October 2002
Volume 66 |
Number 10
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ASA Statement to FDA Committee
Opioid Use and Diversion: Report on Recent Hearings
by FDA and DEA
Peter R. Wilson,
M.B., Ph.D.
Committee on Pain Medicine
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Regulatory scrutiny of illegal and inappropriate prescribing
and diversion of opioids has increased over the last two
years, particularly with respect to sustained release oxycodone.
This caused concern among various patient advocacy groups,
including Last Acts, Wisconsin Cancer Pain Initiative and
pain medicine practitioners. An initial meeting was convened
at the American Academy of Pain Medicine in July 2001 and
included representatives from ASA, the American Society
of Regional Anesthesia and Pain Medicine, the American Pain
Society and other groups. The Drug Enforcement Administration
(DEA) was represented as was the Federation of State Medical
Boards. A meeting of the Food and Drug Administration (FDA)
was scheduled to address the issues of sustained-release
opioids on September 12, 2001, and eventually was held on
January 30 and 31, 2002.
The FDA committee discussed the medical use of opiate analgesics
in various patient populations, including pediatric patients
and patients with chronic pain of nonmalignant etiology
as well as the risk-to-benefit ratio of extending opiate
treatment into these populations. It also addressed concerns
regarding the abuse potential, diversion and increasing
addiction to opiate analgesics, especially to modified-release
opiate analgesics.
The following is a summary of the evidence presented
on behalf of ASA:
Anesthesiology is a specialty devoted primarily to the
relief of pain, whether it occurs during surgery or in other
settings: cancer, acute pain states and chronic pain. We
serve all patients regardless of age or gender.
There is no question that opioids are essential for the
control of pain during surgery and other acute pain states
and for the control of pain in cancer, AIDS and other terminal
diseases. I believe that the preponderance of published
evidence supports the following statements:
1. Opioids are the most effective analgesics available
for acute medical and surgical pain and cancer pain. In
the presence of ongoing pain, long-acting opioids are a
more rational choice than short-acting opioids, as their
kinetics provide a more stable blood level and decrease
the likelihood of potentially dangerous side effects.
2. Long-acting opioid preparations have a lesser incidence
and a slower onset of tolerance and dependence than equipotent
doses of short-acting opioids.
3. Certain forms of chronic pain can be relieved effectively
by opioids with consequent increases in both function and
quality of life.
4. Methadone is the only opioid with an intrinsically long
oral half-life (12-36 hours), but its pharmacokinetics are
extremely variable and impossible to predict. Therefore,
it can be difficult to use in pain medicine, especially
in the aged or infirm patient.
5. Other opioids must be formulated as "sustained
release" preparations to provide optimal pharmacokinetics
via the oral route with reasonable predictability of benefit
and side effects.
6. Chronic pain patients are no more likely than the general
community to attempt suicide or overdose with opioids.
7. Pain management has been significantly improved in the
United States by the greater availability of opioids and
facilitated by education, legislation and regulation regarding
treatment of intractable pain.
8. Prescribers now face legal precedents of litigation
and regulatory intervention either for perceived underprescribing
or overprescribing of opioids.
9. Misuse, aberrant behavior and diversion of appropriately
prescribed opioids by chronic pain patients are rare.
10. Chronic opioids should be a late option in chronic
pain management and always used as part of a comprehensive
pain rehabilitation program, never as monotherapy.
11. Regular monitoring of these patients is necessary to
ensure compliance and discourage aberrant behavior, including
diversion.
12. The use of patient contracts and/or random blood or
urine screening for substances has not been shown to improve
compliance or reduce diversion.
13. Inappropriate patient selection and inappropriate prescribing
reflect primarily a lack of training and experience of the
prescribers, not attempts to divert medications.
Some conclusions can be drawn from this information:
1. It is imperative that prescribers be properly educated
with respect to the medications they supply, including opioids.
2. Aberrant patient behaviors with respect to opioids,
including "doctor shopping" and alteration of
prescriptions, might only be detected by monitoring of prescriptions
filled by the patient. The DEA or state medical and pharmacy
boards would be the appropriate monitoring agencies to help
practitioners be aware of this kind of behavior by patients.
3. The DEA and state medical boards should monitor aberrant
prescriber behavior, including unethical, inappropriate
and illegal behaviors with respect to opioid prescriptions.
4. "Pill mills" and Internet and absentee providers
can be addressed with existing legislation and regulation
available to the DEA and state medical boards.
5. Statistics surrounding this issue are difficult to interpret;
for example; the DEA Web site indicates that the supply
of OxyContin has increased 1,800 percent since 1996, but
the crime related to this has increased by only 75 percent
in the same time.
6. Aberrant prescriber behavior leads to diversion and
is a function of the prescriber not the medication. The
DEA and state medical boards, not the FDA, should address
this.
7. We do not believe that any nonphysician representative
of a federal agency should be put in the position of being
required to make clinical judgments about when an opioid
is indicated in a particular patient or about which opioid
or what dose is appropriate for a given patient's diagnosis.
Those are medical decisions, and the scrutiny of medical
records by regulatory agents should be focused on appropriate
documentation, not appropriate medical judgment. Questions
of that nature should be left to state medical boards.
8. Restriction of the legitimate supply of an opioid will
lead to rationing, which will affect the provision of pain
relief to all pain patients – acute, chronic and terminal.
Rationing will disproportionately affect the very young,
the very old, the uninsured and the indigent.
9. The DEA and Federation of State Medical Boards are to
be commended for their commitment to obtaining expert input
into this difficult and controversial area. ASA will continue
to work with these agencies and the FDA to ensure the continued
availability of all relevant opioids for legitimate and
appropriate use in acute, chronic and terminal pain in all
patient populations.
The outcome of the deliberations of the FDA committee were
that the FDA should not be involved in the surveillance
and disciplinary functions that are in the jurisdiction
of the DEA and the state medical boards. However, the DEA
continues to maintain its political activism with respect
to the sustained-release opioids as browsing the Web site
will show.
The DEA summarized medical examiner reports on oxycodone-related
deaths and concluded that it could verify 146 deaths in
which OxyContin was the direct "cause of" death
or a contributing factor. An additional 318 deaths lacking
acetaminophen and/or salicylates in the toxicological findings
most likely involved OxyContin as well <
www.deadiversion.usdoj.gov/drugs_concern/oxycodone/ oxycontin7.htm
>. The manufacturer had expert re-evaluation of the raw
data with an estimate of less than one-tenth of the DEA
numbers and is challenging these findings.
Deputy Director of the Office of Diversion Control of DEA,
Terrance Woodworth, gave valuable congressional testimony
on pain management with OxyContin. He allowed that the DEA
would support the legitimate, appropriate medical use of
this and other opioids < www.dea.gov/
pubs/cngrtest/ct082801.htm >.
In an otherwise balanced and insightful evaluation of narcoterrorism
by DEA administrator Asa Hutchinson < www.dea.gov/pubs/cngrtest/ct042402.html
>, there appeared a photograph of OxyContin tablets at the
conclusion. There is no apparent reference to OxyContin
in the text, but the implication is obvious.
Long-acting opioids are essential in the management of
otherwise intractable pain, and we must ensure their continued
availability for legitimate medical purposes. We must also
have no tolerance for individuals who do not follow guidelines
for their appropriate use. The saga continues.
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Peter
R. Wilson, M.B., Ph.D., is Professor of Anesthesiology
and Pain Medicine, Mayo Foundation, Rochester, Minnesota. |
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