Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain
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Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain: An educational aid to improve care and safety with opioid therapy 2010 Update What is New in this Revised Guideline New data, including scientific evidence to support the 120mg MED dosing threshold Tools for calculating dosages of opioids during treatment and when tapering Validated screening tools for assessing substance abuse, mental health, and addiction Validated two-item scale for tracking function and pain Urine drug testing guidance and algorithm Information on access to mentoring and consultations (including reimbursement options) New patient education materials and resources Guidance on coordinating with emergency departments to reduce opioid abuse New clinical tools and resources to help streamline clinical care You can find this guideline and related tools at the Washington State Agency Medical Directors’ site at www.agencymeddirectors.wa.gov 1
Table of Contents Introduction............................................. 1 Part II: Guidelines for optimizing treatment when opioid doses are 2010 Update ........................................................1 greater than 120mg MED/day .............. 12 How this guideline is organized ...........................2 Assessing effects of opioid doses greater than Part I. Guidelines for initiating, 120mg MED/day ............................................... 12 transitioning, and maintaining oral opioids for chronic non-cancer pain .... 3 How to discontinue opioids or reduce and reassess at lower doses ................................... 12 Dosing threshold for pain consultation.................3 Referrals to pain centers ................................... 12 BEFORE you decide to prescribe opioids for Recognizing aberrant behaviors during opioid chronic pain .........................................................4 therapy .............................................................. 12 AFTER you decide with the patient to prescribe Reasons to discontinue opioids or refer for chronic opioid therapy .........................................5 addiction management...................................... 12 Principles for safely prescribing chronic opioid Referrals for addiction management ................. 13 therapy ................................................................5 Appendices ........................................... 15 Screening and monitoring your patient ................6 Opioid Risk Tool (ORT) ...................................6 Appendix A: Opioid dose calculations ............... 16 CAGE-AID .......................................................6 Appendix B: Screening Tools ............................ 18 PHQ-9 .............................................................6 Appendix C: Tools for Assessing Function and Tools for assessing function and pain .................6 pain ................................................................... 30 Assessing effects of chronic opioid therapy.........7 Appendix D: Urine Drug Testing for Monitoring Urine drug testing (UDT) .....................................8 Opioid Therapy ................................................. 31 Methods of testing ...........................................8 Appendix E: Obtaining Consultative Assistance – Drugs or drug classes to test...........................9 for WA Public Payers Only ................................ 39 Interpreting results...........................................9 Appendix F: Patient Education Resources ........ 41 Specialty consultation ..........................................9 Appendix G: Sample Doctor-Patient Agreements Unrecognized diagnoses .................................9 for Chronic Opioid Use...................................... 43 Psychological and addiction issues .................9 Appendix H: Additional Resources to Streamline Opioid management ......................................10 Clinical Care ..................................................... 46 Access to specialists and mentors ....................10 Appendix I: Emergency department guidelines Tapering or discontinuing opioids ......................10 help coordinate care with primary care providers .......................................................................... 47 Recognizing and managing behavioral issues during opioid tapering ........................................11 References ............................................ 48 Acknowledgements.............................. 55
Figures and Tables Figure 1. Morphine Equivalent Dose Calculation...........................................................4 Figure 2. Graded Chronic Pain Scale ..................7 Table 1. Guidance For Seeking Consultative Asistance .............................................................4 Table 2. Recommended frequency of UDT .........8 Table 3. Red flag results......................................9 Table 4. Dosing Threshold for Selected Opioids ..............................................................15 Table 5. MED for Selected Opioids ...................16
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) Introduction released several recommendations for how health care providers can help. The recommendations This guideline was originally published in March include: 2007 as an educational pilot. Sponsored by the Use opioid medications for acute or chronic pain Washington State Agency Medical Directors’ Group only after determining that alternative therapies (AMDG) 1 , the original guideline and this updated do not deliver adequate pain relief. The lowest version were developed in collaboration with effective dose of opioids should be used. actively practicing providers with extensive experience in the evaluation and treatment of In addition to behavioral screening and use of patients with chronic pain. It is intended as a patient agreements, consider random, periodic, resource for primary care providers treating patients targeted urine testing for opioids and other drugs with chronic noncancer pain. It does not apply to the for any patient less than 65 years old with treatment of acute pain, cancer pain, or end-of-life noncancer pain who has been treated with (hospice) care. opioids for more than six weeks. If a patient’s dosage has increased to 120 mg Providers prescribing opioids know there is a MED per day or more without substantial delicate balance between the undertreatment and improvement in function and pain, seek a consult overtreatment of chronic non-cancer pain. This from a pain specialist. guideline provides information on the scope of the Do not prescribe long-acting or controlled- challenge, recommendations for prudent prescribing release opioids (e.g., OxyContin®, fentanyl and monitoring, advice on how to get consultative patches, and methadone) for acute pain. assistance, and resources for educating patients. The full report can be found at 2010 Update www.cdc.gov/HomeandRecreationalSafety/ In 2009, the AMDG surveyed medical providers in Poisoning/brief.htm . Washington State to assess the acceptability and usefulness of the guideline and to identify ways to Data collected in Washington state show: improve it (available at http://www.agencymeddirectors.wa.gov/Files/AG During 2004–2007, 1,668 WA residents had ReportFinal.pdf ). Results of the survey support the confirmed unintentional poisoning deaths due to continued use of this guideline with the addition of prescription opioid related overdoses6. Nearly clinical tools and improved information for half of these deaths were in the Medicaid accessing specialty consultations. population. Unintentional opioid-related overdose deaths Recent studies indicate a dramatic increase in increased 17-fold during 1995–2008. accidental deaths associated with the use of Hospitalizations for opioid-related overdoses prescription opioids and an increasing average daily increased 7-fold during 1995–2007. morphine equivalent dose (MED) of the most potent Addiction treatment admissions, where opioids since 19991-3. Between 1999–2006, people prescription opioids were the primary drug of aged 35–54 years had higher poisoning death rates abuse, increased from 1.1% to 7.4% between involving opioid analgesics than those in any other 2000 and 2009. age group4. Prescription opioid-related overdose deaths now exceed non-prescription opioid-related overdose In response to the increasing morbidity and mortality deaths7. associated with the increasing use of opioids, the The death rate from unintentional poisoning Centers for Disease Control and Prevention5 has exceeded the death rate from motor vehicle crashes in 2006, and the gap continues to widen8. 1 The AMDG consists of the medical directors from these WA State Agencies: Corrections, Social and Health Services (Medicaid), Labor and Industries, and the Health Care Authority 1
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) The risks of opioid use are not exclusive to the adult population. According to the Healthy Youth Survey How this guideline is organized 2008 (available at The purpose of Part I of the dosing guideline is http://takeasdirected.doh.wa.gov), Washington to assist primary care providers in prescribing teens are using prescription opioid pain medicine to opioids for adults in a safe and effective get high. This includes: manner. 4% of 8th graders The purpose of Part II is to assist primary care 10 % of 10th graders (21% of these youth providers in treating patients whose morphine obtained their prescriptions from a dentist or equivalent dose (MED) already exceeds physician) 120mg/day. 12% of 12th graders 2
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) increase in overdose risk. Most overdoses were Part I. Guidelines for medically serious, and 12% were fatal. initiating, transitioning, and High dose opioid therapy can be ineffective and/or maintaining oral opioids for unsafe. Higher strength pain medicines may be chronic non-cancer pain associated with poorer functional outcomes than lower strength opioids11,12. Providers must pay Part I of the dosing guideline will assist primary care attention to the development of tolerance and providers in prescribing opioids for adults in a safe adverse outcomes of chronic opioid use13. and effective manner when: Instituting or transitioning opioid therapy from This guideline provides a calculator for determining acute to chronic non-cancer pain; a patient’s daily MED, and a calculator for when the patient needs an opioid taper plan. For patients Assessing and monitoring opioid therapy for already on doses higher than 120mg MED this chronic non-cancer pain; and guideline also provides recommendations for Tapering or discontinuing opioids if an opioid optimizing treatment. Resources for calculating trial fails to yield improvements in function and MED when patients are on one or more opioids can pain. An opioid trial is a period of time during be found in Appendix A. which the effectiveness of using opioids is tested to see if goals of functionality and decreased In summary, available evidence supports the pain are met. A trial should occur prior to following recommendations: treating someone with long-acting opioids and The total daily dose of opioids should not be should include goals. If trial goals are not met, increased above 120mg oral MED without either the trial should be discontinued and an the patient demonstrating improvement in alternative approach taken to treating the pain9. function and pain or first obtaining a consultation from a practitioner qualified in Managing chronic pain and providing appropriate chronic pain management. opioid therapy is a challenging aspect of both primary care and specialty care practices. That is Risks substantially increase at doses at or above why it is critical for prescribers to be very conscious 100mg,10 so early attention to the 120mg MED of the risks, and intentional about the treatment plan benchmark dose is worthwhile. when prescribing these drugs. Best practice Safety and effectiveness of opioid therapy for treatment requires attention to a number of special chronic non-cancer pain should be routinely issues. One must balance the need for scientific evaluated by the prescriber. evidence and skillful clinical decision making in Assessing the effectiveness of opioid therapy these very complex cases. should include tracking and documenting both functional improvement and pain relief. Dosing threshold for pain consultation The hallmark of this guideline is a recommendation If there is evidence of frequent adverse effects or to not prescribe more than an average daily MED of lack of response to an opioid trial, a specialty 120mg without either the patient demonstrating consultation should be considered. Follow the improvement in function and pain or first obtaining guidance for seeking consultative assistance as a consultation from a pain management expert. A described in Table 1. recent cohort study supports the 120mg MED dosing threshold. It “provides the first estimates that directly link receipt of medically prescribed opioids to overdose risk and suggests that overdose risk is elevated in chronic non-cancer pain patients receiving medically prescribed opioids, particularly in patients receiving higher doses”10. Patients receiving 100mg or more per day MED had a 9-fold 3
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) Table 1. Guidance For Seeking Consultative Assistance (see page 9 for more details) Prescribing opioid doses up to 120mg MED/day: Before exceeding 120mg MED/day threshold: (Cumulative daily dose when using one or more (Cumulative daily dose when using one or more opioids. See Table 4 in Appendix A for specific opioid opioids. See Table 4 in Appendix A for specific thresholds.) opioid thresholds.) No assistance from a pain management consultant No assistance from a pain management needed if the prescriber is documenting sustained consultant needed if the prescriber is improvement in both function and pain. documenting sustained improvement in both Consider getting consultative assistance if frequent function and pain. adverse effects or lack of response is evident in In general, the total daily dose of opioid should order to address: not exceed 120 mg oral MED. Risks - Evidence of undiagnosed conditions; substantially increase at doses at or above 100mg10, so early attention to this benchmark - Presence of significant psychological condition dose is worthwhile. affecting treatment; and Seek assistance from a pain management - Potential alternative treatments to reduce or consultant to address: discontinue use of opioids. - Potential alternative treatments to opioids; - Risk and benefit of a possible trial with opioid dose above 120mg MED/day; - Most appropriate way to document improvement in function and pain; and - Possible need for consultation from other specialists Figure 1. Morphine Equivalent Dose Calculation For patients taking more than one opioid, the morphine equivalent doses of the different opioids must be added together to determine the cumulative dose (see Table 5 in Appendix A for MEDs of selected medications). For example, if a patient takes six hydrocodone 5mg / acetaminophen 500mg and two 20mg oxycodone extended release tablets per day, the cumulative dose may be calculated as follows: 1) Hydrocodone 5mg x 6 tablets per day = 30mg per day. 2) Using the Equianalgesic Dose table in Appendix A, 30mg Hydrocodone = 30mg morphine equivalents. 3) Oxycodone 20mg x 2 tablets per day = 40mg per day. 4) Per Equianalgesic Dose table, 20mg oxycodone = 30mg morphine so 40mg oxycodone = 60mg morphine equivalents. 5) Cumulative dose is 30mg + 60mg = 90mg morphine equivalents per day. An electronic opioid dose calculator can be downloaded at www.agencymeddirectors.wa.gov/guidelines.asp 4
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) BEFORE you decide to prescribe 3. The PHQ-9 to screen for depression severity opioids for chronic pain 4. A baseline urine drug test Acute pain is self-limiting and lasts from a few days 5. A baseline assessment of function and pain to a few weeks following trauma or surgery. The with the 2 item Graded Chronic Pain Scale level of pain during an acute phase does not (page 7 and Appendix C) necessarily and accurately predict the pain level in a chronic phase. Chronic pain can result from a See “Screening and Monitoring Your Patient” on number of conditions, diseases or injuries and is Page 6 for more details and see Appendix B for generally considered as pain lasting more than 3 samples of these screening forms. months. Because of the potentially serious adverse long term effects of opioids, it is critical that the prescriber comprehensively assess the risks and AFTER you decide with the patient to benefits of treatment prior to deciding whether to prescribe chronic opioid therapy prescribe opioids. Consider opioid therapy when: When instituting chronic opioid therapy, both Other physical, behavioral and non-opioid prescriber and patient should discuss and agree on measures have failed (e.g. physical therapy, all of the following: cognitive behavioral therapy, NSAIDs, Risks and benefits of opioid therapy supported antidepressants, antiepileptics), and by an opioid agreement (sample agreements can The patient has demonstrated sustained be found in Appendix G) improvement in function and pain levels in Treatment goals, which must include previous opioid trial, and improvements in both function and pain while The patient has no relative contraindication to monitoring for and minimizing adverse effects the use of opioids (e.g. current or past alcohol or Expectation for routine urine drug testing other substance abuse, including nicotine14,15). A follow-up plan with specific time intervals to monitor treatment Chronic opioid therapy (e.g., more than 90 days of therapy) should only be initiated on the basis of an Once a decision is made to institute chronic opioid explicit decision and agreement between prescriber therapy, the prescriber is responsible for routinely and patient. The patient needs to be informed of the monitoring the safety and effectiveness (improved benefits and risks of opioid therapy of indefinite function and pain) of ongoing treatment. duration. Sample agreements for the prescriber and patient can be found in Appendix G. Principles for safely prescribing chronic Screening for potential comorbidities and risk opioid therapy factors is crucial so that anticipated risk can be monitored accordingly. Depression and anxiety Single prescriber disorders are frequently associated with the use of Single pharmacy opioids16. Current and past substance abuse Patient and prescriber sign opioid agreement disorders appear to increase the risks of chronic opioid therapy17-20. If substantial risk is identified Lowest possible effective dose should be used through screening, extreme caution should be used Be cautious when using opioids with conditions and a specialty consultation (e.g. addiction or mental that may potentiate opioid adverse effects health specialist) is strongly encouraged. In such (including COPD, CHF, sleep apnea, current or cases, a baseline risk assessment using the following past alcohol or substance abuse, elderly, or tools should be performed and documented in the history of renal or hepatic dysfunction). record: Do not combine opioids with sedative-hypnotics, 1. The Opioid Risk Tool (ORT) to screen for risk benzodiazepines or barbiturates for chronic non- of opioid addiction cancer pain unless there is a specific medical 2. The CAGE-AID to screen for alcohol or drug and/or psychiatric indication for the combination problems 5
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) and increased monitoring is initiated (see Urine CAGE-AID23-25 drug testing, page 8). Purpose: to screen for alcohol or drug problems Routinely assess function and pain status (see Brief, 4 question-survey Tools for assessing function and pain, page 6). Easily accessible Monitor for medication misuse (for a list of drug-seeking behaviors, see Reasons to Relatively strong psychometric evidence base discontinue opioids or refer for addiction management, page 13). PHQ-926 Random urine drug testing to objectively assure Purpose: to screen for, diagnose, and monitor compliance (see Urine drug testing, page 8 and depression severity detailed guidance in Appendix D). Brief, 9-item questionnaire Easily accessible Special care should be taken when prescribing Superior psychometric evidence base methadone for chronic pain. One helpful article for clinicians is: Methadone Treatment for Pain States21. Additional tools are listed in Appendix B. Also, free mentoring services are available for prescribing methadone, using the Physician Clinical Support System. See Appendix H, "Additional Tools for assessing function and pain Resources." The key to effective opioid therapy for chronic non- cancer pain is to achieve sustained improvement in pain and physical function27,28. Tracking function Screening and monitoring your patient and pain is critical in determining the patient’s Several screening tools are available to help assess ongoing response to opioids and whether any risk for aberrant drug-related behavior, current or improvement is consistent with potential changes in former substance abuse, and mental health disorders. opioid dosing. Critical to this guideline, if function High risk does not necessarily contraindicate the use and pain do not substantially improve with opioid of opioids but additional monitoring is indicated dose increases, then significant tolerance to opioids whenever risk is increased for any reason. may be developing and consultative assistance is Additional monitoring may include increased strongly recommended. frequency of reassessment of pain, function, and aberrant behaviors, decreased number of doses prescribed, and increased frequency of UDT. Based An assessment of function and pain should on a review of the literature and the consensus of the consistently measure the same elements to advisory committee, the following three easy-to-use adequately determine the degree of progress. While tools are recommended for their clinical utility in there is no universally accepted tool to assess opioid therapy’s impact on function and pain, several are screening opioid therapy patients. (The following available and listed in Appendix C. In particular, the screening tools are available in Appendix B.) AMDG recommends using the two item Graded Chronic Pain Scale29,30 (Figure 2) as an ongoing and Opioid Risk Tool (ORT)22 rapid method to easily track function and pain in the Purpose: to assess a patient’s risk of opioid medical record. See Appendix C for instructions on addiction scoring and interpretation. Brief, 5-question survey Easily accessible Other functional assessment tools that may be Currently, there is no screening tool for risk of helpful in monitoring your patient’s progress opioid addiction that has a strong psychometric include, but are not limited to: evidence base SF36 Health Survey* www.rand.org/health/surveys_tools/mos/ mos_core_36item.html Brief Pain Inventory* 6
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) www.ohsu.edu/ahec/pain/paininventory.pdf The prescriber should assess the risks and benefits of QuickDash* for musculoskeletal disorders of the the patient’s current opioid therapy. This assessment upper extremities should include: www.dash.iwh.on.ca/outcome_quick.htm Function and pain status (see Tools for assessing function and pain, page 6); Quality of Life Scale* Possible adverse effects of current opioid doses; www.uic.edu/orgs/qli/questionaires/ questionnairehome.htm Potential psychiatric disorders affecting treatment; Oswestry Disability Index* Possible drug combinations or conditions that www.workcover.com/public/download.aspx?i may potentiate opioid adverse effects (such as d=794&str=disability index oswestry COPD, CHF, sleep apnea, current or past alcohol Neck Disability Index* or substance abuse, advanced age, or history of www.workcover.com/public/download.aspx?i renal or hepatic dysfunction); and d=792&str=disability index neck Any relative contraindication to the use of Short Musculoskeletal Function Assessment* opioids (active alcohol or other substance abuse, including nicotine14,15, see Urine drug testing, See: www.ejbjs.org/cgi/reprint/81/9/1245 page 8). * These instruments have all been independently validated and may be available at websites other than If function and pain do not improve after a sufficient those listed above. opioid trial, consider discontinuing opioids (see Tapering or Discontinuing Opioids, page 10). When Assessing effects of chronic opioid there is evidence of significant adverse effects from therapy opioid therapy, the provider should reduce the opioid Chronic opioid therapy is associated with the dose and reassess the patient’s status. development of tolerance to its analgesic effects31,32. Evidence is accumulating that opioid therapy may Otherwise, if no reasons for dose reduction or also paradoxically induce abnormal pain sensitivity, discontinuation are identified, and the prescriber including hyperalgesia and allodynia33-35. Thus, feels (with support of validated measures of function increasing opioid doses may not improve function and pain) that the patient is benefiting from current and pain control. therapy, continuation can be appropriate. Ongoing Figure 2. Graded Chronic Pain Scale Pain intensity and interference In the last month, on average, how would you rate your pain? Use a scale from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as could be"? [That is, your usual pain at times you were in pain.] No Pain as bad as pain could be 0 1 2 3 4 5 6 7 8 9 10 In the last month, how much has pain interfered with your daily activities? Use a scale from 0 to 10, where 0 is "no interference" and 10 is "unable to carry on any activities"? No Unable to carry on interference any activities 0 1 2 3 4 5 6 7 8 9 10 7
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) therapy, however, entails ongoing assessment. The After opioid therapy has been initiated, the screening described above should be done on a prescriber should randomly repeat testing at the regular basis to assess progression of therapy as the approximate frequency determined by the patient’s patient’s condition changes over time. risk category based on the ORT or similar screening tools (see Table 2). Urine drug testing (UDT) Although UDT and other screening tools are helpful The purpose of drug testing is to identify aberrant in identifying aberrant behavior, it is also important behavior, undisclosed drug use and/or abuse, and for prescribers to use their clinical judgment in the verify compliance with treatment. When used with development of a monitoring plan. Information from an appropriate level of understanding, UDT can third parties, such as family and friends, can be improve the prescriber’s ability to safely and helpful in evaluating behavior. Opioid prescribing appropriately manage opioid therapy (see Appendix should be avoided in patients with active alcohol or D – Using Urine Drug Testing to Monitor Opioid other substance abuse. Extreme caution should be Therapy for Chronic Non-cancer Pain). used, and a consultation with an addiction specialist is strongly encouraged, prior to prescribing opioids Urine drug testing is an important part of the for patients with a history of alcohol or other baseline risk assessment which prescribers should substance abuse. perform on all candidates for chronic opioid therapy (see Before you decide to prescribe opioids for Methods of testing chronic pain, page 5). This baseline UDT should be There is no standard UDT that is suitable for all performed on all transferring patients who are purposes and settings36. Currently, two main types of already using opioids and for those patients who you UDT are available: are considering for chronic opioid therapy (e.g. 3rd Immunoassay drug testing (initial drug test or opioid prescription or >6 weeks after an acute screen) – based in a lab or office (point-of-care). injury). Prior to testing, the prescriber should inform the patient of the reason for testing, the expectation High performance chromatography/mass of random repeat testing and consequences of spectrometry (confirmatory drug test) – available unexpected results. This gives the patient an only through a laboratory opportunity to disclose drug use and allows the prescriber to modify drug testing for the individual Immunoassays are the most common method of circumstances and more accurately interpret the testing and can be performed either in a laboratory results. or at the point-of-care. These tests detect the presence or absence of a drug or drug class according to a predetermined cutoff threshold. Table 2. Recommended Frequency of UDT Risk Category Recommended UDT Frequency Low Risk by ORT Periodic (e.g. up to 1/year) Moderate Risk by ORT Regular (e.g. up to 2/year) High Risk by ORT or opioid doses >120 mg MED/d Frequent (e.g. up to 3–4/year) Aberrant Behavior (lost prescriptions, multiple At time of visit requests for early refill, opioids from multiple providers, unauthorized dose escalation, apparent (Address aberrant behaviors in person, intoxication etc.) not by telephone) 8
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) The advantages of immunoassays are their ability to Contact your local laboratory director, toxicologist concurrently test for multiple drug classes, provide or certified Medical Review Officer (MRO) for rapid results and guide appropriate utilization of questions about drug testing or results. To locate a confirmatory testing. However, immunoassays can MRO in your area, submit a search at the following cross-react with other drugs and vary in sensitivity website: www.aamro.com/registry_search.html. If and specificity. Thus, unexpected immunoassay a point-of-care device is used, contact technical results should be interpreted with caution and support from the manufacturer for questions. verified by confirmatory testing. Table 3. Red Flag Results If verification or identification of a specific drug and/or metabolite(s) is needed, then confirmatory Negative for opioid(s) you prescribed testing is recommended. Laboratory-based confirmation uses gas chromatography/mass Positive for amphetamine or methamphetamine spectrometry or liquid chromatography/tandem mass Positive for cocaine or metabolites spectrometry (GC/MS or LC/MS/MS) to identify a Positive for drug (benzodiazepines, opioids, etc) drug or confirm an immunoassay result. you did not prescribe or have knowledge of Positive for alcohol Drugs or drug classes to test The NIDA 5 (National Institute on Drug Abuse) was established for workplace drug testing and is federally regulated. However, it does not test for Specialty consultation many commonly prescribed or abused drugs such as Specialty consultation is recommended for ongoing benzodiazepines and semi-synthethic or synthetic severe pain symptoms with no significant opioids, which may be important in compliance improvement in function despite treatment with testing. Thus, it may be more useful to order an opioids. Consultation should address possible expanded urine drug panel to include any of the undiagnosed conditions, psychological conditions drugs listed below in addition to drugs you are affecting treatment, and alternative treatments. The prescribing: type of consultation obtained should be determined Cannabinoids Alcohol by the patient’s presenting signs and symptoms and Cocaine Barbiturates history. Consultation may be with, but not limited to, Amphetamines Oxycodone a physician specializing in psychiatry, neurology, Opiates Methadone anesthesiology, pain, physical medicine and rehabilitation, orthopedics, addiction medicine, Benzodiazepines Fentanyl rheumatology, or oncology. Interpreting results Interpreting UDT results can be challenging, Unrecognized diagnoses: In cases of severe especially when the parent drug can be metabolized ongoing pain symptoms with no improvement in to other commonly prescribed drugs. When the function despite treatment with opioids, it is immunoassay result is unexpected and the patient recommended you seek consultative assistance to does not acknowledge or credibly explain the result, address possible undiagnosed conditions. Examples a confirmatory test using either GC/MS or include psychiatry, neurology, internal medicine, LC/MS/MS should be ordered. physical medicine and rehabilitation, orthopedics, addiction medicine, rheumatology, or oncology. If the patient tested negative for prescribed opioids and if confirmatory testing substantiates a “red flag” Psychological and addiction issues: Opioid result (see Table 3), the prescriber should consider a therapy can be challenging in patients with controlled taper or stop prescribing opioids symptoms suggestive of mood, anxiety, and immediately Prescriber may also consider a referral psychotic disorders. Consider psychiatric and/or to an addiction specialist or drug treatment program psychological consultation for intervention if a depending on the circumstances. psychological condition is affecting treatment. Patients with signs of alcohol or other substance 9
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) abuse should be referred to an addiction specialist Access to specialists and mentors (see Referrals for addiction management, page 13). The names of consultants are available at www.agencymeddirectors.wa.gov/guidelines.asp. Opioid management: Consultative assistance for You may also find it helpful to contact one of the opioid management and prudent prescribing of following organizations that offer credentialing or opioids should be with a pain management expert certification in pain medicine: who is familiar with and endorses this guideline. American Board of Pain Medicine Examples of when to seek assistance include: American Board of Anesthesiology with Patients on > 120mg MED/day certification of added qualifications in pain Questions about methadone treatment management Tapering patients off opioids American Board of Physical Medicine and Aberrant behavior Rehabilitation American Board of Psychiatry and Neurology Although pain may be relieved at oral morphine doses up to 120mg MED/day, pain relief is not The University of Washington School of Medicine necessarily associated with psychological or and its academic medical centers offer a toll free functional improvement37. Because sustained consultation and referral service available 24 hours functional improvement is so critical to effective per day 7 days per week. This service helps link you opioid therapy for chronic non-cancer pain, the with a faculty physician with expertise in any prescriber should ensure that the patient meets the particular area. To access these services visit, call following conditions before considering a dosage 800.326.5300, email medcon@washington.edu or above 120mg MED/day: visit, http://uwmedicine.washington.edu/Patient- There are no significant psychological issues or Care/Referrals/Pages/MEDCON.aspx.Click on evidence of drug-seeking behaviors, AND the tab, “Make a Referral” and then the tab “Expertise” and enter the specialty for which you are The patient has demonstrated improvement in seeking assistance. function and pain level previously at a lower dose. If these conditions are met, the prescriber may seek a Tapering or discontinuing opioids pain management consultation or case review to Not all patients benefit from opioids, and a support possible treatment with opioid doses above prescriber frequently faces the challenge of reducing 120mg MED/day. the opioid dose or discontinuing the opioid altogether. From a medical standpoint, weaning Consultation with a specialist does not necessitate from opioids can be done safely by slowly tapering transfer of the patient for care or ongoing opioid the opioid dose and taking into account the prescribing. However, the consultant should advise following issues: the prescribing provider on a pain management plan A decrease by 10% of the original dose per week and may include: alternative treatments to reduce or is usually well tolerated with minimal discontinue use of opioids, explanation of the risks physiological adverse effects. Some patients can and benefits of a possible trial with opioids above be tapered more rapidly without problems (over 120mg/day MED, and the need for ongoing 6 to 8 weeks). documentation of improvement in function and pain. If opioid abstinence syndrome is encountered, it Consultations do not necessarily have to be done is rarely medically serious although symptoms face to face with the patient. See Appendix E for may be unpleasant. alternate forms of consultative assistance. Symptoms of an abstinence syndrome, such as nausea, diarrhea, muscle pain and myoclonus can be managed with clonidine 0.1 – 0.2 mg orally every 6 hours or clonidine transdermal patch 0.1mg/24hrs (Catapres TTS-1™) weekly during the taper while monitoring often for 10
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) significant hypotension and anticholinergic side Attributing one’s deteriorating psychological effects. In some patients it may be necessary to state, including suicidal thoughts, to opioid slow the taper timeline to monthly, rather than withdrawal. weekly dosage adjustments. Symptoms of mild opioid withdrawal may There are no fool-proof methods for preventing persist for six months after opioids have been behavioral issues during an opioid taper, but discontinued. Rapid reoccurrence of tolerance strategies implemented at the beginning of the can occur for months to years after prior chronic opioid therapy are most likely to prevent later use. behavioral problems if an opioid taper becomes necessary (see AFTER you decide with the patient to Consider using adjuvant agents, such as prescribe chronic opioid therapy, page 5). Serious antidepressants to manage irritability, sleep suicidal ideation (with plan or intent) should prompt disturbance or antiepileptics for neuropathic urgent psychiatric consultation39. pain. Do not treat withdrawal symptoms with opioids or benzodiazepines after discontinuing opioids. Referral for counseling or other support during this period is recommended if there are significant behavioral issues. Referral to a pain specialist or chemical dependency center should be made for complicated withdrawal symptoms. An Opioid Taper Plan Calculator is available in Appendix H, Additional Resources. Recognizing and managing behavioral issues during opioid tapering Opioid tapers can be done safely and do not pose significant health risks to the patient. Special care needs to be taken by the prescriber to preserve the therapeutic relationship at this time. Otherwise, taper can precipitate doctor-shopping, illicit drug use, or other behaviors that pose a risk to patient safety. Extremely challenging behavioral issues may emerge during an opioid taper38. Behavioral challenges frequently arise when a prescriber is tapering the opioid dose and a patient places great value on the opioid he/she is receiving. In this setting, some patients may feel overwhelmed or desperate and will try to convince the prescriber to abandon the opioid taper. Challenges may include: Focus on right to pain relief (“You don’t believe I have real pain”) Arguments about poor quality of pain care with threats to complain to administrators or licensing boards 11
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) Part II: Guidelines for maintain the patient off opioids or at the new reduced dose and reassess at a later time. optimizing treatment when opioid doses are greater than Conversely, if there is evidence of functional and symptomatic deterioration following opioid taper, 120mg MED/day the prescriber may consider consulting with a pain Part II of this dosing guideline will assist primary management specialist to evaluate additional care providers in optimizing treatment: therapeutic options. When assessing effectiveness of opioid therapy Referrals to pain centers in patients who exceed 120mg MED/day; A referral for counseling or other support during When reducing the total daily opioid dose; and opioid taper or dose reduction is recommended if When discontinuing opioid therapy. there are significant behavioral issues. In addition, a multidisciplinary pain program may be considered Assessing effects of opioid doses when appropriate to address the psychosocial and greater than 120mg MED/day cognitive aspects of chronic pain together with Ongoing opioid therapy requires ongoing assessment patients’ physical rehabilitation41. Early consultative to optimize therapy. This is important in light of the support may prevent pain from becoming a chronic evidence that not all patients receive pain relief from disabling condition. opioids and some develop hyperalgesia and other abnormal pain sensitivity with chronic high dose opioid therapy. If, after using the guidelines under Recognizing aberrant behaviors during Assessing effects of chronic opioid therapy, page 7), opioid therapy the prescriber feels that current treatment is not Patients who exhibit aberrant behaviors may be at benefiting the patient, a dose reduction or risk for opioid abuse. There is no universally discontinuation is warranted. However, if current accepted screening tool to predict aberrant behaviors treatment is benefiting the patient as demonstrated with opioid therapy for chronic pain. However, it is by objective measures of function and pain, it may important to identify aberrant behaviors as they can be appropriate to continue, while establishing a plan affect the medical management of your patients and to monitor therapy as the patient’s condition changes help predict misue of opioids (see Reasons to over time (see Principles for safely prescribing discontinue opioids or refer for addiction chronic opioid therapy, page 5). management, page 13)42. Patients with a comorbid psychiatric condition or How to discontinue opioids or reduce addiction are at higher risk of opioid misuse despite and reassess at lower doses their attempts to follow the treatment plan38,43,44. Treatment with opioids, even at high doses, will not Prescribers should intensify monitoring and scrutiny eliminate all chronic pain, and some patients may do and seek a consultation with an addiction specialist better on lower doses of opioids13,34,40. A decrease by if there is past or active substance dependence or 10% of the original dose per week is usually well abuse. tolerated. An Opioid Taper Plan Calculator is available in Appendix H, Additional Resources. Behavioral issues or physical withdrawal symptoms can be a major obstacle to an otherwise beneficial dose reduction (see Tapering or discontinuing opioids, page 10, and Recognizing and managing behavioral issues during opioid tapering, page 11). The prescriber should assess the patient’s status periodically during the tapering process. If the chosen assessment tool indicates improved patient status other than subjective pain complaints, or if there is improvement in opioid-related side effects, 12
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) Reasons to discontinue opioids or refer Referrals for addiction management for addiction management A patient who exhibits overt signs of alcohol or No improvement in function and pain or substance use disorder should be referred to an addiction specialist for appropriate treatment. Opioid therapy produces significant adverse Prognosis is poor for patients with a Diagnostic and effects or Statistical Manual of Mental Disorders (DSM) Patient exhibits drug-seeking behaviors or diagnosis of opioid dependence or opioid abuse who diversion such as: do not receive treatment45,46. - Selling prescription drugs - Forging prescriptions - Stealing or borrowing drugs - Frequently losing prescriptions - Aggressive demand for opioids - Injecting oral/topical opioids - Unsanctioned use of opioids - Unsanctioned dose escalation - Concurrent use of illicit drugs - Failing a drug screen - Getting opioids from multiple prescribers - Recurring emergency department visits for chronic pain management (see section on Emergency Department Guidelines in Appendix H, Additional Resources). 13
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) 14
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain (CNCP) Appendices Appendix A: Opioid Dose Calculations Appendix B: Screening Tools Appendix C: Tools for Assessing Function and Pain Appendix D: Urine Drug Testing for Monitoring Opioid Therapy Appendix E: Quick Reference for Obtaining Consultative Assistance – for Washington Public Payers Only Appendix F: Patient Education Resources Appendix G: Sample Doctor-Patient Agreements for Chronic Opioid Use Appendix H: Additional Resources to Streamline Clinical Care Appendix I: Emergency department guidelines help coordinate care with primary care providers 15
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain Appendix A: Opioid dose calculations Table 4. Dosing Threshold for Selected Opioids* Recommended Recommended dose threshold for starting dose for pain consult (not opioid-naïve Opioid equianalgesic) patients Considerations See individual product labeling for maximum dosing of combination products. Avoid concurrent use of Codeine 800mg per 24 hours 30mg q 4–6 hours any OTC products containing same ingredient. See acetaminophen warning, below. Fentanyl Use only in opioid-tolerant patients who have been 50mcg/hour (q 72 hr) Transdermal taking ≥ 60mg MED daily for a week or longer See individual product labeling for maximum dosing of combination products. Avoid concurrent Hydrocodone 120mg per 24 hours 5-10mg q 4–6 hours use of any OTC products containing same ingredient. See acetaminophen warning, below. Hydromorphone 30mg per 24 hours 2mg q 4–6 hours Methadone is difficult to titrate due to its half-life variability. It may take a long time to reach a stable level in the body. Methadone dose should not be Methadone 40mg per 24 hours 2.5-5mg BID – TID increased more frequently than every 7 days. Do not use as PRN or combine with other long-acting (LA) opioids. Immediate-release: Adjust dose for renal impairment. 10mg q 4 hours Morphine 120mg per 24 hours Sustained-release: 15mg q 12 hours Immediate-release: See individual product labeling for maximum dosing of combination products. Avoid concurrent 5mg q 4–6 hours use of any OTC products containing same Oxycodone 80mg per 24 hours ingredient. See acetaminophen warning, below. Sustained Release: 10mg q 12 hours Immediate-release: Use with extreme caution due to potential fatal interaction with alcohol or medications 5–10mg q 4–6 hours containing alcohol. Oxymorphone 40mg per 24 hours Sustained Release: 10mg q 12 hours *Meperidine and propoxyphene products should not be prescribed for chronic non-cancer pain. 16
Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain Acetaminophen warning with combination products Hepatotoxicity can result from prolonged use or doses in excess of recommended maximum total daily dose of acetaminophen including over-the-counter products. Short-term use (
Appendix B: Screening Tools Based on a review of the literature and the consensus of the advisory committee, the first three highlighted tools are recommended for their clinical utility in screening opioid therapy patients. To Screen For To Monitor Tool Characteristics Depression, Risk of Current/Past Available for Mental/ Opioid Time to Length Opioid Substance Administration Public Use Behavioral Therapy Complete Addiction Abuse (Cost) Health Clinician or Opioid Risk Tool (ORT) 5 (yes/no) X patient self- 5 minutes X (Free) See Page 19. questions report CAGE Adapted to Include 4 (yes/no) Drugs (CAGE-AID) X Clinician < 5 minutes X (Free) questions See Page 20. Patient Health Questionnaire Patient self- 9 (PHQ-9) X < 5 minutes 10 items X (Free) report See Page 21. Screener and Opioid X (Free, with Assessment for Patients with Patient self- X < 10 minutes 24 items licensing Pain (SOAPP-R) report agreement) www.painedu.org/soapp.asp Alcohol Use Disorders Clinician or 10 items Identification Test (AUDIT) X patient self- < 5 minutes X (Free) See Page 24. report Center for Epidemiologic Studies Depression Scale Patient self- X 5 minutes 20 items X (Free) (CES-D) report See Page 26. Global Appraisal of Individual Needs Short Staff or patient 15 (yes/no) X 5 minutes X (Free) Screener (GAIN-SS) self-report questions See Page 29. Current Opioid Misuse X (Free, with Patient self- Measure (COMM) X < 10 minutes 17 items licensing report www.painedu.org/soapp.asp agreement) *The tools listed in this table have demonstrated good content, face, and construct validity in screening for risk of addiction and monitoring opioid therapy. Further validation studies and prospective outcome studies are needed to determine how the use of these tools predicts and affects clinical outcomes. 18
Date _____________________________ Patient Name ________________________________ OPIOID RISK TOOL Mark each Item Score Item Score box that applies If Female If Male 1. Family History of Substance Abuse Alcohol [ ] 1 3 Illegal Drugs [ ] 2 3 Prescription Drugs [ ] 4 4 2. Personal History of Substance Abuse Alcohol [ ] 3 3 Illegal Drugs [ ] 4 4 Prescription Drugs [ ] 5 5 3. Age (Mark box if 16 – 45) [ ] 1 1 4. History of Preadolescent Sexual Abuse [ ] 3 0 5. Psychological Disease Attention Deficit Disorder [ ] 2 2 Obsessive Compulsive Disorder Bipolar Schizophrenia Depression [ ] 1 1 TOTAL [ ] Total Score Risk Category Low Risk 0 – 3 Moderate Risk 4 – 7 High Risk > 8 19
CAGE-AID Questionnaire Patient Name __________________________________ Date of Visit ___________________ When thinking about drug use, include illegal drug use and the use of prescription drug other than prescribed. Questions: YES NO_______ 1. Have you ever felt that you ought to cut down on your drinking or drug use? ………………………………………………………………………………………………….... 2. Have people annoyed you by criticizing your drinking or drug use? ……………………………………………………………………………………………............ 3. Have you ever felt bad or guilty about your drinking or drug use? ……………………………………………………………………………………………............ 4. Have you ever had a drink or used drugs first thing in the morning to steady your nerves or to get rid of a hangover?________________________________ Scoring Regard one or more positive responses to the CAGE-AID as a positive screen. Psychometric Properties The CAGE-AID exhibited: Sensitivity Specificity One or more Yes responses 0.79 0.77 Two or more Yes responses 0.70 0.85 (Brown 1995) 20
PHQ-9 — Nine Symptom Checklist Patient Name Date 1. Over the last 2 weeks, how often have you been bothered by any of the following problems? Read each item carefully, and circle your response. a. Little interest or pleasure in doing things Not at all Several days More than half the days Nearly every day b. Feeling down, depressed, or hopeless Not at all Several days More than half the days Nearly every day c. Trouble falling asleep, staying asleep, or sleeping too much Not at all Several days More than half the days Nearly every day d. Feeling tired or having little energy Not at all Several days More than half the days Nearly every day e. Poor appetite or overeating Not at all Several days More than half the days Nearly every day f. Feeling bad about yourself, feeling that you are a failure, or feeling that you have let yourself or your family down Not at all Several days More than half the days Nearly every day g. Trouble concentrating on things such as reading the newspaper or watching television Not at all Several days More than half the days Nearly every day h. Moving or speaking so slowly that other people could have noticed. Or being so fidgety or restless that you have been moving around a lot more than usual Not at all Several days More than half the days Nearly every day i. Thinking that you would be better off dead or that you want to hurt yourself in some way Not at all Several days More than half the days Nearly every day 2. If you checked off any problem on this questionnaire so far, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people? Not Difficult at All Somewhat Difficult Very Difficult Extremely Difficult Copyright held by Pfizer Inc, but may be photocopied ad libitum 1 Tools May be printed without permission 21
PHQ-9 — Scoring Tally Sheet Patient Name Date 1. Over the last 2 weeks, how often have you been bothered by any of the following problems? Read each item carefully, and circle your response. Not Several More than Nearly at all days half the days every day 0 1 2 3 a. Little interest or pleasure in doing things b. Feeling down, depressed, or hopeless c. Trouble falling asleep, staying asleep, or sleeping too much d. Feeling tired or having little energy e. Poor appetite or overeating f. Feeling bad about yourself, feeling that you are a failure, or feeling that you have let yourself or your family down g. Trouble concentrating on things such as reading the newspaper or watching television h. Moving or speaking so slowly that other people could have noticed. Or being so fidgety or restless that you have been moving around a lot more than usual i. Thinking that you would be better off dead or that you want to hurt yourself in some way Totals 2. If you checked off any problem on this questionnaire so far, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people? Not Difficult At All Somewhat Difficult Very Difficult Extremely Difficult 0 1 2 3 Copyright held by Pfizer Inc, but may be photocopied ad libitum 2 Tools May be printed without permission 22
How to Score PHQ-9 Scoring Method Major Depressive Syndrome is suggested if: For Diagnosis • Of the 9 items, 5 or more are circled as at least "More than half the days" • Either item 1a or 1b is positive, that is, at least "More than half the days" Minor Depressive Syndrome is suggested if: • Of the 9 items, b, c, or d are circled as at least "More than half the days" • Either item 1a or 1b is positive, that is, at least "More than half the days" Scoring Method Question One For Planning • To score the first question, tally each response by the number And Monitoring value of each response: Treatment Not at all = 0 Several days = 1 More than half the days = 2 Nearly every day = 3 • Add the numbers together to total the score. • Interpret the score by using the guide listed below: Score Action 5-14 Physician uses clinical judgment about treatment, based on patient’s duration of symptoms and functional impairment. >15 Warrants treatment for depression, using antidepressant, psychotherapy and/or a combination of treatment Question Two In question two the patient responses can be one of four: not difficult at all, somewhat difficult, very difficult, extremely difficult. The last two responses suggest that the patient's functionality is impaired. After treatment begins, the functional status is again measured to see if the patient is improving. Copyright held by Pfizer Inc, but may be photocopied ad libitum 3 Tools How to Score PHQ-9 23
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