Patrick establishes restrictions on Zohydro

In order to prevent people from abusing prescription painkiller Zohydro ER, Massachusetts Gov. Deval Patrick announced Tuesday new restrictions would be placed on the monitoring and availability of the drug.

The immediate restrictions imposed on the painkiller will establish a Prescription Monitoring Program and will require doctors to complete risk assessments and pain management treatment agreements on patients prior to prescribing the drug, the Tuesday press release stated. Drug screening, safe storage and disposal and pill counts are among the issues addressed by the agreement.

A federal judge overturned Patrick’s emergency ban on the painkiller on April 15, but Patrick stood firm in wanting to prevent any harmful uses of the drug.

“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 the Tuesday release. “The broad actions we are taking to address the opioid epidemic will help save lives and give families struggling with addiction new hope.”

Patrick was not alone in his crusade against the painkiller, said Alec Loftus, communications director to Massachusetts Secretary of Health and Human Services. The FDA approved the drug over the objection of its own advisory council, which voted against it 11-2, and a majority of all states, over 30 attorney generals have requested review of approval.

“Late March, Governor Patrick announced a comprehensive plan, declared a public health emergency and banned the drug, Zohydro,” Loftus said. “He put $20 million toward treatment and recovery services and made available Narcan, a nasal spray that helps to reverse the effects of overdoses.”

When a federal judge overturned the March rulings, Patrick established a new set of limitations on the use and distribution of the drug.

In response to Patrick’s actions against the drug, Zogenix, the pharmaceutical company that markets Zohydro ER, stated in a Wednesday press release the two parties should work together to promote safe drug-use and combat drug abuse and addiction.

“The active ingredient in Zohydro ER, hydrocodone bitartrate, is no more potent than most other opioids,” the press release stated. “The amount of drug in each Zohydro ER capsule is consistent with, and on a relative basis, lower than that of comparable extended-release opioid products. In fact, there are more than 30 extended-release opioids on the market and only one has an FDA-approved label indicating it has abuse deterrent properties.”

The release also stated how no product currently on the market addresses the issue of people taking an unsafe number of pills, which is the most prevalent form of abuse, even when it is approved by the FDA.

“It is important to remember that Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical data,” the release stated. “This rigorous FDA review process serves the nation’s public health needs, the medical community and those in severe chronic pain.

A Zohydro spokesperson was unable to comment due to the ongoing nature of the situation.

Several residents said people should always exercise caution when it comes to prescription drug use, but some said this may not be Patrick’s place.

Helene Powers, 32, of Fenway, said she trusts the FDA’s opinion more than she trusts the governor’s.

 “It’s the FDA’s job to govern drug safety,” she said. ”The governor is a politician, not a doctor or a pharmacist or a researcher. People can become addicted to anything, any type of narcotic, but I think it also depends on the person. Either way, I don’t think the governor should get involved in this.”

Hanna Mogul-Adlin, 23, of Roslindale, said she hates the criminalization of drug use and how it can be viewed so negatively.

“In general, I’m pretty pro-drug legalization because I don’t think it makes sense to criminalize drugs,” she said. “This drug provides a treatment option to people who most likely will need one. Doctors should be allowed to administer drugs to those who need it, it would be unfair to restrict someone from having his or her pain alleviated.”

Dennis Palucki, 34, of Charlestown, said people who need the drugs should not be penalized for using them.

“Some people need those painkillers in order to feel better,” he said. “I’m a patient at the veteran’s hospital and they give out painkillers a lot, but because those people need them. They’re in pain. At the same time, it doesn’t seem like the governor should have the authority to get involved. He definitely shouldn’t have control over things like that.”


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