HBA-MPM H.B. 2278 76(R) BILL ANALYSIS Office of House Bill AnalysisH.B. 2278 By: Coleman Public Health 3/25/1999 Introduced BACKGROUND AND PURPOSE The Food and Drug Administration (FDA) is responsible for approving all prescription drugs in the United States for dispensing by pharmacists, including both brand drugs and their generic equivalents. Some generic drugs have been rated as bioequivalent by the FDA (having the same impact on a patient as a brand drug). Some manufacturers of brand drugs have claimed that bioequivalent drugs falling into a class known as narrow therapeutic index (NTI) drugs are unsafe. NTI drugs are those drugs which must be closely monitored by the prescribing physician because a small change in the dosage may significantly affect a patient's condition. In 1997, the 75th Texas Legislature passed legislation designed to protect patients receiving NTI drugs by requiring the patients seeking generic refills to go through additional procedures to obtain them, even if the original prescription by the doctor was signed "product selection permitted." There is concern that this legislation has had a chilling effect on the use of NTI generic drugs, even though they are often less expensive than brand drugs. H.B. 2278 repeals language in the Texas Pharmacy Act requiring the State Board of Pharmacy to establish a list of NTI drugs and to require patients to follow certain procedures when refilling NTI drugs on the list. RULEMAKING AUTHORITY It is the opinion of the Office of House Bill Analysis that this bill does not expressly delegate any additional rulemaking authority to a state officer, department, agency, or institution. SECTION BY SECTION ANALYSIS SECTION 1. Repealer: Subsection (m), Section 40, Article 4542a-1, 1-5 V.T.C.S. (Texas Pharmacy Act), as amended by Section 21, Chapter 1180, Acts of the 75th Legislature, 1997. This subsection makes Section 40 (Substitution) inapplicable to the refill of a prescription for a narrow therapeutic index (NTI) drug, as well as the requirement that the State Board of Pharmacy, in consultation with the Texas Board of Medical Examiners, establish, by rule, a list of NTI drugs subject to this subsection. Further authorizes an NTI drug prescription to 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 physician. Deletes text authorizing a pharmacist, if the same drug product by the same manufacturer is not in stock, to dispense a drug product that is generically equivalent if the pharmacist, before dispensing it, notifies the patient and prescribing practitioner of the substitution within a certain time frame. SECTION 2.Emergency clause. Effective date: 90 days after adjournment.