On June 18, 2014, the Office of Controlled Substances issued an emergency regulation imposing a number of conditions on prescribing extended release hydrocodone that is manufactured without an abuse deterrent formulation (ADF). The move is apparently Delaware’s reaction to the FDA’s approval last year of Zohydro ER, which approval has prompted concern among members of Congress and public health officials in a number of states. According to those officials, because Zohydro does not have an abuse resistant formulation, it can be crushed and inhaled or injected, making the full dose of hydrocodone available immediately, which some fear may lead to opioid addiction and overdose fatalities. In April a federal court blocked Massachusetts’ attempt to ban sales of Zohydro on the ground that the state could not ban the sale of a federally-approved drug.
The new prescription requirements in Delaware are aimed at minimizing use of Zohydro and, for those who are prescribed the drug, minimizing the likelihood of abuse. Effective as of June 18th, practitioners must do (and document) the following prior to prescribing extended release hydrocodone that is manufactured without ADF:
The prescription must be filled within seven days and must not exceed 30 days in duration.
The emergency regulation also requires a practitioner to schedule “periodic” follow up visits with a patient prescribed hydrocodone not manufactured with ADF to evaluate and document whether to continue treatment or if there is an available alternative, whether to refer the patient for pain management or substance abuse consultation, and whether to implement a plan for discontinuing the hydrocodone if the patient has failed to adhere to the Controlled Substance Treatment Agreement.
Practitioners considering prescribing extended release hydrocodone that is manufactured without an ADF, such as Zohydro, should review the full text of the emergency regulation at http://dpr.delaware.gov/boards/controlledsubstances/documents/Emergency_Rule.pdf
Balick & Balick is prepared to assist practitioners with putting procedures in place to meet the requirements of the emergency regulation.