Zohydro ER: A New Chronic Pain Product Launch

Cmdr John Burke
Published Online: Monday, April 14, 2014
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There has been quite a bit of chatter in the law enforcement field, and even among health professionals, about the launch of a brand-new extended-release hydrocodone product called Zohydro ER. The product launched on March 3, 2014, so by now your pharmacy has probably had some experience with orders for this single-entity, CII hydrocodone pharmaceutical indicated for chronic pain.

I was asked to be a member of the External Safe Use Board at Zogenix Pharmaceuticals, which is the manufacturer of Zohydro ER, and attended my first meeting in February 2014 in San Diego. We spent a day and a half at corporate headquarters, and the time was packed full of information about the drug and the programs Zogenix had in place in anticipation of the launch. The company representatives were anxious to hear our response to their programs, and they were very open to any suggestions for improving the programs and for new ideas.

Zogenix is certainly not naïve to the fact that this drug has a propensity for abuse and diversion. One of the obvious signs of this is that Zogenix assembled an External Safe Use Board and then listened intently to suggestions we had for trying to reduce the pathways for diversion. The 2 cofounders—the current chief executive officer and president—attended all of the meetings, making it clear that providing effective pain medication to legitimate patients was their number 1 goal, but they realized that keeping a constant vigil on abuse and diversion, from manufacturing to patient, was also a must.

Those of you who have read my columns over the past decade know that I feel that allowing these medications to be available to legitimate pain patients should be the ultimate goal of law enforcement and regulators. Combating diversion and abuse is a move in favor of patients in severe pain, and that also means keeping a drug like Zohydro ER in check as much as is humanly possible. Will Zohydro ER be abused? Of course, but I came away from this valuable meeting strongly feeling that the company is dedicated to responsible prescribing of Zohydro ER.

I didn’t come up with this conviction just because they assembled our board, but because of my feeling that everyone from the sales force to the chief executive officer is committed to providing education to the prescriber, dispenser, and patient about this new hydrocodone product. In fact, the sales force salaries for at least the first year will be based on educational material dissemination, not sales of the drug. None of us on the board had ever remembered that being part of any pharmaceutical company’s new product launch.

What I ask of all of you is to remember that this extended-release hydrocodone product is the first of its kind ever approved, and it will offer pain prescribers an additional option for patients. One of the methods to address diversion and abuse lies with you, the pharmacist. Don’t hesitate to report diversion of Zohydro ER, but at the same time give it a chance as a viable option for significant pain relief. Zohydro ER is not currently in an abuse-resistant formulation, but Zogenix does have one in the pipeline that it hopes will be available in about 3 years.

As with all abuse and diversion you encounter with any prescription drug, report these offenses to local law enforcement officers. They are your first and best line of defense when it comes to drug diversion crimes that you become aware of in your pharmacy. If you don’t know your local or state law enforcement officer, make it a point to invite him or her to your pharmacy before you have an issue, and introduce yourself and your staff.

Talk to law enforcement authorities about how you and their agency want to handle suspected doctor shoppers, or what the protocol is when someone attempts to pass a bogus prescription. Pharmacy robberies and burglaries continue to occur at an alarming rate, so ask your law enforcement officer to do a security check of your store and discuss how both of you would handle someone coming into your store with a gun, wanting your controlled substances.

Discuss these issues and more with law enforcement now so that you and your local authorities are both ready when a crime is committed in your establishment.


Cmdr Burke is a 40-year veteran of law enforcement and the current president of the National Association of Drug Diversion Investigators. He can be reached by e-mail at burke@choice.net or burke@naddi.org or via the website www.rxdiversion.com.


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