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Capitol reporter Katie Meyer covers Pennsylvania politics and issues at the Pennsylvania state capitol.
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Bill would limit access to new painkiller

Written by Mary Wilson, Former Capitol Bureau Chief | May 6, 2014 5:11 PM

Photo by Wikimedia Commons

The state House could take up a plan to limit access to a newly available and controversial prescription painkiller.

The House Human Services Committee on Tuesday approved proposed restrictions on Zohydro, an opioid medication approved by the federal Food and Drug Administration last fall.

Public health advocates say the drug is dangerously addictive, stronger than other painkillers on the market, and could contribute to an epidemic of drug abuse and fatal overdoses in Pennsylvania.

The plan sent to the full House would require doctors to do a medical evaluation and a risk assessment before writing a prescription for the drug, and would subject patients to urine screenings and pill counts to guard against abuse of the medication.

Sponsor Rep. Gene DiGirolamo (R-Bucks) admits the proposed requirements make up a long list.

“It is – a lot of work for the doctors,” he said. But DiGirolamo remains incredulous that Zohydro was ever approved over the objections of the doctors on the FDA’s expert advisory committee. They voted 11-2 against the drug’s federal approval in 2012.

Pennsylvania wouldn’t be the first state to attempt to limit access to the prescription painkiller.

Vermont’s governor issued emergency restrictions on the drug last month, as reported by the Burlington Free Press:

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...

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

A federal judge blocked a Massachusetts ban on the painkiller issued by Gov. Deval Patrick, as the Associated Press reported:

Patrick ordered the ban after declaring a public health emergency in light of a surge of drug overdoses and overdose deaths in the state. The state argued that Zohydro would ‘‘exacerbate a severe public health crisis’’ because the narcotic can be easily crushed, then snorted or injected to create an immediate and potentially lethal high.

A nearly unanimous vote Tuesday sent the proposed Pennsylvania restrictions to the full House, though several suggested reservations about putting a greater burden on doctors.

“I’m very concerned with the issue here, I’m just wondering if there’s not another way... to do this, without sort of continuing to intervene between a practice and a patient,” said Pam DeLissio (D-Montgomery).

By way of response, DiGirolamo offered a blistering critique of FDA Commissioner Margaret Hamburg.

“She is completely out of touch with the reality of what we’re seeing here on the ground – people dying, people being incarcerated,” said DiGirolamo. “People are dying from this stuff. We don’t need another drug that’s 10 times more – it’s almost pure heroin when you get the maximum dose.”

The New York Times has written about Zohydro’s potency:

[C]ritics note that Zohydro is being made available in doses of up to 50 milligrams of hydrocodone — or five times greater than the largest doses of immediate-release pills. Moreover, Zohydro is sold in capsules that can be crushed into doses to be snorted, injected or sold.

And it is not available in an abuse-resistant formulation, though company officials say they are doing research to develop one. At the moment, the company is offering pill bottles with combination locks on the caps, as well as lockboxes for storing the drug.

F.D.A. officials say they have an obligation to approve new treatment options for the more than 100 million Americans who live with chronic pain, which can be debilitating and can prevent them from working and living productive lives, though that figure has been questioned.

The Pennsylvania Medical Society, which lobbies state lawmakers on issues affecting public health and doctors, is still reviewing issues related to Zohydro's possible restriction. A spokesman said the board is expected to form a position with the next few weeks. 

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