Legal Issues in Pain Medicine

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Transcript Legal Issues in Pain Medicine

Utilization of the Emergency Department by
Chronic Pain Patients to Obtain Pain
Medications:
A Study of Barriers to Treatment, Abusive
Behaviors and Psychological Factors
•
Scott M. Fishman, MD
Chief: Div. of Pain Medicine
Dept. of Anesthesia &
Pain Medicine
UC Davis Medical Center
Professor of Anesthesiology
Univ. of California, Davis
School of Medicine
Background
•
Mayday Foundation RFP
• ED paper
»
Literature review
~ Chronic pain evaluation
•
•
•
•
LBP
Headaches
Sickle Cell
Ureterolithiasis
Wilsey, Fishman, Rose, Papazian, Pain management in the ED. Am J Emerg Med 2004; 22: 51-7
Barriers to Treatment
•
Quantitative data
»
Questionnaires
~ Patients
~ Physicians
~ Nursing staff
•
Qualitative analysis
»
Interviews
~ On perceived barriers to care in the ED from the perspective of
physicians
Utilization of the Emergency
Department by Chronic Pain
Patients to Obtain Pain
Medications: A Study of Barriers
to Treatment, Abusive Behaviors
and Psychological Factors
Scott Fishman, MD, Barth Wilsey, MD,
Ingela Symreng, PhD, Dan Mungas, PhD,
Christine Ogden, BS
Overview
•
Study Structure
• Method of Recruitment
• Selected Population
~ Patient Demographics
~ Provider Demographics
•
Status of Recruited Patients
• Successful and Failed Recruitment
Techniques
Study Structure
Visit 1
•
Subject recruited while they are in the ED
to be treated for chronic pain, duration  6
months
»
Fill out as many questionnaires as possible
~ Demographics, CAGE and Compton/Jameson Questionnaires
»
•
I-S.O.A.P., C.M.S.D., P.B.Q., PDQ-4+, C.S.Q.,
C.P.S.S., S.E.F., S.E.O.S., STAI, and BDI-II
Subject given contact information
»
Advised of a F/U appointment with the
psychologist
~ Scheduled within 14 days after the ED visit
Study Structure
Visit 2
•
Subject contacted within one week of ED Visit to
schedule a F/U visit with psychologist
»
If all questionnaires are not complete
~ Opportunity at time of F/U visit to complete all questionnaires
»
»
•
The patient will meet with the psychologist for the
S.C.I.D.
After meeting with the psychologist, the patient is
informed about payment for participation
Completed Subject
»
A set of complete questionnaires, BDI-II, and S.C.I.D.
evaluation
Method of Recruitment –
Academic Offices
•
Ability to view the ED “Whiteboard” via remote computer in our
Academic Offices enables remote screening
»
•
Research Assistants can utilize computers to look for patients who
complain of the following generalized symptoms:
~ Chronic or Mild Stable Pain
~ Chronic Back Pain
~ Headache
~ Earache
~ Rx Refill Request
~ Diffuse Body Pain
~ Vague Abdominal Pain
Students travel to the ED to recruit these identified subjects
Method of Recruitment – ED
•
Students within the ED have significant access
»
»
•
Electronic “Whiteboard”, patient charts, and physical
“Whiteboard”
Patients recruited using the inclusion/exclusion criteria designated
by the protocol
Students approach patients within different Areas,
including the waiting room, where they will proceed
through the following steps:
»
»
»
»
Brief introduction to the study
Informed Consent
Administration of Study Questionnaires
Collection of all study materials before student and/or patient
departs from the ED
Continued Contact
Post ED Visit
• A Research Assistant will contact subject via
telephone within 1 week of the initial ED visit
»
»
At this time, the subject is scheduled to complete
Visit 2 within 14 days of the initial ED visit
The subject is contacted by telephone up to three
times before the patient will be discontinued due
to lack of compliance
Subject Selection
Exclusion Criteria
Inclusion Criteria
•
•
•
•
•
Male/Female  18 yrs of age
Patient is being seen at the University
of California Davis ED for Schedule II
medications
Patient has had pain for 6 months or
longer prior to enrollment for which
schedule II medications are already
being prescribed
Patient presents to the ED with a
complaint of vague head, abdomen, or
back pain of nonacute onset, diffuse
body paint, etc
Patient is able to read, understand, and
voluntarily sign the approved
informed consent form prior to the
performance of any study specific
procedures
•
Patient arrived by
ambulance
• Patient has an emergency
medical condition
• Patient states that they are
not comfortable reading
and comprehending
English
• Patient is unwilling or
unable to comply with the
study visit schedule
Patient Demographics:
Gender
Female
Male
50
44
45
Number of Patients
40
35
30
25
20
15
10
5
0
33
n = 77
Patient Demographics:
Duration of Chronic Pain
n = 76
50
45
45
40
Number of Patients
35
30
25
20
17
15
10
8
5
5
1
0
< 3 mo
3-6 mo
6mo-1yr
Duration of Pain
1-5yr
5+ yrs
Patient Demographics:
Ethnicity
n = 83
40
35
35
Number of Patients
30
28
25
20
15
10
9
10
5
0
1
0
White
Black
American Indian
Alaskan Native
Asian or Pacific
Islander
Hispanic
Patient Demographics:
Annual Income
n = 70
35
33
30
Number of Patients
25
20
16
15
10
7
7
5
3
3
1
0
0
< 10,000
10,001-20,000 20,001-30,000 30,001-40,000 40,001-50,000 50,001-60,000 60,001-70,000
Dollars
70,001+
Patient Demographics:
Education
n = 73
30
25
24
Number of Patients
25
20
14
15
10
8
5
1
1
Masters
Advanced Degree
0
High School
GED
Some College
Graduated college
Patient Demographics:
Employment
Employed
Not Employed
60
55
Number of Patients
50
40
30
20
10
0
18
n = 73
Types of Employment
•
Currently Employed : Line of Work
•
Currently Unemployed: Longest Employment
~ Building Maintenance
~ Fence Builder
~ Scrub Technician
~ Construction
~ Testing Technician
~ Stock Worker
~ Telemarketer
~ Editor
~ Housekeeper
~ Receptionist
~ Physical Therapist
~ Luggage Handler
~ Drug and Alcohol Counselor
~ Customer Service Clerk
~ Environmental Manager
~ Wildland Firefighter
~ Mental Health Worker
~ Writer
~ Cable
~ Truck Driver
~ Musician
~ Presser/Dry Cleaner
~ Retail Management
~ Engineering Technician
~ Insurance
~ Figure Skater
~ Analytical Chemistry
~ Asst. Supervisor for Distrib.
~ Homemaker
~ Nursery Employee
~ Underground Construction
~ Limousine Company
~ Restaurant Work
~ Bakery Machine Operator
~ Fast Food Customer Service
~ Warehouse Worker
~ Operating Engineer Miner
~ Office Furniture Installer
~ Mental Health Case Mgr.
~ Accounting
~ Sales
~ Cable
~ Dock worker
~ Contractor
~ Housekeeping
~ Janitor
~ Painter
~ Roofing
~ Lumberjack
~ Homemaker
~ Truck Driver
~ Cashier
~ Army
~ Cook
~ Healthcare Research
~ Cabinet Worker
~ Plumbing/Electrical
~ Computer Programmer
~ Mechanic
~ Welder/Fabricator
~ In House Security
Provider Demographics
Provider Demographics:
Different Providers
40
n = 56
36
35
Number of Providers
30
25
20
15
14
10
5
5
1
0
Attending
Resident
Nurse
Nursing Student
Provider Demographics:
Gender
Male
Female
28.5
28
Number of Providers
28
27.5
27
26.5
26
25.5
25
24.5
24
23.5
25
n = 53
Provider Demographics:
Ethnicity
n = 48
45
41
40
Number of Providers
35
30
25
20
15
10
5
1
2
2
2
0
0
White
Black
Asian
Hispanic
Indian
Other
Status of Study Subjects
Completers vs. Non-Completers
Completers vs. Non-Completers
60
n = 90
51
50
Number of Patients
40
39
30
20
10
0
Completers
Non Completers
Non-Completers:
•
Patients have or have not completed some portion of the
questionnaires. They have NOT completed the S.C.I.D.
• Total: 51/90 = 56%
------------------------------------------------------------------ No Information Collected : 2
* Dem = Demographics
- CAGE Only : 1
**C\J = Compton\Jameson
- Dem*, CAGE : 13
- Dem, CAGE, C\J**: 11
- Dem, CAGE, C\J, I-S.O.A.P. : 2
- Dem, CAGE, C\J, I-S.O.A.P., CMSD : 1
- Dem, CAGE, C\J, I-S.O.A.P., CMSD, PBQ, STAI : 1
- Dem, CAGE, C\J, I-S.O.A.P., CMSD, PBQ, PDQ-4+: 1
- Dem, CAGE, C\J, I-S.O.A.P., CMSD, PBQ, PDQ-4+, BDI-II: 2
- Dem, CAGE, C\J, I-S.O.A.P., CMSD, PBQ, PDQ-4+, CSQ: 1
- Dem, CAGE, C\J, I-S.O.A.P., CMSD, PBQ, PDQ-4+, CSQ, CPSS, SEF, SEOS: 1
- Dem, CAGE, C\J, I-S.O.A.P., CMSD, PBQ, PDQ-4+, CSQ, CPSS, SEF, SEOS, STAI: 8
- Dem, CAGE, C\J, I-S.O.A.P., CMSD, PBQ, PDQ-4+, CSQ, CPSS, SEF, SEOS, STAI, BDI-II: 7
Completers:
Patients have completed all necessary questionnaires AND
the S.C.I.D.
Total: 39/90 = 43%
----------------------------------------------------------------------------------------Dem, CAGE, C\J, I-S.O.A.P.,
CMSD, PBQ, PDQ-4+, CSQ,
CPSS, SEF, SEOS, STAI, BDI-II,
S.C.I.D. : 39
Summary of Recruitment
Successful Strategies and Barriers
Recruitment
•
~
Useful Recruitment Strategies
•
Barriers to Recruitment
Presence of recruiter in the ED
~
2nd Visit does not receive as
between the hours of 11am-8pm
much of a response from
M-F (five day coverage to
patients
maximize patient recruitment)
~ 2nd visit can only be completed
~ Patient completion of BDI-II
along with as many
on Fridays
questionnaires as possible within
~ Excluding patients who arrive
the ED
by ambulance: Some chronic
pain patients, utilize the
ambulance to “get a ride” to the
ED.
~ 14 day interval between visits is
too small
Quantitative Study of Barriers
•
Questionnaire for
Patients &
Providers
»
Same questions
~ Framed differently
Lack of Time
•
Patient
• I do not have
adequate time to
assess and treat
ED patients
complaining of
chronic pain
•
Provider
• Doctors and
nurses avoid
spending enough
time to talk about
your chronic pain
5
Strong agreement
4
Moderate agreement
]
Some agreement
3
]
]
Some disagreement
2
Moderate disagreement
1
Strongly disagreement
0
nurse
n=37
patient
n=54
lack of time
physician
n=19
Dunnett t-test post-hoc
ns patient vs physician .113
sig patient vs nurse
.003
Prioritization
•
Provider
• Patient
• The treatment of
• Doctors and
chronic pain in
nurses have more
the ED takes a
pressing issues
back seat to
than chronic pain
treatment of more
(like seeing
pressing issues
injured people or
like trauma or
myocardial
those with heart
infarctions
attacks)
5
Strong agreement
]
]
4
Moderate agreement
]
3
Some agreement
2
Some disagreement
1
Moderate disagreement
Strongly disagreement
0
nurse
patient
physician
n=37
n=54
n=19
more pressing issues
Dunnett t-test post-hoc
ns patient vs physician .184
ns patient vs nurse
.075
Fatalism
•
Provider
• Chronic pain has
little chance of
improving
•
Patient
• Chronic pain has
little chance of
improving
5
Strong agreement
4
Moderate agreement
]
Some agreement
3
2
]
Some disagreement
]
Moderate disagreement
1
Strongly disagreement
0
patient
physician
nurse
n=37
n=54
n=19
Little Chance of Improving
Dunnett t-test post-hoc
sig patient vs physician .001
sig patient vs nurse <.001
Belief in Pathology
•
Provider
• Patient
• I do not believe
• When the doctor
the validity of a
cannot find
pain complaint in
something wrong
the absence of
on exam or by an
physical findings
X-ray, they tend
or a lack of
not to believe you
objective findings
on imaging
could be in pain
studies, EMG, etc
5
Strong agreement
4
Moderate agreement
]
3
Some agreement
2
Some disagreement
]
1
Moderate disagreement
]
Strongly disagreement
0
patient
physician
nurse
n=37
n=54
n=19
Belief in Pathology
Dunnett t-test post-hoc
sig patient vs physician .001
sig patient vs nurse <.001
Fear of Addiction
•
Provider
• I believe that
chronic pain
patients who
come to the ED
are addicted to
their pain
medications
•
Patient
• I think that I am
addicted to pain
medications
5
Strong agreement
4
Moderate agreement
3
Some agreement
]
]
2
1
Some disagreement
Moderate disagreement
]
Strongly disagreement
0
patient
physician
nurse
n=37
n=54
n=19
Fear of Addiction
Dunnett t-test post-hoc
sig patient vs physician .003
sig patient vs nurse
.001
Fear of Dependence
•
Provider
I avoid
administering
opioids because
patients will develop
physical dependence
and go through
withdrawal when
they abruptly halt
the intake of the
medicine
•
Patient
I avoid taking pain
medications because
taking them will
lead to withdrawal
symptoms if I have
to stop them
5
Strong agreement
4
Moderate agreement
3
2
Some agreement
Some disagreement
]
1
Moderate disagreement
]
]
0
Strongly disagreement
patient
n=37
physician
nurse
n=54
Fear of Dependence
n=19
Dunnett t-test post-hoc
sig patient vs physician .018
sig patient vs nurse
<.001
“Bad” Patient
•
Provider
I find myself
labeling chronic
pain patients as
“bad patients” or
“drug seekers”
•
Patient
I believe that
telling doctors
and nurses about
my pain leads
them to consider
me to be a “bad
patient” or a
“drug seeker”
5
Strong agreement
4
Moderate agreement
3
Some agreement
]
2
]
Some disagreement
]
Moderate disagreement
1
Strongly disagreement
0
patient
physician
nurse
n=37
n=54
n=19
“Drug Seeker”
Dunnett t-test post-hoc
ns patient vs physician .108
ns patient vs nurse
.313
Qualitative Research
Through Interviews
•
Access using
conversations and
consultations with
ED physicians
• Taped and
transcribed
interviews
»
Anonymity and
confidentiality
maintained
Qualitative Research
•
Questions
»
»
»
Most problematic chronic pain patient
Limitations on care
Potential sources of improvement
Qualitative Research
•
Responses
»
»
»
»
“ED not designed to see these patients”
“Appropriate referrals to pain specialists
difficult”
Advised patients “find a primary care
doctor”
Provide short acting opioids
~ 20-30 pills of vicodin, codeine, or oxycodone
Estimated Numbers (in Millions) of Lifetime Nonmedical Use of Selected Pain Relievers
among Persons Aged 12 or Older: 2002 http://oas.samhsa.gov/2k4/pain/pain.htm
Abusive Behaviors
Estimated Numbers (in Millions) of Persons Aged 12 or Older with Past Year Illicit Drug
Dependence or Abuse, by Drug: 2002 http://oas.samhsa.gov/2k4/pain/pain.htm\
Prescription Drug Abuse in ED
»
Modeling using multiple regression
~ Dependent variable
• Screener and Opioid Assessment for Patients in Pain (SOAPP)
~ Independent variable
•
•
•
•
Spielberger State-Trait Anxiety Inventory (STAI)
Beck Depression Inventory (BDI-II)
Chronic Pain Self-Efficacy Scale (CPSS)
Coping Strategies Questionnaire (CSQ)
Screener and Opioid Assessment
for Patients in Pain (SOAPP)
•
Unrestricted grant from Endo
Pharmaceuticals Inc.
• Inflexxion, Newton, MA
»
Concept mapping procedures to obtain input
from a panel of pain and addiction medicine
specialists
~ Predict which patients will require more or less monitoring on longterm opioid therapy
http:/www.painedu.org.
Screener and Opioid Assessment
for Patients in Pain (SOAPP)
~ Prescription Drug Use Questionnaire (PDUQ)
~ Judgement by two out of the three staff member groups (e.g.,
using a physician, nurse, and/or a receptionist) that the patient
had a serious drug problem
~ Urine toxicology screening
Compton PJ, Darakjian J, Miotto K. Screening for addiction in patients with chronic pain and
"problematic" substance use: evaluation of a pilot assessment tool. J Pain Symptom Manage
1998;16:355-63.
Katz NP, Sherburne S, Beach M, Rose RJ, Vielguth J, Bradley J, et al. Behavioral monitoring
and urine toxicology testing in patients receiving long-term opioid therapy. Anesth Analg
2003;97(4):1097-102, table of contents.
Predicting Aberrant MedicationRelated Behavior
•
A cutoff score of 8 was
chosen to produce a
sensitive test
• Sensitivity of .90
»
•
Correctly classified 90% of
the patients who actually
went on to exhibit aberrant
behaviors
Specificity of .69
»
31% of the people, who
scored an 8 or higher on the
SOAPP, did not go on to
show detectable aberrant
behavior
14
12
Frequency
10
8
Mean = 19.06
SD = 8.258
6
N = 47
4
2
0
5
10
15
20
25
30
35
SOAPP Version 1.0 Summary Score
40
45
Unexpected Finding
•
Biased population
» Poorly controlled
» Prescription drug abuse relatively
common in ED setting
~ Short acting opioids
~ No opioid contracting
~ Multiple prescribers
•
Instrument not valid in ED
Abusive Behaviors and
Psychological Factors
•
Prescription drug abuse will correlate
with psychological factors
»
Previous study in pain clinics not
confirmatory
~ “Psychosocial testing on clinic admission failed to predict who
would become an opiate abuser”
Chabal C, Erjavec MK, Jacobson L, Mariano A, Chaney E. Prescription opiate abuse in chronic
pain patients: clinical criteria, incidence, and predictors. Clin J Pain 1997;13(2):150-5.
Correlates
•
Self Efficacy for Coping with
Symptoms
Screening for Prescription
Drug Abuse in ED
3 or 4
simple
questions
Prescription Drug Use
Questionnaire
•
I believe that I am addicted to pain
medicine
• I routinely have to take more medication
than my doctor prescribes in order to treat
my pain
• I prefer certain pain medications or ways of
taking these medications (IV, IM routes
over the oral route)
Compton PJ, Darakjian J, Miotto K. Screening for addiction in patients with chronic pain and
"problematic" substance use: evaluation of a pilot assessment tool. J Pain Symptom Manage
1998;16:355-63.
COMPTON SCORE (SUM OF POSITIVES)
3
2.5
2
n = 47
Spearman rho
r = 0.223
p = 0.131
2-tailed
1.5
1
0.5
0
10
20
30
iSOAPP Score
40
CAGE
•
Have you ever felt the need to Cut down on
your use of prescription drugs?
•
Have you ever felt Annoyed by remarks
your friends or loved ones made about your
use of prescription drugs?
•
Have you ever felt Guilty or remorseful
about your use of prescription drugs?
•
Have you Ever used prescription drugs as a
way to "get going" or to "calm down?"
http://www.nida.nih.gov/ResearchReports/Prescription/prescription6.html#Providers
CAGE SCORE (SUM OF POSITIVES)
4
3
n = 45
Spearman rho
r = 0.322
p = 0.031
2-tailed
2
1
0
10
20
30
iSOAPP Score
40
Hx Addiction/Legal Issues
•
Is there a history of alcohol or substance abuse in
your family, even among your grandparents, aunts,
or uncles?
• Have you ever had a problem with drugs or
alcohol or attended Alcoholics Anonymous (AA)
or Narcotics Anonymous (NA) meetings?
• Have you ever had any legal problems or been
charged with driving while intoxicated (DWI) or
driving under the influence (DUI)?
Michna E, Ross EL, Hynes WL, Nedeljkovic SS, Soumekh S, Janfaza D, et al. Predicting aberrant
drug behavior in patients treated for chronic pain: importance of abuse history. J Pain Symptom
Manage 2004;28(3):250-8.
JAMISON SCORE (SUM OF THE POSITIVES)
3
2.5
2
n = 45
Spearman rho
r = 0.418
p = 0.005
2-tailed
1.5
1
0.5
0
10
20
30
iSOAPP Score
40
Conclusions
•
Barriers are present
»
•
Similar to other settings
Chronic pain patients seeking care in
ED are special population
»
Prescription drug abuse
~ More research needed
•
Short questionnaire for prescription drug
abuse
»
No definitive answer
Collaborators
•
•
•
•
•
Barth Wilsey MD
Ingela Symreng PhD
Amy Ernst MD
Dan Mungas PhD
Matt Lewis BS, Jeanna Millman BS, &
Christine Ogden BS