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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…]

Update on Abuse-Resistant Formulations

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As I write this article, a lot is going on in the prescription opiate world, with the main topic being abuse-resistant formulations. In looking at the pros and cons, the only real true data that I know of revolve around Purdue Pharma’s OxyContin, an extended-release oxycodone product that pharmacists are very familiar with in the marketplace.

In August 2010, a new formulation of the drug was introduced. On the surface, the pill doesn’t look any different from the old one except for the indicia change from “OC” to “OP”—and perhaps the slightly larger 80-mg dose. The colors and strengths are identical and the same oxycodone is present inside the pill. The reformulation isn’t remarkable on the outside, but on the inside is new technology that greatly reduces the ability of a person to compromise the new OxyContin. [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…]

Drug Diversion–Is It Simple Math?

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If you accept the definition of drug diversion as “any crime involving a prescription drug,” then the interesting question becomes, “What drives these crimes and what makes one prescription drug more desirable or abused than another?”

Something I learned a long time ago is that the best drugs for pain relief are the best drugs for getting “high.” This is simple but true. When a prescription drug is introduced and does what it says it will do—in this case, provide pain relief—it becomes popular. Patients report positive results, which causes prescribers to write more prescriptions for the drug. [Read more…]

The OxyContin Reformulation: Is It Working?

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In the spring of 2010, the FDA approved the reformulation of OxyContin, opening the doors for Purdue Pharma to begin distributing the new product with the hope that it would be more difficult for abusers to compromise and receive the “high” they crave. I discussed this issue several months ago and expressed hope that this reformulation would prove successful.

In mid-August 2010, the first of the reformulated OxyContin began to make its way into retail pharmacies across the United States. By the end of the year, most if not all pharmacies were no longer dispensing the old OxyContin. Very little cosmetic change can be noticed in the reformulated drug, except that the indicia “OC” is changed to “OP” and the 80-mg pill is slightly larger. [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.

Drug Diversion:
Any Criminal Act Involving a Prescription Drug.

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