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Best Practices: Eight Principles
for Safer Opioid Prescribing
Lynn R. Webster, MD
Vice President of Scientific Affairs
PRA International
Salt Lake City, UT
February 11, 2015
Dr Webster: Disclosures
•
12-Month disclosures of financial relationships with commercial interests:
Honorarium: Consultant
Acura Pharmaceuticals
AstraZeneca
BioDelivery Sciences International
CVS Caremark
Grunenthal USA
Mallinckrodt Pharmaceuticals
Nevro Corporation
Synchrony Healthcare
•
Honorarium: Advisory Board
Depomed
Egalet
Inspirion Pharmaceuticals
Insys Therapeutics
Kaleo
Mallinckrodt Pharmaceuticals
Signature Therapeutics
Teva Pharmaceuticals
Travena
Travel Expenses
Acura Pharmaceuticals
AstraZeneca
BioDelivery Sciences International
Bristol-Myers Squib (BMS)
Depomed
Grunenthal USA
Inspirion Pharmaceuticals
Insys Therapeutics
Jazz Pharmaceuticals
Kaleo
Mallinckrodt Pharmaceuticals
Nektar Therapeutics
Nevro Corporation
Orexo Pharmaceuticals
Teva Pharmaceuticals
Travena
This presentation does not contain off-label or investigational use of drugs or
products
Planning Committee, Disclosures
•
•
•
Vitaly Gordin, MD
Director of Pain Division
Penn State Hershey Medical Center
Hershey, PA

No relevant financial relationships
Jennifer Westlund, MSW
Director of Education
American Academy of Pain Medicine

No relevant financial relationships
Angela Casey
VP, Medical Director
PharmaCom Group

No relevant financial relationships
Target Audience
•
•
The overarching goal of PCSS-O is to offer evidence-based
trainings on the safe & effective prescribing of opioid
medications in the treatment of pain &/or opioid addiction
Our focus is to reach providers &/or providers-in-training
from diverse healthcare professions including physicians,
nurses, dentists, physician assistants, pharmacists, &
program administrators
Educational Objectives
•
At the conclusion of this activity participants should be
able to:
1. Understand the major risk factors for unintentional opioid
overdose deaths in patients with chronic pain
2. Devise a plan to implement 8 simple principles for safer
opioid prescribing that can save lives
Major Reasons for
Opioid-Associated Deaths
•
•
•
Over-prescribing (Physician)




Starting dose too high
Dose escalation too rapid
Over reliance on conversion tables
Inadequate risk assessment
Non-adherence (Patient)



To control pain
To “cope”
Substance abuse
Unanticipated co-morbidities



QT prolongation
Pharmacogenetics & methadone
metabolism
Sleep disordered breathing
Rates of Prescription Opioid Sales &
Deaths, 1999-2013
8
Sales per kg per 100,000 people
Deaths per 100,000 people
7
6
Rate
5
4
3
2
1
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Centers for Disease Control and Prevention. CDC Vital Signs: Prescription Painkiller Overdoses in the
US. 2011. Chen LH, et al. Drug-poisoning deaths involving opioid analgesics: United States, 19992011. NCHS data brief, no. 166. Hyattsville, MD: NCHS. 2014. Warner M, et al. Trends in drugpoisoning deaths involving opioid analgesics and heroin: United States, 1999-2012. CDC Health EStats. 2014. Chen LH, et al. Quick Stats. MMWR. 2015;64:32..
Number of Deaths Involving Opioid
Analgesics, 1999-2013
18000
16000
16235
Number of deaths
14000
12000
10000
8000
6000
4-fold increase in deaths since 1999
4000
4030
2000
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Warner M, et al. Trends in drug-poisoning deaths involving opioid analgesics and heroin: United
States, 1999-2012. CDC Health E-Stats. 2014. Chen LH, et al. Quick Stats. MMWR. 2015;64:32.
Prescription Opioid Deaths Are a
Growing Problem Among Women
Although men are still more likely to die of prescription opioid overdoses,
the gap between men & women is closing
7000
Rate per 100,000
6
6
5
4
3.7
3
2
1
Number of deaths among
women
7
6000
5000
4000
3000
2000
1000
Prescription opioid overdose
deaths among women have
increased >400% since 1999,
compared to 265% among men
0
0
Male
Female
CDC Vital Signs. Prescription Painkiller Overdoses. A growing epidemic, especially among women.
2013. Paulozzi L. CDC. Populations at risk for opioid overdose. 2012.
www.fda.gov/downloads/Drugs/NewsEvents/UCM300859.pdf
1. Assess patients for risk of abuse before starting opioid therapy
and manage accordingly
2. Watch for and treat comorbid mental disease if present
3. Conventional conversion tables can cause harm and should be
used cautiously when rotating (switching) from one opioid to
another
4. Avoid combining benzodiazepines with opioids, especially during
sleep hours
5. Start methadone at a very low dose and titrate slowly regardless
of whether your patient is opioid tolerant or not
6. Assess for sleep apnea in patients on high daily doses of
methadone or other opioids and in patients with a predisposition
7. Tell patients on long-term opioid therapy to reduce opioid dose
during upper respiratory infections or asthmatic episodes
8. Avoid using long-acting opioid formulations for acute, postoperative, or trauma-related pain
Webster LR. Pain Med. 2013;14:959-61.
Assess patients for risk of abuse
before starting opioid
therapy & manage accordingly
1
BEST PRACTICES
Webster LR. Pain Med. 2013;14:959-61.
Oreos As Addictive As Cocaine?
For Rats, At Least
Photo by Bob MacDonnell courtesy of Connecticut College
Student-faculty research suggests Oreos can be compared to drugs of abuse in lab rats. Connecticut
College News. October 15, 2013. www.conncoll.edu/news/news-archive/2013/student-facultyresearch-suggests-oreos-can-be-compared-to-drugs-of-abuse-in-lab-rats.htm
Vulnerability to Opioid Addiction
Individuals respond differently to opioid exposure




 




No addictive disease
with exposure


Addictive disease after
opioid exposure
   No addictive disease due
   to lack of exposure
Genetic Vulnerability to Addiction?
Fischer
344
Abstinence
Drug
rejecting
Lewis
Polysubstance
Abuse
Drug
seeking
SpragueDawley
Average
Drug
neutral
Webster LR, Dove B. Avoiding Opioid Abuse While Managing Pain: A Guide for
Practitioners. North Branch, MD: Sunrise River Press. 2007.
Drug-abusing behavior
Level of Abuse in Stressful
Environments
Low
Moderate
Patient stress level
Webster LR, Dove B. Avoiding Opioid Abuse While Managing Pain: A Guide for
Practitioners. North Branch, MD: Sunrise River Press. 2007.
High
Screening Tools to Assess Patient Risk
Before Prescribing Opioids
•
Use one of several available tools to assess patient risk of
developing problematic drug-taking behaviors
 Based on biological, social, & psychiatric risk factors
Tool
# of items Administered by
ORT Opioid Risk Tool
5
patient
SOAPP® Screener & Opioid Assessment for Patients
with Pain
24, 14, or
5
patient
DIRE Diagnosis, Intractability, Risk, & Efficacy Score
7
clinician
•
Implement a plan according to risk level
 eg, for high-risk patients, refer for psychiatric evaluation or
co-manage with a chemical dependency expert prior to
opioid trial
Webster LR. Pain Med. 2013;14:959-61. Webster LR, Webster RM. Pain Med. 2005:6:43242. Butler SF, et al. Pain. 2004;112:65-75. Belgrade MJ, et al. J Pain. 2006;7:671-81.
Identify Misuse Once Opioid
Treatment Begins
•
Periodic monitoring for effects on analgesia, daily
activities, adverse events, ADRBs, cognition, function, &
QOL can be assisted by tools
Tool
# of items Administered by
PADT Pain Assessment & Documentation Tool
41
clinician
COMM Current Opioid Misuse Measure
17
patient
•
•
Check state prescription monitoring programs
Utilize measures such as urine drug testing
ADRBs=aberrant drug-related behaviors; QOL=quality of life
Webster LR. Pain Med. 2013;14:959-61. Passik SD, et al. J Opioid Manage. 2005:257-66.
Passik SD, et al. Clin Ther. 2004;552-61. Butler SF, et al. Pain. 2007;130:144-56.
Watch for & treat comorbid mental
disease if present
22
BEST PRACTICES
Webster LR. Pain Med. 2013;14:959-61.
Overlapping Effects
Psychiatric
disorders
50%
overlap
Pain
disorders
Peles E, et al. Pain. 2005;113:340-6. Potter JS, et al. Am J Drug Alcohol Abuse. 2008;34:
101-7. Rosenblum A, et al. JAMA. 2003;289:2370-8. Sheu R, et al. Pain Med. 2008;9:911-7.
Overlapping Effects
Psychiatric
disorders
60%
overlap
Addiction
disorders
National Institute on Drug Abuse. Comorbid Drug Abuse and Mental Illness. A Research
Update from the National Institute on Drug Abuse. 2007.
National Institute on Drug Abuse. Comorbidity: Addiction and Other Mental Illness. Research
Report Series. NIH Publication No. 10-5771. 2010.
Comorbid Pain & Mental Disease
•
•
Co-occurrence of mental health disorders with chronic
pain place patient at high risk for:
 Misuse
 Drug-drug interactions
 Overdose
Assess for the presence of mental disease before
initiating opioid therapy
 When indicated, consult with experts in mental health fields
to co-ordinate care
Webster LR. Pain Med. 2013;14:959-61.
An Olympian Challenge:
Managing a Critical Interplay
A “trio diagnosis”
Addiction
disorder
Psychiatric
disorder
Pain
disorder
Webster LR, Dove B. Avoiding Opioid Abuse While Managing Pain: A Guide for Practitioners.
North Branch, MD: Sunrise River Press. 2007.
Suicide
All drugs
Number of ED visits for drugrelated suicide attempts
(thousands)
250
Opioid analgesics
41% increase in drug suicide attempts
225
228.4
212.7
199.5
197.1
200
198.4
182.8
175 161.6
151.6
150
125
100
75
87% increase in opioid suicide attempts
50
25
0
16.9
2004
17.8
2005
24.5
2006
29.9
2007
29.6
26.8
2008
2009
Substance Abuse and Mental Health Services Administration. Drug Abuse Warning Network, 2011:
National Estimates of Drug-Related Emergency Department Visits. HHS Publication No. (SMA) 134760, DAWN Series D-39. Rockville, MD: SAMHSA, 2013.
32.9
2010
31.7
2011
Why Suicide?
Non-Pain Patients
Escape from severe suffering
Hopelessness
Kraft TL, et al. Arch Suicide Res. 2010;14:375-82.
Only option
Permanent solution
Conventional conversion tables can
cause harm & should be used
cautiously when rotating (switching)
from one opioid to another
33
BEST PRACTICES
Webster LR. Pain Med. 2013;14:959-61.
WARNING!
Equianalgesic ≠ Conversion Tables
•
Equianalgesic tables provide insufficient guidance to
determine the equivalent doses of different opioids
 Individual consideration is necessary for every patient
Webster LR. Pain Med. 2013;14:959-61. Knotkova H, et al. J Pain Symptom Manage. 2009;
38:426-39. Webster LR, Fine PG. Pain Med. 2012;13:562-70. Webster LR, Fine PG. Pain
Med. 2012;13:571-4.
Steps in Opioid Rotation
•
Slowly decrease one opioid while
slowly titrating the new opioid to effect
Webster LR. Pain Med. 2013;14:959-61. Webster LR, Fine PG. Pain Med. 2012;13:571-4.
Steps in Opioid Rotation
10%-30%
increments
10%-20% increments
IR Supplement
Webster LR. Pain Med. 2013;14:959-61. Webster LR, Fine PG. Pain Med. 2012;13:571-4.
Steps in Opioid Rotation
10%-20% increments
IR Supplement
10%-30%
increments
Webster LR. Pain Med. 2013;14:959-61. Webster LR, Fine PG. Pain Med. 2012;13:571-4.
Steps in Opioid Rotation
•
•
In most cases, the complete switch
can occur within 3-4 weeks
If you are not experienced in switching
opioids in patients on long-term opioid
therapy, seek expert consultation
Webster LR. Pain Med. 2013;14:959-61. Webster LR, Fine PG. Pain Med. 2012;13:571-4.
Avoid combining benzodiazepines with
opioids, especially during sleep hours
4
BEST PRACTICES
Webster LR. Pain Med. 2013;14:959-61.
Most Common Drugs Involved in
Overdoses in the United States
•
•
•
In 2013, there were 43,982 drug overdose deaths
 22,767 (51.8%) were related to pharmaceuticals
−
−
16,235 (71.3%) involved opioid analgesics
6,973 (30.6%) involved benzodiazepines
People who died of drug overdoses often had a
combination of benzodiazepines & opioids in their bodies
In 2011, ~1.4 million ED visits involved nonmedical use of
pharmaceuticals
 501,207 visits involved anti-anxiety & insomnia medications
 420,040 visits involved opioid analgesics
CDC. Prescription Drug Overdose in the United States: Fact Sheet. 2015.
www.cdc.gov/homeandrecreationalsafety/overdose/facts.html
Benzodiazepines &
Chronic Pain Patients
•
Enhance the respiratory depressant effects of opioids
 Frequently co-prescribed with opioids (up to 50% of patients)
−
−
•
In 1 population, 80% of patients prescribed high-dose opioids
were co-prescribed benzodiazepines
More common in chronic pain patients with substance use
disorders
Consider an alternative
 For anxiety disorders
 When a sleep aid is indicated, eg, an anticonvulsant or lowdose trazodone
−
For patients with neuropathic pain, low-dose trazodone at
bedtime may be dually beneficial
Webster LR. Pain Med. 2013;14:959-61. Webster LR, et al. Postgraduate Med. 2015; early online. Deyo RA, et
al. J Am Board Fam Med. 2011;24:717-27. King SA, Strain JJ. Clin J Pain. 1990;6:143-7. Manchikanti L, et al.
Pain Physician. 2009;12:259-67. Braden JB, et al. Arch Intern Med. 2010;170:1425-32. Dasgupta N. Opioid
analgesic prescribing and overdose mortality in North Carolina [dissertation]. Chapel Hill, NC: University of North
Carolina at Chapel Hill; 2013. Weisner CM, et al. Pain. 2009;145:287-93.
Start methadone at a very low dose &
titrate slowly regardless of whether
your patient is opioid tolerant or not
5
BEST PRACTICES
Webster LR. Pain Med. 2013;14:959-61.
Methadone-Related Deaths
•
Methadone contributed to nearly 1 in 3 prescription opioid
deaths in 2009
•
•
5,000 people die every year of overdose related to methadone
6 times as many people died of methadone overdose in 2009
than a decade before
CDC. Prescription Drug Overdoses. CDC Vital Signs; July 2012.
Death rate per 100 kilograms
Death Rate from Overdose Caused by a
Single Prescription Painkiller
12
10
8
6
4
2
0
Substance Abuse and Mental Health Administration, Center for Behavioral Statistics and
Quality, Drug Abuse Warning Network Medical Examiner Component, 2009.
CDC. Prescription Drug Overdoses. CDC Vital Signs; July 2012.
Simulated Methadone Dosing
α (analgesic)
β (non-analgesic)
Blood level
Toxicity
Analgesia
2
4
2
6
8
3
10
12
4
14
16
5
18
20
6
22
Webster LR. Unintentional overdose deaths: reversing the trend. Presented at: The American
Academy of Pain Medicine’s 28th Annual Meeting; February 22-26, 2012; Palm Springs, CA.
24 Hours
7 Days
Legal Review of Opioid Deaths:
Methadone
•
Starting doses 20-140 mg/day
•
•
•
•
~90% opioid tolerant
~80% died within 4 days of first methadone
Snoring common
Occasional upper respiratory infection/flu onset preceded
death
 Most <30 mg/day
Webster LR, Rich B. Pain Med. 2011;12:S59-65.
Initiating Methadone
•
•
Consider starting patients, whether or not they are opioid
naïve, on ≤15 mg/day in divided doses (qh8)
Increase the total daily dose by no more than 25%-50%,
no more frequently than weekly
If you are not experienced
prescribing methadone, consult with
a clinician who is
Webster LR. Pain Med. 2013;14:959-61.
Assess for sleep apnea in patients on
high daily doses of methadone or
other opioids & in patients with a
predisposition
6
BEST PRACTICES
Webster LR. Pain Med. 2013;14:959-61.
Percent of patients
Sleep Disorders & Opioids:
Events per Hour
90
AHI ≥5 events/hour
80
CAI ≥5 events/hour
70
60
50
OMAI ≥5 events/hour
Sleep apnea: type indeterminate
40
30
20
Bars indicate hi/lo of 95% CI
10
n = 140
0
AHI=apnea-hypopnea index
CAI=central apnea index
OMAI=obstructive & mixed apnea Index
Webster LR, et al. Pain Med. 2008;9:425-32.
Rate Ratios by Increase of Morphine
Equivalent Dose
1.8
Central p<.001
1.7
AWAITING PERMISSION
TO USE FROM
PUBLISHER
Rate ratio
1.6
1.5
Hypopnea p<.001
1.4
1.3
Obstructive p<.001
1.2
1.1
REM apnea/hypopnea
p=.86
1
0.9
0.8
0
25
50
75
100
125
150
175
Morphine equivalent dose (mg/day)
Walker JM, et al. J Clin Sleep Med. 2007;3:455-61.
200
Assess for Sleep Apnea
•
Refer the following patients for formal sleep apnea
evaluation
 Patients who require >50 mg/day of methadone
 Patients who require >150 mg/day of morphine equivalent
•

dose of other opioids
Patients with a predisposition or risk factors for sleep apnea
At risk patients may require inpatient evaluation to monitor
for & determine safety of opioid therapy
Webster LR. Pain Med. 2013;14:959-61.
Tell patients on long-term opioid
therapy to reduce opioid dose during
upper respiratory infections or
asthmatic episodes
7
BEST PRACTICES
Webster LR. Pain Med. 2013;14:959-61.
Reduce Opioid Dose During
•
Because of a decreased margin of safety, advise patients
to reduced their daily opioid doses by ≥30% during events
with acute respiratory tract compromise
 These include:
−
−
−
−
−
−
Flu
Pneumonia
Upper respiratory infections
Cigarette use
Chronic obstructive pulmonary disease
Asthmatic episodes
Webster LR. Pain Med. 2013;14:959-61.
Webster LR, et al. Postgrad Med. 2015; online first.
Avoid using long-acting opioid
formulations for acute, post-operative,
or trauma-related pain
8
BEST PRACTICES
Webster LR. Pain Med. 2013;14:959-61.
Reserve Long-Acting Opioids for
Opioid-Tolerant Patients
•
•
Reserve long-acting/extended-release opioids, including
transdermal patches, for patients who have developed
tolerance to opioids
 ie, who already take regular, daily, around-the-clock opioids
Do not use for acute, postoperative, or trauma-related
pain
Webster LR. Pain Med. 2013;14:959-61.
Webster LR, et al. Postgrad Med. 2015; online first.
References
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Belgrade MJ, et al. J Pain. 2006;7:671-81.
Braden JB, et al. Arch Intern Med. 2010;170:1425-32.
Butler SF, et al. Pain. 2004;112:65-75.
Butler SF, et al. Pain. 2007;130:144-56.
CDC Vital Signs. Prescription Painkiller Overdoses in the US.
2011.
CDC Vital Signs. Prescription Drug Overdoses. July 2012.
CDC Vital Signs. Prescription Painkiller Overdoses. A growing
epidemic, especially among women. 2013.
CDC. Prescription Drug Overdose in the United States: Fact
Sheet. 2015.
Chen LH, et al. Drug-poisoning deaths involving opioid
analgesics: United States, 1999-2011. NCHS data brief, no.
166. Hyattsville, MD: NCHS. 2014.
Chen LH, et al. Quick Stats. MMWR. 2015;64:32.
Dasgupta N. Opioid analgesic prescribing and overdose
mortality in North Carolina [dissertation]. Chapel Hill, NC:
University of North Carolina at Chapel Hill; 2013.
Deyo RA, et al. J Am Board Fam Med. 2011;24:717-27.
King SA, Strain JJ. Clin J Pain. 1990;6:143-7.
Knotkova H, et al. J Pain Symptom Manage. 2009; 38:426-39.
Kraft TL, et al. Arch Suicide Res. 2010;14:375-82.
Manchikanti L, et al. Pain Physician. 2009;12:259-67.
NIDA. Comorbid Drug Abuse and Mental Illness. A Research
Update from the National Institute on Drug Abuse. 2007.
NIDA. Comorbidity: Addiction and Other Mental Illness.
Research Report Series. NIH Publication No. 10-5771. 2010.
Passik SD, et al. Clin Ther. 2004;552-61.
Passik SD, et al. J Opioid Manage. 2005:257-66.
Paulozzi L. CDC. Populations at risk for opioid overdose.
2012.
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Peles E, et al. Pain. 2005;113:340-6.
Potter JS, et al. Am J Drug Alcohol Abuse. 2008;34: 101-7.
Rosenblum A, et al. JAMA. 2003;289:2370-8.
Sheu R, et al. Pain Med. 2008;9:911-7.
Student-faculty research suggests Oreos can be compared to
drugs of abuse in lab rats. Connecticut College News. October
15, 2013.
SAMHSA, Center for Behavioral Statistics and Quality, Drug
Abuse Warning Network Medical Examiner Component, 2009.
SAMHSA. Drug Abuse Warning Network, 2011: National
Estimates of Drug-Related Emergency Department Visits.
HHS Publication No. (SMA) 13-4760, DAWN Series D-39.
Rockville, MD: SAMHSA, 2013.
Walker JM, et al. J Clin Sleep Med. 2007;3:455-61.
Warner M, et al. Trends in drug-poisoning deaths involving
opioid analgesics and heroin: United States, 1999-2012. CDC
Health E-Stats. 2014.
Webster LR, Webster RM. Pain Med. 2005:6:432-42.
Webster LR, Dove B. Avoiding Opioid Abuse While Managing
Pain: A Guide for Practitioners. North Branch, MD: Sunrise
River Press. 2007.
Webster LR, et al. Pain Med. 2008;9:425-32.
Webster LR, Rich B. Pain Med. 2011;12:S59-65
Webster LR, Fine PG. Pain Med. 2012;13:562-70.
Webster LR, Fine PG. Pain Med. 2012;13:571-4.
Webster LR. Unintentional overdose deaths: reversing the
trend. Presented at: The American Academy of Pain Medicine
28th Annual Meeting; Feb 22-26, 2012; Palm Springs, CA.
Webster LR. Pain Med. 2013;14:959-61.
Webster LR, et al. Postgraduate Med. 2015; early online.
Weisner CM, et al. Pain. 2009;145:287-93.
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