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You are here: Home / Archives for Zohydro

DEA Allows Rx Returns

November 7, 2014 by John Burke

Recently, US Attorney General Eric Holder announced a new Drug Enforcement Admini- stration (DEA) regulation that allows hospitals, pharmacies, clinics, and other authorized entities to provide drop-off locations for outdated or unused prescription drugs. Nursing homes will also be allowed to collect medications turned in by their residents, and the general public will have the option of mailing in their medications to authorized collection companies. Holder and the DEA feel that this new regulation, which went into effect in October 2014, will help to curb the rising prescription drug problem in America.

It’s interesting, no matter what you think of this move by the DEA, that it has is being done well after the peak of the prescription drug epidemic in the United States. I’m not saying that there still isn’t a huge problem, but our federal government always seems to be 1 or 2 steps behind the times! [Read more…]

Filed Under: Drug Diversion, Pharmacy Times Article Tagged With: Abuse Deterrent Formulation, OxyContin, Zogenix, Zohydro

Drug Diversion and Abuse: The FDA and Politicians: The Zohydro ER Debate

May 14, 2014 by John Burke

Before I begin this column, I need to provide the disclosure that I sit on the Safe Use Advisory Board for Zogenix, the maker of Zohydro ER. I was chosen for this board to help advise Zogenix on how to prevent diversion when the company can, and how to deal with it if and when it occurs.

That being said, as I write this some incredible things are happening and being reported in the news that I believe are unprecedented. Even though the FDA approved Zohydro ER, a CII extended-release hydrocodone-only product with no current abuse-resistant properties, a few politicians have decided to either ban the drug in their state through executive order or to introduce legislation to do the same. All of this is being done for a drug that has barely been in the marketplace for 30 days. [Read more…]

Filed Under: Drug Diversion, Pharmacy Times Article Tagged With: FDA, Hydrocodone, Zogenix, Zohydro

Zohydro ER: A New Chronic Pain Product Launch

April 14, 2014 by John Burke

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. [Read more…]

Filed Under: Drug Diversion, Pain Management, Pharmacy Times Article Tagged With: Abuse Deterrent Formulation, Hydrocodone, Zogenix, Zohydro

Drug Diversion and Abuse: The Future of Rx Abuse

March 14, 2014 by John Burke

Of course, nobody knows for sure the extent of abuse that pharmaceuticals will see over the next decade and beyond, but perhaps an educated guess can be made based on the history of substance abuse over the past 40 to 50 years. I have been around about that length of time in law enforcement, and unfortunately I have seen some remarkable events unfold.

There is no question in my mind that alcohol abuse far outweighs all of the other substances of abuse, and of course, alcohol is a legal drug. When President Obama indicated that marijuana was no worse than alcohol, I wondered if he really knew what he was saying! That shouldn’t have made the case for marijuana legalization, but should give pause as to the meager job we have done controlling alcoholism and alcohol abuse by our youth. [Read more…]

Filed Under: Drug Diversion, Pain Management, Pharmacy Times Article Tagged With: Abuse Deterrent Formulation, Hydrocodone, Oxycodone, OxyContin, Zogenix, Zohydro

New Painkillers–Friend or Foe?

February 15, 2012 by John Burke

As we start the year, media attention in the drug diversion arena goes to a new hydrocodone product possibly hitting the retail market with the idea that it could “spur a new wave of abuse.” In addition, a US Senator chimed in that he was concerned about the abuse and diversion of this new product and is already urging the FDA not to provide approval.

The concern is primarily with a company called Zogenix of San Diego, California, and their proposed new hydrocodone product called Zohydro. This new product is pure hydrocodone, with no acetaminophen or other products that could restrict dosages. The drug would certainly be a CII controlled substance, and it is an extended-release product designed to provide up to 12 hours of pain relief. Because it is an extended-release product, the strength of the hydrocodone will certainly be very high, with news reports indicating as much as 10 times higher than standard hydrocodone. [Read more…]

Filed Under: Abuse Prevention, Drug Diversion, Pain Management, Pharmacies, Pharmacy Times Article Tagged With: FDA, Hydrocodone, Overdose, Oxycodone, Zogenix, Zohydro

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How BIG is the problem?

Year after year, state and local law enforcement statistics indicate that pharmaceuticals are almost 30% of the overall drug problem in the United States, running a close second only marijuana abuse. However, until recently, law enforcement, health care professionals, and the general public have placed little emphasis on this huge problem.

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About PDE

Pharmaceutical Diversion Education (PDE) is designed to assist a wide range of the population in understanding the potential abuse and addiction that can be associated with prescription medication.

Drug Diversion:
Any Criminal Act Involving a Prescription Drug.

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