SECTION 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.

Source Note: The provisions of this §295.15 adopted to be effective October 4, 1998, 23 TexReg 9745; amended to be effective December 19, 2001, 26 TexReg 10313; amended to be effective December 6, 2009, 34 TexReg 8721; amended to be effective January 1, 2016, 40 TexReg 8788