Federal
Register Notices > Notices - 2006
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Policy Statement: Dispensing Controlled
Substances for the Treatment of Pain
FR Doc E6-14517 [Federal Register: September 6, 2006 (Volume 71, Number 172)]
[Notices] [Page 52715-52723] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se06-137]
[[Page 52715]]
Part V
Department of Justice
Drug Enforcement Administration
21 CFR Part 1306
Dispensing Controlled Substances for the Treatment of Pain; Notice
Issuance of Multiple Prescriptions for Schedule II Controlled Substances;
Proposed Rule
[[Page 52716]]
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.
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
.
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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).
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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).
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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).
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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.''
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\31\ 21
CFR 1306.04(a); United States v. Moore, supra.
\32\ 21
U.S.C. 823(f).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
|