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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.
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.
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.
- Large numbers of prescriptions were issued.
- No physical examination was given.
- The physician warned the patient to fill prescriptions at different drug
stores.
- The physician issued prescriptions to a patient known to be delivering the
drugs to others.
- The physician prescribed controlled drugs at intervals inconsistent with
legitimate medical treatment.
- The physician involved used street slang rather than medical terminology
for the drugs prescribed.
- There was no logical relationship between the drugs prescribed and
treatment of the condition allegedly existing.
- 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
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
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