Bill Text: NJ A4041 | 2010-2011 | Regular Session | Introduced
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-Introduced.html
Sponsored by:
Assemblyman DANIEL R. BENSON
District 14 (Mercer and Middlesex)
Assemblywoman MARY PAT ANGELINI
District 11 (Monmouth)
SYNOPSIS
Requires DHSS to compile and publish list of certain tamper-resistant opioid drugs and prohibits pharmacist from substituting for tamper-resistant opioid drugs in certain situations.
CURRENT VERSION OF TEXT
As introduced.
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:
1. a. The Department of Health and Senior Services 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 department as to which of the listed opioid analgesic drugs incorporating tamper resistance technologies provide substantially similar tamper resistance properties. For purposes of this section "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.
2. 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 drug that incorporates a tamper resistance technology and is included on the list published by the Department of Health and Senior Services pursuant to section 1 of this act, unless the pharmacist first verifies that the substitute drug has been listed by the department as providing tamper resistance technology. If the drug is not included on the published list, the pharmacist shall obtain written, signed consent from the prescribing practitioner for such substitution.
3. This act shall take effect on the first day of the fourth month next following the date of enactment.
STATEMENT
This bill would require the Department of Health and Senior Services (DHSS) to compile and publish a list of opioid analgesic drugs that incorporate tamper resistance technology approved by the federal Food and Drug Administration, and would prohibit a pharmacist from substituting an opioid analgesic drug that is otherwise eligible for such substitution an for opioid analgesic drug that incorporates a tamper resistance technology and is included on the list published by DHSS unless the pharmacist first verifies that the substitute drug is on the list. If the substitute drug is not on the list, the pharmacist shall obtain written, signed consent from the prescribing practitioner for such substitution. The purpose of the bill is to reduce opioid abuse by ensuring that when a practitioner prescribes an opioid analgesic drug that incorporates tamper resistance technology, the pharmacy will not routinely substitute the drug with one that lacks that technology.
The bill further requires DHSS to include on the list a determination as to which of the listed opioid analgesic drugs incorporating tamper resistance technologies provide substantially similar tamper resistance properties. Drugs included on the list would not be required to bear a labeling claim with respect to reduction of tampering, abuse, or abuse potential at the time they are listed.
The bill defines "opioid analgesic drug" to mean 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.
The bill would take effect on the first day of the fourth month next following the date of enactment.
