Is the DEA planning to
restrict the prescribing of OxyContin to pain treatment centers or
physicians specifically accredited as pain management specialist?
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.
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What is the
relationship between DEA and the Food and Drug Administration (FDA) in
regulating drugs like OxyContin?
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.
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What evidence does the
DEA have to support accounts that OxyContin is being abused to the
extent that has been reported by the media?
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.
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What steps are
currently being taken to address the widespread abuse of OxyContin ?
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 heathcare 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 Office of Diversion Control’s web site at
www.DEAdiversion.usdoj.gov. for the document "Working
to Prevent Diversion and Abuse of OxyContin".
What strengths of
OxyContin are most commonly abused or diverted?
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.
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Did DEA have any part
in Purdue’s decision to "temporarily suspend" distribution of
the 160 mg. strength tablet?
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.
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Is DEA going to reduce
manufacturing quotas for oxycodone, the active ingredient in OxyContin?
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.
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