[Federal Register Volume 71, Number 172 (Wednesday, September 6, 2006)]
[Notices]
[Pages 52716-52723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14517]
[[Page 52715]]
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Part V
Department of Justice
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Drug Enforcement Administration
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21 CFR Part 1306
Dispensing Controlled Substances for the Treatment of Pain; Notice
Issuance of Multiple Prescriptions for Schedule II Controlled
Substances; Proposed Rule
Federal Register / Vol. 71, No. 172 / Wednesday, September 6, 2006 /
Notices
[[Page 52716]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-286P]
Dispensing Controlled Substances for the Treatment of Pain
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Policy Statement.
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SUMMARY: On January 18, 2005, DEA published in the Federal Register a
solicitation of comments on the subject of dispensing controlled
substances for the treatment of pain. Many of the comments that DEA
received asked the agency to elaborate on the legal requirements and
agency policy relating to this subject. This document provides such
information.
DATES: September 6, 2006.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537; Telephone: (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Background
On January 18, 2005, the DEA published in the Federal Register a
Solicitation of Comments on the subject of dispensing controlled
substances for the treatment of pain. 70 FR 2883. Many of the comments
sought further information about the legal requirements and agency
policy relating to the prescribing of controlled substances for the
treatment of pain. DEA stated in the Solicitation of Comments that it
would be issuing a document providing such information after reviewing
the comments. Accordingly, this policy statement provides practitioners
with a recitation of the pertinent principles under the Controlled
Substances Act (CSA) and DEA regulations relating to the dispensing of
controlled substances for the treatment of pain.
Extent of Abuse in the United States of Controlled Prescription Drugs
The abuse (nonmedical use) of prescription drugs is a serious and
growing health problem in this country.\1\ As the Administration has
announced, recent data indicate that prescription drug abuse,
particularly of opioid pain killers, has increased at an alarming rate
over the past decade.\2\ Statistics published in the National Survey on
Drug Use and Health (NSDUH) by the Department of Health and Human
Services, Substance Abuse and Mental Health Services Administration
(SAMHSA), demonstrate that prescription drugs account for the second-
most commonly abused category of drugs, behind marijuana and ahead of
cocaine, heroin, methamphetamine, and other drugs.\3\
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\1\ National Institute on Drug Abuse Research Report:
Prescription Drug Abuse and Addiction (revised August 2005).
(available at http://www.drugabuse.gov/PDF/RRPrescription.pdf).
\2\ Office of National Drug Control Policy (ONDCP) press
release, March 1, 2004.
\3\ 2006 Synthetic Drug Control Strategy (available at http://www.whitehousedrugpolicy.gov/publications/synthetic_drg_control_strat/synth_strat.pdf).
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One of the areas of concern is the number of persons who have
recently begun abusing prescription controlled substances. In its NSDUH
Report published in June 2006,\4\ SAMHSA states: ``In 2004, among
persons aged 12 or older, 2.4 million initiated nonmedical use of
prescription pain relievers within the past year. This is more than the
estimated number of initiates for marijuana (2.1 million) or cocaine
(1.0 million).'' Overall, according to the NSDUH report: ``An estimated
31.8 million Americans have used pain relievers nonmedically in their
lifetimes, up from 29.6 million in 2002.''
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\4\ The NSDUH report is available at http://www.oas.samhsa.gov/2k6/pain/pain.pdf. The report extracted data from the 2004 National
Survey on Drug Use and Health.
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Another source of data presented by SAMHSA is that collected by the
Drug Abuse Warning Network (DAWN), which provides national estimates of
drug related visits to hospital emergency departments. According to
DAWN, for 2004:
Nearly 1.3 million emergency department (ED) visits in
2004 were associated with drug misuse/abuse. Nonmedical use of
pharmaceuticals was involved in nearly half a million of these ED
visits.
Opiates/opioid analgesics (pain killers), such as
hydrocodone, oxycodone, and methadone, and benzodiazepines, such as
alprazolam and clonazepam, were present in more than 100,000 ED
visits associated with nonmedical use of pharmaceuticals in 2004.\5\
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\5\ http://dawninfo.samhsa.gov/files/TNDR07EDvisitsNonmedicalUseForWeb.pdf.
A measure of the problem among young people is the 2005 Monitoring
the Future (MTF) survey conducted by the University of Michigan.\6\ The
MTF survey is funded by the National Institute on Drug Abuse (NIDA), a
component of the National Institutes of Health (NIH), and measures drug
abuse among 8th, 10th, and 12th graders. NIDA stated: ``While the 2005
survey showed a continuing general decline in drug use, there are
continued high rates of non-medical use of prescription medications,
especially opioid pain killers. For example, in 2005, 9.5 percent of
12th graders reported using Vicodin in the past year, and 5.5 percent
of these students reported using OxyContin in the past year.'' \7\ In
announcing the latest MTF survey results, NIH Director Dr. Elias
Zerhouni said that ``the upward trend in prescription drug abuse is
disturbing.'' \8\
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\6\ http://monitoringthefuture.org.
\7\ NIDA news release, December 19, 2005 (available at http://www.nida.nih.gov).
\8\ Id.
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Purposes and Structure of This Document
One of the chief purposes of this document is to make clear that
the longstanding requirement under the law that physicians may
prescribe controlled substances only for legitimate medical purposes in
the usual course of professional practice should in no way interfere
with the legitimate practice of medicine or cause any physician to be
reluctant to provide legitimate pain treatment. DEA also wishes to
dispel the mistaken notion among a small number of medical
professionals that the agency has embarked on a campaign to ``target''
physicians who prescribe controlled substances for the treatment of
pain (or that physicians must curb their legitimate prescribing of pain
medications to avoid legal liability).
To achieve these aims, this document begins with a general summary
of the relevant legal principles and an explanation of the role of DEA
with respect to regulation of controlled substances. The document then
addresses specific issues and questions that have been raised on a
recurring basis by physicians who seek guidance on the subject of
dispensing controlled substances for the treatment of pain.
It should be understood that the legal standard under the
Controlled Substances Act (CSA) for prescribing controlled substances
to treat pain is the same as that for prescribing controlled substances
generally: The prescription must be issued for a legitimate medical
purpose by a registered physician acting within the usual course of
professional practice. The reason this document focuses on the
prescribing of controlled substances for the treatment of pain is that
there has been considerable interest among members of the public in
having DEA address this specific issue.
[[Page 52717]]
The Statutory Role of DEA in Regulating the Prescribing of Controlled
Substances
DEA is the agency within the Department of Justice responsible for
carrying out the functions assigned to the Attorney General under the
CSA.\9\ These functions include enforcing and administering the CSA
provisions governing the prescribing, administering, and dispensing of
controlled substances. Thus, the scope of DEA's authority is delineated
by the extent to which Congress itself regulated controlled substances
through the enactment of the CSA and assigned certain functions under
the Act to the Attorney General.
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\9\ 21 U.S.C. 871(a); 28 CFR 0.100.
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While the CSA is one component of the overall regulation of the
practice of medicine in the United States,\10\ it bears emphasis that
the CSA does not regulate the practice of medicine as a whole.
Therefore, although DEA is the agency responsible for administering the
CSA, DEA does not act as the Federal equivalent of a State medical
board overseeing the general practice of medicine. State laws and State
licensing bodies (such as medical licensing boards) collectively
regulate the practice of medicine.\11\ In contrast, the scope of the
CSA (and therefore role of DEA) is much narrower. The CSA regulates
only the segment of medical practice involving the use of controlled
substances, and DEA is correspondingly responsible for ensuring that
controlled substances are used in compliance with Federal law.
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\10\ As the United States Supreme Court stated in an early
decision under the CSA, ``provisions throughout the Act reflect the
intent of Congress to confine authorized medical practice within
accepted limits.'' United States v. Moore, 423 U.S. 122, 141-142
(1975). In Gonzales v. Oregon, 126 S.Ct. 904, 925 (2006), the Court
continued to cite Moore with approval and for the proposition that
the legitimate medical purpose requirement in the CSA ``ensures
patients use controlled substances under the supervision of a doctor
so as to prevent addiction and recreational abuse.'' The Court
further stated: ``As a corollary, the provision also bars doctors
from peddling to patients who crave the drugs for those prohibited
uses.'' Id
\11\ Medical specialty boards also play a crucial role in
providing information to the public, the government, and the medical
profession concerning issues involving specialization and
certification in medicine. Specialty boards maintain the quality of
medical care in the United States by developing and utilizing
professional and educational standards for the evaluation and
certification of physician specialists.
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In particular, DEA's role under the CSA is to ensure that
controlled substances are prescribed, administered, and dispensed only
for legitimate medical purposes by DEA-registered practitioners acting
in the usual course of professional practice and otherwise in
accordance with the CSA and DEA regulations. Each State also has its
own laws (administered by State agencies) requiring that a prescription
for a controlled substance be issued only for a legitimate medical
purpose by State-licensed practitioners acting in the usual course of
professional practice.
There is nothing new in this arrangement of responsibilities
between the Federal and State governments. For more than 90 years
(starting with the Harrison Narcotic Act of 1914, which was superseded
by the CSA in 1970) Federal law has placed certain restrictions on the
medical use of federally controlled substances while, at the same time,
the States have regulated the practice of medicine generally. In this
respect, there has long been a certain amount of overlap between the
Federal and State oversight of controlled substances. Beginning in the
1930s and through to the present, States have adopted uniform
controlled substance laws that were designed to promote standards that
are consistent from State to State and in harmony with Federal law.\12\
One such standard that has always been a fundamental part of these
uniform State laws is the requirement that controlled substances be
dispensed only for a legitimate medical purpose by a practitioner
acting in the usual course of professional practice--a requirement
first articulated in the Harrison Narcotic Act. Accordingly, it has
been the case for more than 70 years that a practitioner who dispenses
controlled substances for other than a legitimate medical purpose, or
outside the usual course of professional practice, is subject to legal
liability under both State and Federal law.\13\
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\12\ The first such uniform act was the Uniform Narcotic Drug
Act of 1932, which was eventually adopted by every state. That act
was replaced in 1970 by the Uniform Controlled Substances Act, which
has been adopted by all but two states (New Hampshire and Vermont).
\13\ Congress expressly intended that there would be a dual
system of Federal-state regulation of controlled substances by
including in the CSA a preemption provision, 21 U.S.C. 903, which
reflects that this field of regulation was to be shared by the
Federal and state governments. Section 903 states: ``No provision of
this subchapter shall be construed as indicating an intent on the
part of Congress to occupy the field in which that provision
operates, including criminal penalties, to the exclusion of any
State law on the same subject matter which would otherwise be within
the authority of the State * * * .'' At the same time, this
provision reiterates what is inherent in the supremacy clause of the
United States Constitution--that no state may enact a law relating
to controlled substances that presents a ``positive conflict'' with
the CSA.
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The Meaning of the ``Legitimate Medical Purpose'' Requirement
As stated above, the core legal standard is that a controlled
substance may only be prescribed, administered, or dispensed for a
legitimate medical purpose by a physician acting in the usual course of
professional practice. This requirement has been construed to mean that
the prescription must be ``in accordance with a standard of medical
practice generally recognized and accepted in the United States.'' \14\
However, Federal courts have long recognized that it is not possible to
expand on the phrase ``legitimate medical purpose in the usual course
of professional practice,'' in a way that will provide definitive
guidelines that address all the varied situations physicians might
encounter. As one court explained:
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\14\ Moore, 423 U.S. at 139 (quoting jury instruction).
There are no specific guidelines concerning what is required to
support a conclusion that an accused acted outside the usual course
of professional practice. Rather, the courts must engage in a case-
by-case analysis of evidence to determine whether a reasonable
inference of guilt may be drawn from specific facts.\15\
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\15\ United States v. August, 984 F.2d 705, 713 (6th Cir. 1992).
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Similarly, another court stated:
A majority of cases [in which physicians were alleged to have
dispensed controlled substances without a legitimate medical
purpose] have dealt with facts which were so blatant that a
statement of clear-cut criteria in a form useful in other cases
would have been superfluous to the decision. We are, however, able
to glean from reported cases certain recurring concomitance of
condemned behavior.\16\
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\16\ United States v. Rosen, 582 F.2d 1032 (5th Cir. 1978).
The foregoing quotation makes a particularly important point: that
the types of cases in which physicians have been found to have
dispensed controlled substances improperly under Federal law generally
involve facts where the physician's conduct is not merely of
questionable legality, but instead is a glaring example of illegal
activity.
Specific Areas of Interest to the Commenters
The comments DEA received covered a variety of issues related to
the dispensing of controlled substances for the treatment of pain.
While some of the viewpoints expressed in the comments were in sharp
contrast with other viewpoints, taken as a whole, the comments indicate
there is significant interest (among those physicians and members of
the public who submitted comments) in having DEA address the following
topics:
[[Page 52718]]
The extent and consequences of the undertreatment of pain
in the United States.
The extent and consequences of excessive use of opioids to
treat nonsevere pain.
Providing medical and legal guidance on prescribing
opioids for pain.
Elaborating on DEA's policy regarding the investigation of
physicians for improper prescribing of controlled substances for pain.
Having DEA provide reassurance that it is not targeting
physicians who prescribe controlled substances for pain.
Each of these topics is addressed in this document.\17\
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\17\ Also of chief concern to commenters was the issuance by
physicians of multiple schedule II prescriptions. DEA addressed this
issue in detail in the August 26, 2005, Federal Register document
titled ``Clarification of Existing Requirements Under the Controlled
Substances Act for Prescribing Schedule II Controlled Substances.''
70 FR 50403. In addition, DEA is today publishing in the Federal
Register a notice of proposed rulemaking (Docket No. DEA-287N) that
would revise the DEA regulations to allow for the issuance of
multiple schedule II prescriptions under certain circumstances.
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Comments Regarding the Use of Opioids
The comments reflect two distinct points of emphasis among
physicians who specialize in the treatment of pain. For some, of
paramount concern is what they describe as the undertreatment of acute
and chronic pain. Illustrative of this viewpoint, one commenter has
stated:
The undertreatment of pain is recognized as a serious public
health problem that results in a decrease in patients' functional
status and quality of life and may be attributed to a myriad of
social, economic, political, legal and educational factors,
including inconsistencies and restrictions in State pain policies.
Circumstances that contribute to the prevalence of undertreated pain
include: (1) Lack of knowledge of medical standards, current
research, and clinical guidelines for appropriate pain treatment;
(2) the perception that prescribing adequate amounts of controlled
substances will result in unnecessary scrutiny by regulatory
authorities; (3) misunderstanding of addiction and dependence; and
(4) lack of understanding of regulatory policies and processes.\18\
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\18\ Federation of State Medical Boards of the United States,
Model Policy for the Use of Controlled Substances for the Treatment
of Pain (2004).
One group representing several organizations of physicians who
specialize in treating pain commented that it agrees with the following
statement made by DEA in the November 16, 2004, Interim Policy
Statement published in the Federal Register (69 FR 67170): ``[C]hronic
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.'' However, this group expressed the view that the Interim
Policy Statement would have ``the exact opposite effect'' by
discouraging some practitioners from properly treating pain. The group
therefore urged DEA to readdress the subject in a way that will promote
proper dispensing of controlled substances for pain. Similar views were
expressed in comments submitted by many other organizations whose
missions relate to the treatment of pain. For example, an organization
representing health care professionals and patient advocates for those
with cancer pain stated: ``We respectfully request that the DEA
reaffirm its support for areas of the law that support the appropriate
use of opioid analgesics for pain control and thereby reduce the fears
and uncertainties of health care professionals who treat patients in
pain.'' With regard to this point, NIDA has stated in a recent report:
``Many healthcare providers underprescribe opioid pain relievers, such
as morphine and codeine, because they overestimate the potential for
patients to become addicted.'' \19\
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\19\ National Institute on Drug Abuse Research Report:
Prescription Drug Abuse and Addiction (available at http://www.drugabuse.gov/PDF/RRPrescription.pdf).
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A few other commenters focused primarily on what they believe is
the overprescribing of opioids by some physicians to treat pain. For
example, one physician who specializes in pain treatment stated that
``the majority of high dose narcotic prescribing is for chronic `non-
malignant' pain,'' that ``the growth of this practice has been
exponential,'' and that ``there have been many problems associated with
this practice, including the tremendous rise in abuse of prescription
drugs in all segments of the population, especially the youth.'' Along
similar lines, another physician commented there has been an
``epidemic'' of deaths and addiction resulting from the illicit use of
prescription narcotics, which, according to this commenter, is due in
large part to the prescribing of narcotics to ``a much wider class of
chronic noncancer patients, including those with moderate subjective
ailments such as bursitis, neuralgia, arthritis, headaches, and lower
back pain.'' Another physician stated the large increase in the use of
prescription narcotics and deaths related thereto ``seem to be
coincident with growing advocacy for use of opioid pain medications in
chronic benign pain syndromes'' and ``also coincide with the marketing
of expensive new opioid drug preparations which are aggressively
promoted by the drug manufacturers, and with the growth of professional
and accrediting organizations that seem determined to promote the use
of opioid pain medications.''
The two distinct areas of emphasis reflected in the comments--the
commenters' views about the undertreatment of pain and what some
perceive as overprescribing of opioids for nonsevere ailments--are not
necessarily mutually exclusive. To the contrary, the comments taken
collectively suggest that there may be some physicians who
``undertreat'' pain and others who improperly prescribe opioids
ostensibly for the treatment of pain. (DEA presumes, however, that most
physicians provide appropriate amounts of pain medication.) The
comments also reflect that there is a lack of consensus among
physicians as to all the circumstances that warrant the use of opioids
to treat pain.\20\ On this latter point, one physician who specializes
in pain treatment commented: ``The treatment of chronic nonmalignant
pain syndromes with narcotic medications remains a controversial area
with the mainstream medical community.'' This commenter suggested there
is a need for randomized, double-blind, controlled clinical trials to
fully evaluate this issue. As explained below, it is not DEA's role to
issue medical guidelines specifying patient characteristics that
warrant the selection of a particular opioid or other medication or
regimen for the treatment of pain.
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\20\ One indication of the lack of consensus among physicians on
this point is the following. The American Medical Association, in a
published policy statement (D-120.999) (``Use of opioids in chronic
noncancer pain''), states: ``Further controlled trials [should] be
conducted on opioid therapy in patients with chronic noncancer pain
in an effort to identify best practice with regard to selection of
both medication and treatment regimens [to] identify patient
characteristics that predict opioid responsiveness [and to] provide
support for guidelines on appropriate precautions,
contraindications, and the degree of monitoring required in such
patients.''
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Requests for Guidance on Treating Patients for Pain
Many commenters expressed the view that it would be beneficial if
physicians had a single document providing clear guidelines on the use
of controlled substances for the treatment of pain. Some believe such a
document would remedy their concerns about the undertreatment of pain
by giving
[[Page 52719]]
physicians assurance that they can avoid scrutiny by Federal and State
regulatory authorities as long as they follow those guidelines when
prescribing opioids. More specifically, it has been suggested that
these guidelines should take the form of a series of questions and
answers to be adopted by DEA. Among the questions that have been
proposed for inclusion in these guidelines are:
What should be the goals of pain management?
How can a clinician assess a patient's pain?
When should a primary care physician turn to a pain
medicine specialist to manage a patient's pain?
How are opioids used to manage chronic pain?
It is certainly appropriate for physicians and medical oversight
boards to explore these types of questions. However, for the following
reasons, it is not appropriate for DEA to address these questions in
the form of a guidance document (or to endorse such a guidance document
prepared by others).
First, one cannot provide an exhaustive and foolproof list of ``dos
and don'ts'' when it comes to prescribing controlled substances for
pain or any other medical purpose. As discussed above, the fundamental
principle under both Federal and State law is that a controlled
substance must be dispensed by a physician for a legitimate medical
purpose in the usual course of professional practice. Throughout the 90
years that this requirement has been a part of United States law, the
courts have recognized that there are no definitive criteria laying out
precisely what is legally permissible, as each patient's medical
situation is unique and must be evaluated based on the entirety of the
circumstances. DEA cannot modify or expand upon this longstanding legal
requirement through the publication or endorsement of guidelines.
Second, as stated earlier in this document, DEA's authority under
the CSA is not equivalent to that of a State medical board. DEA does
not regulate the general practice of medicine. The responsibility for
educating and training physicians so that they make sound medical
decisions in treating pain (or any other ailment) lies primarily with
medical schools, post-graduate training facilities, State accrediting
bodies, and other organizations with medical expertise. Some states
also have continuing medical education requirements for licensing.
Physicians also keep abreast of the latest findings by reading peer-
reviewed articles published in medical and scientific journals. DEA,
however, has neither the legal authority nor the expertise to provide
medical training to physicians or issue guidelines that constitute
advice on the general practice of medicine.\21\
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\21\ As stated above, DEA does have the authority and the
expertise to investigate and determine whether a prescription for a
controlled substance was issued for a legitimate medical purpose in
the usual course of professional practice within the meaning of the
CSA and DEA regulations.
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For these reasons, DEA is not proposing any medical guidelines on
prescribing controlled substances for the treatment of pain.
Whether To Form an Advisory Committee
Several members of the public have suggested that DEA form an
advisory committee, panel, or working group to develop and publish
guidelines on the use of controlled substances for the treatment of
pain. An agency may not utilize an advisory committee (or panel or
working group) to provide advice to the agency or prepare a document
for (or in conjunction with) the agency unless all of the procedural
requirements of the Federal Advisory Committee Act (FACA) are
satisfied.\22\ Compliance with FACA ensures, among other things, that
persons selected by the agency to serve on the committee constitute a
balanced membership that represents a fair cross-section of viewpoints.
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\22\ As set forth in FACA, a charter must be enacted before an
advisory committee can meet. 5 U.S.C. App. 2 Sec. 9(c). For an
agency committee, the charter must be filed with the head of the
agency, the appropriate Senate and House of Representatives standing
committees, the Library of Congress, and the General Services
Administration Secretariat, 41 CFR 102-3.70. The charter must
contain certain information, including, among other things, the
following: the advisory committee's official designation; objectives
and the scope of the advisory committee's activity; the time
necessary to carry out the advisory committee's purposes; a
description of the duties for which the advisory committee is
responsible; the estimated annual costs; the estimated frequency of
the advisory committee's meetings; and the planned termination date.
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If DEA were to conclude that compelling considerations necessitated
the formation of an advisory committee subject to FACA, the agency
would seek to do so in accordance with the law and Executive Branch
directives.\23\ At this time, DEA does not believe that such
considerations exist warranting the formation of such an advisory
committee to address the dispensing of controlled substances for the
treatment of pain. However, there are other means available to an
agency to obtain valuable public input. Within the bounds permissible
by law, DEA remains firmly committed to obtaining the ongoing input of
the medical community, law enforcement officials, and other interested
members of the public. Toward this end, the agency welcomes written
submissions from the public on this document and will continue to
explore other legally appropriate means of hearing the views of
interested members of the public.
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\23\ See Executive Order 12838 (``Termination and Limitation of
Federal Advisory Committees'').
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The Number of Physicians Who Prescribe Controlled Substances in
Violation of the CSA Is Extremely Small and There Is No DEA
``Crackdown'' on Physicians
DEA recognizes that the overwhelming majority of American
physicians who prescribe controlled substances do so for legitimate
medical purposes. In fact, the overwhelming majority of physicians who
prescribe controlled substances do so in a legitimate manner that will
never warrant scrutiny by Federal or State law enforcement officials.
Contrary to the impression of some commenters, DEA has not modified its
criteria for investigating physicians or increased its emphasis on
physicians as part of the agency's overall mission. In any given year,
including 2005, fewer than one out of every 10,000 physicians in the
United States (less than 0.01 percent) lose their controlled substance
registrations based on a DEA investigation of improper prescribing.\24\
This figure alone should correct any mistaken notions about a supposed
DEA ``crackdown'' on physicians. Moreover, as mentioned above, the
responsibility for monitoring and preventing controlled substance abuse
is shared by State and Federal governments. Even in the rare cases
where a physician loses his/her DEA registration for improper
prescribing, it is often State officials--not DEA--who initiate the
investigations.
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\24\ The majority of cases in which physicians lose their DEA
registrations result from actions by state medical boards to revoke
or suspend the physicians' state medical licenses.
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DEA always had, and continues to have, a legal obligation to
investigate the extremely small fraction of physicians who use their
DEA registration to commit criminal acts or otherwise violate the CSA.
DEA takes this obligation seriously because even just one physician who
uses his/her DEA registration for criminal purposes can cause enormous
harm. In the words of one commenter: ``It takes only a few untrained or
unscrupulous physicians to create large pockets of addicts.'' But DEA
takes just as seriously its obligation to ensure that there is no
interference with the dispensing of controlled
[[Page 52720]]
substances to the American public in accordance with the sound medical
judgment of their physicians. It would be a disservice to many patients
if exaggerated statements regarding the likelihood of a DEA
investigation resulted in physicians mistakenly concluding that they
must scale back their patients' use of controlled substances to levels
below that which is medically appropriate.
Furthermore, DEA does not apply a greater level of scrutiny to the
prescribing of controlled substances to treat pain as compared to other
ailments. Regardless of the ailment, DEA applies evenhandedly the
requirement that a controlled substance be prescribed for a legitimate
medical purpose in the usual course of professional practice. The idea
that prescribing opioids to treat pain will trigger special scrutiny by
DEA is false.
Types of Cases in Which Physicians Have Been Found To Have Prescribed
or Dispensed Controlled Substances for Other Than a Legitimate Medical
Purpose or Outside the Usual Course of Professional Practice
Bearing in mind that there are no criteria that will address every
conceivable instance of prescribing, the following examples of cases
are provided to explain how Federal courts and DEA have applied the
requirement that a controlled substance be dispensed for a legitimate
medical purpose in the usual course of professional practice.
Application of the Requirement by Federal Courts
As noted above, the Supreme Court recently stated, in Gonzales v.
Oregon, that the legitimate medical purpose requirement in the CSA
``ensures patients use controlled substances under the supervision of a
doctor so as to prevent addiction and recreational abuse.'' \25\ The
Court further stated: ``As a corollary, the provision also bars doctors
from peddling to patients who crave the drugs for those prohibited
uses.'' \26\
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\25\ 126 S.Ct. at 925.
\26\ Id.
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Consistent with those views, some years ago, the United States
Court of Appeals for the Fifth Circuit summarized the reported cases in
which physicians had been found to have violated the requirement that a
prescription for a controlled substance be issued only for a legitimate
medical purpose in the usual course of professional practice. In this
decision, United States v. Rosen, 582 F.2d 1032 (5th Cir. 1978), the
court looked at the case law and found the following recurring patterns
indicative of diversion and abuse:
(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 knowing that the patient
was 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.
The same fact patterns listed by the Rosen court remain prevalent
today among the cases in which physicians have been found to have
improperly prescribed controlled substances. This does not mean that
the existence of any of the foregoing factors will automatically lead
to the conclusion that the physician acted improperly. Rather, each
case must be evaluated based on its own merits in view of the totality
of circumstances particular to the physician and patient. For example,
what constitutes ``an inordinately large quantity of controlled
substances'' (factor (1) listed by the Rosen court) can vary greatly
from patient to patient. A particular quantity of a powerful schedule
II opioid might be blatantly excessive for the treatment of a
particular patient's mild temporary pain, yet insufficient to treat the
severe unremitting pain of a cancer patient.
Again, rather than focusing on any particular factor, it is
critical to bear in mind that (i) the entirety of circumstances must be
considered, (ii) the cases in which physicians have been found to have
prescribed controlled substances improperly typically involve facts
that demonstrate blatant criminal conduct, and (iii) the percentage of
physicians who prescribe controlled substances improperly (or are
investigated for doing so) is extremely small.
Application of the Requirement by DEA
Any final decision by DEA to revoke or deny a DEA registration is
published in the Federal Register. The following are three examples
from 2005 in which DEA revoked physicians' DEA registrations for
unlawfully prescribing or dispensing controlled substances. (The
complete final orders are published in the Federal Register and are
available online.)
Robert A. Smith, M.D. (70 FR 33207)--Dr. Smith gave one
patient seven to ten prescriptions of OxyContin per visit on a weekly
basis. The prescriptions were written in the patient's name as well as
the names of the patient's father and her fianc[eacute]. Each visit,
the patient paid Dr. Smith a $65 fee for the office visit plus an
additional $100 for the fraudulent prescriptions. Dr. Smith also asked
the patient for sexual favors during office visits. The patient
declined, but, as a substitute, paid another woman $100 to perform a
sexual act on Dr. Smith. Dr. Smith's office assistant also provided the
patient with blank prescriptions, in return for which the office
assistant demanded from the patient $40 and OxyContin tablets.
Another patient would give Dr. Smith a list of fictitious names and
types of controlled substances he desired, and Dr. Smith would issue
three prescriptions under each name, usually for Percocet, OxyContin,
and Xanax, at the same time. Dr. Smith issued between nine and fifteen
fraudulent prescriptions per visit and received $100 for each set of
three prescriptions. The patient then sold the prescriptions to a third
party who, in turn, sold the drugs on the street, all with the
knowledge of Dr. Smith.
Another individual visited Dr. Smith three times in less than a
three-week period, obtaining fraudulent prescriptions each time. The
individual paid Dr. Smith $500 for 15 prescriptions for Xanax,
OxyContin, and Percocet, which were written under five different
fictitious patient names.
James S. Bischoff, M.D. (70 FR 12734)--Dr. Bischoff took a
16-year-old high school student to an out-of-town physician specialist
for emergency medical treatment after the boy's hand was cut in an
accident. When the specialist did not recommend treatment with a
controlled substance, Dr. Bischoff wrote the boy a prescription for 100
OxyContin, which Dr. Bischoff personally took to a pharmacy to be
filled. Dr. Bischoff delivered only 20 tablets to the boy, unlawfully
diverting the remaining 80 tablets. Around the same time, Dr. Bischoff
wrote another prescription in the boy's name for 120 Adderall tablets.
Dr. Bischoff also filled this prescription himself at a pharmacy but
never delivered the tablets to the boy. Later, Dr. Bischoff wrote
another prescription in the name of the boy for 120 Adderall tablets.
The boy's stepmother learned that the boy was taking the medication
only after she
[[Page 52721]]
discovered the bottle a couple of weeks later. She then checked with
the pharmacy and discovered that Dr. Bischoff had written and
personally filled multiple fraudulent prescriptions for controlled
substances in the names of the boy's family members, telling
pharmacists that he was a close friend and that the purported patients
were too busy to get to the pharmacy. In addition, Dr. Bischoff ordered
approximately 46,000 dosage units of schedule III and IV controlled
substances from a supplier, and he was unable to account for 32,000
dosage units.
John S. Poulter, D.D.S. (70 FR 24628)--Local law
enforcement authorities were called after Dr. Poulter was observed
parked in front of a convenience store injecting himself with Demerol.
Dr. Poulter failed a field sobriety test, admitted to injecting himself
with Demerol, and later pleaded guilty to State felony charges of
unlawful possession of a controlled substance. The plea was held in
abeyance for three years pending Dr. Poulter's successful completion of
a monitoring program for impaired professionals. In addition to the
criminal proceedings, his State professional licensing board took
action based on the Demerol incident and several instances of improper
use of Fentanyl. Dr. Poulter entered into a five-year probationary
agreement with the State board, agreeing to abstain from personal use
of mood-altering substances. Before completing these probationary
periods, Dr. Poulter was involved in an automobile accident in which he
drove his car off the road after having injected himself with Fentanyl
and Demerol. Responding officers and medical personnel found him
``incoherent and very confused,'' and there were visible needle marks
on his arm and hands. A search of the automobile revealed a used
syringe and a plastic container holding Demerol and Fentanyl.
These three recent cases provide illustrations of some of the most
common behaviors that result in loss of DEA registration: Issuing
prescriptions for controlled substances without a bona fide physician-
patient relationship; issuing prescriptions in exchange for sex;
issuing several prescriptions at once for a highly potent combination
of controlled substances; charging fees commensurate with drug dealing
rather than providing medical services; issuing prescriptions using
fraudulent names; and self-abuse by practitioners.
In another recent case, United States v. Singh, 390 F.3d 168 (2d
Cir. 2004), a physician who claimed to specialize in pain management
was convicted following a jury trial of improperly prescribing a
controlled substance in violation of the CSA. The court of appeals,
which upheld the conviction, described the nature of the physician's
prescribing practice as follows (id. at 176):
Singh developed a scheme that enabled nurses to see patients
alone, to issue prescriptions for schedule II controlled substances,
and to bill for such services. He and the other physicians would
pre-sign the triplicate forms and provide them to non-physician
personnel to use during patient visits. These employees, although
not trained or legally authorized to do so, filled in all the
required prescription information--drug type, dosage, and quantity--
and provided the prescriptions to the patients.
It appears that the physicians at the practice, including Singh,
signed entire books of triplicate prescription forms in blank
without even knowing the identities of the patients to whom the
prescriptions would be issued or the nature or dosage of the drug to
be prescribed. * * *
Data extracted from Singh's office records revealed that the
nurses issued prescriptions for at least 76,000 tablets of schedule
II controlled substances when Singh was not present in the practice
suite.
Thus, Singh is another example of a prosecution based on blatant
criminal conduct by a physician, and it should cause no concern for any
legitimate pain specialist or other physician who properly prescribes
controlled substances.
Commencement of Investigations
On the subject of when DEA might commence an investigation of
possible improper prescribing of controlled substances, several
commenters sought elaboration on DEA's statements in the November 16,
2004 Interim Policy Statement. In that document, DEA stated, among
other things:
[I]t 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 assurance 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 [CSA].
The foregoing is a correct statement of the law, and DEA is not
unique in this regard. All law enforcement agencies--Federal and
State--have long been governed by this same principle. The reason DEA
mentioned this longstanding maxim in the Interim Policy Statement was
to correct an earlier publication attributed to DEA that embodied a
contrary view.
While those who commented on the subject of investigations
generally acknowledged that DEA had properly stated the law, some
asserted that, by doing so, the agency might have caused some
physicians to fear the prospect of being investigated and thereby
discouraged them from providing proper pain treatment. DEA believes,
however, physicians will understand that correctly stating the legal
standard which has historically applied to regulatory agencies is no
cause for alarm. DEA does not use its investigatory authority in an
arbitrary manner. Further, as DEA has repeatedly stated in this
document and elsewhere, there is no ``crackdown'' or increased emphasis
on investigating physicians, and the statistics bear that out. In 2005,
as in prior years, only a tiny fraction of physicians (less than one in
ten thousand) lost their registration based on a DEA investigation of
improper prescribing of controlled substances.
One commenter suggested DEA should announce it will only commence
an investigation when it has evidence that the physician is prescribing
in a manner outside of accepted medical standards. To adopt such a
standard would conflict with longstanding law, as previously noted. In
addition, from a practical perspective, such a standard would be
impossible to apply because the agency cannot know--prior to commencing
an investigation--whether the activity was proper or improper.
Gathering preliminary information is essential to determining whether a
full-scale investigation is--or is not--warranted. By stating the
governing law, however, DEA is not suggesting that it investigates
every instance of prescribing in order to rule out the possibility of
illegal activity. To the contrary, the agency recognizes that nearly
every prescription issued by a physician in the United States is for a
legitimate medical purpose in the usual course of professional
practice.
Other Recurring Questions
What is fueling the recent increase in prescription drug abuse?
There are a variety of factors that may be contributing to the
increase in prescription drug abuse. The Director of NIDA recently
testified before Congress:
The recent increase in the extent of prescription drug abuse in
this country is likely the result of a confluence of factors, such
as: Significant increases in the number of prescriptions;
significant increases in drug availability; aggressive marketing by
the pharmaceutical industry; the proliferation of illegal Internet
pharmacies that dispense these medications without proper
prescriptions and surveillance; and a greater
[[Page 52722]]
social acceptability for medicating a growing number of
conditions.\27\
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\27\ The NIDA testimony, which was presented July 26, 2006,
before the House Subcommittee on Criminal Justice, Drug Policy, and
Human Resources, Committee on Government Reform, appears in full on
NIDA's Web site at http://www.drugabuse.gov/Testimony/7-26-06Testimony.html.
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Increased availability of prescription drugs and sharing
among family and friends--The United States Government Accountability
Office (GAO) published a report in 2003 on the abuse of the most
prescribed brand name narcotic medication for treating moderate-to-
severe pain.\28\ The report states: ``The large amount of [the drug]
available in the marketplace may have increased opportunities for abuse
and diversion. Both DEA and [the manufacturer of the drug] have stated
that an increase in a drug's availability in the marketplace may be a
factor that attracts interest by those who abuse and divert drugs.''
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\28\ The GAO report, ``Prescription Drugs OxyContin Abuse and
Diversion and Efforts to Address the Problem,'' GAO-04-110 (December
2003), is available at http://www.gao.gov/new.items/d04110.pdf.
---------------------------------------------------------------------------
The 2006 Synthetic Drug Control Strategy states:
Preliminary data suggest the most common way in which controlled
substance prescriptions are diverted may be through friends and
family. For example, a person with a lawful and medical need for
some amount of a controlled substance uses only a portion of the
prescribed amount. Then a family member complains of pain, and the
former patient shares excess medication. Alternatively, for a family
member addicted to controlled prescription drugs, the mere
availability of unused controlled substance prescriptions in the
house may prove to be an irresistible temptation.
Ease of access via the Internet--It is becoming
increasingly easy for persons of any age to obtain controlled
substances illegally by means of the Internet. Numerous Web sites based
in the United States and abroad sell controlled substances to anyone
willing and able to provide a credit card number. Some of these Web
sites do not require a prescription. Others will provide the buyer with
an illegitimate prescription simply by having the buyer fill out an
online questionnaire without seeing a physician. As the 2006 Synthetic
Drug Control Strategy states, ``the anonymity of the Internet and the
proliferation of Web sites that facilitate illicit transactions for
controlled substance prescription drugs have given drug abusers the
ability to circumvent the law as well as sound medical practice.''
Improper prescribing--As the 2006 Synthetic Drug Control
Strategy states: ``The overwhelming majority of prescribing in America
is conducted responsibly, but the small number of physicians who
overprescribe controlled substances--carelessly at best, knowingly at
worst--help supply America's most widespread drug addiction problem.
Although the problem exists, the number of physicians responsible for
this problem is a very small fraction of those licensed to prescribe
controlled substances in the United States.''
Drug formulation and marketing--One of the recommendations
in the 2006 Synthetic Drug Control Strategy is to ``[c]ontinue to
support the efforts of firms that manufacture frequently diverted
pharmaceutical products to reformulate their products so as to reduce
diversion and abuse,'' and to ``[e]ncourage manufactures to explore
methods to render * * * pain control products, such as OxyContin, less
suitable for snorting or injection.'' Whether the marketing of certain
opioids has contributed to abuse and diversion has also been an area of
discussion.\29\
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\29\ A detailed discussion of this issue is contained in the
above-referenced GAO report, ``Prescription Drugs OxyContin Abuse
and Diversion and Efforts to Address the Problem.'' The
manufacturer's statement to Congress in response to the GAO report
is available at http://reform.house.gov/UploadedFiles/9-13-2005%20Purdue%20Testimony.pdf. In 2001, FDA announced that it had
worked with the manufacturer of OxyContin to make changes to the
drug's labeling, including a ``black box warning,'' which FDA states
is ``intended to lessen the chance that OxyContin will be prescribed
inappropriately for pain of lesser severity than the approved use or
for other disorders or conditions inappropriate for a schedule II
narcotic.'' FDA Talk Paper: ``FDA Strengthens Warnings for
OxyContin'' (July 25, 2001), available at http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01091.html.
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What are some of the common methods and sources of diversion?
Diversion of prescription drugs containing controlled substances
occurs on a variety of levels. Some controlled substances are stolen
directly from manufacturers and distributors. Diversion also occurs at
the retail level with thefts from, and robberies of, pharmacies. In one
survey of over 1,000 pharmacists nationwide, 28.9 percent reported that
they had experienced a theft or robbery at their pharmacies within the
past five years.\30\ A very small percentage of physicians also
contribute to the problem of diversion by intentionally, or
unintentionally, providing controlled substances to those who are
themselves drug abusers or who sell the drugs for profit.
---------------------------------------------------------------------------
\30\ The survey was conducted by the National Center on
Addiction and Substance Abuse at Columbia University, which
published the results in a comprehensive report on prescription drug
abuse entitled: ``Under the Counter: The Diversion and Abuse of
Controlled Prescription Drugs in the U.S.'' (available at http://www.casacolumbia.org/absolutenm/articlefiles/380-under_the_counter_-_diversion.pdf).
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Prescription fraud is another common source of diversion. This
occurs whenever prescriptions for controlled substances are obtained
under false pretenses, including when prescriptions are forged or
altered, or when someone falsely claiming to be a physician calls in
the prescription to a pharmacy.
``Doctor shopping'' is another traditional method by which
diversion occurs. Some drug abusers visit multiple physicians' offices
and falsely present complaints in order to obtain controlled
substances.
What are the potential signs to a physician that a patient might be
seeking drugs for the purpose of abuse or diversion?
Many physicians have requested a list of the possible indicators
that a patient might be seeking controlled substances for the purpose
of diversion or abuse. DEA has provided this type of list in various
publications over the years. While not an exhaustive list, the
following are some of the common behaviors that might be an indication
the patient is seeking drugs for the purpose of diversion or abuse:
Demanding to be seen immediately;
Stating that s/he is visiting the area and is in need
of a prescription to tide her/him over until returning to the local
physician;
Appearing to feign symptoms, such as abdominal or back
pain, or pain from kidney stones or a migraine, in an effort to
obtain narcotics;
Indicating that nonnarcotic analgesics do not work for
him/her;
Requesting a particular narcotic drug;
Complaining that a prescription has been lost or stolen
and needs replacing;
Requesting more refills than originally prescribed;
Using pressure tactics or threatening behavior to
obtain a prescription;
Showing visible signs of drug abuse, such as track
marks.
What are the general legal responsibilities of a physician to prevent
diversion and abuse when prescribing controlled substances?
In each instance where a physician issues a prescription for a
controlled substance, the physician must properly determine there is a
legitimate medical purpose for the patient to be prescribed that
controlled substance and the physician must be acting in the usual
course of professional practice.\31\ This is the basic legal
requirement discussed
[[Page 52723]]
above, which has been part of American law for decades. Moreover, as a
condition of being a DEA registrant, a physician who prescribes
controlled substances has an obligation to take reasonable measures to
prevent diversion.\32\ The overwhelming majority of physicians in the
United States who prescribe controlled substances do, in fact, exercise
the appropriate degree of medical supervision--as part of their routine
practice during office visits--to minimize the likelihood of diversion
or abuse. Again, each patient's situation is unique and the nature and
degree of physician oversight should be tailored accordingly, based on
the physician's sound medical judgment and consistent with established
medical standards.
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\31\ 21 CFR 1306.04(a); United States v. Moore, supra.
\32\ 21 U.S.C. 823(f).
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What additional precaution should be taken when a patient has a history
of drug abuse?
As a DEA registrant, a physician has a responsibility to exercise a
much greater degree of oversight to prevent diversion and abuse 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 they will
be used for a nonmedical purpose or that they will be resold by the
patient. Some physicians who treat patients having a history of drug
abuse require each patient to sign a contract agreeing to certain terms
designed to prevent diversion and abuse, such as periodic urinalysis.
While such measures are not mandated by the CSA or DEA regulations,
they can be very useful.
Can a physician be investigated solely on the basis of the number of
tablets prescribed for an individual patient?
The Supreme Court has long recognized that an administrative agency
responsible for enforcing the law has broad investigative
authority,\33\ and courts have recognized that prescribing an
``inordinately large quantity of controlled substances'' can be
evidence of a violation of the CSA.\34\ DEA therefore, as the agency
responsible for administering the CSA, has the legal authority to
investigate a suspicious prescription of any quantity.
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\33\ Morton Salt, 338 U.S. at 642-643 (``an administrative
agency charged with seeing that the laws are enforced'' may
``investigate merely on suspicion that the law is being violated, or
even just because it wants assurance that it is not.'').
\34\ United States v. Rosen, 582 F.2d at 1036.
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Nonetheless, the amount of dosage units per prescription will never
be a basis for investigation for the overwhelming majority of
physicians. As with every other profession, however, among the hundreds
of thousands of physicians who practice medicine in this country in a
manner that warrants no government scrutiny are a handful who engage in
criminal behavior. In rare cases, it is possible that an aberrant
physician could prescribe such an enormous quantity of controlled
substances to a given patient that this alone will be a valid basis for
investigation. For example, if a physician were to prescribe 1,600
(sixteen hundred) tablets per day of a schedule II opioid to a single
patient, this would certainly warrant investigation as there is no
conceivable medical basis for anyone to ingest that quantity of such a
powerful narcotic in a single day. Again, however, such cases are
extremely rare. The overwhelming majority of physicians who conclude
that use of a particular controlled substance is medically appropriate
for a given patient should prescribe the amount of that controlled
substance which is consistent with their sound medical judgment and
accepted medical standards without concern that doing so will subject
them to DEA scrutiny.
Can methadone be used for pain control?
Methadone, a schedule II controlled substance, has been approved by
the FDA as an analgesic. While a physician must have a separate DEA
registration to dispense methadone for maintenance or detoxification,
no separate registration is required to prescribe methadone for pain.
However, in a document entitled ``Methadone-Associated Mortality:
Report of a National Assessment,'' SAMHSA recently recommended that
``physicians need to understand methadone's pharmacology and
appropriate use, as well as specific indications and cautions to
consider when deciding whether to use this medication in the treatment
of pain.'' \35\ This recommendation was made in light of mortality
rates associated with methadone.
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\35\ SAMHSA Publication No. 04-3904. Available at http://dpt.samhsa.gov/reports/index.htm.
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Obtaining Further Input From Physicians and Other Health Care
Professionals
In developing policies and rules relating to the use of controlled
substances in the treatment of pain, DEA is firmly committed to
obtaining input on an ongoing basis from physicians and other health
care professionals authorized to prescribe and dispense controlled
substances, as well the views of Federal and State agencies,
professional societies, and other interested members of the public. DEA
welcomes the written comments that any such persons might wish to
submit in response to this document. DEA will also continue to evaluate
whether it would be beneficial to obtain the additional views of
physicians through in-person meetings, to the extent permissible under
FACA.
Dated: August 28, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-14517 Filed 9-5-06; 8:45 am]
BILLING CODE 4410-09-P