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Step 4: Monitor Patient

Step 4: Monitor Patient

Universal Precautions, Step 4: Monitor Patient

The management of the patient with chronic pain who is receiving prescription opioid therapy is an ongoing process. The diagnosis should be reviewed periodically, and comorbid conditions should be reevaluated.2 In addition, the patient should be frequently reassessed to determine the level of analgesia, the degree of functional improvement (activity), the presence of adverse effects, and the occurrence of any aberrant behavior related to the prescription (ie, signs of substance abuse or addiction; see Glossary).1,2,12 These assessments can be remembered as the “4 A’s.”

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Opioids should be individually titrated to a dose that provides adequate analgesia and minimizes adverse reactions. Based on your follow-up assessment of the patient with chronic pain, it may be appropriate to adjust the opioid dose, discontinue opioid therapy, refer the patient to a specialist, or further examine the patient’s compliance with the prescribed regimen2—by requesting a pill count, for example.5,7

Pill Counts

Occasional pill counts are one method for assessing compliance with the prescribed opioid regimen, although this method has limitations.1-3 The patient is asked to bring the pill bottle to the office on the next visit, and the number of pills remaining is compared with the expected number. Pill counts may detect misuse, abuse, or diversion of opioids. A broader review of all of the patient’s medications may be appropriate as well.4

Reference

  1. 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 May 20, 2014.
  2. Atluri S, Akbik H, Sudarshan G. Prevention of opioid abuse in chronic non-cancer pain: an algorithmic, evidence based approach. Pain Physician. 2012;15(3 suppl):ES177-ES189. PMID: 22786456
  3. Brown J, Setnik B, Lee K, et al. Assessment, stratification, and monitoring of the risk for prescription opioid misuse and abuse in the primary care setting. J Opioid Manag. 2011;7(6):467-483. PMID: 22320029
  4. Tarn DM, Paterniti DA, Kravitz RL, Fein S, Wenger NS. How do physicians conduct medication reviews? J Gen Intern Med. 2009;24(12):1296-1302. PMID: 19813063

If you determine that opioids are no longer safe and/or effective for a patient, opioid therapy should be stopped. The decision to discontinue opioid therapy may be made for a variety of reasons, including failure to provide adequate pain relief or improvement in function, side effects, aberrant or abusive behavior, and/or noncompliance with the treatment plan.13

When it is appropriate to discontinue opioid therapy, a slow tapering of the dose is generally advisable to minimize withdrawal effects.5,6 Symptoms of opioid withdrawal may include craving, restlessness, irritability, increased sensitivity to pain, nausea, cramps, muscle aches, dysphoric mood, insomnia, and anxiety. Some signs may include pupillary dilation, sweating, piloerection (“goosebumps”), tachycardia, vomiting, diarrhea, increased blood pressure, and yawning.13 The speed of the taper may depend on a number of factors, such as the duration of opioid therapy.5 Consult treatment guidelines, as well as individual product labeling for specific recommendations regarding the tapering process.

The conversation with a patient regarding the need to discontinue opioid therapy can be a difficult one. It is important to emphasize your commitment to the patient’s well-being and clearly outline the details of a new treatment plan.

Note that patients being tapered off opioid therapy should be instructed to properly dispose of any unused medication. The US Food and Drug Administration recommends advising patients to flush unused opioid medication down the toilet.15

Select a tab below for more information about patient monitoring.

References

  1. Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84(7):593-601. PMID: 19567713
  2. 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
  3. 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.
  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. Webster LR, Fine PG. Approaches to improve pain relief while minimizing opioid abuse liability. J Pain. 2010;11(7):602-611. PMID: 20444651
  8. Cleeland CS. The Brief Pain Inventory: User Guide. 2009. http://www.mdanderson.org/education-andresearch/departments-programs-and-labs/departments-and-divisions/symptom-research/symptom-assessmenttools/BPI_UserGuide.pdf. Accessed November 6, 2017.
  9. Breivik H, Borchgrevink PC, Allen SM, et al. Assessment of pain. Br J Anaesth. 2008;101(1):17-24. PMID: 18487245
  10. Butler SF, Budman SH, Fernandez KC, et al. Development and validation of the Current Opioid Misuse Measure. Pain. 2007;130(1-2):144-156. PMID: 17493754
  11. Chou R, Fanciullo GJ, Fine PG, Miaskowski C, Passik SD, Portenoy RK. Opioids for chronic noncancer pain: prediction and identification of aberrant drug-related behaviors: a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009;10(2):131-146. PMID: 19187890
  12. Passik SD, Weinreb HJ. Managing chronic nonmalignant pain: overcoming obstacles to the use of opioids. Adv Ther. 2000;17(2):70-83. PMID: 11010058
  13. Kirpalani D. How to maximize patient safety when prescribing opioids. PMR. 2015;7(11):S225-S235. PMID: 26568502
  14. Kosten TR. Opioid drug abuse and dependence. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson JL, Loscalzo J, eds. Harrison's Principles of Internal Medicine 18th ed. New York, NY: McGraw-Hill; 2012:3552-3555. http://accessmedicine.mhmedical.com/Content.aspx?bookId=331&sectionId=40727214. Accessed November 6, 2017.
  15. US Food and Drug Administration. New safety measures announced for extended-release and long-acting opioids: ER/LA opioid analgesic class labeling changes and postmarket requirements [letter to ER/LA opioid application holders]. September 10, 2013. http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM367697.pdf. Accessed November 6, 2017.

The ID Pain Screener

Universal Precautions, Step 4: Monitor Patient

PHQ-4

Adapted with permission from Portenoy R. Curr Med Res Opin. 2006;22(8):1555-1565. PMID: 16870080.

The ID PAIN Screener helps providers identify neuropathic pain. It consists of 6 total questions: 5 sensory descriptor items and 1 item relating to whether pain is located in the joints.1 This brief questionnaire can be self-administered by the patient. Patients are asked to check Yes (or No) for the items that accurately describe (or don’t describe) their pain in the past week. ”Yes” answers to questions 1-5 are scored as 1, while a ”yes” answer to question 6 is scored as-1. All ”no” answers are scored as 0. Total scores can range from -1 to 5, with higher scores (>3) associated with neuropathic pain.1

The ID PAIN Screener was developed in 586 patients with chronic pain of nociceptive, mixed, or neuropathic etiology and validated in 308 patients with similar classifications as determined by pain specialist diagnoses.1 In the validation study, 22% of the nociceptive group, 39% of the mixed group, and 58% of the neuropathic group scored above a 3, indicating the presence of a neuropathic component of their pain.1

Reference

  1. Portenoy R. Development and testing of a neuropathic pain screening questionnaire: ID Pain. Curr Med Res Opin. 2006;22(8):1555-1565. PMID: 16870080

The D.I.R.E. Score

Universal Precautions, Step 4: Monitor Patient

PHQ-4

Adapted with permission from Belgrade MJ et al. J Pain. 2006;7(9):671-681. PMID: 16942953 https://www.sciencedirect.com/science/article/pii/S1526590006006262

Designed for primary care physicians, the Diagnosis, Intractability, Risk, and Efficacy (D.I.R.E) Score is a rating system that can help identify which chronic, noncancer pain patients will have effective analgesia and be compliant with long-term opioid treatment.1 It can be used for those patients already on opioid therapy or for those being considered for therapy.1

The score consists of 4 factors: Diagnosis, Intractability, Risk, and Efficacy.1 The Risk factor is broken down further into subcategories (psychological, chemical health, reliability, and social support). Providers rate each of the 4 factors on a scale of 1 to 3. A score of 1 on each factor indicates the least favorable case for opioid therapy, while a score of 3 indicates the most favorable case. Total scores range from 7 to 21, with higher scores (14 or higher) indicating that the patient is a good candidate for long-term opioid analgesia and lower scores (13 or below) indicating that the patient may not be a suitable candidate.1

A total of 61 patients were included as part of a retrospective study of the D.I.R.E. Score, with 20 or 21 patients included from each of three score groupings: 7-11, 12-16, and 17-21. Three clinical outcomes were measured as part of the study: compliance with prescribing, efficacy of opioid analgesia, and disposition (continuation of opioids at last clinical contact). Sensitivity and specificity for predicting patient compliance were 94% and 87%, respectively. For efficacy, sensitivity and specificity were 81% and 76%, and for disposition, sensitivity and specificity were 86% and 73%.1

The D.I.R.E. Score was shown to be both valid and reliable and showed strong correlation with opioid analgesia and patient compliance.1

Reference

  1. Belgrade MJ, Schamber CD, Lindgren BR. The DIRE Score: predicting outcomes of opioid prescribing for chronic pain. J Pain. 2006;7(9):671-681. PMID: 16942953

Using the Brief Pain Inventory

Universal Precautions, Step 4: Monitor Patient

Using the Brief Pain Inventory (BPI) to Assess Analgesia and Activity

Brief Pain Inventory
Click on image above to view BPI

A patient’s level of analgesia (pain) and activity (function) can be assessed at baseline and throughout opioid therapy using the Brief Pain Inventory (BPI).1-3 This well-established tool can be administered by you or completed by the patient.4 The BPI (short form) assesses current pain severity and the degree of interference with 7 life measures (general activity, walking, work, mood, enjoyment of life, relations with others, and sleep) on a 0-to-10-point scale.1 It also includes questions about current pain medications and associated pain relief. The short form takes about 2 to 3 minutes for a patient to complete.4

The BPI has been used to assess pain and function in hundreds of clinical trials, including studies of fibromyalgia, neuromuscular pain, neuropathic pain, osteoarthritis, and surgical pain.1 Its usefulness has been examined in more than 70 validation studies.1

Brief Pain Inventory. Charles S. Cleeland, PhD. Pain Research Group. Copyright 1991. Used with permission.

Scoring the BPI

  • Pain severity: The items rating “your pain at its worst in the last 24 hours” and “your pain on average” can be used on their own to measure pain severity at baseline and throughout treatment.1 However, the developers of the BPI recommend that all 4 pain-severity items be utilized. A patient’s numerical (0 to 10) score on each of these items can be tracked over time to help assess the effects of treatment.
  • Pain interference: A patient’s 0-to-10 scores on the 7 items measuring pain interference with daily activities can be averaged to produce a single number for ease of reference and tracking over time.1

References

  1. Cleeland CS. The Brief Pain Inventory: User Guide. 2009. http://www.mdanderson.org/education-and-research/departments-programs-and-labs/departments-and-divisions/symptom-research/symptom-assessment-tools/BPI_UserGuide.pdf. Accessed November 6, 2017.
  2. 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.
  3. 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.
  4. Breivik H, Borchgrevink PC, Allen SM, et al. Assessment of pain. Br J Anaesth. 2008;101(1):17-24. PMID: 18487245

Assessing for Potential Aberrant Behavior

Universal Precautions, Step 4: Monitor Patient

An assessment of potential aberrant behavior in a patient receiving opioid therapy may begin with a review of the patient’s use of the medication to date and adherence to the written treatment agreement. This assessment can be supplemented by rechecking the data from the prescription drug monitoring program (PDMP) and potentially repeating urine drug testing (UDT). As a component of ongoing patient monitoring, UDT may best be repeated randomly, 1 or more times per year depending on the patient’s history and risk profile. It may be performed as often as every visit in patients who have demonstrated aberrant behavior related to opioid therapy.1

A number of patient questionnaires also have been developed to help identify aberrant drug-related behaviors in those receiving prescription opioid therapy, but there is currently limited evidence supporting the use of these screening instruments.2

Some data support the use of the Current Opioid Misuse Measure (COMM), a 17-item questionnaire that inquires about a patient’s behavior and mood over the past 30 days.3-5 The COMM is included in some treatment guidelines for the management of patients receiving long-term opioid therapy.6,7

The Current Opioid Misuse Measure (COMM)

Adapted with permission from Butler SF, et al. Clin J Pain. 2010;26(9):770-776. PMID: 20842012 https://insights.ovid.com/pubmed?pmid=20842012

In contrast to many other patient assessment tools, the COMM helps to identify whether a patient, currently on long-term opioid therapy, is exhibiting aberrant behavior.1,2 It is included in some treatment guidelines for the management of patients receiving long-term opioid therapy.3,4

The COMM includes 17 questions that ask about the frequency of a thought or behavior over the past 30 days. Patients are asked to answer each question using a scale of 0 (“never”) to 4 (“very often”).1,2 The 17 items are then scored to create a total score. A higher total score (>9) indicates that the patient may be currently misusing or abusing his or her opioid therapy.2

The COMM was first validated with 86 chronic pain patients.1 A score of 9 yielded a sensitivity of 77% and a specificity of 68%, indicating that it may be an appropriate choice as a COMM cutoff score. The questionnaire was subsequently cross-validated with 226 chronic, noncancer pain patients across 5 pain management centers.2 In addition to completing the 17-item COMM, each patient was rated by a physician, completed a urine toxicology screen, and was classified based on the Aberrant Drug Behavior Index. When gauged against the Aberrant Drug Behavior Index, the COMM was shown to be valid.2

References

  1. Butler SF, Budman SH, Fernandez KC, et al. Development and validation of the Current Opioid Misuse Measure. Pain. 2007;130(1-2):144-156. PMID: 17493754
  2. 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
  3. 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: 20842012
  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.

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, Miaskowski C, Passik SD, Portenoy RK. Opioids for chronic noncancer pain: prediction and identification of aberrant drug-related behaviors: a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009;10(2):131-146. PMID: 19187890
  3. Butler SF, Budman SH, Fernandez KC, et al. Development and validation of the Current Opioid Misuse Measure. Pain. 2007;130(1-2):144-156. PMID: 17493754
  4. 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
  5. Meltzer EC, Rybin D, Saitz R, et al. Identifying prescription opioid use disorder in primary care: diagnostic characteristics of the Current Opioid Misuse Measure (COMM). Pain. 2011;152(2):397-402. PMID: 21177035
  6. 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
  7. 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.