Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain

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Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain
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
    ƒ New data, including scientific evidence to support
      the 120mg MED dosing threshold
    ƒ Tools for calculating dosages of opioids during
      treatment and when tapering
    ƒ Validated screening tools for assessing substance
      abuse, mental health, and addiction
    ƒ Validated two-item scale for tracking function and
      pain
    ƒ Urine drug testing guidance and algorithm
    ƒ Information on access to mentoring and
      consultations (including reimbursement options)
    ƒ New patient education materials and resources
    ƒ Guidance on coordinating with emergency
      departments to reduce opioid abuse
    ƒ 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.)
ƒ No assistance from a pain management consultant        ƒ 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
ƒ Consider getting consultative assistance if frequent     function and pain.
  adverse effects or lack of response is evident in      ƒ 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
                                                         ƒ 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)

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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
                                                         ƒ Negative for opioid(s) you prescribed
testing is recommended. Laboratory-based
confirmation uses gas chromatography/mass                ƒ Positive for amphetamine or methamphetamine
spectrometry or liquid chromatography/tandem mass        ƒ Positive for cocaine or metabolites
spectrometry (GC/MS or LC/MS/MS) to identify a           ƒ Positive for drug (benzodiazepines, opioids, etc)
drug or confirm an immunoassay result.                     you did not prescribe or have knowledge of
                                                         ƒ 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

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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

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                                                                                                             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.

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3   Tools                                                                            How to Score PHQ-9
                                                                                                  23
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