Date Posted: Wednesday, June 18th, 2014
Categories: Department of State
(Dover, Del.) Secretary of State Jeffrey Bullock has put into place emergency regulations around any extended-release hydrocodone (Zohydro) that lacks an abuse-deterrent formulation (ADF) feature following recommendations from the Delaware Controlled Substance Advisory Committee. Abuse-deterrent formulation (ADF) features are physical barriers that cause a drug to be ineffective when chewed, crushed, cut, grated, or ground or chemical barriers that can resist extraction of the opioid using common solvents like water.
“The use of this new and dangerous narcotic painkiller known as Zohydro must be monitored closely because the abuse of it can be deadly,” said Secretary Bullock . “ It carries even higher risks of abuse than other short-acting formulations.”
The regulations require best practices in assessment, prescribing and monitoring of patients for whom the drug has been prescribed. The restrictions and requirements, in conjunction with the Delaware Prescription Monitoring Program, provide an additional safety net in fulfilling obligations to protect the public.
Because of the potential for accidental overdose, intentional abuse or diversion, and available data and information pertaining to extended-release hydrocodone lacking ADF, Secretary Bullock finds that adoption of these emergency regulations is necessary to address the imminent peril to the public health, safety and welfare of all Delawareans.
Prior to prescribing an extended-release hydrocodone that is manufactured without an ADF, the medical practitioner shall conduct and document a thorough medical evaluation and physical examination as part of the patient’s medical record.
For more information about the Division of Professional Regulation Controlled Substances program visit: http://dpr.delaware.gov/boards/controlledsubstances/index.shtml.
Contact: Tammy Stock at (302) 857-3038 or firstname.lastname@example.org. Delaware Department of State, Chief, Community Relations.Related Topics: controlled substances • Division of Professional Regulation • prescription drugs
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