Appropriate Prescribing of Opioids for Chronic Non Cancer Pain

Appropriate Prescribing of Opioids for Chronic Non Cancer Pain Dr. Cheri Olson La Crosse Mayo Family Medicine Residency Assistant Professor of Family Medicine, Mayo Graduate School of Medicine Disclosure Cheri L. Olson, MD has no relevant financial relationships to disclose. 2016 Primary Care Update www.ipmameded.org Page 1 of 38

Learning objectives Discuss 2016 opioid prescribing guidelines and develop a plan to incorporate into practice Identify at least one quality improvement tool that would be useful when doing improvement work in your practice Define the PDSA cycle as a strategy to guide continued improvement work The Opioid Pendulum Where will the pendulum stop? Avoidance Will not prescribe opioids for any reason Driven by fear of regulatory action or being burned Balance Rational pharmacology Driven by continued prescribing with close monitoring Widespread Use Prescribing without recognition of dangers Less than 1% will ever become addicted 2016 Primary Care Update www.ipmameded.org Page 2 of 38

The Past... or the Roaring 90 s Epidemic of untreated pain Pain scales Joint Commission mandates Pain as the 5 th Vital Sign Pain control and Patient Satisfaction Opioids not addictive when used for chronic non cancer pain Aggressive pharma marketing of new meds with less abuse potential The Use of Opioids for the Treatment of Chronic Pain* A Consensus Statement From the American Academy of Pain Medicine and the American Pain Society; 1997 there has been recent activity in state legislatures (e.g., intractable pain treatment acts and the establishment of pain commissions) and at the regulatory level (statements of policy from state boards of medical examiners) to treat undertreated chronic pain the de novo development of addiction when opioids are used for the relief of pain is low Same basic guidelines as now for evaluation and regular assessment 2016 Primary Care Update www.ipmameded.org Page 3 of 38

Aggressively marketed to new populations and new providers... NOW 2016 Primary Care Update www.ipmameded.org Page 4 of 38

In 2011 41,340 Americans DIED FROM DRUG POISONINGS Nearly 17,000 deaths involved prescription opioids In 2008 NCHS Data Brief, No. 166, September 2014. http://www.cdc.gov/nchs/data/databriefs/db166.htm (accessed on 1/6/15). CDC. Policy Impact: Prescription Painkiller Overdoses. http://www.cdc.gov/homeandrecreationalsafety/rxbrief/ (Historical content 2008 data) (accessed on 1/6/15). From the Opioid Prescribing: Safe Practice, Changing Lives education, presented by the Collaboration for REMS Education. 2016 Primary Care Update www.ipmameded.org Page 5 of 38

Universal Precautions No data to support focusing on one population or setting to predict misuse We must often be suspicious, but rarely judgmental Treating everyone with the same screens, diagnostic tests, and administrative procedures can help remove bias and level the playing field CDC: March 2016: Guidelines for Prescribing Opioids for Chronic Pain Narrow focus: primary care doctors non cancer pain, not palliative care age >18 pain lasting more than 3 months 2016 Primary Care Update www.ipmameded.org Page 6 of 38

12 Guidelines for Primary Care Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016. MMWR Recomm Rep 2016;65(No. RR 1):1 49. ASSESS...when to initiate or continue Opioids 1) Opioids are not first line or routine therapy for chronic pain 2) Establish and measure goals for pain and function 3) Discuss benefits and risks and availability of opioid therapies with patient 2016 Primary Care Update www.ipmameded.org Page 7 of 38

MANAGE...opioid selection, dosage, duration, follow up, and discontinuation 4) Use immediate release opioids when starting 5) Start low and go slow 6) When opioids are needed for acute pain, prescribe no more than needed; Do not prescribe ER/LA opioids for acute pain 7) Evaluate benefits and harms REGULARLY; reduce dose or taper and discontinue if needed MONITOR...and Regularly Assess the Risk and Address the Harms of Opioid Use 8) Before starting and periodically during opioid therapy, evaluate risk of opioid harms 9) Check the PDMP for high dosages and prescriptions from other providers 10) Use urine drug testing to identify prescribed substances and undisclosed use 11) Avoid concurrent benzodiazepine and opioid prescribing 12) Arrange treatment for opioid use disorder if needed 2016 Primary Care Update www.ipmameded.org Page 8 of 38

Clinical Interview: Pain & Treatment History Description of pain Location Intensity Quality What relieves the pain? What relieves the pain? What causes or increases pain? Onset/ Duration Variations / Patterns / Rhythms Effects of pain on physical, emotional, and psychosocial function Patient s pain & FUNCTIONAL GOALS Heapy A, Kerns RD. Psychological and Behavioral Assessment. In: Raj's Practical Management of Pain. 4th ed. 2008;279-95. Zacharoff KL, et al. Managing Chronic Pain with Opioids in Primary Care. 2nd ed. Newton, MA: Inflexion, Inc., 2010. From the Opioid Prescribing: Safe Practice, Changing Lives education, presented by the Collaboration for REMS Education. Assess 1: Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain physical therapy, weight loss for knee osteoarthritis, CBT, interventional procedures acetaminophen, NSAIDs, selected antidepressants and anticonvulsants If opioids are used, use in conjunction with above 2016 Primary Care Update www.ipmameded.org Page 9 of 38

Assess 2: Establish and measure goals for pain and function Treatment goals: improvement in pain and FUNCTION; (30%) is clinically meaningful; may be an improvement in depression too Consider viewing as a trial with an exit strategy Optimize treatment of depression and anxiety PEG Scale Krebs, Erin E, et al, Development and Initial Validation of the PEG, a 3 Item Scale Assessing Pain Intensity and Interference. J Gen Intern Med 2009. Jun; 24 (6): 733 738 2016 Primary Care Update www.ipmameded.org Page 10 of 38

Assess 3: Discuss benefits and risks and availability of opioid therapies Benefits of opioids: Opioids can reduce pain during short term use No good evidence that opioids improve pain or function with long term use Complete relief of pain is unlikely Improvement in function is a primary goal Function can improve even when pain is still present Opioid Risks potentially fatal respiratory depression development of a potentially serious lifelong opioid use disorder constipation, dry mouth, nausea, vomiting, drowsiness, confusion, tolerance, physical dependence, and withdrawal symptoms driving, working some jobs increased risks for respiratory depression with benzodiazepines, other sedatives, alcohol, illicit drugs such as heroin, or other opioids 2016 Primary Care Update www.ipmameded.org Page 11 of 38

Access/Availability of Opioids Don t share, Lock em up, Dispose of properly Periodic reassessment Discuss use of prescription drug monitoring program information and urine drug testing Consider including discussion of naloxone use for overdose reversal USE A CONTROLLED SUBSTANCES/PATIENT PROVIDER PAIN AGREEMENT Case: John John is a 48 year old man with chronic neuropathic pain in his legs. His treatment includes: oxycodone ER 10 mg twice a day. He had a good response to this treatment and was stable on this regimen for 2 years. There have been no concerns about his medication use or use of other substances. After a detailed discussion with the patient, you elected to start a trial of an increased dose of oxycodone 10 mg three times a day. 2016 Primary Care Update www.ipmameded.org Page 12 of 38

Case: John After changing John s oxycodone therapy, you should: a) Sign an updated treatment agreement. b) Document the change in the Treatment Plan. c) Schedule a follow up visit. d) All of the above. Case: John Answer d) All of the above. All changes to opioid therapy should be documented and reflected in an updated treatment agreement, and documentation of care plan. 2016 Primary Care Update www.ipmameded.org Page 13 of 38

Patient Provider Pain Agreement Not a true legal document, but check with legal Defines patient and provider roles in management of this pain problem A great discussion starter/patient education tool Standard of care for patients on chronic narcotics What is a PPA? Reinforce expectations for appropriate & safe opioid use Obtain opioids from a single prescriber Fill opioid prescriptions at a designated pharmacy Safeguard opioids Do not store in medicine cabinet Keep locked (e.g., use a medication safe) Do not share or sell medication Instructions for disposal when no longer needed Commitments to return for follow-up visits Comply w/ appropriate monitoring E.g., random UDT & pill counts Frequency of prescriptions Enumerate behaviors that may lead to opioid discontinuation An exit strategy From the Opioid Prescribing: Safe Practice, Changing Lives education, presented by the Collaboration for REMS Education. 2016 Primary Care Update www.ipmameded.org Page 14 of 38

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Manage 4: Use immediate release opioids when starting No evidence LA/ER opioids are safer, in fact evidence of higher risk of overdose Most LA/ER opioids shouldn t be started in opioid naïve No evidence more effective Can accumulate in liver, kidney disease and elderly Use equianagesic tables carefully when initiating or changing ER/LA opioids; reduce total dose (30 50%) to account for cross tolerance Manage 5: Start Low and Go Slow CAUTION for dosage to 50 morphine milligram equivalents (MME)/day AVOID increasing dosage to 90 MME/day or carefully justify a decision to titrate dosage to 90 MME/day (consider a consult) 2016 Primary Care Update www.ipmameded.org Page 16 of 38

Morphine Milligram Equivalent (MME) doses for commonly prescribed opioids OPIOID Codeine 0.15 Fentanyl (transdermal) 2.4 Hydrocodone 1 Hydromoorphone 4 1 20 mg/day 4 21 40 mg/day 8 41 60 mg/day 10 61 80 mg/day 12 Morphine 1 Oxycodone 1.5 Oxymorphone 3 Tapentadol 0.4 CONVERSION FACTOR Manage 6: Chronic Opioid Use often starts with Acute Pain Management... Three days or less More than seven days will rarely be needed physical dependence on opioids is an expected physiologic response in patients exposed to opioids for more than a few days Post operative and traumatic pain is out of scope for this recommendation Do not prescribe ER/LA opioids for acute pain 2016 Primary Care Update www.ipmameded.org Page 17 of 38

Manage 7: evaluate benefits and harms REGULARLY Within 1 to 4 weeks of starting opioid therapy or of dose escalation With continued therapy at least every 3 months Benefits > Harms: continue with good documentation and universal protocol follow up Harms > Benefits: pursue other therapies and work to taper opioids to lower dosages or to taper and discontinue opioids Tapering may need to go slowly for those patients on opioid for many years: goal no more than 10% per week... Document well, regular assessment and follow up: consider the 6 A s Opioid Therapy Monitoring Tool: Activity Analgesia Adverse Effects Aberrant Behaviors Affect Accurate Records Pain Network 2016 Primary Care Update www.ipmameded.org Page 18 of 38

Manage 8: Before starting and periodically during continuation of opioid therapy, evaluate risk factors for opioid related harms Sleep apnea Renal or Hepatic Impairment Concurrent Mental Illness Concurrent Benzodiazepine Use Age over 65 Substance Abuse Disorder including Alcohol Do a numerical RISK ASSESSMENT TOOL (Opioid Risk Tool, or SOAPP). Alter plan for treatment and monitoring per individual risk. Consider prescribing naloxone for those at increased risk of respiratory depression. Opioid Risk Tool (ORT) Mark each box that applies Female Male 1. Family Hx of substance abuse Alcohol Illegal drugs Prescription drugs 1 2 4 3 3 4 2. Personal Hx of substance abuse Alcohol Illegal drugs Prescription drugs 3 4 5 3 4 5 Administer On initial visit Prior to opioid therapy Scoring (risk) 3. Age between 16 & 45 yrs 4. Hx of preadolescent sexual abuse 5. Psychologic disease ADD, OCD, bipolar, schizophrenia Depression Scoring Totals: Webster LR, Webster RM. Pain Med. 2005;6:432-42. 1 1 3 0 2 1 2 1 0-3: low 4-7: moderate 8: high From the Opioid Prescribing: Safe Practice, Changing Lives education, presented by the Collaboration for REMS Education. 2016 Primary Care Update www.ipmameded.org Page 19 of 38

Prescribe naloxone (Narcan)? history of overdose history of substance use disorder higher opioid dosages ( 50 MME/day) concurrent benzodiazepine use other risk factors for overdose or respiratory depression Monitor 9: USE your state prescription drug monitoring program (PDMP) 2016 Primary Care Update www.ipmameded.org Page 20 of 38

Learn about your state s PDMP Delegate role? Mandatory? Intrastate compact? Work flow? Check prior to prescribing and AT LEAST every 3 months; preferably with each prescription Results of PDMP Review other medications such as benzodiazepines that might be prescribed by others Calculate total MME per day dosage Communicate with other prescribers Evaluate for substance abuse disorder Correct errors Communicate with patients regarding results Not meant to be a tool to fire patients 2016 Primary Care Update www.ipmameded.org Page 21 of 38

Case: Mary Mary is a 56 year old woman with chronic leg pain on morphine extended release 40 mg once daily and morphine short acting 15 30 mg prn, up to 6 tablets per day. You have a high level of clinical suspicion she is misusing opioids based on: repeated requests for early refills several urine drug test results that showed unprescribed opioids, You call her asking to schedule a clinic visit to discuss these concerns. She misses this appointment, then calls the following day asking for a refill, 8 days early She says she is unable to come for an appointment because she has been traveling. You check the Prescription Drug Monitoring Program database She received prescriptions for opioids and benzodiazepines two days ago from the Emergency Department in a nearby town. Case: Mary Which approach is most appropriate in this clinical situation? a) Switch to buprenorphine therapy for pain management b) Switch to methadone therapy for pain management c) Initiate slow taper of the prescribed opioids d) Discontinue opioids 2016 Primary Care Update www.ipmameded.org Page 22 of 38

Case: Mary Answer: d) Discontinue opioids Although opioid taper is preferred, an abrupt discontinuation of long term opioid therapy may need to be implemented if it is not safe or appropriate to prescribe a taper. Monitor 10: Urine Drug Testing before starting opioid therapy at least annually; higher risk patients more frequently assess for prescribed medications as well as other controlled prescription drugs and illicit drugs 2016 Primary Care Update www.ipmameded.org Page 23 of 38

Patient: Holly Holly is a 54 year old woman treated with morphine ER 30 mg twice a day and oxycodone prn. She is calling to request a refill. She followed the Clinic Policy and called 72 hours in advance of being due for the refill. The medical assistant (MA), documents that the medical record and Prescription Drug Monitoring Program s data are consistent with patient s reports. The MA notes the patient is overdue for urine drug testing, as the prior one was completed over a year ago, and pends the order for the recommended urine drug test in addition to the requested medications. The clinician reviews the record, documents absence of prior red flags, and signs the pended orders. Patient: Holly Which one of the following statements is correct? a) The patient should not be told in advance, before coming to the clinic for prescription pick up, about the need for urine testing, as such testing would then not be considered random. b) The patient can be told in advance that, when coming to the clinic, she will need to leave a urine sample for drug testing prior to being able to pick up her prescriptions. c) The patient is not allowed to leave a urine sample at a different clinic than the one through which opioid prescriptions are issued. 2016 Primary Care Update www.ipmameded.org Page 24 of 38

Patient: Holly Correct answer: b) Providing patients with an up to 24 hour notice about the need to come to the clinic for random urine drug testing is appropriate. Case: Jocelyn Jocelyn is a 45 year old woman with chronic low back pain, treated with morphine extended release 30 mg three times a day and clonazepam 1 mg twice a day. Her urine drug screening test is positive for opiates and negative for benzodiazepines. These results can be explained by: a) She is taking morphine but not clonazepam b) She is taking morphine and clonazepam c) She is taking clonazepam and using heroin d) Any of the above may be correct 2016 Primary Care Update www.ipmameded.org Page 25 of 38

Case: Jocelyn Correct answer: d) Any of the above may be correct Screening urine drug tests (UDTs) are cheaper than the confirmatory level tests and can quickly provide results. However, they can yield false positive and false negative results. The confirmatory level tests are very sensitive and specific, and can verify the findings of a screening test. Main Types of UDT Methods Initial testing w/ Immunoassay drug panels: Classify substance as present or absent according to cutoff Many do not identify individual drugs within a class Subject to cross-reactivity Either lab based or at POC Cheaper and results available quickly (1 hour sometimes) Identify specific drugs &/or metabolites w/ sophisticated lab-based testing; e.g., GC/MS or LC/MS* Specifically confirm the presence of a given drug e.g., morphine is the opiate causing a positive IA* Identify drugs not included in IA tests When results are contested * GC/MS=gas chromatography/ mass spectrometry IA=immunoassay LC/MS=liquid chromatography/ mass spectrometry From the Opioid Prescribing: Safe Practice, Changing Lives education, presented by the Collaboration for REMS Education. 2016 Primary Care Update www.ipmameded.org Page 26 of 38

Detecting Opioids by UDT Most common opiate IA drug panels Detect opiates morphine & codeine, but doesn t distinguish Do not reliably detect semisynthetic opioids Specific IA panels can be ordered for some Do not detect synthetic opioids (e.g., methadone, fentanyl) Only a specifically directed IA panel will detect synthetics GC/MS or LC/MS will identify specific opioids Confirm presence of a drug causing a positive IA Identify opioids not included in IA drug panels, including semisynthetic & synthetic opioids Identify opioids not included in IA drug panels, including semisynthetic & synthetic opioids From the Opioid Prescribing: Safe Practice, Changing Lives education, presented by the Collaboration for REMS Education. Positive Result Interpretation of UDT Results Demonstrates recent use Most drugs in urine have detection times of 1 3 d Chronic use of lipid soluble drugs: test positive for 1 wk Does not diagnose Drug addiction, physical dependence, or impairment Does not provide enough information to determine Exposure time, dose, or frequency of use Negative Result Does not diagnose diversion More complex than presence or absence of a drug in urine May be due to maladaptive drug-taking behavior Bingeing, running out early Other factors: eg, cessation of insurance, financial difficulties From the Opioid Prescribing: Safe Practice, Changing Lives education, presented by the Collaboration for REMS Education. 2016 Primary Care Update www.ipmameded.org Page 27 of 38

URINE DRUG TESTING CONTROVERSIES Random versus predictable Expense Laboratory specific False positives and negatives Don t use to fire patients, results are good discussion starters What about THC?? Monitor 11: avoid prescribing opioids and benzodiazepines at the same time if possible Potentially increase the risk of fatal overdose and respiratory depression Consider other meds like muscle relaxers, sleep medications, antidepressants etc. also PDMP useful to see what others are prescribing; keep medication list updated Consider naloxone 2016 Primary Care Update www.ipmameded.org Page 28 of 38

Monitor 12: offer or arrange evidencebased treatment for patients with opioid use disorder Evidence based treatments exist: medication assisted treatment with buprenorphine or methadone in combination with behavioral therapies) Should more primary care providers become certified in medication assisted therapies? Controversial: don t fire patient, assist them in finding therapy...how??? WHERE??? Opioid Use Disorder Criteria (DSM 5) Taking more opioid drugs than intended. Wanting or trying to control opioid drug use without success. Spending a lot of time obtaining, taking, or recovering from the effects of opioid drugs. Craving opioids. Failing to carry out important roles at home, work or school because of opioid use. Continuing to use opioids, despite use of the drug causing relationship or social problems. Giving up or reducing other activities because of opioid use. Using opioids even when it is physically unsafe. Knowing that opioid use is causing a physical or psychological problem, but continuing to take the drug anyway Tolerance for opioids. Withdrawal symptoms when opioids are not taken. 2 3 are abnormal and mild, 4 5 moderate and over 6 severe 2016 Primary Care Update www.ipmameded.org Page 29 of 38

Chronic pain and opioids simplified: Do your job: do a good history and physical examination and assessment of patient s pain Use universal precautions: PPA, PDMP, UDT Make this a team project: Reception, nursing, medical assistants, pharmacists can all help TEAM project: Improve Your Practice How will you go home and make a change? Especially one that sticks... This is coming: for good quality care, for board licensing and monitoring, for systems change, for public health and the good of our communities Will require you as an individual to change, but also for you to be a part of systems change: in your clinic, your healthcare system, and your community 2016 Primary Care Update www.ipmameded.org Page 30 of 38

Principles of Quality Improvement Systematic Small tests of change Measure, try, and remeasure Team and PROCESS is key; understanding the process leads to greater success than mandates Toolkit of techniques to help work Some just do its First step: identify a GAP Begin by collecting data on how well your current process (s) is working. The first measurement (called the baseline), will help you to identify problems and to establish baseline results. It will also allow you to track changes over time. Look at your current processes What are you not doing that you feel you should? Or what are you doing that needs to stop? Is this feeling based on a benchmark or standard of care? Once GAP in your practice is identified, you can come up with an AIM statement or SMART goal. Aim Statement must have target goal and timeline in it. we will increase the number of opioid patients who have patient provider agreements from 30% to 50% by January 1, 2017. 2016 Primary Care Update www.ipmameded.org Page 31 of 38

Working with a partner...develop a SMART goal or AIM statement for your practice... We will: improve increase decrease The: number/amount of percentage of (process) From: To: (baseline number/amount/percentage) (goal number/amount/percentage) By: (date) Example: We will increase the percentage of patients with documentation of an opioid agreement in the medical record from 10% to 75% by June 30 th 2017 2016 Primary Care Update www.ipmameded.org Page 32 of 38

Just Do Its!! Can you think of something with these aims or goals that is a just do it ; i.e. you can change without getting a team together? Ideas of Just Do Its Sign up for your state PDMP Read the CDC guideline for prescribing opioids for chronic pain (reference here) Others? 2016 Primary Care Update www.ipmameded.org Page 33 of 38

Team improvement Most changes will not be just do its but will require a team change and a more systematic approach. QI tools are made to help force standardized, systematic tests of change that can be incorporated and sustained into practice 2 excellent tools are process mapping and PDSA (PDCA) worksheet Process Map 2016 Primary Care Update www.ipmameded.org Page 34 of 38

Process Mapping 2016 Primary Care Update www.ipmameded.org Page 35 of 38

One PDSA is not enough... PDSA % of patients with opioid agreement 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Family Medicine Clinic Opioid Agreement Rates 16% PDSA #1 29% 70% April June August Month PDSA #2 2016 Primary Care Update www.ipmameded.org Page 36 of 38

PDSA Using the form on your table, work with a partner to develop a PDSA you want to test when you return home around making sure all patients on opioids have a patient provider pain agreement in their charts IPMA staff will go around to your tables to answer questions and help you Examples of PDSA s 2016 Primary Care Update www.ipmameded.org Page 37 of 38

Chronic pain and opioids simplified : Do your job: do a good history and physical examination and assessment of patient s pain Use universal precautions: PPA, PDMP, UDT Make this a team project to IMPROVE: Reception, nursing, medical assistants, pharmacists can all help bring the pendulum to the middle!! 2016 Primary Care Update www.ipmameded.org Page 38 of 38