What guidance is available for tapering long-term opioid analgesics?

Background

In 2016, the Centers for Disease Control and Prevention (CDC) released a guideline comprised of 12 recommendations on prescribing opioids for chronic non-cancer pain.¹  The authors recommended that opioids should be used at the lowest effective dose when used, and to carefully consider the risks of increasing the dosage above 50 milligram morphine equivalents per day. The guideline also emphasized that clinicians should weigh the risks versus benefits of chronic opioid therapy. The uptake and implementation of the guideline has been broad and helped address some aspects of the opioid crisis.² Unfortunately, since release of those guidelines, there have been policies and practices implemented that are either inconsistent or extend the recommendations of the original guidelines beyond their intended scope.^2-4 Among misapplications of the guideline recommendations include inflexible dosage and duration thresholds leading to abrupt opioid discontinuation. The Food and Drug Administration (FDA) released a drug safety communication earlier this year about reports of serious harm after patients with physical dependence on opioids were suddenly withdrawn from their opioid therapy.⁵ In response to these reports, the FDA is requiring prescribing label changes to help clinicians with individual, gradual tapering.  Most recently, the US Department of Health and Human Services (HHS) released a guide in 2019 on the appropriate dosage reduction or discontinuation of long-term opioid analgesics.⁶

Evaluating risk versus benefits

Opioid therapy is appropriate for certain populations where the benefits outweigh the risks, particularly in patients with cancer pain or pain at the end of life.^6-8 For those whose risk-benefit balance tips in favor of risk, opioid tapering should be considered. However, this process is best initiated as a shared decision process between clinicians and patients. For many patients, if risks are not imminent, it is better to wait for patient buy-in prior to initiating any changes to therapy. Noncollaborative tapering can lead to worse outcomes, particularly in physically dependent patients, such as withdrawal symptoms, worsening pain, anxiety, depression, suicidal ideation or self-harm, and increased risk for patients to seek alternative high-risk sources of opioids.^5,6

Tapering to either reduced dosages or to discontinuation of opioid therapy should be considered more specifically if:^6,7,9

• Pain has improved.
• Patient has not experienced meaningful benefit from opioid therapy in relation to pain and functionality.
• Patient requests to discontinue opioid therapy.
• Patient is experiencing intolerable or severe adverse effects that cannot be adequately managed.
• Patient is receiving higher doses of opioid therapy without realizing additional benefits from the higher dose.
• Patient has experienced an overdose or displayed warning signs of an impending event.
• Patient is currently on other concomitant medications (eg, benzodiazepines) or has other comorbidities (eg, liver or kidney disease, high fall risk, sleep apnea) that place them at higher risk for opioid-related adverse events.
• Lastly, dosage thresholds, such as >90 milligram morphine equivalents per day, should not be considered mandates to initiate an opioid taper.

Further, patients who display opioid misuse behaviors or show signs of opioid use disorder should be further evaluated.^6,7 Patients who do meet criteria for opioid use disorder must be managed differently as they require management of their pain, but also must have their underlying disorder treated. In these cases, medication-assisted treatment is preferred.

Tapering strategies

Overall, tapering strategies should be individualized and account for a patient’s goals and concerns with opioid withdrawal.^6,9 Factors that should be considered include: whether the goal is dose reduction versus complete discontinuation, dose, formulation, and length of previous opioid therapy, comorbid conditions, risk for serious adverse events (eg, overdose), and the patient’s willingness to tolerate physical adjustments to lower doses. Common tapers reduce opioid doses 5 to 20% every 4 weeks; however, tapering speed should be directed by the patient’s response to dose reductions once initiated.^6,10 Some example taper regimens are presented in Table 1. The HHS guideline specifically notes that tapers are still considered successful even if the taper progresses very slowly or if it needs to be paused to allow a patient more time to cope with their pain and new strategies to address it.⁶ Generally, slower tapers are more tolerable, with one retrospective review of Medicaid data demonstrating that each additional week of discontinuation time was associated with a 7% reduction in the probability of having an opioid-related adverse event, defined as an emergency department visit or a hospitalization related to opioid overdose or substance abuse disorder.¹¹

For some patients, opioid tapering can become more complicated, particularly those who may receive multiple products with differing routes of administration.⁸ Unfortunately, there is not much direct guidance for these situations. Expert opinions do recommend considering conversion of all opioid doses into milligram morphine equivalents to help determine overall dose, rotation to an alternative opioid during the taper (eg, switching from transdermal to oral), and possibly, initiation of buprenorphine if tapering plateaus.^6,8,10,12

Lastly, there are a few scenarios that would justify an abrupt discontinuation of opioids when patient safety is at imminent risk.⁹ These can include situations where there is concern for diversion or if a patient is displaying dangerous behaviors, such as issuing threats or suicidal ideation or behaviors. In these cases, a patient should not be dismissed from care and the clinician would need to provide auxiliary support including assessment and management of withdrawal symptoms, treatment for substance use disorder, or immediate psychiatric referral.⁹

Management of withdrawal symptoms

Ideally, patients will have minimal or manageable withdrawal symptoms, particularly when tapers are completed slowly enough to avoid them.^6,7 If withdrawal symptoms are present, the taper may need to be slowed. However, some patients require faster tapers and short-term medications may be necessary to manage withdrawal symptoms. The Veterans Affairs opioid taper tool provides guidance on managing withdrawal symptoms that includes use of adjuvant medications  based on symptoms, recommended dosing, and follow-up evaluations.⁷  Of note, lofexidine is an alpha-2 agonist FDA-approved to provide short-term treatment of autonomic symptoms associated with abrupt opioid withdrawal.^13,14

Keys to success

Shared decision-making is a key component of successful opioid tapers.¹⁵ Unfortunately, many studies that have evaluated the outcomes of opioid tapers used clinician-initiated or mandated tapers, which clouds the limited evidence available on the benefits and risks of opioid tapers.¹⁶ Discussions with patients on the risks and benefits of opioid therapy may require multiple conversations and a multidisciplinary approach.¹⁵ Referrals to pain specialists, psychologists, psychiatrists, physical or occupational therapists may be useful for patients in helping them transition to the idea of using alternative methods for pain relief. Some barriers for patients include low health literacy, apathy, a lack of trust in their pain being appropriately managed without opioids, and potentially, opioid use disorder. Some additional considerations for opioid tapers are presented in Table 2.

Conclusion

Overall, there is not high-quality evidence available to direct opioid tapers. Ultimately, individualization of opioid tapers is needed. The rate of the taper will be dependent on the patient’s response, the reason and goals for tapering, and the patient’s history of opioid use, including both dose and duration. Several resources are freely available to aid in assessing whether a patient should continue or discontinue opioids as well tapering strategies for those who elect to discontinue or reduce the dosage of opioid therapy. Lastly, patients with opioid use disorder should be properly referred for medication-assisted treatment; more information can be located on the Substance Abuse and Mental Health Services Administration website.

Freely available resources:

CDC:

• Assessing benefits and harms: https://www.cdc.gov/drugoverdose/pdf/Assessing_Benefits_Harms_of_Opioid_Therapy-a.pdf
• Pocket guide for tapering: https://www.cdc.gov/drugoverdose/pdf/Clinical_Pocket_Guide_Tapering-a.pdf

HHS:

• Appropriate dose reduction and discontinuation: https://www.hhs.gov/opioids/sites/default/files/2019-10/Dosage_Reduction_Discontinuation.pdf

Veterans Affairs National Academic Detailing Services:

• Opioid taper decision tool – includes example tapers: https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/Academic_Detailing_Educational_Material_Catalog/52_Pain_Opioid_Taper_Tool_IB_10_939_P96820.pdf#

Other resources:

• Tapering guide from Mayo Clinic: https://www.mayoclinicproceedings.org/article/S0025-6196(15)00303-1/fulltext
• Opioid tapering guidance and tools from Oregon Pain Guidance (also includes guidance on benzodiazepine tapering): https://www.oregonpainguidance.org/guideline/tapering/

References

1. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain–United States, 2016. JAMA. 2016;315(15):1624-1645.
2. Dowell D, Haegerich T, Chou R. No shortcuts to safer opioid prescribing. N Engl J Med. 2019;380(24):2285-2287.
3. Kroenke K, Alford DP, Argoff C, et al. Challenges with implementing the Centers for Disease Control and Prevention opioid guideline: a consensus panel report. Pain Med. 2019;20(4):724-735.
4. Darnall BD, Juurlink D, Kerns RD, et al. International stakeholder community of pain experts and leaders call for an urgent action on forced opioid tapering. Pain Med. 2019;20(3):429-433.
5. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. US Food & Drug Administration website. https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes. Published April 9, 2019. Accessed October 22, 2019.
6. HHS guide for clinicians on the appropriate dosage reduction or discontinuation of long-term opioid analgesics. US Department of Health & Human Services website. https://www.hhs.gov/opioids/sites/default/files/2019-10/Dosage_Reduction_Discontinuation.pdf. Published October 10, 2019. Accessed October 22, 2019.
7. VA PBM Academic Detailing Service. Pain management opioid taper decision tool. Veterans Health Administration website. https://www.pbm.va.gov/AcademicDetailingService/Documents/Pain_Opioid_Taper_Tool_IB_10_939_P96820.pdf. Published October 2016. Accessed November 1, 2019.
8. Pergolizzi JV, Jr., Rosenblatt M, Mariano DJ, Bisney J. Tapering opioid therapy: clinical strategies. Pain Manag. 2018;8(6):409-413.
9. VA/DOD clinical practice guideline for opioid therapy for chronic pain. Department of Veterans Affairs website. https://www.healthquality.va.gov/guidelines/Pain/cot/VADoDOTCPG022717.pdf. Published February 2017. Accessed October 22, 2019.
10. Chou R, Ballantyne J, Lembke A. Rethinking opioid dose tapering, prescription opioid dependence, and indications for buprenorphine [published online ahead of print Aug 27, 2019]. Ann Intern Med. doi: 10.7326/m19-1488.
11. Mark TL, Parish W. Opioid medication discontinuation and risk of adverse opioid-related health care events. J Subst Abuse Treat. 2019;103:58-63.
12. Murphy L, Babaei-Rad R, Buna D, et al. Guidance on opioid tapering in the context of chronic pain: Evidence, practical advice and frequently asked questions. Can Pharm J (Ott). 2018;151(2):114-120.
13. Lucemyra [package insert]. Louisville, KY: US WorldMeds LLC; 2018.
14. Pergolizzi JV, Jr., Annabi H, Gharibo C, LeQuang JA. The role of lofexidine in management of opioid withdrawal. Pain Ther. 2019;8(1):67-78.
15. Pergolizzi JV, Varrassi G, Paladini A, LeQuang J. Stopping or decreasing opioid therapy in patients on chronic opioid therapy [published online ahead of print Aug 3, 2019]. Pain Ther. doi: 10.1007/s40122-019-00135-6.
16. Mackey K, Anderson J, Bourne D, Chen E, Peterson K. Evidence Brief: Benefits and Harms of Long-term Opioid Dose Reduction or Discontinuation in Patients with Chronic Pain. In. VA Evidence-based Synthesis Program Reports. Washington (DC): Department of Veterans Affairs (US); 2019.

Prepared by:
Samantha Spencer, PharmD, BCPS
Clinical Assistant Professor, Drug Information Specialist
University of Illinois at Chicago College of Pharmacy

December 2019

The information presented is current as of November 1, 2019. This information is intended as an educational piece and should not be used as the sole source for clinical decision-making.

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