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© Copyright 2018 American College of Physicians. All Rights Reserved. 190 North Independence Mall West, Philadelphia, PA 19106-1572
Toll Free: (800) 523.1546 · Local: (215) 351.2400
January 4, 2005
Michele M. Leonhart
Drug Enforcement Administration
2401 Jefferson Davis Highway
Alexandria, VA 22301
Re: Prescription Pain Medication "Frequently Asked Questions"
and the Interim Policy Statement, "Dispensing of Controlled
Substances for the Treatment of Pain"
Dear Ms. Leonhart:
The American College of Physicians would like to comment on the
Interim Policy Statement in the November 16, 2004 Federal Register,
"Dispensing of Controlled Substances for the Treatment of Pain."
Previous efforts by the Drug Enforcement Administration to address
the questions and fears of health professionals about prescribing
adequate pain medication have been very welcome and helpful. We
applaud those efforts. But the American College of Physicians is
concerned that the recent Interim Policy Statement is causing
confusion and will have negative effects on the care of patients.
The Interim Policy Statement only partially critiques the
Prescription Pain Medications FAQs from last summer, leaving open
questions about the validity of the content of the majority of the
document. And the abrupt withdrawal of the FAQs in October, without
complete and final determinations of policy, itself sends a message
that could have a chilling effect on appropriate pain care.
The College, along with other groups, has said that physicians
have an ethical obligation to provide adequate pain control (ACP
Ethics Manual, fifth edition 2004, in press, Annals of Internal
Medicine). We have provided guidance to physicians on pain
management Management of Pain and Spinal Cord Compression in
Patients with Advanced Cancer (Abrahm JL for the ACP-ASIM
End-of-Life Care Consensus Panel, Ann Intern Med. 1999;
131:37-46) as well as patient education materials for the public,
When You Have Pain at the End of Life.
Clinicians need clear guidance on what factors raise questions
in the prescribing of pain medications. Otherwise, there is a risk
that proper prescribing will be discouraged, and physicians will be
encouraged to turn away legitimate pain patients for fear of having
too many such patients in a practice.
We would like to address the reservations about the FAQs
expressed by the DEA in the November Interim Policy Statement. Some
appear to be a matter of emphasis and context. For example, the
statement from the FAQ that: "The number of patients in a practice
who receive opioids, the number of tablets prescribed for each
patient, and the duration of therapy with these drugs do not, by
themselves, indicate a problem, and they should not be used as the
sole basis for an investigation by regulators or law enforcement."
In the context of the rest of that FAQ, we took that statement to
mean that each of those criteria individually and in the absence of
other factors will not trigger an investigation of the prescribing
physician. That would also be consistent with the previous
endorsement by the DEA of the Model Guidelines of the Federation of
State Medical Boards, which has stressed the context of factors
present in prescribing. If that is not correct, it needs prompt
clarification. Likewise, the language about family members
expressing concern about opioid use could be easily modified to
clarify the role of family members who are aware of drug abuse. As
stated, the FAQ language appeared to be dealing with the concern
that some family members may oppose legitimate pain treatment
because of a lack of knowledge about addiction and other issues, a
concern the College has raised as well.
Other issues raised in the IPS, such as those about refills,
seem to require a final determination of policy by the DEA. It
appears that the language in the FAQ reflected correspondence from
the Office of Diversion Control in January 2004 that multiple
prescriptions issued at one time, with the actual date of issue and
other documentation, would not be considered refills and were
deemed permissible if in accord with state law. The College
strongly supports this previous determination, and clinicians
nationwide have been relying on it. We believe this is critical for
the optimal care of pain patients, especially for patients in rural
communities and for those whose conditions make repeated trips to
the doctor (merely to get a prescription) extremely difficult.
We commend the DEA for its continuing efforts in this area, and
its engagement of the medical community. It is extremely important
that the medical community and the DEA continue this dialogue, and
that final and clear guidance for clinicians and others be made
available as soon as possible. The FAQ document was a very useful
tool for providing much needed guidance to clinicians, law
enforcement personnel, and others. We would urge the rapid
production of a clarified document.
ACP shares your goal of balancing appropriate pain management
with the administration and enforcement of the laws and regulations
governing controlled substances. Thank you for allowing us to raise
these issues. We would be happy to assist with further work in the
area. Please feel free to contact me or Lois Snyder, JD at the ACP
Center for Ethics and Professionalism, 215-351-2835, firstname.lastname@example.org.
Charles K. Francis, MD, FACP, FACC
President, American College of Physicians