Answers to Frequently Asked Questions Regarding OxyContin®
Frequently Asked Questions
- What authority does the DEA have to regulate the handling of controlled substances, like OxyContin®?
- Is the DEA planning to restrict the prescribing of OxyContin® to pain treatment centers or physicians specifically accredited as pain management specialist?
- What is the relationship between DEA and the Food and Drug Administration (FDA) in regulating drugs like OxyContin®?
- What evidence does the DEA have to support accounts that OxyContin® is being abused to the extent that has been reported by the media?
- What steps are currently being taken to address the widespread abuse of OxyContin®?
- What strengths of OxyContin® are most commonly abused or diverted?
- Did DEA have any part in Purdue's decision to "temporarily suspend" distribution of the 160 mg. strength tablet?
- Is DEA going to reduce manufacturing quotas for oxycodone, the active ingredient in OxyContin®?
DEA's authority to regulate pharmaceutical controlled substances is derived from the Controlled Substances Act (CSA) [21 U.S.C. §§ 801-971]. The CSA mandates that DEA prevent, detect and investigate the diversion of legally manufactured controlled substances while, at the same time, ensuring that there are adequate supplies to meet the legitimate medical needs in the United States.
To enable the DEA to achieve these goals, the CSA established five schedules into which controlled substances are separated according to their approved medical use and abuse potential. Schedule I controlled substances are those deemed not to have legitimate medical uses and have a very high potential for abuse. Schedule II substances, including OxyContin®, are approved for medical use and also have a very high abuse potential. Schedules III, IV and V include controlled substances that have all been approved for medical use and have diminishing potential for abuse.
The CSA also established a closed system of distribution that includes the registration of controlled substances handlers, including manufacturers, distributors, importers, exporters, practitioners and pharmacists. Production quotas as well as recordkeeping and security requirements are designed to enable DEA to track and safeguard potentially dangerous controlled substances as they are transferred from the manufacturer to the ultimate user.
Throughout DEA's examination of the abuse of OxyContin®, numerous options have been explored and discussed with the healthcare community and pharmaceutical industry. None of these options will be employed unilaterally by DEA without considering the effects they may have on public health.
The CSA requires that controlled substances be prescribed, dispensed or administered only for legitimate medical purposes by practitioners acting in the usual course of their professional practice. The CSA and its implementing regulations do not define "legitimate medical purpose" nor do they set standards as to what constitutes "the usual course of professional practice." DEA relies on the medical community to make these determinations. DEA has a well-established relationship with experts in the field of pain management and has enlisted their expertise in devising strategies to ensure that OxyContin® and other powerful opioids are appropriately prescribed.
DEA agrees with pain treatment specialists' assertions that many general practitioners have not received adequate training to address complex chronic pain syndromes. These specialists emphasize that Schedule II opioids are best used as the treatment of last resort for chronic pain; and that when they are used, they should be part of a multi-disciplinary approach to pain management, including physical and psychological therapy. DEA has strongly supported the establishment of "Model Guidelines for the Use of Controlled Substances in Pain Management" by the Federation of State Medical Boards. These guidelines reflect currently accepted standards that may be used by both medical professionals and regulators in determining the appropriateness of opioid prescribing.
The FDA is responsible for approving drugs for medical use. These drugs include those sold over-the-counter, those requiring a prescription, and prescription drugs that are controlled under the CSA. The FDA also sets regulations for the marketing of drugs, including controlled substances.
DEA does not directly regulate the marketing of controlled substances. However, in keeping with DEA's mandate to ensure appropriate safeguards against diversion, DEA is concerned when marketing and advertising tactics appear to create an increased possibility for diversion or misuse. If marketing tactics seem to lead to oversupply or minimize the abuse potential of a controlled substance, the DEA makes every effort to work with pharmaceutical companies and the FDA to find appropriate solutions to these problems.
Since its introduction in 1996, the number of OxyContin® prescriptions dispensed has increased 20-fold to about 6 million in 2000. During this same time, medical examiners, drug treatment centers, law enforcement personnel, and pharmacists have reported a substantial increase in the abuse of this product.
Information received from the Drug Abuse Warning Network (DAWN) indicates that instances of emergency department episodes and medical examiners reports involving oxycodone, the active ingredient in OxyContin®, have increased significantly since 1996. Reports from 20 metropolitan areas within the continental U.S. indicate that oxycodone-related deaths and emergency department episodes have increased 400 percent and 100 percent, respectively.
Most deaths reported in the media and attributed to OxyContin® have generally occurred in areas outside the DAWN system, such as Maine, West Virginia, and rural Kentucky. DEA has been actively collecting and evaluating data from medical examiners in these areas to more clearly ascertain the extent of abuse problems.
Drug treatment programs have also provided evidence regarding an increase in OxyContin® abuse. Programs in West Virginia, Pennsylvania, Kentucky, and Virginia, the states that have been most severely affected by this trend, report that 50 to 90 percent of newly admitted patients identified OxyContin® as their primary drug of abuse.
DEA's approach to dealing with the abuse and diversion of OxyContin® is consistent with the methods normally used in combating the diversion of pharmaceutical controlled substances. These approaches include liaison with the healthcare community, the pharmaceutical industry, and other domestic and international agencies; education of medical professionals regarding various scams that are used to obtain controlled substances for illicit purposes; and the investigation of suspected diverters.
For a more detailed description of DEA's strategies you may access the Diversion Control Division's website at www.DEAdiversion.usdoj.gov. for the document "Working to Prevent Diversion and Abuse of OxyContin".
Law enforcement and forensic laboratory data indicate that their exhibits are primarily for the 40 mg. tablets, although all strengths (10 mg., 20 mg., 40 mg., 80 mg., and 160 mg.) have been encountered.
DEA has expressed its concerns to Purdue regarding the diversion and abuse of their OxyContin® products. DEA recognizes the therapeutic value of long-acting opioids in the treatment of chronic pain. However, it has been found that the controlled release formulation used in OxyContin® products can be easily compromised. The ability to quickly release a high dose of oxycodone that is intended for slow release, whether intentional or not, makes this product both attractive to abusers and dangerous to individuals who have not developed a tolerance to opioids.
DEA has not asked Purdue to withdraw the 160 mg. tablet and recognizes that this dosage may be appropriate for a limited number of patients. The Associate Press reported on May 11, 2001, that Purdue stated that government pressure played no part in its decision to suspend distribution of OxyContin® 160 mg. tablets. It would not be appropriate for DEA to speculate about the decision.
All quotas are reviewed annually to ensure that the amount of controlled substances produced are sufficient to meet the legitimate medical, scientific, research, and industrial needs of the U.S. This review includes a yearly forecast of expected changes in medical use, data from prescription and hospital use, as well as abuse, trafficking and diversion data. Quotas may be increased or decreased depending on expected needs or excessive supplies. Excessive inventories of any controlled substance heighten the chances of possible diversion.
In the case of oxycodone, the active ingredient in OxyContin®, all relevant data is being reviewed.