BILL ANALYSIS

C.S.H.B. 678

By: Cortez

Public Health

Committee Report (Substituted)

BACKGROUND AND PURPOSE

Following the 2009 H1N1 influenza pandemic, the state expanded access to vaccinations by allowing pharmacists to administer a flu shot, under a physician's protocol and without a prescription, to anyone seven years of age and older. In spite of the safe and convenient access to flu prevention afforded by this option, limited immunization authority prevents Texas pharmacists from offering the remaining federally recommended childhood vaccinations, for which a physician's prescription is still required. In response to the COVID-19 pandemic, the federal government has authorized pharmacists to provide recommended vaccinations to children three years of age or older during the emergency. C.S.H.B. 678 seeks to increase immunization rates statewide and improve the overall health of Texans by permanently authorizing a pharmacist to order and administer immunizations and vaccinations to patients who are at least three years of age under certain circumstances.

CRIMINAL JUSTICE IMPACT

It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision.

RULEMAKING AUTHORITY

It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution.

ANALYSIS

C.S.H.B. 678 amends the Occupations Code to revise the authorization for a pharmacist to administer a vaccination to certain patients without an established physician-patient relationship as follows:

· expand the pharmacist's authority to administer an influenza vaccination to allow the pharmacist to order or administer any immunization or vaccination that is authorized or approved by the FDA or listed in the routine immunization schedule recommended by the federal Advisory Committee on Immunization Practices and that is ordered or administered in accordance with the advisory committee's vaccine-specific recommendations; and

· change the minimum age of such a patient to whom a pharmacist may administer an immunization or vaccination from over seven years of age to at least three years of age.

The bill clarifies that administration by a pharmacist of an immunization or vaccination to a patient who is younger than three years of age continues to require supervision by a delegating physician who has established a physician-patient relationship with that patient. The bill extends the deadline for a pharmacist who administers an immunization or vaccination prescribed by a physician to notify that physician after its administration from within 24 hours after administering the immunization or vaccination to not later than the 14th day after the date of administration.

C.S.H.B. 678 requires the Texas State Board of Pharmacy (TSBP) to specify conditions under which a pharmacist may order an immunization or vaccination. The bill revises requirements for the TSBP-specified conditions under which a pharmacist may administer medication, including an immunization or vaccination, as follows:

· makes the conditions applicable only to ordering or administering an immunization or vaccination; and

· removes the following required conditions:

o that a licensed health care provider is not reasonably available to administer the medication, immunization, or vaccination;

o that failure to administer the medication, other than an immunization or vaccination, might result in a significant delay or interruption of a critical phase of drug therapy;

o that the pharmacist administers the immunization or vaccination under a physician's written protocol and meets TSBP-established standards; and

o that the administration is not conducted at a patient's residence, other than a licensed nursing home or hospital.

The bill replaces a prohibition against delegating a pharmacist's authority to administer medication, including an immunization or vaccination, with an authorization to delegate that authority respecting an immunization or vaccination to a certified pharmacy technician. The bill extends a requirement for the TSBP to establish minimum and continuing education standards for a pharmacist who administers an immunization or vaccination to also apply to a pharmacist who orders an immunization or vaccination.

C.S.H.B. 678 updates the definition of "practice of pharmacy" for purposes of the Texas Pharmacy Act to account for the additional authority to order and administer immunizations and vaccinations granted to pharmacists under the bill's provisions.

EFFECTIVE DATE

September 1, 2021.

COMPARISON OF ORIGINAL AND SUBSTITUTE

While C.S.H.B. 678 may differ from the original in minor or nonsubstantive ways, the following summarizes the substantial differences between the introduced and committee substitute versions of the bill.

While the original expanded the authority of a pharmacist to administer immunizations and vaccinations by extending the age range of recipients, the substitute also grants pharmacists the additional authority to order immunizations and vaccinations. Accordingly, the substitute includes a provision not in the original requiring the TSBP to extend minimum and continuing education standards to a pharmacist who orders an immunization or vaccination.

The original retained a prohibition against the delegation of a pharmacist's authority to administer a medication, including an immunization or vaccination. The substitute removes this prohibition and instead allows a pharmacist's authority to administer an immunization or vaccination to be delegated to a certified pharmacy technician. The substitute also removes a prohibition that was retained in the original against a pharmacist's administration of medication, including an immunization or vaccination, at a patient's residence other than a licensed nursing home or hospital.

The substitute includes a clarification not found in the original that supervision by a physician who has established a physician-patient relationship with the patient is still required for a pharmacist's administration of an immunization or vaccination to a patient under three years of age.

The substitute updates the definition establishing the scope of the practice of pharmacy in accordance with the bill's provisions, whereas the original did not.