Download Justin Tokorcheck MD, Brandon Seifert MD, Kristopher Atwood PhD

Chronic Pain Agreement Violations in Patients with Cancer; Incidence and Associated Risk Factors
Justin Tokorcheck MD, Brandon Seifert MD, Kristopher Atwood PhD, Oscar DeLeon-Casasola MD
SUNY University at Buffalo, Roswell Park Cancer Institute
Introduction and Objectives
While at present there are multiple strategies, modalities, and medications
available for the treatment of chronic pain, patients who carry a cancer
diagnosis are often treated with a combination of approaches to alleviate
symptoms. Among those who suffer from cancer pain, opioids are the
mainstay for treatment1. While opioid treatments can be effective, the
institution of such therapeutic plans requires careful consideration and
assessment of individual compliance with the prescribed regimen in light of
the opioid abuse epidemic2. Noncompliance or abuse of opioid therapies
can conflict with stringent state and federal laws in place governing the use
of controlled substances and also carries the potential for serious adverse
health effects. In order to establish safe and effective use and disbursement
of opioids, prescribers may require formal acceptance of an agreement
between the provider and each patient to conform to a clearly defined set
of expectations and restrictions guiding opioid therapy. Despite such pain
agreements, some patients receiving opioid medications for the treatment
of their cancer-related pain demonstrate a proclivity towards noncompliance with their agreement. This problem of noncompliance as abuse
or diversion affects the broader community beyond the individual patient
being treated and has gained attention from the media, the government,
and society in general. Due to the potentially severe and far-reaching
consequences of pain agreement violations in such instances, there is an
obvious need for both the detection and prevention of the misuse of opioid
medications. While this issue will persist as a challenge among providers
caring for patients with cancer pain, any improvement in the recognition of
individuals at higher risk for noncompliance with pain agreements can offer
a clear benefit for early intervention. In an effort to establish any patientrelated data that may assist with early recognition of those at higher risk for
abuse, the association of patient demographics and noncompliance with
pain agreements was examined among those treated at Roswell Park Cancer
Institute’s (RPCI) pain clinic. This study investigated the incidence of and
statistical relationships between pain agreement violations and
demographic characteristics among a cross-sectional cohort of cancer pain
patients at RPCI.
Materials and Methods
IRB approval and patient-signed consent were obtained. Urine
toxicology screens and self-reporting among 283 individuals over a 24
month period were followed by monthly tests for 6 months. Demographic
data including age, gender, race, marital and smoking status, history of EtOH
or substance abuse, and psychiatric illness were
compiled. Abuse encompasses positive testing for a non-prescribed opioid
and/or any illicit substance. Diversion is absence of the prescribed opioid(s)
in urine. Abuse rates were tabulated at all visits. Statistical analysis was
performed in SAS v9.3 (Cary, NC) with 95% confidence intervals determined
via the Agresti-Coull method and p-values less than 0.05 considered
statistically significant. Associations between abuse, demographics, and
visits were evaluated with Fisher’s exact and Chi-square tests.
Results
Table 1
Total All Visits
Total First Visits
Abuse
58.25% (64.15-52.34)
48.42% (54.40-42.44)
Diversion
27.72% (33.09-22.35)
19.65% (24.44-14.86)
Other Opioid
24.91% (30.11-19.72)
17.89% (22.52-13.27)
Other Substance
33.68% (39.35-28.02)
29.12% (34.57-23.67)
* Confidence intervals in parentheses
Table 2
Over All Visits
First Visit
Abuse
Diversion
Opioid
Illicit
Abuse
Diversion
Opioid
Illicit
Male
60.1%
23.6%
25%
43.2%
53.4%
16.9%
20.3%
37.2%
Female
56.3%
32.6%
25.2%
23%
43.7%
23%
15.6%
20.7%
< 30 yr
76.5%
23.5%
29.4%
64.7%
70.6%
11.8%
23.5%
58.8%
30-50 yr
62.8%
30.9%
25.5%
39.4%
51.1%
21.3%
14.9%
34%
50+ yr
54.1%
26.7%
24.4%
27.3%
45.3%
19.8%
19.2%
23.8%
White
54.3%
23.4%
22.9%
31.9%
46.8%
16.5%
18.1%
27.1%
Black
67.5%
38.8%
32.5%
37.5%
55%
30%
20%
33.8%
Other
55.6%
33.3%
22.2%
33.3%
11.1%
Table 3
Over All Visits
22.2%
First Visit
Abuse
Diversion
Opioid
Illicit
Abuse
Diversion
Opioid
Illicit
Single
65.4%
33.8%
30.1%
47.1%
53.7%
24.3%
19.1%
41.2%
Married
51%
20.8%
20.8%
21.9%
42.7%
12.5%
17.7%
19.8%
Div/Sep
56.8%
27.3%
20.5%
22.7%
50%
22.7%
15.9%
18.2%
Smoker
67.4%
31.2%
29.7%
42%
58.7%
23.9%
21%
37.7%
Non-smok
51.3%
26.1%
22.7%
24.4%
40.3%
16%
16.8%
21%
Hx Sub
76.5%
23.5%
41.2%
64.7%
64.7%
17.6%
23.5%
52.9%
No Hx Sub
52.8%
32.4%
21.6%
21.6%
42%
23.3%
14.8%
19.9%
* Statistically significant data is bolded and italicized and in red font
* “All Visits” p-values: gender < 0.001, smoking = 0.011 for abuse and = 0.004 for illicits, race = 0.029, marital status < 0.001, history of
substance abuse < 0.001
* “First Visit” p-values: gender = 0.003, age = 0.005, race = 0.037, marital status < 0.001, smoking = 0.004 for abuse and illicits, history of
substance abuse = 0.004
Conclusions and Discussion
Over all visits examined in this study time period statistically significant
associations were seen between smoking and abuse as well as between race
and diversion, and the demographic characteristics of gender, marital status,
smoking status, and a history of substance abuse were all independently
associated with illicit substance consumption. At the first visits of the study
time frame statistically significant associations were seen
between smoking and abuse as well as between race and diversion, and the
demographic characteristics of age, gender, marital status, smoking, and a
history of substance abuse were all independently associated with illicit
substance consumption. Most demographic characteristics examined in this
study had some statistically significant association established between it
and some form of noncompliance with the pain agreement. Only a history
of alcohol abuse and a history of psychiatric illness were found to have no
statistically significant association with pain agreement noncompliance.
However, the specific form of noncompliance varied between demographic
characteristics. Considering the statistically significant findings of this study,
there is clearly the potential to identify specific demographic characteristics
that may be associated with a higher risk of noncompliance with pain
agreements in the forms of abuse or diversion. The elucidation of
associations between such higher-risk characteristics and pain agreement
violations may be beneficial for practitioners providing care for cancer pain
patients by facilitating prevention, early detection, and/or intervention in an
effort to reduce the impact of the opioid abuse and/or diversion epidemic.
While clinical judgement and protocols will dictate the majority of a
decision-making process regarding screening of individual patients, the
addition of objective statistically significant data may assist with
individualized screenings. The incidences of abuse and diversion were
significantly higher in this study than observed in other non-cancer pain
studies3. A possible explanation of this discrepancy is the referral to the
RPCI pain clinic of patients who are either difficult to treat
or exhibit aberrant behaviors. Therefore, these findings may not be
representative of all oncology patients treated for cancer-related pain.
While reproducibility with other studies is an important aspect of forming
any clinical decision from investigational data, these findings suggest that
patients treated at a specialized cancer pain clinic should be actively
monitored for opioid abuse and diversion.
References
1. http://www.nccn.org/professionals/physician_gls/PDF/pain.pdf.
Accessed 7-9-2015
2. deadiversion.usdoj.gov/arcos/retail_drug_summary/index.html
3. Martell BA, et al. Ann Intern Med. 2007;146:116-27