2016 Hawaii Revised Statutes
TITLE 19. HEALTH
328. Food, Drugs, and Cosmetics
328-92 Drug product and biological product selection.

§328-92 Drug product and biological product selection. (a) When filling a prescription order for a drug prescribed by its brand name, a pharmacist or the pharmacist's authorized agent shall:

(1) Offer to the consumer an equivalent generic drug product or an interchangeable biological product from the Hawaii list of equivalent generic drug products and interchangeable biological products adopted pursuant to section 328-96;

(2) Upon the request of the consumer, inform the consumer of the savings; and

(3) Inform the consumer of the consumer's right to refuse substitution.

The pharmacist shall substitute an equivalent generic drug product or an interchangeable biological product if the practitioner does not prohibit substitution under subsection (b), and the substitute equivalent generic drug product or interchangeable biological product results in a savings. The pharmacist shall not substitute if the consumer refuses.

(b) The pharmacist shall not substitute an equivalent generic drug product or an interchangeable biological product if the practitioner indicates "brand medically necessary" or words of similar meaning on the prescription. The designation "brand medically necessary" or other similar words or phrases must be handwritten by the practitioner and shall not be preprinted or stamped on the written prescription. The pharmacist shall not substitute an equivalent generic drug product or an interchangeable biological product if a prescription is orally or electronically ordered and the practitioner or authorized employee of the practitioner indicates "brand medically necessary" or other similar words or phrases.

The pharmacist shall note the practitioner's instructions on the prescription record required to be maintained under section 328-17.7.

This subsection shall not apply when it does not comply with any federal requirement for services reimbursable by medicaid or medicare.

(c) The pharmacist shall not substitute an equivalent generic drug product or an interchangeable biological product for any prescription for an anti-epileptic drug, except upon the consent of the practitioner and the patient or the patient's parent or guardian. This narrow exception for epileptic patients shall not be construed as a policy decision to make exceptions for any other conditions.

(d) Within two business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the practitioner the specific product provided to the patient, including the name of the product and the manufacturer. The communication shall be conveyed by making an entry that is electronically accessible to the practitioner through:

(1) An interoperable electronic medical records system;

(2) An electronic prescribing technology;

(3) A pharmacy benefit management system; or

(4) A pharmacy record.

(e) Entry into an electronic records system as described in subsection (d) is presumed to provide notice to the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication shall not be required where:

(1) There is no interchangeable biological product approved by the United States Food and Drug Administration for the product prescribed; or

(2) A refill prescription is not changed from the product dispensed on the prior filling of the prescription.

(f) The county prosecutors and the attorney general may bring action upon complaint by an aggrieved person or upon their own motion in the name of the State against any person to enjoin any violation of this part.[L 1980, c 187, pt of §1; am L 1982, c 122, §1(4); gen ch 1985; am L 1992, c 193, §§1, 5; am L 1996, c 209, §3; am L 1997, c 214, §6; am L 2003, c 56, §6; am L 2016, c 242, §4]