State lawmakers are wading into the debate over the controversial new painkiller Zohydro.
A Senate committee will take up legislation Tuesday that would impose an 18-month moratorium on the new drug, an especially potent formulation of hydrocodone.
Zohydro hit the market in March and is aimed at patients who need long-term, around-the-clock pain relief. It differs from other hydrocodone-based medications, such as Vicodin, because it isn’t combined with acetaminophen or ibuprofen.
The U.S. Food and Drug Administration approved Zohydro last fall against the recommendation of its own advisory committee, which warned that it could be too easily abused.
The attorneys general of 28 states, including New Hampshire, have asked the FDA to reconsider its decision, as did Sen. Jeanne Shaheen in a letter to the agency last week. In March, New Hampshire's two congresswomen, Rep. Carol Shea-Porter and Rep. Anne Kuster, expressed their concern over the drug's approval as well.
The governors of Massachusetts and Vermont have already joined the growing backlash against Zohydro by taking steps to prohibit or restrict its use.
Massachusetts Gov. Deval L. Patrick announced an immediate ban on prescriptions “until adequate measures are in place to safeguard against the potential for diversion.” The drug’s maker, Zogenix, has filed suit over the ban, arguing states cannot deny patients access to an FDA-approved medication.
Vermont Gov. Peter Shumlin has put in place new rules that will make it more difficult for doctors to prescribe Zohydro. Patients will have to sign informed consent forms acknowledging the potential dangers of the new drug, and providers must certify that no other effective painkiller is available before issuing a prescription.
The New Hampshire legislation was proposed by Sen. Andy Sanborn, R-Bedford, who wants to prohibit Zohydro’s use until Zogenix can produce a tamper-resistant version that can’t be crushed into a powder and snorted or injected. In a statement, he said legislators “must take a close look at highly addictive drugs like this one that could pose new or additional health risks to our population.”
Gil Fanciullo is a professor of anesthesiology at Dartmouth Medical School and director of pain management at Dartmouth-Hitchcock Medical Center, which has said its physicians will not prescribe Zohydro.
Fanciullo said lawmakers are right to take a hard look at the new drug, given the state’s difficulty in controlling the abuse of prescription painkillers that have been on the market for decades.
“Is there an unmet need in pain medicine for a drug like Zohydro? Are there patients out there suffering right now because this drug is not available?” Fanciullo said. “The answer to that question is, I don’t think so. I think it would be a more convenient way for patients to take the drug, but there is certainly no unmet need for this drug.”
Joshua Greenspan, a specialist in pain medicine in Portsmouth, disagrees. Greenspan said hydrocodone is considered a mild opioid with a relatively low risk of becoming habit-forming. He has already prescribed it to patients with “continuous pain” who were making due with shorter-acting Vicodin. And, he said, he will continue to do so.
“All of our opioid medications come in long- and short-acting form,” he said. “So it makes perfect sense to have a long-acting form of the medication because this way you can have something that lasts for 24 hours.”
State health officials have described the abuse of prescription drugs in New Hampshire as an epidemic. Between 2000 and 2011, the number of drug-related deaths annually quadrupled to 200 - 80 percent of which involved prescription drugs, usually opioids such as oxycodone and methadone.
Meanwhile, state-funded treatment programs have seen a 60 percent increase in patients admitted for oxycodone addiction, and the growing number of people dependent on the drug and other prescription opioids has been blamed for a recent spike in heroin overdoses.
Two other legislative efforts to address the abuse and illicit use of opioids have already failed this session.
A Senate bill, sponsored by Sen. Lou D’Allesandro, would have made it harder for claimants in workers compensation cases to get opioids from multiple prescribers. The bill called for doctors to enter into written agreements with injured employees before prescribing a “morphine equivalent” of 120 milligrams or more.
According to the National Council on Compensation Insurance, the use of opioids - oxycontin and oxycodone, in particular - by workers-comp claimants in New Hampshire is much higher than the national average. In 2009, the NCCI reports, more than 15 percent of all prescription drug claims by injured workers in New Hampshire was for oxycontin, compared to 6.5 percent nationally, and five of the 10 most prescribed drugs in workers-comp cases were for opioids.
Deb Stone, an actuary with the state Department of Insurance, said until the state's Prescription Drug Monitoring Program is up and running this summer, agreements between claimants and prescribers make sense.
"I don’t think it hurts to have guidelines that have some real definition and structure and impetus toward making sure people think about what they do," she said.
D'Allesandro's bill, which was opposed by the New Hampshire Medical Society, was referred to interim study, effectively killing it.
The Senate also debated capping individual opioid prescriptions at a 34-day supply or 100 doses, whichever is less. That bill, also opposed by the medical society, passed the Senate - but not before the dose limit was stripped out.
Sen. Peggy Gilmour, a cosponsor, said the state’s controlled-substance statute included a 100-dose limit until 2008, when it was removed at the behest of physicians who said it interfered with their ability to treat chronic pain in cancer and hospice patients.
Gilmore, who has a background in hospice care, said she supported lifting the cap in 2008. But, she said, since then, “the world has changed.”
“We’re seeing a whole new set of problems around the use and misuse and terrible consequences of prescription drugs,” she said. “So how do you manage that? This is the struggle now.”