By: Janek, Shapleigh S.B. No. 409

A BILL TO BE ENTITLED

AN ACT

relating to restrictions on the interchange of anti-epileptic drugs and drugs used to treat or prevent seizures.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

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 [State Board of] Medical Board [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, in consultation with the Texas Medical Board, shall include all anti-epileptic drugs, as defined by Section 562.0141(a), in the list of narrow therapeutic index drugs.

(c) Notwithstanding any other provision of law, this section applies to the refill of a prescription for a narrow therapeutic index drug only if the prescribing practitioner indicates on the prescription or in the directions on the prescription that the drug is for the treatment of epilepsy or seizures, as those terms are defined by Section 562.0141(a).

SECTION 2. Subchapter A, Chapter 562, Occupations Code, is amended by adding Section 562.0141 to read as follows:

Sec. 562.0141. ANTI-EPILEPTIC DRUG PRODUCT SELECTION PROHIBITED. (a) In this section:

(1) "Anti-epileptic drug" means:

(A) any drug prescribed for the treatment of epilepsy; or

(B) a drug used to treat or prevent seizures.

(2) "Epilepsy" means a neurological condition characterized by recurrent seizures.

(3) "Seizure" means an acute clinical change secondary to a brief disturbance in the electrical activity of the brain.

(4) "Interchange" means the substitution of one version of the same anti-epileptic 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 anti-epileptic drug or a different anti-epileptic drug for the anti-epileptic drug originally prescribed.

(b) Notwithstanding Section 562.014, a pharmacist may not interchange an anti-epileptic drug or formulation of an anti-epileptic drug, brand or generic, for the treatment of a patient with seizures or epilepsy without prior notification of and the signed informed consent of such interchange from the prescribing physician.

(c) To comply with Subsection (b), a pharmacist may document the notification of a prescribing physician and secure the informed written consent of such physician by contacting the physician orally or electronically to secure permission to interchange an anti-epileptic drug or formulation of an anti-epileptic drug, brand or generic, and reducing such consent to writing. If the prescribing physician does not authorize a substitute, such denial shall also be documented in the same manner and format. A copy of such communication shall be forwarded to the physician and a copy kept with the records of the pharmacist. The documented notification and consent under this subsection shall be considered as a statement that the prescription is "brand medically necessary" and shall be considered part of the prescription, if applicable.

(d) A pharmacist may provide an emergency refill of an anti-epileptic drug under Section 562.054. Notwithstanding any other provision of this section, a pharmacist may interchange drug products in order to provide an emergency refill of an anti-epileptic drug if the pharmacist is not able to provide the emergency refill without interchanging drug products.

(e) This section applies to a drug provided to a Medicaid recipient in a state fiscal year only if the Health and Human Services Commission determines that funding is available to provide the version of drug required under this section. The Health and Human Services Commission shall notify the board of its determination before September 1 of each year.

SECTION 3. Section 562.009, Occupations Code, is amended by adding Subsection (e) to read as follows:

(e) If the prescription is for an "anti-epileptic drug" as defined by Section 562.0141(a)(1), the pharmacist must comply with the provisions of Section 562.0141.

SECTION 4. This Act takes effect immediately if it receives a vote of two-thirds of all the 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.