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