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You are here: Home / Archives for Overdose

Reformulation of OxyContin: Will it Prevent Illicit Use?

November 23, 2010 by John Burke

The abuse and diversion of OxyContin has not been a secret to the public, law enforcement, pharmaceutical companies, or even patients. The drug has been made out to be a villain by the media, who often refer to the brand-name drug when other forms of oxycodone were actually the drug involved.

Nonetheless, the drug has definitely been a major source of abuse, fetching street prices of $1 per milligram and, in some areas and cases, even higher. Since OxyContin is an extended-release product, it is packed with the pain reliever oxycodone, and designed to be released over the course of approximately 12 hours. Since it is a pure drug, with no acetaminophen or other substances, there is no ceiling dosage.

When OxyContin is taken intact, it releases the powerful CII drug over the course of many hours, providing patients in pain with the promise of continuous relief, hopefully eliminating the peaks and valleys of short-acting pain relievers, and the necessity of taking many more pills over the course of a day. After conversing over the years with thousands of physicians, I am convinced that OxyContin is a superb analgesic—maybe the best for patients with chronic pain ever made. I have never heard any of those physicians complain that the drug did not work effectively, or that their patients were experiencing significant side effects.

An Explosion of Abuse

It sounded like the perfect pain reliever, until 1 or 2 years after the launch, when innovative drug abusers found that if OxyContin is broken down and chewed, injected, snorted, and even smoked, it can create a terrific “high.” This created an explosion of abuse and diversion of Will It Prevent Illicit Use?

This drug, first discovered in the state of Maine, of all places. The rest is history, as they say, and Purdue Pharma has struggled with a huge volume of bad press coverage, sometimes accurate, sometimes incredibly inept.

Something that needs to be mentioned is that over the course of these years, Purdue Pharma has taken unprecedented steps to educate the public, prescribers, and law enforcement about the abuse and diversion of pain relievers, as well as appropriate pain management. They have hired a small elite group of former law enforcement officers who had deep roots in the area of drug diversion to travel the country—educating law enforcement on prescription drug abuse, including their own product.

In the interest of disclosure, Purdue Pharma also provides the National Association of Drug Diversion Investigators (NADDI), of which I am the national president, with unrestricted grant money that we provide in the form of awards to law enforcement. In addition, they have funded our very popular Abused Pharmaceutical Substances brochure that is sent free to law enforcement across the United States.

New Reformulation

In mid-August 2010, after approval by the FDA, Purdue Pharma began distributing a reformulation of OxyContin. The active ingredient inside did not change, but the outside of each pill was produced with the goal of making it much more difficult to compromise, something that if successful, would cause the ire of drug-seekers.

The other change was that the indicia of each strength of OxyContin changed from the letters “OC” on one side, to the letters “OP,” for those dispensed in the United States. The milligram strength of each pill still remains on the other side. The 80-mg pills are slightly larger, although this is difficult to distinguish with the naked eye.

As I write this article, the new formulation has been out at retail pharmacies for 6 weeks. By the time you read this, there will likely be none of the “OC” OxyContin on the shelves. My drug unit immediately began to see the “OP” version on the street for sale, with the chatter going back and forth among abusers as to their displeasure of this new product hitting the scene.

I also monitor law enforcement across the United States, and most have reported a drop in price, with the new formulation at about half of the old OxyContin’s street value. If the difficulty to break this drug down continues, I would expect the illegal street price of OxyContin to continue to drop accordingly. Besides, immediaterelease oxycodone products can contain up to 30 mg of the drug without the hassle of trying to make it suitable for injection, snorting, chewing, or smoking, and it seems to be readily available right now.

I have sincere hope that the new formulation of OxyContin will remain difficult, if not impossible, to break down for illicit use, and yet still remain effective for legitimate patients. Time will tell, as this is truly a unique opportunity to compare “apples to apples” over the next several months and years.

Filed Under: Abuse Prevention, Drug Diversion, Pain Management Tagged With: Abuse Deterrent Formulation, Overdose, Oxycodone, OxyContin

REMS and Opiates— A New Beginning?

September 1, 2009 by John Burke

The FDA’s decision to require manufacturers to develop Risk Evaluation and Mitigation Strategies (REMS) for their new or improved prescription opiates has had a widespread effect on these companies and their plans for distributing their pain relievers. As these companies scramble to develop REMS that will receive FDA approval and allow their products to be approved for distribution, many questions are generated as to exactly what the federal agency wants them to achieve and how to do it.

Of course, REMS for opiates have been mandated due to the continued rise in prescription drug abuse in our country. Some of this abuse is intentional, and some of it is accidental; nonetheless, the FDA is requiring some new ideas and strategies in an attempt to reduce this diversion problem in America. For the first time, generic pharmaceutical companies are also included in this mandate; branded companies feel that this is long overdue. [Read more…]

Filed Under: Abuse Prevention, Drug Diversion, Pain Management Tagged With: FDA, Hydrocodone, Overdose, Oxycodone

Icon Tragedies

August 15, 2009 by John Burke

The recent death of Michael Jackson from a reported overdose of prescription drugs seems to be all too common in the world of celebrities and stars that grace our television or movie screens. Regardless of your opinion of Jackson’s life and career, he was an icon in the field of music, presumably struck down through the overindulgence of pharmaceutical drugs. Millions of people from around the world bought his recordings and idolized him.

I could not help but compare this icon’s life and death with another musical icon, Elvis Presley. Presley was the undisputed rock-and-roll icon for decades, with his only close competition being Jackson. Whether Presley or Jackson emerges as the king is something that will be debated for many years and is really inconsequential to the fact that 2 talented human beings met an untimely death due to the abuse of prescription drugs. [Read more…]

Filed Under: Abuse Prevention Tagged With: Overdose

Crossing Over State Lines with Painkiller Prescriptions

June 1, 2009 by John Burke

For some time now, the Midwest and other locations in the United States have been inundated with prescription drugs flowing in from Broward County, Florida (Fort Lauderdale). The root of the problem appears to be the almost 200 pain management practices located in Broward County and the constant flow of Ohioans and others to these clinics. Some of these clinics are not owned by physicians but by energetic entrepreneurs.

Vanloads of midwesterners have traveled the 1000-plus miles to obtain multiple prescriptions for oxycodone and other controlled substances. Our task force is seeing this firsthand, as we receive offers to purchase as many as 400 tablets at a time, ranging from $6 to $8 per pill and sometimes even more, depending on supply and demand. [Read more…]

Filed Under: Abuse Prevention, Drug Diversion Tagged With: Hydrocodone, Overdose, Oxycodone, Prescription Monitoring Programs

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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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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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