National groups urge Governor Shumlin to broaden Zohydro rules

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National groups urge Governor Shumlin to broaden Zohydro rules

Wed, 04/23/2014 - 7:54am -- tim

The Center for Lawful Access and Abuse Deterrence (CLAAD) sent a letter to Vermont Governor Peter Shumlin on Thursday urging him to use concerns over Zohydro ER, a new opioid pain medication, "as a lightning rod for change."

The American Academy of Pain Management and National Fibromyalgia & Chronic Pain Association co-signed the letter asking the governor and health commissioner to participate in a "multi-lateral meeting to develop a more thorough approach" to stemming Vermont's prescription drug abuse epidemic.

Drug overdoses kill over 38,000 Americans per year -- more than car crashes or incidents involving firearms. Of those deaths, more than 22,000 involve prescription medications, according to statistics from the Centers for Disease Control and Prevention.

The U.S. Food and Drug Administration (FDA) approved Zohydro ER last fall, and the product has been on the market for several weeks. CLAAD opposed the approval of Zohydro ER and petitioned the FDA to require abuse-deterrent features for all new opioid pills, including Zohydro ER, the letter stated. Nevertheless, CLAAD and the co-signing organizations "respect the federal government's authority on drug-approval matters." 

Earlier this month, the Vermont governor issued an emergency rule that requires prescribers to conduct a thorough risk assessment when prescribing Zohydro ER. In announcing the rule, the governor erroneously stated that the drug is stronger than other opioid medications. The joint letter clarifies that Zohydro ER poses "substantially the same risks" as other opioids.

"Vermont's approach does not go far enough," the letter read.  The groups contend that safe-prescribing and abuse-prevention requirements should apply to all similarly powerful controlled substances, as numerous national health care organizations have recommended. 

"We have an opportunity to harness concerns over Zohydro ER to advance the comprehensive, consensus-based National Prescription Drug Abuse Prevention Strategy, which CLAAD and 30 of its not-for-profit health and safety partners have worked since 2008 to develop and refine," the letter stated.

The organizations asked Shumlin to meet with them and Zogenix, the maker of Zohydro ER, to develop a strategy that "incorporates the viewpoints of the public and private sectors, medical and legal professions, abuse-prevention and pain care communities, and patient advocates." 

About the Center for Lawful Access and Abuse Deterrence

The not-for-profit Center for Lawful Access and Abuse Deterrence (CLAAD) coordinates a comprehensive national effort to prevent prescription drug fraud, diversion, and abuse while advancing consumer access to high-quality medical care. CLAAD enables health professionals, law enforcement, businesses, government, and others, to share resources and work together to improve public health and safety.  Follow @claad_coalition.

SOURCE WASHINGTON, April 23, 2014 /PRNewswire/ -- Center for Lawful Access and Abuse Deterrence