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November 2001
Volume 65 |
Number 11
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| What’s the
Fuss Over OxyContin and Other Long-Acting Opioids? |
Lynn Broadman, M.D.
James P. Rathmell, M.D., Chair
Committee on Pain Medicine
What is all the fuss over OxyContin®? The fact is, in recent
times, a great deal of criminal activity has been associated with
OxyContin (controlled-release oxycodone), the likes of which has
not been seen since the release of Quaalude® (methaqualone)
three decades ago. Forty pharmacies in Massachusetts alone have
been held up, mostly at gunpoint and mostly in the Boston area,
just to obtain OxyContin. The problem is so acute that a task
force has been convened in Massachusetts to study the problem.
One of the preliminary suggestions of this task force is that
OxyContin should only be dispensed from hospital pharmacies where
a security force is present to provide protection for pharmacy
personnel and customers.
OxyContin was introduced in 1995. The Food and Drug Administration’s
approved indication for OxyContin is for treatment of patients
with moderate to severe pain who are expected to need continuous
opioids for an extended time. In 1996, only 300,000 prescriptions
were filled for this drug. That number soared to nearly 6 million
in 2000. OxyContin is now the most widely prescribed opioid for
the control of moderate to severe pain. This has led to an increased
opportunity for misuse and diversion of the drug, which in turn
has resulted in an epidemic of oxycodone overdoses in the Appalachian
regions of Maine, Pennsylvania, Virginia and West Virginia, where
heroin and other illicit drugs are difficult to obtain. The death
rate due to oxycodone overdose has more than doubled in the United
States in the past year, from about 100 per year to more than
200. We should, however, view this statistic in context —
during the same time period, nearly 16,000 people died from complications
related to use of nonsteroidal anti-inflammatory drugs.
| “Preventing drug abuse is an
important societal goal, but… it should not hinder patients’
ability to receive the care they need and deserve.” |
Treatment with OxyContin has become so popular because it provides
effective pain relief and does not have the stigma associated
with morphine. It fills a niche not filled by any other opioid
analgesic. We believe that MS-Contin® never gained popularity
outside of pain and oncology clinics because of the stigma associated
with morphine. Most physicians knew that morphine was a potent
opioid analgesic and that it was potentially addicting. On the
other hand, many physicians were familiar with the short-term
use of oxycodone. While they knew that, like morphine, oxycodone
was a Schedule II agent in the Controlled Substances Act, their
experience led them to believe that it was seldom addicting and
not troublesome. Physicians outside the pain and oncology clinic
environment immediately felt comfortable in prescribing OxyContin.
Many still feel comfortable in prescribing OxyContin and other
potent long-acting opioid analgesics, but concerns are rising,
so much so that physician groups are now meeting with government
agencies to formulate a plan to combat the problem.
On July 11, 2001, members of ASA, the American Academy of Pain
Medicine, the American Pain Society, the American Society of Regional
Anesthesia and Pain Medicine and other concerned medical personnel
met with representatives of the Drug Enforcement Administration
(DEA) to discuss the problem and draft a consensus statement.
A joint statement was drafted [see box].
Two further meetings between government agencies and the medical
community were scheduled. The first was set for September 13-14,
2001, in Rockville, Maryland. Here, the Food and Drug Administration’s
Anesthetic and Life Support Drugs Advisory Committee intended
to discuss use of OxyContin and other opioids. The DEA called
a meeting of the Practitioners Working Committee for September
25, 2001, in Arlington, Virginia to discuss “…a dramatic
increase in the illicit availability and abuse of several prescription
drugs.” Both meetings were canceled in the aftermath of the
terrorist attacks on September 11 but are being rescheduled.
Members of the ASA Committee on Pain Medicine will attend each
of these proceedings. Our efforts will be to maintain access to
all opioids for our patients who need them while assisting federal
agencies in developing effective strategies for combating abuse
and diversion.
Due to the rise in OxyContin abuse in the United States, the
DEA and the health organizations mentioned in this article held
a press conference on October 23, 2001, in Washington, D.C. The
organizations involved in this unprecedented meeting discussed
the problems associated with recent diversion and abuse of opioid
pain relievers. For more information on the conference, visit
<www.lastacts.com>.
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Joint Statement on Prescription
Pain Medications
As representatives of the health care community and
law enforcement, we are working together to prevent
abuse of prescription pain medications while ensuring
that they remain available for patients in need.
Both health care professionals and law enforcement
and regulatory personnel share a common responsibility
for ensuring that prescription pain medications are
available to the patients who need them and for preventing
these drugs from becoming a source of harm and abuse.
We all must ensure that accurate information about
both the legitimate use and abuse of prescription
pain medications is made available. The roles of both
the medical professionals and law enforcement personnel
in maintaining this essential balance between patient
care and diversion prevention are critical.
Preventing drug abuse is an important societal goal,
but there is consensus, by law enforcement agencies,
health care providers and patient advocates alike,
that it should not hinder patients’ ability to
receive the care they need and deserve.
This consensus statement is necessary based on the
following facts:
Under-treatment of pain is a serious problem in the
United States, including pain among patients with
chronic conditions and those who are critically ill
or near death. Effective pain management is an integral
and important aspect of quality medical care, and
pain should be treated aggressively.
For many patients, opioid analgesics — when
used as recommended by established pain management
guidelines — are the most effective way to treat
severe pain and often the only treatment option that
provides significant relief.
Because opioids are one of several types of controlled
substances that have potential for abuse, they are
carefully regulated by the Drug Enforcement Administration
and other state agencies. For example, a physician
must be licensed by state medical authorities and
registered with the DEA before prescribing a controlled
substance.
In spite of regulatory controls, drug abusers obtain
these and other prescription medications by diverting
them from legitimate channels in several ways, including
fraud, theft, forged prescriptions and via unscrupulous
health professionals.
Drug abuse is a serious problem. Those who legally
manufacture, distribute, prescribe and dispense controlled
substances must be mindful of and have respect for
their inherent abuse potential. Focusing only on the
abuse potential of a drug, however, could erroneously
lead to the conclusion that these should be avoided
when medically indicated — generating a sense
of fear rather than respect for their legitimate properties.
Helping doctors, pharmacists, health care providers,
law enforcement and the general public become more
aware of both the use and abuse of pain medications
will enable all of us to make proper and wise decisions
regarding the treatment of pain. (More information
about the consensus statement and actions surrounding
it can be found at <www.lastacts.org>.)
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Lynn M. Broadman,
M.D., is Professor of Anesthesiology and Pediatrics, West
Virginia University School of Medicine, Morgantown, West Virginia. |
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James P. Rathmell,
M.D., is Associate Professor, Department of Anesthesiology,
University of Vermont College of Medicine, Burlington, Vermont. |
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