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Step 1: Assess Risk

Step 1: Assess Risk

Universal Precautions, Step 1: Assess Risk

After deciding that opioid therapy may be clinically appropriate for a patient with chronic pain, it is important to assess the patient for existing substance abuse, addiction potential, and the overall risk for aberrant behavior relating to opioid use before providing the prescription.1-7 Aberrant behavior is any patient behavior that suggests the presence of substance abuse or addiction.8,9 These behaviors may indicate misuse, abuse, or diversion of the medication and may range from unauthorized dose-escalation and hoarding of medication to frequent “losing” of medication, “doctor shopping,” tampering with or manipulation of the medication, forging prescriptions, and selling prescriptions.2,3,10,11Note, however, that the definitions of what constitutes aberrant behavior have not been consistent in the literature.1,12

A variety of risk mitigation strategies have been discussed and/or implemented to support the identification of at-risk patients, including risk assessment tools, psychiatric assessments, Prescription Monitoring Programs (PMPs), and Urine Drug Testing or Screening (UDT or UDS). Validated screening tools can provide significant benefit in clinical practice, and numerous tools are now available to help assess opioid abuse, misuse, and diversion and, importantly, to help document that you have done so.6 Note that risk-assessment tools not discussed here also may merit consideration.

The components of risk assessment that are presented here are intended to be used together to help determine the appropriateness of opioid therapy for patients with chronic pain. However, none of these approaches, alone or together, can provide definitive assessment of an individual patient’s risk.13 Ultimately, every patient is potentially at risk for aberrant behavior related to opioids. Universal precautions, applied throughout the course of patient management, are intended to help mitigate that risk.5,7

It is important to explain to patients that the risk-assessment process is a fundamental part of applying universal precautions for opioid therapy and that the process is intended to help ensure they receive the best care possible.6 For more suggestions on how to discuss aspects of the 4-step approach to applying universal precautions in patients receiving or being considered for opioid therapy, refer to the Universal Precautions Implementation Tool.

Select a tab below to learn more about suggested ways to assess prescription opioid risk in patients with chronic pain.

References

  1. Chou R, Fanciullo GJ, Fine PG, et al; American Pain Society–American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130. PMID:19187889
  2. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain. Version 2.0. Washington, DC: US Dept of Veterans Affairs, US Dept of Defense; 2010. http://www.va.gov/PAINMANAGEMENT/docs/CPG_opioidtherapy_summary.pdf. Accessed November 6, 2017.
  3. Washington State Agency Medical Directors’ Group (AMDG). Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain: An Educational Aid to Improve Care and Safety With Opioid Therapy. 2010 Update. Olympia, WA: Washington State Agency Medical Directors Group; 2010. http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf. Accessed November 6, 2017.
  4. Utah Department of Health. Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain. Salt Lake City, UT: Utah Dept of Health; 2009. http://www.dopl.utah.gov/licensing/forms/OpioidGuidlines.pdf. Accessed November 6, 2017.
  5. Webster LR, Fine PG. Approaches to improve pain relief while minimizing opioid abuse liability. J Pain. 2010;11(7):602-611. PMID: 20444651
  6. Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6(2):107-112. PMID: 15773874
  7. Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84(7):593-601. PMID: 19567713
  8. O’Connor AB, Turk DC, Dworkin RH, et al. Abuse liability measures for use in analgesic clinical trials in patients with pain: IMMPACT recommendations. Pain. 2013;154(11):2324-2334. PMID: 24148704
  9. Butler SF, Budman SH, Fanciullo GJ, Jamison RN. Cross validation of the current opioid misuse measure to monitor chronic pain patients on opioid therapy. Clin J Pain. 2010;26(9):770-776. PMID: 20842012
  10. Webster L, St Marie B, McCarberg B, Passik SD, Panchal SJ, Voth E. Current status and evolving role of abuse-deterrent opioids in managing patients with chronic pain [review]. J Opioid Manag. 2011;7(3):235-245. PMID: 21823554
  11. Katz NP, Adams EH, Chilcoat H, et al. Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain. 2007;23(8):648-660. PMID: 17885342
  12. Sullivan M. Clarifying opioid misuse and abuse [editorial]. Pain. 2013;154(11)PMID: 23906553
  13. Sehgal N, Manchikanti L, Smith HS. Prescription opioid abuse in chronic pain: a review of opioid abuse predictors and strategies to curb opioid abuse. Pain Physician. 2012;15(3 suppl):ES67-ES92. PMID: 22786463

Opioid Risk Tool

Universal Precautions, Step 1: Assess Risk

The Opioid Risk Tool May Help With Opioid Risk Assessment

Opoid Risk Tool
Click on image above to view ORT
Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Pain Med. 2005;6(6):432-442. Used with permission.

The Opioid Risk Tool (ORT) consists of 5 items that may help assess a patient’s risk for aberrant behavior before prescribing an opioid (see Glossary).1This tool considers the patient’s family and personal history of substance abuse (alcohol, illegal or prescription drugs), patient age and sex, any history of preadolescent sexual abuse, and the presence of psychological illness.1 The ORT can be completed by the patient or administered by you.2

Each risk factor that is present is assigned a number value. These numbers are totaled, providing a sum that suggests whether the patient is at low (score of 0-3), moderate (score of 4-7), or high (score ≥8) risk for aberrant behavior.1 Of course, these are subjective descriptions of risk, and it is a matter of your discretion how patient management may be influenced by the results of the ORT.

In a preliminary study of 185 patients treated at a single pain clinic, the ORT demonstrated a high degree of sensitivity and specificity for assessing patients’ risk for aberrant behavior relating to prescription opioids.1 However, a more recent single-center study of 125 patients found that the ORT was not strongly predictive of moderate to severe aberrant drug-related behavior.3 Use of the ORT is currently included in several treatment guidelines for the management of patients receiving long-term opioid therapy.4-6 The ORT may be best utilized in conjunction with other risk-assessment approaches, to create the most complete picture possible of a patient’s potential risk.7

Depending on the results of your risk assessment of the patient (based on the ORT and/or other measures), you may decide to initiate opioid therapy or you may wish to consult with or refer to an appropriate specialist (such as a pain medicine or addiction specialist).5,8

References

  1. Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Pain Med. 2005;6(6):432-442. PMID: 16336480
  2. Jones T, Passik SD. A comparison of methods of administering the opioid risk tool. J Opioid Manag. 2011;7(5):347-351. PMID: 22165033
  3. Witkin LR, Diskina D, Fernandes S, Farrar JT, Ashburn MA. Usefulness of the opioid risk tool to predict aberrant drug-related behavior in patients receiving opioids for the treatment of chronic pain. J Opioid Manag. 2013;9(3):177-187. PMID: 23771568
  4. Chou R, Fanciullo GJ, Fine PG, et al; American Pain Society–American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130. PMID: 19187889
  5. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain. Version 2.0. Washington, DC: US Dept of Veterans Affairs, US Dept of Defense; 2010. http://www.va.gov/PAINMANAGEMENT/docs/CPG_opioidtherapy_summary.pdf. Accessed November 6, 2017.
  6. Washington State Agency Medical Directors’ Group (AMDG). Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain: An Educational Aid to Improve Care and Safety With Opioid Therapy. 2010 Update. Olympia, WA: Washington State Agency Medical Directors Group; 2010. http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf. Accessed November 6, 2017.
  7. Sehgal N, Manchikanti L, Smith HS. Prescription opioid abuse in chronic pain: a review of opioid abuse predictors and strategies to curb opioid abuse. Pain Physician. 2012;15(3 suppl):ES67-ES92. PMID: 22786463
  8. Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6(2):107-112. PMID: 15773874

Screener and Opioid Assessment for Patients With Pain (SOAPP-R)

Screener and Opioid Assessment for Patients with Pain (SOAPP-R)

PHQ-4

Adapted with permission from Butler SF, et al. J Addict Med. 2009;3(2):66-73. PMID: 20161199

The SOAPP-R is a self-report questionnaire, composed of 24 items, that helps predict and assess a patient’s risk for opioid abuse.1,2 Each item is rated on a scale of 0 (never) to 4 (very often). A score of 18 or higher is considered a positive SOAPP-R indication and indicates that the patient may be high risk for aberrant behavior.1,2

The SOAPP-R was first found to be a reliable and valid measure in an initial validation study1 and subsequently cross-validated in a study that included 302 chronic, noncancer pain patients on long-term opioid therapy.2 At the cut-off score of 18, the cross-validation study found that sensitivity was 79% and specificity was 52%.2

References

  1. Butler SF, Fernandez K, Benoit C, Budman SH, Jamison RN. Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R) J Pain. 2008;9(4):360-372. PMID: 18203666
  2. Butler SF, Budman SH, Fernandez KC, Fanciullo GJ, Jamison RN. Cross-Validation of a Screener to Predict Opioid Misuse in Chronic Pain Patients (SOAPP-R). J Addict Med. 2009;3(2):66-73. PMID: 20161199

Psychological Assessment With PHQ-2

Universal Precautions, Step 1: Assess Risk

The Patient Health Questionnaire 2 (PHQ-2) May Help With Psychological Assessment

PHQ-4

Adapted with permission from Center for Quality Assessment and Improvement in Mental Health: PHQ-2 Overview & Screener. Available at: http://www.cqaimh.org/pdf/tool_phq2.pdf.

A history of psychological illness has been positively associated with the risk for aberrant behavior (see Glossary) related to prescription opioids.1 Specific psychological illnesses that may contribute to opioid risk include attention-deficit/hyperactivity disorder, obsessive-compulsive disorder, bipolar disorder, and depression.1 Opioid therapy may need to be reconsidered in a patient with moderate to severe psychological illness.2 Referral to a pain or mental health specialist may be considered in such cases.3

The 2-item PHQ-2 is designed to detect the presence of depression and anhedonia and thus may help with the psychological assessment in patients being considered for opioid therapy.4,5 The 2-item PHQ-2 asks patients how often they have experienced depression and anhedonia in the past 2 weeks. The response to each question yields a score from 0 (not bothered at all) to 3 (bothered nearly every day).4,5

In a validation study, a total score of 3 or higher was shown to have 83% sensitivity and 90% specificity for major depressive disorder.4 The study included 6,000 patients from either primary care or obstetrics-gynecology sites who were administered both the PHQ-2 and the Short-Form General Health Survey. A total of 580 of these patients were also assessed against interviews conducted by independent mental health professional interviews. It should be emphasized, however, that this screening tool should not be used independently to definitively diagnose depression and is an adjunct to your clinical assessment.4,5

References

  1. Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Pain Med. 2005;6(6):432-442. PMID: 16336480
  2. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain. Version 2.0. Washington, DC: US Dept of Veterans Affairs, US Dept of Defense; 2010.http://www.va.gov/PAINMANAGEMENT/docs/CPG_opioidtherapy_summary.pdf. Accessed November 6, 2017.
  3. Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6(2):107-112. PMID: 15773874
  4. Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: Validity of a Two-Item Depression Screener. Medical Care. 2003;41(11):1284-1292. PMID: 14583691
  5. Center for Quality Assessment and Improvement in Mental Health: PHQ-2 Overview & Screener http://www.cqaimh.org/pdf/tool_phq2.pdf. Accessed November 6, 2017.

Prescription Monitoring Program

Universal Precautions, Step 1: Assess Risk

Adapted from the Prescription Drug Monitoring Program Training and Technical Assistance Center. Status of Prescription Drug Monitoring Programs (PDMPs). Updated August 2017.1 Accessed November 6, 2017.

Note that this information may change over time and should be verified independently.

All 50 states and the territory of Guam now have an operational prescription monitoring program (PMP), although Missouri does not currently have a state-wide PMP.1 Also known as prescription drug monitoring programs (PDMPs), these programs collect prescribing and dispensing data electronically submitted by pharmacies and practitioners and monitor and analyze these data.2 PMPs provide the data to legally authorized parties, including health care providers, regulatory boards, and law enforcement.2

In some states, physicians are now required to check PMP data prior to prescribing a controlled substance, and other states are considering such legislation.3,4 You may wish to retrieve a patient’s PMP records prior to the office visit, so you can have this information on hand during the visit.

Reviewing the PMP data may help detect ”doctor shopping” or ”pharmacy shopping”—the practice of deliberately obtaining controlled substances from multiple physicians or pharmacies.5,6 The information you obtain should be interpreted with caution since it may contain errors.5 It also may indicate unintentional use of multiple controlled substances. However, any indication of a previously undisclosed history of controlled substance use should be discussed with the patient. Depending on the patient’s response, consultation with or referral to a pain or addiction specialist may be advisable5

One source you may wish to access for state-by-state information about PMPs is the Prescription Drug Monitoring Program Training and Technical Assistance Center.1

Note that potential PMP requirements are just one component of state and federal regulations. For more information about the PMP and other pertinent state and federal laws, check with your state’s medical licensing board and the Drug Enforcement Administration (DEA).You may wish to review a summary of state prescription medication laws compiled by the Centers for Disease Control and Prevention.

References

  1. PDMP Training and Technical Assistance Center. Status of Prescription Drug Monitoring Programs (PDMPs). Updated August 2017. http://www.pdmpassist.org/pdf/PDMP_Program_Status_20170824.pdf. Accessed November 6, 2017.
  2. US Dept of Justice, Drug Enforcement Administration Website. State Prescription Drug Monitoring Programs: Questions and Answers. Updated June 26, 2016. http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm. Accessed November 6, 2017.
  3. National Conference of State Legislatures. Prevention of prescription drug overdose and abuse. Updated July 16, 2013. www.ncsl.org/issues-research/health/prevention-of-prescription-drug-overdose-and-abuse.aspx. Accessed November 6, 2017.
  4. Prescription Monitoring Program (I-STOP). New York State Register: June 19, 2013. http://docs.dos.ny.gov/info/register/2013/june19/pdf/rulemaking.pdf. Accessed November 6, 2017.
  5. Webster LR, Fine PG. Approaches to improve pain relief while minimizing opioid abuse liability. J Pain. 2010;11(7):602-611. PMID: 20444651
  6. McDonald DC, Carlson KE. Estimating the prevalence of opioid diversion by “doctor shoppers” in the United States. PLoS One. 2013;8(7):e69241. PMID: 23874923

Urine Drug Testing

Universal Precautions, Step 1: Assess Risk

Baseline urine drug testing (UDT, or urine toxicology) is appropriate for every patient being considered for prescription opioid therapy for chronic pain.1,5-9 It can reveal the presence of illicit drugs, prescription opioid agents, and other prescription medications that can be abused.3,5

It is important to explain to patients that this baseline UDT is a universal precaution that is used with all patients.5 Patients who decline to provide a specimen for UDT may be considered unsuitable for chronic pain management with prescription opioids.10 For suggestions on how to discuss UDT with patients (as well as other elements of universal precautions for opioid prescribing), see the Universal Precautions Implementation Tool.

Point-of-care, immunoassay testing kits are available and can provide immediate results, although these tests tend to have high sensitivity but low specificity, and may miss some commonly used drugs.4,5,11 Because of the potential for false negatives and false positives, these rapid results may need to be verified via laboratory testing (typically utilizing chromatography/mass spectrometry), which can be costly and time-consuming.4,5,12 Depending on the results of point-of-care testing, you may wish to delay prescribing opioids until follow-up lab results are obtained or provide the patient with a limited quantity of medication.5

All UDT results—whether positive or negative—should be interpreted within the context of individual patient circumstances and the limitations of the testing methodology used.2-4 When interpreting results of follow-up lab testing, it is important to discuss any unexpected results with the laboratory.3,5,10,11

When initial or follow-up test results contradict the patient’s stated history, a discussion with the patient is an appropriate next step. If the discrepancies cannot be resolved to your satisfaction, you may wish to consult with or refer to a pain or addiction specialist.6

References

  1. Washington State Agency Medical Directors’ Group (AMDG). Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain: An Educational Aid to Improve Care and Safety With Opioid Therapy. 2010 Update. Olympia, WA: Washington State Agency Medical Directors Group; 2010. http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf. Accessed November 6, 2017.
  2. Chou R, Fanciullo GJ, Fine PG, et al; American Pain Society–American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130. PMID: 19187889
  3. Heit HA, Gourlay DL. Urine drug testing in pain medicine. J Pain Symptom Manage. 2004;27(3):260-267. PMID:15010104
  4. Schonwald G. What is the role of urine drug testing (UDT) in the management of chronic non-cancer pain with opioids? Pain Med. 2012;13(7):853-856. PMID: 22804903
  5. Peppin JF, Passik SD, Couto JE, et al. Recommendations for urine drug monitoring as a component of opioid therapy in the treatment of chronic pain. Pain Med. 2012;13(7):886-896. PMID:22694154
  6. Webster LR, Fine PG. Approaches to improve pain relief while minimizing opioid abuse liability. J Pain. 2010;11(7):602-611. PMID: 20444651
  7. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain. Version 2.0. Washington, DC: US Dept of Veterans Affairs, US Dept of Defense; 2010. http://www.va.gov/PAINMANAGEMENT/docs/CPG_opioidtherapy_summary.pdf. Accessed November 6, 2017.
  8. Utah Department of Health. Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain. Salt Lake City, UT: Utah Dept of Health; 2009. http://www.dopl.utah.gov/licensing/forms/OpioidGuidlines.pdf. Accessed November 6, 2017.
  9. Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84(7):593-601. PMID: 19567713
  10. Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6(2):107-112. PMID: 15773874
  11. Pesce A, West C, Egan City K, Strickland J. Interpretation of urine drug testing in pain patients. Pain Med. 2012;13(7):868-885. PMID: 22494459
  12. Passik SD, Kirsh KL. Managing pain in patients with aberrant drug-taking behaviors. J Support Oncol. 2005;3(1):83-86.