The 77th Texas Legislature passed S.B. 768 which made some significant changes to the generic substitution section of the Texas Pharmacy Act. Included in the changes to the Act are the elimination of the requirement that a prescription be on a two-line prescription form and specifying that the Board of Pharmacy will adopt rules to provide a "dispensing directive" by which the prescriber will instruct pharmacists on substitution instructions. This portion of the law becomes effective on June 1, 2002. The following should help answer questions concerning this change in law. Pharmacists are encouraged to make sure prescribers are aware of these changes.

Answer: The conditions have not changed. A pharmacist may substitute for a brand name product on a prescription issued by a Texas prescriber if all of the following conditions are met:

(A) the generic product costs the patient less than the prescribed drug product;

(B) the patient does not refuse the substitution; and

(C) the prescriber does not prohibit substitution.

Answer: For written prescriptions, a pharmacist may substitute a generically equivalent drug for the brand prescribed unless the prescriber writes in his/her own handwriting the words "Brand Necessary" or "Brand Medically Necessary" on the face of the prescription.

Answer: The format is no longer specified. However, TSBP encourages prescribers who issue written prescriptions in Texas to use a form that contains:

(A) a single signature line for the prescriber; and

(B) the following reminder statement on the face of the prescription: "A generically equivalent drug product may be dispensed unless the prescriber hand writes the words ‘Brand Necessary’ or ’Brand Medically Necessary’ on the face of the prescription."

The suggested prescription format does not apply to the prescriptions issued by prescribers in the following locations:

(A) in a state other than Texas;

(B) in a prescriber in Mexico or Canada (prescriptions are limited to dangerous drugs only); or

(C) in a federal facility provided the prescribers are acting in the scope of their employment.

Answer: YES. Pharmacists may dispense a prescription that is not in the suggested format and they are not required to contact the prescriber for substitution instructions.

Answer: NO. If a prescriber places multiple prescription orders on one prescription form, the prescriber must clearly indicate which drugs the dispensing directive ("brand necessary") applies. If the prescriber does not clearly indicate to which prescription(s) the dispensing directive applies, the pharmacist may substitute on all prescriptions on the form.

Answer: NO. The prescriber must manually write the substitution instructions on the face of the prescription. The dispensing directive (brand necessary or brand medically necessary) may not be preprinted, rubber stamped, or otherwise reproduced on the prescription form. In addition, two-line prescription forms, check boxes, or other notations on an original prescription drug order which indicate "substitution instructions" are not valid methods to prohibit substitution, and a pharmacist may substitute on these types of written prescriptions.

Answer: YES. If the written prescription was issued prior to June 1, 2002, but presented for dispensing on or after June 1, 2002, the pharmacists must follow the substitution instructions on the prescription.

However, if the prescription was written after June 1, 2002, the prescriber may only prohibit substitution on a written prescription by writing "brand necessary" or "brand medically necessary" on the face of the prescription.

(A) If a prescription drug order is transmitted to a pharmacist orally, the prescriber or agent may prohibit substitution by specifying "brand necessary" or "brand medically necessary." The pharmacists must note any substitution instructions on the file copy of the prescription drug order. If the prescriber or prescriber’s agent does not clearly indicate that the brand name is medically necessary, the pharmacist may substitute a generically equivalent drug product.

(B) If the verbal prescription is to be reimbursed through the Medicaid program, the prescriber must clearly indicate that the brand is necessary when the prescription is communicated and fax or mail a copy of the original prescription drug order with the words "brand necessary" or "brand medically necessary" on the face of the prescription to the pharmacy within 30 days.

(A) To prohibit substitution, the prescriber or prescriber’s agent must note "brand necessary" or "brand medically necessary" on the electronic prescription drug order. If the prescriber or prescriber’s agent does not clearly indicate that the brand is medically necessary, the pharmacist may substitute a generically equivalent drug product.

(B) If the electronic prescription is to be reimbursed through the Medicaid program, the prescriber must indicate that the brand is necessary on the electronic prescription and fax or mail a copy of the original prescription drug order with the words "brand necessary" or "brand medically necessary" on the face of the prescription.

Answer: All refills, must follow the original substitution instructions, unless otherwise indicated by the prescriber or prescriber’s agent including prescriptions issued prior to June 1, 2002.

Answer: YES. There have been no changes in this portion of the rules. Pharmacists must use FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book) as the basis for the determination of generic equivalency. In fact Board rules have been expanded to clarify this issue and now state that pharmacists may only substitute products that are rated therapeutically equivalent in the Orange Book and have an "A" rating. "A" rated drug products include but are not limited to, those designated AA, AB, AN, AO, AP, or AT in the Orange Book.

Pharmacists may not substitute on any product that has a "B" rating. For example, all levothyroxine products currently listed in the Orange Book are rated BX, therefore a pharmacist may not substitute on prescriptions for levothyroxine. In addition, pharmacists may not substitute on products that are not listed in the orange book, e.g., Synthroid®, or Entex®.