In order to implement the requirements of Chapter 563 of the Laws of 2008, the proposed amendment establishes requirements for the certification of pharmacists to administer immunizations to prevent influenza or pneumococcal disease and medications required for emergency treatment of anaphylaxis. The proposed amendment also establishes requirements relating to the execution of patient specific and non-patient specific orders prescribed by licensed physicians or certified nurse practitioners for the administration of such immunizations. The amendment will not have a substantial adverse impact on jobs and employment opportunities, beyond those imposed by statute. Accordingly, a job impact statement is not required, and one has not been prepared.