N.Y. Comp. Codes R. & Regs. tit. 8 § 63.9

Current through Register Vol. 46, No. 45, November 2, 2024

Section 63.9 - Immunizations and emergency treatment of anaphylaxis pursuant to patient specific and non-patient specific orders and protocols

(a) Immunizations.

(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, 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 New York State licensed and registered physician or certified nurse practitioner, with a practice site in New York State; and

(b) if the commissioner of health determines that there is an outbreak of disease, or that there is the imminent threat of an outbreak of disease, then the commissioner of health may issue a non-patient specific regimen applicable statewide.

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

(i) administer to patients 18 years of age or older, immunizing agents to prevent influenza, pneumococcal, acute herpes zoster, hepatitis A, hepatitis B, human papillomavirus, measles, mumps, rubella, varicella, COVID-19, meningococcal, tetanus, diphtheria, or pertussis disease, pursuant to a patient specific order or a non-patient specific order;

(ii) administer to patients between the ages of two and 18 years of age, immunizing agents to prevent influenza, pursuant to a patient specific order or a non-patient specific order; and

(iii) administer other immunizations recommended by the advisory committee on immunization practices of the centers for disease control and prevention for patients 18 years of age or older, pursuant to a patient specific or a non-patient specific order, if the commissioner of health in consultation with the commissioner determines that an immunization:

(a) may be safely administered by a licensed pharmacist within their lawful scope of practice; and

(b) is needed to prevent the transmission of a reportable communicable disease that is prevalent in New York State; or

(c) is a recommended immunization for such patients who:

(1) meet age requirements;

(2) lack documentation of such immunization;

(3) lack evidence of past infection; or

(4) have an additional risk factor or another indication as recommended by the advisory committee on immunization practices of the centers for disease control and prevention.

(3) Requirements for a certificate to administer immunizations. No licensed pharmacist shall administer immunizing agents without a certificate of administration issued by the department. For purposes of this section, a certified pharmacist shall mean a licensed pharmacist who is issued a certificate of administration pursuant to this paragraph. To meet the requirements for a certificate of administration, the licensed pharmacist shall submit an application with the fee specified in section 6828 of the Education Law and present satisfactory evidence of completion of the requirements set forth in one of the following subparagraphs:

(i) Training course. 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. Such course shall include, but not be limited to, instruction in:

(a) techniques for screening patients and for obtaining informed consents;

(b) techniques in the administration of immunizing agents, including the injection of a harmless, non-medicinal saline solution into voluntary recipients;

(c) indications, precautions and contraindications in the use of immunizing agents;

(d) handling of emergencies, including the use of medications required for emergency treatment of anaphylaxis;

(e) cardio-pulmonary resuscitation techniques; and

(f) recordkeeping and reporting of immunizations and information.

(ii) Training course associated with Doctor of Pharmacy degree:

(a) graduation with a Doctor of Pharmacy degree from a professional program of study in pharmacy that is registered by the department pursuant to Part 52 of this Title, or is accredited by an acceptable accrediting agency as defined in section 63.1(a) of this Part, or is determined by the department to be the equivalent of such a registered or accredited program; and

(b) completion of training in the administration of immunization agents satisfactory to the department, including instruction in the areas identified in subparagraph (i) of this paragraph, received as part of his/her pharmacy degree program, provided that such training was completed within the three years immediately preceding application for a certificate of administration.

(iii) Certificate of administration issued by another jurisdiction:

(a) possession of a current certificate of administration issued by another jurisdiction, authorizing the pharmacist to administer immunization agents based on the pharmacists completion of training or coursework in the administration of immunizing agents as described in subparagraph (i) of this paragraph, or its equivalent as determined by the department; and

(b) 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, acceptable to the commissioner and the Commissioner of Health, provided that such retraining incorporates the areas identified in subparagraph (i) of this paragraph.

(4) With the exception of a certified pharmacy intern, a certified pharmacist shall not delegate the administration of immunizations to an- other person. For purposes of this section, a certified pharmacy intern shall mean a pharmacy intern who is certified to administer immunization as specified in section 6806 of the Education Law and has completed the requirements set forth in subdivision (d) of section 63.4 of this Part. Such a certified pharmacy intern may only administer immunizations under the immediate personal supervision of the certified pharmacist.

(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) prior to administering an immunization agent, a certified pharmacist shall ensure that each potential recipient is assessed for contraindications that would preclude immunization(s);

(ii) a certified pharmacist shall be responsible for having emergency anaphylaxis treatment agents, related syringes and needles available at the location at which immunizations will be administered;

(iii) a certified pharmacist shall inform each recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, of potential side effects and adverse reactions, orally and in writing, prior to immunization and shall administer the immunization or immunizations according to the most current recommendations by the advisory committee for immunization practices (ACIP), provided, however, that a pharmacist may administer any immunization authorized when specified by a patient specific prescription;

(iv) a certified pharmacist shall not administer immunizations unless the recipient is adequately informed as prescribed in this paragraph and the recipient consents to the immunization; except for recipients incapable of consenting to the administration of an immunization, in which case, before an immunization may be administered, either a person legally responsible for the recipient shall have given prior written consent to the immunization after having been informed in writing of potential side effects and adverse reactions, or a person legally responsible for the recipient is in attendance during the immunization and consents to the immunization after having been informed of potential side effects and adverse reactions;

(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.

(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;

(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);

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

(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;

(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;

(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;

(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;

(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

(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;

(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

(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.

(b) Anaphylaxis treatment agents.

(1) Pursuant to sections 6801 and 6802 of the Education Law, each pharmacist who is issued a certificate of administration pursuant to this section shall be authorized to administer medications for the emergency treatment of anaphylaxis to patients 2 years of age or older.

(2) Standards, procedures and reporting requirements for the administration of anaphylaxis treatment agents. Each certified pharmacist shall comply with the following requirements when administering medications for the emergency treatment of anaphylaxis under this section:

(i) each certified pharmacist shall ensure that a record of all persons to whom such pharmacist has administered an anaphylaxis treatment agent, including but not limited to: the recipient's name, date, address of administration, administering pharmacist, anaphylaxis treatment agent, manufacturer, and lot number, is recorded and maintained in either a patient medication profile, if one is required, that is prepared and retained in conformity with section 63.6(b)(7) of this Part; or, in the event that a patient medication profile is not required, on a separate form retained by the pharmacist who administered the anaphylaxis treatment agent and shall be maintained in accordance with section 29.2(a)(3) of this Title;

(ii) each certified pharmacist shall contact the local emergency medical services system following the administration of the anaphylaxis treatment agent, or shall ensure that equivalent follow-up care is provided through other arrangements; and

(iii) certified pharmacists shall report to the local emergency medical system or other provider of equivalent follow-up care information concerning the administration of the anaphylaxis treatment agent, including but not limited to: the name of the agent, when it was administered, the dosage, strength, and route of administration. Certified pharmacists shall also report such information to the patient's primary health care practitioner if one exists, unless the patient is unable to communicate the identity of his or her primary health care practitioner.

(3) Non-patient specific order and protocol.

(i) The certified pharmacist shall either 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 to patients 2 years of age or older, in accordance with the requirements of paragraph (1) of this subdivision. The order prescribed in subparagraph (ii) of this paragraph shall incorporate a protocol that meets the requirements of subparagraph (iii) of this paragraph. Such order and protocol shall be considered a record of the patient who receives the anaphylaxis treatment agent and maintained as a record for the patient who receives the anaphylaxis treatment agent. A record of each patient shall be maintained in either:

(a) a patient medication profile that is prepared and retained in conformity with section 63.6(b)(7) of this Part, if one exists; or

(b) 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, in a retrievable format available to the department and the patient. Such record shall be maintained in accordance with section 29.2(a)(3) of this Title.

(ii) The non-patient specific order shall authorize one or more named certified 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. In instances in which the certified pharmacists are not individually named in the order, but are identified as employed or under contract with an entity that is legally authorized to employ or contract with certified pharmacists to provide pharmaceutical services, such pharmacists shall not be authorized by such order to administer anaphylaxis treatment agents outside of such employment or contract. The order shall contain but shall not be limited to the following information:

(a) the specific anaphylaxis treatment agents that the certified pharmacists are permitted to administer;

(b) the period of time that the order is effective, including the beginning and end dates;

(c) the name and license number of the certified pharmacist(s) authorized to administer the anaphylaxis treatment agent(s) pursuant to the order; or the name of the entity that is legally authorized to employ or contract with certified pharmacists to provide pharmaceutical services with whom certified pharmacists who are not individually named are employed or under contract to administer the prescribed anaphylaxis treatment agent(s) pursuant to the order;

(d) in instances in which the certified pharmacists are not individually named in the order, but are identified as employed or under contract with an entity that is legally authorized to employ or contract with certified pharmacists to provide pharmaceutical services, the order shall contain a statement limiting the certified pharmacists to administering anaphylaxis treatment agents only in the course of such employment or pursuant to such contract; and

(e) the name, license number, and signature of the licensed physician or certified nurse practitioner who has issued the order.

(iii) The protocol, incorporated into the order prescribed in subparagraph (ii) of this paragraph, shall include, but need not be limited to, the requirements set forth in paragraph (2) of this subdivision.

N.Y. Comp. Codes R. & Regs. Tit. 8 § 63.9

Amended New York State Register December 30, 2015/Volume XXXVII, Issue 52, eff. 12/30/2015

Amended New York State Register December 26, 2018/Volume XL, Issue 52, eff. 12/26/2018

Amended New York State Register May 22, 2019/Volume XLI, Issue 21, eff. 5/22/2019

Amended New York State Register November 3, 2021/Volume XLIII, Issue 44, eff. 11/3/2021

Amended New York State Register June 1, 2022/Volume XLIV, Issue 22, eff. 6/1/2022