Solicitation of Comments on the Dispensing of Controlled Substances for the Treatment of Pain

Karen P. Tandy, Administrator
Drug Enforcement Administration
2401 Jefferson Davis Highway
Alexandria, VA 22301

Re: Docket No. DEA-261N

Dear Ms. Tandy:
I am writing on behalf of the 94,000 members of the American Academy of Family Physicians (AAFP) in response to the Drug Enforcement Administration’s (DEA), “Solicitation of Comments on the Dispensing of Controlled Substances for the Treatment of Pain” published in the Federal Register on January 18, 2005. This solicitation of comments regarding pain management comes after the DEA’s release of a document entitled, “Prescription Pain Medications: Frequently Asked Questions (FAQs) and Answers for Health Care Professionals and Law Enforcement Personnel” in August 2004 and subsequent withdrawal of the document due to misstatements. The DEA outlined these misstatements in a November 16, 2004 Federal Register notice.

The Academy has previously written in support of the pain management policy outlined in the Pain Management FAQ. The AAFP supported the FAQ’s stated intent of providing medically and legally sound education to health care providers, law enforcement officials and regulators. The document offered a useful set of medical definitions for opioid dependence, tolerance and addiction for all three communities. It is vital for the DEA to have a clear understanding of medical principles and standards of care so that agents can better identify illegitimate activity that lacks a medical purpose. Therefore, the AAFP hopes that the DEA will continue to seek a common understanding with legitimate physicians of what constitutes good medical practice in pain management. From the perspective of family physicians, the FAQ represented a step towards clarity for both the medical and legal communities.

When they prescribe pain medications, physicians need clear guidance on what prescribing practices raise questions for law enforcement purposes. Otherwise, there is a risk that proper prescribing will be discouraged, and physicians will undertreat legitimate pain patients. The November 16, 2004 Federal Register listed several types of behavior as being commonly used by physicians who were illegally diverting controlled substances. In particular, the DEA describes instances where, “physician[s] wrote more than one prescription on occasions in order to spread them out.” While it is obvious this practice could be used as a tool of diversion, the same practice is widely used in physician offices for the management of non-controlled prescription drugs. This inclusion in the November 16 interim policy statement shows a lack of experience with standard physician practices, and should not by itself be interpreted solely as a sign of diversion.

For example, writing more than one prescription during a single visit could be in the best interest of an established patient with a care plan that is agreed to by both the patient and physician. This is especially applicable for established patients struggling with transportation or other access issues in rural or underserved settings. The Academy recommends the DEA consider supporting a Congressional amendment of the Controlled Substances Act so that multiple prescriptions can be written for established patients when they have a care plan that includes a medication contract as described in the article referenced:
A Tool for Safely Treating Chronic Pain, November/December 2001, p. 47.
http://www.aafp.org/fpm/20011100/47atoo.html and
http://www.aafp.org/fpm/20011100/medicationuseagreement.pdf
(The second link is to the medication contract discussed in the article.)

We appreciated the willingness on the part of the DEA to understand legitimate medical practice and its discussions with the medical community. It is extremely important that the medical community and the DEA continue this dialogue, and that final and clear guidance for physicians and other prescribers 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 creation of a clarified document and urge the DEA to include all interested medical specialty societies in the drafting of any such document.

The AAFP looks forward to working with the DEA on issues of common interest such as the elimination of drug diversion.


Sincerely,



Michael O. Fleming, M.D., FAAFP
Board Chair