Designates hydrocodone bitartrate as a schedule I controlled substance

1 Co-sponsor

• Joseph A. Griffo

BILL NUMBER:S7436

Title of bill

An act to amend the public health law, in relation to designating hydrocodone bitartrate as a schedule I controlled substance

Purpose

To designate hydrocodone bitartrate (also known as Zohydro ER) as a schedule I controlled substance.

Summary of provisions

Section 1. Subdivision (b) of schedule I of section 3306 of the public health law is amended by adding a new paragraph 56, which includes hydrocodone bitartrate in the list of controlled substances.

Section 2. Subparagraph 10 of paragraph 1 of subdivision (b) of schedule II of section 3306 of the public health law, as amended by section 1 of part C of chapter 447 of the laws of 2012, is amended to differentiate hydrocodone (also known as dihydrocodeinone) from hydrocodone bitar- trate.

Section 3 sets forth the effective date.

Justification

Hydrocodone bitartrate extended release capsules (also known as Zohydro ER) were approved in October, 2013 by the U.S. Food and Drug Administration (FDA) for the management of pain. Zohydro ER is the first single-entity prescription pain drug, meaning not combined with an analgesic such as acetaminophen like other pain management drugs. The larger amount of hydrocodone present in Zohydro ER exposes patients to the risk of opioid addiction, abuse and misuse, which can then lead to overdose and death. The highest available dosage of Zohydro ER contains 5 to 10 times more hydrocodone than Vicodin or Lortab. An individual unaccustomed to taking opioids could suffer a fatal overdose from just two capsules while just a single capsule could be fatal if swallowed by a child.

Lawmakers in Ohio have introduced legislation to ban Zohydro ER from the state. Members of Congress from Kentucky, West Virginia and Massachu- setts have introduced bills to ban the drug.

Lawmakers are also trying to limit the drug's availability through other avenues, including utilizing the state Boards of Registration in Medi- cine that would require doctors to complete a risk assessment and pain management treatment agreement with patients before prescribing Zohydro ER. Physicians who want to prescribe Zohydro ER would also have to participate in the Prescription Monitoring Program.

In addition, at least 29 state attorneys general have asked the FDA to reconsider its approval of the drug.

This bill will protect patients and individuals with a propensity for drug addiction from obtaining and misusing this powerful and dangerous

prescription painkiller by establishing hydrocodone bitartrate as a schedule I controlled substance.

Legislative history

New legislation

Fiscal implications

To be determined

Effective date

This act shall take effect immediately.