1-1 By: Madla S.B. No. 1524
1-2 (In the Senate - Filed March 12, 1999; March 15, 1999, read
1-3 first time and referred to Committee on Health Services;
1-4 April 22, 1999, reported adversely, with favorable Committee
1-5 Substitute by the following vote: Yeas 3, Nays 2; April 22, 1999,
1-6 sent to printer.)
1-7 COMMITTEE SUBSTITUTE FOR S.B. No. 1524 By: Madla
1-8 A BILL TO BE ENTITLED
1-9 AN ACT
1-10 relating to the refill of a prescription for a narrow therapeutic
1-11 index drug.
1-12 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-13 SECTION 1. Section 40, Texas Pharmacy Act (Article 4542a-1,
1-14 Vernon's Texas Civil Statutes), is amended by amending Subsection
1-15 (m) and adding Subsections (n) and (o) to read as follows:
1-16 (m) Except as provided by this subsection, drug product
1-17 selection authorized in this section does not apply to the refill
1-18 of a prescription for a narrow therapeutic index drug. A
1-19 prescription for a narrow therapeutic index drug may be refilled
1-20 with a generically equivalent drug from another manufacturer if:
1-21 (1) the prescribing physician has, in the manner
1-22 provided by Subsection (h) of this section, indicated on the
1-23 original prescription that product selection is permitted;
1-24 (2) [The board, in consultation with the Texas State
1-25 Board of Medical Examiners, shall establish, by rule, a list of
1-26 narrow therapeutic index drugs that are subject to this subsection.
1-27 A prescription for a narrow therapeutic index drug may be refilled
1-28 only by using the same drug product by the same manufacturer that
1-29 the pharmacist last dispensed under the prescription, unless
1-30 otherwise agreed to by the prescribing physician. If a pharmacist
1-31 does not have the same drug product by the same manufacturer in
1-32 stock to refill the prescription, the pharmacist may dispense a
1-33 drug product that is generically equivalent if the pharmacist,
1-34 before dispensing the generically equivalent drug product,
1-35 notifies:]
1-36 [(1)] the patient or a person acting for the patient
1-37 is notified[,] at the time the prescription is dispensed[,] that a
1-38 substitution of the prescribed drug product has been made; and
1-39 (3) [(2)] the prescribing practitioner is notified of
1-40 the drug product substitution by telephone, facsimile, or mail, at
1-41 the earliest reasonable time, but not later than 72 hours after
1-42 dispensing the prescription.
1-43 (n) As appropriate, but at least every two years, the board,
1-44 in consultation with the Texas State Board of Medical Examiners,
1-45 shall determine under Chapter 2001, Government Code, whether any
1-46 prescription drugs meet the definition of narrow therapeutic index
1-47 drug under Subsection (o) of this section. The board shall make
1-48 the determinations required by this subsection based on scientific
1-49 evidence presented by independent clinical studies, peer-reviewed
1-50 literature, or any other reasonable method demonstrating scientific
1-51 evidence. To assist the board in making its determination, the
1-52 board may appoint an advisory committee consisting of a
1-53 cross-section of persons having professional credentials in
1-54 pharmacology, the practice of medicine, drug manufacturing, or any
1-55 other profession considered appropriate to evaluate prescription
1-56 drugs for the purposes of this subsection. The meetings and
1-57 deliberations of the board or of an advisory committee appointed
1-58 under this subsection shall be recorded and are subject to Chapters
1-59 551 and 552, Government Code. On making its determination, the
1-60 board shall:
1-61 (1) adopt by rule a list of drugs determined to be
1-62 narrow therapeutic index drugs; or
1-63 (2) publish in the Texas Register a statement that:
1-64 (A) lists each drug that was evaluated by the
2-1 board under this subsection; and
2-2 (B) states that none of the evaluated drugs were
2-3 determined to be narrow therapeutic index drugs under this
2-4 subsection.
2-5 (o) For purposes of Subsections (m) and (n) of this section,
2-6 "narrow therapeutic index drug" means a prescription drug that:
2-7 (1) exhibits a therapeutic index ratio of less than a
2-8 two-fold difference in median lethal dose and median effective dose
2-9 values or has a less than two-fold difference in the minimum toxic
2-10 concentrations and minimum effective concentrations in the blood;
2-11 (2) requires careful dosage titration and patient
2-12 monitoring for safe and effective use; and
2-13 (3) has been determined by the board under Subsection
2-14 (n) of this section to pose a health risk to a patient if
2-15 interchanged with a generically equivalent drug product from
2-16 another manufacturer at the time of refill.
2-17 SECTION 2. The importance of this legislation and the
2-18 crowded condition of the calendars in both houses create an
2-19 emergency and an imperative public necessity that the
2-20 constitutional rule requiring bills to be read on three several
2-21 days in each house be suspended, and this rule is hereby suspended,
2-22 and that this Act take effect and be in force from and after its
2-23 passage, and it is so enacted.
2-24 * * * * *