1

Using Treatment Agreements and

Urine Drug Testing in Chronic Pain:

Why, When, and How?

Joanna L. Starrels, MD, MS

Albert Einstein College of Medicine

Montefiore Medical Center

July 29, 2015

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Disclosures

• No relevant conflicts of interest to disclose.

The contents of this activity may include discussion of off label or investigative drug uses.

The faculty is aware that is their responsibility to disclose this information.

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Planning Committee, Disclosures

AAAP aims to provide educational information that is balanced, independent, objective and free of bias

and based on evidence. In order to resolve any identified Conflicts of Interest, disclosure information

from all planners, faculty and anyone in the position to control content is provided during the planning

process to ensure resolution of any identified conflicts. This disclosure information is listed below:

The following developers and planning committee members have reported that they have no

commercial relationships relevant to the content of this webinar to disclose: AAAP CME/CPD

Committee Members Dean Krahn, MD, Kevin Sevarino, MD, PhD, Tim Fong, MD, Tom Kosten,

MD, Joji Suzuki, MD; and AAAP Staff Kathryn Cates-Wessel, Miriam Giles, Sharon Joubert

Frezza, and Justina Andonian.

All faculty have been advised that any recommendations involving clinical medicine must be based on evidence that is

accepted within the profession of medicine as adequate justification for their indications and contraindications in the care

of patients. All scientific research referred to, reported, or used in the presentation must conform to the generally

accepted standards of experimental design, data collection, and analysis. The content of this CME activity has been

reviewed and the committee determined the presentation is balanced, independent, and free of any commercial bias.

Speakers must inform the learners if their presentation will include discussion of unlabeled/investigational use of

commercial products.

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Target Audience

• The overarching goal of PCSS-O is to offer evidence-based

trainings on the safe and effective prescribing of opioid medications

in the treatment of pain and/or opioid addiction.

• Our focus is to reach providers and/or providers-in-training from

diverse healthcare professions including physicians, nurses,

dentists, physician assistants, pharmacists, and program

administrators.

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Educational Objectives

• At the conclusion of this activity participants should

be able to:

Describe current guidelines and evidence about

using treatment agreements and urine drug

testing for patients with chronic pain.

Demonstrate effective communication skills with

patients about expectations about prescribing

opioid therapy.

Illustrate appropriate ordering of urine drug tests

and interpreting the results.

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Outline

• Background

• Treatment agreements

Guidelines

Evidence

Tips for effective use

• Urine drug testing

Guidelines

Evidence

Tips for effective use

• Take home points

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Increase in Opioid Prescription

0

20

40

60

80

100

120

140

1980

1982

1984

1986

1988

1990

1992

1994

1996

1998

2000

2002

2004

2006

Hydrocodone Oxycodone Morphine Methadone Hydromorphone

Source: Automation of Reports and Consolidated Orders System, US DEA, slide adapted from A Gilson

Opio

id s

ale

s (

mg p

er

pers

on

)

8

0

2

4

6

8

10

'70 '74 '78 '82 '86 '90 '94 '98 '02 '06

De

ath

rate

pe

r 10

0,0

00

Heroin

Cocaine

38,329 drug overdose deaths in 2010

National Vital Statistics System, http://wonder.cdc.gov

Year

Rx drugs

Drug Overdose Death on the Rise

16,651 (43%) involved opioid analgesics

8,369 died from HIV/AIDS in 2010

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Outline

• Background

• Treatment agreements

Guidelines

Evidence

Tips for effective use

• Urine drug testing

Guidelines

Evidence

Tips for effective use

• Take home points

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Clinical Question 1

If you decide to prescribe opioids to a patient with

chronic pain, how likely are you to use a written

treatment agreement?

A. Not at all likely

B. It depends on the patient’s risk for misuse

C. Somewhat likely, regardless of risk

D. Very likely, regardless of risk

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Evolving guidelines about using

written treatment agreements

• Federation of State Medical Boards (2004)

− “should consider” for patients “at high risk”

• APS/AAPM (2009)

− “may consider” for any patients

• Washington State (2010)

− “should use” for everyone

• Federation of State Medical Boards (2013)

− Use “is recommended”

All agree that: 1) providers and patients should discuss goals, risks,

and expectations

2) The evidence for using or signing documents is weak

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Do treatment agreements work?

0

10

20

30

40

50

60

Aberrant

medication

taking

behavior(1)

Multiple

sources(2)

Multiple

sources(3)

Illicit drug

use(4)

Before After

Starrels JL, Ann Int Med 2010 (review). 1Weidemer NL, Pain Med 2007; 2Goldberg JC. J

Clin Outc Mgmt 2005; 3Manchikanti L, Pain Phys 2006; 4Manchikanti L, Pain Phys 2006.

Patients

with m

isuse b

ehavio

rs (

%)

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What is a treatment agreement?

Pain Medicine Contract

This contract has 4 parts.

Part 1 Tells you how and when to take your pain

medicine.

Part 2 Lists things you agree to do.

Part 3 Lists things that could happen if you do NOT

do the things listed in Part 2.

Part 4 Sign the form.

You and Dr. _____ must sign the form.

Go to the next page

Medicine Breakfast Lunch Dinner Bedtime

PART 1 MY PAIN MEDICINE

1American Academy of Family Physicians (AAFP)

http://www.aafp.org/fpm/2010/1100/fpm20101100p22-

rt1.pdf

The Utah Department of Health (Utah Department of Health.

Utah Clinical Guidelines on Prescribing Opioids for Treatment

of Pain. Salt Lake City, UT (2009).

http://www.dopl.utah.gov/licensing/forms/OpioidGuidlines.pdf

Wallace LS, Keenum AJ, Roskos SE, McDaniel KS.

Development and validation of a low-literacy opioid contract.

The Journal of Pain. Oct 2007;8(10):759-766.

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What is a treatment agreement?

A document that describes 4 things:

1. Risks & benefits of opioid therapy

2. Treatment plan (multi-modal)

3. Monitoring plan

4. Conditions for discontinuing opioids

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How to use an agreement

• Focus is safety

• Communication tool – get on the same page

• Educate, engage, learn about your patient

• Set goals and expectations

• For everyone

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Many ways to do this

• Written documents vary

“Contract”

Informed Consent

Agreement

Treatment Plan

Dear Patient letter

• Have the conversation (& document it)

I prefer these

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How not to use an agreement

• Not a formality (“sign here to get your

medicine”)

• Not to protect you from liability

• Not a magic bullet

False sense of security

• Not to punish a patient

“I had to put him on a pain contract”

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Agreement should be goal-directed

Goals of treatment

• We do not expect your chronic pain to go away completely.

• Our hope is that treatment will make your pain more

tolerable so that you can do the things you want to do.

• Goals for me are: __________________________

______________________________________

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Agreement should outline the

treatment plan

I understand:

• These medicines are only one part of my treatment. I am

willing to try other things that my provider suggests. Some

examples are physical therapy, counseling, other kinds of

medicine, classes to help me manage my pain, or an

appointment with a specialist.

• It is important to attend all appointments with health care

providers.

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Agreement should describe patient

responsibilities for safe use

• I will talk to my provider if I feel I need more medicine than

was prescribed. I will not change my dose of medicine on my

own or take medicine from other people.

• I will be honest and open with my provider about medicine,

alcohol, and street drugs I take. This is important so my

provider knows how safe the medicine is for me.

• I will never give or sell any of my medicine to anyone else.

This is dangerous and against the law.

• I will allow my provider to check my urine to see what

medicines or drugs I take.

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Agreement should be two-sided

My health care provider will:

• Work with me to find the best treatment for me.

• Be honest and open with me about my medicines and

treatment options.

• Ask me about side effects, and treat these side effects or

change the medicine.

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Conditions for discontinuing opioids

should include benefit-to-risk balance

My health care provider might stop or change my medicine if:

• I do not follow this agreement

• I use medicines, drugs, or alcohol in a way that my provider

thinks is not safe

• My provider thinks that the medicines are not helping

enough

• My medical conditions change

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When Discontinuing Opioids

• Frame your concerns in terms of risks and benefits

At this point, I am concerned about your safety, and I can’t

responsibly continue to prescribe opioids”

Not, “you violated the contract”

• If concerned about addiction, discuss and refer or offer

treatment

• In most cases, opioids should be tapered

• Offer other pain treatments

• Do not fire or abandon patients

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Outline

• Background

• Treatment agreements

Guidelines

Evidence

Tips for effective use

• Urine drug testing

Guidelines

Evidence

Tips for effective use

• Take home points

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Evolving UDT Guidelines

• Federation of State Medical Boards (2004)

− “should consider” for “high risk patients”

• APS/AAPM (2009)

− “should order” for high risk patients and “should

consider” for low-risk patients

• Washington State (2010)

− “should order” for everyone

− At baseline and randomly

All agree that evidence that UDT will impact addiction or overdose

is weak

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Limited UDT Outcome Studies

0

10

20

30

40

50

60

Aberrantmedication

takingbehavior(1)

Multiplesources(2)

Illicit druguse(3)

Before After

Starrels JL, Ann Int Med 2010 (review). 1Weidemer NL, Pain Med 2007; 2Manchikanti L, Pain Phys 2006; 3Manchikanti L, Pain Phys 2006.

Patients

with m

isuse b

ehavio

rs (

%)

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UDT Helps to Identify Risk

• Identifies undisclosed drug use

11% to 32% POS for unreported drugs1

• Confirms adherence to prescribed opioids

7.5% NEG for prescribed opioid2

• 21% to 44% with no other problematic behavior had

inconsistent urine test3

1Fishbain 1999, Katz 2003, Manchikanti 2003, Shuckman 2008; 2Fishbain 1999; 3Katz, Fanciullo. Clin J Pain, 2002; Michna et al. Clin J Pain, 2007; Fleming, 2007

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Clinical Question 2

Rate your agreement:

I feel confident in my ability to interpret urine drug test results for patients prescribed opioids.

A. Strongly disagree

B. Disagree

C. Neutral

D. Agree

E. Strongly agree

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Internal medicine residents’ confidence in UDT interpretation

Starrels JL et al. JGIM 2012.

Not confident

44%

Confident56%

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Confidence in UDT interpretation

does not reflect knowledge

Starrels JL et al. JGIM 2012.

Not confident

44% Passed

27%

Failed 73% Confident

56%

Knowledge

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Clinical Question 3

RT is Rx’d morphine SR BID, & oxycodone/APAP BID

PRN. RT’s UDS returns (+) for opiates, & (-) for

oxycodone. Interpret.

A. Shouldn’t be (+) for opiates. She’s probably using heroin.

B. Shouldn’t be (-) for oxycodone. She is probably selling it.

C. This may be consistent with use as prescribed.

D. I don’t know.

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Two Types of Urine Drug Tests

1. Screening Immunoassay (“urine drug screen”) Detects drug class

− Opiate screen reliably detects morphine and codeine

− Less sensitive for semi-synthetic opioids (e.g., oxycodone)

− Does NOT detect synthetic opioids (e.g., fentanyl)

Above a threshold concentration

2. Confirmatory GC/MS or LC/TMS Detects sub-threshold level

Detects drugs not reliably detected on screen

Confirm presence or absence of a specific drug

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Screening test pitfall:

Common causes of “false negatives”

• Concentration is below the threshold

• Incomplete cross-reactivity of the substance you

want to detect (e.g., low sensitivity of opiate screen

for semi-synthetic or synthetic opioids)

• Order confirmatory test (e.g., GC/MS)

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Screening test pitfall:

Common causes of “false positives”

• Amphetamine assay: Many medications, including

decongestants, beta-blockers, ranitidine, anti-

depressants

• Opiate assay: benadryl, DM, quinolones

• Marijuana assay: PPIs

• Cocaine assay: coca leaves, cocaine in dental procedure

• Order confirmatory test (e.g., GC/MS)

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Two Types of Urine Drug Tests

1. Screening Immunoassay (“urine drug screen”) Detects drug class

− Opiate screen reliably detects morphine and codeine only

− Does NOT detect synthetic opioids (e.g., fentanyl, meperidine)

Above a threshold concentration

2. Confirmatory GC/MS or LC/TMS Detects drugs not reliably detected on screen

May detect a sub-threshold concentration

Confirms presence or absence, and concentration, of a specific drug

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Case

• RT’s screen was positive for opiates, which is

expected for a patient on morphine.

• RT’s screen was negative for oxycodone, but

screen is not sensitive for low doses.

• You add on a GC/MS for opioids.

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Clinical Question 4

The GC/MS is (+) for Rx’d morphine & oxycodone, and for

hydromorphone. She denies taking any other pain meds.

Interpret.

A. It is probably an error

B. She probably took unprescribed hydromorphone

C. Appropriate; morphine metabolizes

to hydromorphone

D. Appropriate; oxycodone metabolizes

to hydromorphone

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Opioid metabolic pathways

Heroin

6-MAM

Morphine

Codeine Hydrocodone Oxycodone

Hydromorphone Oxymorphone

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Clinical Question 5

In a patient prescribed acetaminophen with codeine, one would reasonably expect the following to be detected in the urine:

A. Codeine

B. Oxycodone

C. Morphine

D. All of the above

E. a and c only

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Clinical Question 6

A pt on chronic oxymorphone therapy tests (-) for opioids on a UDS. He claims to be using the medication as Rx’d. Next step?

A. Subject this urine to a different kind of test

B. Re-administer a urine drug screen at the next visit

C. Taper and discontinue opioid therapy

D. Refer the pt to a detoxification/rehabilitation center

E. Notify law enforcement

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Responding to Unexpected Results

• There is a differential diagnosis

• Discuss with patient to gather data

Open-ended questions

− “Your urine test didn’t turn out like I expected. What can you tell

me about that?”

Not a confrontation

• May need additional data

Confirmatory tests, PMP data, pill counts, toxicologist

• Consider the results in context of risks and benefits

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Take Home Points

• Use agreements as a communication tool

• Use urine drug testing and interpret results

with caution

• Continuously reassess the risks and

benefits of opioid therapy

• Deciding to taper opioids is not the end,

can be an opportunity to help patients

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References

• Automation of Reports and Consolidated Orders System, US, DEA, slide adapted from A. Gilson

• Becker WC, Starrels JL, Heo M, Li X, Weiner MG, Turner BJ. Racial differences in primary care opioid risk

reduction strategies. Ann Fam Med. May-Jun 2011;9(3):219-225.

• Fishbain DA, Cutler RB, Rosomoff HL, Rosomoff RS. Validity of self-reported drug use in chronic pain

patients. Clinical Journal of Pain. Sep 1999;15(3):184-191.

• Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD. Substance use disorders in a primary care

sample receiving daily opioid therapy. J Pain. Jul 2007;8(7):573-582.

• Goldberg KC, Simel DL, Oddone EZ. Effect of an opioid management system on opioid prescribing and

unscheduled visits in a large primary care clinic. Journal of Clinical Outcomes Management.

2005;12(12):621-628.

• Katz N, Fanciullo GJ. Role of urine toxicology testing in the management of chronic opioid therapy. Clinical

Journal of Pain. Jul-Aug 2002;18(4 Suppl):S76-82.

• Katz NP, Sherburne S, Beach M, et al. Behavioral monitoring and urine toxicology testing in patients

receiving long-term opioid therapy. Anesth Analg. of contents, Oct 2003;97(4):1097-1102.

• Manchikanti L, Cash KA, Damron KS, Manchukonda R, Pampati V, McManus CD. Controlled substance

abuse and illicit drug use in chronic pain patients: An evaluation of multiple variables. Pain physician. Jul

2006;9(3):215-225.

• Manchikanti L, Manchukonda R, Damron KS, Brandon D, McManus CD, Cash K. Does adherence

monitoring reduce controlled substance abuse in chronic pain patients? Pain physician. Jan 2006;9(1):57-60.

• Michna E, Jamison RN, Pham L-D, et al. Urine Toxicology Screening Among Chronic Pain Patients on Opioid

Therapy: Frequency and Predictability of Abnormal Findings. Clinical Journal of Pain. Feb 2007;23(2):173-

179.

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References

• Manchikanti L, Pampati V, Damron KS, Beyer CD, Barnhill RC. Prevalence of illicit drug use in patients

without controlled substance abuse in interventional pain management. Journal.

• National Vital Statistics System, http://wonder.cdc.gov

• Schuckman H, Hazelett S, Powell C, Steer S. A validation of self-reported substance use with biochemical

testing among patients presenting to the emergency department seeking treatment for backache, headache,

and toothache. Subst Use Misuse. 2008;43(5):589-595.

• Starrels JL, Becker WC, Alford DP, Kapoor A, Williams AR, Turner BJ. Systematic review: treatment

agreements and urine drug testing to reduce opioid misuse in patients with chronic pain. Ann Intern Med. Jun

1 2010;152(11):712-720.

• Starrels JL, Becker WC, Weiner MG, Li X, Heo M, Turner BJ. Low Use of Opioid Risk Reduction Strategies in

Primary Care Even for High Risk Patients with Chronic Pain. J Gen Intern Med. Feb 24 2011.

• Starrels JL, Fox AD, Kunins HV, Cunningham CO. They don't know what they don't know: internal medicine

residents' knowledge and confidence in urine drug test interpretation for patients with chronic pain. J Gen

Intern Med. Nov;27(11):1521-1527.

• Utah Department of Health. Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain. Salt Lake

City, UT (2009). http://www.dopl.utah.gov/licensing/forms/OpioidGuidlines.pdf. Accessed September 30, 2011.

• Wallace LS, Keenum AJ, Roskos SE, McDaniel KS. Development and validation of a low-literacy opioid

contract. The Journal of Pain. Oct 2007;8(10):759-766.

• Wiedemer NL, Harden PS, Arndt IO, Gallagher RM. The opioid renewal clinic: a primary care, managed

approach to opioid therapy in chronic pain patients at risk for substance abuse. Pain Med. Oct-Nov

2007;8(7):573-584.

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PCSS-O Colleague Support Program

• PCSS-O Colleague Support Program is designed to offer general information to health

professionals seeking guidance in their clinical practice in prescribing opioid

medications.

• PCSS-O Mentors comprise a national network of trained providers with expertise in

addiction medicine/psychiatry and pain management.

• Our mentoring approach allows every mentor/mentee relationship to be unique and

catered to the specific needs of both parties.

• The mentoring program is available at no cost to providers.

• Listserv: A resource that provides an “Expert of the Month” who will answer questions

about educational content that has been presented through PCSS-O project. To join

email: pcss-o@aaap.org.

For more information on requesting or becoming a mentor visit:

www.pcss-o.org/colleague-support

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PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership

with: Addiction Technology Transfer Center (ATTC), American Academy of Neurology (AAN), American

Academy of Pain Medicine (AAPM), American Academy of Pediatrics (AAP), American College of

Physicians (ACP), American Dental Association (ADA), American Medical Association (AMA), American

Osteopathic Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA), American

Society for Pain Management Nursing (ASPMN), International Nurses Society on Addictions (IntNSA), and

Southeast Consortium for Substance Abuse Training (SECSAT).

For more information visit: www.pcss-o.org

For questions email: pcss-o@aaap.org

Twitter: @PCSSProjects

Funding for this initiative was made possible (in part) by Providers’ Clinical Support System for Opioid Therapies (grant no. 1H79TI025595) from SAMHSA. The

views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department

of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.