Prohibits the substitution of opioid analgesic drugs for an opioid analgesic drug incorporating tamper resistance technology; requires pharmacist to verify equivalence or obtain written consent of prescribing physician.
TITLE OF BILL: An act to amend the public health law, in relation to prohibiting the substitution of opioid analgesic drugs for an opioid analgesic drug incorporating tamper resistance technology
PURPOSE OR GENERAL IDEA OF BILL: To ensure that every opioid analgesic drug is used for its proper purpose.
SUMMARY OF SPECIFIC PROVISIONS: Section 1 adds a new section 3346 to the Public health law to prohibit without physician over-ride the use of non-tamper resistance opioid analgesic drugs and make definitions of such.
Section 2 is the effective date of the bill.
JUSTIFICATION: Opioid use and abuse has increased greatly in the United States since the 1590's and continues to rise while the benefits of these Products in treating and managing pain are widely recognized, the potential for misuse and abuse of these products has long been a concern of manufacturers, state and federal law enforcement, healthcare providers, legislators, and regulators. Under this proposal, when a physician prescribes an opioid analgesic drug that incorporates a tamper resistance technology, no substitution or interchange shall be permitted for that drug without the pharmacy, (1) verifying that the substitute provides substantially similar tamper resistance properties as determined by the State, or (2) obtaining the prior, written consent of the prescribing physician.
PRIOR LEGISLATIVE HISTORY: S.6062 (2012)
FISCAL IMPLICATIONS: None
EFFECTIVE DATE: This act shall take effect immediately.
STATE OF NEW YORK ________________________________________________________________________ 1753 2013-2014 Regular Sessions IN SENATE (PREFILED) January 9, 2013 ___________Introduced by Sens. MARTINS, LAVALLE -- 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 prohibiting the substitution of opioid analgesic drugs for an opioid analgesic drug incorporating tamper resistance technology 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 3346 to read as follows: S 3346. CERTAIN OPIOID SUBSTITUTIONS PROHIBITED. 1. DEFINITIONS. A. "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 A TAMPER-RESISTANCE TECHNOLOGY ORIGINALLY PRESCRIBED, IRRESPECTIVE OF WHETHER THE SUBSTITUTED DRUG IS RATED AS PHARMACEUTICALLY AND THERAPEUTICALLY EQUIVALENT BY THE U.S. FOOD AND DRUG ADMINISTRATION OR STATE BOARD OF PHARMACY OR WHETHER THE OPIOID ANALGESIC DRUG WITH TAMPER-RESISTANCE TECHNOLOGY BEARS A LABELING CLAIM WITH RESPECT TO REDUCTION OF TAMPERING, ABUSE OR ABUSE POTENTIAL. B. "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. C. "OPIOID ANALGESIC DRUG INCORPORATING A TAMPER-RESISTANCE TECHNOLO- GY" MEANS AN OPIOID ANALGESIC DRUG LISTED AS SUCH BY THE STATE BOARD OF PHARMACY BASED UPON A SUBMISSION OF EVIDENCE BY THE DRUG MANUFACTURER OR DISTRIBUTOR THAT THE DRUG: (I) INCORPORATES A TAMPER-RESISTANCE TECHNOL- OGY; AND (II) HAS BEEN APPROVED BY THE U.S. 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- OREXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD04583-01-3 S. 1753 2
ABUSE-RESISTANCE PROPERTIES OF THE DRUG TO ONE OR MORE OPIOID ANALGESIC DRUGS THAT (A) HAVE BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINIS- TRATION; AND (B) SERVE AS A POSITIVE CONTROL. D. "PHARMACIST" FOR PURPOSES OF THIS SECTION 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. 2. LIST OF OPIOID ANALGESIC DRUGS INCORPORATING A TAMPER-RESISTANCE TECHNOLOGY. THE STATE BOARD OF PHARMACY SHALL CREATE A LIST OF OPIOID ANALGESIC DRUGS FOR WHICH INFORMATION HAS BEEN SUBMITTED CONSISTENT WITH PARAGRAPH C OF SUBDIVISION ONE OF THIS SECTION. INCLUSION OF A DRUG ON SUCH LIST SHALL NOT REQUIRE THAT A DRUG BEAR A LABELING CLAIM WITH RESPECT TO REDUCTION OF TAMPERING, ABUSE OR ABUSE POTENTIAL AT THE TIME OF LISTING. SUCH LIST SHALL ALSO INCLUDE A DETERMINATION BY THE BOARD AS TO WHICH LISTED OPIOID ANALGESIC DRUGS INCORPORATING TAMPER-RESISTANCE TECHNOLOGIES PROVIDE SUBSTANTIALLY SIMILAR TAMPER-RESISTANCE PROPERTIES, BASED SOLELY UPON STUDIES SUBMITTED BY THE DRUG MANUFACTURER CONSISTENT WITH PARAGRAPH C OF SUBDIVISION ONE OF THIS SECTION. 3. PROHIBITION. 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 SECTION SIXTY-EIGHT HUNDRED SIXTEEN-A OF THE EDUCATION LAW FOR AN OPIOID ANALGESIC DRUG INCORPORATING A TAMPER-RESISTANCE TECHNOLOGY THAT IS LISTED PURSUANT TO SUBDIVISION TWO OF THIS SECTION WITHOUT: A. VERIFYING THAT THE OPIOID ANALGESIC DRUG HAS BEEN LISTED BY THE STATE BOARD OF PHARMACY: UNDER SUBDIVISION TWO OF THIS SECTION AS PROVIDING TAMPER-RESISTANCE PROPERTIES SUBSTANTIALLY SIMILAR TO THE PRESCRIBED OPIOID ANALGESIC DRUG INCORPORATING A TAMPER-RESISTANCE TECH- NOLOGY; OR B. OBTAINING WRITTEN, SIGNED CONSENT FROM THE PRESCRIBING PHYSICIAN FOR SUCH INTERCHANGE OR SUBSTITUTION. S 2. This act shall take effect immediately.