22 Tex. Admin. Code § 295.15 - Administration of Immunizations or Vaccinations by a Pharmacist under Written Protocol of Physician
(a) Purpose. The
purpose of this section is to provide standards for pharmacists engaged in the
administration of immunizations or vaccinations as authorized in Chapter 554 of
the Act.
(b) Definitions. The
following words and terms, when used in this section, shall have the following
meanings, unless the context clearly indicates otherwise.
(1) ACPE--The Accreditation Council for
Pharmacy Education.
(2) Act--The
Texas Pharmacy Act, Chapter 551 - 566 and 568 - 569, Occupations Code, as
amended.
(3) Administer--The direct
application of a prescription drug by injection, inhalation, ingestion, or any
other means to the body of a patient by:
(A) a
practitioner, an authorized agent under his supervision, or other person
authorized by law; or
(B) the
patient at the direction of a practitioner.
(4) Antibody--A protein in the blood that is
produced in response to stimulation by a specific antigen. Antibodies help
destroy the antigen that produced them. Antibodies against an antigen usually
equate to immunity to that antigen.
(5) Antigen--A substance "recognized" by the
body as being foreign; it results in the production of specific antibodies
directed against it.
(6) Board--The
Texas State Board of Pharmacy.
(7)
Confidential record--Any health-related record that contains information that
identifies an individual and that is maintained by a pharmacy or pharmacist
such as a patient medication record, prescription drug order, or medication
order.
(8) Data communication
device--An electronic device that receives electronic information from one
source and transmits or routes it to another (e.g., bridge, router, switch, or
gateway).
(9) Immunization--The act
of inducing antibody formation, thus leading to immunity.
(10) Medical Practice Act--The Texas Medical
Practice Act, Subtitle B, Occupations Code, as amended.
(11) Vaccination--Administration of any
antigen in order to induce immunity; is not synonymous with immunization since
vaccination does not imply success.
(12) Vaccine--A specially prepared antigen,
which upon administration to a person will result in immunity.
(13) Written Protocol--A physician's order,
standing medical order, standing delegation order, or other order or protocol
as defined by rule of the Texas Medical Board under the Medical Practice Act.
(A) A written protocol must contain, at a
minimum, the following:
(i) a statement
identifying the individual physician authorized to prescribe drugs and
responsible for the delegation of administration of immunizations or
vaccinations;
(ii) a statement
identifying the individual pharmacist authorized to administer immunizations or
vaccinations as delegated by the physician;
(iii) a statement identifying the location(s)
(i.e., address) at which the pharmacist may administer immunizations or
vaccinations;
(iv) a statement
identifying the immunizations or vaccinations that may be administered by the
pharmacist;
(v) a statement
identifying the activities the pharmacist shall follow in the course of
administering immunizations or vaccinations, including procedures to follow in
the case of reactions following administration; and
(vi) a statement that describes the content
of, and the appropriate mechanisms for the pharmacist to report the
administration of immunizations or vaccinations to the physician issuing the
written protocol within the time frames specified in this section.
(B) A standard protocol may be
used or the physician may develop an immunization or vaccination protocol for
the individual patient. If a standard protocol is used, the physician shall
record what deviations, if any, from the standard protocol are ordered for the
patient.
(c)
Pharmacist certification requirements. Pharmacist who enter into a written
protocol with a physician to administer immunizations or vaccinations shall:
(1) complete a course provided by an ACPE
approved provider which:
(A) requires
documentation by the pharmacist of current certification in the American Heart
Association's Basic Cardiac Life Support for Health-Care Providers or its
equivalent;
(B) is an
evidence-based course which:
(i) includes
study material;
(ii) includes
hands-on training in techniques for administering immunizations or vaccines;
and
(iii) requires testing with a
passing score; and
(C)
meets current Center for Disease Control training guidelines and provides a
minimum of 20 hours of instruction and experiential training in the following
content areas:
(i) standards for pediatric,
adolescent, and adult immunization practices;
(ii) basic immunology and vaccine
protection;
(iii)
vaccine-preventable diseases;
(iv)
recommended immunization schedules (pediatric/adolescent/adult);
(v) vaccine storage and management;
(vi) informed consent;
(vii) physiology and techniques for vaccine
administration;
(viii) pre and
post-vaccine assessment and counseling;
(ix) immunization record management;
and
(x) adverse events:
(I) identification and appropriate response;
and
(II) documentation and
reporting; and
(2) maintain documentation of:
(A) completion of the initial course
specified in paragraph (1) of this subsection;
(B) 3 hours of continuing education every 2
years which are designed to maintain competency in the disease states, drugs,
and administration of immunizations or vaccinations; and
(C) current certification in the American
Heart Association's Basic Cardiac Life Support for Health-Care Providers or its
equivalent.
(d) Supervision. Pharmacists involved in the
administration of immunizations or vaccinations shall be under the supervision
of a physician. Physician supervision shall be considered adequate if the
delegating physician:
(1) is responsible for
the formulation or approval of the physician's order, standing medical order,
standing delegation order, or other order or protocol and periodically reviews
the order or protocol and the services provided to a patient under the order or
protocol;
(2) has established a
physician-patient relationship with each patient under 14 years of age and
referred the patient to the pharmacist; except a pharmacist may administer an
influenza vaccination to a patient over seven years of age without an
established physician-patient relationship;
(3) is geographically located so as to be
easily accessible to the pharmacist administering the immunization or
vaccination;
(4) receives, as
appropriate, a periodic status report on the patient, including any problem or
complication encountered; and
(5)
is available through direct telecommunication for consultation, assistance, and
direction.
(e) Special
Provisions. Pharmacists involved in the administration of immunizations or
vaccinations under their license to practice pharmacy shall meet the following
restrictions and requirements.
(1)
Pharmacists may only administer immunizations or vaccinations pursuant to a
written protocol from a physician authorizing the administration.
(2) Pharmacists may administer immunizations
or vaccinations to a patient under 14 years of age only upon a referral from a
physician who has an established physician-patient relationship with each
patient. However, a pharmacist may administer an influenza vaccination to a
patient over seven years of age without an established physician-patient
relationship.
(3) Pharmacists may
administer immunizations or vaccinations under written protocol of a physician
within a pharmacy or at any other location specifically identified in the
written protocol. Such other location may not include where the patient
resides, except for a licensed nursing home or hospital.
(4) The authority of a pharmacist to
administer immunizations or vaccinations may not be delegated.
(5) Pharmacists may administer immunizations
and vaccinations only when a licensed health-care provider authorized to
administer the medication is not reasonably available to administer the
medication. For the purpose of this section, "reasonably available" means those
times when the licensed health-care provider is immediately available to
administer the immunization or vaccine and is specifically tasked to do
so.
(6) Under the provisions of the
National Vaccine Injury Compensation Program (NVICP), the health-care provider
under whose authority a covered vaccine is administered (i.e., the physician
issuing the written protocol) must maintain certain information in the
patient's permanent record. In order for the physician to comply with the
provisions of the NVICP, the pharmacist shall provide the physician with the
information specified in subsection (g) of this section.
(7) Before preparing an immunization or
vaccine and between each patient contact, the pharmacist shall cleanse his or
her hands with an alcohol-based waterless antiseptic hand rub or shall wash his
or her hands with soap and water. If gloves are worn, the pharmacist shall
change gloves between patients.
(8)
The pharmacist shall comply with all other state and federal requirements
regarding immunizations or vaccinations.
(f) Drugs.
(1) Drugs administered by a pharmacist under
the provisions of this section shall be in the legal possession of:
(A) a pharmacy, which shall be the pharmacy
responsible for drug accountability, including the maintenance of records of
administration of the immunization or vaccination; or
(B) a physician who shall be responsible for
drug accountability, including the maintenance of records of administration of
the immunization or vaccination.
(2) Drugs shall be transported and stored at
the proper temperatures indicated for each drug.
(3) Pharmacists while actively engaged in the
administration of immunizations or vaccinations under written protocol, may
have in their custody and control the drugs for immunization or vaccination
that are identified in the written protocol and any other dangerous drugs
listed in the written protocol to treat adverse reactions.
(4) After administering immunizations or
vaccinations at a location other than a pharmacy, the pharmacist shall return
all unused prescription medications to the pharmacy or physician responsible
for the drugs.
(g)
Notifications.
(1) A pharmacist engaged in
the administration of immunizations or vaccinations shall provide notification
of the administration to:
(A) the physician
who issued the written protocol within 24 hours of administering the
immunization or vaccination; and
(B) the primary care physician of the
patient, as provided by the patient or patient's agent, within 14 days of
administering the immunization or vaccination.
(2) The notifications required in paragraph
(1) of this subsection shall include the:
(A)
name and address of the patient;
(B) age of the patient if under 14 years of
age;
(C) name of the patient's
primary care physician as provided by the patient or patient's agent;
(D) name, manufacturer, and lot number of the
vaccine administered;
(E) amount
administered;
(F) date the vaccine
was administered;
(G) site of the
immunization or vaccination (e.g., right arm, left leg, right upper
arm);
(H) route of administration
of the immunization or vaccination (e.g., intramuscular, subcutaneous, by
mouth); and
(I) name, address, and
title of the person administering the immunization or vaccination.
(h) Records.
(1) Maintenance of records.
(A) Every record, including notifications,
required to be made under this section shall be kept by the pharmacist
administering the immunization or vaccination and by the pharmacy when in legal
possession of the drugs administered. Such records shall be available for at
least two years from the date of such record, for inspecting and copying by the
board or its representative and to other authorized local, state, or federal
law enforcement or regulatory agencies.
(B) Records, including notifications, may be
maintained in an alternative data retention system, such as a data processing
system or direct imaging system provided:
(i)
the records maintained in the alternative system contain all of the information
required on the manual record; and
(ii) the data processing system is capable of
producing a hard copy of the record upon request of the board, its
representative, or other authorized local, state, or federal law enforcement or
regulatory agencies.
(2) Records of administration under written
protocol.
(A) Records of administration shall
be maintained by the pharmacist administering immunizations or vaccinations.
Such records shall include:
(i) all of the
administration record requirements of subparagraph (B) of this paragraph;
and
(ii) include the name and
address of the pharmacy or physician in legal possession of the immunization or
vaccination administered.
(B) A pharmacy, when responsible for drug
accountability, shall maintain a record of administration of immunizations or
vaccinations by a pharmacist. The records shall be kept and maintained by
patient name. This record shall include:
(i)
a copy of the written protocol under which the immunization or vaccination was
administered and any patient-specific deviations from the protocol;
(ii) name and address of the
patient;
(iii) age of the patient
if under 14 years of age;
(iv) name
of the patient's primary care physician as provided by the patient or patient's
agent;
(v) name, manufacturer, and
lot number of the vaccine administered;
(vi) amount administered;
(vii) date the vaccine was
administered;
(viii) site of the
immunization or vaccination (e.g., right arm, left leg, right upper
arm);
(ix) route of administration
of the immunization or vaccination (e.g., intramuscular, subcutaneous, by
mouth); and
(x) name, address, and
title of the person administering the immunization or vaccination.
(3) Written protocol.
(A) A copy of the written protocol and any
patient-specific deviations from the protocol shall be maintained in accordance
with paragraph (2) of this subsection.
(B) A standard protocol may be used or the
attending physician may develop an immunization/vaccination protocol for the
individual patient. If a standard protocol is used, the physician shall record
what deviations, if any, from the standard protocol are ordered for the
patient. The pharmacy that is in possession of the vaccines administered shall
maintain a copy of any deviations from the standard protocol ordered by the
physician.
(C) Written protocols,
including standard protocols, any patient-specific deviations from a standard
protocol, and any individual patient protocol, shall be reviewed by the
physician and pharmacist at least annually and revised if necessary. Such
review shall be documented in the records of the pharmacy that is in possession
of the vaccines administered.
(i) Confidentiality.
(1) In addition to the confidentiality
requirements specified in §
291.27
of this title (relating to Confidentiality) a pharmacist shall comply with:
(A) the privacy provisions of the federal
Health Insurance Portability and Accountability Act of 1996 (Pub. L. No.
104-191 ) and any rules adopted pursuant to this
act;
(B) the requirements of
Medical Records Privacy contained in Chapter 181, Health and Safety
Code;
(C) the Privacy of Health
Information requirements contained in Chapter 28B of the Insurance Code;
and
(D) any other confidentiality
provisions of federal or state laws.
(2) This section shall not affect or alter
the provisions relating to the confidentiality of the physician-patient
communication as specified in the Medical Practice Act, Chapter 159.
Notes
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