Physicians at Dartmouth-Hitchcock Medical Center will not be prescribing a controversial new painkiller to patients.
The drug is Zohydro ER, a time-release formula of hydrocodone that law enforcement and medical experts say could exacerbate the twin epidemics of prescription drug and heroin abuse.
That’s because the new drug does not have the tamper-resistant features that similar medications have, to prevent addicts from crushing the pills and getting the entire dose at once.
Dartmouth-Hitchcock spokesman Clarence Adams Jr. said in an email on Saturday that the Lebanon medical center “does not have, nor does it intend to have, Zohydro on its formulary.”
Opposition to the drug has been mounting since the Food and Drug Administration approved Zohydro ER last fall, despite its own advisory committee’s recommendation against approval because of the potential for abuse and addiction.
Last week, Vermont Gov. Peter Shumlin announced emergency rules that will tightly control how Zohydro ER can be prescribed in that state.
Patients will have to sign informed consent forms acknowledging the potential dangers of the drug, including addiction, overdose and danger to children, and providers will have to certify that there are no other effective drugs available. Prescribers who ignore the new rules can be subject to censure, conditions on their license or even license revocation.
“If they’re going to dispense this particular FDA-approved drug, it’s going to be only after a very thorough discussion with patients, a lot of red tape, a lot of bureaucracy, so that they’re really sure they’re getting this one right,” Shumlin said at a press conference.
A week early, Gov. Deval Patrick of Massachusetts declared a public health emergency in response to the opioid addiction problem there. He directed public health officials to take several steps, including an immediate ban on prescribing Zohydro until “adequate measures are in place to safeguard against the potential for diversion.”
Marc Goldberg, spokesman for Gov. Maggie Hassan, said she is “very concerned about the potential impact of this new drug.”“We are actively reviewing options and working with the attorney general, health officials and members of the medical community on this serious issue,” he said.
Last December, Attorney General Joseph Foster joined his counterparts from 28 other states in a letter urging the FDA to reconsider its approval of the drug.
After Patrick announced the Zohydro ban, Zogenix, the San Diego-based company that makes the drug, said in a statement that the action “will add to patient suffering” in his state.
“We believe Governor Patrick’s ban on Zohydro ER only serves to unfairly restrict patient access to the only hydrocodone pain reliever available for long-term, daily, severe chronic pain patients who are obtaining relief with short-acting hydrocodone combination products, but who are at risk for potentially fatal liver toxicity due to their daily intake of acetaminophen,” the company stated.
On Friday, in response to Vermont’s new emergency rules, Zogenix issued the following statement:
“While we appreciate the fact that Vermont authorities have not completely shut the door on chronic pain patients in their state with regard to access to Zohydro ER, we have serious concerns that they have added additional restrictions to only one specific product.”
The company has repeatedly said it has taken “extraordinary steps to support the appropriate use” of the new drug, including giving patients free locking pill bottle caps and discounted safe-storage units.
And, the company noted, “Zogenix is also compensating our product representatives not on sales volume of Zohydro ER, but rather on their efforts to ensure prescribers, pharmacists and patients are educated to understand the risks and benefits of using extended-release opioids.”