BG C.S.H.B. 2571 75(R)BILL ANALYSIS


PUBLIC HEALTH
C.S.H.B. 2571
By: Berlanga
4-25-97
Committee Report (Substituted)


BACKGROUND 

The Food and Drug Administration (FDA) has identified 
approximately 25 Narrow Therapeutic 
Index (NTI) drugs.  Many of these drugs, such as anitconvulsants, 
antiarrhythmics, and 
anticoagulants, are used to treat critical medical conditions.  
These medications are associated 
with a high risk for toxic reactions and complex drug 
interactions.  They require highly 
individualized doses, and close supervision by the physician or 
health care provider to ensure 
safe use.

Based on the FDA's current methodology, two formulations of the 
same product or two products 
from different manufacturers are deemed bioequivalent when they 
are equivalent with respect to 
the rate and extent of drug absorption.  Substitution is made 
based on an assumption that they 
provide the same dose-effect.  The FDA's current standard states 
that two formulations whose 
rate and extent of absorption differ by "-20 percent or +25 
percent" or less are generally 
considered bioequivalent.

Product interchange in patients stabilized on a specific brand of 
a NTI drug requires very close 
monitoring to ensure there is no loss of efficacy or increased 
risk of adverse consequences. 
Current medical practice makes it difficult to coordinate patient 
monitoring with product 
substitution, because a patient can be switched from one 
formulation to another formulation at 
the pharmacy level without the knowledge of the physician, and 
possibly without the awareness 
of the patient.  Therefore, it is essential that the physician is 
confident that different formulations 
will not introduce clinically significant changes in the 
patient's response to therapy. 

PURPOSE

CSHB 2571 requires the State Board of Pharmacy, in consultation 
with the State Board of 
Medical Examiners, to create a list of narrow therapeutic index 
drugs subject to this subsection. 
In addition, CSHB 2571 allows a pharmacist, before refilling a 
prescription for a NTI drug 
formulation using a different drug product from the one 
previously dispensed, to notify the 
patient and the prescribing practitioner of the substitution.

RULEMAKING AUTHORITY

It is the committee's opinion that this bill grants additional 
rulemaking authority to the State 
Board of Pharmacy, in consultation with the Texas State Board of 
Medical Examiners, in 
SECTION 1. [Section 40(m), Texas Pharmacy Act (Article 4542a-1, 
Vernon's Texas Civil 
Statutes)].  

SECTION BY SECTION ANALYSIS

SECTION 1.  Amends Section 40, Texas Pharmacy Act (Article 
4542a-1, Vernon's Texas Civil 
Statutes) by adding Subsection (m) as follows:

Subsection (m)  establishes that drug product selection 
authorized in this section does not 
apply to the refill of a prescription for a narrow therapeutic 
index drug (NTI), except as 
provided in this subsection.  Requires the State Board of 
Pharmacy, in consultation with 
the State Board of Medical Examiners, to create rules to 
establish a list of NTI drugs that 
are subject to this subsection.  Establishes that a prescription 
for a NTI drug may be
 refilled using only the same drug product by the same 
manufacturer that the pharmacist 
last dispensed under the prescription.  Allows a pharmacist who 
does not have the same 
drug product by the same manufacturer in stock to dispense a drug 
product that is 
generically equivalent if prior to dispensing the medication the 
pharmacist notifies:

(1) the patient, that a substitution of the prescribed drug 
product has been made; 
and

(2) the prescribing practitioner of the drug product substitution 
by telephone, 
facsimile, or mail, at the earliest reasonable time, but not 
later than 72 hours after 
dispensing the medication.

SECTION 2.  Establishes the effective date of this Act to be 
September 1, 1997.

SECTION 3.  Emergency Clause.

COMPARISON OF ORIGINAL TO SUBSTITUTE

CSHB 2571 adds Subsection (m) to Section 40, Texas Pharmacy Act 
(Article 4542a-1, Vernon's 
Texas Civil Statutes), and requires the State Board of Pharmacy, 
in consultation with the Texas 
State Board of Medical Examiners, to create rules to establish a 
list of NTI drugs that are subject 
to this subsection.  CSHB 2571 also requires pharmacists to 
refill a prescription for a narrow 
therapeutic index drug using only the same drug product by the 
same manufacturer that the 
pharmacist last dispensed under the prescription.  Makes an 
exception if the pharmacist does not 
have the same drug product by the same manufacturer in stock, by 
allowing the pharmacist to 
dispense a drug product which is generically equivalent, 
providing the pharmacist notifies the 
patient and prescribing practitioner of the drug substitution. 

HB 2571 amended Section 40(l), Texas Pharmacy Act (Article 
4542a-1, Vernon's Texas Civil 
Statutes), by requiring the written consent from a physician 
prior to the substitution of a 
prescribed drug.

The changes to HB 2571 were made to address concerns regarding 
what drugs were considered 
to be NTI drugs and by whose definition.  A provision was also 
added to address concerns raised 
by patients, physicians, and pharmacists regarding the 
interchange of a medication and who is to