Bill Text: NJ A4041 | 2010-2011 | Regular Session | Amended
Bill Title: Requires that Board of Pharmacy compile and publish list of certain tamper-resistant opioid drugs and that certain conditions be met for pharmacist to substitute for tamper-resistant opioid drug. *
Spectrum: Slight Partisan Bill (Democrat 2-1)
Status: (Introduced - Dead) 2011-11-21 - Reported out of Assembly Comm. with Amendments, 2nd Reading [A4041 Detail]
Download: New_Jersey-2010-A4041-Amended.html
Sponsored by:
Assemblyman DANIEL R. BENSON
District 14 (Mercer and Middlesex)
Assemblywoman MARY PAT ANGELINI
District 11 (Monmouth)
Assemblyman HERB CONAWAY, JR.
District 7 (Burlington and Camden)
SYNOPSIS
Requires that Board of Pharmacy compile and publish list of certain tamper-resistant opioid drugs and that certain conditions be met for pharmacist to substitute for tamper-resistant opioid drug.
CURRENT VERSION OF TEXT
As reported by the Assembly Health and Senior Services Committee on November 21, 2011, with amendments.
An Act concerning tamper-resistant opioid drugs and supplementing P.L.1977, c.240 (C.24:6E-1 et seq.).
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
11. The Legislature finds and declares that:
a. Prescription drug abuse is the fastest-growing drug problem in this nation, and data from the National Survey on Drug Use and Health show that nearly one-third of people aged 12 and over who used drugs for the first time in 2009 began with nonmedical use of a prescription drug;
b. The incidence of opioid abuse, in particular, has increased greatly in the United States in recent years and continues to rise;
c. Opioid overdoses, once almost always due to heroin use, are now increasingly due to abuse of prescription painkillers;
d. Studies show that addicts tend to crush or otherwise break down time-released products into a form that can be snorted or injected for a more intense high, and so formulations that make it more difficult to crush or otherwise manipulate those products may mitigate the potential for abuse;
e. Drug manufacturers have created novel technologies that may help deter the inappropriate use of opioid medications, and the federal Food and Drug Administration has afforded priority review to new drug applications for opioids incorporating such tamper resistance technologies; and
f. Given the critically important public health and law enforcement goals of preventing the abuse and misuse of opioids, it is manifestly in the public interest for the public policy of this State to encourage drug manufacturers to develop opioid products with tamper resistance technologies and thereby promote the efficient use of scarce health care resources.1
1[1.] 2.1 a. 1(1)1 The 1[Department of Health and Senior Services] New Jersey State Board of Pharmacy1 shall compile and publish a list of opioid analgesic drugs that incorporate tamper resistance technology approved by the federal Food and Drug Administration pursuant to an application that includes at least one human tampering or abuse-potential study, or a laboratory study comparing the tamper- or abuse-resistant properties of the drug to one or more opioid analgesic drugs that have been approved by the federal Food and Drug Administration and that serve as a positive control. The list shall include a determination by the 1[department] board1 as to which of the listed opioid analgesic drugs incorporating tamper resistance technologies provide substantially similar1[tamper resistance] tamper-resistant1 properties1, based solely upon one or more studies submitted by the drug manufacturer pursuant to paragraph (2) of this subsection.
(2) It shall be the responsibility of the drug manufacturer to submit to the board such studies as are necessary to meet the requirements for listing by the board pursuant to paragraph (1) of this subsection; and the board, no later than the 60th day following receipt thereof, shall notify the manufacturer of its determination as to whether the submitted study meets the requirements for listing. If the board determines that the study meets the requirements for listing, the board shall immediately update its list to include the drug1.
1(3)1 For 1the1 purposes of this section1,1 "opioid analgesic drug" means a drug in the opioid analgesic drug class that is 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 dosage form.
b. Inclusion of a drug on the list pursuant to subsection a. of this section shall not require that a drug bear a labeling claim with respect to reduction of tampering, abuse, or abuse potential at the time it is listed pursuant to subsection a. of this section.
1[2.] 3.1 Notwithstanding the provisions of any law to the contrary, a pharmacist shall not substitute an opioid analgesic drug that is otherwise eligible for such substitution for an opioid analgesic drug1, whether it is a brand name or generic drug product,1 that incorporates a tamper resistance technology and is included on the list published by the 1[Department of Health and Senior Services] New Jersey State Board of Pharmacy1 pursuant to section 1[1] 21 of this act, unless the pharmacist first verifies that the substitute drug has been listed by the 1[department] board1 as providing 1substantially similar1 tamper resistance technology. If the 1substitute1 drug is not included on the published list, the pharmacist shall obtain1:1 written, signed consent from the prescribing practitioner for such substitution1; or verbal consent from the prescribing practitioner for such substitution that is documented by the pharmacist in the pharmacy records for that patient by a consent form. The consent form shall include: the name of the person who obtained verbal consent from the prescribing practitioner; the date that the verbal consent was obtained; the name of the prescribing practitioner who provided verbal consent; and any special instructions pertaining to the patient that were provided by the prescribing practitioner to the person who obtained the verbal consent1.
1[3.] 4.1 This act shall take effect on the first day of the fourth month next following the date of enactment.
