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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)
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.[The report is available on the SAMHSA Web
site at http://oas.samhsa.gov/NHSDA/2k3NSDUH/2k3results.htm] 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.
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
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:
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
(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 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
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.
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