[Federal Register Volume 69, Number 220 (Tuesday, November 16, 2004)]
[Notices]
[Pages 67170-67172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25469]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-258S]


Dispensing of Controlled Substances for the Treatment of Pain

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Interim policy statement.

-----------------------------------------------------------------------

SUMMARY: In August 2004, DEA published on its Office of Diversion 
Control Web site a document entitled: ``Prescription Pain Medications: 
Frequently Asked Questions and Answers for Health Care Professionals 
and Law Enforcement Personnel'' (August 2004 FAQ). The August 2004 FAQ 
was not published in the Federal Register and was not an official 
statement of the agency. DEA subsequently withdrew the document because 
it contained misstatements. This interim policy statement explains how 
some of the statements in the August 2004 FAQ were erroneous. In 
addition, this interim statement explains how DEA plans to address in a 
future Federal Register document the issue of dispensing controlled 
substances for the treatment of pain.

FOR FURTHER INFORMATION CONTACT: William J. Walker, Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537; Telephone: (202) 307-7165.

SUPPLEMENTARY INFORMATION: In August 2004, DEA published on its Office 
of Diversion Control Web site a document entitled: ``Prescription Pain 
Medications: Frequently Asked Questions and Answers for Health Care 
Professionals and Law Enforcement Personnel'' (August 2004 FAQ). For 
the reasons provided below, the August 2004 FAQ was not an official 
statement of the agency and DEA subsequently withdrew the document 
because it contained misstatements. Nonetheless, the subject matter--
dispensing controlled substances for the treatment of pain--is 
extremely important to the public health and welfare. As the agency 
primarily responsible for enforcement and administration of the federal 
laws and regulations governing controlled substances, DEA believes that 
further discussion of the subject is warranted for two fundamental 
reasons. First, the abuse of pharmaceutical narcotics and other 
prescription controlled substances is increasing in the United States. 
According to the latest National Survey on Drug Use and Health, which 
is published by the Department of Health and Human Services, Substance 
Abuse and Mental Health Services Administration (SAMHSA), the number of 
Americans aged 12 or older who have engaged in illicit (nonmedical) use 
of pain relievers during their lifetime has risen to more than 31 
million.\1\ A portion of this type of drug abuse is directly 
facilitated by a small number of physicians who dispense controlled 
substances for other than legitimate medical purposes and then 
fraudulently claim that the drugs were dispensed for the treatment of 
pain.
---------------------------------------------------------------------------

    \1\ The report is available on the SAMHSA Web site at http://oas.samhsa.gov/NHSDA/2k3NSDUH/2k3results.htm.
---------------------------------------------------------------------------

    Second, chronic pain is a serious problem for many Americans. It is 
crucial that physicians who are engaged in legitimate pain treatment 
not be discouraged from providing proper medication to patients as 
medically justified. DEA recognizes that the overwhelming majority of 
physicians dispense controlled substances lawfully for legitimate 
medical reasons, including the treatment of pain. Accordingly, DEA 
plans to address the subject of dispensing controlled substances for 
the treatment of pain in a future Federal Register document, taking 
into consideration the views of the medical community. The document 
will be aimed at providing guidance and reassurance to physicians who 
engage in

[[Page 67171]]

legitimate pain treatment while deterring the unlawful conduct of a 
small number of physicians and other DEA registrants who exploit the 
term ``pain treatment'' as a pretext to engage in prescription drug 
trafficking. In the meantime, the agency wishes to correct here a few 
of the significant misstatements contained in the August 2004 FAQ.

Misstatements in the August 2004 FAQ

    Although not an exhaustive discussion, the following is an 
explanation of some of the misstatements that were contained in the 
August 2004 FAQ.
    Commencement of investigations--The August 2004 FAQ erroneously 
stated: ``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 fact, each of the foregoing 
factors--though not necessarily determinative--may indeed be indicative 
of diversion. As one federal appeals court has correctly stated, one 
can glean from the reported cases in which physicians have been 
convicted of dispensing controlled substances for other than a 
legitimate medical purpose ``certain recurring concomitance of 
condemned behavior,'' such as the following:

    (1) An inordinately large quantity of controlled substances was 
prescribed.
    (2) Large numbers of prescriptions were issued.
    (3) No physical examination was given.
    (4) The physician warned the patient to fill prescriptions at 
different drug stores.
    (5) The physician issued prescriptions to a patient known to be 
delivering the drugs to others.
    (6) The physician prescribed controlled drugs at intervals 
inconsistent with legitimate medical treatment.
    (7) The physician involved used street slang rather than medical 
terminology for the drugs prescribed.
    (8) There was no logical relationship between the drugs 
prescribed and treatment of the condition allegedly existing.
    (9) The physician wrote more than one prescription on occasions 
in order to spread them out.

    United States v. Rosen, 582 F.2d 1032, 1035-1036 (5th Cir. 1978) 
(citations omitted).
    Moreover, it is a longstanding legal principle that the Government 
``can investigate merely on suspicion that the law is being violated, 
or even just because it wants assurances that it is not.'' United 
States v. Morton Salt Co., 338 U.S. 632, 642-643 (1950). It would be 
incorrect to suggest that DEA must meet some arbitrary standard or 
threshold evidentiary requirement to commence an investigation of a 
possible violation of the Controlled Substances Act (CSA).
    Refills of schedule II prescriptions--The August 2004 FAQ stated: 
``Schedule II prescriptions may not be refilled; however, a physician 
may prepare multiple prescriptions on the same day with instructions to 
fill on different dates.'' (Italics added.) The first part of this 
sentence is correct, as the CSA expressly states: ``No prescription for 
a controlled substance in schedule II may be refilled.'' 21 U.S.C. 
829(a). However, the second part of the sentence (italicized above) is 
incorrect. For a physician to prepare multiple prescriptions on the 
same day with instructions to fill on different dates is tantamount to 
writing a prescription authorizing refills of a schedule II controlled 
substance. To do so conflicts with one of the fundamental purposes of 
section 829(a). Indeed, as the factors quoted above from the Rosen case 
indicate, writing multiple prescriptions on the same day with 
instructions to fill on different dates is a recurring tactic among 
physicians who seek to avoid detection when dispensing controlled 
substances for unlawful (nonmedical) purposes. It is worth noting here 
that the DEA regulations setting forth the requirements for the 
issuance of a controlled substance prescription are set forth in 21 CFR 
1306.01-1306.27.
    Reselling of controlled substances--The August 2004 FAQ listed a 
number of behaviors, or ``red flags,'' that are ``probable indicators 
of abuse, addiction, or diversion.'' These behaviors include ``selling 
medications.'' The document suggested that certain steps be taken to 
deal with such indicators, including ``appropriate management'' and 
possible referral to an addiction specialist. The document went on to 
state that these behaviors (including reselling medications) ``should 
not be taken to mean that a patient does not have pain, or that opioid 
therapy is contraindicated.'' The document also stated: ``Management 
may or may not include continuation of therapy, depending on the 
circumstances.'' Finally, the document stated that ``if continued 
opioid therapy makes medical sense, then the therapy may be continued, 
even if drug abuse has occurred. Additional monitoring and oversight of 
patients who have experienced such an episode is recommended.'' 
(Italics added.)
    The behaviors listed in the August 2004 FAQ as ``red flags'' are 
indeed indicators of possible diversion. However, the August 2004 FAQ 
understated the degree of caution that a physician must exercise to 
minimize the likelihood of diversion when dispensing controlled 
substances to known or suspected addicts. If a physician is aware that 
a patient is a drug addict and/or has resold prescription narcotics, it 
is not merely ``recommended'' that the physician engage in additional 
monitoring of the patient's use of narcotics. Rather, as a DEA 
registrant, the physician has a responsibility to exercise a much 
greater degree of oversight to prevent diversion in the case of a known 
or suspected addict than in the case of a patient for whom there are no 
indicators of drug abuse. Under no circumstances may a physician 
dispense controlled substances with the knowledge that they will be 
used for a nonmedical purpose or that they will be resold by the 
patient.
    In a similar vein, the August 2004 FAQ incorrectly minimized the 
potential significance of a family member or friend expressing concern 
to the physician that the patient may be abusing the pain medication. 
The document stated:

Family and friends, or health care providers who are not directly 
involved in the therapy, may express concerns about the use of 
opioids. These concerns may result from a poor understanding of the 
role of this therapy in pain management or from an unfounded fear of 
addiction; they may be exacerbated by widespread, sometimes 
inaccurate media coverage about abuse of opioid pain medications.

    While it is true that concerns of family members are not always 
determinative of whether the patient is engaged in drug abuse, the 
above-quoted statement is incorrect to the extent it implies that 
physicians may simply disregard such concerns expressed to them by 
family members or friends. Indeed, a family member or friend might be 
aware of information that the physician does not possess regarding a 
patient's drug abuse. Given the addictive and sometimes deadly nature 
of prescription narcotic abuse, the tremendous volume of such drug 
abuse in the United States, and the propensity of many drug addicts to 
attempt to deceive physicians in order to obtain controlled substances 
for the purpose of abuse, a physician should seriously consider any 
sincerely expressed concerns about drug abuse conveyed by family 
members and friends.
    It bears emphasis that none of the principles summarized above is 
new. Rather, these are concepts that have been incorporated for more 
than 80

[[Page 67172]]

years into the federal laws and regulations governing drugs of abuse 
and are reflected in published federal court decisions and DEA final 
administrative orders. A more detailed recitation of these principles, 
as they relate to the dispensing of controlled substances for the 
treatment of pain, will be provided in a future Federal Register 
document to be published by the agency.

Nature of This Document and the August 2004 FAQ Under the 
Administrative Procedure Act

    This document is a statement of policy within the meaning of the 
Administrative Procedure Act (APA). It is termed an ``interim'' 
statement to indicate that a more complete statement on the subject 
will subsequently be issued by the agency. (Given the misstatements in 
the August 2004 FAQ, and the significant questions DEA has received 
following the withdrawal of that document, an immediate preliminary 
explanation is warranted.) The APA expressly requires agencies to make 
available to the public and publish in the Federal Register statements 
of general policy and interpretations formulated and adopted by the 
agency. 5 U.S.C. 552(a)(1)(D). Further, the APA contemplates that 
agencies shall issue policy statements without engaging in the notice-
and-comment proceedings that are required for legislative rules. 5 
U.S.C. 553(b)(A). This is because policy statements, unlike legislative 
rules, are not binding. Consistent with these APA principles, this 
document does not create any new substantive requirements or change the 
rights and duties of any member of the public; nor is DEA applying the 
CSA or DEA regulations in a new manner as a result of this document. 
Rather, this document provides the public with DEA's policy for 
ensuring that the law administered by the agency relating to the 
subject matter of this document is faithfully executed.
    It also bears emphasis that the August 2004 FAQ was not an official 
statement of the agency. As indicated above, the APA requires 
publication in the Federal Register of agency policy statements or 
interpretations of the law administered by the agency. The August 2004 
FAQ was not published by the agency in the Federal Register and did not 
constitute an authoritative or official statement of the agency.

    Dated: November 12, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-25469 Filed 11-12-04; 10:57 am]
BILLING CODE 4410-09-U