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VA/DoD CLINICAL PRACTICE GUIDELINE FOR 

OPIOID THERAPY FOR CHRONIC PAIN

Department of Veterans Affairs

Department of Defense

Clinician Summary

QUALIFYING STATEMENTS

The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best 

information available at the time of publication. They are designed to provide information and assist 

decision making. They are not intended to define a standard of care and should not be construed as one. 

Neither should they be interpreted as prescribing an exclusive course of management. 

This Clinical Practice Guideline is based on a systematic review of both clinical and epidemiological 

evidence. Developed by a panel of multidisciplinary experts, it provides a clear explanation of the logical 

relationships between various care options and health outcomes while rating both the quality of the 

evidence and the strength of the recommendation. 

Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of 

individual patients, available resources, and limitations unique to an institution or type of practice. Every 

healthcare professional making use of these guidelines is responsible for evaluating the appropriateness of 

applying them in the setting of any particular clinical situation.

These guidelines are not intended to represent TRICARE policy. Further, inclusion of recommendations for 

specific testing and/or therapeutic interventions within these guidelines does not guarantee coverage of 

civilian sector care. Additional information on current TRICARE benefits may be found at www.tricare.mil 

or by contacting your regional TRICARE Managed Care Support Contractor.

Version 3.0 – 2017
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Table of Contents

I. Introduction..................................................................................................................................... 4

II. How to Use the Clinical Practice Guideline ....................................................................................... 4

III. Recommendations........................................................................................................................... 6

IV. Algorithm ........................................................................................................................................ 9

A. Module A: Determination of Appropriateness for Opioid Therapy.................................................10

B. Module B: Treatment with Opioid Therapy......................................................................................11

C. Module C: Tapering or Discontinuation of Opioid Therapy .............................................................12

D. Module D: Patients Currently on Opioid Therapy ............................................................................13

V. Scope of the CPG............................................................................................................................ 14

VI. Guideline Work Group ................................................................................................................... 15

VII. Patient-centered Care.................................................................................................................... 16

VIII. Shared Decision Making ................................................................................................................. 16

IX. Chronic Pain Treatment Options.................................................................................................... 17

A. Known Risks and Lack of Benefit of Opioid Therapy for Chronic Pain.............................................17

B. Preferred Chronic Pain Treatment Options......................................................................................17

C. Patient Populations at Additional Risk for Adverse Events with Long-term Opioid Therapy.........18

X. Initiation of Long-term Opioid Therapy .......................................................................................... 18

A. Duration of Opioid Therapy...............................................................................................................18

B. Dose of Opioid Therapy.....................................................................................................................18

C. Selection of Opioid Therapy..............................................................................................................19

XI. Risk Mitigation Strategies for Long-term Opioid Therapy ............................................................... 19

A. Written Informed Consent and Opioid Treatment Agreements .....................................................20

B. Urine Drug Testing.............................................................................................................................20

C. State Prescription Drug Monitoring Programs.................................................................................20

D. Monitoring for Overdose Potential and Suicidality..........................................................................21

E. Prescribing of Naloxone Rescue and Accompanying Education......................................................21

F. Follow-up ...........................................................................................................................................21

XII. Tapering ........................................................................................................................................ 21

XIII. Diagnosis and Treatment of Opioid Use Disorder........................................................................... 23

XIV. Clinical Pearls for Prescribing Opioids............................................................................................. 24
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XV. Additional Resources..................................................................................................................... 24

XVI.VA Signature Informed Consent.......................................................................................................25

References ............................................................................................................................................ 30
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I. Introduction

The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work 

Group (EBPWG) was established and first chartered in 2004, with a mission to advise the “...Health 

Executive Council on the use of clinical and epidemiological evidence to improve the health of the 

population across the Veterans Health Administration and Military Health System,” by facilitating the 

development of clinical practice guidelines (CPGs) for the VA and DoD populations.[1] The VA/DoD CPG is 

intended to provide healthcare providers with a framework by which to evaluate, treat, and manage the 

individual needs and preferences of patients with chronic pain who are on or being considered for longterm opioid therapy (LOT).

In 2010, the VA and DoD published the Clinical Practice Guideline for Management of Opioid Therapy for 

Chronic Pain (2010 OT CPG), which was based on evidence reviewed through March 2009. Since the 

release of that guideline, there has been growing recognition of an epidemic of opioid misuse and opioid 

use disorder (OUD) in America, including among America’s Veterans. At the same time, there is a mounting 

body of research expanding our knowledge and understanding of the troublesome effects of LOT. 

Consequently, a recommendation to update the 2010 OT CPG was initiated in 2015. The updated CPG, 

titled Clinical Practice Guideline for Opioid Therapy for Chronic Pain (OT CPG), includes objective, evidencebased information on the management of chronic pain. It is intended to assist healthcare providers in all 

aspects of patient care, including, but not limited to, diagnosis, treatment, and follow-up. The system-wide 

goal of the guideline is to improve the patient’s health and well-being by providing evidence-based 

guidance to providers who are taking care of patients on or being considered for LOT. The expected 

outcome of successful implementation of the guideline is to:

• Assess the patient’s condition and determine, in collaboration with the patient and his or her

care team, the best treatment methods

• Optimize the patient’s health outcomes and function and improve quality of life

• Minimize preventable complications and morbidity

• Emphasize the use of patient-centered care

II. How to Use the Clinical Practice Guideline

The VA/DoD OT CPG can be used in a variety of ways. It can be used by general clinicians or specialists to 

study and consider the latest information on OT and how and whether to incorporate that information or 

recommendations into their practice. It can be used to provide specific information to guide a patient 

encounter, such as looking up the dosing of a medication used less frequently or the meaning of the urine 

drug test (UDT) result. The section on tapering and its accompanying appendix (in the full text OT CPG) can 

be used to assist in the development of a framework for guiding an individualized, informed discussion 

when tapering is being considered. Patients can examine the guideline to educate themselves and better 

understand their care. A healthcare system can use the CPG to assure that its clinicians and patients have 

the resources available to compassionately, effectively, and safely evaluate and deliver LOT in a timely, 

culturally sensitive manner. The guideline can also be used to suggest specific education for identified 

gaps. 
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The guideline is not intended as a standard of care and should not be used as such. Standards of care are 

determined on the basis of all clinical data available for an individual case and are subject to change as 

scientific knowledge and technology advances and patterns evolve. Today there is variation among state 

regulations, and the guideline does not cover the variety of ever-changing state regulations that may be 

pertinent. The ultimate judgement regarding a particular clinical procedure or treatment course must be 

made by the individual clinician, in light of the patient’s clinical presentation, patient preferences, and the 

available diagnostic and treatment options. As noted previously, the guideline can assist care 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, in the care for an individual patient.
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III. Recommendations

The following recommendations were made using a systematic approach considering four domains as per 

the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach as detailed 

in the section on Methods and Appendix E in the full text OT CPG. These domains include: confidence in 

the quality of the evidence, balance of desirable and undesirable outcomes (i.e., benefits and harms), 

patient or provider values and preferences, and other implications, as appropriate (e.g., resource use, 

equity, acceptability). 

Given the relevance of all four domains in grading recommendations, the Work Group encountered 

multiple instances in which confidence in the quality of the evidence was low or very low, while there was 

marked imbalance of benefits and harms, as well as certain other important considerations arising from 

the domains of values and preferences and/or other implications. In particular, the harms due to the 

potential for severe adverse events associated with opioids, particularly overdose and OUD, often far 

outweigh the potential benefits. As such, in accounting for all four domains, these factors contributed to 

Strong recommendations in multiple instances.

# Recommendation Strength* Category†

Initiation and Continuation of Opioids

1. a) We recommend against initiation of long-term opioid therapy for

chronic pain.

b) We recommend alternatives to opioid therapy such as selfmanagement strategies and other non-pharmacological treatments.

c) When pharmacologic therapies are used, we recommend nonopioids over opioids.

a) Strong

against

b) Strong for

c) Strong for

Reviewed, Newreplaced

2. If prescribing opioid therapy for patients with chronic pain, we 

recommend a short duration. 

Note: Consideration of opioid therapy beyond 90 days requires reevaluation and discussion with patient of risks and benefits.

Strong for Reviewed, Newadded

3. For patients currently on long-term opioid therapy, we recommend 

ongoing risk mitigation strategies (see Recommendations 7-9), 

assessment for opioid use disorder, and consideration for tapering when 

risks exceed benefits (see Recommendation 14).

Strong for Reviewed, Newreplaced

4. a) We recommend against long-term opioid therapy for pain in

patients with untreated substance use disorder.

b) For patients currently on long-term opioid therapy with evidence of

untreated substance use disorder, we recommend close 

monitoring, including engagement in substance use disorder

treatment, and discontinuation of opioid therapy for pain with

appropriate tapering (see Recommendation 14 and

Recommendation 17).

a) Strong

against

b) Strong for

Reviewed, 

Amended

5. We recommend against the concurrent use of benzodiazepines and 

opioids. 

Note: For patients currently on long-term opioid therapy and 

benzodiazepines, consider tapering one or both when risks exceed 

benefits and obtaining specialty consultation as appropriate (see 

Recommendation 14 and the VA/DoD Clinical Practice Guideline for the 

Management of Substance Use Disorders). 

Strong against Reviewed, Newadded
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# Recommendation Strength* Category†

6. a) We recommend against long-term opioid therapy for patients less

than 30 years of age secondary to higher risk of opioid use disorder

and overdose.

b) For patients less than 30 years of age currently on long-term opioid

therapy, we recommend close monitoring and consideration for

tapering when risks exceed benefits (see Recommendation 14 and

Recommendation 17).

a) Strong

against

b) Strong for

Reviewed, Newreplaced

Risk Mitigation

7. We recommend implementing risk mitigation strategies upon initiation 

of long-term opioid therapy, starting with an informed consent 

conversation covering the risks and benefits of opioid therapy as well as 

alternative therapies. The strategies and their frequency should be 

commensurate with risk factors and include:

 Ongoing, random urine drug testing (including appropriate 

confirmatory testing)

 Checking state prescription drug monitoring programs

 Monitoring for overdose potential and suicidality

 Providing overdose education 

 Prescribing of naloxone rescue and accompanying education 

Strong for Reviewed, Newreplaced

8. We recommend assessing suicide risk when considering initiating or 

continuing long-term opioid therapy and intervening when necessary. 

Strong for Reviewed, 

Amended

9. We recommend evaluating benefits of continued opioid therapy and risk 

for opioid-related adverse events at least every three months.

Strong for Reviewed, Newreplaced

Type, Dose, Follow-up, and Taper of Opioids

10. If prescribing opioids, we recommend prescribing the lowest dose of 

opioids as indicated by patient-specific risks and benefits. 

Note: There is no absolutely safe dose of opioids.

Strong for Reviewed, Newreplaced

11. As opioid dosage and risk increase, we recommend more frequent 

monitoring for adverse events including opioid use disorder and 

overdose.

Note:

 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, Newreplaced 

12. We recommend against opioid doses over 90 mg morphine equivalent 

daily dose for treating chronic pain. 

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).

Strong against Reviewed, Newreplaced

13. We recommend against prescribing long-acting opioids for acute pain, as 

an as-needed medication, or on initiation of long-term opioid therapy. 

Strong against Reviewed, Newreplaced

14. We recommend tapering to reduced dose or to discontinuation of longterm opioid therapy when risks of long-term opioid therapy outweigh 

benefits. 

Note: Abrupt discontinuation should be avoided unless required for 

immediate safety concerns.

Strong for Reviewed, Newadded
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# Recommendation Strength* Category†

15. We recommend individualizing opioid tapering based on risk assessment 

and patient needs and characteristics. 

Note: There is insufficient evidence to recommend for or against specific 

tapering strategies and schedules.

Strong for Reviewed, Newadded

16. We recommend interdisciplinary care that addresses pain, substance 

use disorders, and/or mental health problems for patients presenting 

with high risk and/or aberrant behavior.

Strong for Reviewed, Newreplaced

17. We recommend offering medication assisted treatment for opioid use 

disorder to patients with chronic pain and opioid use disorder. 

Note: See the VA/DoD Clinical Practice Guideline for the Management of 

Substance Use Disorders.

Strong for Reviewed, Newreplaced

Opioid Therapy for Acute Pain

18. a) We recommend alternatives to opioids for mild-to-moderate acute

pain.

b) We suggest use of multimodal pain care including non-opioid

medications as indicated when opioids are used for acute pain.

c) 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.

Note: Patient education about opioid risks and alternatives to opioid 

therapy should be offered.

a) Strong for

b) Weak for

c) Strong for

Reviewed, Newadded

*For additional information, please refer to the section on Grading Recommendations (in the full text OT CPG). 

†For additional information, please refer to the section on Recommendation Categorization and Appendix H (in the full text OT 

CPG).
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IV. Algorithm

The CPG follows an algorithm that is designed to facilitate understanding of the clinical pathway and 

decision making process used in management of LOT. The use of the algorithm format as a way to 

represent patient management was chosen based on the understanding that such a format may promote 

more efficient diagnostic and therapeutic decision making and has the potential to change patterns of 

resource use. Although the Work Group recognizes that not all clinical practices are linear, the simplified 

linear approach depicted through the algorithm and its format allows the provider to assess the critical 

information needed at the major decision points in the clinical process. It includes:

• An ordered sequence of steps of care

• Recommended observations and examinations

• Decisions to be considered

• Actions to be taken

For each guideline, the corresponding clinical algorithm is depicted by a step-by-step decision tree. 

Standardized symbols are used to display each step in the algorithm, and arrows connect the numbered 

boxes indicating the order in which the steps should be followed.[2] 
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A. Module A: Determination of Appropriateness for Opioid Therapy

Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. 
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B. Module B: Treatment with Opioid Therapy
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C. Module C: Tapering or Discontinuation of Opioid Therapy
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D. Module D: Patients Currently on Opioid Therapy
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V. Scope of the CPG

The VA/DoD OT CPG is designed to assist healthcare providers in managing or co-managing patients on or 

being considered for LOT. Specifically, the 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. 

The 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 the guideline after taking into consideration the patient’s 

specific circumstances. 

While these guidelines are broadly recommended, their implementation is intended to be patientcentered. 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.
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VI. Guideline Work Group

Guideline Work Group*

Department of Veterans Affairs Department of Defense

Jack Rosenberg, MD, FASAM (Champion) Christopher Spevak, MD, MPH, JD (Champion)

Michael O. Chaffman, PharmD, BCPS Elizabeth Rees Atayde, RN, MSN, FNP, CCM, CPHM

Karen Drexler, MD LTC Robert Brutcher, PharmD, PhD

Franz Macedo, DO Corinne Devlin, MSN, RN, FNP-BC

Aram Mardian, MD LTC William Grief, MD

Anthony J. Mariano, PhD James Hardin, LCSW-C, MAC

Ilene Robeck, MD Connie Kurihara, RN

Friedhelm Sandbrink, MD CDR Marisol Martinez, PharmD, MBA

Maria Silveira, MD, MA, MPH Capt Erick C. Messler, PhD

Nancy Wiedemer, MSN, RN, ANP-BC LTC Jason Silvernail, DPT, DSc, FAAOMPT

CAPT Necia Williams, MD

Office of Quality, Safety and Value

Veterans Health Administration

Office of Evidence Based Practice

U.S. Army Medical Command

Eric Rodgers, PhD, FNP-BC

James Sall, PhD, FNP-BC 

Rene Sutton, BS, HCA

Corinne K. B. Devlin, MSN, RN, FNP-BC 

Lewin Group ECRI Institute

Clifford Goodman, PhD

Christine Jones, MS, MPH, PMP

Erika Beam, MS

Anjali Jain, MD

Kristen E. D'Anci, PhD

Nancy M. Sullivan, BA

James Reston, PhD, MPH

Mrin Joshi, MS

Erin Payne, MS

Raj Stewart, PhD

Stacey Uhl, MS

Allison Gross, MLS

Sigma Health Consulting, LLC Duty First Consulting

Frances Murphy, MD, MPH Anita Ramanathan, BA

Megan McGovern, BA

*Additional contributor contact information is available in Appendix I (in the full text OT CPG).
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VII. 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,[3] and improve treatment adherence.[4] Improved patient-clinician communication through 

patient-centered care 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).

Table 1. Guide in Setting SMART Goals [5]

Specific

A goal should be clear and concise. It is difficult to know when action 

toward a goal has been started and when it has been completed if it is 

not specific.

Measurable

A goal should be measurable so that Veterans can track their progress. 

Veterans need to have clear criteria for progress and completion when 

taking action on a goal. Keeping tabs on progress can be inspiring.

Action 

Oriented

A goal should include action. And that action should be in direct 

control of the Veteran.

Realistic

A goal should be largely within the reach of the Veterans. It is best to 

work on small lifestyle changes that are doable. Avoid the pitfalls of 

having Veterans see only the big picture and not the small steps.

Timed A goal should be tied to a timetable for completing specific, 

measurable and realistic action.

VIII. Shared Decision Making

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. 
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Figure 1. Shared Decision Making for Chronic Pain Treatment and Long-Term Opioid Therapy

IX. Chronic Pain Treatment Options

A. Known Risks and Lack of Benefit of Opioid Therapy for Chronic Pain

There is a rapidly growing understanding of the significant harms of LOT (e.g., overdose, OUD). At the same 

time there is a lack of high-quality evidence that LOT improves pain, function, and/or quality of life. Given 

the lack of evidence showing sustained functional benefit of LOT and moderate evidence outlining harms, 

non-opioid treatments are preferred for chronic pain. When considering the initiation or continuation of 

LOT, it is important to consider patient values, goals, concerns, and preferences and whether LOT will 

result in clinically meaningful improvements in function (e.g., readiness to return to work/duty, 

measurable improvement in other areas of function) such that the benefits of LOT outweigh the potential 

harms.

B. Preferred Chronic Pain Treatment Options

Psychological therapies (e.g., cognitive behavioral interventions such as Cognitive Behavioral Therapy 

[CBT], biofeedback), exercise treatments (e.g., aerobic exercise, physical therapy), and multidisciplinary 

psychosocial rehabilitation (described as a combination of a physical intervention such as graded exercise 

and a psychological, social, or occupational intervention) have been found to be effective for reducing 

pain.[6-11] These interventions are safe and have not been shown to increase morbidity or mortality.

There is insufficient evidence to recommend psychological over physical therapies or vice versa; the choice 

of which to try first should be individualized based on patient assessment and a shared decision making 

process.[6] In light of the low harms associated with exercise and psychological therapies when compared 

with LOT, these treatments are preferred over LOT and should be offered to all patients with chronic pain 

including those currently receiving LOT. 

In addition to non-pharmacological therapies (e.g., exercise, CBT), appropriate mechanism and conditionspecific non-opioid pharmacologic agents should be tried and optimized before consideration of opioid 

medications (e.g., gabapentin in neuropathic pain states).[9] 
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C. Patient Populations at Additional Risk for Adverse Events with Long-term

Opioid Therapy

The following subgroups face additional risk (e.g., for OUD, overdose, death) with use of LOT. We 

recommend against initiating LOT for pain particularly in these patient populations. For patients already on 

LOT, increased monitoring and consideration for tapering should be used as appropriate. See 

Recommendations 4, 5, and 6 in Recommendations. 

• Patients with untreated substance use disorders (SUD)

• Patients concurrently using benzodiazepines

• Patients less than 30 years of age

X. Initiation of Long-term Opioid Therapy

If a clinician determines that LOT may be beneficial, despite the known risks, and if OT is prescribed for a 

patient, all opioid risk mitigation strategies outlined in the guideline should be put into place (see Risk 

Mitigation Strategies for Long-term Opioid Therapy). 

A. Duration of Opioid Therapy

OT should only be used for a short duration. Of utmost concern is the heightened risk for developing 

OUD in patients who receive OT beyond 90 days. Similar to other risk factors, continuing OT beyond 90 

days’ duration should be weighed heavily in the risk-benefit calculus for LOT. Continuing OT for longer 

than 90 days is not an absolute contraindication to LOT. There may be some situations where the 

benefits of LOT clearly outweigh the risks. That must be determined through individual clinical 

assessment. 

Patients should be informed that progression from acute to long-term OT is associated with little evidence 

for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this

information with patients at initiation of OT and continuously thereafter to ensure that the patient 

understands the associated risks and benefits of LOT. Fully informed, some patients may desire 

continuation of OT while others may decline its continued provision. 

B. Dose of Opioid Therapy

The risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and 

increases as dosage increases. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 

to <50 mg morphine equivalent daily dose (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).[12-15] 

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 central nervous 

system (CNS) depression, especially when opioid-naïve. This risk begins to increase with as low as 20-50 
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mg MEDD. Risk is further increased when certain concomitant demographic factors, co-occurring medical 

or psychiatric conditions, or interacting medications or substances exist. 

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. 

C. Selection of Opioid Therapy

Long-acting opioids should not be used for treatment of acute pain, on an as-needed basis, or during 

initiation of LOT. 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. 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 [time interval from the start of the Q wave to the end of the T wave]

monitoring)

Additional information when deciding on appropriate pharmacological treatment of pain for a specific 

patient can be found in the full text OT CPG.

XI. Risk Mitigation Strategies for Long-term Opioid Therapy

Providers should consider and implement risk mitigation strategies prior to prescribing opioids in the 

setting of LOT. Certain patients may appreciate the use of risk mitigation strategies but others may not. 

Patients may decline risk mitigation strategies, however providers should discuss such a decision, how 

that may increase the risks of an adverse outcome, and thus likely outweigh the benefit of the 

treatment. Clinical decision making should remain patient-centered including focusing on patient safety. 

Risk mitigation strategies alone or in combination improve patient safety. The strategies and their 

frequency should be commensurate with risk factors and include:

• An informed consent conversation covering the risks and benefits of opioid therapy as well as

alternative therapies.

• Ongoing, random UDT (including appropriate confirmatory testing)
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• Checking state prescription drug monitoring programs

• Monitoring for overdose potential and suicidality

• Providing overdose education

• Prescribing of naloxone rescue and accompanying education

A. Written Informed Consent and Opioid Treatment Agreements

Opioid therapy entails risks. Providers should inform patients about such risks in a patient-centered 

manner through informed consent. VA policy directs use of an informed consent document for patients on 

LOT. See VA Signature Informed Consent, Taking Opioids Responsibly for Your Safety and the Safety of 

Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain (found at 

http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphy 

forChronicPainPatientTool20May2013print.pdf), and 38 C.F.R. §17.32 (2012).

B. Urine Drug Testing

Substance misuse in patients on LOT is more than 30% in some series.[16] The inaccuracies inherent to 

patient self-report coupled with the evident mortality and morbidity to the treated patients, their families, 

and others require additional methods to ascertain patient and public safety. It is critical that the UDT and 

confirmatory testing be done in a timely, confidential, accurate, and easily available manner to assure the 

prescribers, patients, and public that safety, fairness, and trust are being addressed. In addition, a

mechanism for specimen validity that may include urinary creatinine, temperature, pH (potential of 

hydrogen), specific gravity, and/or nitrates should be in considered. More detailed information on 

evaluating for the possibility of false positives, false negatives, and review of the opiate metabolic pathway 

can be found in Appendix B of the full text OT CPG. It is important that UDT be viewed in a therapeutic 

framework so that appropriate follow-up with SUD evaluation and treatment are offered when indicated. 

There are three main types of UDT currently being used in clinical settings: immunoassay, gas 

chromatography-mass spectrometry (GCMS) confirmatory testing, and liquid chromatography-mass 

spectrometry (LCMS) confirmatory testing. Immunoassay screening is inexpensive, fast, and widely 

available. However, there are a number of drawbacks for using this test alone. There is a higher potential 

for false positives and negatives as well as lack of specificity of the actual opiate or benzodiazepine being 

tested. GCMS is highly sensitive and specific; however, it is expensive and time consuming. LCMS is less 

expensive than GCMS but more expensive than immunoassay. It can provide confirmation for a large 

number of medications, substances, and drugs at one time and may be helpful to many patients at 

initiation of OT, periodically during OT, and following cessation of OT if SUD is a possibility.

C. State Prescription Drug Monitoring Programs

State database queries for detection of multi-sourcing of controlled substances are used throughout the 

country. The Centers for Disease Control and Prevention (CDC) currently recommends at least quarterly 

checks of the state database system.[17] 
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February 2017 Page 21 of 30

D. Monitoring for Overdose Potential and Suicidality

Opioid medications are potentially lethal, and suicide risk should be assessed on an ongoing basis whether 

one is initiating, maintaining, or terminating LOT. The VA/DoD Suicide CPG1 recommends restricting the 

availability of lethal means for patients considered to be at intermediate or high acute risk of suicide. Some 

patients on LOT who suffer from chronic pain and co-occurring OUD, depression, and/or personality 

disorders may threaten suicide when providers recommend discontinuation of opioids. However, 

continuing LOT to “prevent suicide” in someone with chronic pain is not recommended as an appropriate 

response if suicide risk is high or increases. In such cases, it is essential to involve behavioral health to 

assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate 

decision to taper or cease LOT.

E. Prescribing of Naloxone Rescue and Accompanying Education

Naloxone administration has been identified as a life-saving measure following opioid overdose. Clinical 

efficacy has been established for its use on short-acting opioids, but not for its use on long-acting opioids 

such as methadone or exceptionally potent opioids.[18] Providers should discuss providing naloxone 

rescue kits and accompanying education with their LOT patients (and family members). 

F. Follow-up

• Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to

realistic treatment goals must be completed.

• Frequent visits contribute to the appropriate use and adjustment of the planned therapy.

• Follow-up is recommended at least every three months or more frequently.

• The CDC guideline for OT recommends re-evaluating harms versus benefits within one to four

weeks of starting OT or at any dose change, and at least every three months or more frequently

if needed.[17]

• At follow-up visits, the clinician should re-examine the rationale for continuing the patient on

OT.

XII. Tapering

Clinicians prescribing LOT should continually reassess the risks and benefits of LOT, and when risks are 

determined to outweigh benefits or when patients voice a preference for reducing their risk, OT should be 

tapered to a reduced dose or tapered to discontinuation. A biopsychosocial assessment including 

evaluation of co-occurring medical and psychiatric conditions, SUD, as well as the patient’s social support 

system, will guide the opioid tapering process. Determination of the rate of opioid tapering takes into 

1 See the VA/DoD Clinical Practice Guideline for Assessment and Management of Patients at Risk of Suicide. Available at: 

http://www.healthquality.va.gov/guidelines/MH/srb/ 
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account many factors that include initial dose, formulations available, and risk factors that increase 

potential for harm. A gradual taper pace of reducing opioid dosage by 5-20% every four weeks with the 

option to pause periodically allows time for neurobiological equilibration as well as the acquisition of new 

skills to manage pain and emotional distress. In some patients, a faster taper may be needed when risks 

are too high to consider a gradual taper; consider tapering the dose by 5-20% per week in this patient 

population. Regardless of the initial speed of taper, the pace of taper should be reevaluated frequently and 

adjusted as needed to maximize safety and patient comfort as safety allows. When there is evidence of 

diversion, opioids should be discontinued immediately.

Follow-up should occur within a range of one week to one month after any opioid dosage change with the 

frequency and type of follow-up adjusted as needed throughout the course of the taper. Each follow-up 

interaction with the patient is an opportunity to provide education about self-management strategies and 

the risks associated with OT while optimizing whole person approaches to pain care and treatment of cooccurring medical and mental health conditions. The care team should take great efforts to ensure that the 

patient does not feel abandoned during the opioid tapering process by maintaining frequent contact and 

emphasizing that the care team will continue to pursue non-opioid pain care options during and after 

opioid tapering. 

The risks and benefits of continuing OT should be evaluated along with the risks and benefits of tapering 

OT. It is important to maintain vigilance for symptoms of OUD and/or exacerbation of an underlying 

mental health condition that may manifest during an opioid taper. Clinicians should consider using an 

interdisciplinary, team-based approach that may include primary care, mental health, pain 

specialty/rehabilitation, pharmacy, physical therapy, and/or SUD services during the opioid tapering 

process, and in particular for patients with significant risk factors for adverse outcomes including very high 

prescribed opioid doses (> 90 mg MEDD), combined use of opioids and benzodiazepines, high risk patient

behaviors, and the presence of psychiatric, medical, or SUD comorbidities. Patients on LOT with OUD are 

at increased risk of overdose when opioids are either continued or discontinued without appropriate 

treatment for OUD. We recommend medication assisted treatment (MAT) for OUD (e.g., MAT using 

methadone, buprenorphine/naloxone, or extended-release injectable naltrexone) (see the VA/DoD Clinical 

Practice Guideline for the Management of Substance Use Disorders (VA/DoD SUD CPG)2

 and 

Recommendation 17 in the full text OT CPG).

Opioid overdose education should be provided and naloxone should be offered as an antidote to all 

patients at risk for an opioid overdose including those who are in the process of tapering or who have 

recently discontinued OT. Strongly caution patients that it takes as little as a week to lose tolerance to their 

prior opioid dose and that they are at risk of an overdose if they resume their prior dose. 

2 See the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders. Available at: 

http://www.healthquality.va.gov/guidelines/mh/sud/index.asp.
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XIII. Diagnosis and Treatment of Opioid Use Disorder

OUD (also known as opioid addiction, abuse, or dependence) is a chronic brain disease that impairs one’s 

ability to control opioid use. Repeated opioid use over time can lead to OUD, and long-term opioid 

analgesics use is by far the most powerful risk factor for developing OUD. All persons using opioid 

analgesics are at risk for developing an OUD, even those who take opioid analgesics as prescribed. Opioid 

misuse may be an early sign of a developing OUD. Other early signs of developing OUD include: gradually 

becoming more and more preoccupied with opioid use and spending more time seeking the drug, using it, 

or recovering from its effects. Persons with OUD may continue to use opioids even though they: 

• Know that opioid use is harmful

• Often use more than they intended

• Engage in risky behaviors such as driving while intoxicated or combining opioids with alcohol or

other sedatives

• Have multiple unsuccessful attempts to cut down or control opioid use

• Report strong craving or urges to use opioids in response to withdrawal symptoms, stress,

negative emotions, or simply cues that the drug is available

OUD is associated with premature death from opioid overdose and other medical complications such as

acquired immunodeficiency syndrome (AIDS), hepatitis C, and sepsis. On average, OUD carries a 40-60% 

20-year mortality rate.[19] Persons with OUD are at high-risk for premature death, not only from opioid

overdose, but from other consequences. Thus, providing first DRAFT 3- DONOT DISTRIBUTE-line treatment is important to save lives as

well as to improve the quality of life.

Strong evidence supports the use of opioid agonist therapy (e.g., methadone, buprenorphine/naloxone) 

as first-line treatment for moderate-to-severe OUD (see VA/DoD SUD CPG).

3 Patients and their treating 

clinicians may be concerned that treatments proven effective in different OUD populations may not be

effective for patients with chronic pain, or may not be necessary for patients who have become addicted 

to prescription opioid analgesics. This concern may be unfounded and was addressed by Weiss and 

colleagues in the Prescription Opioid Abuse Treatment Study (POATS).[20] 

In studies with patients with Diagnostic and Statistical Manual of Mental Disorders [DSM] IV diagnostic

criteria for opioid dependence (which were conducted prior to use of DSM-5), buprenorphine

maintenance therapy is more effective than a four-week taper. MAT with moderate dose

buprenorphine/naloxone and brief, structured counseling by the prescribing physician can be successful

for about half of selected patients with prescription OUD, whereas withdrawal management alone, even

with close weekly follow-up and counseling, is successful for less than 10% of patients.

3 See the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders. Available at: 

http://www.healthquality.va.gov/guidelines/mh/sud/index.asp.
DRAFT 3 -DO NOT DISTRIBUTE

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Furthermore, the presence of chronic pain does not seem to interfere with the success of MAT.[20,21] 

Given the high mortality associated with OUD and the safety and efficacy of MAT for OUD in multiple 

clinical trials and meta-analyses, we recommend MAT for those chronic pain patients who meet DSM-5 

criteria for OUD. Those who do not respond to minimal counseling may benefit from a comprehensive 

assessment and more intensive treatment of OUD and any co-occurring conditions in SUD specialty care 

settings.

XIV. Clinical Pearls for Prescribing Opioids

1. Chronic pain is a complex human experience strongly influenced by psychosocial factors

including the patient’s relationship with the healthcare system.

a. Opioid prescribing is a powerful way to communicate about the goals, methods, and

responsibilities of chronic pain treatment.

b. Teach your patient that self-management, not effortless relief with medications, is the

foundation of high quality pain care.

2. Safety is always more important than urgent pain relief.

a. Titrating to effect is not a rational prescribing strategy.

b. When risk outweighs benefit or adequate risk mitigation is not possible opioids should not

be used.

3. As risks increase, mitigation and monitoring increases.

a. Opioid risks and benefits can change over time.

b. Opioid prescribing requires ongoing evaluation and documentation of risks and benefits.

4. Generally avoid initiating LOT for chronic pain; however, when opioids are prescribed and when

titrating up, start low and go slow.

a. Do not exceed 50 mg MEDD unless you are able to closely follow and monitor risks.

b. Avoid titrating to doses greater than 90 mg MEDD.

5. Improved function, not pain relief, is the primary clinical goal.

a. Opioids should only be continued when patients demonstrate functional benefit and are

actively engaged in self-management of pain.

b. Opioid prescribing should be conducted as an ongoing trial documenting high benefit and

low risk.

6. When your patient is not benefitting, being exposed to undue risk, or misusing, the question is

not “if” the patient should be tapered but “how.”

a. When tapering down, be clear about the rationale, be specific about the process, be

empathic but not apologetic. Bad care is not an option.

b. Your goal is to ensure safety while supporting and educating your patient. Offer alternative

pain treatments and be prepared to address other problems such as OUD or suicidality.
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XV. Additional Resources

• Veterans Administration Pain Management website: https://www.va.gov/painmanagement/

• Defense and Veterans Center for Integrative Pain Management website:

http://www.dvcipm.org/

• Chronic Pain Information Page from the National Institute of Neurological Disorders and Stroke:

https://www.ninds.nih.gov/Disorders/All-Disorders/Chronic-Pain-Information-Page.

• The patient information guide titled Taking Opioids Responsibly for Your Safety and the Safety of

Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain:

https://www.va.gov/PAINMANAGEMENT/docs/TakingOpioidsResponsibly20121017.pdf
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XVI. VA Signature Informed Consent

For the most current information on informed consent, see the VA National Center for Ethics in Health 

Care website (http://www.ethics.va.gov/).
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