The Practice, Process & Politics of Pain Management
number of persons
Volume XIV, Number 2
Inside this issue
From the Editor, 2
Duncan C. MacIvor, MD
Pain - Politics and Public
Perception: Virginias
Experience, 4
Stephen P. Long, MD
Modern Treatment of
Chronic Pain, 8
John M. Barsanti, MD
Chronic Pain from a Chemical
Dependence Perspective, 11
Peter R. Coleman, MD
The Pharmacology of Opioids, 13
Drs. Michael Weaver, Deborah Haller,
Martha J. Wunsch
The Diagnosis and Treatment
of Headache, 16
Alan R. Towne, MD
Trigeminal Neuralgia, 23
Robert F. Saul, MD
Distinguishing Between Chronic
Pain and Drug-Seeking Behavior
in Pain Management/Opioid
Abuse, 25
Michael Weaver, MD
Chronic Pain Patient or Drug
Seeker, 28
Special Agent Carlton Johnson, Jr.
Listening to the Story of Suffering:
Psychiatric Perspectives of Pain
Diagnosis and Management, 29
James E. Sellman, MD
The Legal Issues: How the
Courts See Pain Management, 32
Stephen D. Rosenthal, Esquire
Issues Regarding Licensure, 34
William L. Harp, MD
Alternative Therapy Approaches:
How Acupuncture Can Be
Effectively Used, 36
M. Craig Pinsker, MD, PhD
The Role of the Physiatrist in
Managing Chronic Nonmalignant
Pain, 38
Jane Pendleton Wootton, MD
From the
President
Karsten F. Konerding, MD
Why Pain?
Thanks to Wilhelm Conrad Roentgen, a
physics professor at the University of
Wurzburg, the world is accustomed to seeing
radiographs of skeletons, hands, feet, lungs
and other major organs. Little did Roentgen
know in 1895, however, that his x-ray would
advance medicine immeasurably and provide
physicians with an invaluable tool in diagnos-
ing illness and disease.
Not surprisingly, the world was slow to appre-
ciate what Professor Roentgen offered. One
New York paper reported that x-rays would be
used to help medical students learn by reflect-
ing anatomic diagrams directly into their
brains. A London newspaper referred to the
invention as a revolting indecency, and cloth-
ing manufacturers quickly promoted
x-rayproof garments for women.
Fortunately, the merits of x-ray slowly became
known through medical education and public
education. Within decades, most people came
to see that, with radiographic methods, injuries
to bones otherwise covered by flesh and tu-
mors hidden deep in the chest could be seen,
treated and, perhaps, cured. Today, the value of
the diagnostic radiologistthe eye of medi-
cineis little disputed.
In many ways, pain management today is
where radiology was in its infancy. We are just
beginning to understand and appreciate the
complexity of the pain problem and to realize
the varieties of treatments available. The world
knows that pain exists, just as it knew that
bones lay beneath flesh, and while a growing
accept that medication
and treatments alleviate
pain, skepticism among
lay persons and physi-
cians persists. Some
people doubt the credi-
bility of the chronic
pain sufferer, others doubt the motives of a too
eager prescriber, many people fear the addic-
tive nature of drugs, and many physicians fear
the legal snares of under or overprescribing.
Yet, chronic pain exists.
Why Pain? Why a special edition of our
newsletter on pain management? The man-
agement of pain is on the cusp of a new hori-
zon in medicine. As physicians, regardless of
our specialty, we cannot afford to delegate
public discussion and policymaking decisions
about pain management to others, for tomor-
row we may wake up and do battle with
certified pain specialists who may not
be physicians.
Why Pain? Because medical literature in-
forms us that an estimated 80 million Ameri-
cans have some form of chronic pain, mostly
of noncancerous origin. A significant number
of these people have pain that does not respond
to commonly used surgical and medical treat-
ments. Too many of these patients endure
chronic pain for too long, simply because too
many physicians do not know how to diag-
nose, refer or treat chronic pain.
Why Pain? Persistent pain is not simply a be-
nign, unpleasant symptom of something that
cannot be fixed. A growing body of scientific
evidence and literature supports the clinical
impression that prolonged pain is aggressive,
physically destructive, and an emotionally ex-
hausting disease. Pain can result in measurably
harmful changes in hormonal and metabolic
Continued on page 2
May 2002
 R A M I F I C AT I O N S

From the President

Continued from page 1
From the Editor
Duncan MacIvor, MD

functions, alterations of brain chemicals An Imperfect World

vital to pain modulation, suppression of
immune system responses, and interfer-
ence with gene expression. These are but
a few of the dangers that underlie in-
tractable pain of any origin (Dubner,
1991; Liebeskind, 1991).
Why Pain? Because mismanagement of
pain by the individual or the provider may
lead to infections, loss of muscle mass
and physical strength, progressive physi-
cal deterioration, and a slow spread of the
pain to other areas, eventually involving
the entire body or, at least, large parts of it.
The social cost of the pain problem trans-
lates into broken marriages, alcoholism,
and family violence. The economic cost
of chronic pain translates into absen-
teeism and job loss. The human cost of
chronic pain includes suffering, depres-
sion, and suicide.
For all of these reasons and many more,
we owe it to ourselves and our patients to
understand pain management better.
Karsten F. Konerding, MD
President
Deborah Love
Executive Director
Lara Watson
Editorial Assistant
Duncan MacIvor, MD
Physician Editor
Nothing in medicine is more fundamental
than relieving suffering. Nothing in medi-
cine should be more scrupulously avoid-
ed than making matters worse; hence the
dictum, First, do no harm. Nothing in
medicine better displays the tension be-
tween these imperatives than the proper
treatment of pain.
Nor are the risks all borne by the patient.
In recent years, physicians have been
sued, disciplined, or prosecuted, not only
for overprescribing or otherwise misus-
ing, abusing, or diverting opioids, but
also for underprescribing, the latter
doubtless occasioned by fear of the
former. Excessive zeal for avoiding even
the appearance of impropriety leads to
the opposite error of permitting needless
suffering.
Opioids and related drugs clearly relieve
suffering when used appropriately. Just as
clearly, they pose threats of toxicity and
addiction when mishandled. The chal-
lenge is to treat pain effectively while
avoiding complications and staying out of
trouble. What is a
beneficent healer to
do? Boning up on a
knotty problem is always a good
beginning.
This special issue of RAMifications ex-
amines the interface between the pharma-
cological treatment of pain and the field
of substance-abuse medicine. Articles by
experts in various disciplines will review
the pathophysiology, psychology, and
pharmacology of pain and substance
abuse, the rational use of pain relievers,
and the distinctions between drug-seek-
ing and relief-seeking behavior, as well
as administrative, legal, and law-enforce-
ment aspects of pain therapy.
There is a prevalent perception that the
line between use and abuse of opioid
pain relievers is finer than it really is. In a
perfect world, of course, there would be
no need for such drugs. In the next best
world, all use of opioids would be legiti-
mate, and the patients who really need
them could reliably get all they need.
That sort of world should be our aim.

Christina Weber The Richmond Academy of Medicine Board of Trustees extends its
Layout
appreciation to our distinguished honorary editor for his help in
The Richmond Academy of Medicine
1200 East Clay Street this special publication:
Richmond, Virginia 23219
(804) 643-6631 Fax (804) 788-9987
Stephen P. Long, MD
Letters to the editor and editorial
contributions are encouraged, Commonwealth Pain Specialists
subject to editorial review.
Associate Clinical Professor of Anesthesiology
Nonmember subscriptions are Virginia Commonwealth University
available for $20/year.

Richmond Academy of Medicine

2
May 2002
 R A M I F I C AT I O N S

You, Your Patient, and Purdue

Purdue has established the Partners Against Pain program to foster an alliance among

physicians, nurses, pharmacists, and hospice personnel. In addition, Purdue and

Partners Against Pain strive to understand the challenges of patients and their
caregivers in the quest for relief from pain.
The Partners Against Pain program is designed to reach both caregivers and patients to
help ensure that every patient receives adequate pain relief.

Visit our website to learn more about pain

management and prevention:

1999, 2001, Purdue Pharma L.P., One Stamford Forum, Stamford, CT 06901-3431 C6147B&W 4/04

3
May 2002
 R A M I F I C AT I O N S
PainPolitics and Public Perception:
Virginias Experience
Stephen P. Long, MD
Commonwealth Pain Specialists
Associate Clinical Professor of Anesthesiology
Virginia Commonwealth University
Pain is a more terrible lord of mankind
than even death itself.
Albert Schweitzer
The word pain invokes great fear, not
only for patients, but also for providers.
We know intellectually that pain exists;
yet we often dont know how to relieve it,
or we fear public/political scrutiny if we
become outspoken advocates for its erad-
ication from our patients lives. From its
inception over 20 years ago, the Ameri-
can Pain Society has sought to focus the
enthusiasm and energy of health care
providers toward appropriate pain man-
agement, attempting to reverse years of
neglect and disregard of this vital public
health field. Over the last decade, Vir-
ginia has been a national leader in the de-
bate over pain management, providing
direction and stimulating dialogue, and
formulating policy.
The last several years have seen tremen-
dous interest on the part of patients,
third-party payors, state and federal gov-
ernments, licensing organizations, and
physicians of all specialties in the area of
pain medicine and the management of
patients with acute, chronic noncancer-
and cancer-related pain. The emergence
of pain medicine as a specialty in its
own right has brought to light the impor-
tance of education and proper treatment
of pain in all spheres.
Since the initial publication in 1992 of
the Agency for Health Care Policy and
Researchs clinical practice guideline for
acute pain management,1 enormous atten-
4
tion has been paid to a historically neg-
lected, poorly understood, and inade-
quately treated area of patient care. Fol-
lowing the publication of these acute
pain guidelines, the Agency published
similar guidelines concentrating on the
management of cancer pain.2
Despite the fact that, in both acute and
cancer pain, the treatment remains pre-
dominantly the use of opioid analgesics,
the need for other analgesic adjuvants,
both pharmacologic and nonpharmaco-
logic, is also clear. The universal usage
of opioid analgesics in these conditions
has led to much discussion and research
on their role in treating chronic non-
cancer (sometimes referred to as non-
malignant) pain. Despite studies show-
ing their efficacy in chronic pain, legal,
educational, social and historical barriers
often preclude patients and prescribers
alike from using them.3
Historically, sparse legislative and public
policy attention has been devoted to pain
medicine, especially in the area of opioid
regulation. In the late 1980s, pioneers in
opioid regulation, e.g. Stratton Hill,
brought public and legislative awareness
to the concerns surrounding the proper
prescribing authority of opioids. Massa-
chusetts and Texas were leaders in ad-
4, 5
dressing these important concerns.
David Joranson of the University of
Wisconsin has devoted numerous articles
and much professional time to examining
historical and legal aspects of opioid pre-
scriptions for all types of intractable
pain.6, 7 Other internationally known opin-
ion leaders, such as Drs. Katherine
Foley, Russell Portenoy, Howard Fields,
and William Fordyce, have lent promi-
nent voices and viewpoints. Recently,
professional societies, such as the Ameri-
can Pain Society and the American Acad-
emy of Pain Medicine, have issued con-
sensus statements publicizing the need
for aggressive pain management. They
continue to serve as professional re-
sources for elected officials and third-
party payors.8
Unfortunately, at the legislative level,
little has been accomplished in terms of
pain and its global social and financial
implications. Most legislation has dealt
with broad issues in a general sense. In
particular, the issue of opioid use in
chronic noncancer pain has been ad-
dressed repeatedly, but superficially, by
often-conflicting state and federal laws.
For example, prescribing heroin to termi-
nal patients was legal in Virginia until a
recent prohibitive federal law superseded
Virginias law. Laws also may fail to re-
flect the current opinion held by state
medical societies or regulatory boards.
By the mid-1990s, several states had ap-
pointed official pain commissions.9
Virginia was one of the first states to seri-
ously address the topics of acute, chronic,
and cancer pain through a comprehensive
task force-like group. The 1994 Session
of the General Assembly enacted Senate
Joint Resolution 72 and, in cooperation
with the Governors office, appointed a
May 2002

joint subcommittee to study Virginias
laws and policies related to acute and
cancer pain management. The group was
chaired by then-Senator Jane Woods, and
consisted of several House and Senate
members, public lay members, and three
physician members (Drs. Stephen P.
Long, John C. Rowlingson, and Vincent
Speckhart). The eleven-member subcom-
mittee engaged in a lengthy study of all
facets of acute and cancer painbasic
and clinical research; medical education;
patient access to care; payor willingness
to cover pain-related expenses; and the
legal, regulatory, and social barriers to
adequate care.
The first year of study was spent gathering
information. The group heard testimony
from nationally known clinicians and re-
searchers, conducted site visits to pain fa-
cilities, and received input from insurance
carriers (e.g., Medicaid, Medicare, private
third-party payors, managed care
providers) and state regulatory agencies
(e.g., State Police, Boards of Medicine and
Pharmacy). By the end of the first year of
study, it was apparent that further public
information sessions were required, and
that Virginia should assume a national
leadership role in emphasizing the impor-
tance of pain medicine.
In 1995, a legislatively mandated historic
symposium on pain management was
held in Richmond. Hundreds of partici-
pants from around the country engaged in
active dialogue with national thought
leaders in the field of pain management.
Keynote speakers led discussions con-
cerning federal guidelines for managing
acute and cancer-related pain. Other
health care providers from all sectors, as
well as legislators and business leaders,
participated in panel discussions, focus-
ing on areas requiring further attention.
By 1996, it was obvious that the subcom-
mittee should be expanded to include the
May 2002
understudied area of chronic pain. Public
support for the work of the committee re-
mained enthusiastic and strong. In partic-
ular, the group studied the economic im-
pact of chronic pain, as well as third-party
coverage for pain management. Comple-
mentary care techniques also were studied
in detail, including the availability and ac-
ceptance of such techniques in the health
care community. The group received testi-
mony describing that process from the
chairman of the Workers Compensation
Commission.
One of the most significant areas ad-
dressed in the 1996 session was the some-
times-controversial use of opioids in the
management of chronic noncancer pain.
The group heard much testimony about
its efficacy and limitations. In addition,
the Virginia Board of Medicine, led by its
executive director, Dr. Warren Koontz,
took a preemptive stance in educating
Board members on the proper use of opi-
oids to treat patients with chronic non-
cancer pain. The Board became a national
leader with the Federation of State Med-
ical Boards of the United States in provid-
ing information about the Virginia effort
on both political and medical fronts. Con-
currently, the Medical Society of Virginia,
encouraged by the joint subcommittee
and through resolution, appointed a spe-
cial committee to develop and implement
comprehensive guidelines. Due to inade-
quate education about pain, particularly
among physicians, the subcommittee en-
couraged the Medical Society of Virginia
to develop these guidelines, realizing that
the problem of pain treatment originates
at the fundamental level of education of
health professionals, particularly physi-
cians. The subcommittee requested Vir-
ginias medical schools to study and re-
port on the educational process. Because
of the many unanswered questions and
problems associated with the treatment of
pain, the subcommittee felt that its work
R A M I F I C AT I O N S
was far from complete and decided to
continue its work into 1998-99 in order to
resolve the legislation enacted in the pre-
ceding four years.
The joint subcommittees accomplish-
ments are too numerous to list, but the
culmination of the Virginia effort has
been the unprecedented adoption by the
Medical Society of Virginia, the state leg-
islature, and the Board of Medicine, of
the Medical Society of Virginias Guide-
lines for the Use of Opioids in the Man-
agement of Chronic, Non-cancer Pain.
This document, the first of its kind in the
United States, allows physicians to more
comfortably, safely, and intelligently pre-
scribe proper analgesics to sufferers of
chronic pain with less fear of regulatory
repercussion.10, 11
The document reflects the view of Vir-
ginianspatients, physicians, legislators,
administratorsthat physicians have an
obligation to treat patients with in-
tractable pain, reaffirming that opioids
may be appropriately and safely pre-
scribed for many pain conditions pur-
suant to acceptable protocols and stan-
dards. While the guidelines are fairly
specific, the intent was to produce a fluid
document to serve, not as a definitive
practice standard, but as a plastic, dynam-
ic statement, providing the practitioner
with a template for the logical and safe
medical practice of prescribing opioids. It
is anticipated that these guidelines will be
updated to reflect changing and expanded
attitudes and experience.12
Inspired by Virginias accomplishments,
many national organizations sought to ad-
dress the undertreatment of pain. Realiz-
ing the dangers of underutilizing opioids
in chronic pain, the American Pain Soci-
ety and American Academy of Pain Med-
icine issued a consensus statement in
1997 entitled, The Use of Opioids for
Continued on page 6
5
 R A M I F I C AT I O N S
the Treatment of Chronic Pain.13 This
statement eased the friction between ad-
vocates for aggressive pain treatment and
others, such as law-enforcement agen-
cies, medical boards, and providers
themselves, who viewed more skeptical-
ly the prescribing of opioids for chronic
pain. A dialogue began that resulted in
policy changes.
In May 1998, the Federation of State
Medical Boards adopted guidelines en-
dorsing the appropriate use of opioid
analgesics, to clarify the Boards posi-
tion on pain control, specifically as relat-
ed to the use of controlled substances, to
alleviate physician uncertainty and to en-
14
courage better pain management. Many
states have published their own opioid
policy statements.
Unfortunately, by the late 1990s, persis-
tent hesitancy on the part of many physi-
cians to treat pain aggressively brought a
state level issue to national attention.
Oregons physician-assisted suicide law
caused the American Medical Associa-
tion, the American College of Physicians,
the Department of Veterans Affairs, and
others to launch aggressive campaigns to
ensure that physicians are sensitive to the
needs of chronic and terminal pain pa-
tients. The Pain Relief Promotion Act of
1999 was designed to override the assist-
ed suicide laws of Oregon. While this bill
was not enacted, it had the effect of fo-
cusing attention on those who suffer in-
tolerably. Congress and other administra-
tive agencies, particularly the Drug
Enforcement Agency, became engaged in
the debate as the decade of pain manage-
ment began in 1999.
Part of the reason for this national offen-
sive was the perceived and actual abuse
of Schedule II opioids throughout the
eastern United States. While the national
health care pendulum was swinging to-
ward the more liberal use of opioids for
chronic pain, illegal trafficking and
6
diversion of narcotics became rampant at
the turn of the century. State and federal
officials began an aggressive public attack
on the problem in the worst areas of
abuseup and down the Appalachian
Trail, from Alabama to Maine. This in-
tense scrutiny has once again put Virginia
in the national limelight of pain medicine.
Because a significant amount of drug traf-
ficking and diversion first occurred in
Southwest Virginia, in May 2001, then-
Attorney General Mark L. Earley con-
vened a Prescription Drug Abuse Task
Force to study the paradox of balancing
aggressive treatment against the problems
of patient, pharmacy, and physician diver-
sion of opioids. While the impact of the
recommendations of the task force are yet
unclear, national organizations are closely
following Virginias efforts to maintain
this delicate balance. In fact, the Drug
Enforcement Agency continues to advo-
cate for the appropriate treatment of
chronic pain patients and encourages
agencies to eliminate any gray areas that
tend to enhance the illegal trade of opioids.
Congress recently has held hearings at-
tempting to remedy the problem. Virginia
continues to play a prominent role. The
jury is still out concerning how patients
can be best protected, physicians less
threatened, and pain preemptively and ag-
gressively eliminated with minimal illicit
involvement.
Yet, it is omnipresent in 2002 that pain
continues to be undertreated, underdiag-
nosed, and misunderstood. Pain remains
the primary reason that patients seek
medical treatment. The majority of
medical students, however, have limited
training in the appropriate treatment for
these patients.15 Similarly, most law-
enforcement officials and legislators
have equally limited understanding of
the tremendous financial, physical, and
psychological impact which stems from
the undertreatment of pain, and view the
use of opioids from the standpoint of ad-
diction and diversion. Dialogue on this
quandary must persevere.
The fact that undertreatment of pain per-
sists, despite nearly three decades of ef-
forts to educate providers, underscores
the tensions outlined above. Pain has
been identified as an important barrier to
the good of health of not only the patient
but also the entire health care system. To
emphasize the scope of this problem and
the urgency to fix the situation of un-
dertreating pain, the Joint Commission on
Accreditation of Healthcare Organiza-
tions, in 2000, mandated that all accredit-
ed facilities devise a plan to educate, as-
sess, and treat patients suffering from
pain.16
Through the historical efforts of the joint
subcommittee, the Medical Society of
Virginia Pain Committee, the Board of
Medicine, the state legislature, the offices
of the Governor and Attorney General of
Virginia, and of groups such as the Rich-
mond Academy of Medicine, Virginia
continues to be a national leader and role
model, by supporting and recommending
educational and legislative activities to
raise the level of awareness of the
provider community with respect to pain
and its management. It is widely recog-
nized that pain, not unlike all of medical
care, cannot be legislated. Neither can
medical care operate independently of
laws necessary to ensure the protection of
the public. Virginia realizes that it can
make pain management more accessible
to its citizens, by taking steps to ensure
that (1) patients are treated by practition-
ers who endorse contemporary methods
of pain therapy, (2) third-party payors in-
clude payment for pain specialty treat-
ment and interventions, and (3) dialogue
and education continue to occur between
health care providers and law-enforce-
ment officials.
May 2002

The cost of pain is astronomicalin 3R.K. Portenoy, Opioid therapy for chronic
human, economic, psychosocial, and nonmalignant pain: a review of the critical
issues, 11 J. PAIN & SYMPTOM MGMT.
legal terms. All patients should expect to 203-17 (1996).
receive appropriate pain therapy. 4Medical Practice Act of Texas art. 4495(c)
Providers must not be intimidated by cur- (1989).
rent legal public opinion and misconcep- 5Mass. Bd. Reg. in Med., Prescribing prac-
tion when it comes to appropriate thera- tices policy and guidelines adopted,
py. Virginia will continue to address the 4 News 1-2 (1989).
6D.E. Joranson, Intractable pain treatment
problem of pain at all levels, and looks
laws and regulations, 5:2 A.P.S. BULL.
forward to sharing its experience, both 1-17 (Mar./Apr. 1995).
perceptively and politically, with those 7D.E. Joranson, State medical board guide-
willing to recognize the problem.17
lines for treatment of intractable pain,
5:3 A.P.S. BULL. 1-5 (May/June 1995).
References
8Am. Acad. Pain Med., The Use of Opioids
1U.S. DEPT HEALTH & HUMAN SERV.,
for the Treatment of Chronic Pain 1-4
AGENCY FOR HEALTH CARE POLY & RES. (Spring Spec. Supp. 1997) (consensus
PUB. NO. 92-0032, CLINICAL PRACTICE statement).
GUIDELINE ACUTE PAIN MANAGEMENT: OPER-
9S.P. Long, The work of Virginias joint sub-
ATIVE OR MEDICAL PROCEDURES AND TRAUMA
(Rockville, Md., Feb. 1992). committee studying laws and policies relat-
ed to acute and cancer pain, 6:3 A.P.S.
2U.S. DEPT HEALTH & HUMAN SERV., AGENCY
BULL. 18 (May/June 1996).
FOR HEALTH CARE POLY & RES. NO. 94-
10S.P Long, Preliminary report of ad hoc
0592, CLINICAL PRACTICE GUIDELINE NO. 9:
MANAGEMENT OF CANCER PAIN (Rockville, committee: pain management, 124 VA.
Md., Mar. 1994). MED. Q. 222-23 (1997).
Trigon Blue Cross Blue Shield is the trade name of Trigon Insurance Company An Independent Licensee of the Blue Cross and Blue Shield Association 2002
The marks of a leader.
May 2002
R A M I F I C AT I O N S
11S.P. Long, MSV house of delegates passes
opioid guidelines, 125 VA. MED. Q. 8-11
(1998).
12W. Koontz, Guidelines for the use of opi-
oids in the management of chronic, non-
cancer pain, 125 VA. MED. Q., supra,
at 11.
13See source cited supra note 8.
14FEDN ST. MED. BDS., MODEL GUIDELINES
FOR THE USE OF CONTROLLED SUBSTANCES
FOR THE TREATMENT OF PAIN 1 pmbl.
(May 2, 1998), available at
http://www.medsch.wisc.edu/painpolicy/
domestic/model.htm.
15N.G. Hoffmann et al., 19 J. ADDICTION
DIS. 1-12 (2000).
16P.H. Berry, J.L. Dahl, Making pain assess-
ment and management a healthcare priority
through the new JCAHO pain standards,
8:2 J. PHARM. CARE IN PAIN & SYMPTOM
CONTROL 5-20 (2000).
17S.P. Long, Painthe public, the politics,
the perception: the Virginia experience, AM.
PAIN SOC. BULL. (May-Aug. 1998).
7
 R A M I F I C AT I O N S
Modern Treatment of Chronic Pain
John Michael Barsanti, MD
Commonwealth Pain Specialists, LLC
In order to understand and appreciate the
rapid advances in pain management, a
historical perspective is needed. In 1992,
the American College of Graduate Med-
ical Education granted the specialty of
anesthesiology a subspecialty board in
pain management. This coincided with
the birth and subsequent proliferation of
pain management physicians and pain
clinics. Prior to this, pain physicians and
clinics were few and predominately locat-
ed in the larger teaching hospitals. Most
physicians and nurses in the community
believed that they could adequately treat
pain; yet they were using outdated tech-
niques that subsequently were proven to
be ineffective. This is not surprising con-
sidering the paucity of classroom time de-
voted to pain management in nursing and
medical schools. As physicians, we re-
ceived most of our training in pain man-
agement during our year of internship.
We were taught that opioids should be
used on a chronic basis only for malig-
nant pain. In acute settings, opioids
should be used sparingly, and on a PRN
basis, not a scheduled basis. The typical
route chosen was intramuscular; other
less traumatic routes (such as PO or intra-
venous) were not considered. We were
taught to use only one or two opioids,
meperidine or morphine, and our PRN
schedule was based on tradition rather
than sound pharmacologic principles. We
accepted the fact that, should the patient
complain or request more pain medicine
than prescribed, he or she was either
weak or drug seeking.
8
The modern tenets of pain management
have challenged successfully, and hence
changed, the practice of medicine. We
now understand that there are many opi-
oids from which to choose, and that the
use of alternative agents has allowed re-
duced dosing of those opioids. Agents
such as injectable NSAIDs, anticonvul-
sants, antidepressants, and sodium chan-
nel blockers allow physicians to match
the drug to the type of pain, thereby
avoiding the use of opioids exclusively.
In the opioid class, most physicians are
moving away from meperidine because
of its active metabolitenormeperi-
dinewhich causes seizures in high
serum concentrations. We are now more
comfortable using morphine, hydromor-
phone (Dilaudid), and even fentanyl.
Our dosing schedule of opioids has
changed from PRN to round the clock.
If the opioids duration of action is four
hours, then our schedule is for every four
hours and not six. We now use oral and
transdermal sustained release opioid
products, which can achieve steady
serum levels and improve compliance.
These are the same factors that have pop-
ularized once-daily medications in other
categories.
Physicians aggressive treatment of pain,
with the right drug at the right time, has
been a major achievement. Pain medi-
cine, however, involves more than phar-
macologic interventions. At the core of
the specialty is the understanding of the
physiological, as well as the psychologi-
cal, components of pain. The physiologi-
cal aspects include understanding the cel-
lular mechanisms of pain, the pain path-
ways in the spinal cord and brain, and
identifying the pain generator. To un-
derstand the generator is the key to treat-
ment. An analogy is to think of a
chemotherapeutic agent, given systemi-
cally, which nonspecifically kills cells.
We are learning of new smart drugs
which can specifically target the offend-
ing tumor. In the same way, we have
treated pain of all kinds with oral and
systemic opioids, whose site of action is
in the brain, with the purpose of masking
or dulling perception of the pain. Ideally,
we want to target our treatment precisely
to the source of pain. This targeted ap-
proach of pain management, and the use
of more advanced techniques, in fact,
takes us even farther away from tradition-
al opioid therapy. Modern treatment of
pain relies on the use of precision injec-
tion techniques and neuromodulation of
pain through implantable devices.
I. Precision Injection Techniques
A. Spinal pain
Spinal anatomy can be divided conve-
niently into three compartments: the pos-
terior, neuraxial, and anterior compart-
ments. Each compartment can be a
source of chronic neck or low back pain,
and the pain often originates from more
than one compartment.1
The posterior compartment contains all
the structures innervated by the dorsal
ramus of the spinal nerve and posterior to
the plane of the transverse process. Pain
May 2002

from the posterior compartment origi-
nates from the paravertebral muscles
and/or the zygapophyseal joints, referred
to simply as facet joints. Treatment of
the muscular component of back pain in-
cludes physical therapy, muscle relax-
ants, mobilization, manipulation and
trigger-point injections. The facet joints
are a common source of low back pain,
but are often ignored. There is little dis-
pute that the joints undergo significant
degeneration as aging occurs. In fact, de-
generative changes were found in two-
thirds of patients under the age of 30 in
cadaveric specimens.2 Disc space nar-
rowing, secondary to degeneration, can
increase the normal weight-bearing load
on the facet joints from a normal 3-25%
to as much as 47%.3 For many patients
with degenerative disc disease, the discs
clearly can be a source of pain. A land-
mark study by Mooney and Robertson
reported that injection of saline into the
facet joints of normal volunteers pro-
duced back and leg pain that subsequent-
ly could be relieved by local anesthetic
injection.4 The ability to diagnose facet
joint pain early can lead to treatment
with corticosteroid injection into the
joint, with quick resolution of pain. On
physical exam, pain with back extension
and lateral rotation, and localized par-
avertebral muscle tenderness, are com-
monly seen with facet pathology.5, 6 There
should be no evidence of nerve root irri-
tation, such as MRI findings of a herniat-
ed disc or physical exam findings consis-
tent with a radiculitis. Unfortunately, the
diagnosis cannot be made by abnormal
findings on MRI or CT scans.7 The gold
standard in the diagnosis of facet joint
pain involves joint injection. Should the
pain relief with corticosteroid injections
be short-lived, the pain physician then
can target the nerves that innervate the
joint. Six to twenty-four months of pain
relief can be achieved by using radiofre-
May 2002
quency to lesion the medial branch of
the dorsal primary rami.
The neuraxial compartment contains all
structures within the epidural space and
neural pathways. To localize neuraxial
pain, the diagnostic goal is to selectively
place anesthetic and corticosteroid into a
limited area of the epidural space. The
traditional epidural technique is a
translaminar approach, directing the nee-
dle between the lamina, and injecting a
large volume of steroid and local anes-
thetic into the epidural space, hoping to
bathe the inflamed nerve root with
steroid. Unfortunately, the injectate may
never reach the target. With fluoroscopi-
cally guided transforaminal injections,
the pain physician can place a needle at
the exact foramen of the injured nerve
root and precisely place the steroid where
needed. This technique aids in both the
diagnosis and treatment of common
radicular symptoms.
The anterior compartment contains the
vertebral bodies and the intervertebral
discs. The intervertebral disc can be a
source of axial low back pain, referred to
as discogenic pain. Lumbar discogenic
pain presents as axial pain with no radic-
ular component. There should be no evi-
dence of disc herniation on MRI. The use
of discography can help identify the disc
as the source of low back pain.8 When
contrast is injected into the disc, both the
chemical stimulus of the contrast, as well
as the mechanical stimulus of the injec-
tion, can elicit pain. At least one control
disc, one that has been injected with con-
trast without eliciting pain, should be in-
jected. Typically, a provocative disc in-
jection indicates disruption of the annular
wall. The patient generally describes pain
similar to his or her typical pain, and CT
scanning post injection can demonstrate
tears in the annular wall. The treatment of
discogenic pain includes the relatively
R A M I F I C AT I O N S
noninvasive procedure of IDET ( intradis-
cal electrothermal therapy), as well as
surgical fusion.
B. Sympathetic pain
Many pain syndromes involve some com-
ponent of the sympathetic nervous sys-
tem. Most notable is the diagnosis of Re-
flex Sympathetic Dystrophy, now known
as Complex Regional Pain Syndrome.
The use of injection techniques to block
the sympathetic nervous system is the
treatment of choice in pain disorders in-
volving the sympathetic nervous system.
II. Neuromodulation
A. Spinal cord stimulation
Spinal cord stimulation can be used for a
variety of painful disease states. The most
common use in the United States is for
patients with low back, leg, or arm pain
following unsuccessful lumbar or cervical
spine surgery. It is also effective for a va-
riety of neuropathic pain conditions, in-
cluding complex regional pain syndrome
and diabetic neuropathy. The use of
spinal cord stimulation is evolving to
treat other diseases, such as intractable
angina, chronic pelvic pain syndromes,
and even stress incontinence. Typically,
the use of spinal cord stimulation is re-
served for patients with severe, unre-
lieved pain, combined with more conser-
vative treatments such as medications and
injections.
B. Intrathecal drug delivery
In the most severe pain disease states, the
use of conventional therapies fails. In
some patients, despite aggressive use of
oral and parenteral opioids and nonopi-
oids, adequate pain relief with an accept-
able side effect profile cannot be achieved.
In these cases, the use of intrathecal ther-
apy is necessary. Opioids are the first
choice for intrathecal use, and morphine
is the most common agent. In addition,
pain practitioners have found that other
Continued on page 10
9
 R A M I F I C AT I O N S

agents can be added to the opioid to in-
crease the analgesia and thereby reduce
the amount of opioid required. Marcaine,
a local anesthetic, is commonly adminis-
tered intrathecally with morphine to aug-
ment the analgesic effect. Clonidine also
has been shown to be effective intrathe-
cally, especially with neuropathic pain
syndromes.
The advances in pain management over
the past 20 years have been astounding.
Our knowledge of the physiological basis
of pain and its pathways is expanding. We
have specific medications, opioids and
nonopioids, to target both the specific type
of pain as well as the pain generator. We
now accept opioids as sometimes neces-
sary for chronic nonmalignant pain. In an
effort to reduce the need for chronic opi-
oids, we have developed precision injec-
tion techniques and neuromodulation
techniques, such as spinal cord stimula-
tion. Modern treatment of pain manage-
ment attempts to target the source of
pain and eradicate it, using all the tech-
niques and pharmaceuticals in our
armamentarium.
References
1R. Derby et al., Precision Percutaneous
Blocking Procedures for Localizing Spinal
Pain, 3 PAIN DIG. 175-88 (1993).
2D. Tobias et al., Human facet cartilage:
Swelling and some physico-chemical char-
acteristics as a function of age, 17 SPINE
694-700 (1992).
3K.H. Yang et al., Mechanism of facet-load
transmission as a hypothesis for low back
pain, 9 SPINE 557 (1984).
4V. Mooney & J. Robertson, The facet syn-
drome, 115 CLIN. ORTHOP. 149-56 (1976).
5T. Helig et al., The lumbar facet syndrome.
13 SPINE 61-64 (1988).
6A. Schwarzer et al., Pain from the lumbar
zygapophysial joints.
7S.W. Wiesel et al., A study of computer as-
sisted tomography: The Incidence of posi-
tive CAT scans in an asymptomatic group
of patients, 9 SPINE 549-51 (1981).
8J. Saal, Management of Chronic Discogenic
Low Back Pain with a Thermal
Intradiscal Catheter, 25:3 SPINE 382-88
(2000).

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10
May 2002

Chronic Pain from a Chemical
Dependence Perspective
Peter R. Coleman, MD
Clinical Assistant Professor
Medical College of Virginia
Medical Director
Outpatient Substance Abuse Services
MCV Family Counseling Center
Chemical dependence is now recognized
as a brain disorder that affects roughly
10% of the general population without
regard to gender, socioeconomic status,
race, or profession. The most useful defi-
nition of chemical dependence is that it
is a disorder characterized by continued
use of mood altering substances, in spite
of negative consequences caused by them.
The cause seems to be a complex inter-
play of bio- and psychosocial factors, but
the most powerful factor seems to be ge-
netic. Approximately 50% of the children
of alcoholics or drug addicts will have a
chemical dependence problem. There also
are animal studies that demonstrate strong
genetic factors affecting the severity of
withdrawal symptoms. In situations of
chronic pain, there is also some evidence
that continued substance use may, over a
period of time, cause permanent brain
changes leading to chemical dependency.
The parts of the brain affected by chemi-
cal dependence include the locus ceruleus
and areas generally referred to as the
pleasure center. An understanding of the
power of chemical dependency may be
gained from studies in which animals are
given free access to a drug, such as co-
caine. Almost all of these animals will die
of starvation within a thirty-day period.
Thus, chemical dependence is a disorder
of the primitive brain. The animals desire
for the drug effect is so strong that it over-
powers basic biological drives, including
the drive to eat and sustain life. While ini-
tial drug use may be a willful act, by the
May 2002
time drug dependence sets in, continued
drug use is largely outside of conscious
control.
Chronic pain and withdrawal states
Chronic pain is a condition that has many
negative consequences will be severely
causes. It frequently leads to continued
narcotic use and then a state of physical
dependence on opiate drugs. When narcot-
ic use is stopped, a withdrawal syndrome
sets in. Narcotic withdrawal is character-
ized by the opposite of the acute narcotic
effects. There is total body pain, diarrhea,
dilated pupils, sweats, cold chills, and in-
tense dysphoriaa profound sense of total
discomfort. Most addicts are unable to tol-
erate this on their own, and the success
rate for enduring the withdrawal period is
very low. There appear to be three phases
to withdrawal. The first is acute withdraw-
al, which lasts from five-to-ten days and
has the most intense withdrawal symp-
toms. Following this, there appears to be
a subacute period of slow improvement,
lasting one-to-eight weeks and consisting
of a powerful sense of fatigue, depression,
and insomnia. The third phase, or protract-
ed withdrawal, is mild, but persists with
low-level symptoms up to two years.
Withdrawal severity is extremely variable.
It appears that people who have a genetic
tendency for chemical dependency have a
much stronger attachment of narcotics to
the brain receptors and a much more in-
tense withdrawal.
Unfortunately, in some instances, chronic
narcotic use seems to actually create an in-
R A M I F I C AT I O N S
crease in pain levels. The brains natural
pain-killing system, the endorphin-
enkephalin system, seems to be negatively
affected by chronic narcotic use. Because
of homeostasis, the brain seems to shut off
its own pain-relieving system, causing
pain to actually increase whenever the
brain level of narcotics starts falling.
Approach to chronic pain patients
Because 10% of the population has a
chemical dependence problem, it seems
obvious that some chronic pain patients
will have a problem with narcotics. Their
management will be more difficult and
their ability to control drugs and not suffer
impaired. My recommendations for the
approach to chronic pain patients includes
the following:
1. Obtain the best possible history, physi-
cal and special test results. If necessary,
refer to specialists in order to make the
most accurate diagnosis of the true pain
state. It is important to determine the
exact nature, expected severity and du-
ration of the pain, and what drugs are
usually needed for these patients.
2. Determine if there is any past history of
substance use or abuse. What is the pat-
tern of narcotic and other mood-alter-
ing substance use in this episode of dis-
ease? Has there been past use, abuse, or
negative consequences with narcotics,
alcohol or other drugs? Has there been
any past attendance at NA, AA, coun-
seling, or other drug treatment pro-
grams? Is there a family history of sub-
stance abuse? Usually, it is necessary to
interview family members to obtain the
most accurate information to these
questions.
3. Decide on a course of action in treating
this pain. If there is evidence of a past
or present chemical dependency prob-
Continued on page 12
11
 R A M I F I C AT I O N S
lem, all attempts should be made to use
nonnarcotic pain medicines. If nar-
cotics or other mood-altering drugs are
needed, strict monitoring will be neces-
sary, and patients should use the least
abusable drugs possible. If there is a
history of moderate abuse, I usually try
to convince the patient and family to try
nonnarcotic use as much as possible. I
also try to make them understand and
agree that, if they will withstand some
current discomfort, their long-term pain
levels will decrease. If there is no evi-
dence of abuse, it is easy to use nar-
cotics, but remember that uncontrolled
chronic narcotic use may lead to physi-
cal dependence and addiction.
Nonnarcotic treatment modalities
Nonnarcotic modalities vary depending
on the cause of the pain. Chronic painful
headaches may be treated acutely with
triptans, nonsteroidals, Tylenol, self-injec-
tions of Toradol, Trilafon, and other drugs.
Prophylactic medicines for headaches are
well outlined in literature. Chronic back
pain usually may be managed with inten-
sive physical therapy, epidural steroids,
trigger-point injections, acupuncture, re-
laxation techniques, accupressure, etc.
When the decision to use narcotics is
made, these nontreatment modalities
should be chosen to minimize the chance
of abuse. Generally, the longer acting
drugs, while having a longer withdrawal
state whenever detoxification is needed,
are also less abusable. Therefore,
methadone is probably the best choice.
Fentanyl patches may also be useful. Fre-
quently, a combination of a long-acting
narcotic, such as methadone, with small
amounts of short-acting drugs, like Perco-
cet, may be helpful for breakthrough pain.
If there is evidence of prescription abuse, I
usually shorten the interval between office
visits. For serious abuse, such as forging
prescriptions, visiting other doctors, etc., I
ask them to seek help elsewhere or even
12
call the police if there is evidence of legal
improprieties.
Pain use and recovering patients
Frequently, patients will tell their doctors
that they are in recovery from chemical de-
pendency. Sometimes, these patients need
narcotics for short-term treatment, includ-
ing acute surgery, kidney stones, dental
procedures, etc. In my experience, when
patients are truthful about these needs and
are willing to follow through with a couple
of simple suggestions, they have no prob-
lem getting readdicted to medicines.
Specifically, I involve either a spouse or an
AA support person to monitor the frequen-
cy of medicine use, and I make sure the
prescribing physician is aware of their past
problem. They should go home with as
small a prescription as possible. I schedule
frequent visits or phone calls in the first
week or two, merely to ask how many nar-
cotics they are using. We use maximum
doses of nonnarcotic analgesics and have
the patients stop narcotics as soon as possi-
ble. In my experience, when people do
these simple things, there is hardly a prob-
lem with anyone becoming readdicted to
narcotics.
New detox methods
The standard detox method for narcotics is
to slowly taper the narcotics over one-to-
eight weeks. Unfortunately, this is fre-
quently unsuccessful because it is still very
painful, and patients often cannot tolerate
the discomfort, especially when they know
that taking a few more narcotics will make
them feel much better. I have now devel-
oped an outpatient detox method that ac-
celerates that process, decreases the dis-
comfort, and has a 95% successful detox
rate. By treating patients with large doses
of Buprenex and benzodiazepines, I can
complete the detox in two-to-three days. It
is a similar process to the rapid detoxifica-
tion under anesthesia (ultra-rapid detoxifi-
cation) but is much safer and better tolerat-
ed by patients. At the end of the detox, I
implant a specially formulated preparation
of naltrexone, a narcotic antagonist. This
pellet is implanted subcutaneously and
dissolves slowly, guaranteeing abstinence
from all narcotics for six-to-ten weeks.
Can chronic implantable Naltrexone
actually treat chronic pain?
Naltrexone is a drug that blocks the endor-
phin receptor system. It will precipitate
immediate and complete withdrawal if any
opiates are left attached to the receptors,
and it will then completely block any nar-
cotic effect, if narcotics are used. For over
three years, I have been performing accel-
erated detoxifications of patients who have
chronic pain and are physically dependent
on their narcotics. Usually, these patients
know they have had a chemical dependen-
cy problem and are aware that they are
now abusing the drugs and that the origi-
nal pain is no longer particularly severe. I
have been completing their detox in one-
to-three days and then implanting a form
of naltrexonea pellet that slowly dis-
solves subcutaneously and provides nal-
trexone therapy for six weeks. I have per-
formed this procedure in over twenty
patients who have had various forms of
chronic pain, including back pain, mi-
graines, trigeminal neuralgia, and RSD. In
every case, patients have completely
stopped taking their narcotics and have re-
ported that their pain is either dramatically
improved or is no worse. All of these pa-
tients are delighted to be free of narcotics.
They have all reported an increased sense
of energy and clarity of thought, and dra-
matic improvement in their depression and
overall well-being. Almost always, their
pain is dramatically less than when they
were on large doses of narcotics. My sense
is that, once we implant the naltrexone, it
removes their ability to use narcotics and,
thus, their brain stops craving. Their en-
dorphin-enkephalin system is able to re-
turn to normal.
May 2002
 R A M I F I C AT I O N S

The Pharmacology of Opioids

Michael Weaver, MD
Assistant Professor of Internal
Medicine and Psychiatry
Department of Internal Medicine
Medical College of Virginia
Virginia Commonwealth University
Deborah Haller, PhD
Professor of Psychiatry
Department of Psychiatry
Medical College of Virginia
Virginia Commonwealth University
Corresponding Author:
Martha J Wunsch, MD
Assistant Professor of Psychiatry
Department of Psychiatry
Medical College of Virginia
Virginia Commonwealth University

Opioidsnaturally occurring alkaloids
derived from the poppy planthave long
been valued for their analgesic efficacy.
They currently are available in natural
(morphine, codeine) and synthetic (hy-
dromorphone, fentanyl) formulations for
medicinal use and also are procured illic-
itly for abuse. The beneficial effects of
opioids include analgesia, changes in
mood including euphoria, a general de-
crease in anxiety, and a decreased re-
sponse to adverse physical and psycho-
logical stimuli. Side effects of the opioids
include somnolence, mild cognitive diffi-
culties, insomnia, muscle twitching, itch-
ing, nausea, vomiting, and constipation.
Adverse effects on the autonomic nervous
system include vasodilatation and subse-
quent hypotension and depression of the
respiratory center. Respiratory depres-
sion, rare in the setting of a patient with
severe acute pain, is more likely to occur
in the opioid-naive individual. Tolerance
develops to both the beneficial and ad-
verse effects of opioids, though at differ-
ent rates. Acclimation to the euphoric
effects occurs before sedation and analge-
sia, while tolerance to respiratory depres-
sion occurs much later. Physical depend-
ence, manifested by the development of
withdrawal symptoms upon abrupt cessa-
tion of opioids, occurs after seven-to-ten
days of administration of the drug. A
patient who is physically dependent on
opioids is not addicted. Patients with
pain who are adequately treated with
opioids will evidence improvement of
their overall quality of life; in contrast,
the consequences of opioid abuse can be
devastating. To meet the diagnostic crite-
ria of addiction to opioids, or any psy-
choactive substance, an individual must
also display compulsive use, continued
use despite harm, impaired control over
the drug, and craving.
Opioids are active by binding to recep-
tors on cell membranes in the central
nervous system, gut, and musculoskeletal
tissues. The primary receptors identified
in humans are labeled mu and kappa.
These are responsible for differing effects
and are present in varying concentrations
throughout human tissues. Opioids are
classified as full agonists or partial ago-
nists, reflecting efficacy and potency at
these receptors. Morphine is a full mu ag-
onist and, therefore, is very potent in in-
ducing analgesia and euphoria. Partial
agonists, such as buprenorphine, may
have less abuse potential due to a thresh-
old effect. Antagonist opioids, such as
naloxone, precipitate withdrawal in phys-
ically dependent individuals through re-
ceptor blockade mechanisms. Typically,
they are not used for pain management
but, rather, for reversal of respiratory de-
pression due to opioid overdose.
The bioavailability of opioids varies
across preparations. While all are metab-
olized primarily in the liver and excreted
by the kidneys, they differ in onset and
length of activity depending on the drug
itself, the specific formulation, and mode
of administration. Heroin and morphine
have a rapid twenty-to-thirty minute
onset of action for both analgesia and eu-
phoria and a relatively short duration of
action (three-to-four hours). When given
parenterally, morphine will provide anal-
gesia for two-to-four hours and, when
given in an oral controlled-release formula-
tion, may be effective for twenty-four
hours. Methadone, a long-acting opioid,
may require seventy-two hours of dosing
to achieve a therapeutic level but will pro-
vide analgesia for six-to-eight hours. Fen-
tanyl, short acting in the parenteral form, is
active for seventy-two hours when admin-
istered through a transdermal patch.
The amount and frequency of dosing will
vary among patients. Dosage should be
titrated to an effective level of analgesia
with minimum side effects. A patient
who is still experiencing pain, but ap-
pears euphoric or sedated, may require a
change to a different opioid. Because of
variability in doses among opioids, clini-
cians must be aware of equianalgesic
dosages. If a patient requires a different
opioid or route of administration, the cli-
nician may calculate an equianalgesic
dose and schedule based on known
bioavailability. Opioids produce incom-
plete cross-tolerance due to subreceptor
variability and individual patient differ-
ences; therefore, when changing to a dif-
Continued on page 14

13
May 2002
 R A M I F I C AT I O N S

ferent opioid, it is best to start with two- in improved quality of life. Another con- When shifting to a different opioid
thirds of the calculated equianalgesic cern is co-morbid addiction. Although pa- drug, remember that there is not 100%
dosage. The patient may then be titrated tients with both pain and addiction may cross-tolerance between different opi-
up to a therapeutic dosage if necessary. benefit from opioid therapy, they require oids. Use equianalgesic conversions
The Table lists several short- and long- thorough evaluation and careful monitor- and reduce the dose by 33%.
acting opioids, their onset and duration of ing by an addiction specialist with knowl-
Do not administer an antagonist or ag-
action across formulations, and suggested edge of pain if they are to have good out-
onist/antagonist to a patient main-
dosage ranges. In addition, it lists the comes. In summary, an understanding of
tained on opioids, as it will abruptly
equianalgesic dosages across different the pharmacology of opioids, coupled
induce withdrawal.
drugs and routes of administration. with sound clinical principles, can result
in improved care for the patient with pain. Bibliography
When opioids are used to treat addiction,
the dosing differs. Patients who are being Clinical Bullets A.W. Graham, T.K. Schultz eds. Princi-
treated for pain will require multiple ples of Addiction Medicine. 2d ed. Chevy
The effective analgesic dose should be
dosages throughout the day to achieve Chase, Md: American Society of Addic-
determined by patient response and
therapeutic analgesic effects. Methadone tion Medicine, Inc., 1998.
side-effect profile, as there are no de-
must be given every six-to-eight hours to
fined maximum dosages (titrate the J.G. Hardman et al. eds. Goodman &
achieve analgesia. In contrast, in the
dose based on effect, not number of Gilmans the pharmacological basis of
treatment of opioid addiction, methadone
milligrams). therapeutics. 10th ed. New York: Mc-
is administered every twenty-four hours,
Graw-Hill Medical Publishing Division,
and patients achieve a suppression of The development of tolerance to opi-
2001.
craving without euphoria. Receptor activ- oids necessitates gradual tapering
ity at the cellular level is responsible for when they are discontinued.
this variation in efficacy. A patient main-
tained on methadone for addiction who
develops pain will not have adequate pain
control if provided only with a once-daily
dose of this opioid.
Pain patients using opioids may benefit
from the addition of adjuvant medica-
tions. Salicylic acid and acetaminophen
often are formulated with opioids for this
purpose. In addition, patients may benefit
from the addition of a COX-2 inhibitor.
For patients with neuropathic pain, mem-
brane stabilizers, such as gabapentin, car-
bamazepine, and valproate, may help
lower pain levels. Tricyclic antidepres-
sants and other antidepressants may also
improve outcomes.
Not all patients are candidates for opioid
maintenance therapy. Decreases in pain
severity in the absence of any improve-
ment in functioning are considered prob-
lematic, as relief from pain should result

14
May 2002
 R A M I F I C AT I O N S
The Diagnosis and Treatment of Headache
Alan R. Towne, MD
Professor and Chair of Neurology
MCV Hospitals and Physicians of the
Virginia Commonwealth University
I. Epidemiology and Impact of Headache
Headache is a common and sometimes
disabling condition which accounts for
approximately 5%-10% of outpatient vis-
its to primary care physicians and 20% of
outpatient visits to neurologists. Migraine
headaches affect 18% of women and 6%
of men in the United States. It begins be-
fore the age of twenty in half of sufferers,
with a prevalence that is highest in ages
twenty-five to fifty-five.
II. Establishing the Diagnosis
Headaches are classified as either pri-
mary or secondary headaches. Primary
headaches are benign, often recurrent and
are not secondary with any known under-
lying pathology. Secondary headaches
are caused by an underlying medical con-
dition, such as infectious or intracranial
pathology.
A. Primary Headaches: The most com-
mon primary headaches are mi-
graine,with and without aura, cluster
headache, and tension-type headache.
i. Migraine with aura: This type of
migraine is associated with an aura
that generally develops gradually
over greater than four minutes,
characterized usually by visual,
sensory or motor symptoms. The
headache usually follows the aura
but may also begin before, or si-
multaneously with, the aura. The
16
pain is usually unilateral, of a pul-
sating quality, moderate or severe
intensity, aggravated by exercise. It
usually is associated with nausea
and/or vomiting, photophobia and
sonophobia. It should be remem-
bered that not all the characteristics
need to be present to classify the
headache as migraine.
ii. Migraine without aura: This type
of migraine has all the characteris-
tics of migraine with aura except
that the aura is not present.
iii. Tension-type headache: This type
of headache is characterized by a
pressing/tightening (nonpulsating)
quality, which is of mild or moder-
ate intensity, usually bilateral, and
generally not aggravated by exer-
cise. Nausea or vomiting is not
present. Photophobia or sonopho-
bia might be present but not
simultaneously.
iv. Cluster headache: This type of
headache generally is seen in
males and occurs in clusters lasting
15-180 minutes, if untreated. It is a
severe unilateral, orbital or super-
orbital pain that is severe. It may
be associated with conjunctival in-
jection, lacrimation, nasal conges-
tion, rhinorrhea, facial sweating,
myosis, ptosis and eyelid edema.
B. New Headache Evaluation
i. Obtain a complete headache histo-
ry, including age of onset, frequen-
cy, precipitating factors, location,
severity, duration of pain, presence
of an aura, headache pattern, and
medications used during the pain.
Other things that should be consid-
ered in the history include other
chronic illnesses or conditions, al-
lergies or sensitivities to medica-
tions, sleep habits, family history
of headaches, and recent life
stressors.
ii. Physical examination to evaluate
any potential red flags, such as
confusion, weakness, sensory loss,
pupillary asymmetry, papilledema,
Babinski response, signs of
meningeal irritation, progressive
visual or neurological changes, and
other evidence to suggest an under-
lying neurological disorder.
iii. Perform diagnostic testing, if ap-
propriate, including blood tests
such as CBC, ESR or C-reactive
protein. Lumbar puncture if
pseudotumor cerebri or infectious
etiologies are entertained. It is not
necessary to perform neuroimaging
procedures in all patients who
present with headache. The pres-
ence of red flags, however,
may make the use of CT or MRI
indicated.
May 2002

iv. Determine working diagnosis and
differential diagnosis.
v. Establish treatment goals and
expectations with patient.
vi. Review diagnosis, treatment
plan, and specific instructions
with patient.
vii. Arrange follow-up care.
III. Managing the Patient with Headache
A. Nonpharmacological Approaches
i. Counseling and psychotherapy in
patients with co-morbidity, such as
depression and anxiety. Psychiatric
consultation may be indicated as
an adjunct to medication.
ii. Relaxation techniques and bio-
feedback. Biofeedback may be
used either alone or in conjunction
with other approaches, such as
medication.
iii. Exercise will help promote proper
sleep patterns and also may reduce
headache frequency and intensity.
iv. Neural blockade. Nerve blocks,
such as greater occipital nerve
blocks, may be helpful in certain
patients. Studies have demonstrat-
ed that the injection of botulinium
toxin may reduce the intensity and
severity of headaches.
v. Acupuncture: Some studies have
demonstrated that patients may
obtain benefits with this technique
when performed by properly
trained practitioners.
vi. Limit factors that may influence
the onset or severity of headaches,
such as fasting/missing meals, hor-
mones, excessive noises, and di-
etary factors (ripened cheeses,
sausage, citrus foods, alcoholic
beverages, etc.).
May 2002
R A M I F I C AT I O N S
vii.Other nonpharmacological ap- c) Frequent headaches (> 2 attacks
proaches include physical therapy, per week).
ultrasound, transcutaneous electri-
d) Uncommon migraine conditions,
cal nerve stimulation, and thera-
such as basilar migraine.
peutic massage. Some of these
techniques are still in their experi- e) Patient preference.
mental stages and have not been IV. Conclusions
shown to be effective in controlled
trials. Headache is a common condition that, in
some patients, is disabling and accounts
B. Pharmacological Approaches for frequent use of medical resources.
i. Abortive therapies. (summarized in The burden of migraine is substantial and
Table 1). The goal of abortive ther- greatest for the most severely affected
apy is to rapidly resolve the mi- sufferers. Despite improvements in diag-
graine attack, hopefully without re- nosis and effective treatments, migraine
currence and to restore the patients remains underdiagnosed and undertreat-
ability to function. Daily or near ed. There are, however, many effective
daily use of abortive medications treatments available.
may not be recommended because Table 1, summarizing selective abortive
of possible liver, kidney or GI toxi- therapies, appears on page 18.
city. Frequent use of some abortive
therapies may lead to habituation Table 2, summarizing selected prophylac-
or the development of rebound tic therapies appears on pages 19 and 20.
headache. Some headache experts,
however, use NSAIDs as both
abortive and prophylactic agents.
Acute migraine medications in-
clude NSAIDs, combination anal-
gesics, opioids, antiemetics, and
corticosteroids. Specific agents in-
clude ergotamine and the triptans.
The triptans are more effective in
migraine and cluster headaches
than in tension-type headaches.
ii. Preventive therapies (summarized
in Table 2). Prophylactic treatment
should be considered when:
a) The migraine significantly inter-
feres with the patients daily rou-
tine despite acute agents.
b) The acute medications are con-
traindicated, ineffective, or have
intolerable adverse effects.
17
 R A M I F I C AT I O N S
TABLE 1 SELECTED ABORTIVE THERAPIES
Medication
COMBINATION THERAPIES
aspirin, 250 mg.; acetaminophen, 250 mg.; 2 tablets stat (p.o.). May cause rebound
caffeine, 65 mg.
Isometheptene mucate, 65 mg.; 2 capsules stat, then 1 q 1 hour to a max of 5 capsules/24 hour
dichloralphenazone, 100 mg.; acetaminophen, 325 OR 2 capsules stat, then repeat 2 capsules in 1 hour. Generic
mg (p.o.)* versions may not be equivalent to Midrin
Butabital 1 tab q 4-6 hours p.r.n. May cause rebound headache
Hydrocodone/acetaminophen or 1 tab q 4-6 hours p.r.n. May cause rebound headache
oxycodone/acetominophen
NSAIDS
NSAIDS may be combined with migraine specific therapies
without vasoconstriction occurring
Acetylsalicylic acid 650 mg. stat (2 regular strength tablets) (p.o.)
Diclofenac 50-100 mg. (p.o.)
Flurbiprofen 100 mg. stat; repeat in 1 hour p.r.n.
Ibuprofen 1200 mg. stat; 600 mg. every hour p.r.n.; max 2400 max/day
Ketoprofen 100 mg. stat; 50 mg. p.r.n. in 1 hour
Ketorolac 60 mg. (IM); limit use to one dose
Meclofenamate 200 mg. stat; repeat x 1 after one hour (p.o.)
Naproxen Sodium 825 mg. stat; repeat 275 mg. in 1 hour p.r.n.
Rofecoxib 25 mg. stat; repeat in 4 hours p.r.n; max 50 mg./day
ACUTE ABORTIVES
**Ergotamine tartrate, 2 mg. sublingual One tablet under tongue at earliest sign of headache; may repeat
every 30 minutes to a max of 3 tablets/24 hours or 5
tablets/week
**Ergotamine tartrate, 1 mg., and caffeine, 100 Two tablets at earliest sign of headache; may repeat one tablet
mg. (p.o.) every 30 minutes, up to 6 tablets/24 hours, 10 tablets/week
**Ergotamine tartrate, 2 mg., and caffeine, 100 Begin with one-quarter to one-half suppository; may repeat dose
mg. (per rectum) in 60 minutes; max 4 mg./24 hours, and 10 mg./week with four-
day hiatus between treatment days
*Sumatriptan succinate, 6 mg. subQ injection 1 injection at onset of headache phase of attack; max
subcutaneous dosage 12 mg. (2 injections)/24 hours, at least 1
hour apart.
Sumatriptan intranasal 20 mg. intranasal stat; repeat in 2 hours p.r.n.; max 40 mg./day
*Sumatriptan succinate, 25 mg., 50 mg., and 100 25-100 mg. at onset of headache phase; greater response rates
mg. available (p.o.) occur with 50 mg. and 100 mg., and 100 mg. orally; if no
satisfactory response within 2 hours, repeat dose every 2 hours;
for recurrence, an additional p.o. dose may be repeated; oral
response rates somewhat lower than subcutaneous or intranasal
routes; max 300 mg./day
*Zolmitriptan, 2.5 mg. and 5 mg. available (p.o.) 2.5-5 mg. at onset of headache phase of attack; repeat dose every
2 hours p.r.n.; max 10 mg./day
ANTIEMETICS
Chlorpromazine, 50 mg. rectal suppository Give one time
Metoclopramide, 10 mg. (p.o.) or 10 mg. slow IV Give by itself or 10 mg. may be given (p.o.) 30 minutes prior to
push NSAIDS or ergots
Prochlorperazine, 10 mg. slow IV push or 25 mg. Give one time; IV administration more effective than rectal
rectal suppository suppository at these doses
OTHER
Oxygen 7-10 l/minute for approximately 10 minutes by face mask

*Triptans are contraindicated in presence of uncontrolled hypertension, history of MI, ischemic or structural
heart disease, cerebrovascular disease, peripheral vascular disease, hepatic or renal impairment, and basilar or
hemiplegic migraine. Triptans should not be used within 24 hours of treatment with ergot-type drugs and other
triptan drugs.
**Ergots are contraindicated in the presence of uncontrolled hypertension, history of MI, ischemic or structural
heart disease, cerebrovascular disease, peripheral vascular disease, hepatic or renal dysfunction, sepsis or
pregnancy, and basilar or hemiplegic migraine. Ergots should not be used within 24 hours of treatment with
triptans and other ergot-type drugs.

18
May 2002
 R A M I F I C AT I O N S
TABLE 2SELECTED PROPHYLACTIC THERAPIES
Medication Doses/Route Clarification

Beta blockers with partial agonist activity have not May cause fatigue, depression, bradycardia, and decreased sexual ability.
been shown to have efficacy in migraine Avoid use in asthma, COPD, and CHF, heart block greater than first degree.
prophylaxis Check for numerous drug interactions
Atenolol 25-100 mg./day (p.o.)
Metoprolol 100-200 mg./day (p.o.)
Nadolol 20-120 mg./day (p.o.)
Propranolol 60-160 mg./day (p.o.)
Timolol 10-20 mg./day (p.o.)
CALCIUM ENTRY BLOCKERS May cause hypotension, constipation, nausea, flushing, light-headedness,
edema
Diltiazem 96-360 mg./day (p.o.)
Nimodipine 30 mg. t.i.d.
Nicardipine 20-30 mg. b.i.d.-t.i.d. (p.o.)
Verapamil 120-480 mg./day (p.o.)
NSAIDS
Acetylsalicylic acid One 325 mg. tablet every other day
Celecoxib 100-200 mg. b.i.d.
Fenoprofen 600 mg. t.i.d. (p.o.)
Flurbiprofen 100 mg. b.i.d. or t.i.d. (p.o.)
Ketoprofen 75 mg. t.i.d. (p.o.)
Nabumetone 1000 mg. (QD (p.o.))
Naproxen 250-500 mg. b.i.d. (p.o.)
Rofecoxib 12.5-25 mg. once daily
TRICYCLIC ANTIDEPRESSANTS Some drugs in this category have not been studied in controlled clinical
headache trials, although clinical experience shows good effect in selected
Nonsedating: patients. Cost and side effect potential should be considered
Desipramine 25-150 mg./day (p.o.)*
Protriptyline 5-30 mg./day (p.o.)*
May be given in divided doses, with the largest portion of daily dose given
Sedating: at bedtime
Amitriptyline 10-150 mg./day (p.o.)*
Doxepin 10-150 mg./day (p.o.)*
Imipramine 10-150 mg./day (p.o.)*
Nortriptyline 10-150 mg./day (p.o.)*
SELECTIVE SEROTONIN REUPTAKE Side effects may include nausea, diarrhea, insomnia, agitation, sexual
INHIBITORS dysfunction
Fluoxetine 10-80 mg./day (p.o.). Fluoxetine has not been shown to be effective in
migraine prophylaxis in a published clinical study*
Fluvoxamine 50-100 mg./day (p.o.)
Paroxetine 20-60 mg./day (p.o.)
Sertraline 50-200 mg./day (p.o.)
OTHER ANTIDEPRESSANTS
Bupropion 200-300 mg./day. Side effects may include CNS agitation and seizures*
(p.o.)
Nefazadone 200-600 mg./day (p.o.). Side effects may include nausea, constipation,
dizziness, dry mouth, fatigue, insomnia, asthenia and agitation*
Trazodone 50-300 mg./day. Use in males may result in priapism
Venlafaxine 75-225 mg./day (p.o.). Side effects may include nausea, constipation,
dizziness, dry mouth, fatigue, insomnia, asthenia, seizures, and agitation*

19
May 2002
 R A M I F I C AT I O N S
TABLE 2 (CONT.)

ANTICONVULSANTS
Divalproex sodium 250-1000 mg./day (p.o.). Avoid in patients with liver disease; liver function
tests should be done prior to and during therapy if clinical symptoms
warrant; weight gain and alopecia possible; may cause pancreatitis and
polycystic ovaries; use with caution in women of child-bearing potential
Gabapentin 300-900 mg./day
Tiagabine 8-32 mg./day
Topiramate 25-150 mg./day. May cause renal stones
SPECIAL USE THERAPIES
Methylergonovine 0.2 mg b.i.d.-q.i.d. (p.o.); max before one month drug holiday is 4-6 months
Phenobarbital, 40 mg.; ergotamine tartrate, 0.6 1 tablet b.i.d. or 1 tablet q.h.s. (p.o.). May cause rash, fatigue, and dry
mg.; belladonna alkaloids (Bellafoline), 0.2 mg. mouth; may be utilized for menstrual migraine
Cyproheptadine Max 4-8 mg q.i.d. (p.o.); begin with 4-8 mg q.h.s., increase to maximum
dose p.r.n. Commonly used in children, often causes weight gain, sedation
and other anticholinergic effects
Methysergide 2 mg b.i.d.-q.i.d. (p.o.) max use before one month drug holiday 6 months.
Fibrotic complications, peripheral ischemia, hallucinations, and peptic
ulcer disease can occur
MAO Inhibitor: Phenelzine requires intensive 15-60 mg/day (p.o.). Significant food and drug interactions; ingestion of
patient education and cooperation large amounts of tyramine may result in hypertensive crisis, MI, or
cerebrovascular accident; allow 14 days between use of tricyclics or
other antidepressants; fluoxetine must be discontinued for at least 5 weeks
before initiating MAO Inhibitor therapy
Isocarboxazid 10-40 mg/day (p.o.). Significant food and drug interactions; ingestion of
large amounts of tyramine may result in hypertensive crisis, MI, or
cerebrovascular accident; allow 14 days between use of tricyclics or
other antidepressants; fluoxetine must be discontinued for at least 5 weeks
before initiating MAO inhibitor therapy
ALTERNATIVE THERAPIES
Feverfew Herbal therapies are difficult to predict for consistent efficacy due to lack of
standardization in the preparations; may interact with other herbal, over the
counter and prescription medications; should be used with the full
knowledge of the physician
Magnesium 400-600 mg/day
Riboflavin (Vitamin B2) 400 mg/day
*Must allow 14 days after discontinuing use of MAOs to begin use

Tables 1 and 2 from US Headache Consortium Guidelines

20
May 2002
 Now we can enjoy our lives together,
without chronic pain getting in the way.

Life, uninterrupted.
DURAGESIC is indicated for patients in chronic pain who require Patients prefer* the DURAGESIC
continuous opioid analgesia and whose pain cannot be managed
by lesser means such as acetaminophen-opioid combinations, patch. DURAGESIC only needs
nonsteroidal analgesics, or p.r.n. dosing with short-acting opioids.
NOTE: Since elderly, cachectic, or debilitated patients may have altered to be applied once every 3 days,
pharmacokinetics due to poor fat stores, muscle wasting, or altered
clearance, they should not be started on DURAGESIC doses higher than maintains consistent serum levels
25 mcg/hr unless they are taking more than 135 mg/day of oral morphine
or equivalent dose of another opioid. over 72 hours,1 and has a favorable
The most common adverse experiences included nausea (23%), vomiting
(22%), somnolence (17%), constipation (14%), diaphoresis (14%), dry side-effect profile. So give your
mouth (13%), confusion (13%), asthenia (12%), anorexia (8%), dizziness
(7%), and nervousness (6%). Many patients were receiving other regimens, patients a life uninterrupted by
including chemotherapy and radiation.
Please see adjacent page for brief summary of full Prescribing Information,
chronic pain.
including Boxed Warning. Reference: 1. Southam MA. Transdermal fentanyl therapy: system design, pharmacokinetics and efficacy.
Anticancer Drugs. 1995;6(suppl 3):29-34.
*Data obtained from 40 patients in clinical trials at a 1-month follow-up evaluation. Previous analgesic regimens
www.duragesic.com included immediate-release oxycodone preparations and short- and long-acting morphine preparations.
Before prescribing, please consult complete prescribing information of which the following is a brief summary.
BECAUSE SERIOUS OR LIFE-THREATENING HYPOVENTILATION COULD OCCUR, DURAGESIC (FENTANYL TRANSDERMAL
SYSTEM) IS CONTRAINDICATED:
In the management of acute or post-operative pain, including use in out-patient surgeries
In the management of mild or intermittent pain responsive to PRN or non-opioid therapy
In doses exceeding 25 g/h at the initiation of opioid therapy
(See CONTRAINDICATIONS for further information.)
DURAGESIC SHOULD NOT BE ADMINISTERED TO CHILDREN UNDER 12 YEARS OF AGE OR PATIENTS UNDER 18
YEARS OF AGE WHO WEIGH LESS THAN 50 KG (110 LBS) EXCEPT IN AN AUTHORIZED INVESTIGATIONAL RESEARCH
SETTING. (See PRECAUTIONS - Pediatric Use.)
DURAGESIC is indicated for treatment of chronic pain (such as that of malignancy) that:
Cannot be managed by lesser means such as acetaminophen-opioid combinations, non-steroidal analgesics,
or PRN dosing with short-acting opioids and
Requires continuous opioid administration.
The 50, 75, and 100 g/h dosages should ONLY be used in patients who are already on and are tolerant to opioid therapy.
INDICATIONS AND USAGE
DURAGESIC (fentanyl transdermal system) is indicated in the management of chronic pain in patients who require continuous
opioid analgesia for pain that cannot be managed by lesser means such as acetaminophen-opioid combinations, non-steroidal
analgesics, or PRN dosing with short-acting opioids.
DURAGESIC should not be used in the management of acute or postoperative pain because serious or life-threatening
hypoventilation could result. (See BOX WARNING and CONTRAINDICATIONS.)
In patients with chronic pain, it is possible to individually titrate the dose of the transdermal system to minimize the risk of
adverse effects while providing analgesia. In properly selected patients, DURAGESIC is a safe and effective alternative to
other opioid regimens. (See DOSAGE AND ADMINISTRATION.)
CONTRAINDICATIONS
BECAUSE SERIOUS OR LIFE-THREATENING HYPOVENTILATION COULD OCCUR, DURAGESIC (FENTANYL TRANSDERMAL
SYSTEM) IS CONTRAINDICATED:
In the management of acute or post-operative pain, including use in out-patient surgeries because there is no oppor-
tunity for proper dose titration (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION),
In the management of mild or intermittent pain that can otherwise be managed by lesser means such as
acetaminophen-opioid combinations, non-steriodal analgesics, or PRN dosing with short-acting opioids, and
In doses exceeding 25 g/h at the initiation of opioid therapy because of the need to individualize dosing by titrating
to the desired analgesic effect.
DURAGESIC is also contraindicated in patients with known hypersensitivity to fentanyl or adhesives.
WARNINGS
DURAGESIC (FENTANYL TRANSDERMAL SYSTEM) SHOULD NOT BE ADMINISTERED TO CHILDREN UNDER 12 YEARS
OF AGE OR PATIENTS UNDER 18 YEARS OF AGE WHO WEIGH LESS THAN 50 KG (110 LBS) EXCEPT IN AN AUTHORIZED
INVESTIGATIONAL RESEARCH SETTING. (See PRECAUTIONS-Pediatric Use.)
PATIENTS WHO HAVE EXPERIENCED ADVERSE EVENTS SHOULD BE MONITORED FOR AT LEAST 12 HOURS AFTER
DURAGESIC REMOVAL SINCE SERUM FENTANYL CONCENTRATIONS DECLINE GRADUALLY AND REACH AN APPROXIMATE
50% REDUCTION IN SERUM CONCENTRATIONS 17 HOURS AFTER SYSTEM REMOVAL.
DURAGESIC SHOULD BE PRESCRIBED ONLY BY PERSONS KNOWLEDGEABLE IN THE CONTINUOUS ADMINISTRATION
OF POTENT OPIOIDS, IN THE MANAGEMENT OF PATIENTS RECEIVING POTENT OPIOIDS FOR TREATMENT OF PAIN, AND
IN THE DETECTION AND MANAGEMENT OF HYPOVENTILATION INCLUDING THE USE OF OPIOID ANTAGONISTS.
THE CONCOMITANT USE OF OTHER CENTRAL NERVOUS SYSTEM DEPRESSANTS, INCLUDING OTHER OPIOIDS, SEDATIVES
OR HYPNOTICS, GENERAL ANESTHETICS, PHENOTHIAZINES, TRANQUILIZERS, SKELETAL MUSCLE RELAXANTS, SEDATING
ANTIHISTAMINES, AND ALCOHOLIC BEVERAGES MAY PRODUCE ADDITIVE DEPRESSANT EFFECTS. HYPOVENTILATION,
HYPOTENSION AND PROFOUND SEDATION OR COMA MAY OCCUR. WHEN SUCH COMBINED THERAPY IS CONTEM-
PLATED, THE DOSE OF ONE OR BOTH AGENTS SHOULD BE REDUCED BY AT LEAST 50%.
ALL PATIENTS SHOULD BE ADVISED TO AVOID EXPOSING THE DURAGESIC APPLICATION SITE TO DIRECT EXTERNAL
HEAT SOURCES, SUCH AS HEATING PADS OR ELECTRIC BLANKETS, HEAT
LAMPS, SAUNAS, HOT TUBS, AND HEATED WATER BEDS, ETC., WHILE
WEARING THE SYSTEM. THERE IS A POTENTIAL FOR TEMPERATURE-
DEPENDENT INCREASES IN FENTANYL RELEASE FROM THE SYSTEM. (See
PRECAUTIONS - Patients with Fever/External Heat.)
PRECAUTIONS
General
DURAGESIC (fentanyl transdermal system) doses greater than 25 g/h are too
high for initiation of therapy in non-opioid-tolerant patients and should not be
used to begin DURAGESIC therapy in these patients. (See BOX WARNING.)
DURAGESIC may impair mental and/or physical ability required for the
performance of potentially hazardous tasks (eg, driving, operating machinery).
Patients who have been given DURAGESIC should not drive or operate danger-
ous machinery unless they are tolerant to the side effects of the drug.
Patients should be instructed to keep both used and unused systems out of
the reach of children. Used systems should be folded so that the adhesive
side of the system adheres to itself and flushed down the toilet immediately
upon removal. Patients should be advised to dispose of any systems remaining
from a prescription as soon as they are no longer needed. Unused systems should be removed from their pouch and flushed
down the toilet.
Hypoventilation (Respiratory Depression)
Hypoventilation may occur at any time during the use of DURAGESIC.
Because significant amounts of fentanyl are absorbed from the skin for 17 hours or more after the system is removed, hypo-
ventilation may persist beyond the removal of DURAGESIC. Consequently, patients with hypoventilation should be carefully
observed for degree of sedation and their respiratory rate monitored until respiration has stabilized.
The use of concomitant CNS active drugs requires special patient care and observation. (See WARNINGS.)
Chronic Pulmonary Disease
Because potent opioids can cause hypoventilation, DURAGESIC (fentanyl transdermal system) should be administered with
caution to patients with pre-existing medical conditions predisposing them to hypoventilation. In such patients, normal analgesic
doses of opioids may further decrease respiratory drive to the point of respiratory failure.
Head Injuries and Increased Intracranial Pressure
DURAGESIC should not be used in patients who may be particularly susceptible to the intracranial effects of CO2 retention
such as those with evidence of increased intracranial pressure, impaired consciousness, or coma. Opioids may obscure the
clinical course of patients with head injury. DURAGESIC should be used with caution in patients with brain tumors.
Cardiac Disease
Fentanyl may produce bradycardia. Fentanyl should be administered with caution to patients with bradyarrhythmias.
Hepatic or Renal Disease
At the present time insufficient information exists to make recommendations regarding the use of DURAGESIC in patients
with impaired renal or hepatic function. If the drug is used in these patients, it should be used with caution because of the
hepatic metabolism and renal excretion of fentanyl.
Patients with Fever/External Heat
Based on a pharmacokinetic model, serum fentanyl concentrations could theoretically increase by approximately one third for
patients with a body temperature of 40C (104F) due to temperature-dependent increases in fentanyl release from the system
and increased skin permeability. Therefore, patients wearing DURAGESIC systems who develop fever should be monitored
for opioid side effects and the DURAGESIC dose should be adjusted if necessary.
ALL PATIENTS SHOULD BE ADVISED TO AVOID EXPOSING THE DURAGESIC APPLICATION SITE TO DIRECT EXTERNAL
HEAT SOURCES, SUCH AS HEATING PADS OR ELECTRIC BLANKETS, HEAT LAMPS, SAUNAS , HOT TUBS, AND HEATED
WATER BEDS, ETC., WHILE WEARING THE SYSTEM. THERE IS A POTENTIAL FOR TEMPERATURE-DEPENDENT INCREASES
IN FENTANYL RELEASE FROM THE SYSTEM.
Drug Interactions
Central Nervous System Depressants
When patients are receiving DURAGESIC, the dose of additional opioids or other CNS depressant drugs (including benzo-
diazepines) should be reduced by at least 50%. With the concomitant use of CNS depressants, hypotension may occur.
Agents Affecting Cytochrome P450 3A4 Isoenzyme System
CYP3A4 Inhibitors: Since the metabolism of fentanyl is mediated by the CYP3A4 isozyme, coadministration of drugs that
inhibit CYP3A4 activity may cause decreased clearance of fentanyl. The expected clinical results would be increased or
prolonged opioid effects. Thus patients coadministered with inhibitors of CYP3A4 such as macrolide antibiotics (e.g.,
erythromycin), azole antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritanovir) while receiving DURAGESIC
should be carefully monitored and dosage adjustment made if warranted.
CYP3A4 Inducers: Cytochrome P450 inducers, such as rifampin, carbamazepine, and phenytoin, induce metabolism and as
such may cause increased clearance of fentanyl. Caution is advised when administering DURAGESIC to patients receiving
these medications and if necessary dose adjustments should be considered.
Drug or Alcohol Dependence
Use of DURAGESIC in combination with alcoholic beverages and/or other CNS depressants can result in increased risk to
the patient. DURAGESIC should be used with caution in individuals who have a history of drug or alcohol abuse, especially if
they are outside a medically controlled environment.
Ambulatory Patients
Strong opioid analgesics impair the mental or physical abilities required for the performance of potentially dangerous tasks such
as driving a car or operating machinery. Patients who have been given DURAGESIC should not drive or operate dangerous
machinery unless they are tolerant to the effects of the drug.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Because long-term animal studies have not been conducted, the potential carcinogenic effects of DURAGESIC are unknown.
There was no evidence of mutagenicity in the Ames Salmonella typhimurium mutagenicity assay, the primary rat hepatocyte
unscheduled DNA synthesis assay, the BALB/c-3T3 transformation test, the mouse lymphoma assay, the human lymphocyte
and CHO chromosomal aberration in-vitro assays, or the in-vivo micronucleus test.
Pregnancy -- Pregnancy Category C
Fentanyl has been shown to impair fertility and to have an embryocidal effect in rats when given in intravenous doses 0.3
times the human dose for a period of 12 days. No evidence of teratogenic effects has been observed after administration of
fentanyl to rats. There are no adequate and well-controlled studies in pregnant women. DURAGESIC should be used during
pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery
DURAGESIC is not recommended for analgesia during labor and delivery.
Nursing Mothers
Fentanyl is excreted in human milk; therefore DURAGESIC is not recommended for use in nursing women because of the
possibility of effects in their infants.
Pediatric Use
The safety and efficacy of DURAGESIC in pediatric patients have not been established. (See BOX WARNING and
CONTRAINDICATIONS.)
DURAGESIC SHOULD NOT BE ADMINISTERED TO CHILDREN UNDER 12 YEARS OF AGE OR PATIENTS UNDER 18 YEARS
OF AGE WHO WEIGH LESS THAN 50 KG (110 LBS) EXCEPT IN AN AUTHORIZED INVESTIGATIONAL RESEARCH SETTING.
Geriatric Use
Information from a pilot study of the pharmacokinetics of IV fentanyl in geriatric patients indicates that the clearance of fentanyl
may be greatly decreased in the population above the age of 60. The relevance of these findings to transdermal fentanyl is
unknown at this time.
Since elderly, cachectic, or debilitated patients may have altered pharmacokinetics due to poor fat stores, muscle wasting, or
altered clearance, they should not be started on DURAGESIC doses higher than 25 g/h unless they are already taking more
than 135 mg of oral morphine a day or an equivalent dose of another opioid (see DOSAGE AND ADMINISTRATION).
Information for Patients
A patient instruction sheet is included in the package of DURAGESIC systems dispensed to the patient.
Disposal of DURAGESIC
DURAGESIC should be kept out of the reach of children. DURAGESIC systems should be folded so that the adhesive side of
the system adheres to itself, then the system should be flushed down the toilet immediately upon removal. Patients should
dispose of any systems remaining from a prescription as soon as they are no longer needed. Unused systems should be
removed from their pouches and flushed down the toilet.
If the gel from the drug reservoir accidentally contacts the skin, the area should be washed with clear water.
ADVERSE REACTIONS
In post-marketing experience, deaths from hypoventilation due to inappropriate use of DURAGESIC (fentanyl transdermal
system) have been reported. (See BOX WARNING and CONTRAINDICATIONS.)
Pre-marketing Clinical Trial Experience:
The safety of DURAGESIC has been evaluated in 357 postoperative patients and 153 cancer patients for a total of 510
patients. Patients with acute pain used DURAGESIC for 1 to 3 days. The duration of DURAGESIC use varied in cancer
patients; 56% of patients used DURAGESIC for over 30 days, 28% continued treatment for more than 4 months, and 10%
used DURAGESIC for more than 1 year.
Hypoventilation was the most serious adverse reaction observed in 13 (4%) postoperative patients and in 3 (2%) of the cancer
patients. Hypotension and hypertension were observed in 11 (3%) and 4 (1%) of the opioid-naive patients.
Various adverse events were reported; a causal relationship to DURAGESIC was not always determined. The frequencies
presented here reflect the actual frequency of each adverse effect in patients who received DURAGESIC. There has been no
attempt to correct for a placebo effect, concomitant use of other opioids, or to subtract the frequencies reported by placebo-
treated patients in controlled trials.
The following adverse reactions were reported in 153 cancer patients at a fre-
quency of 1% or greater; similar reactions were seen in the 357 postoperative
patients studied.
Body as a Whole: abdominal pain*, headache*
Cardiovascular: arrhythmia, chest pain
Digestive: nausea**, vomiting**, constipation**, dry mouth**, anorexia*,
diarrhea*, dyspepsia*, flatulence
Nervous: somnolence**, confusion**, asthenia**, dizziness*, nervousness*,
hallucinations*, anxiety*, depression*, euphoria*, tremor, abnormal coordina-
tion, speech disorder, abnormal thinking, abnormal gait, abnormal dreams,
agitation, paresthesia, amnesia, syncope, paranoid reaction
Respiratory: dyspnea*, hypoventilation*, apnea*, hemoptysis, pharyngitis,
hiccups
Skin and Appendages: sweating**, pruritus*, rash, application site reaction
- erythema, papules, itching, edema
Urogenital: urinary retention*
* Reactions occurring in 3% - 10% of
DURAGESIC patients
** Reactions occurring in 10% or more of DURAGESIC patients
The following adverse effects have been reported in less than 1% of the 510 postoperative and cancer patients studied; the
association between these events and DURAGESIC administration is unknown. This information is listed to serve as alerting
information for the physician.
Cardiovascular: bradycardia
Digestive: abdominal distention
Nervous: aphasia, hypertonia, vertigo, stupor, hypotonia, depersonalization, hostility
Respiratory: stertorous breathing, asthma, respiratory disorder
Skin and Appendages, General: exfoliative dermatitis, pustules
Special Senses: amblyopia
Urogenital: bladder pain, oliguria, urinary frequency
Post-Marketing Experience:
The following adverse reactions reported to have been observed in association with the use of DURAGESIC and not reported
in the pre-marketing adverse reactions section above include:
Body as a Whole: edema
Cardiovascular: tachycardia
Metabolic and Nutritional: weight loss
Special Senses: blurred vision
DRUG ABUSE AND DEPENDENCE
Fentanyl is a Schedule II controlled substance and can produce drug dependence similar to that produced by morphine.
DURAGESIC (fentanyl transdermal system) therefore has the potential for abuse. Tolerance, physical and psychological
dependence may develop upon repeated administration of opioids. Iatrogenic addiction following opioid administration is
relatively rare. Physicians should not let concerns of physical dependence deter them from using adequate amounts of
opioids in the management of severe pain when such use is indicated.
OVERDOSAGE
Clinical Presentation
The manifestations of fentanyl overdosage are an extension of its pharmacologic actions with the most serious significant
effect being hypoventilation.
Treatment
For the management of hypoventilation immediate countermeasures include removing the DURAGESIC (fentanyl transdermal
system) system and physically or verbally stimulating the patient. These actions can be followed by administration of a specific
narcotic antagonist such as naloxone. The duration of hypoventilation following an overdose may be longer than the effects of the
narcotic antagonist's action (the half-life of naloxone ranges from 30 to 81 minutes). The interval between IV antagonist doses
should be carefully chosen because of the possibility of re-narcotization after system removal; repeated administration of naloxone
may be necessary. Reversal of the narcotic effect may result in acute onset of pain and the release of catecholamines.
If the clinical situation warrants, ensure a patent airway is established and maintained, administer oxygen and assist or control
respiration as indicated and use an oropharyngeal airway or endotracheal tube if necessary. Adequate body temperature and
fluid intake should be maintained.
If severe or persistent hypotension occurs, the possibility of hypovolemia should be considered and managed with appropriate
parenteral fluid therapy.
Manufactured by: Distributed by: 7500315
ALZA Corporation, Janssen Pharmaceutica Products, L.P. Revised January 2000, February 2001
Mountain View, CA 94043 Titusville, NJ 08560 Janssen 2001

Trigeminal Neuralgia
Robert F. Saul, MD
Associate Professor of Neurology and Neuro-Ophthalmology
Department of Neurology
Virginia Commonwealth University Health System
MCV Hospitals & Physicians
I am discussing Trigeminal Neuralgia
(TN) in this special edition on pain man-
agement for several reasons. First, al-
though most physicians are familiar with
the classic entity, tic douloureux, it still
comes clinically cloaked in enough guis-
es to present a diagnostic challenge. Sec-
ondly, there are really no better tests
than the history, physical examination,
and neuroimaging to reach a correct diag-
nosis. Thirdly, I wish to review the treat-
ment of this disabling entity.
According to Fromm, quoting Leriche,
the only tolerable pain is someone elses
pain.1 And, attributed to Proust, we are
willing to procrastinate with all our sen-
sory perceptions except painpain we
obey instantly.2 These quotations offer
an analogy of some of the office encoun-
ters between physicians and their patients
with TN.
By definition, TN is a disorder of the sen-
sory divisions of the fifth cranial nerve,
characterized by brief, excruciating
paroxysms of stabbing knife-like, or elec-
tric shock-like, bursts of pain in the cuta-
neous distribution of one or more branch-
es of this nerve. The incidence is four to
five per 100,000 population and 1% of
multiple sclerosis (MS) patients. About
2-3% of TN patients have MS.
May 2002
The painful paroxysms are more common
in the maxillary and mandibular divisions
of the trigeminal nerve. They may be
triggered by light tactile stimulation (fin-
ger touch, shower spray, shaving, eating,
drinking, or brushing ones teeth), and
are preceded by a brief latent period fol-
lowing the stimulus. The neurological ex-
amination is normal, unless signs of CNS
dysfunction or cranial neuropathy are
present, as seen in patients with MS,
skull base tumors, or aneurysmal dilata-
tions of the carotid and vertebral-basilar
arterial systems.
The earliest description of TN is said to
be from the eleventh century, and inter-
estingly, the etiology was attributed to
vascular compression, a concept accepted
today. Nicholas Andre, in 1756, is credit-
ed with coining the term tic douloureux,
and providing the first comprehensive
clinical description.3 His first patient is
said to have had several teeth extracted in
an attempt to treat an infection of the
maxillae, a scenario still not uncommon
even today. In his paper, Andre explained,
What had been regarded as
the end of a mild and tolerable ail-
ment, became the source of the
sharpest and most uncomfortable
pains, I would say the start of a tic
douloureux, that assailed her night
R A M I F I C AT I O N S
and day, deprived her of sleep, and
forbade her some of the bodily
functions necessary for life.4
In fact, these periodic agitations became
so frequent, they allowed only five or six
minutes of peace during an entire hour;
the patient could not drink, eat, cough,
spit, or wipe her face without renewing
all her pains.5 From this clinical picture,
one can easily envision the agony these
patients endure.
Abnormal central or peripheral nervous
system function, in the trigeminal root,
has been suggested in the pathogenesis of
TN. The primary abnormality also may
be found in the trigeminal ganglion.
Compression of the blood vessels induces
ephaptic transmission (or ectopic pulse
generation) by demyelinating trigeminal
root sites, or by indirectly altering pain-
inhibiting circuits in the trigeminal nucle-
us. Even though the exact pathogenesis of
TN is not known, we can effectively treat
patients pharmacologically and surgically.
Voltaires remark of doctors pour drugs,
of which they know little, for diseases of
which they know less, into patients of
whom they know nothing, not so long
ago would have been quite appropriate to
the treatment of TN.6 Phenytoin was just
discovered in 1938. In 1942, Bergouigo-
Continued on page 24
23
 R A M I F I C AT I O N S
nan, building on Trousseaus deduction
that paroxysmal trigeminal nerve dis-
charges were similar to the paroxysmal
cerebral activity in epilepsy, employed
phenytoin as the first truly effective drug
in the treatment of TN.7 Today, with the
addition of newer first-line agents,
phenytoin has taken a back seat.
Currently, carbamazepine is probably the
most effective pharmacological agent, but
has potential dose-limiting side effects.
Gabapentin has been a very useful drug in
my own practice, with low toxicity and a
wide dose range. Baclofen is a good sec-
ond-line drug, which has been in use
since 1980, and we now have three newer
anticonvulsants, topiramate, oxcarbazine,
and lamotrigine. Misoprostol, a
prostaglandin E analogue, has shown
promise in treating TN in patients with
MS.8 One must remember that TN is a re-
lapsing and remitting disorder, and con-
tinuous long-term pharmacological treat-
ment is not warranted without attempts at
drug holidays.
If the neurological examination is normal,
neuroimaging is unremarkable, and ade-
quate drug therapy fails, surgical options
may be highly beneficial. Percutaneous
radiofrequency gangliolysis and rhizoto-
my, retrogasserian glycerol injections,
and microvascular decompression are all
effective. It is theorized that the mi-
crovascular decompression works by re-
activating herpes simplex virus and gan-
glion neuron transcription alteration,
causing a controlled injury of the trigemi-
nal root or ganglion.9 More recently,
24
stereotactic radiosurgery employing 60- ed patients, but I have yet to encounter
90 Gy has been achieving good results in this extreme situation in my practice. In
some difficult cases.10 the case of drug allergy, baclofen, topira-
mate, and lamotrigine are useful adjuncts.
In over twenty years of treating people
After three-to-six months of successful
with facial pain, I rarely see the classic
therapy, I titrate the drug backwards, to
case of isolated tic douloureux. Many pa-
see if a spontaneous remission has oc-
tients have an indolent chronic discom-
curred. If adequate medication fails, neu-
fort in one or more regions on one side of
rosurgical consultation is advised.
their face, which usually adheres to the
appropriate dermatomes. The constant
discomfort is accentuated by more typical
References:
brief paroxysms of pain. These parox-
1G. Fromm, B.J. Sessle eds. Trigeminal Neuralgia.
ysms of a burning or electrical sensation Boston: Butterworth-Heineman, 1991.
suggest neuralgia, which warrants a trial 2Id.
of anticonvulsants. Always ask about tac-
3Id.
tile triggers and dental pathology.11 One
4Id. at 2.
must ask about a history of facial cancer
5Id. Fromm, supra
or MS. In my experience, concomitant
formications, cutaneous analgesia, 6Id.
diplopia, or persistent indolent epistaxis 7Id.
are harbingers of more invasive or com- 8A.T. Reder, B.G.W. Arnason, Trigeminal
pressive skull-base lesions which require Neuralgia in Multiple Sclerosis relieved by a
prostaglandin E analogue, 45 NEUROLOGY
endoscopic paranasal sinus examination,
1097-1100 (1995).
cranial MRI, and sometimes sinus or
9Id.
skull-base CT.
10D. Kondziolka et al., Stereotactic radiosurgery
If there are no confounding factors, I start for the treatment of Trigeminal Neuralgia, 18
CLIN. J. PAIN 42-47 (2002).
the patient on gabapentin, 100-300 mg.
11W.P. Cheshire, The Shocking Truth About Trigem-
t.i.d., and increase it weekly, to a maxi-
inal Neuralgia. 342 N. ENGL. J. MED.
mal dose of 1200 mg. t.i.d., depending on 2003 (2000).
the response. If no improvement is seen,
or the pain is unbearable from the begin-
ning, I use carbamazepine, beginning at
200 mg. a day, and increase it every few
days to a range of 600-800 mg./day in
three divided doses, measuring serum
drug levels, before elevating the dosing
further. Intravenous fosphenytoin has
been used to quickly load severely affect-
May 2002
 R A M I F I C AT I O N S

Distinguishing Between Chronic Pain

and Drug-Seeking Behavior in Pain
Management/Opioid Abuse
Michael Weaver, MD
Assistant Professor of Internal Medicine and Psychiatry
Division of General Medicine and Primary Care
Medical College of Virginia, Virginia Commonwealth University

Pain is the most common complaint con-
veyed to physicians by patients. Ten to six-
teen percent of outpatients seen by general
practitioners and twenty-five to forty per-
cent of hospitalized patients have prob-
lems related to drug or alcohol addiction.1
No firm conclusions may be drawn about
the rate of addiction that results from pa-
tient abuse of pain-requiring opioids, be-
cause medical literature is inconsistent
concerning the study of patient popula-
tions or definitions of addiction.2-8 Drug-
seeking behavior may be due to addiction
or undertreatment of pain. Despite harmful
consequences, addicted patients display a
loss of control with continued drug use,
which eventually will become apparent to
the observant physician.
Manifestations of drug-seeking behavior
Drug-seeking behavior may manifest as
aggressive complaints about the need for
more pain medication, or phone calls at
night or on weekends when a physician is
more likely to order a prescription. Pa-
tients may request specific medications by
name, such as Demerol, or use pain med-
ication to treat another symptom, such as
anxiety or insomnia. On occasion, patients
may escalate the dose without a doctors
permission or obtain similar medications
from an emergency department or another
physician.
Undertreatment of pain may lead to drug-
seeking behavior by the patient. The mani-
festation of drug-seeking behavior to
achieve pain relief is known as pseudoad-
diction.9 It will disappear if the patients
pain is controlled adequately. To avoid
pseudoaddiction, believe that the patients
complaints are legitimate, but continue to
observe the patient closely to determine
whether the present therapy is beneficial.
Some types of drug-seeking behavior may
be more predictive of prescription medica-
tion abuse due to addiction.10 These include
multiple episodes of lost prescriptions;
multiple dose escalations without prior au-
thorization, despite warnings that this is in-
appropriate; and concurrent alcohol or il-
licit drug abuse. Evidence of deteriorating
work performance and family relation-
ships, or reduction of social activities due
to the effects of medication, may indicate
consequences of addiction. More flagrant
behaviors, such as stealing or borrowing
medication from others, or obtaining pre-
scription drugs from nonmedical sources
(the street), demonstrate a level of des-
peration that is more consistent with addic-
tion. Injection of an oral formulation of a
prescription medication is risky behavior
that indicates loss of control by the patient.
These behaviors should prompt the physi-
cian to immediately address the possibility
of addiction with the patient.
Differentiating drug-seeking behavior
It is difficult to differentiate an addicted pa-
tient who escalates the dose of medication
to obtain euphoria from a nonaddicted pa-
tient with undertreated pain, since both ex-
hibit drug-seeking behavior. The initial
course of action for the physician should
be to provide the patient with that which he
requestsmore pain medication. Starting
at the lowest dose, with long intervals be-
tween analgesic doses, may prolong un-
necessarily the time within which to
reach effective analgesia. This may
prompt some patients to resort to drug-
seeking behavior. Observation of individ-
ual patient behavior will aid in distin-
guishing between pseudoaddiction and
addiction. The distinction may not be ob-
vious during the first few visits, but will
become apparent as the physician learns
more about the patient through subse-
quent visits and adjustment of the opioid
dose.
A nonaddicted patient experiencing pain
will stop escalating the opioid dose once
the pain is controlled. Often, patients will
decrease the dose slightly as they become
comfortable and feel that the physician
will continue adequate dosage of the
medication. Patients who use analgesics
appropriately for pain control will not
show signs of addiction if given adequate
doses to control pain. These patients
focus primarily on side effects with the
goal of maintaining function. Tolerance
to the analgesic effects of opioids does
not develop rapidly in patients who are
medicated adequately for pain;11 however,
selective tolerance develops quickly to
euphoric effects, thereby requiring larger
doses to achieve the same effects. An ad-
dicted patient usually will escalate the
opioid dose to try to achieve euphoria.
Signs of intoxication may become appar-
Continued on page 26

25
May 2002
 R A M I F I C AT I O N S
ent, such as sedation and confusion, but the
patient will continue to request larger doses
and focus solely on the dosage rather than
side effects or consequences. Addicted pa-
tients often will focus on taking opioids
rather than following recommendations for
other forms of treatment. These differences
in behavior pattern help physicians differ-
entiate pseudoaddiction from addiction.
Monitoring for addiction
Most pain problems will not improve for
patients who abuse alcohol, drugs, or pain
medication. Therefore, physicians should
make a conscious effort to identify and ad-
dress addiction.12 Physicians can actively
monitor for signs of medication misuse.
Count the amount of remaining opioid
medication at each office visit to determine
whether the patient has used all available
doses. Obtain random urine drug screens
for the presence of illicit drugs or controlled
substances not prescribed by the physician.
Urine screening verifies whether the patient
is taking the prescribed medication. Infor-
mation provided by the patients family or
friends about the patients behavior outside
the physicians office may be addressed di-
rectly with the patient. Physicians should
view with suspicion patients who claim that
their previous physician has retired or make
excuses why previous charts are not avail-
able. The physician is under no regulatory
or legal obligation to prescribe on demand
or at the first visit. This prevents patients
with a criminal intent from walking into the
office and immediately receiving large
doses of controlled substances. Many phar-
macists will call physicians to alert them to
the problem of receiving prescriptions to be
filled from several sources.13 Document on
the patients chart any inappropriate behav-
ior regarding pain medications, along with
a plan for follow-up discussion with the pa-
tient or closer monitoring.
26
Dealing with addiction 7D.A. Fishbain et al., Drug abuse, dependence and
For less serious addiction problems, it is addiction in chronic pain patients, 8 CLIN. J. PAIN
77-85 (1992).
appropriate to initiate closer monitoring
8K. Kouyanou et al., Medication misuse, abuse
with more frequent visits and to limit the
and dependence in chronic pain patients, 43
amount of medication prescribed at a time. J. PSYCHOSOMATIC RES. 497-504 (1997).
Referral of the patient for specific addic- 9D.E. Weissman & J.D. Haddox, Opioid
tion treatment may be appropriate. In cases pseudoaddiction: an iatrogenic syndrome,
36 CLIN. J. PAIN 363-66 (1989).
of health-endangering behavior or crimi-
10R.K. Portenoy, Opioid therapy for chronic
nal activity, such as prescription forgery or
nonmalignant pain: current status, in 1
diversion of controlled substance medica- PROGRESS IN PAIN RESEARCH AND MANAGEMENT,
tions, the physician must stop providing PHARMACOLOGICAL APPROACHES TO THE TREATMENT
OF CHRONIC PAIN: NEW CONCEPTS AND CRITICAL ISSUES
opioids due to the risk of continued abuse.
(IASP Pub., H.L. Fields & J.C. Liebeskind eds.,
Concerns are not only for the safety of pa- 1994).
tients with serious medication abuse, but 11R. Melzack, The tragedy of needless pain. 262
also for legal and licensing issues if the SCI. AM. 27-33 (1990).
physician knowingly prescribes medica- 12S.R. Savage, Addiction in the treatment of pain:
tions that are being diverted. A physician significance, recognition, and management,
8 J. PAIN SYMPTOM MGMT. 265-78 (1993).
should taper the patient from opioids in a
13S.H. Schnoll & J. Finch, Medical education for pain
controlled fashion, continue to see the
and addiction: making progress toward answering a
patient, and provide other forms of pain need, 22 J. LAW MED. ETHICS 252-56 (1994).
treatment without controlled substance
prescriptions.
Controlled substances are beneficial for the
good health of many patients. Physicians
should be comfortable prescribing opioids
for pain, since the majority of patients
will not suffer problems associated with
addiction.
References
1B. KISSEN, Medical management of alcoholic
patients, TREATMENT AND REHABILITATION OF THE
CHRONIC ALCOHOLIC (Plenum Pub.Co. 1997).
2T. Maruta et al., Drug abuse and dependency in
patients with chronic pain, 54 MAYO CLINIC PROC.
241-44 (1976).
3LB. Ready et al., Self-reported vs. actual use of
medications in chronic pain patients, 12 CLIN. J.
PAIN 285-94 (1982).
4J.A. Turner et al., Drug utilization pattern in
chronic pain patients. 12 CLIN. J. PAIN 357-63,
supra.
5F.P. Buckley et al., Medication management in pa-
tients with chronic nonmalignant pain: a review of
the use of a drug withdrawal protocol, 26 CLIN. J.
PAIN 153-66 (1986).
6R.D. Finlayson et al., Substance dependence and
chronic pain: profile of 50 patients treated in an
alcohol and drug dependence unit, 26 CLIN. J. PAIN
167-74 (1986).
May 2002
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www.hcarichmond.com
 R A M I F I C AT I O N S
Chronic Pain Patient or Drug Seeker
Special Agent Carlton Johnson, Jr.
Pharmaceutical Diversion Investigation Unit
Virginia State Police
I appreciate the opportunity to enlighten
the medical community, from a law-en-
forcement viewpoint, to the criminal ac-
tivities of drug seekers, and hope that we
remain partners in effectively lessening,
if not eradicating, this activity. I joined
the Pharmaceutical Diversion Investiga-
tion Unit of the Department of State Po-
lice in 1995, and was surprised to learn
that approximately a third of the drug
cases investigated by the Bureau of
Criminal Investigations are pharmaceuti-
cal cases. Health care professionals re-
port the majority of these cases to the
State Police. While most cases involve
patients who seek various narcotic pain
medications and stimulants illegally,
some involve health care professionals as
suspects, the very people who report
cases to us.
The Pharmaceutical Diversion Investiga-
tion Unit depends on health care profes-
sionals to alert us to ongoing criminal ac-
tivity, and we are grateful for this
assistance. In the remainder of this arti-
cle, I will provide you with information
concerning drug-seeking activity as expe-
rienced by law enforcement and will sug-
gest ways that we may further assist each
other in diminishing this activity.
I bring to your attention some of the
common methods used by drug seekers
to illegally obtain pharmaceuticals. Ill
begin with doctor shopping. The term
doctor shopping refers to the patient
who attempts to obtain medications from
multiple physicians. Defrauding a physi-
cian in this manner is a felony. Physi-
28
cians may assist the State Police in these est patient off guard, and it will be easy
cases by asking their patients whether to detect attempted fraud. Most people
they are being treated by any other physi- carry some kind of picture identification,
cians, and if so, what medications have and it is wise for you to require adequate
been prescribed. Please note the answer identification before treating a patient.
to these questions in the patients file.
The next method of pharmaceutical di-
This is valuable evidence to us when try-
version by drug seekers is prescription
ing to prove a case of fraud. Quite often,
forgery. A forgers favorite method is to
a doctor shopper will pay for the visit
steal a physicians prescription pad.
with cash rather than use health insur-
Once the physician becomes distracted
ance. They often will suggest which med-
or leaves the examination room, the pa-
ication works best for them and will
tient will take all or part of a prescription
claim to be allergic to medications they
pad that is in plain sight. The forger also
do not prefer.
will search for prescription pads in the
Another scam occurs when the patient re- cabinets and drawers of an examination
ceives a prescription, such as Percocet. room. One drug seeker confessed that,
Later, the patient will report to the physi- after attempting unsuccessfully to scam
cians office that he or she is experienc- physicians in a hospital emergency room,
ing a bad reaction to the Percocet and she roamed the hospital halls until she
will request something less strong. The found a physicians office door unlocked.
physician usually will prescribe hy- She searched the office until she found
drocodone. The drug seeker now has ob- prescription pads. A prescription pad is
tained two prescriptions. We realize this more important than cash to a drug seek-
is a judgment call that only the physician er, so remember to secure those prescrip-
can make, but if you note the incident tion pads.
and the additional prescription in the pa-
Still another scam involves the photo-
tients file, it later may be used as evi-
copying of physician-written prescrip-
dence if we discover that the patient is re-
tions. With the technology available
ceiving Percocet from other physicians.
today, it is difficult to distinguish a pho-
The doctor shopper also will provide in-
tocopy from an original. The word
formation about himself or herself that is
void, however, will appear on the pho-
false, such as name, social security num-
tocopy of a prescription that has been
ber, date of birth, telephone number, and
written on prescription pads printed on
address. The physicians office staff may
special paper. Although these pads are
request to see a drivers license to verify
expensive, they ultimately may save the
patient identification, preferably after the
physician valuable time.
patient has completed the new patient in-
formation form. This will catch a dishon-
May 2002
 R A M I F I C AT I O N S

The drug seeker who telephones in a pre-
scription to the pharmacy is very com-
mon. The fraudulent caller will claim to
be the prescribing physician or a physi-
cian staff member. Most pharmacists are
skilled at detecting fraudulent call-in pre-
scriptions and will contact the prescribing
physicians office to verify suspicious
prescriptions. It is important that the
pharmacist have quick and easy access to
the physician or his staff so that a fraudu-
lent prescription will not be filled. If a
fraudulent prescription is verified in a
timely manner, the pharmacist often will
contact the local police who may arrest
the offender at the pharmacy.
Altering prescriptions is also a favorite
scam of the drug seeker. The offender
will alter the quantity of prescribed pills,
e.g., they will change the number 10 to
100. The physician may counter this by
writing the prescription as one would
write a check, by both printing and
spelling out the numeral(s). The physi-
cian should also spell out the number of
refills on the prescription to avoid alter-
ation. Some physicians use duplicate pre-
scription pads to help combat this prob-
lem. Duplicate prescription pads are a
good recordkeeping method and may be
used as evidence in the prosecution of a
drug seeker.
I have not covered every method used by
drug seekers in this article, nor have I seen
or heard of every scam they may devise. I
do believe, however, that if you watch for
the indicators I have provided and imple-
ment the safeguards, you will deter many
drug seekers.
Please feel free to contact me if you have
questions or need assistance in handling a
pharmaceutical diversion problem. You
may reach me at 804-659-2331 (pager), or
804-323-2469 (voice mail). The contact
person in the western portion of the state is
William S. Purcell, Assistant Special
Agent in Charge, 540-387-5553 (office).

Listening to the Story of Suffering: Psychiatric

Perspectives of Pain Diagnosis and Management
James E. Sellman, MD
President and Practitioner
James E. Sellman, MD & Associates, PC
Clinical Director Community Education and Integrated Medicine
Poplar Springs Hospital

Chronic pain and psychological disorders
are the two most common problems seen
by American physicians. In the United
States, in any given year, 28% of the
American population suffer from chronic
pain, and an additional 22% suffer from a
diagnosable mental disorder, especially
depression, followed by generalized anxi-
ety disorder, somatization disorder, drug
dependence, and, less frequently, person-
ality disorders. Chronic pain is a complex
biopsychosocial phenomenon in which
biological, psychological, and social fac-
tors dynamically interact. Consequently,
two-thirds of all patients diagnosed with
chronic pain also experience significant
levels of psychological distress. Axiomat-
ic to pain treatment is the essential need
to identify and diagnose psychopatholo-
gy prior to embarking on diagnostic and
treatment procedures. Equally axiomatic
is the imperative requirement to distin-
guish chronic nonmalignant pain and
chronic pain syndrome. Chronic nonma-
lignant pain refers to pain that is both
persistent and not associated with pro-
gressive tissue destruction. Some pa-
tients with chronic pain develop a pattern
of behaviors, difficulties, and health-care
utilization that is best described as
chronic pain syndrome. Chronic pain
syndrome is as much a behavioral prob-
lem as one of nociception, and its major
feature is the excessive adoption of the
sick role. The U.S. Commission on Eval-
uation of Pain lists six features of chronic
pain syndrome:
1. Intractable pain greater than six
months.
2. Marked alteration of behavior, depres-
sion, or anxiety.
3. Marked restriction of daily activities.
4. Excessive use of medication and med-
ical services.
5. No clear relationship to organic
disorder.
6. Multiple nonproductive tests, treatment,
and surgeries.
Continued on page 30

29
May 2002
 R A M I F I C AT I O N S
Patients with chronic pain syndrome fre-
quently have moderate to severe psy-
chopathology. They have a story to tell
you, and its a story of suffering. Suffer-
ing takes many forms, including depres-
sion, anxiety, somatiform disorders, drug
dependence, pathological operant learn-
ing, personality disorders, impaired cog-
nition, labile affect, unstable interperson-
al relationships, and poor impulse control.
Many of these people are trapped in the
regression of the sick role that typifies
chronic pain syndrome, complicated by
impaired boundaries and few resources.
Psychological determinants of chronic
pain may be better understood using the
self-discrepancy theory (SDT) and the
concept of locus of control. SDT pro-
poses that conflicting or incompatible be-
liefs about the self will lead to emotional
discomfort. The discrepancy between the
actual and ideal self focuses on unat-
tained goals and lack of positive out-
comes. This leads to frustration, disap-
pointment, and dissatisfaction, which are
associated with anger against the self,
self-blaming, and guilt. In chronic pain,
we find that distress is a direct result of a
discrepancy between actual and ideal
selves because of the impact of pain and
illness. Clinically, it is important to sepa-
rate patients with chronic pain or distress
about the situational constraints second-
ary to the pain from those who have the
additional emotional baggage of believ-
ing that the negative consequences of
pain mean that they are fundamentally
flawed and worthless. A second concept
is locus of control, which refers to the
perception that events are either a conse-
quence of the individuals own behavior
[internal control] or are contingent upon
outside forces, such as family members,
30
physicians, or chance happenings. Those
patients whose locus of control is internal
believe that they, themselves, play a
major role in determining their future.
Such people feel and function better than
others who see events as controlled by
fate or other people. Chronic pain pa-
tients with chance external locus of
control feel depressed, anxious, and help-
less to deal with their pain, and rely on
maladaptive coping strategies. Decreased
perceptions of self-control may explain
much of the relationship between pain
and depression. These people often make
statements such as I will resume living
after I am well, I cant go out if Im in
pain, and I shouldnt exercise if it
hurts. Such a belief system has an obvi-
ously negative effect on adaptation and
results in an endless cycle of depression,
tension, anger-blame, and an increasing
sense of hopelessness and helplessness.
By understanding SDT and the concept
of locus of control, the clinician can
begin to confront these problems and
make appropriate multidisciplinary refer-
rals. Claudio, in Act III of Shakespeares
Measure for Measure, stated: The mis-
erable have no other medicine, but only
hope. Listening to the patients story of
suffering can be quite time-consuming
and often associated allied staff are better
able to do this. It is important to know if
the patients parents experienced chronic
pain, depression, or alcoholism/drug ad-
diction. Additionally, exploring the pa-
tients childhood for physical, sexual or
emotional abuse, neglect, abandonment,
or early responsibility is fundamental to
understanding their suffering, their story,
and to providing appropriate diagnosis
and treatment.
A special concern is the diagnosis of ad-
diction in chronic pain patients. The cor-
nerstones of addiction are:
1. Preoccupation with pain and
medication.
2. Loss of control of medication use.
3. Ignoring adverse consequences of be-
havior and medication.
Addiction in pain patients should be sus-
pected when such patients exhibit fre-
quent intoxication, irritability, mood
changes, and inattention to hygiene, and
the suffering or sick-role behavior seems
significantly disproportionate to the sus-
pected medical pathology. It is difficult to
distinguish inappropriate behavior due to
addictive disorders from that caused by
psychological or behavioral factors. Pa-
tients should be asked about multiple
sources of drugs, forged prescriptions,
whether their physicians have been con-
cerned about their medication consump-
tion in the past, and whether they find it
necessary to change physicians frequent-
ly. The familys role in the patients ad-
diction may pose special difficulties. My
experience is that patients and their fami-
lies can be astonished at the reduction in
pain and suffering that occurs after detox-
ification. Some of these findings suggest
that continued use of harmful substances
is due more to ignorance than to denial. If
the cornerstones of addiction are present,
then a referral to someone with experi-
ence in addiction medicine is medically
necessary.
Guidelines for pain management include
pharmacotherapy and psychological in-
terventions. Experience and expression of
pain are complicated multifactoral
events. Most clinicians, however, ignore
these factors and, consequently, miss an
excellent opportunity to achieve more sub-
stantial benefits for their patients.
May 2002

Major issues must be addressed, including:
1. Fear.
2. Hypervigilance and excessive attention
to pain sensation.
3. Catastrophizing and worrying.
4. Avoidance.
5. Depression.
6. Anger.
7. Self-denigration.
If unaddressed, all of these factors make
not only the patient but also the physician
miserable, resulting in frustration and
failure for all. Chronic pain patients expe-
rience not only pain but also associated
problems such as sleep difficulties, fa-
tigue, and depression. They become in-
creasingly interpersonally isolated and
develop dysfunctional family roles and
responsibilities. Nontherapeutic reliance
on social and medical support systems
develops with these patients who contin-
ue to seek and receive treatment. For pa-
tients with complex presentations or
chronic pain syndrome, antidepressants,
psychotropic anticonvulsants, and some
of the new atypical antipsychotics
(Risperdal, Zyprexa, Geodon, Seroquel)
often used in combination can be enor-
mously beneficial. Although this is con-
troversial, many clinicians advocate opi-
ate use in chronic pain and oppose its use
in chronic pain syndrome.
Adjunctively, the treatment of choice is
cognitive behavioral therapy (CBT),
preferably delivered by an interdiscipli-
nary pain management team. Without
such input, treatments are not only largely
ineffective, but also, at times, even harm-
ful. Using CBT, the focus of treatment
can be shifted away from the pain to-
wards the detrimental effects of pain.
May 2002
CBT puts the patient in charge of recov-
ery rather than the burden being carried
by the physician. The patient is the part-
ner in both intervention and prevention.
CBT emphasizes realistic expectations
and patient-driven goals regarding recov-
ery, switching the emphasis from sick-
ness to wellness. CBT is aimed at reduc-
ing or extinguishing the influence of
factors that maintain the patients malad-
dictive behaviors, including belief sys-
tems and patterns of thought. There are
six elements of CBT that may be utilized
in the physicians office in just a few
minutes.
1. Address direct positive reinforcement
of patient behavior by being sensitive
to situations in which patients are di-
rectly enforced for pain behaviors that
seek to minimize the effect.
2. Address indirect positive reinforce-
ment of pain behavior, specifically
avoidance behavior. CBT benefits pa-
tients by encouraging them to set
achievable goals and avoid symptom-
contingent patterns of activities, which
ultimately result in a steady decline of
overall activity.
3. Provide positive reinforcement of well
behavior.
4. Encourage physical fitness and
function.
5. Employ cognitive reframing in which
self-defeating and self-denigrating pat-
terns of thinking are challenged and an
informed psychological perspective
developed in which one can under-
stand the effects of thoughts upon feel-
ings, including improved problem-
solving, communication, stress
reduction, anger management, and re-
laxation response.
R A M I F I C AT I O N S
6. Provide education and empowerment,
which could include improved sleep
hygiene, doctor/patient communica-
tions, assertiveness skills, and even
biomechanics and anatomy. It is im-
perative with chronic pain to have a
contract that specifically details restric-
tions on phone calls between office
visits, using more than one physician,
and rules regarding lost medications.
My rule is to give everyone a one-time
exception to the contract with dis-
missal from the practice if subsequent
infractions occur.
Summary and Conclusion: The experi-
ence of chronic pain and disability may
be understood only if psychological fac-
tors are considered central to the delivery
of effective treatment. Ultimately, the pa-
tient is in charge of his own recovery and
there is no chance of success if a psycho-
logical plan, often with multidisciplinary
staff, is not in place. Locus of control
must be shifted internally. Issues of self-
discrepancy, unrealistic expectations, and
the high co-morbidity of other psychi-
atric illness are keys to effective treat-
ment. Recognizing that pain is truly suf-
fering and listening to the story the
patient has to tell are critical in achieving
any advances. As Dr. Jerri Nielson in her
recent book, Icebound, notes, There is
no such thing as a crazy patient, just a
stupid doctor. Improvement in pain man-
agement may be accomplished by very
simple, if subtle, changes in clinical prac-
tice. Although some of the ideas set forth
in this article are simple, these changes
may have significant effects in the pa-
tients experience of pain, ultimate out-
come, and his use of health-care
services and resources.
The mind is in its own place, and in it-
self can make a heaven of hell, a hell of
heavenJohn Milton
31
 R A M I F I C AT I O N S
The Legal Issues: How the Courts See
Pain Management
Stephen D. Rosenthal, Esquire
Troutman Sanders Mays &Valentine, LLP
Based on recent news coverage, you
might think that the only legal issues in
pain management today involve the im-
proper prescription of OxyContin and
similar drugs. The unlawful prescription
of excessive amounts of pain medication,
however, is not the only source of legal
concern in the field of pain management.
Indeed, the underprescription of pain re-
lief drugs also could cause legal prob-
lems for physicians. Although the law of
pain management is still developing, the
cases thus far have shown that physicians
who engage in either improper or inade-
quate pain management practices run the
risk of incurring civil liability or criminal
sanctions.
Criminal Consequences for Improper and
Excessive Prescriptions
Courts appear to view the improper or
excessive prescription of pain relief drugs
primarily as a criminal concern. Because
many pain medications are controlled
substances under federal and state laws,
physicians who improperly prescribe
these drugs risk criminal indictment for
unlawful distribution. In Southwest Vir-
ginia, for example, a large-scale investi-
gation by state and federal officials into
health care fraud and abuse has led to the
prosecution of several physicians under
federal drug laws.1
Such prosecutions are made possible by a
1975 decision of the Supreme Court of
32
the United States, in which the Court
ruled that physicians registered under the
federal Controlled Substances Act2 can
be prosecuted under [the Act] when their
activities fall outside the usual course of
professional practice.3 Each time a
physician knowingly or intentionally pre-
scribes a controlled substance without a
legitimate medical purpose, the physician
can be charged with unlawfully distrib-
uting a controlled substance.4 As a re-
sult, physicians who abuse the pain man-
agement process over an extended period
of time may face indictments with hun-
dreds of counts that carry the potential
for long prison terms under the sentenc-
ing guidelines used by the federal courts.
Last year, for instance, a federal jury con-
victed a Southwest Virginia physician of
427 counts of unlawful distribution of
controlled substances for having pre-
scribed, among other drugs, pain medica-
tions such as OxyContin, Tylox, Lorcet,
and Lortab without a legitimate medical
purpose. Under the federal sentencing
guidelines, the weight of the tablets pre-
scribed, along with other factors, resulted
in a sentencing range of 210-to-262
months, although that range was reduced
by the court to 70-to-87 months because
of the physicians diminished capacity at
the time of the offenses.5
Many state statutes also prohibit unlawful
selling or distribution of controlled sub-
stances, and those laws can provide the
basis for prosecutions and convictions of
physicians.6 Thus, many courts appear to
view physicians who prescribe pain med-
ications without legitimate medical rea-
sons as drug pushers rather than pain
managers.7
Furthermore, courts and juries may hold
physicians responsible when their pa-
tients overdose from unlawfully pre-
scribed pain medications.8 A Florida jury
recently convicted a physician of
manslaughter through culpable negli-
gence after four of his patients died from
overdoses of OxyContin and other drugs
that he had prescribed. The physician ar-
gued during the trial that he had followed
standard medical practice and could not
be held accountable for patients misuse
of the drugs that he prescribed. Prosecu-
tors, however, portrayed the physicians
practice as a prescription mill where
patients loitered outside the office and
congratulated one another when they
emerged with prescriptions. The state
contended that the physician recklessly
prescribed OxyContin and other narcotics
to anyone willing to pay for an office
visit.9 In a similar case, California prose-
cutors charged the top OxyContin pre-
scriber under Californias Medi-Cal in-
surance program with manslaughter in
connection with overdose deaths related
to allegedly improper prescriptions.10
May 2002

In addition, a physician in Florida awaits
trial on first-degree murder charges in
connection with a patients death by over-
dose. Florida prosecutors based the
charge on the states felony murder law,
alleging that the patients overdose death
was caused in the commission of felony
drug trafficking by the physician. If con-
victed, the Florida physician could face
the death penalty.11
While many of these criminal prosecu-
tions are a result of particularly egregious
behavior by a few physicians, all doctors
who practice pain management should
be aware of these new theories of
prosecution.
An Emerging Civil Liability Theory for
Inadequate Pain Management
Although many of the cases involving
pain management are criminal in nature
and stem from the improper and exces-
sive prescription of pain medications,
there appears to be a trend developing in
civil courts that focuses on physicians
who provide inadequate pain manage-
ment by failing to prescribe enough pain
medication. While there is not yet any de-
finitive case law establishing that mis-
management of pain through undermed-
ication is malpractice, several legal
scholars have advocated for such a theory
of liability and have pointed to cases that
may indicate the direction in which the
law is moving.12
For instance, in a negligence lawsuit filed
in the early 1990s, a North Carolina jury
awarded $15 million to the family of a
cancer patient whose last days were made
more painful by a nurses act of withhold-
ing or reducing the amount of pain med-
ication that had been prescribed by his
physician. The nurse determined that the
patient was addicted to the morphine that
had been prescribed for him and thus re-
duced or withheld the pain medication in
favor of mild tranquilizers. Testimony
May 2002
during the case focused on the proper
standard of care in the administration of
medications, such as morphine, for pa-
tients with intractable pain.13
In a more recent case, a California jury
awarded $1.5 million to the family of a
deceased patient on the novel theory that
the patients physician violated the states
elder abuse law by providing the patient
with an inadequate amount of pain med-
ication. The California verdict is signifi-
cant, because the jury apparently accept-
ed the familys theory that the physician
violated the standard of care by underpre-
scribing medication for his patients pain,
thus possibly paving the way for future
malpractice claims.14
The trend toward recognizing a malprac-
tice claim, based on a physicians failure
to prescribe an appropriate amount of
medication to a patient with severe pain,
also could draw support from two state
supreme court cases dealing with the
right to refuse medical treatment. The
Georgia Supreme Court has stated, and
the Nevada Supreme Court has agreed,
that the patients right to be free from
pain, after the patient has made the deci-
sion to refuse treatment, is inseparable
from his right to refuse medical treat-
ment in the first place.15 Legal scholars
have contended that the Georgia case in-
dicates a recognition by the courts that
proper pain management is an integral
part of medical treatment.16
Thus, although the development of a mal-
practice theory based on inadequate pain
management is still in the early stages, it
appears that more courts could be willing
to recognize such claims in the future.
Legal scholars point to the promulgation
of clinical pain management guidelines
as evidence of an emerging standard of
care in pain management.17
In conclusion, courts today seem increas-
ingly willing to impose criminal and civil
R A M I F I C AT I O N S
liability on physicians in the context of
both under and overprescription of pain
medication. Physicians must be aware of
both sides of this legal spectrum when
managing their patients pain.
References
1News Release, United States Attorneys Office,
Western District of Virginia (Oct.16, 2000), avail-
able at http://www.oig.dol.gov/public/media/oi/
sutherland.html.
221 U.S.C. ch. 13, 801-971 (2000).
3United States v. Moore, 423 U.S. 122, 124
(1975); see also Sharon B. Roberts, All Pushers
Are Not Created Equal! The Inequities of Sanctions
for Physicians Who Inappropriately Prescribe
Controlled Substances, 23 NOVA L. REV. 881, 886-
87 (1999) (discussing Moore).
4Roberts, supra, at 884.
5United States v. Sutherland, Nos. 1:00CR00052,
1:01CR00009, 2001 U.S. Dist. LEXIS 19310, at
*2, *30-31 (W.D. Va. Nov. 27, 2001); see also
supra note 1 (discussing drugs prescribed by Dr.
Sutherland).
6Scott W. Parker, Note, An Argument for Preserv-
ing the Agency Defense as Applied to Prosecutions
for Unlawful Sale, Delivery, and Possession of
Drugs, 66 FORDHAM L. REV. 2649, 2664 (1998)
(noting that almost every state legislature [has]
adopted the Controlled Substances Act into its own
statutory regime).
7E.g., Moore, 423 U.S. at 138; see also Roberts,
supra note 3, at 887 (discussing Moore).
8Barry Meier, OxyContin Prescribers Face Charges
in Fatal Overdoses, N.Y. TIMES, Jan.19, 2002,
available at http://www.nytimes.com/2002/
01/19/health/19OXYC.html.
9Barry Meier, Doctor Guilty in 4 Deaths
Tied to OxyContin, N.Y. TIMES, Feb. 20, 2002,
available at http://www.nytimes.com/2002/02/20/
health/20OXYC.html; Associated Press, Closing
Arguments Made in Trial of Doctor in OxyContin
Deaths, N.Y. TIMES, Feb. 19, 2002, available at
http://www.nytimes.com/2002/02/19/national/19O
XYC.html.
10Meier, supra note 8.
11Peter Franceschina, Saleswoman Testifies in Drug
Case; Doctor Accused in OxyContin Patients
Death, SUN-SENTINEL (Fort Lauderdale, FL), Jan.
11, 2002, at 1B; Mitch Lipka & Nancy McVicar,
OxyContin Prescription Leads to Murder Charge,
CHI. TRIB., July 29, 2001, at C8; Meier, supra
note 8; John Pacenti, Prosecutor: Documents
Tip of Iceberg in OxyContin Case, PALM
BEACH POST, Aug. 30, 2001, at 1B.
33
 R A M I F I C AT I O N S
12Tonya Eippert, Note, A Proposal to Recognize a
Legal Obligation on Physicians to Provide Ade-
quate Medication to Alleviate Pain, 12 J.L. &
HEALTH 381, 382 (1997/1998); Barry R. Furrow,
Pain Management and Provider Liability: No
More Excuses, 29 J.L. MED. & ETHICS 28, 31-
34, 43 (2001); Michael J. Reynolds, Note, Mor-
phine or Malpractice: Should Courts Recognize
a Legal Duty to Prescribe Opiates For Treating
Chronic Pain?, 15 ST. JOHNS J. LEGAL COM-
MENT. 79, 81 (2000); Ben A. Rich, A Prescrip-
tion For Pain: The Emerging Standard of Care
for Pain Management, 26 WM. MITCHELL L.
REV. 1, 2-3 (2000); Robyn S. Shapiro, Health
Care Providers Liability Exposure For Inappro-
priate Pain Management, 24 J.L. MED. &
ETHICS 360-64 (1996).
13Reynolds, supra note 12, at 105; Rich, supra
note 12, at 84-86; Shapiro, supra note 12.
14Mark Crane, Treating Pain: Damned If You
Dont?, MED. ECON., Nov. 19, 2001, at 78; see
also Rich, supra note 12, at 84 (discussing Dr.
Chins case).
15State v. McAfee, 385 S.E.2d 651, 652 (Ga.
1989), quoted in McKay v. Bergstedt, 801 P.2d
617, 631 (Nev. 1990).
16Furrow, supra note 12, at 33 n.87; Shapiro,
supra note 12.
17Eippert, supra note 12, at 393-94; Furrow, supra
note 12, at 31-33; Reynolds, supra note 12, at
95-98, 108; Rich, supra note 12, at 81-83;
Shapiro, supra note 12.
34
Issues Regarding Licensure
William L. Harp, MD
Executive Director
Virginia Board of Medicine
Since 1884, the Board of Medicine has
been issuing licenses and regulating the
practice of medicine in the Common-
wealth of Virginia. As licensed physicians,
we are expected to know and abide by the
laws and regulations governing our prac-
tice, and physicians who do not may come
to the attention of the Board through the
complaint process.
A word about the disciplinary process at
the Board is in order. The disciplinary
process is complaint-driven. The Board
does not have the resources to visit all
physician offices and assess all practices.
If, however, a patient or a patients family
member, colleague, nurse, pharmacist,
hospital CEO, managed care plan, mal-
practice carrier, federal agency, etc., report
to the Board that a physician may have en-
gaged in unprofessional conduct, then a
case is docketed and a proper investigation
ensues. The Board carefully reviews a
completed investigative report to deter-
mine if probable cause of a violation ex-
ists. If the evidence appears likely to sup-
port a violation of any law or regulation,
the physician receives a notice to appear
before the Board. Unprofessional
conduct is defined under the laws that
govern the Board of Medicine. Sections
54.1-2914 and 54.1-2915 outline the pro-
scribed behaviors; to be found in violation
of one or more may result in a sanction
from the Board.
The authority to prescribe medication is
conferred with the license to practice med-
icine. Physicians must be aware of and fol-
low the laws and regulations that come
with that privilege. The Drug Control Act
and related laws are also found in Title
54.1 of the Code of Virginia. Specifically,
54.1-3303, 54.1-3404, 54.1-3408 and
54.1-3408.1 speak to the lawful use of
controlled substances, including the pre-
requisite bona fide physician-patient rela-
tionship. Physicians should also be famil-
iar with Drug Enforcement Administration
guidelines and possess a valid DEA num-
ber to prescribe Schedules II through V
drugs.
No one wants to appear before the Board
of Medicine. Such appearance should be
easy to avoid provided one follows the
laws and regulations. But what if the laws
and regulations are difficult for the practi-
tioner to interpret?
It is just a reality that the laws and regula-
tions always seem to lag behind the chang-
ing patterns of clinical practice. New inno-
vations and treatments can become fairly
commonplace before it is determined how
to address them by law and regulation. In
this circumstance, practicing good medi-
cine can clash with the laws and regula-
tions or, at least, appear to do so. In the
case of chronic pain, new approaches, at
times, have been tested against the Boards
interpretation of the laws and regulations
May 2002
 R A M I F I C AT I O N S

governing both our practice and the pre-
scription of controlled substances. Physi-
cians who treat chronic pain to the stan-
dard of care would like to do so without
fear that the Board of Medicine may seek
to take their license.
In 1997, the Medical Society of Virginia,
in conjunction with the Board of Medi-
cine, developed guidelines for the treat-
ment of chronic nonmalignant pain. The
General Assembly allowed the Board of
Medicine to endorse the guidelines, which
were published in the Board Briefs in
Spring 1998. They remain an excellent
guide for those who wish to treat chronic
pain patients and meet the expectations of
the Board of Medicine in the process.
Broadly speaking, the guidelines address
history and physical examination, diagno-
sis, treatment plan, informed consent, opi-
oid contract, periodic review, consultation,
and documentation. Attention to these ele-
ments should result in quality care that is
well-documented and defensible.
Complaints regarding the treatment of
chronic pain may derive from several
sources and contain divergent allegations.
A patient may complain of being under-
treated. A family member may feel that
the patient was overtreated. A pharmacist
may report massive amounts of controlled
substances being written for a patient. A
managed care plan may detect a pattern of
care that raises concerns.
It is not about the quantity of drug pre-
scribed. Quantity alone will not result in a
violation if the standard of care is met, and
there is good documentation. As with the
treatment of other clinical conditions, the
Board is interested in protecting the public
and ensuring that the public receives the
care for which they are paying. Any physi-
cian who does not meet the standard of
care, who places patients at risk, and
against whom a complaint is filed with the
Board of Medicine should take heed.
There may be a hearing, and if a violation
is found, there may be a sanction.
The bottom line with the treatment of
chronic pain is to make sure you dot all the
Is and cross all the Ts. Stay within the
laws and regulations and follow the
Boards guidelines. Document in a manner
for anyone to follow the progression of the
case and describe your clinical rationale
for the approach chosen.
The laws, regulations, and guidelines ref-
erenced in this article are available for re-
view on the Department of Health Profes-
sions website, at www.dhp.state.va.us.
You may access the laws, regulations and
guidelines for each specific Board by se-
lecting from the Boards dropdown menu.
You may also search the Code of Virginia
and the Administrative Code under the
Law & Policy dropdown menu.

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35
May 2002
 R A M I F I C AT I O N S
Alternative Therapy Approaches: How
Accupuncture Can Be Effectively Used
M. Craig Pinsker, MD, PhD
Chief of Anesthesia
Richmond Eye and Ear Hospital
If a reliable method of controlling pain
were available, there would be no need
for this special edition of RAMifications.
We could simply prescribe a remedy that
would relieve the pain without side ef-
fects. Of course, this magical medication
would not interfere with our normal re-
sponse to injury, such as stepping on a
nail or closing a door on a finger. Since
this magical formula does not exist, we
employ polypharmacy to maximize anal-
gesia and minimize ill effects. We pre-
scribe opiates, nonsteroidals, antidepres-
sants, anticonvulsants, clonidine,
ketamine, dextromethorphan, etc. Some-
times we try to block pain fibers with
local anesthetics or destroy them with
freezing or burning. Ice, heat, and other
physical methods also are used in con-
junction with medications.
Acupuncture, used alone or with other
modalities, is a physical method of reduc-
ing pain. Acupuncture (sometimes a syn-
onym for traditional Chinese medicine) is
the insertion of needles to achieve a clini-
cal response (i.e., analgesia). Acupunc-
ture is a form of complementary medi-
cine. In1997, over 41% of the population
in the United States reported using com-
plementary medicine.1 Insertion of a nee-
dle causes a current of injury. Could this
be what makes it work? Adding electrical
stimulation to the needles adds to the al-
teration of electrical and magnetic fields
in the body. Acupuncture points have de-
creased electrical resistance. Whatever
mechanism of action is eventually discov-
36
ered, it will need to explain not only as a treatment for low back pain,2
acupunctures analgesic properties but headaches,3 pain from bony metastasis,4
also its effect on the immune system, its and diabetic neuropathy.5 In the treatment
antiemetic effect, and its role in control of of pain, it may be more palatable to say
substance abuse, especially cocaine. What that we insert needles into the
is special about acupuncture? paraspinous muscles, not the gallbladder
meridian, and that we use PENS to stim-
Acupuncture generally is known as a
ulate the needles, not an electroacupunc-
mysterious Eastern technique complete
toscope. Hopefully, this will help bring
with well-described theories, nomencla-
this procedure into standard medical
ture, and applications that do not fit into
practice. We should consider acupuncture
our Western understanding of nature. Not
by whatever name we give it as a com-
understanding this science, we tend to
plementary, not an alternative, compo-
discount it. It is beyond the scope of this
nent of standard medical practice. Unfor-
article, and unnecessary at this time, to
tunately, there is a shortage of physicians
discuss its mechanism of action. We
qualified in acupuncture in Virginia. Non-
should recall that, not long ago, we used
medical doctors have filled this gap. I
aspirin without understanding the manner
feel strongly that patients treated by non-
in which it works. We should note that
physicians should be monitored by physi-
our new understanding of aspirins mech-
cians so that the acupuncture is a comple-
anism of action does not make it work
mentary, and not an alternative,
any better! Acupuncture can be very help-
treatment. For physicians treating pa-
ful in the treatment of myofascial pain
tients, it is best to regard acupuncture as a
and headaches, and it is especially useful
technique that may be used to reduce de-
if nausea is also present. Radicular pain
pendence on medications or other anal-
usually is helped, possibly due to the my-
gesic modalities, thereby producing a
ofascial aspect of this pain. It is less like-
more comfortable patient.
ly to help with central pain. We ought to
try acupuncture on a given patient just as References
we might try any other modality. If it 1D.M. Eisenberg et al., 280 JAMA 1,569 (1998).
helps, continue its use; if not, stop the 2E.A. Ghoname et al., 281 JAMA 818 (1999).
treatment. We would evaluate any other 3H.E. Ahmed et al., 40 HEADACHE 311 (2000).
medical treatment this same way. 4H.E. Ahmed et al., 14 CLIN. J. PAIN 320 (1998).
There is an effort under way to create a 5M.A. Hamza et al., 23 DIABETES CARE 365 (2000).
new CPT code for percutaneous electrical
nerve stimulation (PENS). Several arti-
cles from Paul Whites group described it
May 2002
 Pain, pain, go away...
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Known for quality care, St. Marys offers a wide range of specialized services, including our
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quality of care and overall quality of doctors care in the ER. Consultants survey based on emergency room patient satisfaction. among hospitals nationwide in 2000 and in cardiac care by
** Style Magazine, 2001 www.healthgrades.com in 2002.
 R A M I F I C AT I O N S
The Role of the Physiatrist in Managing
Chronic Nonmalignant Pain
Jane Pendleton Wootton, MD
Physiatrist
Sheltering Arms Physicians Rehab Services
Physiatrists (specialists in physical medi-
cine and rehabilitation) have a great deal to
offer patients suffering chronic nonmalig-
nant pain. Residency training programs in-
corporate and emphasize the treatment of
chronic pain in patientsa vastly under-
served population. Many of the best pro-
grams, including that of the Medical Col-
lege of Virginia, offer fellowships in
chronic pain management.
The rehab physician offers conservative
(nonsurgical) management of pain, and
works as a team player with surgeons and
anesthesiologists who offer palliative or
curative measures, such as neurosurgical
(intracranial or spinal) procedures, amputa-
tions, nerve blocks, spinal pumps for deliv-
ery of intrathecal opioids, etc.
Family physicians are a most important
part of the team, as are patients families
and, most especially, the patient. Clear,
honest communication, using plain lan-
guage and visual aids, enhances mutual un-
derstanding among the team members.
Rehab physicians specializing in pain man-
agement offer the advantage of emphasiz-
ing a team approach with other highly
skilled health professionals, such as physi-
cal and occupational therapists, psycholo-
gists, psychiatrists, and social workers.
Many of these professionals are proficient
at counseling and coaching patients and
families suffering the stress of chronic pain.
The services of a dedicated attorney are
sometimes essential to keep the system
moving in ways that are helpful to the pa-
38
tient, especially when the patient is threat-
ened by sudden termination of insurance
benefits or disability payments. An effec-
tive attorney may lessen the stress and de-
spair which aggravate the patients misery.
Other valuable team members may include
massage therapists, pharmacists, pharma-
cologists, acupuncturists, athletic trainers,
ministers, and, of course, nurses who
teach, support, counsel, and soothe patients
with their kindness.
The physiatrist is responsible for discern-
ing whether and when such services are
appropriate in a particular case, and for co-
ordinating the overall treatment effort. This
work is quite time and labor intensive,
since the treating doctor must follow the
patient closely and be available by phone,
fax, or e-mail, especially when opioid anal-
gesics are part of the treatment. Neverthe-
less, the opportunity to relieve pain and
help the patient move toward a fuller, more
fulfilling and purposeful life (whether or
not that includes returning to work) is most
rewarding to the physician.
It must be understood that chronic pain
(meaning pain that persists longer than six
months) is a serious, debilitating disruption
to a patients life and (usually) work. Most
of these patients rate the pain at least 3 to 4
on a visual analogue scale of 10, with
10/10 being unbearable. Prolonged seri-
ous pain associated with depression leads
many people to consider suicide, or to
abuse alcohol or illegal drugs in their des-
perate search for relief. Such destructive
measures are unnecessary in todays med-
ical environment.
The care of an attentive physician within
the boundaries of a contract, which clarifies
the patients compliance responsibilities,
offers the patient assurance and hope that
there is a constructive, multidisciplinary
plan aimed at achieving the most comfort-
able life possible. All necessary consulta-
tions and diagnostic procedures should be
performed in the early stages of the patient-
physician relationship, to ensure that the
etiology of the pain is delineated clearly,
insofar as possible, and that no reversible
contributing etiology is missed. Patients
and their families need to know that no
stone has been left unturned in uncovering
fixable causes of pain.
Far from being the exception, treatment of
chronic nonmalignant pain with opioid
analgesics is the standard of care today.
This requires courage, strict control over
the dispensation of opioid medication,
close patient follow-up, and a thorough un-
derstanding of not only the patients med-
ical condition, but also his or her reliability,
stability, personality traits, support system,
and environment. It also requires a thor-
ough knowledge of Virginias laws and the
need for extensive documentation. Patients
with a history of addiction, borderline per-
sonality disorders, serious mental illness,
impaired intelligence, and those in a delin-
quent or potentially criminal environment
usually make poor candidates for such care.
May 2002
R A M I F I C AT I O N S

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