HB3956ham001 98TH GENERAL ASSEMBLY

Rep. Sara Feigenholtz

Filed: 3/26/2014

09800HB3956ham001 LRB098 15516 ZMM 57504 a

AMENDMENT TO HOUSE BILL 3956

AMENDMENT NO. ______. Amend House Bill 3956 by replacing everything after the enacting clause with the following:

"Section 5. The Pharmacy Practice Act is amended by adding Section 25.25 as follows:

(225 ILCS 85/25.25 new)

Sec. 25.25. Opioid analgesic drugs.

(a) For the purposes of this Section:

"Interchange or substitution of an opioid analgesic drug" means the substitution of any brand name or generic opioid analgesic drug for a prescribed opioid analgesic drug incorporating a tamper-resistance technology, whether or not the substituted drug is rated as pharmaceutically and therapeutically equivalent by the United States Food and Drug Administration or the Board or whether the opioid analgesic drug with tamper-resistance technology bears a labeling claim with respect to reduction of tampering, abuse, or abuse potential.

"Opioid analgesic drug" means a drug in the opioid drug class prescribed to treat moderate to severe pain or other conditions, including opioid dependence, 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.

"Opioid analgesic drug incorporating a tamper-resistance technology" means an opioid analgesic drug listed as such by the Board under subsection (b).

(b) The Board shall establish a list of the opioid analgesic drugs for which it has received evidence from the drug manufacturer or distributor that the drug incorporates a tamper-resistance technology.

The list shall also include a determination by the Board as to which of the opioid analgesic drugs incorporating tamper-resistance technologies on the list provide substantially similar tamper-resistance properties. Such a determination by the Board shall be based solely on any studies submitted to the United States Food and Drug Administration with the drug manufacturer's application for approval.

(c) The Board shall not exclude an opioid analgesic drug from the list established under subsection (b) on the basis that the drug does not bear a labeling claim with respect to reduction of tampering, abuse, or abuse potential at the time the drug is being considered for placement on the list or any time after the drug's placement on the list.

(d) A pharmacist shall not interchange or substitute a brand name or generic opioid analgesic drug otherwise eligible for interchange or substitution under this Section without doing one of the following:

(1) verifying that the Board has determined under subsection (b) that the opioid analgesic drug provides tamper-resistance properties substantially similar to the prescribed opioid analgesic drug incorporating a tamper-resistance technology; or

(2) obtaining written, signed consent from the prescriber for the interchange or substitution.

Section 99. Effective date. This Act takes effect January 1, 2015.".