Guidelines + Resources + Studies

FDA Drug Safety Announcement: April 2019
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress (For tapering and additional recommendations, see Additional Information for Health Care Professionals).

Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain. Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal (See Additional Information for Patients). Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.

https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes

Study Highlight: August 2018
Choosing Wisely Clinical Decision Support Adherence and Associated Inpatient Outcomes

Ideally, an EHR infrastructure could overcome these obstacles and provide real-time computerized clinical decision support (CDS) to inform healthcare providers when their care deviates from evidence-based guidelines.

CDS comprises a variety of tools, including computerized alerts and reminders with information such as diagnostic support, clinical guidelines, relevant patient information, diagnosis-specific order sets, documentation templates, and drug–drug interactions. CDS provides the ability to modify tests and treatments based on context- and patient-specific information presented at the point of care. Utilizing CDS can help providers avoid ordering a low-value test or intervention that could lead to additional non therapeutic interventions or harm. CDS has been shown to improve a variety of processes, including prescribing practices, appropriate use of diagnostic radiology, adherence to quality measures, and conformance to evidence-based care. Systems that automate CDS, provide tailored recommendations based on patient characteristics, and prompt clinicians to provide a reason for overriding recommendations have been shown to be significantly more likely to succeed than systems that provide only patient assessments.

https://www.ajmc.com/journals/issue/2018/2018-vol24-n8/choosing-wisely-clinical-decision-support-adherence-and-associated-inpatient-outcomes

Patients Do Better When Physicians Follow Computerized Alerts
When physicians follow computer alerts embedded in electronic health records, their hospitalized patients experience fewer complications and lower costs, leave the hospital sooner and are less likely to be readmitted, according to a study of inpatient care.
https://www.optum.com/about/news/patients-do-better-physicians-follow-computerized-alerts.html

American Academy of Physical Medicine and Rehabilitation

〉Pain Management and Opioid Prescribing Policies by State
https://www.aapmr.org/docs/default-source/advocacy/pain-management/pain-management-and-opioid-prescribing-policies-by-state.pdf

American Society of Anesthesiologists

〉ASA Commends FDA for Statement on Opioid Labeling and Tapering Guidance
https://www.asahq.org/advocacy-and-asapac/fda-and-washington-alerts/washington-alerts/2019/04/asa-commends-fda-for-statement-on-opioid-labeling-and-tapering-guidance

Center for Disease Control and Prevention

〉CDC Guideline for Prescribing Opioids for Chronic Pain
https://www.cdc.gov/drugoverdose/prescribing/guideline.html

〉POCKET GUIDE: TAPERING OPIOIDS FOR CHRONIC PAIN
https://www.cdc.gov/drugoverdose/pdf/clinical_pocket_guide_tapering-a.pdf

〉CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain
https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html

Choosing Wisely Clinical Decision Support Adherence and Associated Inpatient Outcomes

Ideally, an EHR infrastructure could overcome these obstacles and provide real-time computerized clinical decision support (CDS) to inform healthcare providers when their care deviates from evidence-based guidelines.

CDS comprises a variety of tools, including computerized alerts and reminders with information such as diagnostic support, clinical guidelines, relevant patient information, diagnosis-specific order sets, documentation templates, and drug–drug interactions. CDS provides the ability to modify tests and treatments based on context- and patient-specific information presented at the point of care. Utilizing CDS can help providers avoid ordering a low-value test or intervention that could lead to additional non therapeutic interventions or harm. CDS has been shown to improve a variety of processes, including prescribing practices, appropriate use of diagnostic radiology, adherence to quality measures, and conformance to evidence-based care. Systems that automate CDS, provide tailored recommendations based on patient characteristics, and prompt clinicians to provide a reason for overriding recommendations have been shown to be significantly more likely to succeed than systems that provide only patient assessments.

https://www.ajmc.com/journals/issue/2018/2018-vol24-n8/choosing-wisely-clinical-decision-support-adherence-and-associated-inpatient-outcomes

Patients Do Better When Physicians Follow Computerized Alerts
When physicians follow computer alerts embedded in electronic health records, their hospitalized patients experience fewer complications and lower costs, leave the hospital sooner and are less likely to be readmitted, according to a study of inpatient care.
https://www.optum.com/about/news/patients-do-better-physicians-follow-computerized-alerts.html

Federation of State Medical Boards

〉FSMB Releases Updated Guidelines for Chronic Use of Opioid Analgesics
http://www.fsmb.org/siteassets/advocacy/news-releases/2017/fsmb-releases-updated-guidelines-for-chronic-use-of-opioid-analgesics.pdf

〉To read the updated Guidelines for Chronic Use of Opioid Analgesics, click here. If you are interested in learning more about all of FSMB’s officially adopted policy guidelines, please click here.

Food and Drug Administration

〉Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids
https://www.fda.gov/news-events/press-announcements/statement-douglas-throckmorton-md-deputy-center-director-regulatory-programs-fdas-center-drug-0

Health Resources & Services Administration

〉The Nation is in the midst of an unprecedented opioid epidemic. More than 130 people a day die from opioid-related drug overdoses...

https://www.hrsa.gov/opioids

How Much Does Opioid Treatment Cost?

An analysis suggested that the total costs of prescription opioid use disorders and overdoses in the United States was $78 billion in 2013.

〉Although the price for opioid treatment may vary based on a number of factors, recent preliminary cost estimates from the U.S. Department of Defense for treatment in a certified opioid treatment program (OTP) provide a reasonable basis for comparison:
- methadone treatment, including medication and integrated psychosocial and medical support services (assumes daily visits):  $126.00 per week or $6,552.00 per year
- buprenorphine for a stable patient provided in a certified OTP, including medication and twice-weekly visits: $115.00 per week or $5,980.00 per year
- naltrexone provided in an OTP, including drug, drug administration, and related services: $1,176.50 per month or $14,112.00 per year

〉To put these costs into context, it is useful to compare them with the costs of other conditions. According to the Agency for Healthcare Research and Quality, annual expenditures for individuals who received health care are $3,560.00 for those with diabetes mellitus and $5,624.00 for kidney disease.

〉It is also important to remember the costs associated with untreated opioid use disorders, including costs associated with:
- criminal justice
- treating babies born dependent on opioids
- greater transmission of infectious diseases
- treating overdoses
- injuries associated with intoxication (e.g., drugged driving)
- lost productivity

〉The amount paid for treatment of substance use disorders is only a small portion of the costs these disorders impose on society. An analysis suggested that the total costs of prescription opioid use disorders and overdoses in the United States was $78 billion in 2013. Of that, only 3.6 percent, or about $2.8 billion, was for treatment.

https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioid-addiction/how-much-does-opioid-treatment-cost

Mortality After Discontinuation of Primary Care–Based Chronic Opioid Therapy for Pain: a Retrospective Cohort Study

Main Outcomes and Measures
Discontinuation from the opioid registry was the exposure of interest. Pre-specified main outcomes included mortality, prescription and primary care utilization data, and reasons for discontinuation. Data was collected through March 2015.

Key Results
The study cohort comprised 572 patients with a mean age of 54.9 ± 10.1 years. COT was discontinued in 344 patients (60.1%); 254 (73.8%) discontinued patients subsequently filled at least one opioid prescription in Washington State, and 187 (54.4%) continued to visit the clinic. During the study period, 119 (20.8%) registry patients died, and 21 (3.7%) died of definite or possible overdose: 17 (4.9%) discontinued patients died of overdose, whereas 4 (1.75%) retained patients died of overdose. Most patients had at least one provider-initiated reason for COT discontinuation. Discontinuation of COT was associated with a hazard ratio for death of 1.35 (95% Cl, 0.92 to 1.98, p = 0.122) and for overdose death of 2.94 (1.01-8.61, p = 0.049), after adjusting for age and race.

Conclusions
In this cohort of patients prescribed COT for chronic pain, mortality was high. Discontinuation of COT did not reduce risk of death and was associated with increased risk of overdose death. Improved clinical strategies, including multimodal pain management and treatment of opioid use disorder, may be needed for this high-risk group.

Mortality After Discontinuation of Primary Care–Based Chronic Opioid Therapy for Pain: a Retrospective Cohort Study

National Academy of Medicine

〉Action Collaborative on Countering the U.S. Opioid Epidemic
https://nam.edu/programs/action-collaborative-on-countering-the-u-s-opioid-epidemic/

〉Tapering Guidance for Opioids: Existing Best Practices and Evidence Standards
https://nam.edu/wp-content/uploads/2019/08/Tapering-webinar-two-pager-FINAL.pdf

National Institute on Drug Abuse

〉National statistics, information, resources, publications, policy briefs, infographics, news releases, and more
https://www.drugabuse.gov/drugs-abuse/opioids

〉Opioid Summaries by State: https://www.drugabuse.gov/drugs-abuse/opioids/opioid-summaries-by-state

National Safety Council

〉Drug poisoning is now the No. 1 cause of unintentional death in the United States. In 2017, a total of 61,311 people died from drug overdoses – many from prescription opioid medicine.

〉Many adults prescribed opioids by doctors subsequently become addicted or move from pills to heroin. Seventy percent of people who have misused prescription painkillers reported getting them from friends or relatives. Most people don't even know that sharing opioids is a felony.

〉People who take opioid painkillers for too long and in doses too large are more at risk of addiction and more likely to die of drug poisoning. The numbers are staggering. A survey by the Substance Abuse and Medical Health Services Administration says there are 4.3 million nonmedical users of painkillers. Nearly 2 million people have painkiller substance use disorders.

https://www.nsc.org/home-safety/safety-topics/opioids

Oregon Pain Guidance

〉Tapering – Guidance & Tools | Clinical Update Dec. 2018
https://www.oregonpainguidance.org/guideline/tapering/

OSU Study: Opioid Epidemic Costs Ohio Up to $8.8 Billion a Year

〉OHIO ACADEMY OF FAMILY PHYSICIANS | Weekly Family Medicine Update
https://www.ohioafp.org/wfmu-article/osu-study-opioid-epidemic-costs-ohio-up-to-8-8-billion-a-year/

State-by-State Summary of Opioid Prescribing Regulations and Guidelines

https://www.azdhs.gov/documents/prevention/womens-childrens-health/injury-prevention/opioid-prevention/appendix-b-state-by-state-summary.pdf

Study Shows Opioid Crisis Costs Long Island Nearly $8 billion a Year

https://www.newsday.com/long-island/opioid-crisis-economic-cost-long-island-1.35885801

Additional Resources

CDC guideline for prescribing opioids for chronic pain – Dowell D, Haegerich TM, Chou R. March 2016.

Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients with Chronic Back Pain or Hip or Knee Osteoarthritis Pain – The SPACE Randomized Clinical Trial Krebs

Patient Outcomes in Dose Reduction or Discontinuation of Long-Term Opioid Therapy: A Systematic Review – Joseph W. Frank, MD, MPH; Travis I. Lovejoy, PhD, MPH; William C. Becker, MD; Benjamin J. Morasco, PhD; Christopher J. Koenig, PhD; Lilian Hoffecker, PhD, MLS; Hannah R. Dischinger, BS; Steven K. Dobscha, MD; Erin E. Krebs, MD, MPH

Our Other Prescription Drug Problem – Lembke, Papac, Humphreys – NEJM Perspective Feb 2018

Perioperative Buprenorphine – Lembke et al Pain Medicine Feb 2018

Perioperative Considerations for the Patient with Opioid Use Disorder on Buprenorphine, Methadone, or Naltrexone Maintenance Therapy – Thomas Kyle Harrison, Howard Kornfeld, Anuj Kailash Aggarwal, Anna Lembke

Patient-Centered Prescription Opioid Tapering in Community Outpatients With Chronic Pain – Darnall et al AMA May 2018

Manhapra A, Arias AJ, Ballantyne JC. The conundrum of opioid tapering in long-term opioid therapy for chronic pain: A commentary.

Darnall BD, Ziadni MS, Stieg RL, Mackey IG, Kao MC, Flood P. Patient-centered prescription opioid tapering in community outpatients with chronic pain. JAMA Intern Med. 2018. doi:10.1001/jamainternmed.2017.8709

Prescription Opioid Taper Support for Outpatients with Chronic Pain: A Randomized Controlled Trial – Sullivan MD, Turner JA, DiLodovico C, D’Appollonio A, Stephens K, Chan Y-F. J Pain. 2017. doi:10.1016/j.jpain.2016.11.003

Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Washington, DC: American Psychiatric Association; 2013.

Weighing the Risks and Benefits of Chronic Opioid Therapy – Anna Lembke, MD; Keith Humphreys, PhD; and Jordan Newmark, MD – American Family Physician June 2016