BILL ANALYSIS

C.S.H.B. 25

By: Shofner

Public Health

Committee Report (Substituted)

BACKGROUND AND PURPOSE

The bill author has informed the committee that ivermectin is an anti-parasitic drug that was first used as a veterinary medicine used to prevent and treat a wide variety of internal and external parasites. Today, ivermectin tablets are approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. Furthermore, some topical forms of ivermectin are approved by the FDA to treat external parasites like head lice and for skin conditions such as rosacea. C.S.H.B. 25 seeks to provide easier accessibility to ivermectin by authorizing a licensed pharmacist to dispense ivermectin without requiring a health care practitioner's prescription order.

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 rulemaking authority is expressly granted to the Texas State Board of Pharmacy in SECTION 1 of this bill.

ANALYSIS

C.S.H.B. 25 amends the Health and Safety Code to authorize a pharmacist to dispense ivermectin to a person, without requiring a prescription order from a licensed health care practitioner, in accordance with any written standardized procedures or protocols issued by the Texas State Board of Pharmacy (TSBP), including, if required, providing the person with instructions on the proper use of ivermectin. The bill establishes that, notwithstanding any other law, a pharmacist acting in a reasonably prudent manner is not criminally or civilly liable or subject to professional disciplinary action for dispensing ivermectin in accordance with that authorization. The bill authorizes the TSBP to adopt the rules necessary to implement the bill's provisions.

EFFECTIVE DATE

91st day after the last day of the legislative session.

COMPARISON OF INTRODUCED AND SUBSTITUTE

While C.S.H.B. 25 may differ from the introduced in minor or nonsubstantive ways, the following summarizes the substantial differences between the introduced and committee substitute versions of the bill.

The substitute omits the following provisions from the introduced:

· a requirement for the commissioner of state health services to issue a statewide order authorizing a licensed pharmacist to dispense ivermectin without a health care practitioner's prescription order notwithstanding any other law; and

· a requirement for the statewide order to include written, standardized procedures or protocols for a pharmacist to follow when dispensing ivermectin and require the pharmacist to provide each patient with instructions on the proper use of ivermectin.

While the introduced authorized a pharmacist to dispense ivermectin in accordance with the statewide order, the substitute authorizes a pharmacist to dispense ivermectin to a person, without requiring a prescription order from a licensed health care practitioner, in accordance with any written standardized procedures or protocols issued by the TSBP including, if required, providing the person with instructions on the proper use of ivermectin.

While the introduced established that, notwithstanding any other law, a pharmacist acting in a reasonably prudent manner is not criminally or civilly liable or subject to professional disciplinary action for dispensing ivermectin in accordance with the statewide order, the substitute establishes that, notwithstanding any other law, a pharmacist acting in a reasonably prudent manner is not criminally or civilly liable or subject to professional disciplinary action for dispensing ivermectin in accordance with the substitute's authorization to dispense ivermectin without a prescription.

The substitute omits a requirement from the introduced for a pharmacist dispensing ivermectin to provide an annual written report in the form and manner the Department of State Health Services prescribes on the number of doses of ivermectin the pharmacist dispensed in accordance with the statewide order in the preceding calendar year.

While the introduced authorized both the executive commissioner of the Health and Human Services Commission and the TSBP to adopt the rules necessary to implement the bill's provisions, the substitute authorizes only the TSBP to do so.

The substitute omits the following provisions from the introduced:

· a prohibition against the issuance of the statewide order by the commissioner of state health services, notwithstanding any other law, from being the basis for criminal or civil liability against the commissioner or disciplinary action by a licensing entity in Texas that issues a license to the commissioner; and

· a requirement for the commissioner of state health services to issue a statewide order in accordance with the introduced version's provisions as soon as practicable after the bill's effective date.