BILL ANALYSIS

 

 

Senate Research Center                                                                                                 C.S.S.B. 625

                                                                                                                                            By: Janek

                                                                                                                  Health & Human Services

                                                                                                                                            3/21/2007

                                                                                                        Committee Report (Substituted)

 

 

AUTHOR'S / SPONSOR'S STATEMENT OF INTENT

 

Current law allows a pharmacist to substitute a generic drug for a brand-name prescription. However, certain immunosuppressant transplant surgeries require specific medication that work in different phases of the immune response, minimize side effects, and produce effective immunosupression to prevent rejection of a transplanted organ and maintain sufficient immunity to prevent infection. Certain generic forms of these medications may cause adverse effects prior to a transplant surgery because generic products do not always contain the same amount of an active ingredient or are formulated in a different manner than their brand-name counterpart. As a result, patients are placed at a health risk if the brand of prescription is changed without a doctor's notice.

 

C.S.S.B. 625 requires a pharmacist to obtain a prescribing doctor's signature before a substitution of a prescribed immunosuppressant medication can be made.

 

RULEMAKING AUTHORITY

 

This bill does not expressly grant any additional rulemaking authority to a state officer, institution, or agency.

 

SECTION BY SECTION ANALYSIS

 

SECTION 1. Amends Subchapter A, Chapter 562, Occupations Code, by adding Section 562.0142, as follows:

 

Sec. 562.0142.   TRANSPLANT IMMUNOSUPPRESSANT DRUG PRODUCT SELECTION PROHIBITED.  (a)  Defines "immunosuppressant drug" and "interchange."

 

(b) Prohibits a pharmacist from interchanging an immunosuppressant drug or formulation of an immunosuppressant drug, brand or generic, for the treatment of a patient following a transplant without prior notification of and the signed informed consent of such interchange from the prescribing physician, notwithstanding  Section 562.014 (Application to Narrow Therapeutic Index Drugs).

 

(c) Authorizes a pharmacist to document the notification of a prescribing physician and secure the informed written consent of the physician through oral or electronic contact to secure permission to interchange an immunosuppressant drug or formulation of an immunosuppressant drug, brand or generic, and reducing such consent to writing.  Requires a denial of an authorization to substitute by a physician to be documented, in the same manner and format as an approval. Requires a copy of such communication to be forwarded to the physician and that a copy be kept with the records of the pharmacist. Requires the documented notification and consent to be considered as a statement that the prescription is "brand medically necessary" and to be considered part of the prescription, if applicable.

 

SECTION 2.  Amends Subchapter A, Chapter 562, Occupations Code, by adding Section 562.009(e), to require a pharmacist to comply with the provisions of Section 562.0142, if the prescription is for an "immunosuppressant drug."

 

SECTION 3. Effective date: upon passage or September 1, 2007.