BARRE — The Vermont Department of Health has issued an emergency rule restricting health care providers from prescribing a new narcotic painkiller officials fear could be even more addictive than other opiates.
The Health Department’s emergency rule against Zohydro takes effect Friday. Zohydro is a one-ingredient hydrocodone product.
Gov. Peter Shumlin made the announcement at a news conference Thursday in Barre. The governor said he is also worried about prescription painkillers coming over the Canadian border in a crushable form no longer allowed in Vermont.
Shumlin and the New England governors, have sent a letter to the Canadian ambassador urging Canada to apply similar safety measures.
“We’re finding that since Canada doesn’t have the same standards that we have, we’re having a challenge with pills coming across the borders being crushed and snorted and abused,” Shumlin said.
The rule requires medical professionals to conduct a risk assessment of patients to whom they want to prescribe Zohydro and document that no other drug will effectively manage severe pain.
Health care providers must also query the Vermont Prescription Monitoring System to ensure patients have not already been prescribed the drug. They must also determine a maximum daily dose and schedule follow-up visits before prescribing Zohydro, according to the rule. Patients must sign a consent form acknowledging the risks.
Harry Chen, the commissioner of the Department of Health said, “You have to clearly state that all the other alternatives are not available or not effective.”
Shumlin said the U.S. Food and Drug Administration’s decision to approve a powerful painkiller that is manufactured without safeguards, at a time when much of the country has acknowledged an opiate addiction crisis, is irresponsible.
“Zohydro is been approved by the FDA to the bewilderment of many of us,” Shumlin said.
Chen said the drug was approved against the advice of the FDA’s scientific advisory committee and despite the FDA’s own proposed rules that require drugs to be manufactured with abuse-deterrent formulations.
“One might wonder if they’re on the same planet,” Chen said.
Chen said the Health Department rule will help Vermont get ahead of any problems the drug might cause.
The rule goes into effect Friday but will still be subject to public comment as part of the regular rulemaking process, Chen said.
A contingent of mayors from across the state joined Shumlin and Chen at the news conference.
Rutland Mayor Chris Louras said he was reluctant to attend because he hoped for “bolder action” against Zohydro. He said he was confident the governor and the Health Department will hold people accountable to the new rule.
“This frankly is as bold as we can get, and I’m confident we’re going to hold those to account for not complying with the guidelines,” Louras said.
Massachusetts health officials have banned prescribing or dispensing Zohydro in the Bay State.
New England governors have also sent a letter to FDA as well as Zohydro’s manufacturers asking for tamper-proof packaging, Shumlin said.
To read the complete text of the rule, click here.
