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Restrictions on the potent new painkiller Zohydro are within the Massachusetts' right to regulate the dispensing of prescription drugs, state officials argued in a legal brief filed Wednesday in a federal lawsuit challenging the rules' constitutionality.
Gov. Deval Patrick, Public Health Commissioner Cheryl Bartlett and members of the state Board of Registration in Medicine maintained that the restrictions do not impose "anything close" to an "effective ban" on the drug, as its manufacturer, Zogenix, claims in a lawsuit filed last month.
Instead, officials say, the mandates are "rooted in best-practice procedures" in the medical community.
State officials say the rules preserve the rights of qualified patients to access the drug while seeking to ensure that Zohydro, a hydrocodone-based narcotic, does not exacerbate the state's prescription drug abuse problems, which Patrick has already declared a public health emergency. The state also notes the measures are "nearly identical" to steps already taken by Vermont to restrict the drug's distribution.
A federal judge last month lifted Patrick's outright ban on the prescription of Zohydro in Massachusetts, siding with the company's argument that the ban was unconstitutional because the U.S. Food and Drug Administration had already approved its use for chronic and severe pain.
Massachusetts regulatory boards, in response, issued guidelines to doctors and dentists prescribing Zohydro.
The new regulations are meant to evaluate a patient's likelihood of abuse. They require prescribers, among other things, examine a patient's substance abuse history and current medications and utilize the state's online database for controlled substances. They also require doctors and dentists submit a "letter of medical necessity" to a patient's pharmacist explaining the diagnoses and treatment plan.
Pharmacists, meanwhile, have been instructed not to dispense the drug if they do not receive the letter. They are also required to keep the drug in a secure location and must review with the patient the specific dangers of the drug, which public health officials have said can be easily abused in its current form.
A Zogenix spokesman said the San Diego-based company would not comment beyond its lawsuit.
Bartlett, the state's public health commissioner, said in an interview Wednesday that the Patrick administration is weighing further restrictions affecting other controlled substances. A task force examining the state's opiate crisis is expected to issue its recommendations to the governor by the end of the month.
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