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