Amend SB 625 on third reading by striking all below the
enacting clause and substituting the following:
SECTION 1. Section 562.014, Occupations Code, is amended to
read as follows:
Sec. 562.014. [APPLICATION TO] NARROW THERAPEUTIC INDEX
DRUGS. (a) Except as provided by this section, drug selection as
authorized by this subchapter does not apply to the refill of a
prescription for a narrow therapeutic index drug. The board, in
consultation with the Texas Medical [State] Board [of Medical
Examiners], shall by rule establish a list of narrow therapeutic
index drugs to which this subsection applies. A prescription for a
narrow therapeutic index drug may be refilled only by using the same
drug product by the same manufacturer that the pharmacist last
dispensed under the prescription, unless otherwise agreed to by the
prescribing practitioner [physician]. If a pharmacist does not
have the same drug product by the same manufacturer in stock to
refill the prescription, the pharmacist may dispense a drug product
that is generically equivalent if the pharmacist, before dispensing
the generically equivalent drug product, notifies:
(1) the patient, at the time the prescription is
dispensed, that a substitution of the prescribed drug product has
been made; and
(2) the prescribing practitioner [physician] of the
drug product substitution by telephone, facsimile, or mail, at the
earliest reasonable time, but not later than 72 hours after
dispensing the prescription.
(b) The board and the Texas Medical Board shall establish a
joint committee to recommend to the board a list of narrow
therapeutic index drugs and the rules, if any, by which this section
applies to those drugs. The committee must consist of an equal
number of members from each board. The committee members shall
select a member of the committee to serve as presiding officer for a
one year term. The presiding officer may not represent the same
board as the presiding officer's predecessor.
(c) The committee shall make a recommendation to the board
on whether to include a drug on the list of narrow therapeutic index
drugs as required by Section 562.0142. In the event of a tie vote by
the committee on whether to recommend that a drug listed in this
subsection be included on the list of narrow therapeutic index
drugs, the committee shall recommend to the board that the drug not
be placed on the list. The committee shall consider for inclusion in
the list of narrow therapeutic index drugs the following drugs:
(1) Prograf;
(2) Cellcept;
(3) Neoral;
(4) Rapamune; and
(5) Sandimmune.
(d) Subsection (c) and this subsection expire December 31,
2008.
SECTION 2. Subchapter A, Chapter 562, Occupations Code, is
amended by adding Sections 562.0141 and 562.0142 to read as
follows:
Sec. 562.0141. TRANSPLANT IMMUNOSUPPRESSANT DRUG PRODUCT
SELECTION PROHIBITED. (a) In this section:
(1) "Immunosuppressant drug" means any drug
prescribed for immunosuppressant therapy following a transplant.
(2) "Interchange" means the substitution of one
version of the same immunosuppressant drug, including a generic
version for the prescribed brand, a brand version for the
prescribed generic version, a generic version by one manufacturer
for a generic version by a different manufacturer, a different
formulation of the prescribed immunosuppressant drug, or a
different immunosuppressant drug for the immunosuppressant drug
originally prescribed.
(b) A pharmacist may not interchange an immunosuppressant
drug or formulation of an immunosuppressant drug, brand or generic,
for the treatment of a patient following a transplant without prior
consent to the interchange from the prescribing practitioner.
(c) To comply with Subsection (b), a pharmacist shall notify
a prescribing practitioner orally or electronically to secure
permission to interchange an immunosuppressant drug or formulation
of an immunosuppressant drug, brand or generic. The practitioner's
authorization or denial of authorization must be documented by the
pharmacist and by the practitioner.
(d) If a pharmacist does not have the same drug product by
the same manufacturer in stock to refill the prescription, or if the
practitioner is unavailable to give authorization, the pharmacist
may dispense a drug product that is generically equivalent if the
pharmacist, before dispensing the generally equivalent drug
product:
(1) notifies and receives consent from the patient, at
the time the prescription is dispensed, to substitute the
prescribed drug product; and
(2) notifies the prescribing practitioner of the drug
product substitution orally or electronically at the earliest
reasonable time, but not later than 24 hours after dispensing the
prescription.
(e) This section is only effective subject to the conditions
established by Section 562.0142.
Sec. 562.0142. ADOPTION OF RULES. (a) If, not later than
October 1, 2007, a drug manufacturer requests that the joint
committee under Section 562.014 conduct a hearing and make a
recommendation to include a drug listed in Section 562.014(c) on
the list of narrow therapeutic index drugs, the joint committee
shall make a recommendation to the board to enable the board to
adopt a rule and issue findings not later than July 1, 2008.
(b) If, not later than October 1, 2007, no drug manufacturer
requests that the joint committee conduct a hearing and make
recommendations to the board to include a drug listed in Section
562.014(c) on the list of narrow therapeutic index drugs, Section
562.0141 expires October 1, 2007.
(c) If all drug manufacturers that request, before October
1, 2007, the joint committee to conduct a hearing and make a
recommendation to the board to include a drug listed in Section
562.014(c) on the list of narrow therapeutic index drugs
subsequently withdraw those requests before the date the joint
committee makes a recommendation to include the drug on that list,
Section 562.0141 expires effective on the date of the
manufacturers' withdrawal of those requests.
(d) If the joint committee receives a request under
Subsection (a), the recommendation of the joint committee under
that subsection may include the drugs listed in Section 562.014(c)
or the joint committee may recommend that no drug should be added to
the list of narrow therapeutic index drugs following the review by
the joint committee.
(e) If the joint committee receives a request under
Subsection (a) and, not later than July 1, 2008, the board adopts a
rule to include any drug listed in Section 562.014(c) on the list of
narrow therapeutic index drugs or determines by rule that no drug
should be added to the list of narrow therapeutic index drugs,
Section 562.0141 expires on July 1, 2008.
(f) If the joint committee receives a request under
Subsection (a) and the board does not before July 1, 2008, adopt a
rule to include any drug listed in Section 562.014(c) on the list of
narrow therapeutic index drugs or determine by rule that no drug
should be added to the list of narrow therapeutic index drugs,
Section 562.0141 takes effect July 1, 2008.
(g) If the joint committee receives a request under
Subsection (a) and litigation or a request for an attorney
general's opinion regarding this section, Section 562.014, or
Section 562.0141 is filed by a drug manufacturer between the
effective date of this section and July 1, 2008, the time limits
established by Subsections (e) and (f) are tolled until the
litigation is resolved or the attorney general renders an opinion.
(h) For purposes of this section, notice of the following
must be published in the Texas Register not later than the third
business day after the date of occurrence:
(1) a request by a drug manufacturer for inclusion of a
drug on the list of narrow therapeutic index drugs;
(2) withdrawal of a request described by Subdivision
(1);
(3) litigation described by Subsection (g);
(4) resolution of litigation described by Subsection
(g); and
(5) a request for an attorney general's opinion
described by Subsection (g).
SECTION 3. Section 562.009, Occupations Code, is amended by
adding Subsection (e) to read as follows:
(e) If the prescription is for an immunosuppressant drug, as
defined by Section 562.0141(a)(1), the pharmacist must comply with
the provisions of Section 562.0141. This subsection expires if
Section 562.0141 expires under the requirements of Section
562.0142.
SECTION 4. The Texas State Board of Pharmacy and Texas
Medical Board shall establish the joint committee required by
Section 562.014(b), Occupations Code, as added by this Act, not
later than the 90th day after the effective date of this Act or
September 1, 2007, whichever date occurs first.
SECTION 5. This Act takes effect immediately if it receives
a vote of two-thirds of all members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect September 1, 2007.