BILL ANALYSIS

 

 

                                                                                                                                              S.B. 625

                                                                                                                                            By: Janek

                                                                                                                                      Public Health

                                                                                                       Committee Report (Unamended)

 

 

 

BACKGROUND AND PURPOSE

 

Several leading clinicians, including scholars at Texas Tech University, have completed studies on the dangers of substituting transplant medications – either brand to brand, brand to generic or generic to generic – without the permission of the transplant team or patient’s transplant surgeon because of the frail nature of the patient and the sensitivity of immune-compromised patients to small changes in drug strength and active or inactive ingredients.

 

The Texas Tech University study promotes the fact that pharmacists should notify the prescribing physician whenever a critical dose drug is dispensed differently and that “therapeutic substitution should not be made unless the prescribing physician has granted approval.” The National Kidney Foundation (NKF) produced a white paper on the subject-created consensus treatment guidelines calling for pharmacists to inform physicians any time switching has been recommended to take place from brand products to generic products. The American Heart Association echoed the same concerns in its support of the NKF guidelines.

 

Finally, the United Network on Organ Sharing, the largest Transplant organization in the United States, provides this advice for its membership:

 

• Generic products use the same active ingredient and have      the same intended use as brand-name counterparts

 

• Generic drugs are not formulated in an identical manner to      their brand name counterparts

 

• Generic products can have variations in the active      ingredient that could affect absorption into the patient’s bloodstream, as      well as different inactive ingredients (binders, fillers), that can cause      differences in the patient’s response and side effects. (United Network      of Organ Sharing)

 

Federal Medicaid law only allows brand-name products to be dispensed when a physician writes “brand name necessary” on the prescription; this legislation does not interfere in that process but goes further to put a duty on the pharmacist to contact a physician, most likely a member of the transplant team, to make sure that a generic product is what the physician intended to dispense.   SB 625 aims to protect the highly sensitive nature of transplant patients by requiring physician authorization to interchange transplant medications.

 

 

RULEMAKING AUTHORITY

 

It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution. 

 

ANALYSIS

 

SB 625 amends the Occupations Code to provide that, notwithstanding Section 562.014. APPLICATION TO NARROW THERAPEUTIC INDEX DRUGS, a pharmacist may not interchange 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.  SB 625 establishes the  procedures for a pharmacist to document the notification of, and to secure the informed written consent of, a prescribing physician regarding the interchange of certain drugs.  A copy of the communication is required to be forwarded to the physician and a copy kept with the pharmacist.  The documented notification and consent is considered a statement that the prescription is “brand medically necessary” and is considered part of the prescription. The bill defines "immunosuppressant drug" and "interchange,"  and provides that if the prescription is for an “immunosuppressant drug” the pharmacist must comply with this legislation.

 

EFFECTIVE DATE

 

Upon passage, or, if the Act does not receive the necessary vote, the Act takes effect September 1, 2007.