Provides for the substitution of opioid drugs incorporating abuse-deterrent technology for opioid drugs under certain circumstances.
Ayes (59): Addabbo, Avella, Ball, Bonacic, Boyle, Breslin, Carlucci, DeFrancisco, Diaz, Dilan, Espaillat, Farley, Felder, Flanagan, Gallivan, Gianaris, Gipson, Golden, Griffo, Grisanti, Hannon, Hoylman, Kennedy, Klein, Krueger, Lanza, Larkin, Latimer, LaValle, Libous, Little, Marcellino, Marchione, Martins, Maziarz, Montgomery, Nozzolio, O'Brien, O'Mara, Parker, Peralta, Perkins, Ranzenhofer, Ritchie, Rivera, Robach, Sampson, Sanders, Savino, Serrano, Seward, Skelos, Squadron, Stavisky, Stewart-Cousins, Tkaczyk, Valesky, Young, Zeldin
Excused (2): Hassell-Thomps, Smith
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.
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
This act shall take effect immediately.
STATE OF NEW YORK ________________________________________________________________________ 7125 IN SENATE 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-DETERRENCEEXPLANATION--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.