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After a federal judge struck down the governor’s emergency ban on Zohydro, Gov. Deval Patrick moved on Tuesday to impose restrictions on prescribing the powerful new painkiller that include mandatory risk assessments for patients.
The Patrick administration announced late Tuesday afternoon that doctors would be required to complete a risk assessment and pain management treatment agreement before prescribing any drug like Zohydro, which is a hydrocodone-only medication that state public health officials say is not yet manufactured in an abuse-deterrent form.
Zohydro only hit the market in March after the Food and Drug Administration approved the drug for commercial use in October. Other states such as Vermont have taken similar steps to protect against the potential abuse of Zohydro by making it more difficult for doctors to prescribe.
The Board of Registration in Medicine voted to approve the new restrictions on Tuesday, and Department of Public Health Commission Cheryl Bartlett issued an emergency order requiring physicians to utilize the state’s Prescription Monitoring Program before prescribing Zohydro, which is a way for state authorities and prescribers to track where patients are getting their drugs.
“We are in the midst of a public health emergency around opioid abuse and we need to do everything in our power to prevent it from getting worse,” Patrick said in a statement. “The broad actions we are taking to address the opioid epidemic will help save lives and give families struggling with addiction new hope.”
U.S. District Court Judge Rya Zobel last week sided with Zogenix, the pharmaceutical company that markets Zohydro and challenged Patrick’s ban, calling the state's arguments “without merit.” The Patrick administration tried to ban the drug under the cover of a public health emergency, but the judge ruled that the state could not substitute its own judgment for that of the FDA. The preliminary injunction lifting Patrick’s ban took effect Tuesday.
Zogenix officials describe Zohydro ER as a drug that manages pain severe enough to require continuous, long-term opioid treatment for which alternative options are inadequate.After the federal judge’s ruling last week, Zogeniz CEO Roger Hawley, said, "We invite concerned officials to engage with us to discuss fair and appropriate safeguards for pain medications like Zohydro ER rather than seeking to ban or restrict one specific treatment."Zogenix officials have said they have taken steps to prevent misuse of Zohydro, and dispute claims that it is more addictive or powerful than other commonly prescribed opioids.
The agreements now required between doctors and patients before Zohydro can be prescribed must cover drug screening, pill counts, safe storage and disposal and other safeguards against abuse. The administration said additional state boards that regulate doctors and pharmacists will meet soon to consider adopting further restrictions around opioids.
“The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opioids and to the public at large,” Bartlett said in a statement. “These new safeguards are critical to prevent misuse.”
Patrick declared a public health emergency around opioid addiction in late March, taking steps to make Naloxone, commonly known as Narcan, more widely available to first responders and through pharmacies. He also allocated an additional $20 million for treatment and recovery services, accelerated the timetable for prescribers to enroll in the prescription monitoring program, and asked the state’s Interagency Council on Substance Abuse and Prevention to make recommendations for further actions.