How is your comfort level in regards to managing patients with CNCP on opioids now? Not comf at all -------------------------------------------------------------------------Very comf

AnMed Health Family Medicine Residency Program Implementing a Urine Drug Screening Protocol to Teach Appropriate Opioid Prescribing in a Residency Practice STFM Annual Conference May 2, 2016 Nata Young, MD Hunter Woodall, MD Amanda Davis, MD Stuart Sprague, PhD AnMed Health Family Medicine Residency Program Anderson, SC

Agenda Background: Opioids are a problem! Safe Opioid Prescribing Initiative Intended and Unintended Consequences Take a poll? Who’s in the audience Stand up UDS in practice, standing if protocol, standing if you have outcomes We have 30 min

AnMed Health Family Medicine Residency Program 7800 patients, 30,000 visits/ year 49 providers (34 residents, 14 faculty, 1 NP) Voted on “Safe Opioid Prescribing” as the QI initiative 3/2015. We are a community based program in Anderson SC We serve a rura- suburban population Discomfort from staff about safety, diversion, misuse Discomfort from residents and providers about same Faculty retreat 2/2015 where all faculty completed 2 hour mandated CME on controlled rx prescribing We already had a robust didactic curriculum in place for the past 6 years in conjunction with Dr. Woodall being our champion on a SBIRT grant.

KEY CONCEPTS Opioid Curriculum Adequate evaluation of pain syndrome Informed consent for chronic opioid use Proper patient evaluation Set Functional goals Six A’s UDS interpretation How to say no How to handle aberrant behavior Discuss how many of these dovetail with new CDC recs – refer folks to the handout of the full guidelines. Discuss how this curriculum was already robust and in place in the didactic curriculum but during our Safe Opioid Prescribing QI we added the registry, the UDS workflow, and mandated the CSA , as well as reviewed with chart audits.

Steps in our Safe Opioid Prescribing Initiative Create opioid registry Controlled substance agreement for all patients Random UDS protocol Opioid chart audits Amanda Initially we felt that the cornerstone to doing this was starting a UDS protocol – we realized to do this we needed to first do several other things. We had each provider make their own registry and combined to a practice registry. Part of the teaching process and help with the buy-in. - needed to define ‘chronic opioid use’ at the individual patient level We had a nursing workflow to help capture all patients on controlled meds to get all to sign the CSA We contracted with a company to provide UDS services and allow us to have practice reports as well as patient-specific reports We implemented a workflow for random UDS after baseline UDS testing.

Safe Opioid Prescribing Initiative 4/2016- SCRIPTS mandate begins Timeline Safe Opioid Prescribing Initiative 3/2016- Switch UDS lab provider 11/2015- QI conference chart audit#2 2/2016-QI conference chart audit #3, registry update 9/2015- QI conference review initial chart audits 7/2015- New interns start 8/2015- Noon conference with toxicologist, ethicist 5/2015- Providers update registry Nata- 1 year time line 3 months before we could start UDS protocol Since then reviewing and auditing and studying it. Also reviewed monthly at all-staff meetings our UDS reports and CSA percentages 6/2015- Start baseline UDS workflow 2/2015- faculty retreat 4/2015- Phone nurse workflow opioid contracts 3/2015-Initial QI conference

Safe Opioid Prescribing Initiative 4/2016- SCRIPTS mandate begins Timeline Safe Opioid Prescribing Initiative 3/2016- Switch UDS lab provider 11/2015- QI conference chart audit#2 2/2016-QI conference chart audit #3, registry update 9/2015- QI conference initial chart audits 7/2015- New interns start 8/2015- Noon conference with toxicologist, ethicist 5/2015- Providers update registry Nata It was a big push first 3 months We run approx 30-35 random UDS per month since we started our protocol. 6/2015- Start baseline UDS workflow 2/2015- faculty retreat 4/2015- Phone nurse workflow opioid contracts 3/2015-Initial QI conference

Steps to Safe Opioid Prescribing Create opioid registry Controlled substance agreement for all patients Random UDS protocol Opioid chart audits

Nata- Test we use has a panel of rx and illicit drugs we screen for. All confirmed by LS chromatography. At standardized cut-offs. Turn around time 2-7 days.

Example of UDS Report

Example of UDS practice monthly report

Woody Data from UDS company for entire practice. Have not separated out just opioids Unexpected- a lot of illicits, as well as false neg benzo A fair number of pregnant late to prenatal care- SC mandates reporting of illicits

Steps to Safe Opioid Prescribing Create opioid registry Controlled substance agreement for all patients Random UDS protocol Opioid chart audits

Did not address unexpected UDS result Opioid Audit Date Did not address unexpected UDS result 7/14/15 1/14 11/30/15 3/5 2/23/16 3/15 Opioid Audit Date 6As? 7/14/15 6/14 11/30/15 2/5 2/23/16 4/15 Amanda Way to hold ourselves accountable Mention tie to CDC Guidelines. Done by residents and faculty as part of QI Conference Purpose Are we documenting properly? Are we following workflow? What can we improve?

Agenda Background: Opioids are a problem! Safe Opioid Prescribing Initiative Intended and Unintended Consequences

Intended Consequences Goal: increase resident knowledge, skills and comfort with chronic opioid therapy and management of chronic pain Goal: improve patient safety Did we accomplish these?

Ethics and Unintended Consequences Ethical? Does it even work? Erodes doctor/patient relationship UDS testing Reliability Cost Assumes wrongdoing Variations on dealing with unexpected results Reference: Joanna L. Starrels, MD, MS; William C. Becker, MD; Daniel P. Alford, MD, MPH; Alok Kapoor, MD, MSc; Arthur Robinson Williams, MA; and Barbara J. Turner, MD, MSEd. Systematic Review: Treatment Agreements and Urine Drug Testing to Reduce Opioid Misuse in Patients With Chronic Pain. Ann Intern Med. 2010;152:712-720. Synopsis: systematic review of 11 studies using CSA and UDS show much variability and only weak evidence that they reduce opioid misuse. There is no standardized definition of opioid misuse, especially one that is strongly linked to clinical outcomes such as overdose, death, or dependence/ addiction. More studies are needed. Reference Cochran review about treatment agreements and adherence. Bosch-Capblach X, Abba K, Prictor M, Garner P. Contracts between patients and healthcare practitioners for improving patients’ adherence to treatment, prevention and health promotion activities. Cochrane Datase Syst Rev. 2007:CD004808. However these strategies increase provider satisfaction, comfort and sense of mastery in managing chronic pain. UDS is a valuable tool to detect use of nonprescribed drugs and confirm adherence, beyond patient self-report or physician impression. (less bias and assumption) May strengthen but may also harm if misinterpretation of UDS results leads to falsely accusing patients of misuse. Potential benefits, but possible harms (under treating pain b/c of burden of opioid risk management by providers, or patients forgoing pain treatment b/c of perceived stigma). CSA’s for example may need to be more goal-directed. Joanna L. Starrels, MD, MS; William C. Becker, MD; Daniel P. Alford, MD, MPH; Alok Kapoor, MD, MSc; Arthur Robinson Williams, MA; and Barbara J. Turner, MD, MSEd. Systematic Review: Treatment Agreements and Urine Drug Testing to Reduce Opioid Misuse in Patients With Chronic Pain. Ann Intern Med. 2010;152:712-720.

Unintended Consequences 237 205 Net decrease in opioid patients – 82 off the list and 50 were added – for a net loss of 32 as above. What about the 127 patients who are on chronic opioids but managed by others: 4- oncology (metastatic cancer) 1- neurology (MS) 2-orthopedics (osteoarthritis) 1-rheumatology (RA) 119- pain management What do YOU think happened to these patients? We thought dismissed or transferred to PM

Breakdown of Missing Opioid Patients Nata

Feedback from Residents/Faculty/Staff 1. Has the safe opioid rx initiative made it easier or harder to deal with chronic pain patients? “easier-patients have clearly defined expectations” “takes the burden off provider for who to screen (with UDS)” 2. Is opioid prescribing safer in our clinic now? “makes the provider re-evaluate the amount of medication prescribed” “allows providers to evaluate all patients without bias”

How is your comfort level in regards to managing patients with CNCP on opioids now? Not comf at all ---------------------------------------------------------------Very comf

Resident Survey Results I am more comfortable managing opioid patients now than I was at the start of residency. 0 1 2 3 4 5 6 7 8 9 10 Strongly Strongly Disagree Agree PGY1,2,3=7.42 (N=23) (Range 5-10)

Resident Survey Results I prefer to have my patients on chronic opioids be managed by pain management. 0 1 2 3 4 5 6 7 8 9 10 Strongly Strongly Disagree Agree Is this in the patient’s best interest to send to pain management? PGY1,2,3=7.6 (N=23)(Range 1-10)

Resident Survey Results I am comfortable dealing with ‘unexpected’ UDS results or other aberrant behaviors in opioid patients. 0 1 2 3 4 5 6 7 8 9 10 Strongly Strongly Disagree Agree Is this in the patient’s best interest to send to pain management? PGY1,2,3=7.4 (N=23)(Range 4-10)

Resident Survey Results In the future, I plan to pursue more training in pain management, such as a CAQ or suboxone prescribing. 0 1 2 3 4 5 6 7 8 9 10 Strongly Strongly Disagree Agree PGY1,2,3=3.18 (N=23)(Range 0-9)

Discussion/Future Steps Mandated PMP (physician monitoring program)/ SCRIPTS database review (effective 4/1/2016) CDC guidelines 2016

What we learned Structured approach to safe opioid prescribing with . . . . Opioid registry CSA UDS protocol Opioid audits Scripts database . . . . resulted in increased resident comfort and ? competence with opioid prescribing. And increased patient safety????

Handouts Staff workflow for updating opioid contracts Patient letter re: opioid contract/UDS protocol Drug screening (UDS) protocol Opioid audit Resident survey CDC Opioid Guidelines 2016 references

AnMed Health Resident Survey: Safe Opioid Rx Initiative Questions included a 0-10 scale with 0=strongly disagree, 10=strongly agree.   Please circle: - - - - PGY 1 - - - - PGY 2 - - - - PGY 3 1. Opioids are effective for controlling chronic non-cancer pain. 2. I am more comfortable now managing opioid patients now then I was at the start of residency. 3. Having a controlled substance agreement for chronic opioid patients is important. 4. Instituting a random UDS protocol for chronic opioid patients is important. 5. I am comfortable dealing with ‘unexpected’ UDS results or other aberrant behaviors in opioid patients. 6. I prefer to have my patients on chronic opioids be managed by pain management. 7. In the future, I plan to pursue more training in chronic pain management (such as a certificate of added qualification or becoming a suboxone prescriber).

CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 (12 RECOMMENDATIONS) 1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate (cat A, type 3).   2. Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety (cat A, type 4) 3. Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy (cat A, type 3). 4. When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids (cat A, type 4). 5. When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day (cat A, type 3). 6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed (cat A, type 4).

  CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 (cont) 7. Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids (cat A, type 4).   8. Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present (cat A, type: 4). 9. Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months (cat A, type 4). 10. When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs (cat B, type 4). 11. Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible (cat A, type 3). 12. Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder (cat A, type 2).