Legal Issues in Pain Medicine

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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

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

Exclusion Criteria

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

15

10

5

0

30

25

20

50

45

40

35

Patient Demographics:

Gender

Female

Male n = 77

44

33

35

30

25

20

15

10

5

0

50

45

40

1

< 3 mo

Patient Demographics:

Duration of Chronic Pain

5

8

17

3-6 mo 6mo-1yr

Duration of Pain

1-5yr n = 76

45

5+ yrs

Patient Demographics:

Ethnicity

40

35

30

25

20

15

10

5

0

35

White

28 n = 83

10

9

Black

1

0

American Indian Alaskan Native Asian or Pacific

Islander

Hispanic

Patient Demographics:

Annual Income n = 70

35

30

25

20

15

33

16

10

5

0

7 7

3 3

1

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 70,001+

Dollars

Patient Demographics:

Education

30

25

20

15

25

10

5

0

High School

8

24

14 n = 73

GED Some College Graduated college

1

Masters

1

Advanced Degree

60

50

40

30

20

10

0

Patient Demographics:

Employment

Employed

Not Employed n = 73

55

18

Types of Employment

• Currently Employed : Line of Work

~ Building Maintenance

~ 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

• Currently Unemployed: Longest Employment

~ Fence Builder

~ Presser/Dry Cleaner

~ Retail Management

~ Cable

~ Dock worker

~ Contractor

~ Engineering Technician

~ Insurance

~ Figure Skater

~ Analytical Chemistry

~ Housekeeping

~ Janitor

~ Painter

~ Roofing

~ Asst. Supervisor for Distrib.

~ Lumberjack

~ Homemaker ~ Homemaker

~ Nursery Employee ~ Truck Driver

~ Underground Construction ~ Cashier

~ Limousine Company

~ Restaurant Work

~ Army

~ Cook

~ Bakery Machine Operator ~ Healthcare Research

~ Fast Food Customer Service ~ Cabinet Worker

~ Warehouse Worker

~ Operating Engineer Miner

~ Office Furniture Installer

~ Mental Health Case Mgr.

~ Accounting

~ Sales

~

~

~

~

~

Plumbing/Electrical

Computer Programmer

Mechanic

Welder/Fabricator

In House Security

Provider Demographics

25

20

15

10

5

0

40

35

30

14

Attending

Provider Demographics:

Different Providers

36 n = 56

5

Resident Nurse

1

Nursing Student

26

25.5

25

24.5

24

23.5

28.5

28

27.5

27

26.5

Provider Demographics:

Gender

28

Male

Female n = 53

25

Provider Demographics:

Ethnicity

30

25

20

15

10

5

0

45

40

35

41

White

1

Black n = 48

2

Asian

2

Hispanic

0

Indian

2

Other

Status of Study Subjects

Completers vs. Non-Completers

60

50

40

30

20

10

0

Completers vs. Non-Completers n = 90

51

39

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

CAGE Only : 1

Dem* , CAGE : 13

Dem , CAGE , C\J** : 11

* Dem = Demographics

**C\J = Compton\Jameson

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

~

Presence of recruiter in the ED between the hours of 11am-8pm

M-F (five day coverage to maximize patient recruitment)

~ Patient completion of BDI-II along with as many questionnaires as possible within the ED

• Barriers to Recruitment

~

2 nd Visit does not receive as much of a response from patients

~ 2 nd visit can only be completed on Fridays

~ Excluding patients who arrive 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

4

3

2

1

0

] nurse n=37

]

Strong agreement

Moderate agreement

Some agreement

]

Some disagreement

Moderate disagreement patient n=54 lack of time physician n=19

Strongly disagreement

Dunnett t-test post-hoc ns patient vs physician .113

sig patient vs nurse .003

Prioritization

• Provider

The treatment of chronic pain in the ED takes a back seat to treatment of more pressing issues like trauma or myocardial infarctions

• Patient

Doctors and nurses have more pressing issues than chronic pain

(like seeing injured people or those with heart attacks)

5

4

3

2

1

0

] ]

Strong agreement

Moderate agreement

]

Some agreement

Some disagreement

Moderate disagreement nurse patient physician n=37 n=54 n=19 more pressing issues

Strongly disagreement

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

4

Strong agreement

Moderate agreement

]

3

2

1

]

]

Some agreement

Some disagreement

Moderate disagreement

0 patient physician nurse n=37 n=54 n=19

Little Chance of Improving

Strongly disagreement

Dunnett t-test post-hoc sig patient vs physician .001

sig patient vs nurse <.001

Belief in Pathology

• Provider

I do not believe the validity of a pain complaint in the absence of physical findings or a lack of objective findings on imaging studies, EMG, etc

• Patient

When the doctor cannot find something wrong on exam or by an

X-ray, they tend not to believe you could be in pain

5

4

Strong agreement

Moderate agreement

]

3 Some agreement

2

1

0

Some disagreement

] Moderate disagreement

] patient physician nurse n=37 n=54 n=19

Belief in Pathology

Strongly disagreement

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

4

Strong agreement

Moderate agreement

3

2

]

]

Some agreement

Some disagreement

1

0

Moderate disagreement

] patient physician nurse n=37 n=54 n=19

Fear of Addiction

Strongly disagreement

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

4

Strong agreement

Moderate agreement

3

2

]

Some agreement

Some disagreement

1

0

Moderate disagreement

]

] patient physician nurse n=37 n=54 n=19

Fear of Dependence

Strongly disagreement

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

4

Strong agreement

Moderate agreement

3

2

1

]

]

]

Some agreement

Some disagreement

Moderate disagreement

0 patient physician nurse n=37 n=54 n=19

“Drug Seeker”

Strongly disagreement

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 Medication-

Related 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

6

4

2

14

12

10

8

0

5 10 15 20 25 30 35

SOAPP Version 1.0 Summary Score

40 45

Mean = 19.06

SD = 8.258

N = 47

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.

3

2.5

2

1.5

1

0.5

0

10 20 30 iSOAPP Score

40 n = 47

Spearman rho r = 0.223

p = 0.131

2-tailed

CAGE

• Have you ever felt the need to

C ut down on your use of prescription drugs?

• Have you ever felt

A nnoyed by remarks your friends or loved ones made about your use of prescription drugs?

• Have you ever felt

G uilty or remorseful about your use of prescription drugs?

• Have you

E ver used prescription drugs as a way to "get going" or to "calm down?" http://www.nida.nih.gov/ResearchReports/Prescription/prescription6.html#Providers

4

3

2

1

0

10 20 30 iSOAPP Score

40 n = 45

Spearman rho r = 0.322

p = 0.031

2-tailed

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.

3

2.5

2

1.5

1

0.5

0

10 20 30 iSOAPP Score

40 n = 45

Spearman rho r = 0.418

p = 0.005

2-tailed

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

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