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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
2
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.
3
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.
4
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.
5
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.
6
Outline
• Background
• Treatment agreements
Guidelines
Evidence
Tips for effective use
• Urine drug testing
Guidelines
Evidence
Tips for effective use
• Take home points
7
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
9
Outline
• Background
• Treatment agreements
Guidelines
Evidence
Tips for effective use
• Urine drug testing
Guidelines
Evidence
Tips for effective use
• Take home points
10
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
11
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
12
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 (
%)
13
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.
14
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
15
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
16
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
17
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”
18
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: __________________________
______________________________________
19
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.
20
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.
21
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.
22
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
23
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
24
Outline
• Background
• Treatment agreements
Guidelines
Evidence
Tips for effective use
• Urine drug testing
Guidelines
Evidence
Tips for effective use
• Take home points
25
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
26
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 (
%)
27
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
28
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
29
Internal medicine residents’ confidence in UDT interpretation
Starrels JL et al. JGIM 2012.
Not confident
44%
Confident56%
30
Confidence in UDT interpretation
does not reflect knowledge
Starrels JL et al. JGIM 2012.
Not confident
44% Passed
27%
Failed 73% Confident
56%
Knowledge
31
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.
32
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
33
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)
34
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)
35
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
36
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.
37
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
38
Opioid metabolic pathways
Heroin
6-MAM
Morphine
Codeine Hydrocodone Oxycodone
Hydromorphone Oxymorphone
39
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
40
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
41
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
42
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
43
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.
44
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.
45
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
46
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.
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