NationalSummit onOpioid SafetyConvened withsupport from the Group Health Foundation Co-sponsored by: Group Health Research Institute, Project ROAM, and Physicians for Responsible Opioid Prescribing (PROP)
National Summit on Opioid Safety: Our Goals 1. Develop a working consensus among Summit participants on principles for more selective, cautious, and effective use of opioids for chronic noncancer pain. 2. Share effective approaches and tools to mitigate risks of chronic opioid therapy. 3. Share information and experience on how to change practice and implement guidelines to achieve more selective, cautious, and effective opioid prescribing. 4. Build a national network of people working to achieve safer and more effective chronic pain management in community practice settings.
National Summit on Opioid Safety: Background The following slides and videos provide essential background information that will help you fully participate in the Summit. We ask everyone attending the Summit to : (1) Take ten minutes to review these slides. (2) Watch the video developed by Group Health, and the four PROP videos. Each video is about five minutes long. If you wish, review the materials that Group Health used in implementing its COT risk mitigation initiative: The on-line physician education program (link provided) Full review of this program takes about 90 minutes, including 30 minutes for 11 vignettes of potentially difficult doctor-patient encounters. There is also a resources page with links to relevant materials. Group Health’s guideline and materials (links provided) Please feel free to send links to these materials to others who may be interested.
National Summit on Opioid Safety: Background The following slides provide background information on trends in opioid prescribing and the epidemic of prescription opioid overdose and addiction. Information on COT effectiveness and safety is also presented.
Starting in the 1990’s, U.S. retail sales ofprescription opioids increased dramatically Milligrams per 100 persons per year Source: Kenan K, Mack K, Paulozzi L. Open Medicine 2012; 6:e41.
Group Health research found large increases in per capita use ofChronic Opioid Therapy (COT). Was this change in practice warranted? Percent in episode of long-term opioid use for chronic pain Long-Term Episode: > 90 days & > 10 Rx fills and/or > 120 days supply Boudreau et al., 2008
Nationally, with increased opioid prescribing, drug overdose deathsinvolving prescription opioids increased four-fold from 1999 to 2009 Fatal Overdose Involving Prescription OpioidsSource: CDC
And, United States drug abuse treatment admissions for prescriptionopioid addiction increased six-fold, to over 140,000 a year Drug Abuse Tx Admissions: Non-Heroin Opiate addiction Source: SAMHSA TEDS data
In terms of effectiveness, short-term trials suggested onlymodest benefits of COT for chronic non-cancer pain “Short-term use of opioids [for chronic pain] is associated with modest but favorable effects on pain and physical functioning.” Papaleontiou et al, JAGS 2011.
Chronic Opioid Therapy (COT) guidelines were widelydisseminated based on low quality evidence“In the Canadian guideline, just 3 of 24 recommendations were based on RCTs.Nineteen recommendations were based solely or partially on consensus opinion.In the United States guideline, 21 of 25 recommendations were viewed as supportedby only low-quality evidence.In other words, the developers of the guidelines found that what we know aboutopioids is dwarfed by what we don’t know.” Roger Chou, CMAJ 2010.
Randomized trial data for COT were meager relativeto other drugs commonly used long-term Number US AdultsMedication Class N of Trials N of Patients Person-Years (est.) Using Long-TermAnti-hypertensivesa 147 464,000 1,857,000 48 millionStatinsb 26 169,000 753,000 34 millionNSAIDsc 31 116,000 117,000 6 millionOpioids: chronic paind 62 12,000 1,500 5 million Source: a. Law et al., BMJ 2009. b. CTT Collaboration, Lancet 2010. c. Trelle et al., BMJ 2011. d. Furlan et al. Pain Res Manage 2011.
The lack of large trials is significant given uncertainties about thelong-term safety of COT. There are initial data pointing to a widespectrum of potential adverse health effects including... System Potential adverse effects Respiratory Overdose, Sleep apnea, Community-acquired pneumonia Gastrointestinal Bowel obstruction, Chronic constipation Musculoskeletal Fractures, Osteoporosis Reproductive Hypogonadism, Infertility, Amenorrhea, Sexual dysfunction Immune system Immunosuppression, Infection Cardiovascular Myocardial infarction Oral health Xerostomia (dry mouth), Tooth decay Neuropsychological Depression, Anxiety, Apathy Cognitive impairment Hyperalgesia Opioid dependence and addiction Behavioral Opioid misuse and abuse Opioid diversion Motor vehicle accidents Baldini, Lin & Von Korff, Primary Care Companion CNS, 2012.
Given uncertainties and controversies, research was initiated atGroup Health concerning key questions How is COT being managed by physicians and used by patients? What are the risks and benefits of COT in primary care settings? Given what is known, what steps should be taken to reduce patient risks?
In a large survey, we found COT patients typically reportedmoderate to severe pain--at all opioid dose levels. Average Pain Intensity <50 mg. MED 50 to <120 mg. MED >120 mg. MED Source: CONSORT Survey (N=2119) Group Health Cooperative and Kaiser Permanente N CA
We found that most COT patients reported substantialpain-related activity limitation, increasing with opioid dose. Pain-Related Activity Limitation Days in Last 3 months <50 mg. MED 50 to <120 mg. MED >120 mg. MED Source: CONSORT Survey (N=2119) Group Health Cooperative and Kaiser Permanente N CA
We found that COT patients receiving higher opioid dosewere less likely to be working. 100% 80% 39% 36% Employment Status 56% 60% Working 18% Retired 32% 40% Not working 26% 20% 46% 30% 18% 0% Lower dose Medium Dose Higher dose <50 mg. MED 50 to <120 mg. MED >120 mg. MED Source: CONSORT Survey (N=2119) Group Health, Seattle WA and Kaiser Permanente N CA
And, we found that more than half of COT patients onmedium to high dose were clinically depressed. Percent with PHQ-8 depression scale > 10 Merrill et al., In press
We were the first to report markedly higher overdose risk amongCOT patients on higher opioid dose, others soon replicated. GHRI findings replicated in Veterans Health Administration and Canadian studies published in 2011 * * * p<0.05 * * * * **
In addition to direct risks to COT patients, opioid diversion has also been increasing, placing community members at risk of prescription opioid overdose and addiction. Percent of US population aged 12+ ever using Percent of US 12th graders using prescription prescription opioids non-medically opioids non-medically in the past year16% Vicodin Oxycontin 13.6% 12%14%12% 9.6% 9.6% 10% 9.8% 8.1%10% 8%8% 5.8% 6% 5.2% 4.9%6% 4.0% 4%4%2% 2%0% 0% 1998 2001 2008 2002 2007 2011Source: National Survey of Drug Use and Health Source: Monitoring the Future
National data show that most persons using prescription opioids non-medically obtain them from friends or relatives. Source: National Survey of Drug Use and HealthOther includes:drug dealer, Othermultiple doctors,internet, fake Rx,stealing. 10 % Rx from One Doctor Rx from Free from One Doctor 19 % Friend/Relative 19 % Other 81 % 56 % 15 % Bought/Took from Friend/Relative Where the person with non-medical Where the relative/friend use obtained the drug obtained the drug
And, most of the morphine equivalents dispensed arereceived by COT patients on higher dose regimens, therebybecoming available for diversion for non-medical use. Percent total morphine equivalents (ME) dispensed in 2008 100% 80% 27 % Average daily of total ME dispensed dose < 50 mg. 60% 40% Average daily dose > 50 mg. 13 % 60 % of total ME 20% of total ME dispensed dispensed 0% Chronic Pain Patients All Other Pain Patients Using Opioids Long-term (Acute & Cancer Pain)
In April 2011, the White House Office of National Drug ControlPolicy declared an epidemic of prescription drug abuse. “Prescription drug misuse and abuse is a major public health and public safety crisis. As a nation, we must take urgent action to ensure the appropriate balance between the benefits of these medications and the risks they pose. ”
Based on initial research, and remaining uncertainties, what stepsshould be taken now to increase prescription opioid safety? Group Health undertook major initiatives to reduce risks to patients We helped establish Physicians for Responsible Opioid Prescribing to educate physicians and advocate for safer prescribing practices to integrate research, efforts to improve care and public advocacy. Care Science Advocacy Group Health implemented a risk mitigation initiative to make opioid prescribing for chronic noncancer pain as safe and effective as possible.
In 2010, Group Health implemented uniform COT standards withpatient care plans documented in the EMR for all COT patients. Percent of COT patients with care plans Guideline implementation September 2010 Within one year, COT care plans were developed and documented in the EMR for almost all of the 7,000 + Group Health patients using opioids long-term. Trescott et al, Health Affairs, 2011
As part of this initiative, urine drug screening of COT patientswas markedly increased in Group Health clinics. Baseline Guideline Guideline (2008-9) Planning Implementation (2009-10) (2010-11) Turner et al, work in progress
From 2007 to 2011, the percent of Group Health COT patientson high opioid doses was cut in half, by reducing dose escalation. Percent of COT patients receiving > 120 mg. morphine equivalent dose Community Physicians 17.8 % > 120 mg. MED Group Health 9.4 % > 120 mg. MED Von Korff et al, work in progress
To achieve more selective and cautious COT prescribing, newpractice norms are needed. The National Summit on OpioidSafety will consider the following draft principles: Draft Principles for More Selective and Cautious Use of Opioids for Chronic Pain 1) Begin treatment of chronic pain with non-opioid modalities, including encouragement to resume rewarding life activities, gradual increases in physical activities such as walking, physical therapy, massage, cognitive behavioral therapy, chronic pain support groups, and safer medications such as anti-depressants. Learning to manage chronic pain can take time, so don’t give up on safer modalities too soon. 2) Carefully evaluate patient risks of addiction before considering opioids for chronic non- cancer pain. Ask about personal and family history of substance use problems. If available, check a Prescription Monitoring Program database to see if the patient is obtaining controlled substances from other sources. Do not overestimate your ability to identify patients who are at high risk of prescription opioid addiction.
Draft principles continued: 3) If opioids are considered, start with short-term or intermittent opioid use for severe pain flare- ups as an alternative to sustained opioid use. The claimed benefits of long-acting opioids and time-scheduled opioid dosing for management of chronic non-cancer pain have not been proven by controlled studies, and they lead to higher opioid dose. Tell patients that around the clock opioid use over long periods of time may not sustain analgesic benefits that may be needed when pain is severe. Do not be afraid of well controlled PRN use of opioids. 4) When chronic opioid therapy is considered, initiate treatment cautiously as a time-limited therapeutic trial. Agree upon criteria for decisive improvement in performance of activities in work, family and social life, and for pain control, to test whether the therapeutic trial achieves hoped-for benefits. Set expectations that the therapeutic trial will not be continued unless decisive benefits are observed. Use of opioids requires an ongoing, open and honest dialogue about pain control, function and problems with the medications. If the clinician and/or the patient is not ready for ongoing, open and honest dialogue, then opioids should not be considered. 5) Avoid opioid dose escalation to levels where discontinuation becomes difficult and risks of adverse events are increased.
Draft principles continued: 6) Taper patients off opioids (or to a lower dose if that is not possible) if benefits are limited, problems arise, or benefits for quality of life are not sustained over time. Continually revisit whether the patient is ready to discontinue opioid use or reduce dose. Many patients using opioids long-term remain ambivalent about opioid use, so opportunities to discontinue use or lower dose may arise over time. 7) Do not overestimate your ability to predict which patients will misuse or abuse prescription opioids, or even to detect opioid misuse or abuse among patients using opioids long-term. Remain vigilant for adverse medical effects of opioids as well as indications of abuse, misuse or diversion. 8) Patients who abuse opioids or develop addiction should be treated for addiction. If you are prescribing opioids long-term, referral resources for addiction treatment should be available. Management with buprenorphine may be a helpful option for some patients.
Chronic Opioid Therapy Reconsidered Please take 20 minutes to review the brief videos providing important information. The first video was developed by Group Health. The other four were developed by Physicians for Responsible Opioid Prescribing. They present expert opinions and relevant patient stories. The expert opinions are based in scientific evidence, but uncertainties remain. Most experts now agree there is markedly increased opioid-related morbidity and mortality. And, most experts now agree there is inadequate evidence to be assured that long-term opioid use for chronic pain is safe and effective. Clinicians observe that some patients do well, but patients are also harmed. The balance of benefits to harms remains controversial. NOTE: Please feel free to pass along links to these materials and videos to interested colleagues, even if they are not able to attend the National Summit on Opioid Safety.