Using Treatment Agreements and Urine Drug Testing in Chronic Pain: Why, When, and How?

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 1

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. 2

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. 3

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. 4

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. 5

Outline Background Treatment agreements Guidelines Evidence Tips for effective use Urine drug testing Guidelines Evidence Tips for effective use Take home points 6

Opioid sales (mg per person) Increase in Opioid Prescription 140 Hydrocodone Oxycodone Morphine Methadone Hydromorphone 120 100 80 60 40 20 0 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 Source: Automation of Reports and Consolidated Orders System, US DEA, slide adapted from A Gilson 7

Death rate per 100,000 Drug Overdose Death on the Rise 10 38,329 drug overdose deaths in 2010 Rx drugs 8 6 16,651 (43%) involved opioid analgesics 8,369 died from HIV/AIDS in 2010 4 2 Heroin Cocaine 0 '70 '74 '78 '82 '86 '90 '94 '98 '02 '06 National Vital Statistics System, http://wonder.cdc.gov Year 8

Outline Background Treatment agreements Guidelines Evidence Tips for effective use Urine drug testing Guidelines Evidence Tips for effective use Take home points 9

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 10

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 11

Patients with misuse behaviors (%) Do treatment agreements work? 60 50 40 Before After 30 20 10 0 Aberrant medication taking behavior(1) Multiple sources(2) Multiple sources(3) Illicit drug use(4) Starrels JL, Ann Int Med 2010 (review). 1 Weidemer NL, Pain Med 2007; 2 Goldberg JC. J Clin Outc Mgmt 2005; 3 Manchikanti L, Pain Phys 2006; 4 Manchikanti L, Pain Phys 2006. 12

What is a treatment agreement? This contract has 4 parts. Pain Medicine Contract Part 1 Part 2 Part 3 Part 4 Tells you how and when to take your pain medicine. Lists things you agree to do. Lists things that could happen if you do NOT do the things listed in Part 2. Sign the form. You and Dr. must sign the form. PART 1 MY PAIN MEDICINE Medicine Breakfast Lunch Dinner Bedtime American 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 Go to the next page 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. 1 13

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 14

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 15

Many ways to do this Written documents vary Contract Informed Consent Agreement Treatment Plan Dear Patient letter I prefer these Have the conversation (& document it) 16

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 17

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: 18

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. 19

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. 20

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. 21

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 22

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 23

Outline Background Treatment agreements Guidelines Evidence Tips for effective use Urine drug testing Guidelines Evidence Tips for effective use Take home points 24

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 25

Patients with misuse behaviors (%) Limited UDT Outcome Studies 60 50 40 30 20 10 0 Aberrant medication taking behavior(1) Multiple sources(2) Before After Illicit drug use(3) Starrels JL, Ann Int Med 2010 (review). 1 Weidemer NL, Pain Med 2007; 2 Manchikanti L, Pain Phys 2006; 3 Manchikanti L, Pain Phys 2006. 26

UDT Helps to Identify Risk Identifies undisclosed drug use 11% to 32% POS for unreported drugs 1 Confirms adherence to prescribed opioids 7.5% NEG for prescribed opioid 2 21% to 44% with no other problematic behavior had inconsistent urine test 3 1 Fishbain 1999, Katz 2003, Manchikanti 2003, Shuckman 2008; 2 Fishbain 1999; 3 Katz, Fanciullo. Clin J Pain, 2002; Michna et al. Clin J Pain, 2007; Fleming, 2007 27

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 28

Internal medicine residents confidence in UDT interpretation Not confident 44% Confident 56% Starrels JL et al. JGIM 2012. 29

Confidence in UDT interpretation does not reflect knowledge Knowledge Not confident 44% Confident 56% Passed 27% Failed 73% Starrels JL et al. JGIM 2012. 30

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. 31

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 32

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) 33

Screening test pitfall: Common causes of false positives Amphetamine assay: Many medications, including decongestants, beta-blockers, ranitidine, antidepressants Opiate assay: benadryl, DM, quinolones Marijuana assay: PPIs Cocaine assay: coca leaves, cocaine in dental procedure Order confirmatory test (e.g., GC/MS) 34

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 35

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. 36

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 37

Opioid metabolic pathways Heroin Codeine Hydrocodone Oxycodone 6-MAM Morphine Hydromorphone Oxymorphone 38

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 39

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 40

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 41

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 42

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. 43

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. 44

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. For more information on requesting or becoming a mentor visit: www.pcss-o.org/colleague-support 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. 45

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