STATE HOUSE, BOSTON, APRIL 2, 2014…..Five days after Gov. Deval Patrick directed state public health authorities to implement an immediate ban on the prescribing and dispensing of the painkiller Zohydro, which he said poses a “significant risk,” state health authorities on Tuesday night formally conveyed instructions to doctors.
Declaring a public health emergency, Patrick last Thursday outlined steps to address an opioid addiction epidemic, banning any hydrocodone-only formulation, commonly known as Zohydro, with the administration saying it poses “significant risk to individuals already addicted to opiates and to the public at large.” The ban will last until authorities determine measures are in pace to “safeguard against the potential for diversion, overdose and misuse.”
A spokesman for the Massachusetts Medical Society, responding to a News Service inquiry Tuesday, said he was not aware of any subsequent communication about Zohydro to doctors from the state Department of Public Health. After the News Service inquired with DPH about how the ban has been communicated to doctors, a DPH spokeswoman late Tuesday said a “circular letter” would be going out on Tuesday evening. On Wednesday, the spokeswoman confirmed the letter went out by email and was also being sent through the regular mail.
In the letter, Deborah Allwes, director of prescription monitoring and drug control at the Department of Public Health, specified that registered providers in Massachusetts providing care to a patient in another state may not write a prescription for hydrocodone-only extended release drugs to be filled in another state.
Allwes also reported that a physician in a hospital or extended care facility may not order hydrocodone-only extended release for an admitted patient under their care, and also said a pharmacy in Massachusetts may not fill a prescription for hydrocodone-only extended release from a neighboring state.
Patrick and Department of Public Health Commissioner Cheryl Bartlett announced the opiate overdose and abuse emergency at a 3 p.m. press conference last Thursday. At 10 a.m. Thursday, the state Public Health Council had convened an emergency meeting on Washington Street in Boston, where the council voted 12-0 to authorize the commissioner to take actions to address the emergency and 11-1 to approve an emergency amendment authorizing the use by first responders of Naloxone, known as Narcan, an opioid antagonist that can prevent deaths in overdose cases. Asked about public notice of the meeting, a DPH spokesman said it was posted on the DPH website.
In her letter, Allwes wrotes that the U.S. Food and Drug Administration “recently approved a new medication which consists entirely of hydrocodone in higher levels than any currently available hydrocodone combination product” and said the product “is not in an abuse-deterrent formulation.” Allwes said the department “is concerned about the high likelihood of misuse, diversion and abuse of the medication, further adding to the opiate abuse epidemic and increasing the likelihood of additional opiate-related overdoses.”
Allwes reported that state authorities would provide notification when the ban on the new painkiller is lifted, saying it will stay in place “until such time as there are adequate safety measures in place.”
The makers of Zohydro, the San Diego-based Zogenix, say its use is reserved for patients “for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”
In a statement, the company said Patrick’s ban “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. Ultimately, the ban on the prescription medication will add to patient suffering in the state.”
The company said most other opioid medications on the market “are both equal to or more potent than” Zohydro and “available in higher strengths per unit-of-use than” Zohydro.
Saying it has taken steps to prevent misuse of Zohydro, Zogenix estimated that more than 360,000 prescriptions for extended-release opioids were dispensed in Massachusetts over the last 12 months.
Disputing claims that Zohydro is “more powerful” or “more addictive” than other commonly prescribed opioids, the company added, “We fail to see how banning the sale of a single new product will achieve the governor’s policy objectives when all of the products that are currently part of the epidemic remain available for sale in the state.”
In February 2012, nine state senators wrote to the Food and Drug Administration urging extreme caution as the agency considered approving what was described then as a newer form of Vicodin containing pure hydrocodone.
“As the elected representatives of a state in the grips of a growing opiate drug epidemic that was, we believe, touched off by the FDA’s 1996 approval of OxyContin, we are very wary of the impact a new, powerful opiate will have on the Commonwealth’s already high drug addiction rate,” senators wrote in the letter to Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research.
The letter was signed by Sens. John Keenan (D-Quincy), Jennifer Flanagan (D-Leominster), Robert Hedlund (R-Weymouth), Jamie Eldridge (D-Acton), Daniel Wolf (D-Harwich), Stephen Brewer (D-Barre), former Sen. Katherine Clark (D-Melrose), Jamie Welch (D-West Springfield) and Bruce Tarr (R-Gloucester).
The News Service reported at the time the new drug could contain 10 times the amount of hydrocodone as Vicodin. The lawmakers also suggested requiring that any new hydrocodone-based painkiller be manufactured in a tamper-resistant form like OxyContin , whose formula was changed causing it to form a “crumbly gel” rather than a powder when crushed to prevent pills from snorted by abusers.
Copyright 2014 State House News Service