Mass. takes new direction on regulating Zohydro

Massachusetts officials this week enacted restrictions on the prescribing of the potent painkiller Zohydro that they say are more in line with conventional policies to monitor opioid prescribing, after a judge earlier had temporarily blocked the state from enforcing an outright ban of the medication.

Among the provisions of the action taken by Gov. Deval Patrick's administration, a physician seeking to prescribe the hydrocodone product would be required to execute a risk assessment agreement with a patient, with ongoing drug screening included as part of the protocol. In addition, the physician would have to enter data into the state's prescription drug monitoring program (PDMP) for tracking opioid prescribing and potential misuse.

“We are in the midst of a public health emergency around opioid abuse and we need to do everything in our power to prevent it from getting worse,” Patrick said in a statement this week.

It is believed that these restrictions will withstand any legal challenge, unlike the prior executive order that effectively had banned the prescribing of the federally approved Zohydro. A federal judge this month had temporarily blocked enforcement of the executive order, stating that it interfered with the Food and Drug Administration's (FDA's) authority to evaluate new medications and protect public safety, and she indicated in her ruling that drug manufacturer Zogenix would ultimately prevail in the matter.