MISSISSIPPI LEGISLATURE
2014 Regular Session
To: Public Health and Human Services
By: Representative Dixon
AN ACT TO PROHIBIT PHARMACISTS FROM SUBSTITUTING ANALGESIC DRUGS FOR AN OPIOID ANALGESIC DRUG INCORPORATING A TAMPER RESISTANCE TECHNOLOGY WITHOUT VERIFYING EQUIVALENCE OR OBTAINING THE WRITTEN, SIGNED CONSENT OF THE PRESCRIBING PHYSICIAN; TO DEFINE CERTAIN TERMS; TO PROVIDE DUTIES OF THE STATE BOARD OF PHARMACY; TO AMEND SECTIONS 73-21-81 AND 73-21-117, MISSISSIPPI CODE OF 1972, IN CONFORMITY; AND FOR RELATED PURPOSES.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI:
SECTION 1. The following words and phrases shall have the meanings ascribed herein unless the context clearly indicates otherwise:
(a) "Interchange or substitution of an opioid analgesic drug" means the substitution of any opioid analgesic drug, brand or generic, for the opioid analgesic drug incorporating a tamper-resistance technology originally prescribed, irrespective of whether the substituted drug is rated as pharmaceutically and therapeutically equivalent by the United States Food and Drug Administration or State Board of Pharmacy or whether the opioid analgesic drug with tamper-resistance technology bears a labeling claim with respect to reduction of tampering, abuse or abuse potential.
(b) "Opioid analgesic drug" means a drug in the opioid analgesic drug class prescribed to treat moderate to severe pain or other conditions, whether in immediate release or extended release form and whether or not combined with other drug substances to form a single tablet or other dosage form.
(c) "Opioid analgesic drug incorporating a
tamper-resistance technology" means an opioid analgesic drug listed as such by the State Board of Pharmacy based upon a submission of evidence by the drug manufacturer or distributor that the drug: (i) incorporates a tamper-resistance technology; and (ii) has been approved by the United States Food and Drug Administration pursuant to an application that includes at least one (1) human tampering or abuse potential study or a laboratory study comparing the tamper- or abuse-resistance properties of the drug to one or more opioid analgesic drugs that 1. have been approved by the United States Food and Drug Administration; and 2. serve as a positive control.
(d) "Pharmacist" for purposes of this act includes any pharmacist dispensing drugs under the jurisdiction of the State Board of Pharmacy, including, but not limited to, community pharmacists, pharmacists in hospital-based pharmacies when filling prescriptions for inpatient or outpatient care, and pharmacists in mail order pharmacies licensed by the state to distribute in the state.
SECTION 2. The State Board of Pharmacy shall create a list of opioid analgesic drugs for which information has been submitted consistent with Section 1(c) of this act. Inclusion of a drug on such list shall not require that a drug bear a labeling claim with respect to reduction of tampering, abuse or abuse potential at the time of listing. Such list shall also include a determination by the State Board of Pharmacy as to which listed opioid analgesic drugs incorporating tamper-resistance technologies provide substantially similar tamper-resistance properties, based solely upon studies submitted by the drug manufacturer consistent with Section 1(c).
SECTION 3. Notwithstanding any other provision of law to the contrary, no pharmacist shall interchange or substitute an opioid analgesic drug, brand or generic, for an opioid analgesic drug incorporating a tamper-resistance technology that is listed pursuant to Section 2 without (a) verifying that the opioid analgesic drug has been listed by the State Board of Pharmacy under Section 2 as providing tamper-resistance properties substantially similar to the prescribed opioid analgesic drug incorporating a tamper-resistance technology; or (b) obtaining written, signed consent from the prescribing physician for such interchange or substitution.
SECTION 4. Section 73-21-81, Mississippi Code of 1972, is amended as follows:
73-21-81. The responsibility for the enforcement of the provisions of this chapter shall be vested in the board. The board shall have all of the duties, powers and authority specifically granted by and necessary to the enforcement of this chapter. The board may make, adopt, amend and repeal such rules and regulations as may be deemed necessary by the board from time to time for the proper administration and enforcement of this chapter, in accordance with the provisions of the Mississippi Administrative Procedures Law (Section 25-43-1 et seq.). The board shall enforce the provisions of House Bill No. , 2014 Regular Session.
SECTION 5. Section 73-21-117, Mississippi Code of 1972, is amended as follows:
73-21-117. (1) Except as otherwise provided in House Bill No. , 2014 Regular Session, a pharmacist may select a generic equivalent drug product only when such selection results in lower cost to the purchaser, unless product selection is expressly prohibited by the prescriber.
(2) A pharmacist shall select a generic equivalent drug product when:
(a) The purchaser requests the selection of a generic equivalent drug product;
(b) The prescriber has not expressly prohibited product selection; and
(c) Product selection will result in lower cost to the purchaser.
Before product selection is made, the pharmacist shall advise the purchaser of his prerogatives under this subsection.
(3) When requested by the purchaser to dispense the drug product as ordered by the prescriber, a pharmacist shall not select a generic equivalent drug product.
SECTION 6. This act shall take effect and be in force from and after July 1, 2014.