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In spite of important changes in pain medicine, including the increased use of opioids in the treatment of nonmalignant pain, increased acceptance of long-term use of opioids to treat all types of pain, and the existence of more than 30 assorted professional organizations that publish guidelines and protocols, pain remains effectively mismanaged.1-6 In 1999, the Joint Commission on Accreditation of Healthcare Organizations (renamed the Joint Commission in January 2007) released standards of care for patients in pain. They suggested that pain be considered the fifth vital sign and indicated that all patients in pain reserve the right to treatment. These standards, of course, included patients with active addictive disease and those patients with a history of addiction in recovery.7
As opioids are increasingly prescribed for patients without cancer pain, the rate of misuse of these medicinal drugs is on the rise. It is reported that 56% more Americans abuse opioid prescription drugs than abuse cocaine, heroin, hallucinogens, and inhalants combined.8 These activities have created a serious public health problem, as evidenced by the following reported data collected from 1992 to 2003. The number of Americans abusing drugs increased by 94%, and abuse by children, ages 12-17, during the same period increased by 212%. A 542% increase in addiction to prescribed opioids alone was also reported.9 Some of these reported statistics may reflect diversion or misuse of prescribed opioids by nonpatients; however, even when opioids are appropriately prescribed to an individual with a history of a substance abuse disorder, these drugs may precipitate a craving for and relapse to the original drug of choice, or may initiate an addiction to a new, previously unknown substance.10
In light of this information, it may seem an impossible task to be able to treat pain in an addicted individual. This is not the case. With proper assessment, a strategic stepwise approach to therapeutic management, a full complement of health care professionals, and detailed documentation, treatment is not only possible, it is achievable.
How do we, as clinicians, recognize the addicted pain patient, one who may be in the recovery process for addiction, or one who may be at risk of addiction? The answer is, with much difficulty. Although survey assessment tools exist, none offers 100% sensitivity. If we rely solely on patient self-report, we remain doubtful. The best strategy may be a universal approach, treating all chronic pain patients considered for prescribed opioid trial as patients at risk for opioid misuse until proven otherwise.
"Universal precautions" related to standardized pain management, not prevention of infection as is the more recognizable use of the term, is a treatment methodology deserving of our attention. Using this method, we approach all patients in pain who may require opioid therapy as patients at risk for opioid misuse. By taking a thorough and respectful, yet strategic, precautionary approach to patient assessment and management in chronic pain treatment, stigma associated with opioid therapy can be reduced, patient care is improved, and overall risk contained.11,12
Step One: Assessment
A comprehensive patient workup is considered the first step in pain management. This includes13:
The urine drug screen is a valuable tool used to help determine active or risk of drug abuse. Requesting a broad range of assays provides a broad range of answers. The urine may be tested for synthetic opioids, agonist or antagonist opioids, short-acting benzodiazepines and barbiturates, some over-the-counter (OTC) agents (eg, ephedrine, diphenhydramine, and phenylpropanolamine), alcohol, cocaine, and marijuana.10 The patient should be questioned regarding the use and/or misuse of other types of addictive substances such as nicotine use (eg, cigarette smoking), OTC drugs, and herbal preparations; and nutritional supplements, such as energy drinks and dietetic weight loss preparations.10
There are three medications that are not scheduled (ie, do not require Drug Enforcement Agency (DEA) license to prescribe) yet deserve special mention. Each is considered risky for addicted persons in recovery, and all are associated with de novo addiction.
Carisoprodol (Soma®) is a muscle relaxant which metabolizes to meprobamate, a tranquilizer similar to diazepam. Butalbital is a short-acting barbiturate found in several headache preparations such as Fioricet® and Esgic®. Tramadol (Ultram®, Ultracet®) is an atypical, synthetic, mu-receptor opioid agonist, of the morphine type, which acts centrally as an analgesic and is used for treating moderate-to-severe pain. It appears to have actions on the GABAergic, noradrenergic, and serotonergic systems. Prescribing information for Ultram ER® (tramadol HCl) warns that tramadol "like other opioids used in analgesia, can be abused."14
Speaking with a family member or significant other also adds valuable information. Obtaining a perspective on the patient’s history and behaviors from a person who shares a history with the patient provides another dimension to the evaluation.10 If patient or family dialogue reveals a history of abuse, or active addiction, a discussion surrounding the process of recovery must occur. The patient may deny an addiction disorder, and further discovery, to limit risk and insure safe therapy, is warranted. Some commonly used assessment tools to determine substance abuse or risk of abuse are the Screener and Opioid Assessment for Patients in Pain, or SOAPP®; the Opioid Risk Tool, or ORT; and CAGE.
SOAPP, a survey tool used to predict opioid abuse, is available as a 5, 14, or 24-item questionnaire. The major benefit in using one of the longer SOAPP forms is the increased sensitivity and specificity of the survey tool. Table 1 demonstrates the differences among the three types of SOAPP tools.15
Table 115
| SOAPP Version | SOAPP Cutoff Score | Sensitivity | Specificity | Positive Predictive Value | Negative Predictive Value | Positive Likelihood Ratio | Negative Likelihood Ratio |
| 5Q Short Form | Score 4 or above | .86 | .67 | .69 | .85 | 2.59 | .20 |
| 14 & 24 Q Standard | Score 7 or above | .91 | .69 | .71 | .90 | 2.94 | .13 |
The ORT, a questionnaire, measures the following risk factors associated in scientific literature with substance abuse: personal and family history of substance abuse, age, history of preadolescent sexual abuse, and certain psychological diseases. Scores of 0-3 (low risk), 4-7 (moderate risk), or ≥ 8 (high risk), indicate the probability of opioid-related aberrant behaviors.16
CAGE is an easily administered screening instrument used primarily to determine alcohol abuse, although a revised version that adds drug use to the original questions, called CAGE-adapted to include drugs or AID, is used to alternately screen for both alcohol and drug abuse.17,18 The CAGE acronym is based upon letters contained within the text of the four questions used, which include17:
An answer of "yes" to one or more questions on the CAGE questionnaire indicates a need for further assessment. CAGE-AID includes an additional reference to drug use meant to target drug abuse. Two or more affirmative answers derived from the CAGE-AID questionnaire demonstrates high sensitivity and specificity for drug abuse and should result in further evaluation of the patient.18
During the physical examination, several signs may also point to alcohol abuse. The most obvious is the odor of alcohol on the breath of the patient at time of visit. Hepatomegaly, or enlarged liver, may present as a sign of cirrhosis; ascites, or excessive abdominal fluid, may indicate hepatic and/or pancreatic disease; hand tremors, or involuntary hand shaking, may indicate nerve disease secondary to alcoholism; and skin petechiae, or superficial blood vessels that have broken or ruptured, are also signs of alcohol abuse. Petechiae are frequently a result of microscopic vascular damage, secondary to cirrhosis of the liver. Rhinophyma, or hypertrophy of the nose, should not be considered a clear-cut sign of alcoholism as it is also related to the final stages of rosacea, a common centrofacial dermatosis with unknown etiology.19-21
Laboratory tests such as gamma-glutamyl transferase (GGT), mean corpuscular volume (MCV), and serum uric acid, may offer additional information related to alcohol abuse. The physical exam and lab test results, when used as sole predictors, offer low sensitivity and inconclusive results for confirming long-standing alcohol abuse.10
Assessment of comorbid conditions, which may often accompany pain and addiction, is also recommended. Depression, anxiety, sleep disorders, and psychiatric disorders (somatoform or personality) are all common comorbidities. To assess depression, the Hamilton Rating Scale for Depression (HAM-D) or Beck Depression Inventory (BDI) are used most frequently, and are well studied and validated. Anxiety, which often accompanies depression, is assessed using the Hamilton rating Scale for Anxiety (HAM-A). Sleep disorders which can contribute to increased pain and vice versa, especially in patients with fibromyalgia, can be assessed with polysomnographic testing.22-26
Each comorbid condition may be considered a unique disease entity, but all may be exacerbated by one another. Not identifying comorbid conditions may delay or prevent improvement in therapeutic pain management and contribute to pain worsening. Concomitant therapy using disease appropriate therapies may improve outcomes for one or more comorbid disease entities.10
The initial comprehensive assessment is time consuming and labor intensive. It is, however, a critical and essential first step in planning for safe and risk-reduced treatment management. The documentation resulting from the assessment will lay the groundwork for step two: strategic treatment agreement development, which is considered the blueprint of pain management.
Step Two: Patient-Centric Treatment Agreement
A treatment agreement is truly a dynamic blueprint for moving forward and details each parameter and goal of treatment, even as they shift and change. The treatment agreement serves many functions. It provides structure, expectations, consequences, and documentation. It begins by involving the patient in his or her own health care journey through informed consent, detailing roles and responsibilities. It states what is expected from the patient (and clinicians) through the course of treatment, and will identify therapeutic goals. It also highlights consequences of noncompliance, and establishes boundaries for referrals and exit strategies. When a detailed treatment agreement is well written and used dynamically, there is little room for surprise.10
The treatment agreement should be initialized as soon as possible after the intake assessment, and will become an evolving document based upon patient behaviors and treatment decisions. A living, breathing treatment agreement satisfies the requirement for due diligence, and is a benefit to the physician-practice.10
Step Three: Multidisciplinary Approach
A single physician treating a pain patient is vulnerable to interpretation of the regulatory and legal enforcement agencies. It is recommended that a multidisciplinary approach be adopted. Not only will the patient benefit from receiving specialized care, but the network of clinicians and health care providers receive support from one another and validate impressions and diagnoses while providing layered documentation. Multidisciplinary care is considered a "share-the-risk" model.10
Table 2 lists the specialists who may be included in the patient’s care and may review and sign the treatment agreement.
Table 2. Multidisciplinary Specialists
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Step Four: Formalize Treatment Agreement
After the treatment agreement has been drafted, the document should circulate for review and signature to all parties involved in the care of the patient, including the patient. This may be done using a hardcopy or an electronic file format. A formal meeting may be scheduled with all concerned, if feasible, and can be face-to-face or conducted via a telephone conference call, depending on practice location and clinician-patient availability. The primary objectives of the meeting are to agree on set treatment goals, define roles, and reassure the patient.
Figure 1 is a sample treatment agreement for a patient assessed as at risk for addictive disorder. The plan demonstrates the necessity of an accurate first-step assessment.
Figure 1:
Sample Revised Opioid Treatment Agreement Patient: Sue Ross Physician: Dr. Miller Therapist: Joan Small Acupuncture: Dr. Wong This treatment plan is being revised in response to concerns on the part of the treatment team that a dependence on opioids may be developing. The primary purpose of the plan is to control the pain associated with my fibromyalgia while allowing for good function and preventing complications related to potentially dangerous medications. Activities for Pain Management:
Special Activities for Pain Management:
Response to Intensified Pain:
Important Agreement Provisions:
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Step Five: Reassess, Review, Revise
The final step is as important as the first. We live in a dynamic world and nothing is static. This concept also applies to the treatment agreement. As treatment progresses, the patient must return for periodic reassessment. This step will help to determine if therapy is effective, if the patient is adhering to his or her responsibilities, and will provide opportunities to reassess behaviors. Scheduled urine drug testing is highly suggested. If results are negative for illegal drugs or other prescribed medications, this form of testing may be reduced or eliminated as therapy progresses unless behavior occurs that stimulates reinstatement. If the urine screen is negative for the medication being prescribed in the treatment agreement, such nonadherent behavior also requires careful reassessment and modification of the plan.
Aberrant behaviors, also known as behaviors of noncompliance, may not be evident upon first meeting the patient and may only surface after treatment begins. These behaviors may be interpreted as warning signs for addiction or drug diversion.
Table 3. Behaviors that may indicate addiction.10
Warning signs of developing addiction in pain patients
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In the patient who may not have demonstrated risk of addiction, these behaviors may also manifest as a result of ineffective pain treatment. Pseudoaddiction is a term that defines aberrant behaviors in an undertreated patient. Chronic and undertreated pain drives patients to behave abnormally. It is theorized that tolerance to the prescribed opioid regimen may also result in hyperalgesia.27 This condition may occur in patients who have been prescribed chronic opioid therapy, and this subpopulation of pain patients may also begin to exhibit aberrant behaviors driven by the pain and frustration of the newly perceived ineffectiveness of their long-prescribed, once effective drug regimen. If an established and relatively constant opioid plasma level changes abruptly, either by dosing changes on behalf of the patient or through direct orders of the physician, signs of physical dependence may also manifest as aberrant behaviors. Frequent reassessment and open discussion is essential to differentiate true addiction from pseudoaddiction, tolerance, or physical dependency.23
Certain patients may possess a catastrophizing mentality based upon experience, genetics, or behavior. These patients have learned, over time, to adapt to chronic adverse conditions. Adrenal glucocorticoids, which are normally secreted to offer protection (flight or fight) from stress producing adversities, are chronically secreted in this population. It is theorized that the constant allostatic load (the cost to the body of physiochemical adaption) will eventually cause plasticity of the brain’s hippocampus. Experts in this area of study believe it is conceivable that damage of the hippocampus caused by morphological rearrangements will then alter certain memory functions and perceptions of chronic pain.27,28
It is known that stress exacerbates pain. Patients who possess high allostatic loads, especially addicts, who are fearful of experiencing pain without receiving adequate analgesia, begin to obsess about the pain before it manifests, resulting in a physiochemical stress response that intensifies perceptions of pain to a level higher than would normally be expected. Effects from high allostatic loads will not only contribute to other conditions, such as behavioral inhibitions and sleep disorders, but are also considered a predilection to addictive disorder.28-33 Recognition of contributory issues such as family adversity, adolescent psychiatric disorders, or adolescent drinking in chronic pain patients might not only be associated with, but causally related to, the risk of addiction. High allostatic load-chronic pain patients, once identified as patients at risk of addiction, are candidates for preventive interventions. It is critical to implement therapeutic strategies that contain risk for both patient and practice, address preventive measures for potential addiction, and provide adequate therapy and care for the patient’s primary condition: chronic pain. It is important to note that the primary contributing factor to hyperalgesia remains unknown. Uncontrolled pain may be due to central sensitization and neuronal morphologic changes as a result of chronic opioid therapy or due to secondary effects from exposure to high allostatic load. Additional research is needed to determine accurate cause and effect mechanisms of hyperalgesia.
Proactive communications with not only the patient, but with family members, significant other, friends and/or employer will help provide a clearer picture of the patient’s progress and/or challenges related to therapy. Informed consent and signed releases of information must be in place prior to making these contacts in order to protect the patient’s right to privacy and confidentiality. Additional group health care provider meetings may also be periodically scheduled for the same reason. Updating documentation and reviewing new medical records is a great way to validate the network provider’s navigation of care. Changes in therapeutic direction may be recommended and the original treatment agreement amended to reflect personalized patient care.10
When there is a positive diagnosis of addictive disease in the chronic pain patient, the goal of therapy automatically changes to achieving maximal pain relief while protecting the patient against exacerbation or reactivation of addictive disease. The same strategic, patient-centric, stepwise approach, as previously outlined for therapeutic management, is instituted, but it is designed with greater precautions and layered with added boundaries. Novel pharmacotherapies may be prescribed on a trial basis to eliminate or minimize the use of prescribed opioids. Anticonvulsants (eg, gabapentin or lamotrigine) have been shown to be helpful in controlling neuropathic and musculoskeletal pain, and migraine-specific agents, such as triptans have also demonstrated positive analgesic effects on pain. Alternate and complementary therapies, such as advanced rehabilitative medicine, acupuncture, biofeedback, and hypnosis may also be introduced. The network of health care providers is an essential component, as specialized care for substance abuse is required.10
The treatment agreement will include more restrictions in the face of known addiction. If opioids are a necessary therapeutic agent, restrictions must be encoded in the plan to include10:
The prescribing protocol, if opioids are essential to therapy, is restrictive. A single pharmacy for prescription fulfillment will be assigned. Again, proactive communication between prescribing physician and the lead pharmacist at the establishment is strongly suggested. The pharmacist becomes a secondary observer of the patient’s behavior and is part of the care provider network. Single pharmacy prescription filling provides a true drug profile. Naturally, if the patient is doctor shopping, the patient may use multiple prescribers and pharmacies. Unfortunately, unless the state where the medical practice is located has initiated a prescription monitoring program (PMP), a database of registered controlled substance prescribers and their writing activities, these types of aberrant patient behaviors may not be easily identified. In fact, the only states to report a decrease in substance misuse activity are the states that currently have PMPs in place: Kentucky, Ohio, Michigan, Nevada, and Utah.34 Financial gain, derived from misappropriation and diversion of prescribed opioids, is the primary reason for patients without prior history of substance abuse to begin selling their drugs illegally.10
Signature of the treatment agreement will become the decisive moment of truth for the addicted patient. Until that point in time the patient may have been cooperative and friendly. When asked to sign the treatment agreement, the patient may become agitated and abusive, may abruptly refuse to sign, and refuse further treatment. Figure 2 demonstrates the severely restrictive nature of a treatment agreement designed for a patient with active addiction. Behavior modification, in terms of addiction counseling and formal substance-abuse treatment, will then be necessary before attempting any further opioid pain treatment goal setting with this patient type.10
Sample Pain Treatment Agreement Patient: Irene Simpson Doctor: Dr. Miller Date: 1-19-07 This treatment plan has been developed to manage neck pain and tension headaches. It is open to changes when both the doctor and I agree that the changes are in my best interest and are likely to improve my pain management or other overall health. A primary goal of the plan is to protect my recovery from the disease of addiction.
Important Phone Numbers:
Patient:______________________ Doctor:__________________ Date:_________ This agreement is a plan for managing neck pain and headaches in a recovering alcoholic with a history of abusing pain medications prior to entering the Pain Management Clinic. In most cases, this combination of medications and alternative therapies will allow good pain control and improved function while strengthening the patient’s recovery program and preventing relapse. It does, however, reassure the patient that opioids will be considered if her pain is not controlled with this approach. |
During the course of the patient’s treatment, when aberrant behaviors are identified and/or they continue in spite of restrictive protocols, the patient must be confronted and the treatment agreement with its expectations and consequences reviewed by all parties involved. It is recommended that at least two health care providers speak to the patient together; one can lead the discussion, while the other documents details of the conversation. This communication model discourages anecdotal reporting from either patient or physician.10
If the patient is not already under the care of an addictionologist, a referral to an addiction counselor or addiction treatment provider is initiated. If previous referrals have been made and behaviors are not conducive to treatment, care may be terminated, with a caveat for a clearly documented plan for medical withdrawal. If care is terminated due to known criminal activity on the part of the patient, the criminal activity must be reported as soon as possible by the clinician to the local law enforcement agencies and the patient informed of this action. It is important the health care team reassure the patient, clarify that the decision of treatment discontinuation is in the patient’s best interest, and reinforce that the health care team is not abandoning the patient. It is best that an exit strategy be considered at onset of treatment while designing the treatment agreement, and not during the emergent crisis of treatment termination. As with all other steps of the treatment agreement, the exit strategy resulting in termination of care must be fully documented.10,35,36
Figure 3. Suggested exit strategy algorithm.

Used with permission of Thomson Professional Postgraduate Services® (PPS®). This guide is part of the Opioid Analgesia Tool Kit, ©2004 Thomson Professional Postgraduate Services® (PPS®). All rights reserved.
It is essential that the prescribing clinician provide sufficient prescription to the patient for a one-month taper or maintenance treatment once the patient is promised admission to a new treatment program. A sincere attempt should be made by the prescriber to tide the patient over with analgesia until new treatment can begin, and not abandon the patient to acute drug withdrawal.10,35,36
All chronic pain patients reserve the right to be treated with dignity and respect, and to receive adequate analgesia. Comprehensive patient assessment is a key component in the design and development of a strategic treatment agreement that offers promise of a high rate of success. In spite of many challenges, both chronic pain patients at high risk of addictive disorder and active addicts can be treated successfully. Using a strategic, precautionary, multidisciplinary, and stepwise therapeutic agreement is considered best practice. By scheduling frequent patient visits through a network of multidisciplinary providers, treatment can be discussed and patient behaviors observed. These frequent updates will help identify aberrant behaviors early in the program, optimize treatment, and contain risk. The value of accurate and frequent documentation provided by diagnostic results, urine drug screens, reported observations, or patient office visit notes cannot be underestimated. As knowledge of chronic pain and addiction continues to evolve, options for increased treatment performance will improve.