[Federal Register: November 16, 2004 (Volume 69, Number 220)]
[Notices]
[Page 67170-67172]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no04-82]
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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.
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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.
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\1\ The report is available on the SAMHSA Web site at http://oas.samhsa.gov/NHSDA/2k3NSDUH/2k3results.htm
.
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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]
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