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

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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…]

Drug Diversion and Abuse: “Medical” Marijuana Revisited

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Some time ago, I wrote a column on the problems and fallacies regarding the voters approving something described as “medical marijuana.” I must say, I received more e-mails about this topic than probably any other I have ever written about for Pharmacy Times. Some of them less than complimentary, as you might imagine, as I found that not all pharmacists agree with me on this topic!

My thoughts on this matter have not changed, and in fact, they are even more solidified. If medical marijuana is a legitimate medicine, then let manufacturers go through the same process as other pharmaceuticals and get final approval from the FDA. The product, like every other prescription drug, would be sold only through licensed pharmacies by licensed pharmacists who could legally dispense this “wonder” drug. After all, we have cannabis-based pharmaceuticals currently—medical marijuana would just be another one. [Read more…]

Drug Diversion and Abuse: OxyContin and the FDA

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By now you are all well aware of the FDA ruling in April 2013 on the issue of whether OxyContin has abuse-deterrent properties since the reformulation, and if it does, whether the generic companies that want to manufacture an extended-release oxycodone can go forward without those properties.

Just prior to this ruling, I had prepared a presentation on law enforcement’s perspective as to whether the reformulation of OxyContin was working or not. As you may remember, the reformulated product appeared on retail pharmacy shelves in August 2010. Since there had been extensive abuse of the old product, it was interesting to see what impact the reformulation had on the product, and we knew it would not be difficult to compare “apples to apples.” [Read more…]

Rx Abuse and Diversion 2013

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As I have stated many times before in this column, I am the president of the National Association of Drug Diversion Investigators (NADDI), a nonprofit organization made up of individuals involved in the problem of prescription drug abuse. We recently concluded our 2012 annual conference in Nashville, Tennessee, and it made me think about the upcoming year and our challenges.

One of the questions we get from different entities is “What is the stance of NADDI on abuse-resistant opiates?” A few years ago when this question first came up, I thought just for a second that maybe it was some kind of trick question! This not only gets asked by multiple entities in different facets of industry, but also by the press. [Read more…]

New Painkillers–Friend or Foe?

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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…]

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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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.

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