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Vermont Restricting Access to Powerful Painkillers

By Pharmaceutical Processing | April 4, 2014

BARRE, Vt. (AP) — The state is restricting access to a new class of narcotic painkillers that law enforcement and public health officials across the country fear could worsen drug abuse, officials announced Thursday.

Gov. Peter Shumlin said Vermont wouldn’t go as far as neighboring Massachusetts, where Gov. Deval Patrick moved to ban the drug Zohydro, the first single-ingredient hydrocodone drug approved for U.S. patients. But Shumlin did issue emergency rules making it harder for physicians to prescribe the most powerful painkillers.

The move is part of a growing chorus of concern from across the country that follows the Food and Drug Administration’s approval of Zohydro in October.

The drug, which began shipping to pharmacies last month, contains more of the narcotic pain reliever than older combination pills, such as Vicodin. It belongs to a family of medicines known as opiates or opioids. Others include morphine, heroin and oxycodone, the painkiller in OxyContin.

“What we believe this rule will do is ensure that we are very, very careful about prescribing this FDA-approved opiate in Vermont with the hope that we won’t repeat the mistakes that we made with OxyContin with an even more powerful form,” Shumlin said at a Barre news conference alongside Health Commissioner Dr. Harry Chen and a number of the state’s mayors.

San Diego-based Zogenix, which makes Zohydro, responded to Thursday’s announcement by referring to a statement it issued last week in which it said the drug is no more potent than other hydrocodone medications. The company also said it set up a board of experts to guard against abuse of the drug and that its sales representatives are not being paid based on the volume of sales, but rather on their efforts to ensure prescribers, pharmacists and patients are educated to understand the risks and benefits of extended-release opioids.

In January, Shumlin devoted the bulk of his State of the State address to the state’s “full blown heroin crisis.” Law enforcement and public health officials say many turned to heroin after becoming addicted to prescription painkillers. The speech helped ignite a nationwide focus on the abuse of heroin and prescription drugs.

Last week, Patrick declared a public health emergency in Massachusetts in response to what he called the state’s growing epidemic of heroin overdoses and opioid addiction. He also moved to ban the prescription and dispensing of Zohydro.

Shumlin said he didn’t want to go that far, in part to avoid what could be expensive litigation over an outright ban.

“I expect that Massachusetts is likely to confront that and we really wanted to get something done quickly,” Shumlin said.

Vermont’s emergency rules require that prescribers of Zohydro conduct a thorough medical evaluation and risk assessment.

Madeleine Mongan, of the Vermont Medical Society, which represents about two-thirds of the state’s physicians, said it supported the emergency rule.

Also Thursday, Shumlin released a letter to the Canadian ambassador in Washington urging that country to require drug companies to make prescription painkillers harder to abuse. Some painkillers produced in Canada, unlike their U.S. counterparts, are easily crushable, making them easier to abuse.

An official for Health Canada referred to a 2012 statement that announced tougher licensing of those painkillers.

___

Associated Press reporter Wilson Ring in Montpelier, Vt., contributed to this report.

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