NEW HAMPSHIRE is facing one of its toughest public health problems, and it could get much worse very quickly. The addiction to and abuse of long-term pain medication has already contributed to doubling the number of fatal overdoses in our state, and it is threatening the fiscal stability of our workers’ compensation system. Now a new drug, five times as powerful as anything currently available, may soon hit the streets.
California-based Zogenix has won FDA approval for Zohydro ER, a time-released capsule of the powerful painkiller hydrocodone bitartrate. Most opiods contain acetaminophen, the active ingredient in Tylenol. Some patients have trouble tolerating acetaminophen, or develop side effects with prolonged use. So at first glance, Zohydro would seem to fill a gap for patients needing medication for long-term pain management.
Increased abuse of OxyContin, the long-acting form of oxycodone, led the manufacturer to develop an abuse-deterrent formula for the drug, which prevented addicts from circumventing the time-release mechanism by simply crushing the pills. No such safety measure yet exists for Zohydro.
Because Zohydro is time-released throughout the day, each pill contains five times the dose of a standard pill. The dangers of abuse are that much greater; at least until an abuse-deterrent formula is available.
This dangerous potential for abuse is why a majority of states opposed FDA approval for Zohydro, and why states are taking steps to prevent the new drug from making its way onto the black market.
Vermont has taken steps to make Zohydro harder for doctors to prescribe, while Massachusetts Gov. Deval Patrick issued an executive order directing the drug be banned from the Bay State. This brought a legal challenge from Zogenix, which argued that state governments did not have the authority to ban prescription drugs once the FDA has deemed them safe for public use. A federal judge has suspended Patrick’s order as the case proceeds, deciding that the drug maker is likely to prevail.
As Chairman of the Senate Commerce Committee, I drafted an 18-month moratorium on Zohydro in New Hampshire, and held a public hearing on the proposal last month. With strong beliefs on protecting personal freedom and concern about the Legislature wedging itself in between doctors and patients, I was reluctant to bring forward a statewide ban on an FDA-approved drug, even temporarily. But I had hoped that putting the issue on the public agenda would bring doctors, hospitals and state public health officials together to address it.
And we did. There was consensus that Zohydro has tremendous potential for abuse if widely available before it is tamper-proof. Several hospitals, including the Dartmouth-Hitchcock network, have decided to refuse to prescribe it. Pharmacists worry that stocking such a potent painkiller will make them targets, forcing them to relive the barrage of OxyContin robberies that only subsided when that drug was tamper-proofed.
I applaud our state’s medical community for being so pro-active in recognizing and addressing this threat by passing a resolution to stop its distribution in our state. Too often, we pass onerous laws in the face of public pressure to “do something,” even if a legislative solution isn’t the best solution.
We can address Zohydro through the framework of our existing laws if Gov. Maggie Hassan is willing to do so. I strongly recommend that the Department of Health and Human Services classify Zohydro as a Schedule I drug, given its high potential for abuse and likelihood of psychological and physical dependence. When and if Zogenix develops an abuse-resistant formula, we can reclassify Zohydro in Schedule II, along with current opiods.
Should the governor oppose this step to protect the public from Zohydro abuse, the Legislature can reclassify the drug itself. This last happened in 1998, when the Legislature placed Rohypnol, known as the Date Rape Drug, in Schedule I. I would support such legislation in the absence of executive action, or a tamper-proof version of Zohydro.
Sen. Andy Sanborn, R-Bedford, is chairman of the Senate Commerce Committee.