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OPIOID THERAPY FOR PAIN: A MULTIDISCIPLINARY APPROACH

by William W. Deardorff, Ph.D, ABPP.


4 Credit Hours - $79
Last revised: 06/29/2017

Course content © Copyright 2010 - 2017 by William W. Deardorff, Ph.D, ABPP. All rights reserved.



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Course Outline

 

Learning Objectives

Introduction and Guidelines

The Multidisciplinary Approach

Prevalence of Chronic Opioid Therapy or Use

Translating Research into Practice: The “Disconnect”

A Brief Review of the Biopsychosocial Nature of Chronic Pain

General Patient Selection Guidelines

Moderate to Severe Pain

Failure of Previous Treatments

Impact on Level of Function and Quality of Life

Risk Stratification and Risk-Benefit Assessment

Self-Report Risk Assessment Screening Questionnaires

Putting it All Together

Components of an Opioid Treatment Contract

Establishing Personally Relevant Goals

Adverse Effects  

Initiation and Titration   

Monitoring

Analgesia

Activities of Daily Living

Aberrant Drug Related Behavior

Assessment and Specific Analgesic Plan

Objective Monitoring Tools

Pain Assessment and Documentation Tool (PADT)

Numerical Opioid Side Effect (NOSE) Tool

Translational Analgesia Scale (TAS)

The SAFE Score

Additional Methods of Monitoring

Urine Drug Tests

Pill Counts

Report from Family Members

Prescription Monitoring Program

Breakthrough Pain

Managing the High Risk Patient

Dose Escalation and Managing High Dose Patients

Dose Escalations Due to a Substance Use Disorder

Diversion

Pseudoaddiction. 

High Dose Opioid Therapy

Opioid Induced Hyperalgesia

Strategies For Managing Hyperalgesia

Reducing and/or Discontinuing Opioid Therapy

Opioid Rotation

Use of Adjunctive Medications

The Use of Non-pharmacological Treatments

Chronic Opioid Therapy and Mortality

Psychotherapeutic Interventions

Understand the Medical Intervention

Obtain Appropriate Releases

Assist with Monitoring

Ethical and Risk Management Issues

Be Ready for “Crises”. 

Safety Issues

Tapering, Discontinuation, and Problems

Glossary of Terms

References

 

Learning Objectives

 

·         List the four questions that summarize patient selection for opioid therapy

·         List five features of a patient less likely to benefit from opioid therapy

·         Describe the process of risk stratification

·         Explain the four A’s of opioid monitoring

·         Discuss the importance of a multidisciplinary approach

 

Introduction and Guidelines

 

The use of opioids is accepted in the treatment of acute pain (e.g. post-traumatic, postoperative, etc.) and cancer pain.  Over the past two decades, chronic opioid treatment (COT) has gained increased acceptance amongst practitioners and is becoming much more common.  Even so, using COT to treat chronic non-cancer pain (CNCP) remains controversial.  The treatment philosophy underlying COT is one of beginning a “positive adaptive cycle” once the pain is brought under reasonable control.  As discussed by Nicholas et al. (2006, p. 141), examination of the guidelines and associated literature reveals a common theme that may be characterized as “get the pain under control (with the opioid), then the patient will feel able/more willing to do more.”  This has also been described as “capitalizing on improved analgesia by an increase in physical and psychosocial functioning.”  This model may be characterized in the following diagram. 

positivefunctionalcycle 

Idealized Model of Chronic Opioid Therapy

 

However, some of the controversy around COT is based on clinical and research evidence that this model may not be entirely accurate.  As discussed by Nicholas (2006), “Although this expectation may hold with acute pain, like post-surgical cases and with cancer pain, the overall evidence reviewed here for patients with chronic noncancer pain does not support this position yet (p. 141). 

 

In my experience, one of the reasons for the controversy surrounding COT therapy for CNCP may be the disconnect between tightly controlled clinical research projects (those that get published) and the use of these methods in routine practice.  In controlled research projects related to COT, investigators utilize strict criteria and methodologies related to selecting patients for the COT trials, monitoring the treatment closely, and following through on discontinuation of the treatment if necessary.  As will be discussed throughout this course, there is certainly support for COT for well selected patients when it is done in an appropriate manner.  This course will review the clinical research and guidelines relative to the appropriate implementation of COT for the chronic noncancer pain (CNCP) patient.  Although there are many consensus statements and guidelines supporting the appropriate use of opioid analgesics for chronic non-cancer pain (see Passik and Squire, 2009) these do not provide step by step guidance for implementation of this treatment approach.  There are several issues related to actually implementing COT treatment and these will be discussed in this course consistent with the various guidelines and consensus statements. 

 

One of the most comprehensive guidelines was recently published as a joint project of the American Pain Society and the American Academy of Pain Medicine (2009).  This project resulted in publication of the, Opioid Treatment Guidelines: Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Non-Cancer Pain (Chou et al., 2009).  This course will roughly use these recent opioid treatment guidelines as a template for guiding the clinician relative to COT treatment.  Other example guidelines can be found in Table 1.  Of particular interest is the State of WA guidelines for opioid use with the injured worker.

 

 

Table 1.  Example Guidelines for Opioid Treatment

 

 

The following are some example guidelines for chronic opioid therapy.  There are many available, all of which review the literature and suggest management strategies.  Most can be downloaded for free from the web site of the publishing agency.  As can be seen, many States have developed specific guides but just a few are provided as examples.

 

Opioid Treatment Guidelines: Clinical Guidelines for the Use of Chronic Opioid Therapy in Noncancer Pain

 

This is a joint project of the American Pain Society and the American Academy of Pain Medicine resulting in a literature review and publication of guidelines for chronic opioid therapy.

 

The Management of Opioid Therapy for Chronic Pain

 

These are clinical practice guidelines for opioid therapy for chronic pain developed by the Veterans’ Administration and Department of Defense.

 

Utah Clinical Guidelines on Prescribing Opioids

 

Like many other States, Utah has guidelines for the prescribing of opioids for acute and chronic pain.  The link above is to the complete guidelines (86 pages) and there is a Summary Version (15 pages).

 

Washington Guidelines for Outpatient Prescription of Oral Opioids for Injured Workers with Chronic, Non-cancer Pain (State of WA Department of Labor and Industries)

 

The State of Washington has lead the way in managing opioid use with injured workers.  This document provides guidelines for opioid use with injured workers who demonstrate chronic noncancer pain.

 

 

One of the critical factors that is emphasized throughout the various consensus statements and guidelines is the recommendation of a multimodal and multidisciplinary approach to these patients.  The intensity and structure of the multidisciplinary intervention will vary depending upon the comprehensive initial evaluation of the individual being considered for COT.  Again, one of the failures I see commonly in clinical practice is a lack of utilization of an appropriate multidisciplinary intervention.  Given the biopsychosocial nature of chronic pain (see Introduction to Chronic Pain Management or QME Chronic Pain Management Concepts), a multidisciplinary intervention is certainly appropriate in the vast majority of these cases.  As discussed in the other pain courses, this applies to most chronic pain patients, whether COT is being utilized or not.  It is probably even more important when COT is being considered due to the various risks associated with this type of intervention.  Of course, the mental health professional plays a critical role in this process as a member of the multidisciplinary team.  The role of the mental health professional is important through all phases of COT including the initial evaluation, risk stratification relative to implementing the treatment, initiation and titration of the opioid dose, monitoring the patient’s response to COT, ongoing assessment for possible aberrant behavior, augmenting the intervention with psychological pain management techniques, and assisting with discontinuation of the COT if problems arise. 

 

Prevalence of Chronic Opioid Therapy or Use

 

It is probably useful to distinguish between chronic opioid therapy (COT) and chronic opioid use.  These are not official distinctions, but rather of my own conceptualization for this course.  I would characterize COT as being a more structured and formalized approach to providing opioids to a CNCP patient over the long term (similar to what is presented in this course and the literature).  On the other hand, chronic opioid use is often seen when physicians simply prescribe opioids to a patient over the long term without any type of structured initial evaluation, contract, re-assessment of benefits, side effects and risk, etc.  The following data are all categorized under COT but, in reality, may contain a number of patients who simply show chronic opioid use without being part of any formalized treatment.  For the purposes of this discussion, and consistent with what is found in the literature, we will use the term COT for all of these patients.

 

Although exact data is difficult to collect, research indicates that the prevalence of chronic opioid therapy is increasing. The most recent Cochrane review (Noble, 2010) estimated that 9% of Americans have moderate to severe chronic non-cancer pain.  As reviewed in Nicholas et al. (2006), a review of national US data revealed that office-based prescription of opioids for chronic musculoskeletal pain cases had doubled from 8% in 1980 to 16% in 2000 with an even greater increase for stronger opioids, up from 2% in 1980 to 9% in 2000.  (This rate has likely continued to increase over the past 10 years due to acceptance of this approach and aggressive marketing by the pharmaceutical companies.)  The increase in opioid prescriptions was not due to more clinic visits or musculoskeletal pain, but rather changing prescribing patterns.  Chronic opioid use of at least six months or greater has been estimated to be 0.65% of a US insured population.  Research has demonstrated that, in the US, 10% of people who were prescribed opioids had at least a three month supply. 

 

It has been estimated that 19% of Europeans have moderate to severe chronic non-cancer pain (Noble, 2010), and opioid use trends similar to those seen in the U.S. have also been seen in other countries.  As documented by Eriksen et al. (2006), Denmark has had an extremely high usage of opioids for many years.  These opioids are mainly prescribed for chronic non-cancer pain conditions.  Recent epidemiological data excluding cancer patients has demonstrated that about 3% of the Danish population uses opioids on a regular or continuous basis.  Chronic pain (greater than six months) is reported by 19% of the adult Danish population and among these, 12% use opioids.  As discussed by Eriksen (2006), during the last two decades, the use of opioids for the treatment of chronic non-cancer pain has increased more than 600% in Denmark.  In addition, the vast majority of prescription opioids are used for chronic non-cancer pain, and less than 33% are used for cancer patients.  Similar trends have also been observed in Australia and Canada (Nicholas et al., 2006; Dhalla et al., 2009). Chronic opioid use of at least six months or greater has been estimated to be approximately 0.27% of Dutch epidemiologic survey respondents.

 

Translating Research into Practice: The “Disconnect”

 

Clearly, based on this data, the long term use of opioids for chronic non-cancer pain is not uncommon.  As I mentioned previously, it has been my experience that chronic opioid therapy as implemented in routine practice is markedly different than what is recommended in the various guidelines and clinical research (this is my distinction between “chronic opioid use” and “chronic opioid therapy”).  My anecdotal impressions appear to be at least somewhat supported by what little data is available relative to this issue.  Research has demonstrated that physicians in routine practice who utilize chronic opioid therapy often show problems with inadequate patient selection procedures, poor documentation, a lack of adequate monitoring of COT patients, among other things (see Smith & Kirsh, 2007).  As discussed by Passik & Squire (2009) this may be, in part, due to the fact that primary care physicians are being placed in a role of providing COT when their practice is not properly equipped to manage these patients.  In fact, Passik and Squire (2010) make the point that there are a limited number of pain specialists currently practicing in the United States (e.g. Board Certified by the American Board of Pain Medicine, and American Board of Medical Sub-Specialties).  Passik and Squire (2010) reviewed of a recent survey of primary care physicians investigating their concerns regarding opioid treatment for CNCP and these can be seen in Table 2.  

 

 

Table 2.  Primary Care Physician Concerns About COT

 

 

prescription drug abuse (84%)

addiction (75%)

adverse effects (68%)

tolerance (61%)

medication interactions (32%). 

 

 

Given these concerns, the primary care physician that utilizes COT may do so ineffectually simply due to the fact that their practice is not set up for this type of intervention.  However, as discussed by Passik and Squire (2010) “despite these concerns, opioid based therapy can be safe and effective for many patients with CNCP given this type of therapy is indicated and when prescribed in the context of appropriate risk management” (p. S102).  Given the biopsychosocial factors that influence chronic pain, a multidisciplinary approach is indicated in the vast majority of cases.  Any physician implementing chronic opioid therapy can be benefited by having an easily implemented structure for this type of treatment and relying on allied healthcare providers to address the psychosocial issues of the chronic pain syndrome. 

 

The Biopsychosocial Nature of Chronic Pain

 

There are many things that can increase or decrease a patient’s perception of pain and these factors are discussed in greater detail in other courses (see Introduction to Chronic Pain Management or QME Chronic Pain Management Concepts).  These various factors influence chronic pain, disability, and suffering. Thus, a person can have severe pain with minimal physical findings and minimal pain with horrendous physical findings. The “onion” model pictured subsequently describes in a simple format what is currently known about aspects of chronic noncancer pain.

 

It is important to always keep these in mind when evaluating and managing a patient on COT that, unlike acute pain, the chronic pain patient has multiple factors that are impacting the pain problem.  These factors are not static and can influence the patient’s response to COT at any time.  A common mistake among clinicians providing COT is that any change in the patient’s response must be due to a change in nociceptive input (e.g. disease progression or tissue damage).  Certainly, this must be ruled out, but in the CNCP, this is often not the case.  Rather, some other influence on the pain behavior has changed.  Brief definitions of the various "layers" of pain in the model can be seen in Table 3.  

 

 

Table 3.  The Multi-Factorial Nature of CNCP

 

 

Tissue damage or nociception.  This is defined as mechanical, thermal (heat or cold), or chemical energy acting on specialized nerve endings that send an impulse, or "signal," into the nervous system that negative events are occurring.

 

Pain sensation.  In the simplest terms of this model, pain is the actual perception that occurs in the brain after the nerve signal (due to nociception) travels from the periphery to the central nervous system. Pain sensation is experienced in the brain, while nociception occurs at the site of injury.

 

Thoughts. Cognitions or thoughts occur in higher brain centers and are an assessment of the pain-sensation signal coming into the nervous system as well as events surrounding it. These thoughts can be conscious or unconscious and will greatly influence how the pain signal is perceived. For instance, general body aches and stiffness are perceived as "good pain" when these occur after a vigorous exercise session, whereas they are perceived as "bad pain" when related to a medical condition, such as fibromyalgia. Changing a patient’s thoughts about his or her chronic pain is one of the most powerful psychological treatment tools and this will be discussed in the chapter on cognitive behavioral interventions.

 

Emotions.  The emotional aspect of pain is a person’s response to thoughts about the pain. If you believe (thoughts) the pain is a serious threat, then emotional responses will include fear, depression, and anxiety, among others. Conversely if you believe the pain is not a threat, then the emotional response will be negligible.

 

Suffering.  The term “suffering” is often used as a synonym for “pain” even though they are theoretically and conceptually distinct.  For instance, a broken bone may cause pain without suffering or a great level of suffering.  When faced with the same level of nociceptive input, understanding why one individual will demonstrate a great level of suffering while another will show minimal suffering is critical to the evaluation and treatment of chronic pain.  Unfortunately, the theoretical and conceptual distinction between pain and suffering is often neglected in clinical practice, which can negatively impact the evaluation and treatment of the patient’s condition.

 

Pain behaviors.  Pain behaviors are defined as things people do when they suffer or are in pain. These are behaviors that others observe as typically indicating pain such as:

 

talking or complaining about the pain

grimacing, moaning, crying, limping, moving slowly

taking pain medicine, rubbing a painful area

moving more slowly, asking for help, lying down

avoidance of certain activities, seeking further treatment

 

Pain behaviors are in response to all the other factors in the pain system model (tissue damage, pain sensation, thoughts, emotions, and suffering). Pain behaviors are also affected by previous life experiences, expectancies, and cultural influences in terms of how the pain is expressed.

 

Psychosocial environment.  Psychosocial environment includes all of the environments in which we live, work, and play. Research has consistently shown that these environments influence how much a person will show pain behaviors. Exactly how these environments can affect the patient’s pain and suffering are important to evaluate since this can help guide the treatment intervention.

 

 

General Patient Selection Guidelines

 

Prior to actually selecting a patient for possible COT, one must consider some general issues relative to patient selection.  If a patient meets these criteria, then a detailed multidimensional evaluation is appropriate prior to initiating any type of COT.  General guidelines for patient selection have been developed by many experts in the field.  For instance, Portenoy (2010) suggests that when considering the potential benefits and risks of COT, the clinician should frame the analysis around the answers to four questions:

 

What is conventional practice with respect to the particular type of pain and patient?  The answer to this question relies on the clinician having a good understanding of the pain problem in question as well as the patient who is experiencing the suffering.  This includes such things as pain etiology and pathophysiology, relevant medical and psychiatric comorbidities, effects on function, and the outcomes of prior therapies.  In other words, what would be the standard of care relative to this patient and his or her presenting chronic noncancer pain problem. 

 

Do other treatments have more favorable risk-benefit ratios than opioids have?  In answering this question, the clinician must have a good understanding of available treatment options, other than chronic opioid therapy.  This would include such things as non-opioid pharmacotherapy, interventional strategies, psychological and rehabilitative approaches, complementary and alternative medicine treatments, etc.  As Portenoy (2010, p. 18) points out, if the clinician is not familiar with these other various treatment approaches, it may be reasonable to refer the patient to a consultant so that these non-opioid methods might be adequately assessed. 

 

Is the patient at a relatively high risk for opioid side effects?  As discussed by Portenoy (2010), there is a continuum of side effects and risk factors associated with chronic opioid therapy ranging from low to serious.  Lower risk side effects include such things as constipation and sedation which can often be effectively managed.  More serious risks include such things as respiratory depression and neuroendocrine changes.  The clinician should be aware of any prior history of significant opioid toxicity as well as medical comorbidities that may predispose the patient to serious problems with COT. 

 

Are there concerns about responsible medication use over time?  When initially considering a patient for COT, the prominent risk factors for opioid misuse should be considered.  Although these will be discussed in more detail subsequently, these include such things as a personal and family history of drug or alcohol abuse and/or history of a psychiatric disorder.

 

The clinician should begin by attempting to answer the aforementioned  questions even before chronic opioid therapy is suggested to the patient as a viable treatment option.  In addition to these issues, selection of patients for chronic opioid therapy has been addressed in the various clinical guidelines.  As discussed in the Opioid Treatment Guidelines (Chou et al., 2009), COT may be considered under the following conditions: 

 

Before initiating COT, a clinician should conduct a history, physical examination, and appropriate testing, including an assessment of risk of substance abuse, misuse or addiction. 

 

Clinicians may consider a trial of COT as an option if CNCP is moderate or severe, pain is having an adverse impact on function or quality of life, and potential therapeutic benefits outweigh or are likely to outweigh potential harm.

 

A benefit-to-harm evaluation including a history, physical examination, and appropriate diagnostic testing should be performed and documented before and on an ongoing basis during COT. 

 

These guidelines essentially embody the method for answering the four questions as proposed by Portenoy (2010) discussed previously.  The guidelines suggest that proper patient selection is critical to the success of COT and that a thorough risk assessment and stratification is appropriate “in every case.”  The evaluation must include a comprehensive benefit-to-harm analysis including the recognition that an opioid trial may not be appropriate.  The patient should demonstrate at least moderate to more severe pain and failure of previous non-opioid treatments should be carefully documented.  Patients with poorly defined pain conditions, or vague and diffuse pain complaints, generally do not respond well to COT over the long term.  Based on these general Guidelines, and the clinical research (See also the State of WA Guides; Passik and Squire, 2009), Table 4 demonstrates the example features of a potentially good candidate for COT versus a poor candidate. 

 

 

Table 4.  Is An Opioid Trial Appropriate?

 

 

More Likely to Benefit

 

 

Less Likely to Benefit

 

The patient has not responded to previous non-opioid therapies

 

The patient has taken opioids in the acute and subacute phases with some improvement in pain and function

 

The pain diagnosis falls into one of three categories:

 

Nociceptive such as tissue destruction, arthritis, arachnoiditis.

 

Neuropathic such as sciatica, trigeminal neuralgia, herpetic neuralgia, complex regional pain syndrome.

 

Mixed nociceptive and neuropathic.

 

The patient is able to establish well-defined treatment goals

 

Patient motivation has been demonstrated when involved in previous treatments.

 

 

The patient has not attempted previous non-opioid treatments, or has shown a lack of motivation when participating

 

The patient has taken opioids in the acute phase of pain and they were not beneficial

 

The pain diagnosis includes somatoform features (vague, diffuse, ill-defined, unclear pain generator, etc.)

 

Poorly defined functional goals if pain relief achieved

 

Established risk factors for poor outcome are present:

 

History of personal or family substance abuse

 

Active alcohol or substance abuse

 

History of psychiatric or psychological disorders

 

Previous DUI conviction

 

Male

 

Younger age

 

Smoker

 

Legal, disability issues related to the pain

 

Poor social support

 

History of adverse childhood events (abuse)

 

In work injury cases, not worked greater than 6 months

 

 

As discussed by Passik (2009), the various guidelines and consensus statements provide general guidance for the implementation of COT, but not step-by-step suggestions.  The initial step is for the clinician to have at least some information related to the above issues prior to even suggesting COT to a particular patient.  Certainly, there are some patients who are obviously such poor candidates that even suggesting a comprehensive evaluation would not be appropriate.  This is not to conclude that patients with risk factors may not be viable candidates for COT.  As we will discuss subsequently, there are methods for appropriately managing high risk patients on COT therapy successfully.  However, there are other patients who have so many risk factors that the clinician would not be wise to even suggest undergoing evaluation for COT.  This might be the patient who is actively abusing substances, has obvious psychiatric comorbidities, is showing exceptional drug seeking behavior, shows no interest in alternative forms of pain treatment, and presents with a pain condition that is not well defined. 

 

Assuming the clinician has determined that the patient may be a candidate for COT, then the comprehensive evaluation and risk assessment (“stratification”) should be completed.  The goal of this comprehensive evaluation is to provide objective data relative to the questions posed previously.  The following areas of assessment assume that a physical examination, history, and any appropriate medical diagnostic testing has already been completed.  The following assessment also assumes that the physician has a reasonable understanding of the chronic noncancer pain syndrome.  This does not mean that an exact pain generator has always been identified, since this is often not possible in chronic noncancer cases.  However, patients with absolutely no physical findings or basis for their somatic complaints should likely be ruled out.  Areas of assessment for possible COT should include at least the following: 

 

Moderate to Severe Pain

 

Most clinicians will simply ask patients “how bad is your pain?” or in some cases complete a single pain rating scale such as, “On a scale of 0-10, how bad has your pain been over the past week?”  When someone is being considered for COT, more objective and comprehensive assessment of the patient’s perception of pain is probably indicated.  This more comprehensive and objective assessment allows for several things including:

 

Being able to get a more accurate idea of the patient’s pain levels over time.

 

Determining variability of pain ratings and whether the patient is even capable of assessing differences in pain.  In my experience, chronic pain patients will often say that they are suffering from “10/10 pain all of the time.”  If the patient is unable or unwilling to distinguish varying pain levels, then the success of the COT for this domain (pain perception) cannot be determined. 

 

The objective pain ratings provide a more accurate baseline against which the success of COT can be measured.

 

Having the patient complete an assignment of keeping a pain diary can be one gauge of his or her willingness to follow through on “homework assignments” relative to pain management.  As will be discussed subsequently, the success of COT must always be determined within the context of the patient taking responsibility for also improving his or her situation relative to pain management, function, and other areas of his or her life. 

 

There are several pain monitoring instruments available for use that can be easily implemented into the clinician’s practice.  Typically, one might have the patient complete these pain diaries over the course of 2-4 weeks to establish a reasonable baseline to assess treatment efficacy.  Often, these pain diaries can also reveal patterns of pain exacerbation that can help guide opioid dosing as well as non-pharmacological pain management interventions (e.g. psychological pain management techniques). 

 

Examples of pain diaries (and many other clinician “tools”) can be downloaded for free from Partners Against Pain, Pain Knowledge, Pain Clinician, and PainEdu

 

Failure of Previous Treatments

 

All of the guidelines discuss failure to respond to previous treatments as a key factor when considering COT. Table 5 shows some of the various nonpharmacological treatment for chronic noncancer pain (adapted from Passik, 2009, p.594).  However, the guidelines do not offer pragmatic methods for assessing a patient’s response to previous treatments.  In my experience, the clinician will simply ask “what kind of treatments have you undergone previously” and then “did any of them help.”  Invariably, the chronic noncancer pain patient will provide an extensive list of treatments (e.g. physical therapy, acupuncture, counseling, various nonopioid medications, surgery, etc.) and report that “none of them helped.”  This is probably an inadequate assessment of the patient’s response to previous treatments. 

 

 

Table 5. Nonpharmacological Treatments for Chronic Pain

 

 

Physical

Self-administered

Bandages, Corsets

Topical analgesic cream

Exercise

Modalities (hot, cold)

Activity modifications

Body mechanics

Physical medicine

Reactivation of deconditioning

Hydrotherapy

Massage

Physical devices

Physical and occupational therapies

Work hardening/functional restoration

Range of motion interventions

 

Psychological

Attention control and distraction

Biofeedback

Cognitive-behavioral therapy

Behavioral and operant interventions

Desensitization

EMDR

Family therapy

Goal-setting and pacing

Guided imagery

Hypnosis

Patient education

Psychotherapy for co-morbid conditions

 

Interventional Techniques

Bracing

Injection and radiation therapy

Nerve blocks

Neurodestructive surgical techniques

Spinal cord stimulation

TENS

 

 

Obtaining and documenting more detailed information to the patient’s previous response to treatments can be facilitated by the following questions: 

 

What specific treatments have you attempted for your chronic pain problem, specifically?  Either through clinical interview, pain questionnaire, or both, have the patient review previous treatments that have been attempted for the pain problem.  Do not allow vague responses such as “I’ve tried everything and nothing worked.”  And then for each previously attempted treatment, the clinician should ascertain the following:

 

What was the exact nature of the treatment?  For instance, a patient may respond that he or she has undergone multiple trials of physical therapy without benefit.  Of course, “physical therapy” encompasses a number of different things ranging from entirely passive modalities (hot packs, ultrasound, massage) to functional restoration and strengthening.  The same can be said for any of the other treatments. 

 

How long did you undergo the treatment?  The clinician should really have a good understanding of the “dose” of the treatment that was attempted.  I have had many chronic pain patients tell me that they have undergone previous trials of physical therapy, acupuncture, counseling, etc.  Upon more detailed questioning, it was determined that the physical therapy consisted of six sessions of modalities, the acupuncture was one or two sessions, and the pain “counseling” involved several sessions of marital therapy that was really unrelated to the pain condition.  In this situation, there has really been no reasonable trial of previous non-opioid treatments. 

 

What was the reason the treatments were discontinued and why did they fail?  It is important for the clinician to get an understanding of why previous treatments have not been successful or if any treatment provided benefit at all.  One of the critical issues for treating chronic pain patients is determining the individual’s willingness to participate in his or her own treatment.  Often, pain patients will take a passive attitude consistent with a guiding principle of “fix the pain and then I will start doing things for myself.”  If the individual shows a pattern of essentially dropping out of treatment due to a lack of motivation or non-compliance, this can be a critical issue relative to COT. 

 

Did any treatment provide any benefit?  On occasion, the patient will report that there was a particular treatment that did provide benefit, but it was discontinued through some factor essentially out of his or her control.  For instance, I had a patient who was regularly attending a swimming exercise class and found it very beneficial in terms of helping with her pain and improving her function.  Unfortunately, continued authorization for this intervention was denied by the insurance carrier (even though it was extremely cost-effective therapy) and the patient stopped the self-guided treatment.  Through a series of problem solving sessions, we were able to establish another method for her to obtain the same exercise while paying a minimal amount out of pocket.  In a case like this, the patient may be a reasonable COT candidate and the program would include having her return to the previously successful non-opioid treatment (water exercise).  This combination approach might result in being able to maintain the patient on the lowest opioid dose possible (“opioid sparing”) while achieving the best results.   

 

As can be seen, more detailed questioning regarding the patient’s response to previous treatments can provide a wealth of information about (1) how the patient approaches his or her chronic pain problem, (2) whether a previously successful or partially successful treatment might be attempted again prior to initiating COT and (3) whether augmenting non-opioid treatments with the COT might help enhance the overall outcome. 

 

Of course, in a busy medical practice, physicians will often recoil at the idea of gathering this type of detailed information.  This is largely due to the time constraints that are placed on the clinician within this type of practice.  This issue can be addressed in several ways.  For instance, we will often use some type of chronic pain patient questionnaire that simply lists these questions and encourages the patient to answer them in detail.  These questionnaires can be taken home and completed by the patient at their leisure so that adequate information can be obtained.  The questionnaire can then be used as the basis for an efficient clinical interview.  If the physician works in conjunction with a mental health professional, much of this information can be gathered by that individual.  Any mental health professional working in this capacity should have knowledge and experience relative to working with this patient population.

 

Impact on Level of Function and Quality of Life

 

All of the guidelines and clinical research suggest that individuals being considered for COT should show pain that is significantly interfering with their quality of life and overall level of function.  Even so, I have found that this is rarely objectively addressed either in the initial evaluation or as part of monitoring a patient’s response to COT.  This is probably the case since it is perceived as taking more of the clinician’s time and being difficult to evaluate.  Even so, it is probably one of the more critical factors in chronic opioid therapy.  I will routinely ask a patient to describe his or her “typical day” in a brief assessment of level of function.  More often than not, one will obtain an answer similar to the following: 

 

I get up out of bed at various times in the morning depending on my pain and how I have slept the previous night.  I may get out of bed anywhere from 3 AM to noon.  I will take my pain medication and return to bed for 30-60 minutes “until it starts working.”  I will then have breakfast and spend the rest of the day at home, since I am unable to do anything.  I will occasionally walk around the yard for exercise.  I do not have any hobbies or recreational activities.  I am “up all night” due to the pain.  Overall, I can’t do anything. 

 

As can be seen, in response to vague, open-ended questions about function, chronic pain patents will often be similarly vague in their responses.  Of course, this very low level in function rarely correlates with their actual daily activities.  A more objective assessment of the patient’s level of function can be obtained in several ways.  One of the most efficient methods is to use a brief self-report measure such as those listed in Table 6.  These measures do rely on the patient being open and honest relative to their level of function and this should be discussed as part of the instructions.  In addition, valuable information regarding a patient’s level of function can often be obtained from a significant other.  Again, these methods do not have to be particularly time consuming if a medical practice takes the time to set up COT assessment and monitoring tools that can be used on every patient. 

 

 

Table 6.  Assessments of Function

 

 

Patient Diary

 

A patient diary requires the most effort on the part of the patient and can be a good indicator of motivation and compliance.  The patient is basically asked to track, on a daily basis, variables associated with the chronic pain problem.  An example of a patient diary that tracks pain, function, and medication is the Pain and Activity Tracking Log and others track just pain and medication (Daily Pain Diary).  Many of these types of forms are available and the clinician can tailor the log to his or her own needs in managing patients. In many cases, hourly tracking is simply not feasible and compliance will be low.  Another method is to have the patient record pain intensity, activity and medication use at 3 or 4 intervals throughout the day (e.g. breakfast, lunch, dinner, bedtime). 

 

Clinician Assessed

 

Other measures of function are derived from the clinician at the time of a follow-up visit.  This information will not be as accurate as the patient diary and does not test for motivation or  compliance.  The Functional Progress Form is a charting tool used by the clinician to assess the patient’s functional progress at each office visit.  It is based upon the patient’s recount of function since the previous visit.

 

A more comprehensive measure is the Pain Assessment and Documentation Tool (PADT; download for free) which is designed as a structured progress note for patients in COT.  Although this will be discussed in more detail later in the course, it includes a clinician rated assessment of Activities of Daily Living (ADL; Better, Same, Worse) in response to the COT.

 

Brief Standardized Questionnaires

 

The Roland Morris Disability Questionnaire (RMDQ) is a commonly used measure to assess function in patients with back pain.  The Oswestry Disability Questionnaire is also used for this patient population. 

 

Other brief measures that have been used extensively in research to assess change in Mental Health and Function include the SF-36, the shorter version SF-12, and the new even shorter SF-8 (for those not familiar with these questionnaires, the numbers are the actual number of questions on the test).  All detailed information about these measures can be found at the web links.

 

More Lengthy Questionnaires

 

There are more lengthy assessments of function usually as part of a multidimensional questionnaire.  One example is the Activity Scales on the Multidimensional Pain Inventory (MPI; See also Evaluation and Treatment of Chronic Pain or QME Chronic Pain Management Evaluation and Treatment for a review of this test).  This test requires purchase (unlimited uses) and computer scoring, but does yield a wealth of information.

 

 

Risk Stratification and Risk-Benefit Assessment

 

Equally important to assessing a patient’s potential benefit from COT is careful evaluation of potential risks.  Some of the general risk factors have been outlined in Table 4 under the example of a poor candidate for COT.  These variables are listed in Table 7.  It should be noted that any one of these variables would not necessarily preclude COT.   Also, some of these variables have been associated with opioid misuse but there are likely intervening factors (e.g. the DUI conviction, younger age, and being male).  All of these risk variables are listed so that the clinician can complete a careful assessment.  As an example, a 27 year old male with one previous DUI conviction while in college and no other risk factors, might not be considered “at-risk”.  The evaluation depends upon the number, severity and patterning of risk factors.

 

 

Table 7.  Risk Factors for Opioid Misuse

 

 

The patient has not attempted previous non-opioid treatments, or has shown a lack of motivation when participating

 

The patient has taken opioids in the acute phase of pain and they were not beneficial

 

The pain diagnosis includes somatoform features (vague, diffuse, ill-defined, unclear pain generator, etc.).  Low threshold for an adverse bodily symptoms.

 

Limited stress management skills

 

The patient shows a history of personal or family substance abuse problems or is showing active alcohol or substance abuse

 

Current dysfunctional or chaotic living environment (drug abuse in a close

family member)

 

Regular contact with high-risk people (e.g., drug-using friends) or involvement with high-risk activities (e.g., regular time spent in a bar or on the street)

 

Previous criminal behavior

 

There is a history of psychiatric or psychological disorders

 

Previous DUI conviction

 

Male

 

Younger Age

 

Smoker or prior tobacco abuse

 

Legal, disability issues related to the pain

 

Poor social support

 

History of adverse childhood events (abuse)

 

In work injury cases, not worked greater than 6 months

 

 

Beyond general assessment of these factors, various brief self-report questionnaires have been developed to help assess a patient’s risk for aberrant opioid related behaviors. These types of assessments can be easily added to the clinician’s “tool kit” since they are free to obtain, brief, and easy to score.  These assessments are important as part of the initial evaluation and many can be used as part of periodic monitoring for aberrant opioid use behavior.  They also provide objective documentation that the issue of aberrant behavior has been assessed, documented, and (hopefully) addressed.  Two of the most commonly used self-report measures are presented in Table 8.  In addition to these self-report measures completed by the patient, there are also structured interviews completed by the clinician (See Passik and Squire, 2009 for a review).  Many clinicians prefer the self-report measure due to time savings.

 

 

Table 8.  Example of Self-Report Risk Assessment Screening Questionnaires

 

 

Test

 

Items

 

Description

 

 

ORT

 

 

 

 

 

 

 

 

 

SOAPP-R

 

 

 

 

 

 

 

 

 

 

 

 

10-items

 

 

 

 

 

 

 

 

 

24-items

 

 

 

 

 

 

 

 

The patient simply checks which items apply in areas of personal/family history of substance abuse, preadolescent sexual abuse, and “psychological disease”.  Items are weighted for scoring (e.g. being male will yield higher scores for certain variables).  The test predicts aberrant opioid behavior for chronic pain.  Scoring is as follows:

low risk (0-3)

moderate risk (4-7)

high risk (8-10)

 

Each question is answered from Never (0) to Very Often (4) giving a range of 0-96.  All 24 questions on the SOAPP have been empirically identified as predicting aberrant medication-related behavior 6 months after testing and starting opioid therapy.  Scoring is as follows:

not at risk (<9);

moderate risk (10-21 with more significance as scores approach 18);

high risk (greater than 22).

The test includes guidelines for managing patients that fall into each classification.

 

 

ORT- Opioid Risk Tool

SOAPP-R - Screener and Opioid Assessment for Patient with Pain-Revised

 

 

Putting it All Together

 

Once the above data is collected, the clinician will be able to make a reasonable assessment of pain severity, the pain’s impact on the patient’s level of function, the patient’s response to previous treatments, and a benefit-to-risk ratio relative to considering a COT trial.  This type of assessment also provides valuable baseline data against which the efficacy of the COT intervention can be periodically assessed. 

 

Based on this comprehensive assessment, risk stratification can also be completed.  As discussed in the literature, a moderate to high risk patient does not necessarily preclude COT treatment.  However, it does require that the COT intervention be modified accordingly.  Management of the high risk patient will be reviewed in more detail subsequently.  As discussed by Passik (2009, p. 596) “on the assumption that every patient has a degree of risk, a universal precautions approach is advised, beginning with a thorough risk assessment for every patient who is to be prescribed opioid therapy for chronic pain.”  Passik goes on to state that “risk management comprises a suite of assessment, monitoring, and treatment tools that need to be considered for each patient and individualized as clinically indicated.” 

 

After the comprehensive evaluation is completed, a treatment plan is developed.  It is prudent to codify the treatment plan in an opioid treatment agreement (OTA) or chronic opioid therapy contract (OTC).  This should also achieve appropriate informed consent for patient participation.  An opioid treatment agreement generally includes the rationale for COT, the benefits and risks, minimizing side effects, and expectations of the patient and physician (Passik, 2009).  A written OTA is recommended and is consistent with informed consent, good practice, and meeting the guidelines of various regulatory agencies such as the Federation of State Medical Boards (document related to use of controlled substance for the treatment of pain can be found here).  According to most guidelines (e.g. Chou et al., 2009) the OTA should at least address the issues as described in Table 9. 

 

 

Table 9. Example Components of an Opioid Treatment Contract

 

 

Specific goals of the therapy

How the opioids will be prescribed and taken

Expectations for follow-up and monitoring

Alternative treatments to opioid therapy

Expectations regarding use of concomitant therapies

Potential indications for tapering or discontinuing COT 

failure to make progress towards therapeutic goals

intolerable adverse effects

repeated or serious aberrant drug-related behaviors 

 

 

The OTA contract should also include other issues relative to the clinician’s practice including such things as obtaining prescriptions from one designated pharmacy, random urine drug screens; office visits at a specified minimal interval, use of pills counts, limiting prescriptions in appropriate cases (e.g. weekly, biweekly, monthly), and enumeration of behaviors that may lead to discontinuation of opioids.  Since there is increasing awareness that theft from medicine cabinets is a major source of diverted opioids, patients should be encouraged to lock their medications in a secure fashion. 

 

There are many template examples of chronic opioid therapy contracts and opioid therapy agreements.  One has to simply complete an Internet search for “sample opioid contract” to obtain many examples.  These templates can be easily modified for the clinician’s individual practice and various contingencies appropriate to the individual patient can be easily included.  I believe it is important to underscore that using a boiler-plate COT contract for each and every patient is probably not the highest standard of care.  Ideally, the agreement would be slightly modified and individually tailored for each patient.  Again, this does not have to be an onerous task nor does it have to be time consuming.  Table 10 shows a simple example of a generic contract although I have found those that are 10 pages long (contract). When designing an opioid contract, it is important to keep in mind  readability and comprehension by the patient.  Some research has indicated that the reading level for most OTC’s is grade 13.8 (Passik and Squire, 2009).  Lower literacy opioid contracts (grade 7 reading level) have been developed and validated (Wallace et al., 2007).  The nature of the clinician’s practice will determine what type of OTC template is appropriate.

   

 

Table 10. Sample Opioid Treatment Contract

 

 

This is an agreement between (the patient) and (the doctor) concerning the use of opioid analgesics (narcotic pain-killers) for the treatment of a chronic pain problem.  The medication will probably not completely eliminate my pain, but is expected to reduce it enough that I may become more functional and improve my quality of life.

 

I understand that opioid analgesics are strong medications for pain relief and have been informed of the risks and side effects involved with taking them.

 

In particular, I understand that opioid analgesics could cause physical dependence.  If I suddenly stop or decrease the medication, I could have withdrawal symptoms (flu-like symptoms such as nausea, vomiting, diarrhea, aches, sweats, chills) that may occur within 24-48 hours of the last dose. 

 

I understand that opioid withdrawal is quite uncomfortable, but not a life-threatening condition.

 

I understand that if I am pregnant or become pregnant while taking these opioid medications, my child would be physically dependent on the opioids and withdrawal can be life-threatening for a baby.

 

Overdose on this medication may cause death by stopping my breathing; this can be reversed by emergency medical personnel if they know I have taken narcotic pain-killers.  It is suggested that I wear a medical alert bracelet or necklace that contains this information.

 

If the medication causes drowsiness, sedation, or dizziness, I understand that I must not drive a motor vehicle or operate machinery that could put my life or someone else's life in jeopardy.

 

I understand it is my responsibility to inform the doctor of any and all side effects I have from this medication.

 

I agree to take this medication as prescribed and not to change the amount or frequency of the medication without discussing it with the prescribing doctor.  Running out early, needing early refills, escalating doses without permission, and losing prescriptions may be signs of misuse of the medication and may be reasons for the doctor to discontinue prescribing to me.

 

I agree that the opioids will be prescribed by only one doctor and I agree to fill my prescriptions at only one pharmacy.  I agree not to take any pain medication or mind-altering medication prescribed by any other physician without first discussing it with the above-named doctor.  I give permission for the doctor to verify that I am not seeing other doctors for opioid medication or going to other pharmacies.

 

I agree to keep my medication in a safe and secure place.  Lost, stolen, or damaged medication will not be replaced.

 

I agree not to sell, lend, or in any way give my medication to any other person.

 

I agree not to drink alcohol or take other mood-altering drugs while I am taking opioid analgesic medication.  I agree to submit a urine specimen at any time that my doctor requests and give my permission for it to be tested for alcohol and drugs.

 

I agree that I will attend all required follow-up visits with the doctor to monitor this medication and I understand that failure to do so will result in discontinuation of this treatment.  I also agree to participate in other chronic pain treatment modalities recommended by my doctor.

 

I understand that there is a small risk that opioid addiction could occur. This means that I might become psychologically dependent on the medication, using it to change my mood or get high, or be unable to control my use of it. People with past history of alcohol or drug abuse problems are more susceptible to addiction.  If this occurs, the medication will be discontinued and I will be referred to a drug treatment program for help with this problem.

 

I have read the above, asked questions, and understand the agreement.  If I violate the agreement, I know that the doctor may discontinue this form of treatment.

 

 

This is another area where a mental health professional working in conjunction with the physician can provide significant assistance.  I work closely with many physicians who provide COT and will often participate in a multidisciplinary initial assessment as well as the appropriate monitoring to assess the impact of the intervention.  Mental health professionals typically spend much more time with the patient than do physicians and, as such, are in a unique position to provide important initial evaluation data as well as assistance in “monitoring” the treatment.  Part of this process includes making sure the patient understands the treatment contract. 

 

Establishing Personally Relevant Goals

 

Another important concept relative to the success of COT is helping the patient establish “personally relevant goals” (Nicholas et al., 2006).  This is consistent with what we discussed previously relative to establishing concrete, definable, and measurable functional goals.  This can be done in a general fashion through the use of the various questionnaires discussed previously.  These questionnaires give some indication of a patient’s overall level of function; however, they do not establish behaviors and goals that are important to the individual patient.  Establishing personally relevant goals at the initiation of COT is important for the patient as well as the practitioner.  Goals should not only be personally relevant but also “cast in terms of their specificity, achievability, and measurability” (Nicholson et al., 2006, p. 142).  Passik (2009) discusses defining goals in terms of the SMART acronym.   The definition and examples of  SMART goal setting can be seen in Table 11.

 

 

Table 11.  Defining Functional Goals

 

 

 

 

Good Example

 

 

Poor Example

 

 

S

 

Specific

 

Return to work at previous job or similar.

 

 

Get some type of job “when I feel better”

 

M

 

Measurable

 

Return to work beginning with 3 hours per day and gradually increasing.

 

 

Find a great job and enjoy my life more

 

 

 

A

 

Achievable

 

Return to work 3 hours per day initially with restrictions and modifications

 

Change careers to become a writer-director of feature films. Something I’ve always wanted to do.

 

 

R

 

Relevant

 

Return to previous job or similar for which the patient has appropriate skills

 

 

Make money so I can buy the boat I have always wanted

 

 

 

T

 

Time-Bound

 

Initiate return to work trial within one month of initiation of COT

 

 

Find a career “when I feel better”

 

 

 

Adverse Effects

 

Opioids are associated with side effects ranging from mild to severe.  Any patient on long term chronic opioid therapy must be warned about possible adverse effects and the clinician must manage these appropriately.  A review article of opioid side effects by Benyamin et al. (2008) can be printed for free.  Table 12 shows some of the more common side effects that occur in opioid therapy.  Other adverse effects such as tolerance and hyperalgesia are discussed elsewhere. It is important for all clinicians involved in the patient’s care (e.g. physician, mental health professional, nurse, etc.) to be aware of these side-effects and assess for them on a routine basis.

 

 

Table 12. Common Adverse Side Effects to Opioids

 

 

Constipation

 

The most common and persistent side effect from opioids is bowel dysmotility leading to constipation. Constipation occurs in 40% to 95% of patients treated with opioids.  Associated symptoms might include difficult or painful elimination, abdominal discomfort, bloating and distention, hemorrhoids, rectal pain, nausea and anorexia. Rarely, constipation progresses to serious complications such as bowel obstruction and rupture.  Unlike other side effects (e.g. nausea, sedation), constipation is unlikely to improve over time and must be managed throughout opioid treatment.

 

Nausea and vomiting

 

Nausea may occur after the administration of an opioid; however, tolerance usually develops rapidly. Some patients experience symptoms severe enough to interrupt treatment and a small proportion have symptoms that are persistent and difficult to manage despite a trial of different agents. Nausea and vomiting have many etiologies, and potential contributing factors should be evaluated if it is suspected that the opioid is not the entire explanation. Other abnormalities, such as electrolyte disturbances, gastritis, gastroesophageal reflux, or other intra-abdominal pathology, also should be addressed.

 

Somnolence and cognitive impairment

 

Initiation of opioid therapy or significant dose escalation can cause somnolence or mental clouding, which typically wanes over a period of days or weeks. However, some patients continue to have problems, particularly if other contributing factors exist.  Somnolence can range from mild (merely a tendency to fall asleep when not active) to severe. Cognitive impairment may range from slight inattention to disorientation, severe memory impairment, or extreme confusion.  Some patients also experience mood disturbances associated  with opioid use including dysphoric/depression or euphoria/ hypomania.

 

Myoclonus

 

Myoclonus is a movement disorder described as focal or generalized, sudden, brief, shock-like, involuntary movements caused by muscle contractions.  Myoclonus is a common dose-related adverse effect of opioids. It is associated with somnolence and cognitive impairment and, like these problems, is often determined by multiple factors.

 

Pruritus

 

Opioid-induced pruritus (itching) can occur with any opioid and is believed to be caused by opioid-mediated release of histamine from mast cells.

 

Dental Effects

 

Xerostomia (dry mouth) is defined as a lack of saliva in the mouth and can be caused due to a variety of reasons, one of which is long term opioid use.  The functions of saliva include lubrication, taste mediation, digestion, re-mineralization of teeth and an antimicrobial role. Changes to saliva can have a significant impact on the patient’s quality of life as well as dental health.   The clinical signs of xerostomia can include red (erythematous) oral mucosa which is dry and maybe ulcerated often secondary to trauma. Rampant dental caries (decay) requiring extensive restoration of teeth is a common clinical occurrence. Patients placed on COT are rarely warned about the occurrence of xerostomia, the severe dental side-effects and the preventive treatment options that might be available.

Neuroendocrine effects

 

Opioids can interfere with the functioning of the hypothalamic-pituitary-adrenal axis and result in opioid-induced sexual dysfunction and other problems.  The prevalence of clinically significant effects related to these changes neuroendocrine changes, includes sexual dysfunction, fatigue, accelerated bone loss, and mood disturbance.  The role of replacement therapy is ill-defined, but again, a trial of replacement therapy could be justified if pain relief is satisfactory and symptoms that could be addressed by exogenous hormone therapy undermine quality of life.

 

Immunologic Effects

 

Opioid analgesics have effects on immune function. It is known that acute and chronic opioid administration can cause inhibitory effects on antibody and cellular immune responses, natural killer cell activity, cytokine expression and phagocytic activity.

 

Respiratory Depression

 

Respiratory depression is rarely a problem when opioids are administered according to accepted guidelines. Tolerance to this effect usually develops quickly, allowing rapid escalation of the dose by typical increments in the range of 30% to 100% of total daily dose. Combination of opioids with benzodiazepines, barbiturates, and other sleep-inducing or hypnotic drugs requires an added measure of caution because of synergistic effects.  The risk of adverse respiratory effects is often preceded by lowered respirations and other signs of central nervous system depression, including somnolence, cognitive impairment, and myoclonus. These signs usually provide a warning that the patient is at risk.

 

 

Initiation and Titration

 

The COT trial can be initiated once the patient is determined to be a reasonable candidate, and a treatment agreement including risk stratification has been established.  The expectation of both the physician/clinician and the patient should be that the COT will initially be implemented on a trial basis.  This initial course of treatment with opioids for CNCP should be viewed as a short term, therapeutic trial lasting from several weeks to several months (Chou et al., 2009).  The decision to continue with the COT program will be dependent upon the patient’s response to this initial trial in terms of the various factors assessed as part of the comprehensive initial evaluation.  Response to the initial trial should be judged according to the following:

 

·         meeting therapeutic goals

·         presence of opioid-related adverse effects

·         changing in the underlying pain condition

·         changes in psychiatric or medical comorbidities

·         identification of aberrant drug related behaviors, addiction, or diversion

 

The therapeutic trial period includes individualizing the dose for the patient through incremental dose escalations until adequate results are obtained, while side effects are kept under reasonable control.  Although there is no definitive empirical evidence, the guidelines suggest that short acting opioids are probably safer for initial therapy since they have a shorter half life and may be associated with a lower risk of unintentional overdose.  There is also no evidence that any one opioid is superior to another for initial therapy.  Although there is inconsistent research support, clinical guidelines often suggest transitioning patients from short-acting to long-acting opioids for long term maintenance.  The idea behind this treatment approach is that the long-acting opioids will provide better coverage and control of the pain, are less susceptible to abuse, decrease the focus on pill-taking behavior, decrease the risk of addiction or abuse, and improve compliance. 

 

Assuming that a patient makes reasonable progress towards established goals during the therapeutic trial, he or she will gradually be transitioned to longer term maintenance.  Even during this stage, ongoing “monitoring” is essential for the success of COT. 

 

Monitoring

 

The monitoring of COT must be done on an individualized basis depending on the results of the initial evaluation and the patient’s response to the therapeutic trial.  This information will determine the nature of the monitoring aspect of the COT program.  Monitoring includes the routine assessment of various treatment outcome domains.  The monitoring program can be structured in many ways and includes a variety of different components.  Conceptually, the critical outcomes to assess relative to COT may be described as the four A’s of pain management.  These can be seen in Table 13. 

 

 

Table 13.  The Four A’s of Opioid Pain Management

 

 

Analgesia or the degree to which the patient reports persistent meaningful pain relief.

 

Activities or the degree to which the opioid therapy improves function.

 

Adverse events including side effects that may warrant discontinuation of therapy, activities, the patient’s progress towards the personally defined functional outcomes. 

 

Aberrant drug related behaviors or the degree to which the patient may be demonstrating opioid abuse issues. 

 

 

Many standardized and objective techniques have been developed to help the clinician evaluate the four A’s in an efficient manner.  Again, having this established as part of your COT “tool kit” or program beforehand will make the process much simpler and more effective.  Some of these approaches for multidimensional monitoring are as follows.

 

Objective Monitoring Tools

 

The Pain Assessment and Documentation Tool

 

The pain assessment and documentation tool (PADT; download for free) is a simple progress note format that incorporates the concept of the four A’s.  Completion of the PADT at each monitoring session documents that the clinician has evaluated each of the important domains individually.  The PADT is completed by the clinician although it appears some of it is amenable to a patient self-report format.

 

Analgesia.  Under the analgesia section, the patient is asked to rate his or her pain for average and worst levels over the past week.  The patient is also asked to assess the percentage of pain that has been relieved during the past week as well as whether the amount of pain relief is “enough to make a real difference in your life.” 

 

Activities of Daily Living.  Under the activities of daily living section, the patient’s functioning is assessed with the current pain reliever across six dimensions including physical functioning, family relationships, social relationships, mood, sleep patterns, and overall functioning.  Each of these categories is rated on a simple scale of “better, same, or worse.” 

 

Adverse Events.  Under the adverse events section, the clinician can rapidly evaluate whether the patient is reporting any side effects from the current medication treatment.  These include such things as nausea, vomiting, constipation, itching, mental cloudiness, sweating, fatigue, drowsiness, or “other.”  The patient is also asked to rate the severity of the side effects. 

 

Aberrant Drug Related Behavior.  The last section requires the clinician to acknowledge a review of possible aberrant drug related behaviors.  The clinician is instructed to check any of the items that are discovered during the course of interaction with the patient.  These include the such things as purposeful over-sedation, appears intoxicated, reports lost or stolen prescriptions, etc.   

 

Assessment and Specific Analgesic Plan.  At the conclusion of the progress note, the clinician will provide an overall impression as to whether the patient is benefiting from the COT or not.  Treatment recommendations can then be documented including such things as continuing with the current regimen, making an adjustment, or tapering and discontinuing the COT. 

 

The PADT provides a powerful method of objectively assessing and documenting a patient’s response to COT throughout the monitoring period.  The revised PADT is certainly an excellent way to rapidly assess the four A’s of pain management and to help monitor a patient’s response to COT.  Smith and Kirsh (2007) have discussed that there are also other objective measures that can help in the monitoring process.  These measures can be utilized depending on the individual treatment plan and the nature of the clinician’s practice.  These instruments are as follows: 

 

The Numerical Opioid Side Effect (NOSE) Assessment Tool

 

The NOSE is a ten question self-report measure completed by the patient in just a few minutes.  The NOSE includes ten common opioid side effect symptoms that the patient rates on a scale of 0 (not present) to 10 (“as bad as you can imagine”).  Through the use of this type of instrument, the clinician can rapidly evaluate the presence and severity of any opioid side effects.  In addition, if the goal is to attempt to get the side effects under control, their severity can be monitored from visit to visit through the use of the ten point rating system.  Again, this is easily administered to the patient, can be quickly reviewed by the clinician, and provides ongoing documentation in the chart relative to the monitoring of adverse side effects. 

  

 

Numerical Opioid Side Effects (NOSE) Assessment Tool

 

 

 

Not

Present

               

 

As Bad As

You Can

Imagine

 

 

0

1

2

3

4

5

6

7

8

9

10

Nausea, vomiting and/or lack of appetite

 

 

 

 

 

 

 

 

 

 

 

Fatigue, sleepiness, trouble concentrating, Hallucinations, and/or drowsiness/somnolence

 

 

 

 

 

 

 

 

 

 

 

Constipation 

 

 

 

 

 

 

 

 

 

 

 

Itching 

 

 

 

 

 

 

 

 

 

 

 

Decreased sexual desire/function and/or

Diminished Libido

 

 

 

 

 

 

 

 

 

 

 

Dry Mouth

 

 

 

 

 

 

 

 

 

 

 

 

Abdominal pain or discomfort/cramping

or bloating

 

 

 

 

 

 

 

 

 

 

 

Sweating

 

 

 

 

 

 

 

 

 

 

 

 

Headache and/or dizziness

 

 

 

 

 

 

 

 

 

 

 

 

Urinary retention

 

 

 

 

 

 

 

 

 

 

 

 

 

Reprinted by permission from Howard S. Smith, MD.  In Smith and Kirsh (2007).  Documentation and potential tools in long-term opioid therapy for pain.  The Medical Clinics of North America, 91, p. 216.

 

 

The Translational Analgesic Score (TAS)

 

As discussed by Smith and Kirsh (2007), “Translational Analgesia refers to improvements in physical, social, or emotional function that are realized by the patient as a result of improved analgesia, or essentially what did the pain relief experience by the patient translate into in terms of perceived improved quality of life” (p. 218).  In essence, the concept of translational analgesia is exactly what we were discussing previously relative to how much the COT therapy helps the patient achieve functional (SMART) goals and improved quality of life.  Again, this goes far beyond the simple reassessment of a pain rating. 

 

Smith and Kirsh (2007) discuss the issue of a patient who may have pain ratings that decreased from 9 (0-10) to 8 (0-10) after escalating a dose of long acting morphine.  Even so, the patient, and the patient’s family cannot describe any significant “translational analgesia” relative to function in any domain.  The authors go on to state that a patient with chronic pain who may report a one point decrease in pain rating as a result of the COT, but continues to be unable to “get off the couch” should not be considered a therapeutic success.  In these patients, after taking all factors into account, it may be reasonable to conclude that the COT intervention was a failure and the individual may do better being tapered off of the opioids.  This decision may be based not only due to the fact that “translational analgesia” was not achieved, but also the risk of more serious side effects with longer term COT such as hyperalgesia (to be discussed subsequently) and other problems. 

 

The TAS is a patient generated self-report instrument that attempts to quantify the degree of “translational analgesia.”  It is designed to be rapidly completed by the patient prior to the clinician visit.  The patient simply answers ten questions (0-10 scale for each) that assess his or her estimation of how much the pain treatment has improved ability to complete such tasks as daily activities, concentration or work, improvement in mood, improvement in sleep, etc.  The overall TAS score is simply the average of the ten responses. 

 

 

Translational Analgesia Score (TAS)

 

 

INSTRUCTIONS.  For each of the following questions – respond by comparing your current state over the past month to your baseline state before you started your current treatment regimen by circling a number  from 0 to 10 with (0) being no improvement and 10 being maximal improvement.

 

 

Over the past month, my pain treatment has improved my ability to do usual daily activities—including household work, work, school, and/or social activities.

 

0      1      2      3      4      5      6      7       8      9      10

 

Over the past month, my pain treatment has improved my ability to concentrate on work or daily activities

 

0      1      2      3      4      5      6      7       8      9      10

 

Over the past month, my pain treatment has improved the degree to which I feel too tired to do work (feeling that I could not get going and everything I do is an effort), or too tired to perform daily activities, and/or socialize because of my pain.

 

0      1      2      3      4      5      6      7       8      9      10

 

Over the past month, my pain treatment has improved the degree to which I feel distress, restless, agitated, or could go and lie down and/or be alone because of my pain.

 

0      1      2      3      4      5      6     7       8      9      10

 

Over the past month, my pain treatment has improved my mood or feelings of being: depressed, frustrated, anxious, irritable, tense, hopeless, annoyed, or just plain fed up because of my pain.

 

0      1      2      3      4      5      6      7       8      9      10

 

Over the past month, my pain treatment has improved my ability to sleep.

 

0      1      2      3      4      5      6      7       8      9      10

 

Over the past month, my pain treatment has improved my ability to walk, sit, and/or stand for long periods.

 

0      1      2      3      4      5      6      7       8      9      10

 

Over the past month, my pain treatment has improved my ability to go up stairs, and/or move or lift objects.

 

0      1      2      3      4      5      6      7        8      9      10

 

Over the past month, my pain treatment has improved the extent to which my pain interferes with optimal interpersonal relationships and/or intimacy?

 

0      1      2      3      4      5      6      7       8      9      10

 

Over the past month, to what degree have you, your significant other, your family, your co-workers, and/or your friends noticed any improvement in your socializing, recreational activities, physical functioning, concentration, mood, interpersonal relationships, activities of daily living, and/or overall quality of life?

 

0      1      2     3      4      5      6      7       8      9      10

 

Please write below specific examples of things you can now do or currently do frequently that you couldn’t do or only did rarely when your pain was not controlled as well as it is now:

 

 

 

TAS = _____

 

 

Scoring.  If all the questions are answered, the sum of responses will range from 0-100.  The scoring is very straight forward: it is the average of all of the response values (range 0-10).  A patient scoring at or near 0.0 represents a sub-optimal therapeutic result in terms of translational analgesia.  More success is documented as the score approaches 10.0.  Certain patients will not be able to complete some of the activity-related questions due to medical issues other than the chronic pain.  In these cases, the Mean of just the questions answered may be used (e.g. Sum of Questions Answered/Total Questions).  The clinician must determine that all appropriate questions have been answered.  

 

 

Reprinted by permission from Howard S. Smith, MD.  In Smith and Kirsh (2007). Documentation and potential tools in long-term opioid therapy for pain.  The Medical Clinics of North America, 91, p. 220-222.

 

 

The TAS measure is just one follow-up questionnaire that might be used to assess this concept of “translational analgesia.”  As discussed previously, any one of the brief measures of function might also be applicable depending on the patient population (e.g. back pain, complex regional pain syndrome, headache, etc.).  The issue of which measure to use is really up to the individual clinician and the nature of his or her practice.  The translational analgesia concept underscores the need for some type of assessment of functional response to the COT at each of the follow-up monitoring sessions.  It is also most prudent to document this in some type of operationalized format rather than simply asking the patient “are you doing more as a result of your opioid therapy.”  Patients simply do not respond in concrete and measurable terms when asked these types of open ended questions. 

 

The SAFE Score 

 

Dr. Smith has also developed a concept of a SAFE score, which is an acronym for Social, Analgesia, Function, and Emotional domains.  Basically, each of the domains is rated by the clinician on a scale of 1-5 (1= excellent and 5=poor).  As discussed by Smith and Kirsh (2007), “the goals of the safe tool are multi-fold.  Specifically, they include the need to demonstrate that the clinician has routinely evaluated the efficacy of the treatment from multiple perspectives; guide the clinician toward a broader view of treatment options beyond adjusting the medication regimen; and document the clinician’s rationale for continuation, modification, or cessation of opioid therapy” (p. 224).  Again, the SAFE assessment during monitoring of COT is one of many methods to document that the multiple treatment outcome domains are being appropriately and regularly assessed.  In routine practice, my guess is that this is rarely done in an objective and systematic fashion. 

 

 

SAFE Clinician Assessment

 

 

Domain

 

 

Rating

 

Criterion

 

 

SOCIAL

Marital, family, friends, leisure, recreational

 

 

 1         2          3         4        5

 

supportive                         conflictual

harmonious                        discord

socializing                          isolated

engage                              bored

 

 

ANALGESIA

Intensity, frequency, duration

 

 

 

 

 1         2          3         4        5

 

comfortable                        intolerable

effective                             ineffective

controlled                           uncontrolled

 

FUNCTION

Work, ADL’s, home management, school, training, physical activity

 

 

 

 1         2          3         4        5

 

independent                        dependent

active                                 unmotivated

productive                           passive

energetic                             deconditioned

 

 

EMOTIONAL

Cognitive, stress, attitude, mood, behavior, neuro-vegetative signs

 

 

 

 1         2          3         4        5

 

clear                                    confused

relaxed                                 tense

optimistic                              pessimistic

upbeat                                  depressed

composed                             distressed

 

 

TOTAL SCORE

 

 

 

INSTRUCTIONS: Rate the patient in each of the four domains as follows: (1) Excellent, (2) Good, (3) Fair, (4) Borderline, (5) Poor

 

 

CATEGORY-

 

_______

 

 

 

 

 

 

 

 

 

GREEN ZONE – Considered to be doing well- Defined as a score between 4 and 12, or a decrease of 2 points in total score from baseline.  Maintain Treatment.

 

YELLOW ZONE – Defined as a Total Score between 13 to 16, or a rating of 5 in any category, or an increase of 2 or more points from baseline.  Increase monitoring and frequency of visits.

 

RED ZONE – A Total Score greater than or equal to 17. A change in the treatment is indicated.

 

 

Reprinted by permission from Howard S. Smith, MD.  In Smith and Kirsh (2007). Documentation and potential tools in long-term opioid therapy for pain.  The Medical Clinics of North America, 91, p. 223.

 

 

The “take home” message relative to monitoring is that the clinician should seek to routinely and objectively assess the four A’s at each follow-up visit.  If developed ahead of time, a monitoring program can be done effectively and efficiently through the use of these various instruments.  Not only do they help guide the treatment, but also provide important documentation that is necessary for COT interventions. 

 

Additional Methods of Monitoring

 

The previous discussion of a monitoring program generally includes data that is either supplied by the patient or gathered through self-report measures during the follow-up clinical visit.  Although gross indicators of aberrant opioid misuse may be determined during the course of the follow-up clinical visit (e.g. obvious sedation and mental clouding due to opioid overuse as noticed on direct observation), objective measures are also useful.  As the risk score of the patient increases, the clinician must rely on additional monitoring techniques.  Some additional monitoring techniques are as follows:

 

Urine Drug Tests

 

As discussed in the Guidelines (Chou et al., 2009), occasional urine drug testing (UDT) can be a helpful tool in monitoring patients on COT.  It is advised that UDT be done on a random basis since scheduled or routine testing will allow patients to change their behavior in response to being tested.  As discussed by Passik (2009), UDT’s can be particularly useful for patients who are demonstrating an inadequate response to the COT or being treated with opioid analgesics on a long term basis.  In addition, the use and frequency of UDT can be adjusted depending on the features of the specific patient.  For instance, the patient who has been successfully maintained on a stable dose of opioids for several months, has no identified risk factors for aberrant behavior, and is showing progress towards specified goals, could likely be managed with minimal UDT.  On the other hand, if a patient had a difficult time with the therapeutic trial, has a history of substance abuse problems, and shows some indicators of possible aberrant behavior, then frequent UDT may be indicated.  UDT really serves three purposes and answers the following questions: 

 

Is the patient taking the opioids as prescribed? 

 

Is the patient utilizing other substances that are not prescribed or are illicit?

 

Is the patient showing any evidence of diversion? 

 

In this instance, diversion is defined as “redirection of a prescription drug from its lawful purpose to illicit use and can be done with criminal intent.”  In my practice working with physicians who provide COT, I have had on more than one occasion a patient who ultimately admitted to selling the medication on the street after the UDT came back negative for opioids even though the patient was on a COT program.  In these cases, the patients were often financially distressed and at $80.00 per Oxycontin pill, the illicit income can be quite significant.  Other interesting data came from a colleague of mine who directs a chronic pain management center.  He recently completed a study in which every patient presenting for treatment was tested for opioid medications.  Of all the patients who verbally reported they were on some type of chronic opioid therapy, about 33% actually demonstrated no evidence of opioids in their system.  Therefore, they were either not taking the medication as prescribed, or engaging in some type of diversion behavior. 

 

All of these important factors underscore the usefulness of UDT in a practice that provides chronic opioid therapy.  In fact, many pain physicians who provide COT on a frequent basis simply require that all patients undergo UDT as part of the treatment program.  The schedule of randomized UDT testing is adjusted based on risk factors. 

 

Pill Counts

 

Another fairly simple method is “pill counts.”  For instance, a patient may be given a certain supply of medication (e.g. one month), but be required to follow-up in the clinic every two weeks.  During those follow-up times, a count of the pills would be required to determine that the patient is taking the medication as prescribed.  This is essentially an intermediate step between allowing a patient a one month supply without in-between monitoring versus dispensing medication only on a weekly basis.  Counting the pills in this manner ensures that the patient is not escalating the dose. 

 

Report from family members.  An excellent source of information that is often underutilized is obtaining information from family members.  This is a role in which the mental health professional working with the prescribing physician can be quite helpful.  In essence, the clinician can briefly interview the family member or significant other alone, just before the follow-up session with the patient.  During the follow-up session with the significant other, or family member, the clinician can get another viewpoint relative to the patient’s progress towards the four outcome domains discussed previously.  In my experience, there is often a marked discrepancy between the family member’s report of the patient’s progress and his or her own self-assessment. 

 

Prescription Monitoring Programs 

 

According to the U.S. Office of Diversion Control (2010 Report), 34 states have some type of prescription monitoring programs in place and an additional 5 states have such programs under proposal.  These programs vary greatly in terms of their structure, sophistication, and clinical utility.  For instance, some states allow the physician access to a patient’s prescription data at any time and collects new data twice per month; while others require as long as six months to fill information requests by physicians.  Given these issues, and the ability for patients to “slip through the cracks,” the clinician should not rely entirely on a prescription monitoring program to ensure that aberrant opioid abuse behaviors are not occurring.  It is simply one more tool that is available to the clinician relative to COT.

 

Breakthrough Pain

 

The concept of “breakthrough pain” (BTP) involves the patient who is stabilized on an around-the-clock  regimen and occasionally experience pain exacerbations that “breaks through” the medication.  When breakthrough pain occurs, the first task is to ensure that there has not been a progression of the disease process or injury that requires medical attention.   Once that has been ruled out, the clinician should attempt to determine the reason for the BTP.   Breakthrough pain is often classified as follows:

 

Spontaneous – Idiopathic in nature and not related to any provoking cause.

 

Incident – Precipitated by an event

Volitional-Precipitated by increased activity or related to ADL’s

Non-volitional-Precipitated by an involuntary activity (e.g. coughing, breathing)

Procedural-Related to therapeutic intervention (medical procedure or other)

 

Analgesic dose-related - Due to decreased analgesic blood levels or drug-drug interactions.

 

Once the likely reason for the BTP is determined, medications and non-medication treatments might be utilized to assist with symptom management.  In the clinical research and Guidelines, short acting medications can be used on an as-needed bases for these occasional episodes.  Whenever this is done, the same risk-to-benefit evaluation must be completed and the reasons for the breakthrough pain established. 

 

There is limited research to guide the clinician in the use of breakthrough medication.  Certainly, nonpharmacological techniques should be considered, possibly even before adding more medication (See Table 5).  Generally, only patients with a lower risk profile should be considered for breakthrough pain medication therapy.  This is due to the fact that the short acting opioids, especially taken on an as-needed basis, open the door for abuse.  In addition, I have seen many patients who are on a long-acting opioid in addition to a short-acting acting opioid taking on a structured basis (e.g., tid).   For instance, a recent patient was on Oxycontin (bid; twice per day) for long term pain control and Norco (qid; four times per day) for “breakthrough pain”.  This medication regimen is not a breakthrough pain protocol even though I see it all the time.  In my experience, this increases a patient’s focus on “medication taking behavior” and can work against the achievement of functional goals (“wellness behaviors”).   The use of breakthrough pain medication regimens should be done cautiously; generally, only with lower risk patients, only as justified by increased function, and not done on an around-the-clock scheduling in addition to a long acting opioid formulation. 

 

Managing the High Risk Patient

 

One of the greatest concerns in any COT program is adequate management of the moderate to high risk patient.  As discussed previously, the presence of risk factors in a chronic pain patient does not necessarily preclude the use of COT; however, they certainly require a modification of the intervention approach.  In fact, utilizing strategies appropriate for a low risk patient on an individual who has demonstrated moderate to high risk factors would likely be considered below the standard of care and expose the clinician to a variety of problems while also endangering the patient.  This, again, underscores the importance of an adequate multimodal and often multidisciplinary initial evaluation of the patient to be sure that all factors have been adequately assessed. 

 

High risk patients involved in COT involve much more intense monitoring as can be seen in Table 14.  In these patients, the full arsenal of tools available to the clinician must be brought to bear.  This is absolutely essential since inadequate management of the high risk patient can lead to serious problems, including death.  The intensity and nature of the COT program can be adjusted based on the high risk patient’s progress and evidence of compliance with the treatment regimen.  In all cases involving high risk patients, the treatment should start out at an appropriate level of intensity with a decrease in monitoring as justified by objective evidence of compliance.  These decisions to modify the intensity of the program should be done cautiously and with sound clinical reasoning based on objective evidence. 

 

 

Table 14. Managing the High Risk Patient

 

 

·         Be sure an Opioid Treatment Agreement/Contract is established

·         Be sure the OTA documents all expectations of the patient

·         Be sure the OTA clearly lists reasons for COT discontinuation

·         Increase the frequency of visits

·         Increase the intensity of monitoring (with documentation)

·         Use compliance monitoring techniques

·         Limit prescription quantities

·         Consult with other specialists (e.g. addiction, psychological, psychiatric, etc.)

·         Use a multidisciplinary approach with open communication among professionals

·         Use a prescription monitoring program if available

·         Add psychotherapy (pain focused or other) as part of the intervention

·         Involve family members

·         Use a 12-step or similar program

·         When the contract is violated follow through on discontinuation

 

 

In the Guidelines (Chou et al., 2009) it is suggested that the occurrence of aberrant drug-related behavior always suggests the need for reevaluation and possibly a change in the treatment intervention.  However, the guidelines point out that aberrant drug related behavior varies in seriousness.  Aberrant drug related behavior may range from a slight dose escalation not consistent with how the medication was prescribed (e.g. running out of the opioid one or two days before the next scheduled follow-up) to very serious infractions including such things as obtaining medications from multiple physicians, concomitant use of illicit drugs, etc.  When aberrant drug related behavior is discovered, it must first be categorized based on its level of seriousness.  As discussed in the guidelines, “the response to aberrant drug related behavior reflects a clinical judgment about its seriousness, its cause or causes, the likelihood that behaviors of this type will recur, and the clinical context” (p. 119).  The panel members suggested that patients who are not assessed as being at high risk and engage in relatively non-serious aberrant behavior (one or two episodes of unauthorized opioid escalations) can often be successfully managed with patient education and enhanced monitoring.  However, it is suggested that for any risk level, when serious aberrant drug behavior is noted, a major restructuring or discontinuation of the therapy is most appropriate.  The Guidelines discuss that in one study, four or more previous aberrant drug related behaviors were a strong predictor of a current substance use disorder. 

 

Restructuring the COT intervention in response to aberrant drug behavior may be done in several ways and is most often individualized to the patient depending on what type of behavior has occurred.  In general, the intensity of any or all of the management principles for high risk patients as reviewed in Table 14 might be implemented.  If not already completed, the use of appropriate consultants should certainly be considered as part of the restructured program.  In these cases, a multidisciplinary approach is absolutely essential.  At this stage, the patient should also be made aware that if he or she is not compliant with the restructured program, then tapering and discontinuation of the opioids will commence.  These contingencies should be reviewed with the patient, documented in a revised opioid treatment agreement, and an updated opioid treatment contract signed.  If the patient is unwilling to accept the revised chronic opioid treatment plan, then tapering and discontinuation of the COT should commence immediately. 

 

Dose Escalation and Managing High Dose Patients

 

As discussed in the clinical research literature and summarized in the various guidelines, frequent dose escalations may be due to a number of factors and clinicians should evaluate potential causes in an effort to effectively address the problem.  Frequent dose escalations may not necessarily be due to substance abuse issues.  This type of aberrant medication use behavior may be due to a number of factors including the following:  A substance use disorder, diversion, or pseudoaddiction.  Each of these situations is managed differently in terms of treatment and, therefore, determining the reasons for the dose escalation is essential. 

 

Dose escalations due to a substance use disorder.  The presence of a substance use disorder should have been determined at the time of the initial evaluation.  However, since it is not a perfect clinical world, this is not always the case.  When the clinician observes frequent dose escalations, then a more intensive search for a possible substance use disorder should be completed.  Dose escalations can occur in basically two ways:  Under the guidance of the clinician or in a more patient driven manner.  In the first case, the patient will be compliant with the COT, but repeatedly report inadequate pain relief during the course of the monitoring follow-up sessions.  In response to these issues, the clinician will continue to escalate the dose in an effort to find the appropriate level of medication.  In the other case, the patient simply accelerates the dose and then either reports this to the clinician (running out early, requesting more medication in between office visits) or it is determined in some other fashion.  The most common example is the patient who frequently “runs out” of the pain medication well before the scheduled follow-up appointment.  In either case, the presence of a substance abuse disorder must be determined if that has not already been completed.  As discussed previously, if a substance abuse disorder is determined (or is already known), then frequent dose escalations would be handled in a specific manner.  For instance, the treatment agreement may be modified to include the requirement that the patient attend some type of 12 step program and the intensity of monitoring increased.  If a substance use disorder is suspected, then UDT frequency should be increased along with testing for other substances.

 

Diversion.  Diversion is defined as the redirection of a prescription drug from its lawful purpose to illicit use.  Diversion might include such things as selling the medication or giving it to family/friends.  In either case, the dose escalations are occurring in an effort to increase the supply of drugs for sale or distribution.  If diversion is suspected, then this should be objectified via the results of random UDT.  The UDT testing can also give the clinician an idea of exactly how much medication the patient is actually taking.  In these cases, once diversion has been established, it is generally most appropriate to taper the individual off whatever medication he or she may actually be taking and discharge from COT. 

 

The only instance where diversion may be successfully managed from a clinical standpoint is a situation in which the patient is utilizing a certain percentage of their medication appropriately (e.g. 60-70% of the prescribed dose) and then “diverting” the remaining 30-40% of medication to a family member who may also have chronic pain issues.  This is certainly illegal behavior, but I am familiar with more than one case in which a chronic pain patient was involved in COT treatment that was covered by insurance and was diverting some of the medication to a family member, who had chronic pain, was impoverished, and had minimal access to medical care.  Again, clearly illegal behavior, but in this situation, the physician discussed that this diverting behavior would not be tolerated, an updated opioid treatment agreement was established, and the patient was subsequently compliant (at the appropriate dose required which was actually 60% of the previous level due to the diversion).  This example is certainly not meant to provide guidance to the individual clinician; however, it does underscore the complexity of issues that can arise in this type of treatment. 

 

Pseudoaddiction.  Pseudoaddiction is an iatrogenic syndrome resulting from poorly controlled pain due to the fact that the patient is not receiving a medication level adequate to control his or her pain.  In response to this sub-therapeutic level of medication management, the patient will show behaviors generally associated with drug addiction that are actually driven by other issues.  In these patients, once adequate pain control is achieved, the behaviors diminish.  Pseudoaddiction behaviors are often very similar to those of addiction including such things as repeated requests to increase the dose, “increased pain behaviors,” as well as other “drug seeking” indicators.  These behaviors may even go to the extreme of being fairly egregious relative to the chronic opioid treatment contract such as obtaining pain medications from more than one provider.  As discussed by Passik and Squire (2009), patients who develop tolerance to the opioids may be predisposed to pseudoaddiction because they have a physical need for a higher dose that is met with ambivalence by the physician who is reluctant to provide more medication.  In these cases, the patients are being under-dosed and this leads to the pseudoaddiction behaviors. 

 

Distinguishing amongst these various causes for dose escalations can be quite difficult and is certainly not an exact science.  In these cases, the mental health professional, along with other consultants (e.g. an addiction specialist), can be quite helpful in determining diagnostic formulation and structuring future treatment. 

 

High Dose Opioid Therapy

 

As discussed in the various guidelines (see Guidelines; Chou et al., 2009), and the clinical research literature, from a theoretical standpoint, opioids have no maximum or ceiling dose.  In addition, there is little evidence to guide safe and effective prescribing at higher doses and there is no standardized definition of what constitutes a “high dose.”  By consensus of the panel (Chou et al., 2009, p. 120), it was asserted that a reasonable definition for high dose opioid therapy is greater than 200 mg daily of oral morphine or equivalent.  This was based on available research.  The panel discussed that when opioid doses reached 200 mg daily of morphine or equivalent, more frequent and intense monitoring is often appropriate.  At these higher doses, a multidisciplinary intervention is certainly critical.  This would include such things as non-opioid methods of pain control in an effort to augment the medication intervention.  Also, even more so than at lower doses, it is essential to routinely assess exactly what impact the high dose of opioid therapy is having on the patient’s life across multiple domains of function.  Certainly, the clinician would not want to be managing the patient on a high dose of opioid therapy and simply asking “how is your pain” at each follow-up monitoring visit.  Rather, all domains of COT outcome should be assessed including pain relief, improved function, well being, quality of life, etc.  At these higher doses, it is also essential that adverse side effects be routinely assessed and monitored more closely.  The patient must be informed about the risk of these side-effects through an updated opioid treatment agreement that is codified in a written contract and signed by the patient.  Some of the more significant side effects of opioid therapy, with greater risk at higher doses, have been listed in Table 12. 

 

Opioid Induced Hyperalgesia

 

Since opioid induced hyperalgesia (OIH) is one of the critical potential problems with high dose COT, it will be discussed in slightly greater detail.  The clinical features of opioid hyperalgesia can be seen in Table 15. 

 

 

Table 15.  Symptoms of Opioid Induced Hyperalgesia

 

 

Increasing sensitivity to pain stimuli (hyperalgesia)

 

Worsening pain despite increasing doses of opioids

 

Pain that becomes more diffuse and extends beyond the distribution of preexisting pain

 

Hyperalgesia can occur at any dose of opioid, but is more common with high parenteral doses of morphine or hydromorphone and/or in the setting of renal failure. 

 

The physical examination demonstrates pain elicited from ordinarily non-painful stimuli such as stroking the skin with cotton (allodynia).

 

OIH often includes the presence of other opioid hyper-excitability effects (myoclonus), delirium, or seizures.

 

 

It should be noted that the hyperalgesia results in “atypical pain that appears to be unrelated to the original nociceptive stimulus” (DuPen et al., 2007, p. 113).  Interestingly, although opioid induced hyperalgesia (OIH) has only recently been an area of focus in pain management (approximately the last ten years), it was observed as early as 1870 and documented by Albutt:

 

At such times I have certainly felt it a great responsibility to say that pain, which I know is an evil, is less injurious than morphia, which may be an evil.  Here experience is needed.  Does morphia tend to encourage the very pain it intends to relief?...In the cases in question, I have much reason to suspect that a reliance on hypodermic morphia only ended in that curious state of perpetuated pain.”  (As cited in Silverman, 2009, p. 680). 

 

Many researchers have suggested that tolerance and hyperalgesia present with similar clinical manifestations, but require a different approach in terms of management.  As discussed by DuPen et al. (2007), the essential clinical manifestation of opioid induced tolerance and hyperalgesia are essentially the same, including the fact that increasing opioid doses are required to achieve adequate analgesia (short term solution).  The authors also discuss some of the research indicating that there are similarities in the neuronal and cellular mechanisms that result in these conditions.  It is beyond the scope of this course to discuss the possible neurobiological mechanisms for opioid induced hyperalgesia and the reader is referred elsewhere (see Silverman, 2009, for a review).  Silverman also distinguishes between tolerance and hyperalgesia.  In addition, he discusses the difference between “primary” hyperalgesia and “secondary hyperalgesia.”  In this conceptualization, primary hyperalgesia is defined as sensitization to pain occurring in neural injury and involves mediators of inflammation at the peripheral level of the nervous system.  Silverman states that primary hyperalgesia is seen clinically with peripheral nerve injuries. 

 

Secondary hyperalgesia occurs as a result of neuronal changes at the spinal cord level and above.  Therefore, it may be conceptualized as more of a central phenomenon.  Thus, its origination and maintenance is due to changes relatively far removed from the site of injury.  Silverman makes the point that tolerance is characterized by decreasing efficacy of the drug that can be overcome by increasing the dose.  Although opioid induced hyperalgesia may be overcome in the short term by increasing the dose, it cannot be successfully treated in this manner over the long term; this approach will ultimately result in a worsening of the hyperalgesia.  In opioid induced hyperalgesia, the pain is actually worsened with increased opioid dosing and is improved by reducing or eliminating the opioid.  As concluded by Silverman (2009, p. 680), “tolerance is a necessary condition for OIH, but the converse is not true.  Clinically, this is an important distinction that has obvious ramifications with respect to continued use of opioids in a given patient.” 

 

Opioid induced hyperalgesia has been documented clinically and supported in animal models.  A review of the neurobiological mechanisms of tolerance and hyperalgesia are beyond the scope of this course and the reader is referred elsewhere (Silverman, 2009; DuPen et al., 2007).  Adequate treatment of opioid induced hyperalgesia first depends on accurately identifying the condition.  The clinician must have a thorough understanding of the differing clinical manifestations between tolerance, pseudotolerance, pseudoaddiction, and hyperalgesia (See definition of terms at the end of the course).  Once it is determined that hyperalgesia has occurred, appropriate steps can be implemented.  The interventions for these various conditions are quite different and an incorrect diagnosis or inaccurate conceptualization will lead to problems and a poor treatment outcome (e.g. treating hyperalgesia when it is actually tolerance).  As discussed by Silverman (2009), several features of opioid induced hyperalgesia may help the clinician differentiate it from other problems.  These are listed as follows: 

 

Rule out disease progression.  Opioid induced hyperalgesia must be differentiated from an increase in the preexisting pain due to further disease progression or tissue damage.  Hyperalgesia will exacerbate a preexisting painful condition and increase pain intensity above baseline levels.  Therefore, further disease progression needs to be ruled out since this might also result in an increased pain beyond previous levels. 

 

Rule out activity changes. The clinician must also rule out a process whereby the increased pain is due to an increase in activity or physical demands (similar to pseudotolerance).  This can be done by careful reexamination as well as the use of activity diaries. 

 

Quality of OIH pain.  Opioid induced hyperalgesia typically emerges as diffuse pain that is less defined in quality and generally extends to other areas of distribution beyond the preexisting pain.  The hyperalgesia is often characterized by a degree of sensitivity that is unlike what the patient was experiencing previously. 

 

Strategies For Managing OPIOID INDUCED Hyperalgesia

 

Once it has been identified, management of opioid induced hyperalgesia might include the following: 

 

·         Reducing or eliminating the opioid

·         Opioid rotation

·         Use of non-opioid medications to augment the COT

·         Use of non-pharmacological pain management techniques

 

Reducing and/or Discontinuing Opioid Therapy

 

The treatment of opioid induced hyperalgesia can be very time consuming for the clinician and frustrating for the patient.  Therefore, the best strategy is to attempt to avoid its emergence through careful monitoring and keeping the opioid doses at the lowest level possible while achieving the maximum benefit.  This is often done through the use of a multidisciplinary approach, even at the early stages of treatment.  When opioid induced hyperalgesia occurs, tapering and/or discontinuation of the opioids is one of the most common treatment approaches.  In this situation, a multidisciplinary approach is certainly reasonable.  Also, a referral to a pain management physician specialist who has expertise in this area is often indicated.  Tapering and/or discontinuing opioids in a patient who has been on COT for quite some time can be very challenging due to common problems including an increase in pain, withdrawal symptoms, resistance from the patient and family, among other things.  Symptoms of opioid withdrawal can be very unpleasant, but are generally not life threatening (Chou et al., 2009). 

 

If a patient is not on a particularly high dose of opioid, a gradual weaning can be quite successful.  However, this obviously requires a motivated and compliant patient.  Gradual weaning of the opioids can help avoid withdrawal symptoms.  Recommendations for a tapering schedule range from a slow 10% dose reduction per week to a more rapid 25-50% reduction every few days.  A gradual weaning tends to avoid withdrawal side effects (see the Guidelines for a review of these issues).  As discussed previously, and in the research literature, in cases where hyperalgesia has occurred, it is not uncommon to actually see an improvement in pain once the patient is off of the opioids.  I have seen this in many cases and will often tell patients at the beginning of the tapering program that it is not uncommon for patients to ultimately notice that their pain intensity is either unchanged or improved as the opioids are tapered and discontinued.  I will also discuss with patients that they will likely experience some of the benefits of being off of the opioids including remission of side effects such as mental cloudiness, anergia, constipation, etc.  The mental health professional working with the pain management physician is a unique position to provide this type of information since it helps to increase motivation and compliance with the tapering schedule.  It also involves a great deal of time on the part of the practitioner since the patient is not going to readily “believe” that these benefits will occur as a result of being tapered off of the opioids (which were originally prescribed to control their chronic pain).  As such, the clinical evidence must be reviewed with the patient in a redundant fashion along with research and patient education materials that are understandable by the lay person.  If the patient is accepting of this information, compliance with the tapering program is certainly enhanced and resistance to the idea is diminished.  Involvement of the mental health professional at this stage is also critical since the patient will necessarily need other non-opioid techniques to help manage the pain over the long term. 

 

Other methods of tapering and discontinuing opioids have also been developed.  Most recently, the use of buprenorphine has become quite common.  Buprenorphine is a partial opioid agonist with antagonistic properties which has been used for decades in anesthesia and for the treatment of pain.  It is commonly used in its sublingual form (Suboxone, Subutex) to treat opioid dependence and for the tapering and discontinuation of opioids.  Buprenorphine tapering and detoxification is most often administered by pain management physicians who have undergone specialized training in the use of this medication.  Typically, the opioids are discontinued and the patient is brought to a point of just beginning withdrawal symptoms when the buprenorphine therapy is initiated.  The patient is then tapered off the buprenorphine which is thought to be much more tolerable than tapering off of the opioids.  It is beyond the scope of this course to discuss all of the features of buprenorphine detoxification and the reader is referred elsewhere for more details such as US Department of Health and Human Services Guide for Nurses (114 pages); Sublingual buprenorphine in the treatment of chronic pain;  and guides for use in the VAMC.  

 

In some cases, discontinuation of opioid therapy, for whatever reason (hyperalgesia, side-effects, violation of the contract), may require a referral to a specialized program or facility.  If substance abuse issues are prevalent, then a structured inpatient chemical dependency program may be appropriate.  In other instances, referral to an outpatient center or other type of provider may be indicated. 

 

Opioid Rotation

 

Another strategy for managing opioid induced hyperalgesia, or patients who experience intolerable side effects to a particular medication, is termed “opioid rotation.”  Opioid rotation simply refers to the process of switching from one opioid to another.  The rationale of opioid rotation is based upon concepts of incomplete cross-tolerance to the analgesic and non-analgesic effects across opioids and the high degree of individual variation in response to different opioids (Chou et al., 2009).  For a number of reasons, a patient may develop tolerance, hyperalgesia, or side effects to one opioid that do not necessarily transfer to another opioid.  If this strategy is attempted, it is important to establish accurate analgesic equivalents using dose conversion tables.  In addition, opioid rotation protocols are available in the literature.  The Guidelines (Chou et al., 2009, p. 120) recommend that switching to a new medication should be accompanied by a moderate reduction in the calculated equianalgesic dose (usually 25-50%).  During the opioid rotation procedure, more intense monitoring of the patient may be appropriate. 

 

If the clinician is faced with a patient who has demonstrated dose escalation that is simply due to inadequate pain control, and not any aberrant issues, than developing a future COT treatment plan can be challenging.  Again, it is critical in these cases to add the services of other interventions that may help augment and potentiate the COT.  In conjunction with these non-opioid strategies, opioid rotation may be beneficial. 

 

Use of Adjunctive Medications

 

Even before any issue of opioid induced hyperalgesia emerges, the clinical research literature recommends the use of non-opioid adjunctive medications as appropriate.  The pain management literature is replete with research on non-opioid medications that have been shown to have analgesic properties.  It is beyond the scope of this course to review all of these medications and the reader is referred elsewhere (non-opioid treatment) in addition to the chronic pain management courses for an overview (Special issues in chronic pain treatmentQME chronic pain treatment issues).  Briefly, the two most common classes of non-opioid, non-analgesic medications that have been found to actually have analgesic effects include the anticonvulsants and antidepressants.  Although these medications have been researched for a variety of pain conditions, their effect may be most prominent for neuropathic conditions.  Even so, using them in conjunction with chronic opioid therapy may help keep the opioid levels to a minimum (“opioid-sparing treatments”) while enhancing the effect of the opioid.  When this type of polypharmacy is implemented, it is generally most appropriately done by a physician who has special expertise in this area.

 

As discussed in other courses, acetaminophen (Tylenol) is a very commonly used OTC analgesic both alone and compounded with other medicines.  In chronic pain patients, the acetaminophen is most often taken combined with some other analgesic. This is usually codeine (e.g., Tylenol #3), hydrocodone (e.g., Vicodin, Lorcet, Norco) or oxycodone (Percocet). It is generally recommended that patients not exceed a total of 4000 mgs per day of acetaminophen from all sources due to possible negative effects on liver function. It is important for the mental health clinician be aware of these issues, since he or she may be the first to uncover a problem. A common example might be the patient who is taking 5 Vicodin per day as prescribed by the physician (500 mg of acetaminophen per pill yielding 2500 total) and then decides to add an over the counter Extra Strength Tylenol with each dose to try and get better relief (5 per day at 500 mgs each yields 2500 total). The total dose is 5000 mg per day, which is well over the recommended amount. Add to this a patient who has an alcohol drink or two each evening and problems can develop. Often, the patient will not mention adding the OTC medications to their doctor and blood tests may not be regularly scheduled. When this is discovered, the issue must be discussed with the patient and a follow-up visit with the physician scheduled.

 

The Use of Non-pharmacological Treatments

 

The use of non-pharmacological pain management treatment should be considered long before a patient demonstrates aspects of opioid induced hyperalgesia.  There are a myriad of non-pharmacological pain management techniques and some of these are listed in Table 5.  Clearly, the use of these various techniques from the very beginning of treatment will help ensure a maximum response to the opioids, help prevent any problems, and produce the best clinical outcomes.  Unfortunately, in routine clinical practice, a multidisciplinary intervention is often not considered until the COT patient reaches very high levels of opioid use, begins to experience problems or show aberrant drug use behavior, or is being considered for detoxification. 

 

Chronic Opioid Therapy and Mortality

 

This section of the course is being provided to basically remind anyone who treats chronic opioid therapy patients that there can be serious consequences if these cases are not managed appropriately.  As discussed previously, most of the side effects, even the serious ones, can be addressed medically with reasonable success.  However, there is always the risk of fatality when utilizing opioids in the treatment of chronic pain patients.  Therefore, a brief review of the literature will help the multidisciplinary team develop the most effective, efficient, and safe COT program possible.  As we discussed, the use of opioids in pain management has increased fairly consistently over the past two decades.  Not surprisingly, mortality related to opioid overdose has also increased in a similar fashion. 

 

The US Department of Health and Human Services provides some excellent data relative to what they term “fatal poisonings” involving opioid analgesics in the United States from 1999 through 2006.  For a complete copy of the research article, see Increase in Fatal Poisonings Involving Opioid Analgesics in the United States, 1999-2006.  In the research, poisoning deaths is defined as “including those resulting from accidental or intentional overdoses of a drug, being given the wrong drug, taking the wrong drug in error, or taking a drug inadvertently.  Poisoning deaths also include those involving biological or other toxic substances, gases, or vapors.”  However, the data does include sub-analysis of deaths strictly due to opioid analgesics.  Most of these factors (accidental or intentional overdose, taking the wrong drug, taking the wrong drug in error, or taking a drug inadvertently) apply to the management of COT pain patients. 

 

figure1

 

As discussed in the survey research, poisoning is the second leading cause of injury death overall and the leading cause of death for people ages 35-54 years-old, greater than both firearm-related and motor vehicle related deaths in that age group.  Amongst this group, drug poisonings are most common and opioid analgesic-related deaths are among the fastest increasing drug poisoning deaths.  This trend is illustrated in Figure 1.  As can be seen, opioid analgesics were involved in almost 40% of all poisoning deaths in 2006, up from 20% in 1999.  As can be seen in Figure 2, the combined group of “opioid analgesics” (other synthetic narcotics, methadone, and other opioids) resulted in more deaths than any other drug category.  The data also revealed that in 2006, the rate of poisoning deaths involving opioid analgesics was higher for males, persons ages 35-54 years-old, and non-Hispanic white individuals.  Given the survey data, these factors might be added to the risk stratification profiling done at initial assessment.  Also, as documented in other research, in approximately 50% of the deaths involving opioid analgesics, more than one type of drug was specified as contributing to the death with benzodiazepines specified with opioid analgesics being the most frequent.  This data is summarized in Figure 3.  This data is valuable in alerting the physician who is managing the COT patient that combining opioid analgesics with benzodiazepines increases the risk for mortality.  In some cases, this medication combination may certainly be appropriate; however, given this mortality data, patients on this combination of drugs should be monitored more closely and carefully assessed for appropriateness, clinical response to the intervention, and risk stratification.  This data does not indicate the reasons for the drug overdose (e.g. intentional versus unintentional), but the outcome is the same.  I have been referred patients who have overdosed on analgesics and benzodiazepines that were clearly not suicidal and did so unintentionally.  This generally resulted from a misunderstanding of how to take the medication, lack of proper monitoring, or improper dosing leading to confusion and a medication mistake. 

 

figure2opioid

 

This data does not differentiate between short acting and long acting opioids, and cause of death.  Additional information that may help clarify these trends is available from recent epidemiological research completed in Canada.  The Canadian socialized medical system provides a valuable source of information since many data bases are interlinked and patterns of medication use can be more easily analyzed.  This is exactly what was done in a study by Dhalla et al. (2009, download free), Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone.  These researchers looked at the prescribing of opioid analgesics and related mortality both before and after the introduction of long acting oxycodone (Oxycontin).  As discussed in previous research, the authors review the fact that there has been an increase in the use of opioid analgesics in CNCP patients over the past two decades due to many factors including research suggesting it is beneficial in certain patients, an increase in physician’s willingness to use these medications, and the availability of long acting formulations.  The authors also point out that the data indicates that there has been a concomitant increase in opioid abuse and opioid related deaths during this period.  The study focuses on one long acting formulation (Oxycontin), although these trends might be applied to any similar medication.  The authors also point out that the product’s controlled-released characteristics could be easily defeated by simply chewing or crushing the tablets.  The purpose of the study was to investigate mortality rates before and after the introduction of Oxycontin into the national healthcare formulary.  This is a fascinating study and it is recommended that the entire research article be reviewed. 

 

figure3

 

In summary, the investigators examined the trends and prescribing of opioid analgesics in the Province of Ontario, Canada, from 1991 to 2007.  A component of this evaluation included reviewing all of the deaths related to opioid use between 1991 and 2004.  The important variable under investigation was the introduction of long acting oxycodone (Oxycontin) to the drug formulary in early 2000.  Therefore, the researchers could compare data pre- and post-introduction of Oxycontin.  Given the interlinking of databases, the researchers could also investigate healthcare utilization among individuals who died of opioid-related causes.  A summary of the results can be found in Table 16. 

 

 

Table 16.  Patterns of Mortality Related to Long Acting Opioids  

 

 

Prescription Patterns

 

From January, 1991 to May, 2007 the prescribing of opioid analgesics in Ontario, Canada, increased by 29%.  During this time, codeine was the most frequently prescribed agent, but the number of prescriptions for this medication declined gradually during the study period   In contrast, the number of oxycodone prescriptions rose more than 850% during the same period.  Although far lower, the prescribing of hydromorphone, fentanyl, and morphine also increased considerably. 

 

By 2006, oxycodone accounted for more than 32% of the almost 7.2 million prescriptions for opioids dispensed during that year.  Of the 2.3 million oxycodone prescription dispensed in 2006, 28% were for the long acting formulation.   The long acting formulation (OxyContin) was introduced to the formulary in early 2000.

 

Opioid Related Deaths

 

The majority of opioid-related deaths involved at least one nonopioid central nervous system depressant.  The most commonly implicated non-opioid central nervous system depressant in deaths related to oxycodone use were benzodiazepines (60%), alcohol (44%), and cyclic antidepressants (26%). 

 

Opioid related mortality doubled from 1991 to 2004.  The median age at death was 40-years-old and 67% were male.  The coroner determined that death was unintentional in 52% of the cases, suicide in 24% of the cases, and undetermined in 22% of the cases. 

 

There was a substantial increase in overall opioid-related mortality following the addition of long acting oxycodone to the medication formulary in January of 2000. 

 

Healthcare Utilization Before Death

 

In the Canadian socialized medical system, the researchers were able to link coroner’s records, medication prescriptions, and healthcare utilization.  It was found that most of the patients (66%) had been seen by a physician at least once within four weeks prior to death.

 

The median number of physician visits in the year prior to death was 15.  The median number of days between the final visit with the physician and death was 11. 

 

Analysis of physician claims for these office visits revealed that diagnoses of mental health problems (e.g. anxiety, depression, or drug dependency) and pain related complaints were the most common reason for seeking medical attention.

 

 

This data is remarkably consistent with that reviewed previously as provided by the US Department of Health and Human Services, but it provides even more details and correlations.  The data also underscore the fact that, although COT has been found effective in the clinical research literature in well selected patients, it is certainly not without serious risk.  The use of COT must not be done in a cavalier fashion and adhering to some type of established and structured protocol is absolutely necessary.

 

Malpractice claims.  Not surprisingly, with an increase in the use of chronic opioid therapy, the rate of malpractice claims has increased in this area.  Fitzgibbon et al. (2010) investigated malpractice claims from 2005 to 2008 as tracked by the American Society of Anesthesiologists.  Medication management represented 17% of the 295 chronic noncancer pain claims.  Most of the patients were prescribed opioids (94%) and also additional psychoactive medications (58%).  Of the patients, 80% had one risk factor commonly associated with medication misuse and 24% had 3 or more risk factors.  Most claims (82%) involved patients who did not cooperate with the care (69%) or inappropriate medication management by the physician (59%).  Death was the most common outcome in medication management claims (57%).  Factors associated with death included long-acting opioids, additional psychoactive medications, and 3 or more risk factors for misuse.  The authors conclude that most malpractice claims for medication management problems involve patients with medication misuse risk factors.       

 

All of this data underscores the appropriateness of a multidisciplinary intervention when implementing COT for the vast majority of cases.  Not only does pain bring with it various psychosocial consequences (see the pain management course), but psychiatric comorbidities seem to place patients on COT at a much higher risk for adverse events including fatality (See Table 17).

 

 

Table 17. Opioid Mortality: An At-Risk Profile

 

 

Long acting opioid used in conjunction with another CNS depressant, especially a benzodiazepine

 

Male

 

About 40 years old

 

Co-morbid psychiatric issues

 

Three or more risk factors overall (See Table 7).

 

 

Psychotherapeutic Interventions

 

Consistent across the clinical research and COT Guidelines is the recommendation that psychotherapeutic interventions be considered as part of a COT program.  However, in my experience, this consideration is often done at the later stages of COT or only when significant problems arise.  Certainly, involving a mental health professional at the early stages of COT (including the initial evaluation, initiation and titration phase, and ongoing monitoring) will help prevent problems and enhance the overall outcome.  The various psychological pain management techniques have been reviewed in detail in other courses (Evaluation and treatment; QME Evaluation and Treatment) this information will not be reiterated here.  Table 5 lists just some of the psychotherapeutic interventions appropriate for this patient population.  If you are a mental health professional and are involved in treating pain patients on chronic opioid therapy, you should be aware of issues outlined in Table 5. 

 

Understand the medical intervention.  The mental health professional should have a thorough understanding of the medical aspects of chronic opioid therapy including familiarity with the medications that are being used, common side effects, indicators of aberrant behavior, etc.  Although you are not actually prescribing or managing the medical aspects of COT, your interactions with the patient will likely be more frequent and of longer duration than that of the physician.  As such, you will be in a unique position to identify and monitor a patient’s response to the COT including benefits (analgesia, activities, etc.) as well as side effects or risk. 

 

In all but the most straightforward cases of COT, it is generally appropriate to obtain a multidisciplinary initial evaluation including both medical and psychological assessments.  Again, this is due to the fact that the physician and mental health professional will be investigating unique aspects of the chronic pain problem and the patient’s potential to succeed with a chronic opioid therapy program.  Of course, the mental health professional must have a good understanding of evaluation techniques utilized when working with these patients, including the structure of the clinical interview, evaluation of risk factors, and appropriate use of psychological testing or questionnaires. 

 

Obtain appropriate releases. Open communication between members of the treatment team is essential and in the vast majority of cases confidential releases should be required for initiation of treatment.  As a mental health professional, if you evaluate a patient who is being considered for COT and s/he either refuses or is reluctant to sign a release for communication with the physician, this must be discussed extensively.  If the patient has certain areas of psychological treatment that he or she desires not be disclosed to the physician, this can be negotiated relative to the release of information.  In my practice, I will not accept the patient for treatment as part of a chronic opioid therapy intervention (e.g. psychological pain management) unless communication with the physician relative to important issues is allowed.  If this issue is addressed at the very beginning stages, then there will not be a problem later on.  One scenario might be the case where a patient does not allow disclosure and the mental health professional decides to take him or her as a patient.  The COT is initiated by the physician and, after a few months, the mental health professional becomes aware that aberrant opioid misuse is occurring (e.g. diversion, overuse, concomitant use of illicit substances, obtaining prescriptions from multiple physicians, etc.).  Since the mental health professional does not have a release of information, and the situation may not rise to the level of danger to self, a complex ethical and legal problem has arisen.  If the practitioner initially requires some type of release of information relative to the COT treatment, these issues are always avoided. 

 

Assist with monitoring. Be prepared to assist the physician with the monitoring process as reviewed previously in this course.  Since you will be seeing the patient more frequently, you are in a unique position to aid the physician in monitoring the patient’s response to treatment.  This might include documentation of benefits and side effects through the use of the instruments reviewed previously.  Open communication of these results can be done by providing the physician with a summary progress note.  Again, this provides for a much more powerful intervention since you will be spending much more time with the patient relative to a 10 or 15 minute physician follow-up visit. 

 

Ethical and risk managements issues. You must be aware of ethical and malpractice principles when working with patients involved in COT.  For instance, one of the goals might be to help the patient decrease his or her reliance on the opioids while the use of psychological pain management techniques improves.  Certainly, this is a reasonable goal, but the mental health professional must be very careful in terms of how it is implemented.  For instance, the mental health professional would never want to suggest that the patient “try and take less of your pain medications this week while substituting your relaxation and self-hypnosis exercises.”  In making this kind of recommendation, you are essentially practicing medicine without a license and possibly placing the patient at risk.  Open  collaboration with the physician solves this problem.  If a medicine reduction goal is agreed upon, the physician can simply prescribe the medication in such a way that allows for the patient to attempt to gradually decrease the dose as the power of the psychological interventions is enhanced (e.g. allow for a limited range of medication dosing to be decided upon by the patient depending upon his or her symptoms).  Working with this patient population, and this type of medical practice, might be considered somewhat “high risk” for the mental health professional.  The reader is referred to the Liability and Risk Management and the Ethical Issues in Behavioral Health Practice courses for more information. 

 

Be ready for “crises”.  The mental health professional working with the COT patient must be equipped to manage any crises that might arise.  Given the fact that these patients have lethal amounts of medication at their disposal, ongoing assessment of any suicidality or issues that may lead to unintentional overdose must be assessed on a regular basis and documented. The mental health professional should have an “action plan” already established to implement in response to such crises.  This is especially important given the fact that the rates of depression and suicide are significantly higher in chronic pain patient groups relative to the normal population. 

 

Safety issues.  The issue of safely storing the medication should also be addressed.  One of the most common methods of unintentional diversion is theft from the medicine cabinet.  This might be done by a family member (adolescent) or guest in the home.  Accidental overdose can occur when an individual attempts to use these long acting opioids in a recreational fashion.  If the tablets (except for some newer formulations) are chewed or broken (e.g. shared), overdose can be a significant risk.   Abusing OxyContin the way you would Vicodin or Norco (e.g. “take a bunch of pills”; break or crush them to share; etc.) could be lethal.  The same safety issue applies if there are  children in the home.    

 

Tapering, discontinuation, and problems.  The mental health professional should be prepared to help manage the tapering and discontinuation of opioid therapy if the physician determines that this is the appropriate course of action.  In some cases, the mental health professional may acquire information that suggests discontinuation of COT is most appropriate.  In these cases, the issues should be discussed with the physician and a joint treatment plan developed.  Many patients are very upset when the decision is made to taper and discontinue COT.  The mental health professional can help with this process.

 

“Managing” the physician’s behavior.  Lastly, the mental health professional should also be equipped to deal with erratic or inconsistent behavior on the part of the physician managing the chronic opioid therapy program.  I work with many physicians who very successfully implement COT and appropriately coordinate with other disciplines, including the mental health professional.  However, I have had situations in which a physician had been managing a patient on COT for quite some time with doses stable and no significant problems.  Then, some type of relatively mild aberrant opioid use behavior occurred (e.g. the patient runs out of her medication two days early due to more pain) and, in response, the physician simply states that the COT program is being discontinued.  In the few cases when this has occurred, the patient was given a prescription for enough opioids to last approximately two weeks and discharged from the practice.  She was not scheduled for follow-up with the physician and was told to “find someone else to manage your medications.”  Of course, when I saw the patient after this issue, she was in a state of complete psychological distress and the situation had to be addressed quickly and effectively. 

 

Glossary of terms

 

The following links will provide glossaries of the terms used in this course as well as more detailed information.

 

American Pain Society Glossary of Terms

 

Pain Treatment Topics

 

Pain and Policy Studies Group

 

State of Oregon Pain Management

 

 

References

 

NOTE:  All web resources in this course accessed May 20, 2010

 

 

Benyamin et al. (2008). Opioid complications and side effects.  Pain Physician Special Opioid Issue, 11, S105-S120.

 

Chou et al. (2009).  Opioid Treatment Guidelines: Clinical Guidelines for the Use of Opioid Therapy in Chronic Noncancer Pain.  The Journal of Pain, 10, 113-130.

 

Dhalla et al. (2009). Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone.  Canadian Medical Association Journal, 181, 891-896.

 

DuPen et al. (2007).  Mechanisms of opioid-induced tolerance and hyperalgesia.  Pain Management Nursing, 8, 113-121.

 

Eriksen et al. (2006). Critical issues on opioids in chronic non-cancer pain: An epidemiological study.  Pain, 125, 172-179.

 

Fitzgibbon et al. (2010).  Malpractice claims associated with medication management for chronic pain.  Anesthesiology, 112, 948-956.

 

Nicholas et al. (2006). Using opioids with persisting noncancer pain: A biopsychosocial perspective.  Clinical Journal of Pain, 22, 137-146.

 

Passik, S.D. (2009).  Issues in long-term opioid therapy: Unmet needs, risks, and solutions.  Mayo Clinic Proceedings, 84, 593-601.

 

Passik, S.D. and Squire, P. (2009).  Current risk assessment and management paradigms: Snapshots in the life of the pain specialist.  Pain Medicine, 10, S101-S114.

 

Passik et al. (2004). A new tool to assess and document pain outcomes in chronic pain patients receiving opioid therapy.  Clinical Therapeutics, 26, 552-561.

 

Portenoy, R.K. (2010).  Patient selection for long-term opioid therapy.  In P.G. Fine (Ed.), Chronic Pain and Risk Management Compendium (p. 17-21).  New York: Albert Einstein College of Medicine.

 

Silverman, SM. (2009). Opioid induced hyperalgesia: Clinical implications for the pain practitioner.  Pain Physician, 12, 679-684.

 

Smith, H.S., and Kirsh, K.L. (2007).  Documentation and potential tools in long-term opioid therapy for pain.  The Medical Clinics of North America, 91, 213-228.

 

Stanos, S.P. (2007).  Biopsychosocial assessment of chronic opioid use.  Pain Management Nursing, 8, S14-S22.

 

Noble et al. (2010).  Long-term opioid management for chronic noncancer pain (Review). Cochrane Database of Systematic Reviews, Issue 1, Article CD006605.

 

Wallace et al. (2007). Development and validation of a low-literacy opioid contract.  Journal of Pain, 8, 759-766.



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