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Outcome Studies Limitations Inconsistency Imprecision Type of evidence Other factors Estimates of effect/findings
Effectiveness and comparative effectiveness (KQ1)
Effectiveness of long-term opioid therapy versus placebo or no opioid therapy for long-term (≥1 year) outcomes
Pain, function, and quality of life None Insufficient No evidence
Harms and adverse events (KQ2)
Risks of opioids versus placebo or no opioids on opioid abuse, addiction, and related outcomes; overdose; and other harms
Abuse or addiction 1 cohort study (n = 568,640) Serious limitations Unknown (1 study) No imprecision 3 None identified One retrospective cohort study found long-term use of prescribed opioids associated with an increased risk of abuse or dependence diagnosis versus no opioid use (adjusted OR ranged from 14.9 to 122.5, depending on dose).
Abuse or addiction 10 uncontrolled studies (n = 3,780) Very serious limitations Very serious inconsistency No imprecision 4 None identified In primary care settings, prevalence of opioid abuse ranged from 0.6% to 8% and prevalence of dependence from 3% to 26%. In pain clinic settings, prevalence of misuse ranged from 8% to 16% and addiction from 2% to 14%. Prevalence of aberrant drug-related behaviors ranged from 6% to 37%.
Overdose 1 cohort study (n = 9,940) Serious limitations Unknown (1 study) Serious imprecision 3 None identified Current opioid use associated with increased risk of any overdose events (adjusted HR 5.2, 95% CI = 2.1–12) and serious overdose events (adjusted HR 8.4, 95% CI = 2.5–28) versus current nonuse.
Fractures 1 cohort study (n = 2,341) and 1 case–control study (n = 21,739 case patients) Serious limitations No inconsistency No imprecision 3 None identified Opioid use associated with increased risk of fracture in 1 cohort study (adjusted HR 1.28, 95% CI = 0.99–1.64) and 1 case-control study (adjusted OR 1.27, 95% CI = 1.21–1.33).
Myocardial infarction 1 cohort study (n = 426,124) and 1 case–control study (n = 11,693 case patients) No limitations No inconsistency No imprecision 3 None identified Current opioid use associated with increased risk of myocardial infarction versus nonuse (adjusted OR 1.28, 95% CI = 1.19–1.37 and incidence rate ratio 2.66, 95% CI = 2.30–3.08).
Endocrinologic harms 1 cross-sectional study (n = 11,327) Serious limitations Unknown (1 study) No imprecision 3 None identified Long-term opioid use associated with increased risk for use of medications for erectile dysfunction or testosterone replacement versus nonuse (adjusted OR 1.5, 95% CI = 1.1–1.9).
How do harms vary depending on the opioid dose used?
Abuse or addiction 1 cohort study (n = 568,640) Serious limitations Unknown (1 study) No imprecision 3 None identified One retrospective cohort study found higher doses of long-term opioid therapy associated with increased risk of opioid abuse or dependence than lower doses. Compared to no opioid prescription, the adjusted odds ratios were 15 (95% CI = 10–21) for 1 to 36 MME/day, 29 (95 % CI = 20–41) for 36 to 120 MME/day, and 122 (95 % CI = 73–205) for ≥120 MME/day.
Overdose 1 cohort study (n = 9,940) and 1 case–control study (n = 593 case patients in primary analysis) Serious limitations No inconsistency No imprecision 3 Magnitude of effect, dose response relationship Versus 1 to <20 MME/day, one cohort study found an adjusted HR for an overdose event of 1.44 (95% CI = 0.57–3.62) for 20 to <50 MME/day that increased to 8.87 (95% CI = 3.99–19.72) at =100 MME/day; one case-control study found an adjusted OR for an opioid-related death of 1.32 (95% CI = 0.94–1.84) for 20 to 49 MME/day that increased to 2.88 (95% CI = 1.79–4.63) at ≥200 MME/day.
Fractures 1 cohort study (n = 2,341) Serious limitations Unknown (1 study) Serious imprecision 3 None identified Risk of fracture increased from an adjusted HR of 1.20 (95% CI = 0.92–1.56) at 1 to <20 MME/day to 2.00 (95% CI = 1.24–3.24) at ≥50 MME/day; the trend was of borderline statistical significance.
Myocardial infarction 1 cohort study (n = 426,124) Serious limitations Unknown (1 study) No imprecision 3 None identified Relative to a cumulative dose of 0 to 1,350 MME during a 90-day period, the incidence rate ratio for myocardial infarction for 1350 to <2700 MME was 1.21 (95% CI = 1.02–1.45), for 2,700 to <8,100 MME was 1.42 (95% CI = 1.21–1.67), for 8,100 to <18,000 MME was 1.89 (95% CI = 1.54–2.33), and for ≥8,000 MME was 1.73 (95% CI = 1.32–2.26).
Motor vehicle crash injuries 1 case–control study (n = 5,300 case patients) No limitations Unknown (1 study) No imprecision 3 None identified No association between opioid dose and risk of motor vehicle crash injuries even though opioid dosages ≥20 MME/day were associated with increased odds of road trauma among drivers.
Endocrinologic harms 1 cross-sectional study (n = 11,327) New for update: 1 additional cross-sectional study (n=1,585) Serious limitations Consistent No imprecision 3 None identified Relative to 0 to <20 MME/day, the adjusted OR for =120 MME/day for use of medications for erectile dysfunction or testosterone replacement was 1.6 (95% CI = 1.0–2.4).
One new cross-sectional study found higher-dose long-term opioid therapy associated with increased risk of androgen deficiency among men receiving immediate-release opioids (adjusted OR per 10 MME/day 1.16, 95% CI = 1.09–1.23), but the dose response was very weak among men receiving ER/LA opioids.
Dosing strategies (KQ3)
Comparative effectiveness of different methods for initiating opioid therapy and titrating doses
Pain 3 randomized trials (n = 93) Serious limitations Serious inconsistency Very serious imprecision 4 None identified Trials on effects of titration with immediate-release versus ER/LA opioids reported inconsistent results and had additional differences between treatment arms in dosing protocols (titrated versus fixed dosing) and doses of opioids used.
Overdose New for update: 1 cohort study (n = 840,606) Serious limitations Unknown (1 study) No imprecision 4 None identified One new cross-sectional study found initiation of therapy with an ER/LA opioid associated with increased risk of overdose versus initiation with an immediate-release opioid (adjusted HR 2.33, 95% CI = 1.26–4.32).
Comparative effectiveness of different ER/LA opioids
Pain and function 3 randomized trials (n = 1,850) Serious limitations No inconsistency No imprecision 3 None identified No differences
All-cause mortality 1 cohort study (n = 108,492) New for update: 1 cohort study (n = 38,756) Serious limitations Serious inconsistency No imprecision 4 None identified One cohort study found methadone to be associated with lower all-cause mortality risk than sustained-release morphine in a propensity-adjusted analysis (adjusted HR 0.56, 95% CI = 0.51–0.62) and one cohort study among Tennessee Medicaid patients found methadone to be associated with higher risk of all-cause mortality than sustained-release morphine (adjusted HR 1.46, 95% CI = 1.17–1.73).
Abuse and related outcomes 1 cohort study (n = 5,684) Serious limitations Unknown (1 study) Serious imprecision 4 None identified One cohort study found some differences between ER/LA opioids in rates of adverse outcomes related to abuse, but outcomes were nonspecific for opioid-related adverse events, precluding reliable conclusions.
ER/LA versus immediate-release opioids
Endocrinologic harms New for update: 1 cross-sectional study (n = 1,585) Serious limitations Unknown (1 study) No imprecision 4 None identified One cross-sectional study found ER/LA opioids associated with increased risk of androgen deficiency versus immediate-release opioids (adjusted OR 3.39, 95% CI = 2.39–4.77).
Dose escalation versus dose maintenance or use of dose thresholds
Pain, function, or withdrawal due to opioid misuse 1 randomized trial (n = 140) Serious limitations Unknown (1 study) Very serious imprecision 3 None identified No difference between more liberal dose escalation versus maintenance of current doses in pain, function, or risk of withdrawal due to opioid misuse, but there was limited separation in opioid doses between groups (52 versus 40 MME/day at the end of the trial).
Immediate-release versus ER/LA opioids; immediate-release plus ER/LA opioids versus ER/LA opioids alone; scheduled and continuous versus as-needed dosing of opioids; or opioid rotation versus maintenance of current therapy
Pain, function, quality of life, and outcomes related to abuse None Insufficient No evidence
Effects of decreasing or tapering opioid doses versus continuation of opioid therapy
Pain and function 1 randomized trial (n = 10) Very serious limitations Unknown (1 study) Very serious imprecision 4 None identified Abrupt cessation of morphine was associated with increased pain and decreased function compared with continuation of morphine.
Comparative effectiveness of different tapering protocols and strategies
Opioid abstinence 2 nonrandomized trials (n = 150) Very serious limitations No inconsistency Very serious imprecision 4 None identified No clear differences between different methods for opioid discontinuation or tapering in likelihood of opioid abstinence after 3–6 months
Risk assessment and risk mitigation strategies (KQ4)
Diagnostic accuracy of instruments for predicting risk for opioid overdose, addiction, abuse, or misuse among patients with chronic pain being considered for long-term opioid therapy
Opioid risk tool 3 studies of diagnostic accuracy (n = 496)
New for update:2 studies of diagnostic accuracy (n = 320)
Serious limitations Very serious inconsistency Serious imprecision 4 None identified Based on a cutoff score of ≥4 (or unspecified), five studies (two fair-quality, three poor-quality) reported sensitivity that ranged from 0.20 to 0.99 and specificity that ranged from 0.16 to 0.88.
Screener and Opioid Assessment for Patients with Pain, Version 1 2 studies of diagnostic accuracy (n = 203) Very serious limitations No inconsistency Serious imprecision 3 None identified Based on a cutoff score of ≥8, sensitivity was 0.68 and specificity was 0.38 in one study, for a positive likelihood ratio of 1.11 and a negative likelihood ratio of 0.83. Based on a cutoff score of >6, sensitivity was 0.73 in one study.
Screener and Opioid Assessment for Patients with Pain-Revised New for update: 2 studies of diagnostic accuracy (n = 320) Very serious limitations No inconsistency Serious imprecision 3 None identified Based on a cutoff score of >3 or unspecified, sensitivity was 0.25 and 0.53 and specificity was 0.62 and 0.73 in two studies, for likelihood ratios close to 1.
Brief Risk Interview New for update: 2 studies of diagnostic accuracy (n = 320) Very serious limitations No inconsistency Serious imprecision 3 None identified Based on a “high risk” assessment, sensitivity was 0.73 and 0.83 and specificity was 0.43 and 0.88 in two studies, for positive likelihood ratios of 1.28 and 7.18 and negative likelihood ratios of 0.63 and 0.19.
Effectiveness of risk prediction instruments on outcomes related to overdose, addiction, abuse, or misuse in patients with chronic pain
Outcomes related to abuse None Insufficient No evidence
Effectiveness of risk mitigation strategies, including opioid management plans, patient education, urine drug screening, use of prescription drug monitoring program data, use of monitoring instruments, more frequent monitoring intervals, pill counts, and use of abuse-deterrent formulations, on outcomes related to overdose, addiction, abuse, or misuse
Outcomes related to abuse None Insufficient No evidence
Effectiveness of risk prediction instruments on outcomes related to overdose, addiction, abuse, or misuse in patients with chronic pain
Outcomes related to abuse None Insufficient No evidence
  Effectiveness of risk mitigation strategies, including opioid management plans, patient education, urine drug screening, use of prescription drug monitoring program data, use of monitoring instruments, more frequent monitoring intervals, pill counts, and use of abuse-deterrent formulations, on outcomes related to overdose, addiction, abuse, or misuse
  Outcomes related to abuse None Insufficient No evidence
  Comparative effectiveness of treatment strategies for managing patients with addiction to prescription opioids
  Outcomes related to abuse None Insufficient No evidence
Effects of opioid therapy for acute pain on long-term use (KQ5)
  Long-term opioid use New for update:
2 cohort studies
(n = 399,852)
Serious limitations No inconsistency No imprecision 3 None identified One study found use of opioids within 7 days of low-risk surgery associated with increased likelihood of opioid use at 1 year (adjusted OR 1.44, 95% CI = 1.39–1.50), and one study found use of opioids within 15 days of onset of low back pain among workers with a compensation claim associated with increased risk of late opioid use (adjusted OR 2.08, 95% CI = 1.55–2.78 for 1 to 140 MME/day and OR 6.14, 95% CI = 4.92–7.66 for ≥450 MME/day).

Table 1. Grading of Recommendations Assessment, Development and Evaluation (GRADE) clinical evidence review ratings of the evidence for the key clinical questions regarding effectiveness and risks of long-term opioid therapy for chronic pain

Abbreviations: CI = confidence interval; ER/LA = extended release/long-acting; HR = hazard ratio; MME = morphine milligram equivalents; OR = odds ratio.
*Ratings were made per GRADE quality assessment criteria; “no limitations” indicates that limitations assessed through the GRADE method were not identified.
†Not applicable as no evidence was available for rating.

 

Opioid Conversion factor*
Codeine 0.15
Fentanyl transdermal (in mcg/hr) 2.4
Hydrocodone 1
Hydromorphone 4
Methadone
1–20 mg/day 4
21–40 mg/day 8
41–60 mg/day 10
≥61–80 mg/day 12
Morphine 1
Oxycodone 1.5
Oxymorphone 3
Tapentadol 0.4

Table 2. Morphine milligram equivalent (MME) doses for commonly prescribed opioids

Source: Adapted from Von Korff M, Saunders K, Ray GT, et al. Clin J Pain 2008;24:521–7 and Washington State Interagency Guideline on Prescribing Opioids for Pain (http://www.agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf).
*Multiply the dose for each opioid by the conversion factor to determine the dose in MMEs. For example, tablets containing hydrocodone 5 mg and acetaminophen 300 mg taken four times a day would contain a total of 20 mg of hydrocodone daily, equivalent to 20 MME daily; extended-release tablets containing oxycodone 10mg and taken twice a day would contain a total of 20mg of oxycodone daily, equivalent to 30 MME daily. The following cautions should be noted: 1) All doses are in mg/day except for fentanyl, which is mcg/hr. 2) Equianalgesic dose conversions are only estimates and cannot account for individual variability in genetics and pharmacokinetics. 3) Do not use the calculated dose in MMEs to determine the doses to use when converting opioid to another; when converting opioids the new opioid is typically dosed at substantially lower than the calculated MME dose to avoid accidental overdose due to incomplete cross-tolerance and individual variability in opioid pharmacokinetics. 4) Use particular caution with methadone dose conversions because the conversion factor increases at higher doses. 5) Use particular caution with fentanyl since it is dosed in mcg/hr instead of mg/day, and its absorption is affected by heat and other factors.
†Tapentadol is a mu receptor agonist and norepinephrine reuptake inhibitor. MMEs are based on degree of mu-receptor agonist activity, but it is unknown if this drug is associated with overdose in the same dose-dependent manner as observed with medications that are solely mu receptor agonists.

 

Determining When to Initiate or Continue Opioids for Chronic Pain
1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.

2. Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.

3. Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.
Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation
4. When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.

5. When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day.

6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.

7. Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.
Assessing Risk and Addressing Harms of Opioid Use
8. Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present.

9. Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

10. When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

11. Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.

12. Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.
* All recommendations are category A (apply to all patients outside of active cancer treatment, palliative care, and end-of-life care) except recommendation 10 (designated category B, with individual decision making required); see full guideline for evidence ratings.

Box 1. CDC recommendations for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care

 

Recommendation Categories
Based on evidence type, balance between desirable and undesirable effects, values and preferences, and resource allocation (cost).

Category A recommendation: Applies to all persons; most patients should receive the recommended course of action.

Category B recommendation: Individual decision making needed; different choices will be appropriate for different patients. Clinicians help patients arrive at a decision consistent with patient values and preferences and specific clinical situations.
Evidence Type
Based on study design as well as a function of limitations in study design or implementation, imprecision of estimates, variability in findings, indirectness of evidence, publication bias, magnitude of treatment effects, dose-response gradient, and constellation of plausible biases that could change effects.

Type 1 evidence: Randomized clinical trials or overwhelming evidence from observational studies.

Type 2 evidence: Randomized clinical trials with important limitations, or exceptionally strong evidence from observational studies.

Type 3 evidence: Observational studies or randomized clinical trials with notable limitations.

Type 4 evidence: Clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations.

Box 2. Interpretation of recommendation categories and evidence type

CME / ABIM MOC / CE

CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016

  • Authors: Deborah Dowell, MD, MPH; Tamara M. Haegerich, PhD; Roger Chou, MD
  • CME / ABIM MOC / CE Released: 6/23/2017; Reviewed and Renewed: 8/6/2018
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 8/6/2019
Start Activity


Target Audience and Goal Statement

This activity is intended for primary care clinicians, nurses, and other clinicians prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.

The goal of this study was to describe recommendations for primary care clinicians prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care, based on a guideline from the Centers for Disease Control and Prevention.

Upon completion of this activity, participants will be able to:

  1. Distinguish recommendations for starting or continuing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care, based on a guideline from the Centers for Disease Control and Prevention (CDC)
  2. Identify recommendations for opioid selection, dosage, duration, follow-up, and discontinuation, based on a CDC guideline
  3. Distinguish recommendations for evaluating risk and addressing harms associated with opioid use, based on a CDC guideline


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Authors

  • Deborah Dowell, MD, MPH

    Senior Medical Advisor, Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia

    Disclosures

    Disclosure: Deborah Dowell, MD, MPH, has disclosed no relevant financial relationships.

  • Tamara M. Haegerich, PhD

    Deputy Associate Director for Science, Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia

    Disclosures

    Disclosure: Tamara M. Haegerich, PhD, has disclosed no relevant financial relationships.

  • Roger Chou, MD

    Professor, Oregon Health & Science University, Portland, Oregon; Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia

    Disclosures

    Disclosure: Roger Chou, MD, has disclosed no relevant financial relationships.

Nurse Planner

  • Amy Bernard, MS, BSN, RN-BC

    Lead Nurse Planner, Medscape, LLC

    Disclosures

    Disclosure: Amy Bernard, MS, BSN, RN-BC, has disclosed no relevant financial relationships.

CME Author

  • Laurie Barclay, MD

    Freelance writer and reviewer, Medscape, LLC

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed the following relevant financial relationships:
    Owns stock, stock options, or bonds from: Alnylam; Biogen; Pfizer Inc.

CME Reviewer

  • Robert Morris, PharmD

    Associate CME Clinical Director, Medscape, LLC

    Disclosures

    Disclosure: Robert Morris, PharmD, has disclosed no relevant financial relationships.


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CME / ABIM MOC / CE

CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016

Authors: Deborah Dowell, MD, MPH; Tamara M. Haegerich, PhD; Roger Chou, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME / ABIM MOC / CE Released: 6/23/2017; Reviewed and Renewed: 8/6/2018

Valid for credit through: 8/6/2019

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Summary

This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care. The guideline addresses 1) when to initiate or continue opioids for chronic pain; 2) opioid selection, dosage, duration, follow-up, and discontinuation; and 3) assessing risk and addressing harms of opioid use. CDC developed the guideline using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework, and recommendations are made on the basis of a systematic review of the scientific evidence while considering benefits and harms, values and preferences, and resource allocation. CDC obtained input from experts, stakeholders, the public, peer reviewers, and a federally chartered advisory committee. It is important that patients receive appropriate pain treatment with careful consideration of the benefits and risks of treatment options. This guideline is intended to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death. CDC has provided a checklist for prescribing opioids for chronic pain (http://stacks.cdc.gov/view/cdc/38025) as well as a website (http://www.cdc.gov/drugoverdose/prescribing/resources.html) with additional tools to guide clinicians in implementing the recommendations.