Datasets:

Hieu-Pham

/

cpgQA

like 0

At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms.

Recommendations

What is included in the ongoing OT prescribing practice?

At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms.

Recommendations

What to be aware of during follow-ups?

At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms.

Recommendations

What is the relationship between the length of OT and opioid-related harms?

If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. (Strong for | Reviewed, New-replaced) Note: There is no absolutely safe dose of opioids. As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Risks for opioid use disorder start at any dose and increase in a dose-dependent manner. • Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose. (Strong for | Reviewed, New- replaced) We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. (Strong against | Reviewed, New-replaced) Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation (see Recommendations 14 and 15).

Recommendations

What is the recommended dose of opioids?

If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. (Strong for | Reviewed, New-replaced) Note: There is no absolutely safe dose of opioids. As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Risks for opioid use disorder start at any dose and increase in a dose-dependent manner. • Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose. (Strong for | Reviewed, New- replaced) We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. (Strong against | Reviewed, New-replaced) Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation (see Recommendations 14 and 15).

Recommendations

Is there any absolutely safe dose of opioids?

If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. (Strong for | Reviewed, New-replaced) Note: There is no absolutely safe dose of opioids. As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Risks for opioid use disorder start at any dose and increase in a dose-dependent manner. • Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose. (Strong for | Reviewed, New- replaced) We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. (Strong against | Reviewed, New-replaced) Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation (see Recommendations 14 and 15).

Recommendations

What to do with the increment of opioid dosage and risk?

If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. (Strong for | Reviewed, New-replaced) Note: There is no absolutely safe dose of opioids. As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Risks for opioid use disorder start at any dose and increase in a dose-dependent manner. • Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose. (Strong for | Reviewed, New- replaced) We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. (Strong against | Reviewed, New-replaced) Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation (see Recommendations 14 and 15).

Recommendations

At what dose do risks for opioid use disorder begin?

If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. (Strong for | Reviewed, New-replaced) Note: There is no absolutely safe dose of opioids. As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Risks for opioid use disorder start at any dose and increase in a dose-dependent manner. • Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose. (Strong for | Reviewed, New- replaced) We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. (Strong against | Reviewed, New-replaced) Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation (see Recommendations 14 and 15).

Recommendations

At what dose do risks for opioid use disorder increase?

If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. (Strong for | Reviewed, New-replaced) Note: There is no absolutely safe dose of opioids. As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Risks for opioid use disorder start at any dose and increase in a dose-dependent manner. • Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose. (Strong for | Reviewed, New- replaced) We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. (Strong against | Reviewed, New-replaced) Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation (see Recommendations 14 and 15).

Recommendations

At what dose do the risks for overdose and death increase?

If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. (Strong for | Reviewed, New-replaced) Note: There is no absolutely safe dose of opioids. As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Risks for opioid use disorder start at any dose and increase in a dose-dependent manner. • Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose. (Strong for | Reviewed, New- replaced) We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. (Strong against | Reviewed, New-replaced) Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation (see Recommendations 14 and 15).

Recommendations

What opioid dose is not recommended for treating chronic pain?

If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. (Strong for | Reviewed, New-replaced) Note: There is no absolutely safe dose of opioids. As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Risks for opioid use disorder start at any dose and increase in a dose-dependent manner. • Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose. (Strong for | Reviewed, New- replaced) We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. (Strong against | Reviewed, New-replaced) Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation (see Recommendations 14 and 15).

Recommendations

What is recommended for patients who are currently prescribed doses over 90 mg morphine equivalent daily dose?

There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133]

Recommendations

Is there any evidence that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses?

There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133]

Recommendations

At what dosage there is a significant risk?

There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133]

Recommendations

At what dosage does the risk increase even further?

There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133]

Recommendations

How much does the risk increase at a daily dosage range of 20 to <50 mg MEDD?

There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133]

Recommendations

How much does the risk increase at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD?

In a nested case-control study of U.S. Veterans (not included in our evidence review as it was published after the end of the search date range), Bohnert et al. (2016) examined the association between prescribed opioid dose as a continuous measure (in 10 mg MEDD increments) and overdose.[134] Prescribed opioid dosage was a moderately good predictor of overdose death, but the study did not reveal a specific dosage cut point or threshold above which risk of overdose increased dramatically. Lower prescribed opioid dosages were associated with reduced risk for overdose, but risk was not completely eliminated at lower doses; approximately 40% of overdoses were observed in patients who were prescribed <50 mg MEDD.

Recommendations

What is a good predictor of overdose death?

In a prospective cohort study (not included in the evidence review as it did not include information on acute versus chronic pain in the patient population), Dasgupta et al. (2015) compared residents of North Carolina who had received an opioid prescription in the last year to residents who had not. The study examined the outcome of population-based rates of opioid overdose mortality by opioid dose, without use of a presupposed threshold (Table 3).[135] There was no safe dose of opioid. Among the over nine million individuals followed for one year, 629 died from opioid overdose. Of these 629 individuals, 151 had no record of having been dispensed an opioid. It is possible these opioids were obtained through illicit channels or social sharing/diversion. Of the 478 patients who died from an opioid overdose who were prescribed opioids, 235 (49%) had been prescribed <80 mg MEDD. Overdose incidence rate ratios (IRRs) doubled each time the MEDD ranges increase from 60.0-79.9 mg to 80.0-99.9 mg (IRR 2.9 to 6.2), then to 120-139.9 mg (IRR 14.1), 160-179.9 mg (IRR 29.5), and 350-399.9 mg (IRR 63.2).

Recommendations

Is there any study on the outcome of population-based rates of opioid overdose mortality by opioid dose, without the use of a presupposed threshold?

Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist.

Recommendations

Which step should be taken to address the problem of opioid-related overdose epidemic?

Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist.

Recommendations

What is the relationship between opioid dosage and risks of opioid overdose?

Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist.

Recommendations

Which factors increase the risk of opioid overdose?

Recognizing the lack of evidence of long-term benefit associated with LOT used alone and the risks of harms with use of opioids without risk mitigation, dosing determinations should be individualized based upon patient characteristics and preferences, with the goal of using the lowest dose of opioids for the shortest period of time to achieve well-defined functional treatment goals. Understandably, there will be greater mortality, co-occurring medical conditions, and other adverse events in patients who require higher doses of opioids, even in those who benefit from such therapy. When closer follow-up is needed, healthcare resources and patient adherence should be considered.

Recommendations

What should be individualized based upon patient characteristics and preferences?

Recognizing the lack of evidence of long-term benefit associated with LOT used alone and the risks of harms with use of opioids without risk mitigation, dosing determinations should be individualized based upon patient characteristics and preferences, with the goal of using the lowest dose of opioids for the shortest period of time to achieve well-defined functional treatment goals. Understandably, there will be greater mortality, co-occurring medical conditions, and other adverse events in patients who require higher doses of opioids, even in those who benefit from such therapy. When closer follow-up is needed, healthcare resources and patient adherence should be considered.

Recommendations

Who will have greater mortality, co-occurring medical conditions, and other adverse events?

Recognizing the lack of evidence of long-term benefit associated with LOT used alone and the risks of harms with use of opioids without risk mitigation, dosing determinations should be individualized based upon patient characteristics and preferences, with the goal of using the lowest dose of opioids for the shortest period of time to achieve well-defined functional treatment goals. Understandably, there will be greater mortality, co-occurring medical conditions, and other adverse events in patients who require higher doses of opioids, even in those who benefit from such therapy. When closer follow-up is needed, healthcare resources and patient adherence should be considered.

Recommendations

Who will have greater mortality?

Recognizing the lack of evidence of long-term benefit associated with LOT used alone and the risks of harms with use of opioids without risk mitigation, dosing determinations should be individualized based upon patient characteristics and preferences, with the goal of using the lowest dose of opioids for the shortest period of time to achieve well-defined functional treatment goals. Understandably, there will be greater mortality, co-occurring medical conditions, and other adverse events in patients who require higher doses of opioids, even in those who benefit from such therapy. When closer follow-up is needed, healthcare resources and patient adherence should be considered.

Recommendations

Who will have co-occurring medical conditions?

Recognizing the lack of evidence of long-term benefit associated with LOT used alone and the risks of harms with use of opioids without risk mitigation, dosing determinations should be individualized based upon patient characteristics and preferences, with the goal of using the lowest dose of opioids for the shortest period of time to achieve well-defined functional treatment goals. Understandably, there will be greater mortality, co-occurring medical conditions, and other adverse events in patients who require higher doses of opioids, even in those who benefit from such therapy. When closer follow-up is needed, healthcare resources and patient adherence should be considered.

Recommendations

Who will have other adverse events?

Recognizing the lack of evidence of long-term benefit associated with LOT used alone and the risks of harms with use of opioids without risk mitigation, dosing determinations should be individualized based upon patient characteristics and preferences, with the goal of using the lowest dose of opioids for the shortest period of time to achieve well-defined functional treatment goals. Understandably, there will be greater mortality, co-occurring medical conditions, and other adverse events in patients who require higher doses of opioids, even in those who benefit from such therapy. When closer follow-up is needed, healthcare resources and patient adherence should be considered.

Recommendations

What should be considered when a closer follow-up is needed?

Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]

Recommendations

Who is at a high risk of prescription opioid overdose?

Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]

Recommendations

Following an elevated baseline adjusted risk ratio (ARR) of 3.96, what were the odds of overdose in depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD?

Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]

Recommendations

What does increase the risk for serious prescription opioid-related toxicity or overdose across opioid dosages in patients?

Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]

Recommendations

What does increase the risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges?

There is moderate quality evidence to support that opioids taken PRN (as needed) for chronic cancer pain versus regularly scheduled doses, or simultaneous PRN plus regularly scheduled, places patients at elevated risk for opioid overdose (HR: 2.75, 95% CI: 1.31-5.78 for as needed; HR: 1.00 for regularly scheduled; HR: 1.84, 95% CI: 0.83-4.05 for simultaneous PRN plus regularly scheduled).[59]

Recommendations

What does place patients at elevated risk for opioid overdose?

In patients receiving LOT, moderate quality evidence indicated that men are 50% more likely (HR: 1.44, 95% CI: 1.21-1.70) to escalate to high-dose opioids (defined as >200 mg MEDD) and twice as likely to experience an opioid-related death (adjusted HR: 2.04, 95% CI: 1.18-3.53) compared to women.[136] Risk of opioid overdose morbidity or mortality is also increased in non-Hispanic white versus non-Hispanic black patients (moderate quality evidence).[59,136]

Recommendations

In patients receiving LOT, who are 50% more likely to escalate to high-dose opioids and twice as likely to experience an opioid-related death?

Future Research: Future research is needed to better determine the impact of systematic reductions in MEDD in terms of pain relief, specific pain and medical conditions, overdose morbidity and mortality as well as potential adverse outcomes (e.g., the incidence of associated OUD, infectious diseases related to intravenous drug use disorder, and drug-related crime and diversion) and to determine whether/which conditions may be appropriately treated with LOT. Research is also needed to determine how frequency of monitoring should be impacted by dose.

Recommendations

What needs to be better determined by researchers?

Long-acting opioids, as further discussed below, should not be used for treatment of acute pain, on an as needed basis, or during initiation of LOT (see Short-acting versus Long-acting Opioids). In general, however, no single opioid or opioid formulation is preferred over the others. However, individuals may have a better response, degree of safety, or tolerability depending on their individual characteristics and preferences. Additional information for use when deciding on appropriate pharmacological treatment of pain for a specific patient can be found in Appendix D.

Recommendations

What should not be used for treatment of acute pain?

Long-acting opioids, as further discussed below, should not be used for treatment of acute pain, on an as needed basis, or during initiation of LOT (see Short-acting versus Long-acting Opioids). In general, however, no single opioid or opioid formulation is preferred over the others. However, individuals may have a better response, degree of safety, or tolerability depending on their individual characteristics and preferences. Additional information for use when deciding on appropriate pharmacological treatment of pain for a specific patient can be found in Appendix D.

Recommendations

Which opioid/opioid formulation is preferred over the others?

There was insufficient evidence to recommend for or against any specific opioid or opioid formulation, specifically the following: Short-acting versus long-acting opioids (for LOT for chronic pain), Route of administration/delivery among alternatives such as transdermal, buccal, sublingual, or pumps, Abuse deterrent formulations of opioids compared to non-abuse deterrent formulations, Tramadol and other dual-mechanism opioids. Buprenorphine for pain (compared to other opioids), Methadone (with QT monitoring).

Recommendations

Which opioid/opioid formulation did not have enough evidence to be recommended for or against?

Short-acting versus Long-acting Opioids: Avoid use of long-acting agents for acute pain (with exception of oxycodone/acetaminophen extended release [ER] tablets), on an as-needed basis, or for initiation of OT.[10,137-139] There is very low quality evidence to recommend for or against short-acting versus long-acting opioids for maintenance of OT. There were two RCTs included in the evidence review that looked at safety and efficacy. One RCT comparing long-acting to short-acting dihydrocodeine found no statistically or clinically significant differences in stability of pain intensity between the two groups, as well as no difference in adverse events. Although study results may be inconclusive due to poor study design, the authors state that they do not support the use of long-acting agents for chronic non-malignant pain.[140]

Recommendations

Which long-acting agents can be used for acute pain?

A second non-inferiority RCT compared once-daily hydromorphone ER to twice-daily oxycodone controlled-release in patients with moderate-to-severe cancer pain. The primary efficacy endpoint was patient assessment of “Brief Pain Inventory (BPI) worst pain in the past 24 hr.” Results demonstrated similar improvements in BPI and that the once-daily hydromorphone formulation was non-inferior to the twice-daily oxycodone formulation. Treatment-emergent adverse events were comparable between the groups as well.[141] The efficacy of long-acting opioids used once-daily is non-inferior to twice-daily use. There was a lack of statistical analysis of the outcomes and a lack of statistical power in both studies, and a small sample size in one study.

Recommendations

What was the efficacy of long-acting opioids used once-daily compared to twice-daily use?

There is concern for additional overdose risk associated with long-acting versus short-acting opioids. A study (not included in the evidence review due to its design) suggests increased risk for non-fatal overdose in VA patients with initiation of a long-acting opioid compared with immediate-release opioids.[137] Also, recent research demonstrates that patients with CNCP on long-acting OT have a significantly increased risk of all-cause mortality compared to patients with CNCP who are taking an analgesic anticonvulsants or a low-dose antidepressant.[10]

Recommendations

Who has a significantly increased risk of all-cause mortality compared to patients with CNCP who are taking an analgesic anticonvulsants or a low-dose antidepressant?

Route of Administration/Delivery: The systematic evidence review for this CPG did not find any studies that compared alternative delivery systems (e.g., fentanyl transdermal, fentanyl buccal) to other delivery systems (e.g., oral, intravenous) (information on transdermal and sublingual buprenorphine is included in the following section on Buprenorphine for Pain). The concomitant use of oral and transdermal opioids or oral and intrathecal pumps should be approached with extreme caution and warrants specialty consultation. Discussions of intrathecal pumps are beyond the scope of this guideline.

Recommendations

What should be approached with extreme caution and warrants specialty consultation?

Although some patients may prefer either transdermal or buccal opioid delivery for opioids, there is significant potential for harm from OT with these delivery mechanisms, with no evidence of benefit over traditional opioid delivery systems in patients with chronic pain. Clinicians need to be especially aware of the risks associated with a fentanyl transdermal delivery system (or patch) (Appendix D) including its: Unique pharmacokinetic profile, Continuous delivery, even after the patch is removed due to depot effect, Increased rate of delivery, Unpredictable variation in rate of delivery - Due to alterations in temperature due to external heat, skin integrity, and amount of adipose tissue, Among patients with fever, skin damage, or cachexia.

Recommendations

Which opioid delivery for opioids has significant potential for harm from OT?

Although some patients may prefer either transdermal or buccal opioid delivery for opioids, there is significant potential for harm from OT with these delivery mechanisms, with no evidence of benefit over traditional opioid delivery systems in patients with chronic pain. Clinicians need to be especially aware of the risks associated with a fentanyl transdermal delivery system (or patch) (Appendix D) including its: Unique pharmacokinetic profile, Continuous delivery, even after the patch is removed due to depot effect, Increased rate of delivery, Unpredictable variation in rate of delivery - Due to alterations in temperature due to external heat, skin integrity, and amount of adipose tissue, Among patients with fever, skin damage, or cachexia.

Recommendations

Which delivery mechanism has no evidence of benefit ove traditional opioid delivery systems in patients with chronic pain?

Although some patients may prefer either transdermal or buccal opioid delivery for opioids, there is significant potential for harm from OT with these delivery mechanisms, with no evidence of benefit over traditional opioid delivery systems in patients with chronic pain. Clinicians need to be especially aware of the risks associated with a fentanyl transdermal delivery system (or patch) (Appendix D) including its: Unique pharmacokinetic profile, Continuous delivery, even after the patch is removed due to depot effect, Increased rate of delivery, Unpredictable variation in rate of delivery - Due to alterations in temperature due to external heat, skin integrity, and amount of adipose tissue, Among patients with fever, skin damage, or cachexia.

Recommendations

What are the risks associated with a fentanyl transdermal delivery system (or patch)?

Given the potential serious risks with starting fentanyl and challenges with tapering, clinicians intent on prescribing transdermal fentanyl for chronic pain are encouraged to consult with other clinicians (e.g., pain specialists, pharmacists) and to be familiar with the unique properties of fentanyl. Specific safety precautions that all clinicians should be aware of regarding transdermal fentanyl include: Transdermal fentanyl should not be used in opioid-naïve patients; Patients need to be informed that: Heat (e.g., sun exposure, heating pad, febrile condition) can increase the rate and quantity of absorption, Proper application includes: being sure to take old patch off; never applying damaged patch or a patch to non-intact skin; proper disposal to avoid exposure to children and pets, and precautions taken against possible diversion of remaining drug in used patch; Adjusted dose (i.e., decreased patch size) should be used in patients with renal or hepatic insufficiency and considered in elderly patients and those with febrile illness

Recommendations

Which specific safety precautions should all clinicians be aware of regarding transdermal fentanyl?

Abuse Deterrent Formulations of Opioids: The aim of most abuse deterrent formulations is to present a physical barrier to prevent chewing, crushing, cutting, grating, or grinding of the dosage form, or present a chemical barrier, such as a gelling agent, that will resist extraction of the opioid with use of a common solvent. Alternatively, an opioid antagonist (naloxone or naltrexone) can be added to interfere with, reduce, or defeat the euphoria associated with abuse of an agent intended for oral use when taken nasally or parenterally.[142] While these properties deter abuse they do not fully prevent abuse; no opioid formulation prevents consumption of a large number of intact capsules or tablets which continues to be the most common method of abuse.

Recommendations

What is the aim of most abuse deterrent formulations?

Abuse Deterrent Formulations of Opioids: The aim of most abuse deterrent formulations is to present a physical barrier to prevent chewing, crushing, cutting, grating, or grinding of the dosage form, or present a chemical barrier, such as a gelling agent, that will resist extraction of the opioid with use of a common solvent. Alternatively, an opioid antagonist (naloxone or naltrexone) can be added to interfere with, reduce, or defeat the euphoria associated with abuse of an agent intended for oral use when taken nasally or parenterally.[142] While these properties deter abuse they do not fully prevent abuse; no opioid formulation prevents consumption of a large number of intact capsules or tablets which continues to be the most common method of abuse.

Recommendations

What can be added to interfere with, reduce, or defeat the euphoria associated with abuse of an agent intended for oral use when taken nasally or parenterally?

Abuse Deterrent Formulations of Opioids: The aim of most abuse deterrent formulations is to present a physical barrier to prevent chewing, crushing, cutting, grating, or grinding of the dosage form, or present a chemical barrier, such as a gelling agent, that will resist extraction of the opioid with use of a common solvent. Alternatively, an opioid antagonist (naloxone or naltrexone) can be added to interfere with, reduce, or defeat the euphoria associated with abuse of an agent intended for oral use when taken nasally or parenterally.[142] While these properties deter abuse they do not fully prevent abuse; no opioid formulation prevents consumption of a large number of intact capsules or tablets which continues to be the most common method of abuse.

Recommendations

What is the most common method of abuse?

We do not recommend for or against abuse deterrent formulations for LOT. Our searches identified two RCTs in which the benefits of co-prescribing of naloxone with opioids were examined.[143,144] However, both RCTs were rated as low to very low quality with short-term follow-up. One open-label RCT enrolling 453 patients with chronic low back pain considered the safety and tolerability of an abuse deterrent formulation of oxycodone/naloxone relative to oxycodone or morphine at 12-week follow-up.[143] Another RCT considered the safety and efficacy of oxycodone/naloxone prolonged-release relative to oxycodone prolonged-release in 184 patients with moderate-to-severe chronic cancer pain at four-week follow-up.[144] An observational study (not included in the evidence review) suggested that the Introductory information of abuse deterrent opioid formulations did not help reduce abuse of opioids as a class and that patients may switch from one opioid to another based on the availability or the lack of availability of abuse deterrent formulations.[145]

Recommendations

What is the stance regarding the abuse deterrent formulations for LOT?

Future research is needed to ascertain whether abuse deterrent formulations actually reduce OUD when used for chronic pain, and whether said formulations differ across clinical outcomes such as pain, function, and adverse events.

Recommendations

What is needed to ascertain whether abuse deterrent formulations actually reduce OUD when used for chronic pain?

Future research is needed to ascertain whether abuse deterrent formulations actually reduce OUD when used for chronic pain, and whether said formulations differ across clinical outcomes such as pain, function, and adverse events.

Recommendations

What is needed to ascertain whether said formulations differ across clinical outcomes such as pain, function, and adverse events?

Dual-Mechanism Opioids: Dual-mechanism opioids include formulations of an opioid medication with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI). Two common examples are tramadol and tapentadol. While both are dual-mechanism opioids, they differ in their affinity for the mu opioid receptor, resulting in partial versus full agonist effects, and as such are discussed separately.

Recommendations

What is included in the dual-mechanism opioids?

Dual-Mechanism Opioids: Dual-mechanism opioids include formulations of an opioid medication with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI). Two common examples are tramadol and tapentadol. While both are dual-mechanism opioids, they differ in their affinity for the mu opioid receptor, resulting in partial versus full agonist effects, and as such are discussed separately.

Recommendations

What are the examples of dual-mechanism opioids?

Dual-Mechanism Opioids: Dual-mechanism opioids include formulations of an opioid medication with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI). Two common examples are tramadol and tapentadol. While both are dual-mechanism opioids, they differ in their affinity for the mu opioid receptor, resulting in partial versus full agonist effects, and as such are discussed separately.

Recommendations

What are the differences between tramadol and tapentadol?

Tramadol: There is low quality evidence that tramadol may be more effective than placebo for pain relief. In one short-term study, compared to placebo, tramadol was more effective for pain.[146] There is no long-term evidence of the comparative efficacy of tramadol versus another opioid or a non-opioid comparison such as non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen. Due to tramadol’s partial mu agonist activity and demonstrated safety profile when used in conjunction with acetaminophen in elderly patients, it may be a preferred agent in that patient group.[147,148]

Recommendations

Is there any evidence of the comparative efficacy of tramadol versus another opioid or a non-opioid comparison such as non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen?

We recommend alternatives to opioids for mild-to-moderate acute pain. (Strong for). We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. (Weak for). If take-home opioids are prescribed, we recommend that immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated. (Strong for). Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.

Recommendations

What is recommended for mild-to-moderate acute pain?

We recommend alternatives to opioids for mild-to-moderate acute pain. (Strong for). We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. (Weak for). If take-home opioids are prescribed, we recommend that immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated. (Strong for). Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.

Recommendations

What is sugested when opioids are used for acute pain?

We recommend alternatives to opioids for mild-to-moderate acute pain. (Strong for). We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. (Weak for). If take-home opioids are prescribed, we recommend that immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated. (Strong for). Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.

Recommendations

What is recommended if take-home opioids are prescribed?

We recommend alternatives to opioids for mild-to-moderate acute pain. (Strong for). We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. (Weak for). If take-home opioids are prescribed, we recommend that immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated. (Strong for). Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.

Recommendations

What should be offered to patients?

As this guideline is related to LOT, the use of opioids for acute pain is not reviewed in detail. However, because acute OT can be a gateway to LOT, it is part of this CPG. A review of the literature indicates that LOT can result from acute opioid use initially intended for short-term therapy. Further, there is a risk of opioid-related overdose even during acute OT. While it is understood that acute OT for severe pain due to injuries or surgery is the most effective option for many patients, the risks associated with acute therapy must be addressed when opioids are prescribed or considered.

Recommendations

What can can be a gateway to LOT?

The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187]

Recommendations

Who are at an increased risks of acute OT extending into LOT?

The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187]

Recommendations

What does increase the risk of acute post-operative OT progressing into LOT?

In addition, the risk of overdose includes the use of opioids for acute pain. Factors that increase overdose risk when opioids are used for acute pain include high prescribed dose, history of SUD, and history of mental health concerns. While the risk of overdose increases at doses above 20 mg MEDD or greater, this risk increases even further as doses increase to over 50 or 100 mg MEDD.[58,59,188]

Recommendations

What does risk of overdose include?

In addition, the risk of overdose includes the use of opioids for acute pain. Factors that increase overdose risk when opioids are used for acute pain include high prescribed dose, history of SUD, and history of mental health concerns. While the risk of overdose increases at doses above 20 mg MEDD or greater, this risk increases even further as doses increase to over 50 or 100 mg MEDD.[58,59,188]

Recommendations

Which factors increase overdose risk when opioids are used for acute pain?

There are situations in which opioids may be necessary therapy for acute pain, even when substantial risk factors exist. It is important to incorporate opioid risk mitigation strategies into opioid prescribing for acute pain. These strategies should include patient education, use of non-opioid adjunctive therapy, and structured reassessment of opioid risks and benefits for all on acute OT. Also, consider checking the PDMP and performing a UDT.

Recommendations

Which opioid risk mitigation strategies should be incorporateed into opioid prescribing for acute pain?

For those at higher risk of adverse events related to opioid therapy, the following strategies may help to decrease opioid-related overdose events and unintended long-term use: checking the PDMP, performing a UDT, placement in an inpatient setting or monitored environment, and/or providing OEND.

Recommendations

Which strategies may be helpful for those at higher risk of adverse events related to opioid therapy?

Monitoring standards with administration of OT for acute pain vary depending on a number of factors including the setting, specifics of the painful insult, patient medical factors, and selected medication potency/dose/route of administration/adjunct selection.

Recommendations

Depending on which factors monitoring standards with administration of OT for acute pain vary?

This OT CPG is in line with the efforts described above to improve our understanding and treatment of pain, as well as to mitigate the inappropriate prescribing and ill effects of opioids. It is intended for VA and DoD healthcare practitioners including physicians, nurse practitioners, physician assistants, physical and occupational therapists, psychologists, social workers, nurses, clinical pharmacists, chaplains, addiction counselors, and others involved in the care of Service Members and their beneficiaries, retirees and their beneficiaries, or Veterans on or being considered for LOT. In conjunction with other efforts already under way, this CPG is aimed at improving safe and appropriate prescribing and use of opioids to treat chronic pain.

Features and overview

For whom is this guideline intended?

As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient.

Features and overview

What are the limitation of this CPG?

As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient.

Features and overview

How are the standards of care determined?

As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient.

Features and overview

What is not the intention of this guideline?

As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient.

Features and overview

This CPG is based on what?

As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient.

Features and overview

How to use a CPG?

This OT CPG is designed to assist healthcare providers in managing or co-managing patients on or being considered for LOT. Specifically, this CPG is intended for adults, including Veterans as well as deployed and non-deployed Active Duty Service Members, their beneficiaries, and retirees and their beneficiaries, with chronic pain who are receiving care from the VA or DoD healthcare delivery systems. This CPG is not intended for and does not provide recommendations for the management of pain with LOT in children or adolescents, in patients with acute pain, or in patients receiving end-of-life care. As is so for any pharmacotherapy, any decision about prescribing opioids, or alternative medications for pain, for pregnant women should be made with due caution and cognizance of applicable U.S. Food and Drug Administration (FDA) labeling. Any patient in the VA or DoD healthcare system should be offered access to the interventions that are recommended in this guideline after taking into consideration the patient’s specific circumstances.

Features and overview

What is this OT CPG designed to do?

This OT CPG is designed to assist healthcare providers in managing or co-managing patients on or being considered for LOT. Specifically, this CPG is intended for adults, including Veterans as well as deployed and non-deployed Active Duty Service Members, their beneficiaries, and retirees and their beneficiaries, with chronic pain who are receiving care from the VA or DoD healthcare delivery systems. This CPG is not intended for and does not provide recommendations for the management of pain with LOT in children or adolescents, in patients with acute pain, or in patients receiving end-of-life care. As is so for any pharmacotherapy, any decision about prescribing opioids, or alternative medications for pain, for pregnant women should be made with due caution and cognizance of applicable U.S. Food and Drug Administration (FDA) labeling. Any patient in the VA or DoD healthcare system should be offered access to the interventions that are recommended in this guideline after taking into consideration the patient’s specific circumstances.

Features and overview

For whom is his CPG is intended?

This OT CPG is designed to assist healthcare providers in managing or co-managing patients on or being considered for LOT. Specifically, this CPG is intended for adults, including Veterans as well as deployed and non-deployed Active Duty Service Members, their beneficiaries, and retirees and their beneficiaries, with chronic pain who are receiving care from the VA or DoD healthcare delivery systems. This CPG is not intended for and does not provide recommendations for the management of pain with LOT in children or adolescents, in patients with acute pain, or in patients receiving end-of-life care. As is so for any pharmacotherapy, any decision about prescribing opioids, or alternative medications for pain, for pregnant women should be made with due caution and cognizance of applicable U.S. Food and Drug Administration (FDA) labeling. Any patient in the VA or DoD healthcare system should be offered access to the interventions that are recommended in this guideline after taking into consideration the patient’s specific circumstances.

Features and overview

What does this CPG not do?

While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making.

Features and overview

What kind of approach is highly recommended for communication with a patient?

While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. The information that patients are given about treatment and care should be culturally appropriate and also available to people with limited literacy skills. It should also be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family involvement should be considered if appropriate.

Features and overview

Why is an empathetic and non-judgmental approach highly recommended for communication with a patient?

The systematic review conducted for the update of this CPG encompassed interventional studies (primarily randomized controlled trials [RCTs]) published between March 2009 and December 2016 and targeted nine key questions (KQs) focusing on the means by which the delivery of healthcare could be optimized for patients on or being considered for LOT. Because a comprehensive review of the evidence related to LOT was not feasible, the nine selected KQs were prioritized from many possible KQs. Therefore, many of the 2010 OT CPG recommendations were considered for inclusion in the updated version of the guideline without an updated review of the evidence. The section on Recommendations delineates whether or not the current CPG recommendations were based on an updated evidence review. Appendix H delineates whether the 2010 OT CPG recommendations were considered for inclusion in the update based on an updated evidence review or based on the evidence included in the 2010 OT CPG. The section on Recommendation Categorization further describes the methodology used for the categorization.

Features and overview

Why only nine key questions (KQs) were prioritized from many possible KQs?

The 2017 version of the VA/DoD OT CPG is the second update to the original CPG. It provides practice recommendations for the care of populations with chronic pain already on or being considered for LOT. Although there are many other approaches to the treatment of chronic pain, the scope of this CPG is to focus on the use of opioids for chronic pain rather than being comprehensive about all treatment options. A particular strength of this CPG is the multidisciplinary stakeholder involvement from its inception, ensuring representation from the broad spectrum of clinicians engaged in the treatment and management of patients with chronic pain on or being considered for LOT.

Features and overview

What does the 2017 version of the VA/DoD OT CPG provide?

The 2017 version of the VA/DoD OT CPG is the second update to the original CPG. It provides practice recommendations for the care of populations with chronic pain already on or being considered for LOT. Although there are many other approaches to the treatment of chronic pain, the scope of this CPG is to focus on the use of opioids for chronic pain rather than being comprehensive about all treatment options. A particular strength of this CPG is the multidisciplinary stakeholder involvement from its inception, ensuring representation from the broad spectrum of clinicians engaged in the treatment and management of patients with chronic pain on or being considered for LOT.

Features and overview

What is the scope of this CPG?

The 2017 version of the VA/DoD OT CPG is the second update to the original CPG. It provides practice recommendations for the care of populations with chronic pain already on or being considered for LOT. Although there are many other approaches to the treatment of chronic pain, the scope of this CPG is to focus on the use of opioids for chronic pain rather than being comprehensive about all treatment options. A particular strength of this CPG is the multidisciplinary stakeholder involvement from its inception, ensuring representation from the broad spectrum of clinicians engaged in the treatment and management of patients with chronic pain on or being considered for LOT.

Features and overview

What is the strength of this CPG?

The framework for recommendations in this CPG considered factors beyond the strength of the evidence, including balancing desired outcomes with potential harms of treatment, equity of resource availability, the potential for variation in patient values and preferences, and other considerations (see Methods for more information). Applicability of the evidence to VA/DoD populations was also taken into consideration. A structured algorithm (see Algorithm) accompanies the guideline to provide an overview of the recommendations in the context of the flow of patient care and clinician decision making and to assist with training providers. The algorithm may be used to help facilitate translation of guideline recommendations into effective practice.

Features and overview

Which factors were considered for the framework for recommendations in this CPG?

The current document is an update to the 2010 VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. The methodology used in developing the 2017 CPG follows the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The VA/DoD Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (“Champions”) and other subject matter experts from within the VA and DoD, known as the “Work Group,” and ultimately, the development and submission of an updated OT CPG. The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified two clinical leaders, Jack Rosenberg, MD, FASAM from the VA and Christopher Spevak, MD, MPH, JD from the DoD, as Champions for the 2017 CPG.

Features and overview

What methodology was used in developing the 2017 CPG?

The current document is an update to the 2010 VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. The methodology used in developing the 2017 CPG follows the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The VA/DoD Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (“Champions”) and other subject matter experts from within the VA and DoD, known as the “Work Group,” and ultimately, the development and submission of an updated OT CPG. The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified two clinical leaders, Jack Rosenberg, MD, FASAM from the VA and Christopher Spevak, MD, MPH, JD from the DoD, as Champions for the 2017 CPG.

Features and overview

What does the VA/DoD Guideline for Guidelines provide?

VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, patient-centered care may decrease patient anxiety, increase trust in clinicians,[77] and improve treatment adherence.[78] Improved patient-clinician communication through patient-centered care can be used to convey openness to discuss any future concerns.

Features and overview

What does VA/DoD CPGs encourage clinicians to do?

VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, patient-centered care may decrease patient anxiety, increase trust in clinicians,[77] and improve treatment adherence.[78] Improved patient-clinician communication through patient-centered care can be used to convey openness to discuss any future concerns.

Features and overview

What should all patients in the healthcare system be offered?

VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, patient-centered care may decrease patient anxiety, increase trust in clinicians,[77] and improve treatment adherence.[78] Improved patient-clinician communication through patient-centered care can be used to convey openness to discuss any future concerns.

Features and overview

What is the purpose of patient-centered care?

VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, patient-centered care may decrease patient anxiety, increase trust in clinicians,[77] and improve treatment adherence.[78] Improved patient-clinician communication through patient-centered care can be used to convey openness to discuss any future concerns.

Features and overview

What can be used to convey openness to discuss any future concerns?

As part of the patient-centered care approach, clinicians should review the patient’s history including previous treatment approaches, their results, and any other outcomes with the patient. They should ask the patient about his or her willingness to accept a referral to an addiction or other behavioral health specialist when appropriate. Lastly, they should involve the patient in prioritizing problems to be addressed and in setting specific goals regardless of the selected setting or level of care. The below approach may be used in setting SMART (Specific, Measurable, Action Oriented, Realistic, Timed) goals for the patient (Table 1).

Features and overview

What should the clinicians do as part of the patient-centered care approach?

As part of the patient-centered care approach, clinicians should review the patient’s history including previous treatment approaches, their results, and any other outcomes with the patient. They should ask the patient about his or her willingness to accept a referral to an addiction or other behavioral health specialist when appropriate. Lastly, they should involve the patient in prioritizing problems to be addressed and in setting specific goals regardless of the selected setting or level of care. The below approach may be used in setting SMART (Specific, Measurable, Action Oriented, Realistic, Timed) goals for the patient (Table 1).

Features and overview

What should the clinicians ask the patient?

The shared decision making process for chronic pain treatment planning is based on the foundation of a patient-centered assessment of risks and benefits and a clinical synthesis performed by the provider (Figure 1). The patient-centered assessment incorporates a patient-centered interview, and exploration of patient values, goals, questions, concerns, and expectations. Next, the clinician performs a biopsychosocial assessment and determines clinically appropriate therapeutic options in which benefits are likely to outweigh risks. The process culminates in a shared decision making process to develop a patient-centered treatment plan by the patient selecting from the clinically appropriate treatment options generated in the first two steps.

Features and overview

What is the basis of the shared decision making process for chronic pain treatment planning?

The shared decision making process for chronic pain treatment planning is based on the foundation of a patient-centered assessment of risks and benefits and a clinical synthesis performed by the provider (Figure 1). The patient-centered assessment incorporates a patient-centered interview, and exploration of patient values, goals, questions, concerns, and expectations. Next, the clinician performs a biopsychosocial assessment and determines clinically appropriate therapeutic options in which benefits are likely to outweigh risks. The process culminates in a shared decision making process to develop a patient-centered treatment plan by the patient selecting from the clinically appropriate treatment options generated in the first two steps.

Features and overview

What does the patient-centered assessment incorporate?

There are electronic tools to facilitate clinical risk assessment and adherence to risk mitigation. Two tools currently used in the VA are the Opioid Therapy Risk Report (OTRR) and the Stratification Tool for Opioid Risk Mitigation (STORM). The OTRR allows VA providers to review clinical data related to opioid pain treatment within the electronic medical record (EMR), providing an efficient way of monitoring the data. The STORM tool incorporates co-occurring medical and mental health conditions, SUD, opioid dose, co-prescribed sedatives, and information about prior adverse events and generates estimates of patients’ risk or hypothetical risk when considering initiation of opioid therapy. It quantifies risk for poisoning or suicide-related events and for drug-related events, accidents, falls, and drug-induced conditions over a three-year window. Further, it provides suggestions as to what alternative treatments have not been tried and what risk mitigation strategies need to be applied. Evidence supporting their use is poor but they facilitate providers’ determination of current, past and potential therapies and strategies.

Features and overview

What can facilitate clinical risk assessment and adherence to risk mitigation?

There are electronic tools to facilitate clinical risk assessment and adherence to risk mitigation. Two tools currently used in the VA are the Opioid Therapy Risk Report (OTRR) and the Stratification Tool for Opioid Risk Mitigation (STORM). The OTRR allows VA providers to review clinical data related to opioid pain treatment within the electronic medical record (EMR), providing an efficient way of monitoring the data. The STORM tool incorporates co-occurring medical and mental health conditions, SUD, opioid dose, co-prescribed sedatives, and information about prior adverse events and generates estimates of patients’ risk or hypothetical risk when considering initiation of opioid therapy. It quantifies risk for poisoning or suicide-related events and for drug-related events, accidents, falls, and drug-induced conditions over a three-year window. Further, it provides suggestions as to what alternative treatments have not been tried and what risk mitigation strategies need to be applied. Evidence supporting their use is poor but they facilitate providers’ determination of current, past and potential therapies and strategies.

Features and overview

Which electronic tools are currently used in the VA?

There are electronic tools to facilitate clinical risk assessment and adherence to risk mitigation. Two tools currently used in the VA are the Opioid Therapy Risk Report (OTRR) and the Stratification Tool for Opioid Risk Mitigation (STORM). The OTRR allows VA providers to review clinical data related to opioid pain treatment within the electronic medical record (EMR), providing an efficient way of monitoring the data. The STORM tool incorporates co-occurring medical and mental health conditions, SUD, opioid dose, co-prescribed sedatives, and information about prior adverse events and generates estimates of patients’ risk or hypothetical risk when considering initiation of opioid therapy. It quantifies risk for poisoning or suicide-related events and for drug-related events, accidents, falls, and drug-induced conditions over a three-year window. Further, it provides suggestions as to what alternative treatments have not been tried and what risk mitigation strategies need to be applied. Evidence supporting their use is poor but they facilitate providers’ determination of current, past and potential therapies and strategies.

Features and overview

What does the OTRR do?

There are electronic tools to facilitate clinical risk assessment and adherence to risk mitigation. Two tools currently used in the VA are the Opioid Therapy Risk Report (OTRR) and the Stratification Tool for Opioid Risk Mitigation (STORM). The OTRR allows VA providers to review clinical data related to opioid pain treatment within the electronic medical record (EMR), providing an efficient way of monitoring the data. The STORM tool incorporates co-occurring medical and mental health conditions, SUD, opioid dose, co-prescribed sedatives, and information about prior adverse events and generates estimates of patients’ risk or hypothetical risk when considering initiation of opioid therapy. It quantifies risk for poisoning or suicide-related events and for drug-related events, accidents, falls, and drug-induced conditions over a three-year window. Further, it provides suggestions as to what alternative treatments have not been tried and what risk mitigation strategies need to be applied. Evidence supporting their use is poor but they facilitate providers’ determination of current, past and potential therapies and strategies.

Features and overview

What does the STORM tool do?