senate Bill S7125

Amended

Provides for the substitution of opioid drugs incorporating abuse-deterrent technology for opioid drugs under certain circumstances

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Bill Status


  • Introduced
  • In Committee
  • On Floor Calendar
    • Passed Senate
    • Passed Assembly
  • Delivered to Governor
  • Signed/Vetoed by Governor
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actions

  • 30 / Apr / 2014
    • REFERRED TO HEALTH
  • 03 / Jun / 2014
    • COMMITTEE DISCHARGED AND COMMITTED TO RULES
  • 03 / Jun / 2014
    • ORDERED TO THIRD READING CAL.1126
  • 09 / Jun / 2014
    • PASSED SENATE
  • 09 / Jun / 2014
    • DELIVERED TO ASSEMBLY
  • 09 / Jun / 2014
    • REFERRED TO HIGHER EDUCATION
  • 16 / Jun / 2014
    • RECALLED FROM ASSEMBLY
  • 16 / Jun / 2014
    • RETURNED TO SENATE
  • 16 / Jun / 2014
    • VOTE RECONSIDERED - RESTORED TO THIRD READING
  • 16 / Jun / 2014
    • AMENDED ON THIRD READING (T) 7125A
  • 19 / Jun / 2014
    • REPASSED SENATE
  • 19 / Jun / 2014
    • RETURNED TO ASSEMBLY
  • 19 / Jun / 2014
    • REFERRED TO HIGHER EDUCATION

Summary

Provides for the substitution of opioid drugs incorporating abuse-deterrent technology for opioid drugs under certain circumstances.

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Bill Details

See Assembly Version of this Bill:
A9881
Versions:
S7125
S7125A
Legislative Cycle:
2013-2014
Current Committee:
Assembly Higher Education
Law Section:
Public Health Law
Laws Affected:
Add ยง3340, Pub Health L

Sponsor Memo

BILL NUMBER:S7125

TITLE OF BILL: An act to amend the public health law, in relation to
the use of abuse-deterrent technology for analgesic opioids as a
mechanism for reducing abuse and diversion of opioid drugs.

PURPOSE OR GENERAL IDEA OF BILL:

To help prevent the abuse and diversion of opioid analgesic drugs by
ensuring that opioid analgesic drugs which incorporate abuse-deterrent
technologies are dispensed whenever possible.

SUMMARY OF SPECIFIC PROVISIONS:

Section 1 adds a new section 3340 to the Public health law to prohibit
the substitution of opioids which have abuse-deterrent technologies
with those which do not have such abuse-deterrent technologies without
the consent of the prescribing physician.

Section 2 is the effective date of the bill.

JUSTIFICATION:

While pain management is an important and integral part of the health
care system, abuse and diversion of opioids has necessitated the
implementation of anti-abuse policies. These policies need to be
approached comprehensively by government, law enforcement, health care
providers and manufacturers and an important component is to ensure
that opioids incorporating abuse-deterrent technologies are dispensed
whenever possible.

The U.S. Food and Drug Administration (FDA) has recognized that the
development and implementation of abuse-deterrent technologies is an
important "step towards the goal of creating safer opioid analgesics".
In recently published FDA guidance on abuse-deterrent technologies for
opioids, the FDA provided that they "consider(s) the development of
these products a high public health priority".

Under this proposal, when a physician prescribes an opioid analgesic
drug that incorporates abuse-deterrent technologies, no substitution
or interchange shall be permitted for that drug without the pharmacy,
(1) verifying that the substitute provides substantially similar
abuse-deterrent properties, or (2) obtaining the prior, written
consent of the prescribing physician.

While New York State has been at the forefront of fighting
prescription drug abuse, it is imperative that the State continue to
strengthen its laws and protect against abuse while enhancing the
integrity of its health care system. Enacting this proposal will be
consistent with these goals and with the priorities set out by the
FDA.

PRIOR LEGISLATIVE HISTORY: a

New Bill.

FISCAL IMPLICATIONS:


None

EFFECTIVE DATE:

This act shall take effect immediately.

view bill text
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  7125

                            I N  S E N A T E

                             April 30, 2014
                               ___________

Introduced  by  Sen.  HANNON -- read twice and ordered printed, and when
  printed to be committed to the Committee on Health

AN ACT to amend the public health law, in relation to the use of  abuse-
  deterrent technology for analgesic opioids as a mechanism for reducing
  abuse and diversion of opioid drugs.

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. The public health law is amended by adding  a  new  section
3340 to read as follows:
  S  3340.  SUBSTITUTION OF OPIOIDS WITH ABUSE-DETERRENT TECHNOLOGY.  1.
NOTWITHSTANDING THE PROVISIONS OF SECTION SIXTY-EIGHT HUNDRED  SIXTEEN-A
OF  THE  EDUCATION LAW, NO PHARMACIST SHALL INTERCHANGE OR SUBSTITUTE AN
OPIOID ANALGESIC DRUG, BRAND OR GENERIC,  OTHERWISE  ELIGIBLE  FOR  SUCH
INTERCHANGE  OR  SUBSTITUTION UNDER SUCH SECTION FOR AN OPIOID ANALGESIC
DRUG INCORPORATING ABUSE-DETERRENT TECHNOLOGY WITHOUT:
  (A) VERIFYING THAT THE DRUG TO BE SUBSTITUTED IS AN  OPIOID  ANALGESIC
DRUG  INCORPORATING  ABUSE-DETERRENT  TECHNOLOGY  WITH  THE  SAME DEGREE
(TIER) OF FEDERAL FOOD AND DRUG ADMINISTRATION APPROVED  LABELING  CLAIM
RELATED TO ABUSE DETERRENCE AS THE PRESCRIBED OPIOID ANALGESIC DRUG; OR
  (B)  OBTAINING  WRITTEN, SIGNED CONSENT FROM THE PRESCRIBING PHYSICIAN
FOR SUCH INTERCHANGE OR SUBSTITUTION.
  2. A PRESCRIPTION SHALL NOT BE ISSUED OR FILLED FOR ANY  OPIOID  ANAL-
GESIC  DRUG  THAT  IS  FORMULATED  AS A NON-ABUSE DETERRENT OPIOID DRUG,
UNLESS AN OPIOID ANALGESIC DRUG INCORPORATING ABUSE-DETERRENT TECHNOLOGY
IS NOT AVAILABLE AS A SUBSTITUTE FOR THE INDICATED DRUG OR SUBSTANCE.
  3. DEFINITIONS. AS USED IN THIS SECTION:
  (A) "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.
  (B)  "OPIOID  ANALGESIC DRUG INCORPORATING ABUSE-DETERRENT TECHNOLOGY"
MEANS AN OPIOID ANALGESIC DRUG APPROVED AS SUCH BY THE FEDERAL FOOD  AND
DRUG  ADMINISTRATION  WITH  LABELING  CLAIMS RELATED TO ABUSE-DETERRENCE

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD14934-01-4

S. 7125                             2

BASED UPON AN APPLICATION THAT  INCLUDES  LABORATORY,  PHARMACOKINECTIC,
CLINICAL ABUSE POTENTIAL, AND/OR POST MARKETING STUDIES.
  (C)  "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  AN  ABUSE-DETERRENT   TECHNOLOGY
ORIGINALLY  PRESCRIBED,  AS DETERMINED TO BE PHARMACEUTICALLY AND THERA-
PEUTICALLY EQUIVALENT BY THE FEDERAL FOOD  AND  DRUG  ADMINISTRATION  OR
STATE BOARD OF PHARMACY TO THE PRESCRIBED DRUG. ANY SUBSTITUTABLE OPIOID
ANALGESIC  DRUG  SHALL  CONTAIN  THE  SAME  OPIOID ACTIVE PHARMACEUTICAL
INGREDIENT AND THE SAME DRUG  RELEASE  CHARACTERISTICS  WITH  REGARD  TO
IMMEDIATE RELEASE, OR EXTENDED RELEASE/LONG-ACTING PROPERTIES.
  (D)  "PHARMACIST"  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.
  (E) "ABUSE-DETERRENT TECHNOLOGY OR FORMULATION" MEANS THE FRAMEWORK OF
ABUSE-DETERRENT  PROPERTIES,  AS  DESCRIBED BY THE FEDERAL FOOD AND DRUG
ADMINISTRATION.
  (F)  "LABELING  CLAIMS  FOR  OPIOID  ANALGESIC   DRUGS   INCORPORATING
ABUSE-DETERRENT  TECHNOLOGIES"  MEANS  THE  FOUR GENERAL TIERS OR CLAIMS
AVAILABLE TO DESCRIBE THE POTENTIAL ABUSE  DETERRENT  PROPERTIES  FOR  A
DRUG, AS DESCRIBED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION.
  S 2. This act shall take effect immediately.

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