| (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
Cont'd... |
