Chapter 359 permits a pharmacy intern to receive a certificate of administration which permits administration of immunizations under the immediate and personal supervision of a licensed pharmacist certified to administer immunizations; establishes procedures and requirements for a pharmacy intern to receive a certificate of administration; and requires a patient to be informed that a pharmacy intern, certified to administer immunizations, will be administering the immunization and that the patient must be given the option of having the immunization administered by the certified pharmacist.

Chapter 359 directs the Commissioner to promulgate regulations that establish standards for training of a pharmacy intern in the following areas: techniques for screening individuals and obtaining informed consent; techniques of administration; indications, precautions and contraindications in the use of an agent or agents; recordkeeping of immunization and information; and handling emergencies, including anaphylaxis and needlestick injuries. Chapter 359 also requires the Commissioner to promulgate rules and regulations relating to the documentation required from the dean or other appropriate official of the registered program that the pharmacy intern has completed the required training.

The proposed addition of subdivision (d) to section 63.4 of the Regulations of the Commissioner of Education establishes the requirements for a pharmacy intern to obtain a certificate to administer immunizations and establishes the required training coursework for such certification.

The proposed amendment to subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education authorizes a certified pharmacist to delegate the administration of immunizations to a pharmacy intern that is properly trained and certified to administer immunizations under the immediate personal supervision of the certified pharmacist.

In addition, the proposed amendment to subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education requires the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, to be informed when a certified pharmacy intern will be administering the immunization and consent to it. The proposed amendment further provides that, if the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, does not consent, then the certified pharmacist will administer the immunization.

The proposed amendment was presented to the Professional Practice Committee for recommendation and to the Full Board for adoption as an emergency action at the January 2019 meeting of the Board of Regents, effective January 15, 2019. Since the Board of Regents meets at fixed intervals, the earliest the proposed rule can be presented for permanent adoption, after expiration of the required 60-day comment period provided for in the State Administrative Procedure Act (SAPA) sections 201(1) and (5), would be the May 6-7, 2019 Regents meeting. Furthermore, pursuant to SAPA 203(1), the earliest effective date of the proposed rule, if adopted at the May meeting would be May 22, 2019, the date the Notice of Adoption would be published in the State Register. However, the January emergency rule will expire on April 15, 2019. If the rule were to lapse, it would impede the ability of certified pharmacy interns to continue to administer immunizations to the public, which would adversely impact the public’s access to immunizations against several diseases, including, but not limited to, seasonal influenza. It would further impede the ability of certified pharmacy interns to gain valuable hands on clinical experience by administering immunizations to the public.

Therefore, emergency action is necessary at the April 2019 meeting for the preservation of the public health and general welfare in order to continue to implement Chapter 359, which is already in effect, to, inter alia, authorize the administration of immunizations by a pharmacy intern, certified to administer immunizations, after completing required training, under the immediate and personal supervision of a licensed pharmacist certified to administer immunizations, in order to improve the public’s access to immunizations and provide certified pharmacy interns with valuable hands on clinical experience.

It is anticipated that the proposed rule will be presented for adoption as a permanent rule at the May 6-7, 2019 Regents meeting, which is the first scheduled meeting after the 60-day public comment period prescribed in SAPA for State agency rule makings.

Subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education is amended, as follows:

(b) Immunizations

(1) …

(2) …

(3) …

[(4)] (5) 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) . . .

(iv) . . .

(v) a certified pharmacist shall not allow a certified pharmacy intern to administer immunizations unless the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, is informed that the pharmacy intern will be administering the immunization and the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, consents to administration of the immunization by the certified pharmacy intern. If the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, does not consent to administration by the certified pharmacy intern, then the option to receive the immunization from a certified pharmacist shall be provided.

[(v)] (vi) a certified pharmacist shall provide written instructions to the recipient regarding the appropriate course of action in the event of contraindications or adverse reactions, which statements are required to be developed by a competent entity knowledgeable about the adverse reactions of the immunization agent which shall be administered, such as the Centers for Disease Control of the U.S. Department of Health and Human Services, which issues vaccine information statements;

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

(b) education materials on influenza vaccines for children as determined by the commissioner and the commissioner of the department of health.

[(vii)] (viii) a 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;

[viii] (ix) a certified pharmacist shall provide to each recipient or other person legally responsible when the recipient is incapable of consenting to immunization, a signed certificate of immunization with the recipient’s name, date of immunization, address of administration, administering pharmacist, immunization agent, manufacturer and lot number. With the consent of the recipient or a person legally responsible when the recipient is incapable of consenting, the certified pharmacist shall communicate this information to the recipient’s primary health care practitioner, if one exists, within one month of the administration of such immunization, and such communication may be transmitted in electronic format;

[(ix)] (x) a certified pharmacist shall report any adverse outcomes as may be required by Federal law on the vaccine adverse event reporting system form of the Centers for Disease Control of the U.S. Department of Health and Human Services, or on the successor form;

[(x)] (xi) a certified pharmacist shall ensure that a record of all persons immunized including the recipient’s name, date, address of administration, administering pharmacist, immunization agent, manufacturer and lot number is recorded and maintained in accordance with section 29.2(a)(3) of this Title;

[(xi)] (xii) to the extent required by the Public Health Law, the Education Law and/or the New York City Health Code, a certified pharmacist shall report the administration of any immunizations to the New York State Department of Health and/or the New York City Department of Health and Mental Hygiene, in a manner required by the Commissioner of Health of the State of New York or of the City of New York, as applicable. Such report shall not include any individually identifiable health information unless:

(a) such information is otherwise required by law; or

(b) the recipient has consented to the disclosure of such information, in which case the information may be included to the extent permitted by law; and

[(xii)] (xiii) 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;

[(xiii)] (xiv) 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

[(xiv)] (xv) Reporting of administration of immunizing agent;

(a) 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.

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 of Education to promulgate regulations in administering the admission to and the practice of the professions.

Subdivision (7) of section 6527 of the Education Law authorizes physicians to prescribe and order a patient specific order or non-patient specific regimen to a licensed pharmacist for administering immunizations to prevent, inter alia, influenza and pneumococcal disease and medications required for emergency treatment of anaphylaxis.

Section 6801 of the Education Law defines the practice of the profession of pharmacy and establishes various requirements relating to the administration of immunizations by licensed pharmacists, including, inter alia, the training requirements licensed pharmacists must satisfy to become certified to administer immunizations, reporting requirements for all vaccines administered by certified pharmacists and requirements regarding the provision of information by the certified pharmacist, regarding the immunization, to either the patient or the person legally responsible for the patient, as well as the requirement that a certified pharmacist, when administering an immunization in a pharmacy, provide for an area that provides for the patient’s privacy.

Paragraphs (a) and (b) of subdivision (22) of section 6802 of the Education Law defines the terms administer and immunizing agent and authorizes licensed pharmacists to execute patient specific and non-patient specific orders prescribed by a licensed physician or certified nurse practitioner to administer immunizations to prevent influenza, pneumococcal, acute herpes zoster, meningococcal, tetanus, diphtheria or pertussis disease and medications required for emergency treatment of anaphylaxis to adults and influenza immunizations to children between two and eighteen years of age and medications required for emergency treatment of anaphylaxis resulting from such immunizations.

Subdivision (2) of section 6806 of the Education Law, as amended by Chapter 359 of the Laws of 2018, provides that a pharmacy intern may receive a certificate of administration if he or she provides satisfactory evidence to the Commissioner the he or she meets the requirements in subdivision (3) of section 6806 of the Education Law, as amended by Chapter 359 of the Laws of 2018.

Subdivision (3) of section 6806 of the Education Law, as amended by Chapter 359 of the Laws of 2018, directs the Commissioner, in consultation with the Commissioner of the State Department of Health, to promulgate regulations that establish standards for training of a pharmacy intern, seeking a certificate of administration, in the following areas: techniques for screening individuals and obtaining informed consent; techniques of administration; indications, precautions and contraindications in the use of an agent or agents; recordkeeping of immunization and information; and handling emergencies, including anaphylaxis and needlestick injuries. Chapter 359 also requires that to receive a certificate of administration, a pharmacy intern must submit an application, on a form prescribed by the State Education Department, from the dean or other appropriate official of the registered program that the intern has completed the required training pursuant to the Commissioner’s Regulations.

Subdivision (6) of section 6806 of the Education Law, as amended by Chapter 359 of the Laws of 2018, provides that a pharmacy intern, certified to administer immunizations, can only administer immunizations under the immediate personal supervision of a licensed pharmacist certified to administer vaccines; and requires that the person receiving the vaccine must be informed that a pharmacy intern, certified to administer immunizations, will be administering the vaccine and advise him or her that he or she has the option to receive the immunization from a certified pharmacist instead. Paragraph (1) of section 6902 of the Education Law defines the practice of the profession of nursing for registered professional nurses.

Subdivision (7) of section 6909 of the Education Law authorizes nurse practitioners to prescribe and order a patient specific order or non-patient specific regimen to a licensed pharmacist for administering immunizations to prevent, inter alia, influenza.

2. LEGISLATIVE OBJECTIVES:

The proposed rule is necessary to conform the Regulations of the Commissioner of Education to Chapter 359 of the Laws of 2018.

3. NEEDS AND BENEFITS:

Pharmacists licensed in New York State were first authorized to administer immunizations to prevent influenza and pneumococcal disease in December 2008. In order to administer such immunizations, a pharmacist must be certified by the Department following completion of a satisfactory training program. Since that time, more than 14,800 registered pharmacists in New York State have received the required certification. In 2012 and 2013, vaccinations against acute herpes zoster (shingles) and meningococcal disease, respectively, were added to the types of immunizations that appropriately certified pharmacists are authorized to administer. Additionally, in 2018, pharmacists were authorized to administer seasonal influenza immunizations to children between two and eighteen years of age.

The proposed rule implements Chapter 359 of the Laws of 2018 (Chapter 359), which, effective December 7, 2018, inter alia, amended Education Law section 6806 to allow the administration of immunizations by certain pharmacy interns who are certified to administer immunizations under the immediate and personal supervision of a licensed pharmacist certified to immunize. Chapter 359 was enacted, in part, to make immunizations more readily available and to provide certified pharmacy interns with valuable hands-on clinical experience, while under the oversight and supervision of a licensed pharmacist, who is certified to administer immunizations.

Chapter 359 permits a pharmacy intern to receive a certificate of administration which permits administration of immunizations under the immediate and personal supervision of a licensed pharmacist certified to administer immunizations; establishes procedures and requirements for a pharmacy intern to receive a certificate of administration; and requires a patient to be informed that a pharmacy intern, certified to administer immunizations, will be administering the immunization and that the patient be given the option to have the immunization administered by the certified pharmacist.

Chapter 359 directs the Commissioner to promulgate regulations that establish standards for training of a pharmacy intern in the following areas: techniques for screening individuals and obtaining informed consent; techniques of administration; indications, precautions and contraindications in the use of an agent or agents; recordkeeping of immunization and information; and handling emergencies, including anaphylaxis and needlestick injuries. Chapter 359 also requires that to receive a certificate of administration, a pharmacy intern must submit an application, on a form prescribed by the State Education Department, from the dean or other appropriate official of the registered program that the intern has completed the required training pursuant to the Commissioner’s Regulations.

The proposed addition of subdivision (d) to section 63.4 of the Regulations of the Commissioner of Education establishes the requirements for a pharmacy intern to obtain a certificate to administer immunizations and establishes the required training for such certification. Additionally, as required by Chapter 359, Department staff have consulted with the New York State Department of Health regarding these proposed training requirement provisions.

The proposed amendment to subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education authorizes a certified pharmacist to delegate the administration of immunizations to a pharmacy intern who is properly trained and certified to administer immunizations under the immediate personal supervision of the certified pharmacist.

In addition, the proposed amendment to subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education requires the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, to be informed when a certified pharmacy intern will be administering the immunization and consent to it. The proposed amendment further provides that, if the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, does not consent, then the certified pharmacist will administer the immunization.

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: There are no mandatory costs to private regulated parties.

(d) Cost to the regulatory agency: There are no additional costs to the Department.

5. LOCAL GOVERNMENT MANDATES:

The proposed rule does not impose any program service, duty, responsibility, or other mandate on local governments.

6. PAPERWORK:

The proposed rule does not impose any paperwork mandates because it does not require pharmacy interns to become certified to administer immunizations. For pharmacy interns, who choose to become certified to administer immunizations, they can only administer immunizations under the immediate personal supervision of a licensed pharmacist, who is certified to administer immunizations, this pharmacist would be responsible for complying with any of the reporting, recordkeeping or other requirements that certified licensed pharmacists must comply with when administering immunizations. For instance, such a pharmacist, pursuant to the provisions of section 63.9(b)(4), would be required to, inter alia, ensure that that the immunizations administered by pharmacy interns under his or her immediate personal supervision are reported to the patient’s attending primary health care practitioner, and to the New York State Immunization Information System or if administered in New York City, to the Citywide Immunization Registry, as required by the Public Health Law or the New York City Health Code.

7. DUPLICATION:

There is no other state or federal requirements on the subject matter of the proposed rule. Therefore, the amendment does not duplicate other existing state or federal requirements.

8. ALTERNATIVES:

The proposed rule is necessary to conform the Regulations of the Commissioner of Education to Chapter 359 of the Laws of 2018. There are no significant alternatives to the proposed rule and none were considered.

9. FEDERAL STANDARDS:

There are no applicable federal standards for authorizing pharmacy interns, who are certified to administer immunization under the immediate personal supervision of a licensed pharmacist, who is certified to administer immunizations, to administer immunizations to patients, pursuant to patient specific or non-patient specific orders prescribed by a licensed physician or certified nurse practitioner.

10. COMPLIANCE SCHEDULE:

It is anticipated that the regulated parties will be able to comply with the proposed rule by the effective date.

The purpose of the proposed rule is to implement Chapter 359 of the Laws of 2018 (Chapter 359), which, effective December 7, 2018, inter alia, amended Education Law section 6806 to allow the administration of immunizations by certain pharmacy interns who are certified to administer immunizations under the immediate and personal supervision of a licensed pharmacist certified to immunize. Chapter 359 was enacted, in part, to make immunizations more readily available and to provide certified pharmacy interns with valuable hands-on clinical experience, while under the oversight and supervision of a licensed pharmacist, who is certified to administer immunizations.

Chapter 359 permits a pharmacy intern to receive a certificate of administration which permits administration of immunizations under the immediate and personal supervision of a licensed pharmacist certified to administer immunizations; establishes procedures and requirements for a pharmacy intern to receive a certificate of administration; and requires a patient to be informed that a pharmacy intern, certified to administer immunizations, will be administering the immunization and that the patient be given the option to have the immunization administered by the certified pharmacist.

Chapter 359 directs the Commissioner to promulgate regulations that establish standards for training of a pharmacy intern in the following areas: techniques for screening individuals and obtaining informed consent; techniques of administration; indications, precautions and contraindications in the use of an agent or agents; recordkeeping of immunization and information; and handling emergencies, including anaphylaxis and needlestick injuries. Chapter 359 also requires that to receive a certificate of administration, a pharmacy intern must submit an application, on a form prescribed by the State Education Department, from the dean or other appropriate official of the registered program that the intern has completed the required training pursuant to the Commissioner’s Regulations.

The proposed addition of subdivision (d) to section 63.4 of the Regulations of the Commissioner of Education establishes the requirements for a pharmacy intern to obtain a certificate to administer immunizations and establishes the required training for such certification. Additionally, as required by Chapter 359, Department staff have consulted with the New York State Department of Health regarding these proposed training requirement provisions.

The proposed amendment to subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education authorizes a certified pharmacist to delegate the administration of immunizations to a pharmacy intern who is properly trained and certified to administer immunizations under the immediate personal supervision of the certified pharmacist.

In addition, the proposed amendment to subdivision (b) of section 63.9 of the Regulations of the Commissioner of Education requires the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, to be informed when a certified pharmacy intern will be administering the immunization and consent to it. The proposed amendment further provides that, if the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, does not consent, then the certified pharmacist will administer the immunization.

The proposed rule does not impose any new reporting, recordkeeping, or other compliance requirements on local governments 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.

The purpose of the proposed amendment is to implement Chapter 359 of the Laws of 2018 (Chapter 359), which, effective December 7, 2018, inter alia, amended Education Law section 6806 to allow the administration of immunizations by certain pharmacy interns who are certified to administer immunizations under the immediate and personal supervision of a licensed pharmacist certified to immunize. Chapter 359 was enacted, in part, to make immunizations more readily available and to provide certified pharmacy interns with valuable hands-on clinical experience, while under the oversight and supervision of a licensed pharmacist, who is certified to administer immunizations. Chapter 359 permits a pharmacy intern to receive a certificate of administration which permits administration of immunizations under the immediate and personal supervision of a licensed pharmacist certified to administer immunizations; establishes procedures and requirements for a pharmacy intern to receive a certificate of administration; and requires a patient to be informed that a pharmacy intern, certified to administer immunizations, will be administering the immunization and that the patient be given the option to have the immunization administered by the certified pharmacist.

Chapter 359 directs the Commissioner to promulgate regulations that establish standards for training of a pharmacy intern in the following areas: techniques for screening individuals and obtaining informed consent; techniques of administration; indications, precautions and contraindications in the use of an agent or agents; recordkeeping of immunization and information; and handling emergencies, including anaphylaxis and needlestick injuries. Chapter 359 also requires that to receive a certificate of administration, a pharmacy intern must submit an application, on a form prescribed by the State Education Department, from the dean or other appropriate official of the registered program that the intern has completed the required training pursuant to the Commissioner’s Regulations.

The proposed amendment implements Chapter 359 by establishing the requirements for a pharmacy intern to obtain a certificate to administer immunizations, including, but not limited to, the required training for such certification, authorizing a certified pharmacist to delegate the administration of immunizations to a pharmacy intern who is properly trained and certified to administer immunizations under the immediate personal supervision of the certified pharmacist, requiring the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, to be informed when a certified pharmacy intern will be administering the immunization and consent to it, and providing that, if the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, does not consent, then the certified pharmacist will administer the immunization.

Chapter 359 does not provide any exceptions from these requirements for pharmacy interns, pharmacists, and pharmacies located in rural areas. Thus, the proposed amendment does not impact entities in rural areas of New York State because all New York State pharmacy interns, pharmacists, and pharmacies must comply with the same requirements. Accordingly, no further steps were needed to ascertain the impact of the proposed amendment on entities in rural areas and none were taken. Thus, a rural flexibility analysis is not required, and one has not been prepared.

It is not anticipated that the propose rule will not impact jobs or employment opportunities. This is because the proposed amendment implements Chapter 359 of the Laws of 2018 (Chapter 359) by authorizing the administration of immunizations by certain pharmacy interns who are certified to administer immunizations under the immediate and personal supervision of a licensed pharmacist certified to immunize. Chapter 359 permits a pharmacy intern to receive a certificate of administration which permits administration of immunizations under the immediate and personal supervision of a licensed pharmacist certified to administer immunizations; establishes procedures and requirements for a pharmacy intern to receive a certificate of administration; and requires a patient to be informed that a pharmacy intern, certified to administer immunizations, will be administering the immunization and that the patient be given the option to have the immunization administered by the certified pharmacist. Chapter 359 directs the Commissioner to promulgate regulations that establish standards for training of a pharmacy intern in the following areas: techniques for screening individuals and obtaining informed consent; techniques of administration; indications, precautions and contraindications in the use of an agent or agents; recordkeeping of immunization and information; and handling emergencies, including anaphylaxis and needlestick injuries. Chapter 359 also requires that to receive a certificate of administration, a pharmacy intern must submit an application, on a form prescribed by the State Education Department, from the dean or other appropriate official of the registered program that the intern has completed the required training pursuant to the Commissioner’s Regulations. Therefore, any impact on jobs or employment opportunities created by the proposed amendment is attributable to the statutory requirements, not the proposed amendment, which simply establishes standards that conform the requirements to the statute.

The proposed 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.

The agency received no public comment.