Removal of FAQs about prescriptions on DEA Web site causes turmoil

The agency's "clarification" appears to criminalize a practice now taught in pain medicine programs.

By Andis Robeznieks — Posted Dec. 20, 2004

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What was once considered a feel-good document co-authored by U.S. Drug Enforcement Administration staff and pain medicine experts is now causing ill will, confusion and concern that relations between the agency and the medical community have taken a turn for the worse.

The DEA wrote in the Nov. 16 Federal Register that a "frequently asked questions" document it co-authored with the University of Wisconsin Pain & Policy Studies Group and the Last Acts Partnership contained "misstatements." These included remarks on what could trigger an investigation and the appropriateness of writing multiple prescriptions on the same date. These items in particular have caused concern in the pain medicine community because they appear to reverse policies endorsed in the original document, which was taken off the DEA Web site in October.

The DEA's Nov. 16 interim policy statement said documents must be published in the Federal Register to obtain status as an official policy or statement, and the FAQ document never was. It also stated that a more complete statement responding to agency concerns about the FAQ would be published in the future.

The published announcement included a promise to take "into consideration the views of the medical community." But in the meantime, those involved in the creation of the FAQ say they have had no contact with DEA officials. In contrast, Pain & Policy Studies Group Director David Joranson said there was frequent consultation over the 20 different drafts of the original FAQ document.

Russell K. Portenoy, MD, who served as the leading expert on pain medicine for the panel that wrote the FAQ document, said the interim policy statement appears to criminalize practices such as allowing doctors to write smaller, multiple prescriptions with different dates for dispensing.

Dr. Portenoy, chair of the Dept. of Pain Medicine and Palliative Care at New York City's Beth Israel Medical Center and a faculty member for the AMA online pain management program, said this allowed better medication management and helped prevent gaps in treatment that could lead to pain or withdrawal -- especially for patients who rely on mail-order pharmacies. In addition, he said, it's a practice that is now regularly taught in physician pain programs.

Dr. Portenoy said he also was concerned about statements in the Federal Register notice about what physician behavior could trigger law enforcement scrutiny.

The DEA did not respond to questions, which it required be sent via e-mail, but its Federal Register posting noted that it can start an investigation if it suspects laws are being broken or if it wants assurances that they aren't.

The AMA had no comment on the DEA action, but its policy supports the position that "physicians who appropriately prescribe and/or administer controlled substances to relieve intractable pain should not be subject to the burdens of excessive regulatory scrutiny, inappropriate disciplinary action or criminal prosecution."

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External links

U.S. Drug Enforcement Administration/Dept. of Justice's interim policy statement on the dispensing of controlled substances for the treatment of pain, Federal Register, Nov. 16 (link)

AMA position on pain management using opioid analgesics (link)

AMA online CME series on pain management (link)

University of Wisconsin Pain & Policy Studies Group's Nov. 24 response to the Drug Enforcement Administration's Nov. 16 interim policy statement, in pdf (link)

Drug Enforcement Administration's announcement regarding removal of the prescription pain medication FAQ from its Web site (link)

Letter from Patricia M. Good, chief of the Liaison and Policy Section of the Drug Enforcement Administration, explaining DEA policy on writing multiple prescriptions, Jan. 31, 2003, in pdf (link)

Speech by Chief of the Liaison and Policy Section of the Drug Enforcement Administration's Office of Diversion Control Patricia M. Good before the Federation of State Medical Boards Symposium on Pain Management and State Regulatory Policy, March 17, 1998 (link)

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