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.
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