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Delaware Office of Controlled Substances Issues Emergency Regulation Restricting Prescriptions of Extended Release Hydrocodone

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:

  • conduct and document a thorough medical evaluation and physical examination as part of the patient’s medical record
  • evaluate and document relative risks and benefits for the individual patient of the use of such a hydrocodone.
  • document in the medical record that the prescription of a hydrocodone without an ADF is required for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, for which alternative treatment options, including non-pharmacological treatments, are ineffective, not tolerated, or would otherwise be inadequate to provide sufficient pain management
  • receive a signed informed consent form from the patient, or if the patient is not competent to provide informed consent, from the patient’s legal representative. The form must include information regarding the drug’s potential for addiction, abuse, and misuse and of the drug’s risks of
    • life-threatening respiratory depression
    • overdose as a result of accidental exposure, potentially fatal especially in children
    • neonatal opioid withdrawal symptoms
    • potentially fatal overdose when interacting with alcohol.
  • receive a signed Controlled Substance Treatment Agreement from the patient, which includes requirements such as urine screening (no less frequently than every 120 days), pill counts, safe storage and disposal, and other appropriate conditions as determined by the practitioner to reasonably and timely inform the practitioner if the patient is misusing the prescribed substance.
  • query the Delaware Prescription Monitoring Program (PMP) and review other controlled substances prescribed to the patient. For any patient prescribed 40 mg or greater per day, the practitioner must query the PMP no less frequently than once every 120 days for as long as the patient possesses a valid prescription for that amount.
  • determine a maximum daily dose or a “not to exceed value” for the prescription to be transmitted to the pharmacy.

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

Balick & Balick is prepared to assist practitioners with putting procedures in place to meet the requirements of the emergency regulation.

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