First Regular Session

Sixty-first General Assembly

LLS NO. 97­0830.01D MTJ SENATE BILL 97­238

STATE OF COLORADO

BY SENATORS Lacy, Hopper, Perlmutter, Tebedo, and Wattenberg;

also REPRESENTATIVES Epps and Clarke.

HEALTH, ENVIRONMENT,

WELFARE & INSTITUTIONS

HEALTH, ENVIRONMENT,

WELFARE & INSTITUTIONS

BILL FOR AN ACT

CONCERNING THE ACHIEVEMENT OF IMPROVED CONSUMER PROTECTION THROUGH LIMITATIONS ON THE INTERCHANGE OF PRESCRIPTION NARROW THERAPEUTIC INDEX DRUGS.

Bill Summary

(Note: This summary applies to this bill as introduced and does not necessarily reflect any amendments which may be subsequently adopted.)

Prohibits the interchange of narrow therapeutic index drugs without the notification and the written consent of the practitioner. Requires a participating provider to determine the appropriate drug therapy for a managed care plan enrollee, and requires a narrow therapeutic index drug to be refilled using the same drug product by the same manufacturer that the pharmacist last dispensed under a prescription, unless the participating provider is notified by the pharmacist and the participating provider gives documented consent to the substitution.

Be it enacted by the General Assembly of the State of Colorado:

SECTION 1.  Legislative declaration. The general assembly hereby finds and declares that patient protection is of paramount importance in the regulation of health care providers; that it has been established that continuing changes in the health care industry require the careful monitoring of goods and services provided to patients, for both medical efficacy and cost effectiveness; that there are drugs that have a narrow therapeutic index that require careful dosage titration and patient monitoring for their safe and effective use; and that these same drugs are necessary and widely prescribed in the treatment of a number of diseases, including but not limited to asthma, epilepsy, heart disease, and bipolar personality disorder. It is the duty of the general assembly to list those drugs for which interchanges may not be made without consulting the health care professional who originally prescribed such medication.

SECTION 2.  12­22­124, Colorado Revised Statutes, 1991 Repl. Vol., is amended BY THE ADDITION OF A NEW SUBSECTION to read:

12­22­124.  Substitution of prescribed drugs authorized ­ when ­ conditions ­ rules. (1.5) (a)  NOTWITHSTANDING THE PROVISIONS OF SUBSECTION (1) OF THIS SECTION, A PHARMACIST SHALL NOT INTERCHANGE AN EQUIVALENT DRUG PRODUCT FOR A NARROW THERAPEUTIC INDEX DRUG, AS DEFINED IN PARAGRAPH (b) OF THIS SUBSECTION (1.5), WITHOUT NOTIFICATION AND THE DOCUMENTED CONSENT OF THE PRACTITIONER.

(b)  FOR THE PURPOSES OF THIS SUBSECTION (1.5), A "NARROW THERAPEUTIC INDEX DRUG" MEANS A DRUG PRODUCT FOR WHICH THERE IS LESS THAN A TWO­FOLD DIFFERENCE IN MEDIAN LETHAL DOSE AND MEDIAN EFFECTIVE DOSE, OR FOR WHICH THERE IS LESS THAN A TWO­FOLD DIFFERENCE IN THE MINIMUM TOXIC CONCENTRATIONS AND MINIMUM EFFECTIVE CONCENTRATIONS IN THE BLOOD, AND FOR WHICH SAFE AND EFFECTIVE USE OF THE DRUG PRODUCT REQUIRES CAREFUL DOSAGE TITRATION AND PATIENT MONITORING. NARROW THERAPEUTIC INDEX DRUG PRODUCTS SHALL INCLUDE, BUT SHALL NOT BE LIMITED TO, THE FOLLOWING:

(I)  AMINOPHYLLINE TABLETS AND EXTENDED RELEASE TABLETS;

(II)  CARBAMAZEPINE TABLETS AND ORAL SUSPENSION;

(III)  CLINDAMYCIN HCL CAPSULES;

(IV)  CLONIDINE HCL TABLETS;

(V)  CLONIDINE TRANSDERMAL THERAPEUTIC SYSTEM;

(VI)  DYPHYLLINE TABLETS;

(VII)  DISOPYRAMIDE PHOSPHATE CAPSULES AND EXTENDED RELEASE CAPSULES;

(VIII)  ETHINYL ESTRADIOL ORAL CONTRACEPTIVE TABLETS;

(IX)  GUANETHIDINE SULFATE TABLETS;

(X)  ISOETHARINE MESYLATE INHALATION AEROSOL;

(XI)  ISOPROTERENOL HCL INHALATION AEROSOL;

(XII)  LITHIUM CARBONATE CAPSULES, TABLETS, AND EXTENDED RELEASE TABLETS;

(XIII)  METAPROTERENOL SULFATE TABLETS;

(XIV)  MINOXIDIL TABLETS;

(XV)  OXTRIPHYLLINE TABLETS, DELAYED RELEASE TABLETS, AND EXTENDED RELEASE TABLETS;

(XVI)  PHENYTOIN SODIUM CAPSULES (PROMPT OR EXTENDED) AND ORAL SUSPENSION;

(XVII)  PRAZOSIN HCL CAPSULES;

(XVIII)  PRIMIDONE TABLETS AND ORAL SUSPENSION;

(XIX)  PROCAINAMIDE HCL CAPSULES, TABLETS, AND EXTENDED RELEASE TABLETS;

(XX)  QUINIDINE SULFATE CAPSULES, TABLETS, AND EXTENDED RELEASE TABLETS;

(XXI)  QUINIDINE GLUCONATE TABLETS AND EXTENDED RELEASE TABLETS;

(XXII)  THEOPHYLLINE CAPSULES, EXTENDED RELEASE CAPSULES, TABLETS, AND EXTENDED RELEASE TABLETS;

(XXIII)  VALPROIC ACID CAPSULES AND SYRUP;

(XXIV) DIVALPROEX SODIUM DELAYED RELEASE CAPSULES AND DELAYED RELEASE TABLETS;

(XXV)  WARFARIN SODIUM TABLETS;

(XXVI)  LAMOTRAGINE;

(XXVII)  GABAPENTIN;

(XXVIII)  FELBAMATE; AND

(XXIX)  TOPIRAMATE.

SECTION 3.  10­16­705, Colorado Revised Statutes, 1994 Repl. Vol., as enacted by House BILL 97­2381122, enacted at the First Regular Session of the Sixty­first General Assembly, is amended BY THE ADDITION OF A NEW SUBSECTION to read:

10­16­705.  Requirements for carriers and participating providers. (16) (a)  A PARTICIPATING PROVIDER SHALL DETERMINE THE APPROPRIATE DRUG THERAPY FOR AN ENROLLEE. A PRESCRIPTION FOR A NARROW THERAPEUTIC INDEX DRUG SHALL BE REFILLED USING ONLY THE SAME DRUG PRODUCT BY THE SAME MANUFACTURER, WHETHER BRAND NAME OR GENERIC, THAT THE PHARMACIST LAST DISPENSED UNDER SUCH PRESCRIPTION UNLESS, PRIOR TO THE DISPENSING OF ANOTHER MANUFACTURER'S PRODUCT, THE PHARMACIST SO NOTIFIES THE PARTICIPATING PROVIDER AND THE PARTICIPATING PROVIDER GIVES DOCUMENTED CONSENT THERETO. A CARRIER SHALL NOT PENALIZE THE PARTICIPATING PROVIDER, THE DISPENSING PHARMACIST, OR THE ENROLLEE, FINANCIALLY OR OTHERWISE, FOR PRESCRIBING, DISPENSING, OR REQUESTING A SPECIFIC NARROW THERAPEUTIC INDEX DRUG BY BRAND OR GENERIC NAME.

(b) (I)  FOR PURPOSES OF THIS SUBSECTION (16), "REFILL" INCLUDES A NEW PRESCRIPTION WRITTEN AT THE EXPIRATION OF THE THEN CURRENT ISSUED PRESCRIPTION THAT CONTINUES THE PATIENT'S THERAPY ON THE PARTICULAR NARROW THERAPEUTIC INDEX DRUG.

(II)  FOR THE PURPOSES OF THIS SUBSECTION (16), "NARROW THERAPEUTIC INDEX DRUG" SHALL HAVE THE SAME MEANING AS IN SECTION 12­22­124 (1.5) (b), C.R.S.

SECTION 4.  Safety clause. The general assembly hereby finds, determines, and declares that this act is necessary for the immediate preservation of the public peace, health, and safety.