Opioid refill clinic.

1. PAIN MEDICINE
Volume 8 • Number 7 • 2007
© American Academy of Pain Medicine 1526-2375/07/$15.00/573 573–584 doi:10.1111/j.1526-4637.2006.00254.x
Blackwell Publishing IncMalden, USAPMEPain Medicine1526-2375American Academy of Pain Medicine? 200687573584
Original ArticleOpioids in Primary CareWiedemer et al.
Reprint requests to: Nancy Wiedemer, CRNP, Pain Management Coordinator, Philadelphia VA Medical Center, Mail: 118,
3900 Woodland Ave, Philadelphia, PA 19104, USA. Tel: 215-823-5800 extension 3933; Fax: 215-823-4256; E-mail:
nancy.wiedemer@med.va.gov.
REVIEW ARTICLE
The Opioid Renewal Clinic: A Primary Care, Managed Approach
to Opioid Therapy in Chronic Pain Patients at Risk for
Substance Abuse
Nancy L. Wiedemer, RN, MSN, CRNP,* Paul S. Harden, Pharm.D,* Isabelle O. Arndt, MD, PhD,*
and Rollin M. Gallagher, MD, MPH*†
*Philadelphia VA Medical Center, Philadelphia, Pennsylvania; †
University of Pennsylvania School of Medicine, Philadelphia,
A B S T R A C T
Pennsylvania, USA
ABSTRACT Objective. To measure the impact of a structured opioid renewal program for chronic pain run by
a nurse practitioner (NP) and clinical pharmacist in a primary care setting.
Patients and Setting. Patients with chronic noncancer pain managed with opioid therapy in a pri-
mary care clinic staffed by 19 providers serving 50,000 patients at an urban academic Veterans
hospital.
Design. Naturalistic prospective outcome study.
Intervention. Based on published opioid prescribing guidelines and focus groups with primary care
providers (PCPs), a structured program, the Opioid Renewal Clinic (ORC), was designed to support
PCPs managing patients with chronic noncancer pain requiring opioids. After training in the use
of opioid treatment agreements (OTAs) and random urine drug testing (UDT), PCPs worked with
a pharmacist-run prescription management clinic supported by an onsite pain NP who was backed
by a multi-specialty Pain Team. After 2 years, the program was evaluated for its impact on PCP
practice and satisfaction, patient adherence, and pharmacy cost.
Results. A total of 335 patients were referred to the ORC. Of the 171 (51%) with documented
aberrant behaviors, 77 (45%) adhered to the OTA and resolved their aberrant behaviors, 65 (38%)
self-discharged, 22 (13%) were referred for addiction treatment, and seven (4%) with consistently
negative UDT were weaned from opioids. The 164 (49%) who were referred for complexity
including history of substance abuse or need for opioid rotation or titration, with no documented
aberrant drug-related behaviors, continued to adhere to the OTA. Use of UDT and OTAs by PCPs
increased. Significant pharmacy cost savings were demonstrated.
Conclusion. An NP/clinical pharmacist-run clinic, supported by a multi-specialty team, can success-
fully support a primary care practice in managing opioids in complex chronic pain patients.
Key Words. Opioids; Primary Care; Chronic Noncancer Pain; Substance Abuse; Pharmacy Costs;
Pain Medicine

2. 574 Wiedemer et al.
Introduction
hronic noncancer pain is a common problem
facing primary care providers (PCPs) and the
health care system [1]. Epidemiologic studies esti-
mate that between one-third and one-half of
adults live with some form of daily or recurrent
pain [2]. Fifty percent of veterans seen in primary
care report at least one type of chronic pain [3,4].
Timely, aggressive treatment of pain can prevent
the adverse effects that often result from untreated
or mismanaged pain, such as delays in healing,
changes in the central nervous system (sensitiza-
tion, neuronal plasticity, cortical reorganization,
spontaneous pain), chronic stress and its medical
consequences, family stress, depression, job loss,
and suicide [5–10].
Comprehensive chronic pain management
based on the biopsychosocial model of pain
generation and perception improves outcomes
[11–15]. Treatment methods include rational
polypharmacy, physical therapy, psychotherapy,
family therapy, interventional pain management,
and complementary modalities. Opioids are usu-
ally considered after appropriate nonpharmaco-
logic and pharmacologic modalities fail to relieve
pain or when they are deemed safer than alterna-
tives [5,16,17]. If monitored appropriately, opioids
have safety advantages over non-steroidal anti-
inflammatory medications, which are associated
with known morbidity and mortality, for certain
patients requiring daily medication [18–20].
However, despite a growing body of literature
supporting the use of opioids in the treatment of
chronic pain [21–25], and consensus statements
available to guide practice [17,26–28], controversy
over their use continues.
A major factor contributing to the contro-
versy is the abuse potential of opioids. Clini-
cians are faced with a dilemma—how to safely
incorporate opioids into treatment plans that
maximize the possibility of successful pain con-
trol while minimizing the risk of misuse or
abuse. This dilemma is heightened for PCPs.
PCPs shoulder most of the burden of pain
management [3,29,30] despite having received
little specific training in pain medicine or addic-
tionology [31,32] and being generally con-
strained to brief visits for evaluating and
managing complex problems. The specter of
state (medical practice boards) and federal
(Drug Enforcement Agency) sanctions adds to
their discomfort, even fear, of using opioids in
clinical practice [33,34].
C
Another problem is the nomenclature used in
clinical assessment and diagnosis. Confusion over
terms used to define substance abuse disorders
results in misconceptions about rates of addiction
in the chronic pain population and in mislabeling,
and stigmatizing patients. For example, patients
taking chronic opioids for pain may be incorrectly
diagnosed with addiction disorder when, in fact,
they actually are just physically dependent on opi-
oids. This confusion may bias clinicians against
using or continuing to use opioids in patients with
chronic pain [35,36]. The suggestion to a patient
that their medical use of opioids for pain relief is
drug addiction creates cognitive dissonance and
distrust of the clinician, impairing the clinician–
patient relationship. Of equal concern is the prac-
tice of providing opioids for chronic pain without
following standard practice guidelines regarding
assessment and monitoring [22]. This results in
potentially mistreating chronic pain as well as
missing the opportunity to identify and treat a
comorbid substance abuse disorder. Either course,
avoiding opioids when indicated for pain or pro-
viding opioids without following clearly docu-
mented clinical guidelines, risks a negative
outcome.
Like for other common chronic diseases (e.g.,
hypertension, diabetes, depression, substance
abuse), specialists in pain medicine cannot possi-
bly assume care for all patients with chronic
pain, numbering in the tens of millions. The
majority of care must fall to primary care practi-
tioners [11,12,37]. Although traditional special-
ties, such as orthopedics, rheumatology, and
neurology, are often consulted in cases of
chronic pain, they generally have neither the
expertise nor interest in providing the longitudi-
nal, biopsychosocial care, in a chronic disease
management model, that is required for large
numbers of patients with chronic pain. Thus, the
common practice pattern is a succession of refer-
rals to specialists and subspecialists with an inter-
est in a narrow area of medical practice, the
“sequential care model” of care [11] that does
not address the totality of the biopsychosocial
clinical challenge.
Since early, successful treatment impacts longi-
tudinal outcomes [38], the challenge facing health
care systems is how to incorporate evidence-based
and consensus-based guidelines for treatment of
pain disorders, including the use of opioids, into
primary care practice where persistent pain usually
first presents [39]. This challenge is formidable
when considering the present nature of primary

3. Opioids in Primary Care 575
care practice in managed care, in which a typical
visit lasts 10 minutes or less.
Thus, a new model of care—the Pain Medicine
and Primary Care Community Rehabilitation
Model—is proposed [11,12]. In this model, pri-
mary care practitioners use evidence-based algo-
rithms supported by pain medicine specialty
programs and community resources to care for
chronic pain. Care is focused on the notion of
secondary prevention, i.e., appropriate acute
pain treatment and early recognition and effective
early management of chronic pain disorders will
reduce both the incidence and morbidity of
chronic pain in the community. Recognizing enor-
mous resource variability in communities and
health care systems, the model emphasizes an
approach based upon several principles: 1) primary
care treatment supported by evidence-based algo-
rithms; 2) timely access to pain medicine consul-
tation and care, appropriate to priority of level of
need, to prevent or reduce morbidity and improve
functional outcomes; 3) goal-oriented, selectively
multimodal, integrated outcomes-driven care; and
4) efficient use of available community resources
to positively affect outcomes for the largest
number in any health system or community
population.
This article describes how a nurse practitioner
(NP) and clinical pharmacist, supported by a mul-
tidisciplinary team of consultants, planned and
implemented a structured approach to prescribing
opioids in a large primary care practice at an
urban, academic Veterans Affairs Medical Center,
the Opioid Renewal Clinic (ORC) [40]. The arti-
cle also describes the impact of that program on
the use of opioids in the clinical practice of PCPs
and their satisfaction as well as the impact of that
intervention on patient outcomes and resource
utilization in the medical center.
The development of the ORC coincided with a
number of events nationally that brought pain
management into the forefront of health care and
in a negative turn, to the front pages of newspapers
with the publicity about the misuse of Oxycontin®
(Purdue Pharma LP, Stamford, CT) (referred to
as oxycodone SA [sustained action]). The Veterans
Health Administration (VHA) in 1998 and Joint
Commission on Accreditation of Healthcare
Organizations ( JCAHO) in 2000 mandated
through required standards that pain management
is a right of all patients. The Philadelphia VA
Medical Center (PVAMC), like all institutions
across the country, adopted policies based on the
current standards and guidelines [41,42]. The
PVAMC’s success in screening for pain in all vet-
erans seeking care at our institution resulted in our
identifying challenges in assessing and treating
chronic pain in complex patients. The concurrent
liberalization of the use of opioids for chronic
noncancer pain and the trend toward using long-
acting formulations also influenced our practice
[16,17,21,23–25]. In 2000, the PVAMC was iden-
tified as one of the highest prescribers of oxyc-
odone SA in the Veterans Administration (VA)
system. The same year, the VHA removed oxyc-
odone SA from the national formulary and man-
dated that all VHA medical centers to decrease
oxycodone SA to 3% of all opioids prescribed.
Oxycontin represented 22.5% in the first quarter
in fiscal year 2001 at a cost of $129,793 at the
PVAMC.
This mandate created a problem for the Pri-
mary Care Service. PCPs were screening for pain
as mandated by JCAHO, but most PCPs were
inexperienced in prescribing opioids for chronic
pain. Following trends in the literature [16,21] and
advice from experts who were invited to update
the PCPs, prescribing long-acting opioids made
sense. As many of our patients were already pre-
scribed daily short-acting oxycodone/acetami-
nophen, the switch to oxycodone SA seemed easy.
However, managing patients on chronic opioids
already presented problems for PCPs and now
they were mandated to convert their patients to
another opioid.
Opioid-prescribing guidelines promoted by
professional organizations [26,27] and federation
of state medical boards [28] recommend consider-
ation of the use of opioid treatment agreements/
contracts which include the use of urine drug
testing (UDT). Although efficacy of these tools
remains unproven, their inclusion as policy in clin-
ical settings is widespread. When used routinely
for all patients, these tools can minimize conflicts
associated with treatment with chronic opioids
[43–46]. However, Fishman et al. [47] emphasize
the limitations of relying solely on treatment
agreements and UDTs to monitor adherence to
chronic opioids.
Using precise terminology for substance misuse
and addiction disorder reduces confusion and mis-
labeling of patients [48]. A range of aberrant drug-
taking behaviors in patients treated with opioids
for chronic pain has been described. Differential
diagnosis includes under-treated pain (pseudoad-
diction) [49], recreational drug use, undiagnosed
psychiatric disorder (i.e., anxiety disorders, unipo-
lar and bipolar depression, schizophrenia, per-

4. 576 Wiedemer et al.
sonality disorder), encephalopathy, dementia,
addiction, and diversion [50,51]. In the context of
opioid treatment for pain, the disease of addiction
is characterized by a persistent pattern of aberrant
opioid use over time, including one or more of the
following: loss of control over use of opioids, con-
tinued use despite harm, compulsive use, and crav-
ing [27]. There is no validated tool to predict the
risk of substance abuse in patients with chronic
pain being considered for opioid therapy [47].
Patients’ self-report of drug use is frequently unre-
liable in this setting [44]. Observation and docu-
mentation of aberrant drug-taking behaviors while
managing pain with a range of strategies that
acknowledge the potential for abuse, misuse, and
addiction allows for effective pain management
and the identification of patients at risk for sub-
stance misuse and addiction [35].
Methods
Setting
The PVAMC is an urban university affiliated ter-
tiary care center which provides health care for
approximately 50,000 veterans (FY 2003). The
PVAMC Primary Care Center has an enrollment
of 17,000. Primary care is staffed by 19 physicians,
15 NPs, and one physician assistant. Guidelines
and policies for management of chronic pain with
opioids were made available to these PCPs in con-
junction with education in the form of grand
rounds and in-service seminars in 2000. An audit
after 18 months revealed that clinical pra-
ctice guidelines were rarely followed, indicating
the need for a new plan for improving pain
management.
Procedure
The mandate to decrease oxycodone SA to 3% of
all prescribed opioids presented an onerous task to
the Primary Care Service. To assist, the pharmacy
donated a full-time clinical pharmacist, which pre-
sented an opportunity to improve practice. This
led to the formation of the ORC, which developed
in three phases. In Phase I, one of the authors
(NW) reviewed the literature, interviewed leaders
in the field locally and nationally. She also held
focus groups with the PCPs to obtain their input
in designing a program. Several themes emerged
that influenced the design of the ORC. PCPs
believed that available pain management guide-
lines were impractical in primary care for several
reasons: the complexity of veterans with pain, who
tend to have multiple medical and psychiatric
comorbidities; the brevity of outpatient encoun-
ters; inexperience in using opioids for chronic
pain; and, the added time burden of utilizing opi-
oid treatment agreements (OTAs), which included
monitoring of chronic opioids with random UDT.
They reported that conflicts with patients about
opioid use were common, often resulting in angry
interactions and interfering with the PCPs ability
to focus on patients’ medical comorbidities. PCPs
asked specifically for help with what they viewed
as “the problem patients.” The literature and the
opinions of leaders in pain medicine reinforced the
importance of strategies such as OTAs [47], UDT
[44,45], a formal clinic policy [43], and the use of
precise terminology for addiction disorder, physi-
cal dependence and tolerance to minimize confu-
sion and labeling [31,35,48].
During Phase II, we designed and developed the
ORC based upon the information provided in
Phase I and the needs of our particular case mix
of patients, which included a high percentage of
patients with pain and psychiatric and addiction
comorbidity. The ORC aimed to: 1) provide
appropriate treatment for each patient—opioid
therapy when indicated and addiction therapy
when indicated; 2) improve PCP confidence in
prescribing opioids; 3) improve monitoring and
documentation; and 4) reduce overall costs of care
both by decreasing misuse or overuse of resources
(i.e., reducing emergency room [ER] and walk-in
visits and complaints to the patient advocate
requiring administrator and clinician time) and by
meeting pharmacy budget goals for decreasing
oxycodone SA use.
The program was managed by an NP and clin-
ical pharmacist. PCPs referred patients by order-
ing a consult on the VA’s Computerized Patient
Record System. Consultation required a signed
OTA with their PCP and UDT performed prior
to enrollment. For convenience and speed, the
following tools were made readily available in the
electronic record for ease of use by PCPs: 1) an
assessment template to document the key domains
of pain treatment outcomes, called the “4As”—
analgesia, activities of daily living, adverse events,
aberrant drug-taking behaviors (Appendix I) [52];
2) an electronic note for the OTA; and 3) a UDT
order set placed in the primary care order screen.
A multidisciplinary pain management team
(addiction psychiatrist, rheumatologist, orthope-
dist, neurologist, and physiatrist) met biweekly to
support the NP and Pharm.D by reviewing cases
and advising on treatment plans based on multi-

5. Opioids in Primary Care 577
modal management including, besides opioids,
NSAIDs and acetaminophen for osteoarthritis,
transcutaneous electrical stimulation (TENS)
units, antidepressants and anticonvulsants for neu-
ropathic pain, and reconditioning exercises. They
were also available for phone consultation. Early
on, many cases were reviewed by the team, but as
the PCPs became more comfortable with the pro-
gram and the NP and Pharm.D acquired experi-
ence, most cases were managed by the Pharm.D
and PCPs. The NP and Pharm.D were located in
the primary care clinic (PCC) so that PCPs could
drop in as needed to discuss cases face to face or
by telephone as well as consulting the electronic
medical record.
After referral, all patients were given the same
instructions regarding the ORC structured pro-
gram: they were expected to follow their individ-
ualized multimodality pain treatment plan (e.g.,
physical therapy, chronic pain school, tests and
visits requested by PCP or Pain Team), and agree
to be monitored with frequent (UDTs). Patients
with aberrant drug-taking behaviors required
more structured prescribing and monitoring,
including frequent visits, prescribing small quan-
tities of opioids, more frequent UDT, pill counts,
and education and counseling.
Phase III consisted of maintenance and evalua-
tion. The program was monitored by regular team
meetings and review of patients and protocols.
Evaluation of the program included patient adher-
ence to OTA, PCP satisfaction and rates of use of
OTAs and UDTs by PCPs.
Outcome Measures
The outcomes of the program on providers, phar-
macy budget, and patients were evaluated through
December of 2003, 22 months after the start of
Phase I.
Providers: The effect of the program on PCPs
was measured by behavioral changes and by satis-
faction. PCP behavior change was assessed
by counting the absolute number of UDTs and
OTAs ordered by PCPs on the electronic medical
record. PCP satisfaction with the program was
assessed by a questionnaire (Appendix II). Phar-
macy: The effect on the pharmacy budget goals for
2001–2002 was measured by extracting cost data
on patients. Patients: The impact on patient care
was assessed by the percentage who were adherent
to the OTAs and by results of UDTs.
Results
Provider Behavior
The number of OTAs more than doubled from
their baseline in 2001 (63) to 2002 (144) and more
than tripled by 2003 (214). The increase in UDT
testing is illustrated in Figure 1, which shows a
slight increase from the first month, February
2002 (74), to the second month, March 2002 (84),
a relatively stable rate over the next 6 months
(range 84–148), and then a steady increase to an
average of 200 per month over the last 6 months
of data collection ( July–December 2003). Follow-
ing the initiation of the program in February 2002,
Figure 1 Rate of increase in use of UDT by PCPs. UDT = urine drug testing; PCP = primary care provider.
Urine Drug Testing
0
50
100
150
200
250
300
Feb
2001
M
arch
2001
A
pril2001
M
ay
2001
June
2001
July
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ugust2001
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ct2001
N
ov
2001
D
ec
2001
Jan
2002
Feb
2002
M
arch
2002
A
pril2002
M
ay
2002
June
2002
July
2002
A
ug
2002
Sept2002
O
ct2002
N
ov
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D
ec
2002
Jan
2003
Feb
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arch
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pril2003
M
ay
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June
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ug
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ct2003
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ov
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D
ec
2003
Feb 2001 through Dec 2003
NumberofTests
UDT w/confirm
UDT w/oxycodone
UDT w/fentanyl
Total

6. 578 Wiedemer et al.
the largest percentage increase in use occurred
between May 2002 and October 2002. Pharmacy
budget goals for reducing costs of oxycodone SA
were met (see Table 1), with a reduction from
$129,793 (Q1 FY 01) to $5,236 (Q1 FY 03). The
number of prescriptions for opioids per month
remained constant, demonstrating a shift from
oxycodone SA to other less costly long-acting
opioids.
Reduction in Utilization of Health Care Services
We conducted a retrospective analysis of the first
108 patients enrolled in the ORC. We compared
resource utilization, calculated as the average
number of visits monthly during the 12 months
before enrolling in the ORC compared with the
average number of visits per month after enroll-
ment. Preliminary analyses showed that ORC
enrollees demonstrated an average decline, per
patient, in ER visits of 72.7% and unscheduled
PCP visits of 59.6%.
Provider Satisfaction
Table 2 lists how the providers rated the impact of
the program on their practice. A total of 35 PCPs
received questionnaires; 19 (54%) were returned.
In total, 84% of the those who responded referred
to the service. The majority of the PCPs who
completed the survey found the program helpful
in their practice, both in changing abnormal ill-
ness behavior (walk-ins, medication complaints)
and in freeing up more time to deal with important
medical problems. Table 3 lists the comments
written about the program at the end of the
questionnaire. These comments were uniformly
positive.
Patient Behavior
A total of 335 patients were referred to ORC over
a 22-month period for the structured treatment
strategy. In total, 171 (51%) were referred because
of documented aberrant drug-taking behaviors. Of
this latter group, 166 patients had urine toxicology
testing positive for illegal drugs, unprescribed
medications or were consistently negative for pre-
scribed medication (see Table 4). Five patients’
aberrant behavior consisted of one or more of
the following behaviors: frequent early renewal
requests, not following plan for renewal, getting
opioids from multiple providers.
Table 4 presents the outcomes of these referred
patients. Of the patients who were referred for
aberrant drug-taking behaviors (N = 171), 45%
adhered to the OTA, but 38% self-discharged
from the practice when the structured program
Table 1 Pharmacy data
Total No. Opioid Rx Total Cost for All Opioids % Oxycontin®
/All Opioids Oxycontin®
Costs
Q1 FY 01 5,202 $190,681 22.5 $129,793
Q2 FY 01 5,273 $206,242 22.3 $127,528
Q3 FY 01 5,662 $174,447 16.0 $100,067
Q4 FY01 5,265 $153,288 12.3 $67,495
Q1 FY02 4,821 $130,133 9.6 $47,595
Q2 FY02 4,801 $121,059 6.2 $31,136
Q3 FY02 5,034 $111,898 0.8 $6,161
Q4 FY02 4,909 $101,579 0.5 $4,721
Q1 FY03 4,959 $109,868 0.4 $5,236
Table 2 Results of provider satisfaction survey
Change in PCP practice
I use the opioid agreement more often.
37% Strongly agree
26% Agree
21% Disagree
16% Neutral
I routinely order urine drug screens.
63.2% Strongly agree
26.3% Agree
10.5% Disagree
The consistent approach to chronic opioid therapy promoted by the
Pain Team and put into practice by the Opioid Renewal Clinic has
helped me feel comfortable in managing chronic pain.
61% Strongly agree
28% Agree
11% Neutral
I receive fewer complaints regarding pain medications.
65% Strongly agree
12% Agree
18% Neutral
5% Disagree
There are fewer walk-ins for pain management issues.
76% Strongly agree
6% Agree
18% Neutral
I can spend more time with the patients’ other medical problems
when they are being medical problems when they are being
followed by this service.
76.4% Strongly agree
11.7% Agree
11.7% Neutral
PCP = primary care provider.

7. Opioids in Primary Care 579
was offered. Only 22 (13%) required referral for
addiction treatment. Seven (4.09%) were weaned
from opioids due to consistently negative urine
drug tests. In total, 164 of referred patients
(48.9%) had no documented aberrant behaviors.
They were referred due to complexity including
h/o substance abuse, conflicts with PCP regarding
opioids, opioid rotation or titration. This group
continued to adhere to the OTA without any aber-
rant behaviors.
Table 5 presents the number and percentage of
each drug that was found collectively in the UDTs,
with cocaine and THC being by far the most com-
monly abused.
Discussion
During the last decade, the use of opioids for the
treatment of noncancer pain, once almost solely in
the realm of pain specialists, has increased in
the primary care setting [3,4,29]. PCPs are now
expected to manage this controversial and techni-
cally difficult therapy, often without guidance
from pain management specialists. Although
guidelines exist [17,26–28] and hospital policies
support opioid therapy, PCPs often feel ill-
prepared and overwhelmed by its demands. Thus,
opioids are usually either avoided or, if prescribed,
guidelines are followed variably for various rea-
sons, particularly time constraints, but also the
personal opinions of the provider rather than evi-
dence. The implementation of the ORC demon-
strates that a primary care-based pain service that
supports PCPs in managing opioids can overcome
barriers to opioid prescribing. To our knowledge,
there is no other literature documenting such
results in a pain management program in primary
care.
After 22 months, the ORC demonstrated
improvement in all outcomes: 1) change in pro-
vider practice measured by increased use of urine
drug toxicology testing, increased documentation
of the OTA, and decreased prescribing of oxyc-
odone SA; 2) improved patient adherence to the
OTA; and 3) the differentiation of addiction and
other aberrant behaviors as well as documentation,
by negative UDT, of possible diversion.
Change in PCP Practice
The use of OTAs and monitoring with UDTs are
widely accepted tools intended to improve patient
adherence with opioid therapy [47]. Although the
Federation of State Medical Boards of the United
Table 3 Comments from PCPs
Comments from PCP Satisfaction Questionnaire
• This service is excellent and a big help with our most difficult
patients.
• The service has made a positive impact on our patients.
• I appreciate the service availability by phone for questions while
I am seeing patients.
• This program has made my life and my patients life easier. It gives
me time to address all the other important health care issues
during the visit.
• It has helped me to improve my relationship with my chronic pain
patients.
• I strongly am in favor of this program.Where I came from, primary
care was buried in opioid renewals and behavioral issues.
• This service has been a godsend for primary care providers. It
has enabled us to effectively treat chronic pain.
It allows us the time to care for other medical problems. It also
gives us an effective mechanism for dealing with very prevalent
substance abuse issues.
• Before this service, patients seeking opioids would disrupt the
delivery of care. Shouting in the waiting area was common.
Security frequently had to be called in. Providers felt threatened.
Prescriptions for opioids were not managed systematically.
Providers who could not handle these patients had nowhere to
turn. The establishment of this service has ended the
disorganized way we managed pain and introduced a safer, more
effective approach. It’s one of the best innovations I’ve seen in
primary care.
PCP = primary care provider.
Table 4 Outcomes of referred patients (N = 335)
Outcomes Number (%)
171 (51%) documented aberrant drug-taking behaviors
Resolution of aberrant behaviors 77 (45)
Self-discharged from ORC 65 (38)
Referred for addiction treatment 22 (13)
Consistently negative UDT (weaned from
opioids)
7 (4)
164 (49%) no documented aberrant drug-related behaviors at
referral
Adherence to OTA 164 (100)
ORC = Opioid Renewal Clinic; UDS = urine drug testing; OTA = opioid
treatment agreement.
Table 5 Urine drug testing (UDT) results of the N = 166
referred with abnormal UDT
Abnormal UDT Drug N (%)
Cocaine 61 (37.75)
THC 60 (33.14)
Morphine 24 (14.46)
Benzodiazepines 22 (13.25)
Oxycodone 13 (7.83)
Propoxyphene 13 (7.83)
Hydrocodone 11 (6.63)
Codeine 8 (4.82)
Methadone 4 (2.41)
6-acetyl morphine (heroin) 3 (1.81)
Butalbital 1 (0.60)
Meperidine 1 (0.60)
PCP 1 (0.60)
UDT = urine drug testing.

8. 580 Wiedemer et al.
States guidelines [28] for opioid prescribing rec-
ommend these tools, consistent with our experi-
ence, they are not routinely used [29,44]. Prior to
the implementation of the ORC, an average of 20
UDTs were ordered per month by Primary Care.
OTAs were documented on average two to four a
month in the 6 months prior to starting the pro-
gram. PCPs reported that they only required
OTAs and UDTs for patients they deemed as
potentially problematic patients.
After implementation of the program, the
added support provided by immediate access to
the clinical pharmacist and NP came with a pre-
requisite: an OTA and routine UDTs on all
patients treated with opioids for chronic noncan-
cer pain. When the PCPs first started performing
UDTs on patients they were already following, in
some cases for years, the number of positives (pos-
itive for illicit or unprescribed medications or neg-
ative for prescribed medications) was surprising
(see Table 3). This is similar to the findings of Katz
and Fanciullo [44] who found positive UDTs
(either positive for illicit drug, unprescribed con-
trolled substance or negative for prescribed med-
ication) in 27% of patients with no previous
behavioral issues and another series [53] which
found that 21% had concealed substance misuse
from their providers when it was discovered by
UDT. Positive urines illustrated for PCPs the
importance of UDTs for all patients on chronic
opioid therapy, rather than their prior practice of
selecting patients based on opinion. Our findings
support Gourlay et al.’s proposal for “universal
precautions” for all patients being considered for
opioid therapy [46]. This universal application of
the chronic opioid policy (including OTA and
UDT) in a respectful and matter-of-fact manner
was surprisingly well received by our patients.
Based upon the authors’ formal and informal
daily contact while working in close proximity to
the PCP practice, the process of building confi-
dence in PCPs’ use of opioids appears to be due
to at least four factors. First, daily access to the
support of the NP, Pharm.D, and the multidisci-
plinary Pain Team meant that PCPs never felt
isolated and on their own in making decisions.
Second, the Pharm.D’s documentation provided
them with laboratory data and clinical outcomes
data to support their clinical decisions and to
increase their confidence in discussing these deci-
sions with their patients—for example, enabling
them to say “it wasn’t just my decision.” Third,
when good outcomes were documented, this
increased their confidence that they could pre-
scribe opioids with success even in the context of
apparent aberrant behaviors. Fourth, by outlining
clear responsibilities in the treatment agreement,
PCPs gave the patient an opportunity to partici-
pate in the clinical process of demonstrating that
opioids were safe, manageable, and effective rather
than burdening the PCPs with that decision based
upon bias and unreliable data.
Patient Outcomes
All of the 335 patients referred to the ORC over
a 22-month period were classified as having a
medically stable noncancer pain condition. A total
of 164 referrals were considered complex and “at
risk”—these will be discussed in more detail
below. In total, 171 referrals were patients with
objective aberrant behaviors, and of these 77
(45%) were able to resolve their aberrant drug-
taking behavior and continue opioid medication;
65 (38%) chose not to follow the structured pro-
gram and left the ORC and 22 (13%) remained in
the program but were unable to adhere to the
OTA and were referred for addiction treatment.
Based on the entire sample (N = 335), the rate of
manifest addiction was 6.5%. However, if one
assumes that those who dropped out have addic-
tion or substance abuse, the rate in the entire sam-
ple (N = 335) may be as high as 26% (22 referred
for addiction treatment and 65 self-discharged).
Importantly, our structured program reduced
the apparent number of patients with addiction
(assuming that aberrant drug-taking behaviors
equals addiction, as many clinicians erroneously
do), from N = 171 to the actual N = 22 with con-
firmed addiction who were referred for treatment.
These results suggest that a health care system
can anticipate considerable savings in professional
hours by avoiding unnecessary referrals for addic-
tionology consultations for the large group of
patients, in this case 77 patients whose aberrant
behavior resolved in the ORC.
Of the 171 patients referred for aberrant behav-
ior, we hypothesize that the 65 (38%) who initially
refuse participation may have done so for obvious
reasons such as ongoing addiction, diverting med-
ications for profit or to obtain illegal drugs or,
simply not wanting to be bothered with the struc-
tured program. However, this study cannot test
this. We do know from our longitudinal clinical
work in primary care that a few of the patients who
initially refused monitored opioid therapy in ORC
eventually returned and agreed to participate—
these “returnees” are not reflected in our data as
it was outside the time frame of our project. Fur-

9. Opioids in Primary Care 581
ther studies will be needed to elucidate causes of
initial refusal. Consideration of the problem of
diversion is particularly important. The recent
national mandates to identify and treat pain have
occurred with a concomitant increase in illicit use
of prescription opioids [54]. To reduce diversion
and to preserve the legitimate treatment of
chronic pain with opioids, published clinical prac-
tice guidelines for prescribing opioids for noncan-
cer pain include monitoring both for effectiveness
and for aberrant drug-taking behaviors [55,56].
Available data suggest addiction rates of 6–
16.7% in the general US population [57], 20–26%
in hospitalized patients, and 40–65% in trauma
patients [58]. Our addiction rates fall within these
ranges although meaningful comparisons are dif-
ficult due to methodological differences such as in
criteria for selection of study samples, in the def-
initions of abuse and addiction, and in methods of
assessment. This problem manifests as well in esti-
mates of prevalence rates in primary care popula-
tions. Reid et al. [3], in a retrospective review of
diagnoses recorded in the medical record of
patients being treated with opioids for chronic
noncancer pain, reported an 18% lifetime preva-
lence of narcotic abuse/dependence in a VA PCC
(VA) compared with a 38% prevalence in a univer-
sity-based PCC. Documentation of “prescription
opioid abusive behaviors” was found in 24% (VA)
and 31% (PCC). Other retrospective chart reviews
documented rates of drug abuse rates of 6% in a
large university-based primary care practice [29]
and 21% in a VA sample [4]. In our review of 208
patients referred for a chronic noncancer pain
consultation at the Philadelphia VA from 2000 to
2002, 22% had documented addiction disorder.
In contrast to these cross-sectional chart
reviews, confidence in our categorization lies in
the strength of the longitudinal, prospective
assessment of actual substance abuse behaviors
within a structured program. The diagnosis of
addiction was made based upon observed behav-
iors over time while pain was managed aggres-
sively, therefore eliminating the possibility that
behaviors were due to pseudoaddiction.
Of the 335 referrals, 164 (49%) were complex
“problem patients” (e.g., past history of addiction,
conflicts with PCP over opioids, pharmacological
complexity) who the PCPs felt unprepared to
manage on their own and were referred for the
“potential” of developing substance misuse. It is
important to note that all of these patients success-
fully adhered to the OTA using the minimum
amount of structure (e.g., brief monthly visits to
the pharmacist) in the ORC protocol. The risks of
exposing individuals with past or present addiction
disorder to opioid analgesics are not well studied.
Many experienced pain clinicians believe that the
majority of individuals with chronic pain can be
managed safely with opioids if monitored appro-
priately [10,16,23,26,50], whereas some practitio-
ners believe that the risks outweigh the benefits
[59]. A more refined, nuanced assessment of risk,
based upon evidence not opinion, is not possible
given our present knowledge. Thus, we as a field
are challenged to develop methods of distinguish-
ing patients with chronic pain who have, or are at
risk for, a substance abuse disorder.
Our study’s several limitations preclude gener-
alizations. We cannot be sure how often and to
what degree patients in our sample received other
health care outside the VA system, as many
patients have additional insurance in their family.
We did not measure important pain treatment
outcomes, such as physical and psychosocial func-
tioning. The sample size is relatively small and
derived from a Veterans Medical Center in an
urban setting. Other health care systems, without
an integrated electronic medical record and the
availability of easy team consultation, may be chal-
lenged to implement this system. Thus, testing
this intervention in larger, more demographically
diverse samples drawn from several different set-
tings would provide results that could be more
easily generalized to the larger health care system.
For example, would this program be cost-effective
or even feasible within a suburban context with
less poverty and addiction comorbidity? Finding
demographically similar groups matched for dis-
ease and illness severity would enable us to analyze
differences between this approach and treatment
as usual in different settings. Each clinical settings
will differ in the experience and training of avail-
able practitioners that can be convened to form a
multidisciplinary team to support an ORC.
Future studies of the Pain Medicine and Pri-
mary Care Community Rehabilitation Model,
instructing PCPs to use evidence-based medica-
tion management algorithms for different types of
pain (e.g., neuropathic, nociceptive, myofascial)
and including a broader range of treatments,
including acupuncture, behavioral therapies,
and interventional pain medicine, should further
improve performance as measured by patient out-
comes and reduced system costs. The relative suc-
cess of this intervention indicates that further
multicenter studies of the ORC approach are war-
ranted, using additional measures of outcome such

10. 582 Wiedemer et al.
as pain levels and psychosocial, physical, and occu-
pational functioning. It is hoped that a gold stan-
dard of outcomes, measurable behavior, such as is
available in an integrated and self-contained health
system such as VA, will be utilized in such studies.
Conclusions
We implemented a structured program for opioid
management for chronic noncancer pain in a pri-
mary care setting, based on the current standards
and guidelines for opioid prescribing. Strategies
utilized in the NP/clinical pharmacist-run clinic
included: standardized documentation, OTAs,
UDT, frequent visits, and patient education. We
demonstrated that PCPs increased their use of
OTAs and UDT and prescribed opioids with more
confidence. We suggest that an ORC-like model,
tailored to the needs of each particular setting, can
help make this important treatment modality
available to more patients at lower risk.
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Appendix I
OPIOID RENEWAL NOTE
Opioid Treatment Plan Provider/Team:
Diagnosis:
Level of Analgesia:
(Pain scale—NRS)
Average: Best: Worst: Goal:
Functional Ability:
ADR’s/SE:
Current Therapy:
Aberrant Behavior:
Recommendations/Comments:
Appendix II
Opioid Renewal Clinic
Provider Satisfaction and Program Evaluation
Strongly
Agree
Agree ? Disagree Strongly
Disagree
1. The goals of the program and services offered are clear to me. 5 4 3 2 1
2. The strategies utilized by this service to manage patients on
chronic opioid therapy have influenced my practice.
5 4 3 2 1
2a. I use the opioid agreement more often. 5 4 3 2 1
2b. I routinely order urine drug screens when indicated. 5 4 3 2 1
2c. Once I make the decision to start chronic opioids, I titrate to
effectiveness.
5 4 3 2 1
2d. I automatically initiate constipation prophylaxis when I start
opioids.
5 4 3 2 1
3. Have you referred patients for this service? Yes No
4. I have never referred but I use the service as a resource for
assistance with management.
frequently occasionally never
5. I have referred to the service and I also utilize the service as a
resource for assistance with other cases.
frequently occasionally never
Strongly
Agree
Agree ? Disagree Strongly
Disagree
If you have referred please complete the following:
6a. The methods of communication between the Opioid Renewal
Clinic Clinicians and me are helpful.
5 4 3 2 1
6b. The Pharm.D’s progress note provides pertinent information. 5 4 3 2 1
6c. I prefer to be notified by View Alert (note requiring cosignature) and
email.
Yes No
6d. I prefer to be notified by email and would prefer not to have to
cosign the note.
Yes No
Strongly
Agree
Agree ? Disagree Strongly
Disagree
Complete whether you have referred or not:
7a. The service has a positive impact on the Primary Care practice. 5 4 3 2 1
7b. I receive fewer complaints regarding pain medications. 5 4 3 2 1
7c. There are fewer walk-ins for pain management issues. 5 4 3 2 1
7d. I can spend more time with the patient’s other medical problems
when they are being followed by this service.
5 4 3 2 1
Strongly
Agree
Agree ? Disagree Strongly
Disagree
8. The consistent approach to chronic opioid therapy promoted by the
Pain Team and put into practice by the Opioid Renewal Clinic has
helped me feel comfortable in managing chronic pain.
5 4 3 2 1
9. Your patients have reported their level of satisfaction with the Opioid
Renewal Clinic as
Very
Satisfied
Satisfied Dissatisfied No
Comment