By: Madla S.B. No. 1524
Line and page numbers may not match official copy.
Bill not drafted by TLC or Senate E&E.
A BILL TO BE ENTITLED
AN ACT
1-1 relating to the refill of a prescription for a narrow therapeutic
1-2 index drug.
1-3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-4 SECTION 1. Section 40 (m), Texas Pharmacy Act (Article
1-5 4542a-1, Vernon's Texas Civil Statutes), is amended to read as
1-6 follows:
1-7 (m) Except as provided by this subsection, drug product
1-8 selection authorized in this section does not apply to the refill
1-9 of a prescription for a narrow therapeutic index drug. [The board,
1-10 in consultation with the Texas State Board of Medical Examiners,
1-11 shall establish, by rule, a list of narrow therapeutic index drugs
1-12 that are subject to this subsection. A prescription for a narrow
1-13 therapeutic index drug may be refilled only by using the same drug
1-14 product by the same manufacturer that the pharmacist last dispensed
1-15 under the prescription, unless otherwise agreed to by the
1-16 prescribing physician. If a pharmacist does not have the same drug
1-17 product by the same manufacturer in stock to refill the
1-18 prescription, the pharmacist may dispense a drug product that is
1-19 generically equivalent if the pharmacist, before dispensing the
1-20 generically equivalent drug product, notifies:]
1-21 (1) For the purposes of this subsection, "narrow
1-22 therapeutic index drug" means a prescription drug:
2-1 (A) that exhibits a therapeutic index ratio of
2-2 less than a 2-fold difference in median lethal dose and median
2-3 effective dose values, or has less than a 2-fold difference in the
2-4 minimum toxic concentrations and minimum effective concentrations
2-5 in the blood, and requires careful dosage titration and patient
2-6 monitoring for the safe and effective use of the drug products; and
2-7 (B) has been determined by the board, subject to
2-8 the provisions of Subdivision (2) (A), to pose a health risk to a
2-9 patient if interchanged with a generically equivalent drug product
2-10 from another manufacturer at the time of refill.
2-11 (2) As deemed appropriate, but not less than every two
2-12 years, the board, in consultation with the Texas State Board of
2-13 Medical Examiners, shall determine, under the administrative
2-14 procedure law, Chapter 2001, Government Code, if there are any
2-15 prescription drugs which meet the definition of a narrow
2-16 therapeutic drug in subdivision (1).
2-17 (A) The board shall make its determinations
2-18 relevant to this subdivision and subdivision (1) (B) based on
2-19 scientific evidence presented by:
2-20 (i) independent clinical studies;
2-21 (ii) peer-reviewed literature; or
2-22 (iii) any other reasonable method
2-23 demonstrating scientific evidence.
2-24 (B) To assist the board in making its
2-25 determination, the board may appoint an advisory committee
2-26 comprised of a cross-section of individuals possessing professional
3-1 credentials in pharmacology, the practice of medicine, drug
3-2 manufacture, or any other profession deemed appropriate to evaluate
3-3 prescription drugs for the purposes of this subsection
3-4 (C) Upon making its determination, the board
3-5 shall:
3-6 (i) adopt, by rule, list of the drugs
3-7 determined to be narrow therapeutic index drugs as defined by this
3-8 Section; or
3-9 (ii) publish, in the Texas Register, a
3-10 statement:
3-11 a. listing the drugs that
3-12 were evaluated for the purposes of this section; and
3-13 b. specifying that no drug
3-14 evaluated was defined as a narrow therapeutic index drug under this
3-15 section.
3-16 (D) All meetings and deliberations by the board
3-17 or an advisory committee created under paragraph (B) concerning
3-18 this subsection shall be recorded and subject to the open meetings
3-19 law, Chapter 551, Government Code and the open records law, Chapter
3-20 552, Government Code.
3-21 (3) a prescription for a drug defined as a narrow
3-22 therapeutic index drug under this section may be refilled with a
3-23 generically equivalent drug from another manufacturer if:
3-24 (A) the prescribing physician has, in the manner
3-25 prescribed under subsection (h) of this Section, indicated on the
3-26 original prescription that product selection is permitted;
4-1 (B) the patient, or a person acting on behalf of
4-2 the patient, is notified, at the time the prescription is
4-3 dispensed, that a substitution of the prescribed drug product has
4-4 been made; and
4-5 (C) the prescribing practitioner is notified of
4-6 the drug product substitution by telephone, facsimile, or mail, at
4-7 the earliest reasonable time, but not later than 72 hours after
4-8 dispensing the prescription.
4-9 SECTION 2. The importance of this legislation and the
4-10 crowded condition of the calendars in both houses create an
4-11 emergency and an imperative public necessity that the
4-12 constitutional rule requiring bills to be read on three several
4-13 days in each house be suspended, and this rule is hereby suspended,
4-14 and that this Act take effect and be in force according to its
4-15 terms, and it is so enacted.