Drugs and Chemicals of Concern > Oxycodone > Action Plan to Prevent the Diversion and Abuse of OxyContin®

Drugs and Chemicals of Concern

Action Plan to Prevent the Diversion 
and Abuse of OxyContin®

Summary

In response to growing concern among federal, state and local officials about the dramatic increase in the illicit availability and abuse of the prescription drug OxyContin® , the Drug Enforcement Administration (DEA) has embarked on a comprehensive effort to prevent its diversion and abuse.

The pharmacological effects of OxyContin® , a brand name formulation of the Schedule II narcotic oxycodone, make it attractive to abusers as it offers reliable strength and dosage levels and may, in some instances, be covered by the abuser's health insurance. Abusers have discovered that the controlled release formula of OxyContin® can be easily compromised allowing inhalation or injection for a powerful, morphine-like high.

Reports of the diversion and abuse of OxyContin® are currently concentrated in rural areas of the eastern United States; however, DEA's Office of Diversion Control has identified this activity as a growing problem throughout the nation¹. It has been described by some local law enforcement officials as a national epidemic in the making. National indicators such as DAWN (Drug Abuse Warning Network) and STRIDE (System to Retrieve Information from Drug Evidence) show recent increases in oxycodone overdoses and law enforcement encounters. Some jurisdictions report as much as a 75% increase in property and other crimes that they specifically attribute to the abuse of OxyContin® . Tazewell County, VA estimates that OxyContin® addiction is behind 80 to 95% of all crimes committed there.

Criminal activities resulting from the abuse of OxyContin® are quickly depleting the resources, financial as well as human, of local law enforcement. Some states, such as Maine, Virginia and Kentucky, have become so alarmed by this problem that they have begun to take extraordinary action to deal with it. Officials in Kentucky are utilizing a powerful new tool called KASPER (Kentucky All-Schedule Prescription Electronic Reporting), a database of all controlled substances dispensed by Kentucky pharmacists, in their investigations of OxyContin® -related crime². The Attorney General of Virginia recently convened a meeting of officials from five states to discuss ways to halt illegal trafficking in OxyContin® .

Data from the Office of Diversion Control Quarterly Reports indicate that OxyContin® has risen dramatically in recent months in terms of mention by the field offices as a 'most abused' drug.

Article published in the Louisville, KY The Courier-Journal, February 8, 2001

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The Problem

OxyContin® is a Schedule II controlled release form of the narcotic oxycodone manufactured by Purdue Pharma L.P. in 10mg, 20mg, 40mg, 80mg, and 160mg tablets. The controlled release method of delivery used in OxyContin® allows for a longer duration of drug action, and consequently, the manufacture of tablets containing larger doses of the active ingredient. It is legitimately used as a medication to treat moderate to severe pain and is becoming the drug of choice in many pain management clinics. In a little over four years, sales have reached $1 billion.

Table 1 shows the dramatic increase in the number of OxyContin® prescriptions over the past three years.

Oxycodone has been marketed in combination products with aspirin and acetaminophen (Percodan® and Percocet® ) for many years. Diversion and abuse of these products continue. However, because they contain these other ingredients and only 5 to 10mg of oxycodone, they are primarily abused orally. While prescriptions for oxycodone combination products have increased during the period from 1996 to 2000, prescriptions for oxycodone single entity products (such as OxyContin® ) have increased over fourteen-fold.

OxyContin® has become a target for diverters and abusers of controlled substances because of the larger amounts of the active ingredient in relation to other previous oxycodone products and the ability of abusers to easily compromise the controlled release formulation. Simply crushing the tablet can negate the timed effect of the drug, enabling abusers to swallow, inhale, or inject the drug, which is water soluble, for a powerful morphine-like high.

Common means of OxyContin® diversion are fraudulent prescriptions, doctor shopping, over-prescribing, and pharmacy theft. There have been many instances of pharmacies being robbed strictly for their supply of OxyContin® . Investigations have uncovered organized rings of individuals diverting, selling and abusing OxyContin® . Intelligence has also shown that foreign diversion is another source of the OxyContin® being sold and used illegally in the United States.

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Objective

Continued increases in the diversion and abuse of OxyContin® are considered likely unless firm and immediate action is taken. It is the goal of this action plan to reduce the existing and potential costs to public health and safety by having a significant and immediate impact on the diversion and abuse of OxyContin® .

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Action Plan

In order to combat the serious and growing problems stemming from the diversion and abuse of OxyContin® , DEA has developed a four-part action plan. The elements of the plan are as follows:

1. Enforcement and Intelligence: DEA must focus existing resources and management attention on investigations of the diversion and abuse of OxyContin® . These investigations require coordination and support from enforcement, diversion, and intelligence groups. Coordinated operations have been initiated in field offices to target individuals and organizations involved in the diversion, illegal sale, pharmacy theft, fraud and abuse of OxyContin® . DEA is using all available enforcement tools to disrupt these illegal operations. This includes interagency efforts on the federal, state, and local levels and extends to the international as well as the domestic arena.

DEA is continuing to identify large volume purchasers of OxyContin® for referral to field offices for appropriate action. All exports of OxyContin® are being closely scrutinized in order to detect possible diversion trends particularly in those countries having limited controls on pharmaceutical products.

A complete assessment of the scope and magnitude of OxyContin® legitimate use and abuse is being undertaken utilizing traditional and novel data sources. DEA has initiated contact and continues to work with the National Institute of Drug Abuse, the Substance Abuse and Mental Health Services Administration, the National Institute of Justice, and others, to modify data sources (e.g., National Household Survey, Monitoring the Future Survey, etc.) to improve the specificity of the data collected to reflect OxyContin® abuse.

2. Regulatory and Administrative: DEA is utilizing its full range of regulatory and administrative authority to pursue action as necessary to prevent the diversion and abuse of OxyContin® . In doing so, it is essential that DEA elicit the support of other regulatory agencies. These actions are not intended to impact on the availability of legitimate drug products for medical use.

DEA continues to examine the rapid increase in the requested levels of oxycodone quota by the manufacturer of OxyContin® .

DEA continues to work closely with the Food And Drug Administration (FDA) in strongly urging the rapid reformulation of OxyContin® to the extent that it is technically possible, in order to reduce the abuse of the product, particularly by injection. Additionally, both agencies will continue monitoring practices that may contribute to diversion or abuse.

DEA continues to work with the Interagency Narcotic Treatment Review Board and the Federation of State Medical Boards to develop further cooperation on such issues as physician education on the treatment of pain, the recognition of addiction, and implementation of the Federation’s Model Guidelines on Pain Treatment.

DEA will pursue legislative initiatives to assist states with funding for prescription data collection and analysis.

3. Seek Industry Cooperation: DEA continues to stress the importance of voluntary cooperation from industry in adhering to the spirit and substance of existing law and regulations. The agency is increasing its cooperative efforts with all levels of industry in order to stem the abuse and diversion of OxyContin® .

As the sole manufacturer of OxyContin® , the cooperation of Purdue Pharma L.P. is integral to the success of DEA’s Action Plan in preventing the abuse and diversion of OxyContin® .

Purdue Pharma has been encouraged to develop a balanced marketing strategy that ensures appropriate use of OxyContin® . Purdue agrees that OxyContin® should only be prescribed to patients where use of an opioid is appropriate for moderate to severe pain lasting more than a few days. Moreover, OxyContin® should only be prescribed by physicians who are knowledgeable about the use of opioids in the treatment of pain. Purdue Pharma will be encouraged to support and provide educational programs alerting legitimate patients as well as the general public to the dangers inherent in the abuse of such drugs.

In order to assist in identifying sources of diversion, DEA proposes that Purdue Pharma modify the shape, indicia, and color of OxyContin® tablets manufactured for export from the United States.

DEA is working with medical organizations and institutions, government agencies and international health care groups to better assess the legitimate medical needs for narcotic analgesics including OxyContin® . Such groups include the American Pain Society, American Academy of Pain Medicine, the Joint Commission on Accreditation of Healthcare Organizations, the World Health Organization, and the National Institutes of Health.

4. Awareness / Education / Outreach Initiatives: Recognizing the importance of the appropriate use of opioids in the treatment of pain, DEA must work to increase national awareness of the dangers associated with the abuse of OxyContin® . An aggressive, national outreach effort to educate the public, schools, the healthcare industry, and state and local governments on the dangers related to the abuse of OxyContin® will be implemented.

DEA must work proactively with the American Medical Association, Federation of State Medical Boards, National Association of Chain Drug Stores, National Association of Boards of Pharmacy, etc., to alert the healthcare industry to the growing problems associated with OxyContin® abuse. DEA is enhancing existing public awareness programs, including the Demand Reduction Program and the DEA’s public internet web sites, in order to educate the public on the dangers of OxyContin® abuse.

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