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Step 3: Dialogue With Patient

Step 3: Dialogue With Patient

Universal Precautions, Step 3: Dialogue With Patient

After you have assessed a patient’s risk and decided on a specific prescription opioid agent, an important next step is to have a discussion with the patient regarding therapy. This discussion may be thought of in 2 parts. The first part is informed consent: a discussion of treatment expectations, including the potential benefits and risks of the prescription opioid medication. The second part is a discussion of the patient’s responsibilities with respect to the opioid prescription, which should conclude with the signing of a treatment agreement.1-5 Reinforce with the patient that this step is part of the universal precautions you take with every patient who is receiving a prescription opioid medication for chronic pain.

Select a tab below for more information about these aspects of the patient dialogue.

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. 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
  5. Webster LR, Fine PG. Approaches to improve pain relief while minimizing opioid abuse liability. J Pain. 2010;11(7):602-611. PMID: 20444651

Discussing Treatment Expectations (Informed Consent)

Universal Precautions, Step 3: Dialogue With Patient

Topics That May Be Covered During Informed Consent Relating to an Opioid Prescription
  • The reason for the prescription (ie, the diagnosis)1
  • The fact that prescription opioids are only part of a broader pharmacologic and nonpharmacologic treatment plan, which may include physical and occupational therapy, behavioral interventions, and/or injection therapies2
  • Potential benefits, including expectations for the extent and onset of pain relief and functional improvement3-6
  • Potential risks, including adverse effects and possible opioid addiction, abuse, and misuse, which can lead to overdose and death3-8
  • The rationale for an abuse-deterrent opioid (if prescribed)9
  • The need for monitoring, and the possibility that treatment will be discontinued at some point, based on response (“exit strategy”)3,5,7,10
  • The continued importance of additional nonpharmacologic modalities, eg, exercise, acupuncture, or meditation2

As with any medication, when prescribing opioids for chronic pain it is important to review the potential benefits (including the potential extent and onset of pain relief and functional improvement) and risks (including potential adverse events) with the patient and answer any questions about the medication.1,7 Discussion of opioid risks should include an explanation of the possibility of opioid addiction, abuse, and misuse, which can lead to overdose and death.7,11

To inform your discussion, refer to the patient counseling information in the labeling of the opioid agent you prescribe.11 In addition, advise the patient to read the FDA-approved patient labeling (ie, Medication Guide) for the agent.12 You may wish to provide patients with a copy of the Medication Guide, which is contained within the product labeling. Patients should receive another copy from the pharmacy.

During your discussion with the patient it may be helpful to explain that this is a “trial” of opioid therapy: depending on the response to treatment, the specific opioid medication may be changed, the dose may be adjusted, or opioid therapy may be tapered and discontinued.3-5,7,10 Having this conversation at the beginning of opioid therapy may help set expectations; some patients may expect to continue on opioid therapy indefinitely, while others may wish to take opioids for the shortest period possible.13,14

References

  1. American Medical Association. Informed consent. https://www.ama-assn.org/delivering-care/informed-consent. Accessed November 6, 2017.
  2. Institute of Medicine of the National Academies. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press; 2011.
  3. Cheatle MD, Savage SR. Informed consent in opioid therapy: a potential obligation and opportunity. J Pain Symptom Manage. 2012;44(1):105-116. PMID:22445273
  4. 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.
  5. 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.
  6. 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.
  7. 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
  8. 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.
  9. Webster LR, Fine PG. Approaches to improve pain relief while minimizing opioid abuse liability. J Pain. 2010;11(7):602-611. PMID: 20444651
  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. 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 November 6, 2017.
  12. US Food and Drug Administration. Guidance for Industry: Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products—Content and Format [draft guidance]. Silver Spring, MD: FDA; 2013.
  13. Matthias MS, Krebs EE, Collins LA, Bergman AA, Coffing J, Bair MJ. “I'm Not Abusing or Anything”: Patient-physician communication about opioid treatment in chronic pain. Patient Educ Couns. 2013;93(2):197-202. PMID: 23916677
  14. Matthias MS, Parpart AL, Nyland KA, et al. The patient-provider relationship in chronic pain care: providers' perspectives. Pain Med. 2010;11(11):1688-1697. PMID: 21044259

Obtaining a Written Treatment Agreement

Universal Precautions, Step 3: Dialogue With Patient

Topics That May Be Covered By a Written Treatment Agreement1-4
  • Keeping regularly scheduled office visits
  • Adhering to prescribed therapy
  • Refilling medications on schedule
  • Submitting to urine drug testing
  • Storing medications in a secure place
  • Being an active participant in the pain management plan
  • Not using illegal substances
  • Never sharing medications
  • No “doctor shopping” or “pharmacy shopping”

After reviewing treatment expectations with the patient, it is advisable to procure a written treatment agreement with respect to opioid therapy.1-6 This agreement can help prevent misunderstandings about how the prescription should be used, advise the patient against aberrant behavior with respect to the prescription, and underscore the potential consequences of such behaviors.1-4

The written treatment agreement can be an important tool for both you and your patients receiving opioid therapy for chronic pain, helping you educate them about the treatment plan and documenting their agreement to participate.2

Sample opioid treatment agreements are available from a variety of organizations. Some of these sample agreements are listed in the Guidelines and Templates section.

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. 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
  6. Cheatle MD, Savage SR. Informed consent in opioid therapy: a potential obligation and opportunity. J Pain Symptom Manage. 2012;44(1):105-116. PMID: 22445273