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Tools and Resources: Universal Precautions Implementation Tool

Universal Precautions Implementation Tool

This tool provides an overview of the 4 universal precautions steps for opioid therapy in patients with chronic pain, for your reference. It also presents some discussion points about universal precautions that may help you prepare for a dialogue with patients about the steps. You can download this tool or view the content here on the Web site.

Applying the 4 Steps

A 4-step approach to universal precautions for opioid prescribing in patients with chronic pain has been developed as part of the Rethink Opioids initiative.* This graphic presents all of the components of the process at a glance. Click to expand the 4 steps

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 May 20, 2014.
  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 May 20, 2014.
  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 May 20, 2014.
  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. 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
  9. Kroenke K, Spitzer RL, Williams JB, Löwe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009;50(6):613-621. PMID: 19996233
  10. Löwe B, Wahl I, Rose M, et al. A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire 4 (PHQ-4) in the general population. J Affect Disord. 2010;122(1-2):86-95. PMID: 19616305
  11. Alliance of States With Prescription Monitoring Programs. Prescription monitoring frequently asked questions (FAQ). http://www.pmpalliance.org/pdf/PMP%20FAQ%202012%20-%20FinalForPrint.pdf Accessed May 20, 2014.
  12. 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
  13. 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
  14. US Food and Drug Administration. ER/LA Opioid Analgesic Class Labeling Changes and Postmarket Requirements. Letter to ER/LA opioid application holders. http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM367697.pdf Accessed May 20, 2014.
  15. 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 May 20, 2014.
  16. Breivik H, Borchgrevink PC, Allen SM, et al. Assessment of pain. Br J Anaesth. 2008;101(1):17-24. PMID: 18487245
  17. 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
  18. 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
  19. US Food and Drug Administration. Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling [draft guidance]. Silver Spring, MD: FDA; 2013.
  20. Stanos S. Continuing evolution of opioid use in primary care practice: implications of emerging technologies. Curr Med Res Opin. 2012;28(9):1505-1516. PMID: 22937723

Preparing for a Dialogue With Patients

Patients may question the necessity of universal precautions or ask for more details about the 4-step process. The following suggestions may help you prepare for discussion with your patients.

Importance of Universal Precautions

  • Explain that universal precautions are intended to help protect patients, their families, and society from the known risks of opioid medications.1,2 (Refer to the Patient Counseling Information and Medication Guide in product labeling for guidance on discussing risks and benefits of specific agents.)
  • Emphasize that you apply these precautions to every patient being considered for opioid therapy for chronic pain.
  • Briefly review the 4 steps in the process: Assess Risk, Select Agent, Dialogue With Patient, Monitor Treatment.

Rationale for Risk Assessment Tools

  • Risk questionnaires: Explain that these tools (eg, Opioid Risk Tool) are intended to help you make appropriate treatment decisions and are an important part of the universal precautions process.3
  • Psychological assessment: Point out that this is an important step because a personal or family history of psychological illness has been linked to increased risk with opioids.4
  • Prescription monitoring program: If your state has a program in place, explain that you check prescription records to document the patient’s prescriptions for controlled substances. Point out (if it is true in your state) that you are required to check these records before prescribing a controlled substance such as an opioid.5,6
  • Urine drug testing: Explain that these tests are an important part of your risk assessment for all patients being considered for opioid therapy for chronic pain.1,3,7 Point out that urine tests may be repeated randomly if opioid therapy is continued long-term.3

Selection of an Abuse-deterrent Opioid

  • If you are prescribing an abuse-deterrent opioid, explain that these products are designed with technology intended to make manipulation of the medication more difficult or to make abuse of the manipulated medication less attractive or rewarding.8 Provide an example appropriate to the abuse-deterrent opioid you are prescribing.
  • Explain that you prescribe abuse-deterrent opioids, when they are appropriate and available, to every patient who takes opioids long-term, as part of universal precautions.1
  • Point out that abuse-deterrent opioids do not stop people from taking too many pills, which is the most common form of opioid abuse.8

Purpose of a Written Treatment Agreement

  • Explain that a written treatment agreement is intended to help prevent misunderstandings about how the opioid medication should be used.3
  • Point out that the agreement serves to summarize and formalize your discussion about the proper use of the medication.7

References

  1. Webster LR, Fine PG. Approaches to improve pain relief while minimizing opioid abuse liability. J Pain. 2010;11(7):602-611. PMID: 20444651
  2. Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84(7):593-601. PMID:19567713
  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 May 20, 2014.
  4. 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
  5. Federation of State Medical Boards. Prescription drug monitoring programs: state-by-state overview. Updated October 2013. http://www.fsmb.org/pdf/GRPOL_pmp_overview_by_state.pdf. Accessed May 20, 2014.
  6. US Dept of Justice, Drug Enforcement Administration Website. State Prescription Drug Monitoring Programs: Questions and Answers. Updated October 11, 2011. http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm. Accessed October 8, 2014.
  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 May 20, 2014.
  8. US Food and Drug Administration. Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling [draft guidance]. Silver Spring, MD: FDA; 2013.