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Mass. limits use of the potent painkiller Zohydro

Addiction concerns raised

Saying the state faces a continuing public health crisis, Governor Deval Patrick’s administration imposed sweeping restrictions Tuesday on prescribing the powerful painkiller Zohydro, just before a ban on the controversial drug was set to expire.

A federal judge overturned the state’s ban last week, saying the Patrick administration was overstepping its authority. But she delayed the decision until Tuesday, giving the governor time to respond with controls he said will allow regulators to monitor how the drug is being prescribed and used.

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The state Board of Registration in Medicine approved one restriction Tuesday that would require prescribers to complete a risk assessment and pain management treatment agreement with patients before prescribing the drug. The agreement would require drug screening and monitoring of the number of pills prescribed, among other conditions the prescriber may find necessary.

The prescriber would also be required under a state executive order to participate in the Prescription Monitoring Program, which would monitor the number of times the drug is prescribed, a measure designed to detect misuse.

State officials said other Massachusetts agencies, including the state Board of Registration in Pharmacy, could consider additional controls.

“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,” the governor said in a statement late Tuesday.

Cheryl Bartlett, the state’s commissioner of public health, said that the restrictions mirror policies enacted elsewhere to monitor opioid prescriptions.

“Bold actions are necessary — we are in the middle of a crisis,” she said, predicting the restrictions will withstand any legal challenges. “We wanted to make sure safeguards are in place for this drug. . . . It’s making sure it’s prescribed and used in the safest way possible.”

A representative for Zogenix, the maker of Zohydro, did not respond to requests for comment Tuesday.

Patrick had effectively singled out Zohydro in declaring a state of emergency last month to confront the state’s growing opiate addiction epidemic. The governor banned any analgesic that has the pain reliever hydrocodone as its sole active ingredient and that could be susceptible to abusers crushing the medication so that it can be snorted or injected.

Zohydro is the only drug that fell within that category. Zogenix challenged the ban in federal court, saying the US Food and Drug Administration had already approved the drug after proper screening. US District Court Judge Rya W. Zobel ruled that the state could not overrule the agency’s decision.

The controversy over the drug, which can be five times as powerful as Vicodin, has continued, with critics saying it could lead to addiction. Nearly 30 states asked the FDA to reject Zohydro, and US Representative Stephen F. Lynch of South Boston cosponsored a bill that would overturn the FDA’s decision. Vermont, which faces its own epidemic of opiate addictions, also enacted restrictions.

Joanne Peterson, executive director of Learn to Cope, a support group for families of people fighting drug addiction, welcomed the governor’s order, saying her group had failed to persuade Zogenix to reconsider release of the drug.

“We’re really frightened about another powerful opiate finding its way out into our streets,” said Peterson, speaking from the National Rx Drug Abuse Summit in Atlanta, where she is giving a lecture.

Dr. Ronald Dunlap, president of the Massachusetts Medical Society, said in a statement Tuesday that physicians recognize the severity of the prescription abuse problem and support the Board of Registration in Medicine vote Tuesday.

The statement added, however, that treatment for pain is complex, and that doctors and regulators must strike a balance between providing treatment and overprescribing “so that patients who can truly benefit from such medications may be able to do so.”

Leo Beletsky, an associate professor of law and health sciences at Northeastern University, said Tuesday the new restrictions emulate what other states are doing to confront opiate abuse and better monitor prescriptions, and that they “are very reasonable and justified kinds of regulatory changes.”

He said, though, that restrictions would go only so far in confronting addiction: He said the state will need to better follow up with the findings of the Prescription Monitoring Program to make sure that people fighting addictions get the treatment they need.

“What are the next steps, that’s my question,” he said.

Joshua Miller of the Globe staff contributed to this report. Milton J. Valencia can be reached at mvalencia@globe.com.
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