Abstract
Opioid use disorder risk assessment tools cannot be used in isolation. In combination with standardized clinical examination, and, when indicated, urine drug screening, a validated risk assessment tool, improves the ability to detect opioid misuse. Even though no single tool has been shown to have both high interobserver reliability and high sensitivity, the standardized approach has still been shown to be superior to subjective care giver assessment. This article will provide a global approach to risk assessment in addition to reviewing the available tools.
Introduction
This is the fifth essay in the Missouri Medicine series stemming from the Larry Lewis Symposium in August 2017 exploring the transdisciplinary responses to an ongoing opioid epidemic.1 The series moves beyond a focus on epidemiology and blame to evaluate actions to simultaneously address pain compassionately while mitigating the potential risks of opioid exposures. This essay explores evidence-based approaches to risk-stratifying individual patient’s current or future likelihood of developing an opioid use disorder (OUD).
Interacting with patients who you suspect suffer from a substance use disorder (SUD) - and who may deny they have such a disorder - can often result in a confrontational, emotional situation. It may be stressful to both the caregiver and the patient. Minimizing such an emotional response and avoiding escalation of situations are critical in providing compassionate and optimal care. Despite requirements by oversight agencies, available guidelines, and widespread epidemic rates of overdose and death, many practitioners do not use a standardized approach for the risk assessment for substance misuse or addiction either at the time of the initial evaluation, or at follow-up visits. Many are still relying on their subjective impressions or poorly validated red flags (specific medication requested or dose) for judging risk level when screening patients.2
The concern for addiction risk is shared by physicians, patients, and their families. An important subset of patients with chronic pain syndromes may suffer from a SUD or a prior history of addiction. Similarly, some patients without any prior substance use issues may go on to develop aberrant drug related behaviors (ADRB) and SUD. It is difficult to label particular behaviors as ADRBs for many of the same features are also seen in patients suffering from oligoanalgesia. These include using other people’s analgesics, accelerating dosing, running out of medications early, and seeking opioids from more than one physician. Other behaviors inherently suggestive of SUD include: selling prescription drugs, forging prescriptions, using alternative routes of ingestion, multiple incidences of lost medications or prescriptions, or theft of paraphernalia from hospitals for injection.3 There is considerable variability in the literature about the risk for de-novo addiction or SUD in patients who are started on opioid therapy for acute or chronic pain, but that risk exists. In a structured evidence-based review Fishbain estimated that 0.19% of chronic pain patients undergoing chronic opioid analgesic therapy developed ADRB’s or SUD when no prior or current history of abuse or addiction was reported at the time of opioid initiation.4
Assessment requires the care giver use a standardized systematic approach to all patients who will be receiving (or are at risk of misusing) opioids. Practitioners are encouraged to embrace a “universal precautions” and rational approach to the treatment of pain, as published by Douglas Gourlay in 2005.5 When HIV first entered the medical world, emotions also ran high: fear - even paranoia – was pervasive. Patients with HIV were isolated both medically and socially. It was only after universal precautions for blood borne pathogens became standard practice that those fears dissipated, and care improved.6 Such an approach to the emotional situation surrounding opioids can be equally effective: assume all patients who are being prescribed opioids are at risk for addiction; screen all patients with a tool to establish possible or already existing opioid risk. When in a situation of uncertainty or of moderate risk, know that urine drug testing may provide additional help.
Any other approach, such as reserving risk assessment tools for patients in whom you have a clinical suspicion of misuse or addiction could lead to suboptimal patient care:
We will miss patients who have a SUD. We will prescribe opioids unwittingly to patients with a SUD and fail to initiate steps to help treat that disease. We will also appear to be inappropriately suspicious of those not suffering from, or who never develop a SUD.
We will not prevent the development of addiction. Many patients that we encounter have already been ‘primed’ to develop an addiction disorder due to genetic traits as well as social experiences and nutrigenic factors.7 If that is the case, a single prescription can place them in danger. First do no harm. Identification of patients at high risk prior to prescribing an opioid can allow for movement toward a pain management approach not involving opioids. It can also make them aware of risk of addiction if use of opioids might seem to be a good option for pain relief in the future.
In the next sections, we will review the various risk assessment tools, how they help minimize patient risk in those suffering from chronic pain, and discuss briefly how urine screening might complement an addiction risk assessment tool.
Although this essay’s focus is on the use of risk assessment tools, these tools cannot be used in isolation. The assessment of a patient presenting with either acute or chronic pain involves several distinct steps:
Biological assessment: history and physical examination should be performed to assess the anatomical and pathophysiologic sources of pain as well as previous diagnoses and treatment modalities for similar or other pain episodes. The pain intensity, pattern, quality and location are essential elements of this initial step. All of these descriptors aid in correctly diagnosing the type of pain a patient suffers and the types of analgesics that would be optimal. For many types of chronic pain, including neuropathic and diffuse wide spread pain, opioids offer little or no benefit.
Social assessment: home and work circumstances, social functioning, and any possible disability or impairment resulting from or related to pain
Psychological Assessment: It is important to assess patient’s coping skills, any ADRB, SUD, addiction risk and history. The focus on addiction risk assessment and ongoing risk mitigation is outlined in the following sections.
Overview of Risk Assessment Tools
Many studies have examined the prevalence of SUD and non-medicinal opioid use in specific populations, including those suffering from chronic pain. Important risks to patients who are prescribed opioids for pain include death, overdose and the development of an OUD. Given the enormous burden of opioid addiction, chronic non-cancer pain guidelines strongly suggest screening all patients for risk of substance abuse, misuse, and addiction before prescribing opioids.8 Quantifying that risk can be challenging.
Multiple risk assessment tools were developed in an attempt to help quantify and identify patients more likely to suffer from SUD. These often rely on self-reporting and are thus dependent on patients answering questions honestly: misrepresentation of their past histories or behaviors may significantly impact the resulting risk score. While the possibility of dishonesty may make us skeptical of answers, it should not preclude using these tools. Variability in the patient populations included in derivation studies as well as in some of the outcomes measured also weaken the ability to generalize the value of these tools. As a result, there is no one risk assessment tool that can guarantee accurate risk for any one patient. Until we incorporate DNA testing in our routine clinical care, the only way to prevent the development of an OUD is to keep a patient opioid-naïve, a solution that for many is neither practical nor optimal care. Ongoing prescribing of an opioid should be made understanding the limitations of the risk assessment tools, following the patient appropriately, and screening for ADRB on a regular basis. The performance of these tools in specific clinical environments (e.g. emergency department, hospital ward, pain clinic) has not been sufficiently studied for a specific tool to be recommended for a specific environment. Despite these limitations, it has been shown that use of a standardized tool is superior to practitioner subjective impressions; the latter is not recommended for risk assessment. The extra time to do a standardized risk assessment is well worth it, not only by reducing stress but also by providing better patient outcomes. For example, the Opioid Risk Tool takes only a minute, and usually provides useful information in a standardized manner. The authors use a risk assessment tool for every patient for whom they are considering prescribing an opioid outside of the hospital setting. This aligns with the ‘universal precautions’ mindset described above.
Once a risk is estimated, the use of that information is not always straightforward. As stated above, the tools are not infallible. The results need to be placed in context with other efforts to help reduce risk, such as limiting the quantity or duration of prescriptions, urine drug screening, communication with other care providers, making sure that the patient is obtaining the expected benefits from the opioids, ensuring access to appropriate follow-up for pain management10 and other efforts to monitor for SUD11 or ADRB.
Included in the review are 16 different opioid risk assessment tools, listed alphabetically in Table 1. The next few paragraphs will outline what the authors consider to be the best performing of those tools. The two tools most used by the authors are the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R)12, and the Opioid Risk Tool (ORT)13. The other two tools discussed are perhaps the best to use when working with a patient already being prescribed opioids. It is to be noted that some of the tools, such as the Aberrant Drug Behavior Index include some of the other tools as part of their overall assessment.14
Table 1.
Opioid Risk Assessment Tools
| Tool | Validated (y/n) | Year of publication |
|---|---|---|
| Aberrant Drug Behavior Index14 | N | 2007 |
| Addiction Behaviors Checklist25 | Y | 2006 |
| Brief Risk Interview26 | Y | 2013 |
| Brief Risk Questionnaire20 | Y | 2015 |
| Current Opioid Misuse Measure15 | Y | 2007 |
| Diagnosis Intractability Risk and Efficacy Score9 | Y | 2006 |
| Drug Misuse Index27 | N | 2007 |
| Opioid Compliance Checklist28 | N | 2014 |
| Opioid Risk Tool13 | Y | 2005 |
| Patient Medication Questionnaire22 | Y | 2004 |
| Prescription Drug Use Questionnaire29 | N | 1998 |
| Prescription Drug Use Questionnaire Self-Report30 | Y | 2008 |
| Prescription Opioid Misuse Index31 | N | 2008 |
| Prescription Opioid Therapy Questionnaire32 | N | 2004 |
| Screener and Opioid Assessment for Patients with Pain-Revised12 | Y | 2008 |
| Screening Instrument for Substance Abuse Potential33 | N | 2008 |
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Recommended Risk Assessment Tools
Current Opioid Misuse Measure (COMM®)
The COMM is a 17-question patient assessment tool designed to identify ADRB’s during chronic opioid therapy. Each of the 17 items is scored 0–4 points. Total score can range from 0–68. A score of ≥9 is suggestive of current ADRB with 77% sensitivity and 66% specificity. The COMM is one of the most commonly used tools for patients on long-term opioid therapy and has been validated by high quality studies.15 One validation study found 71% sensitivity and 71% specificity using the cutoff of 9.16 A subsequent study has shown a 77% sensitivity and 77% specificity when a cutoff of 13 is used.17
Opioid Risk Tool (ORT)
This is a 5-question screening tool designed for use in adults to assess the risk for opioid abuse or ADRB. A score is given for a range of responses on each of the 5 items and the total used to predict for low, moderate or high risk for ADRB. A score of 0–3 is low risk, 4–7 moderate risk, and 8 or higher is considered high risk for opioid misuse. The ORT is widely used, despite lack of evidence demonstrating superior performance over other tools. In fact, there have been no trials comparing performance of any of these tools side by side. The original study demonstrated that patients in a low risk category had no ADRB’s 94% of the time while 91% of those categorized as high risk exhibited ADRB’s.13 Subsequent studies found the range of sensitivity to be much lower, varying between 18%–75%. Specificity was found to be between 54%–88%.18,19,20,21 A benefit of the ORT is that it is included in Smartphone apps such as MDCalc® increasing bedside accessibility.
Patient Medication Questionnaire (PMQ)
The PMQ is a 26-question assessment tool using 0–4 point scale to assess for ADRB in patients already taking opioid medications for pain. Scores can range from 0–104. In the derivation study, a score <25 is considered low risk for opioid misuse, 25–30 indicates problematic use, and >30 close monitoring and consideration of titrating the patient off opioids.22 One validation study found 74% sensitivity and 93% specificity for a reduced item PMQ.23 A subsequent high quality study, however, demonstrated 36% sensitivity and 78% specificity.18
Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP®-R)
This is a 24-question screening tool, and is a revision of the original SOAPP®. It is designed to predict ADRB prior to initiation of long-term opioid therapy. Each of the 24 items is rated 0 (never),1, 2, 3, 4 (very often) for a total maximum of 96. A score of ≥18 indicates a patient is at higher risk for misusing prescribed opioids.12 Validation studies suggest 81% sensitivity and 68% specificity. External studies found sensitivity to range between 41%–79% and the specificity between 50%–71%.21,24 The SOAPP-R has been extensively studied and is very methodologically compelling, but its sensitivity seems to be lower than other tools.
What Research Do We Need to Move Forward?
To reach the point where a risk assessment tool can be highly reliable for the patient in front of you will be extremely difficult – it is why the use of the available tools must be combined with other factors as we have indicated. How do researchers overcome possible dishonesty of patients, something almost never seen in other types of clinical research? We would need to identify and demonstrate reproducibility of test results, interobserver reliability and consistency of results in different clinical settings. It is easy for the clinician to be skeptical of these tools and continue to rely on subjective impressions; nevertheless, such an approach, as stated above, may lead to worse outcomes for the patient. Next steps should be evaluating the more used tools in conjunction with the universal precautions approach so see if the standardized approach is superior to a risk tool alone.
Urine Drug Monitoring
Healthcare providers who treat chronic pain should be familiar with urine drug monitoring as risk assessment is greatly enhanced by properly employing and interpreting these tests. In fact, it is one of the few objective measures available that can provide valuable information often not forthcoming when implementing other comprehensive strategies for risk mitigation. Furthermore, there is some evidence that urine drug monitoring improves patient compliance with opioid treatment.34,35 Despite evidence to support it, many physicians do not use drug monitoring in their patients on opioid therapy.36
Urine drug monitoring is an essential part of clinical assessment of patients before and during opioid therapy. As with other risk assessment tools, a “universal precautions” approach simplifies patient expectations and conversations about urine drug monitoring. Both routine and random urine testing may be useful in specific contexts of chronic pain management. In the lowest risk groups and in those who show a high degree of reliability with results, it may be reasonable to screen infrequently and on a scheduled basis. In high-risk individuals or in those who have unexpected results, are clinically unstable, or exhibit ADRB’s, frequency may need to be as frequent as every week and incorporate random screening.
Clinicians need to understand test characteristics including the possibilities for false positive and false negative results before ordering or attempting to interpret urine drug tests. Communicating with the lab facility may allow clarification of the limitations and proper interpretation of results; consultation with the lab you will use should be sought out before employing urine drug testing with patients. The tests should include a package insert which explains their limitations, i.e., what will turn the test positive. Not understanding this leads to poor patient care. For instance, patients have been fired after receiving a prescription for oxycodone and having a negative opioid screen as the provider did not realize the assay did not detect oxycodone.
Planning for discussions or conversations with patients is time well spent before employing urine drug monitoring. It is essential to strategize and discuss with patients how abnormal test results will be treated. A positive point of care test result may be sent for confirmatory testing using gas chromatography or mass spectrometry. In addition, a planned consequence of abnormal test results often includes an increased frequency of testing. All results, patient responses, and ADRB’s should be addressed as soon as possible, with the actions taken documented. In patients being treated for an OUD, a positive screen should not automatically result in patients being removed from treatment.
Point of Care Testing
Point of care or screening urine drug monitoring “dipstick” testing is cheap, quick to interpret, and sensitive enough to be useful for most situations where the risk or reliability of patient reporting is in question.37 It is the usual office-based test that can help guide more specific tests. Results are immediate and may be interpreted and appropriate actions can be taken during the office visit.
Although quite specific, these tests can be tampered with and results altered. Temperature measurement, specific gravity, and pH can all be helpful in identifying tampering, but centers dealing with opioid agonist therapy for addiction may require more elaborate efforts to detect and prevent tampering. This may include observed urine collection. It should be noted that some opioids require specific testing, as some drugs such as methadone, oxycodone, hydrocodone, buprenorphine, or fentanyl are not identified by the specific antibodies used for the immunoassay testing for morphine. Understanding this is growing increasingly important as the illicit opioid supply changes as few of the designer drugs will result in positive tests. As such, a patient can easily have a current OUD and a negative urine drug monitoring test. Other tests for non-opioids may be very specific. A positive result for cocaine, marijuana, or heroin is rarely falsely positive because of the specific analytes measured. However, benzodiazepines suffer many of the same limitations as do non-heroin opioids. Just as important is that even though these tests result in a binary ‘positive’ or ‘negative’, there are cut-offs to turn them positive. This is why eating a poppy seed bagel or being around marijuana smoke will not result in a positive immunoassay.
Confirmation Testing
These tests, which are generally done by very large laboratories, take much longer than point of care tests and are significantly more expensive but provide reliable, definitive results. Confirmation testing includes gas chromatography/mass spectrometry or liquid chromatography. They generally provide evidence for a specific level of detection and may detail information about metabolites. Interpretation of these results may still require a detailed understanding of timing, substances prescribed, and the metabolism of specific opioids and other drugs. Additionally, these tests are more expensive than immunoassays and are not readily available for bedside testing in the office or the hospital.
Risks from Concurrent Use of Other Substances: Screening for Non-opioid General Substance Abuse
Further complicating the issue of opioid therapy and SUDs, many other substances interact with opioids and alter the effectiveness and safety of opioid therapy for analgesia. Smoking tobacco alters the metabolism of opioids; chronic smokers are more likely to exhibit ADRB and suffer from drug dependence.38 Additionally, combining opioids with other sedatives increases the morbidity and mortality from opioids.39
Written Agreements
There is poor evidence for the effectiveness of opioid treatment agreements, but they may help clarify a “universal precautions” approach. Furthermore, a written agreement may clarify the goals of opioid trials, tapers, and also when it may be reasonable to terminate opioid therapy. The authors recommend using treatment agreements for use of opioids for chronic non-cancer pain.
Tamper Resistant Formulations
Some formulations may help reduce the possibility or convenience of misusing or changing the route of administration of certain medications. These formulations intend to make it more difficult (but not impossible) to inject, nasally insufflate, or manipulate the release timing in order to achieve a more desirable intoxication effect. Although tamper-resistant formulations may be helpful in specific circumstances, individuals may switch to using other opioids without tamper resistant strategies in order to achieve intoxication or to decrease drug costs.
Risk Assessment for Opioid Use Disorder After Hospital Discharge
Patients who are on opioid agonist therapy, but who require admission for an acutely painful condition are at high risk for returning to opioid misuse. There is understandable reluctance – both from the provider and the patient – to include opioids within the pain management plan. It has been recognized however that failure to adequately control acute severe pain carries greater risk of return to opioid misuse than does proper – controlled – use of opioids to manage the pain. For those patients who do require opioids as part of their pain management, a locked patient-controlled analgesia pump is the preferred method of delivering the opioids. In addition, if they are discharged on opioids, having a responsible adult monitor their use is also recommended.
Predicting chronic opioid therapy after hospital discharge has been studied.40 Whether use of such a model can also identify the subgroup of these patients requiring longer opioid use who are at risk for opioid misuse remains unknown. It would also be of value to see if combining this predictive model with an existing opioid risk assessment tool could better identify at-risk patients.
When Addiction is Highly Suspected or Confirmed
For patients in acute opioid withdrawal and a clear history of addiction, referral to appropriate opioid agonist therapy addiction services is recommended.41 Methadone and buprenorphine programs are effective strategies for OUD that are cost-effective and reduce mortality and morbidity. Initiation of buprenorphine is an option in the emergency department or hospital ward in some jurisdictions, but should only be undertaken by those with a clear understanding of the mechanisms and pathway to ongoing care.42 Ideally, patients who have buprenorphine initiated in the emergency department should be referred to an opioid-agonist therapy clinic (or a buprenorphine certified primary physician) within the next 48 hours.
Summary
None of the risk assessment tools are able to predict perfectly which patients will ultimately suffer from OUD if prescribed opioids in their pain management. Of the tools used to assess risk for ADRBs in patients being considered for opioid therapy, the SOAPP-R, and ORT most accurately add to the clinician’s ability to predict OUD risk. Each instrument has unique limitations and validity across different populations is unclear. Once patients have initiated opioid therapy and transitioned to long-term opioid therapy, the PMQ and the COMM appear to be somewhat better than other tools to predict the development of ADRB in that setting. Despite relatively weak evidence to support the use of any one tool, recommendations strongly encourage use of risk assessment tools prior to initiating opioid therapy. Risk assessment should be repeated regularly during the course of opioid therapy. To optimize a combination of universal precautions and risk assessment prior to prescribing, clinicians should also make use of urine drug screening to provide the most consistent approach for opioid risk assessment. Risk assessment tools and urine drug screening both have flaws, but using them provides better patient outcomes than physician subjective impressions.
Footnotes
James Ducharme, MD, (above), is a Clinical Professor of Medicine, McMaster University, Hamilton, Ontario. Sean Moore, MD, is Assistant Professor, Northern ontario School of Medicine in Kenora, Ontario.
Contact: paindoc22000@yahoo.com
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Disclosure: None reported.
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