Drug Diversion and Abuse: OxyContin and the FDA

Drug task force data reveal the abuse-deterrent reformulation of OxyContin to be an overwhelming success.

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.”

The data I used were the statistics of my own large drug task force in Warren County, Ohio, the most recent RxPatrol data, and a SurveyMonkey I had done just a week before my presentation last April. All of the slides of this presentation are available by going to www.naddi.org.

Looking at my own drug task force, I thought the statistics were very interesting. We went back to our OxyContin statistics from 2008 through 2012, and although each year varies, we seized or identified as diverted 27,800 dosage units from 2008 through 2010. The overall statistics for 2011 and 2012 were approximately 530 dosage units! And this doesn’t even take into account that most likely some of the early 2011 statistics may have been the original formulation.

The second interesting finding was reported by RxPatrol, financed by Purdue Pharma and run by a police officer with the Stamford, Connecticut, police department. RxPatrol tracks pharmacy robberies and burglaries across the country and compiles facts on a variety of information, and specifically on the actual drug that is taken from the stores.

The data illustrated that in 2011 and 2012, even though pharmacy robberies had skyrocketed compared with the prior years, the instances of OxyContin being the target of the crime dropped, almost in half, from 60% to 33%, in those years. So the criminals who could demand any drug that was behind the pharmacy counter found the reformulated OxyContin to be much less desirable than its predecessor.

Finally, the National Association of Drug Diversion Investigators got involved in a SurveyMonkey e-mail questionnaire where respondents were asked about street prices and the demand for OxyContin before and after the reformulation. Once again, the facts consistently showed that the street prices and demand for the reformulated drug had dropped. Most of the 247 respondents answered the current street price question as I did, saying they didn’t know what the current street price of OxyContin was in their area. The demand had dropped so much that we have very few people even trying to sell it, and thus trying to figure out a bona fide street price is very difficult.

These data are very similar to other studies about the reformulation of OxyContin that include more than one of the Researched Abuse, Diversion and Addiction-Related Surveillance System survey methods. Although a handful of people still did not want to concede to the success of the reformulation, the evidence, in my opinion, is overwhelming.

In addition to giving Purdue Pharma a Tier 3 statement of the abuse-deterrent formulation’s success, the FDA banned generic oxycodone ER products from coming to market without properties that would ensure lessened abuse.

This answered the long-standing question by many as to what the FDA would do with the generics, considering the new formulation of OxyContin was a success. I certainly could see their concern in going either way on this topic. Do you allow a cheaper version of the much-abused formulation, or do you require generic companies to adhere to the now new standards set by Purdue Pharma’s success?

Since the selection is now made by the FDA, how does that impact legitimate pain patients? With the abuse/ diversion issues not being as great with the new medication, some might say that physicians may now feel more comfortable in prescribing OxyContin, but the cost for the patient will likely stay at the current level.

Regardless, it was a monumental decision by the FDA, and a positive reinforcement of its push to require pharmaceutical companies to seek abuse-deterrent formulations, especially for CII pain medications.

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, via the website www.rxdiversion.com, or by phone at 513-336-0070.