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Taking the “Ouch” Out of
Pain Management
in Patients With Addiction
S. Hughes Melton M.D.,FAAFP
Chief Medical Officer and Vice President
Mountain States Health System – Virginia Hospitals
Sarah T. Melton, PharmD,BCPP,BCACP,CGP,FASCP
Associate Professor of Pharmacy Practice
Gatton College of Pharmacy at
East Tennessee State University
Disclosure
Sarah and Hughes Melton,
DO NOT have a financial interest/arrangement or
affiliation with one or more organizations that
could be perceived as a real or apparent conflict
of interest in the context of the subject of this
presentation AND
DO anticipate discussing the
unapproved/investigative use of a commercial
product/device during this activity or
presentation (medications used for adjunctive
agents pain, but not necessarily FDA approved
for this purpose)
Learning Objectives
1. Apply appropriate risk assessment strategies
(i.e., Risk Evaluation and Mitigation Strategies
[REMS], Universal Precautions) for the abuse,
misuse, and diversion of opioid therapies used
in the management of chronic pain.
2. Select screening instruments to identify
patients at risk for opioid dependence and/or
abuse.
Learning Objectives
3. Evaluate abuse-deterrent technologies
associated with opioid therapy.
4. Evaluate evidence-based literature for
patient-related factors associated with risk of
relapse if opioid medications are used to
treat pain in patients with a history of
addiction.
Learning Objectives
5. Formulate a response to challenges
encountered in the management of chronic
pain in patients at risk for, or with a history of,
addiction.
6. Contrast options for pharmacotherapy (e.g.,
nonsteroidal anti-inflammatory drugs
[NSAIDs], opioid therapies, adjunctive
agents) for chronic pain in patients at risk for,
or with a history of, addiction.
Definitions
•
•
•
•
Addiction
Physical dependence
Tolerance
Pseudo-addiction
Trends in Prescription Drug Abuse
• In 2008, there were 24 million patients with
diabetes and 22 million patients with substance
abuse (SA)
• Non-medical use of prescription drugs ranks
second only to marijuana as the most prevalent
category of drug abuse
• Nonmedical use of prescription pain relievers was
the illicit drug category with the largest number of
new abusers (7.0 million) or 2.3% of the current
US population
U.S. Department of Health and Human Services; Substance Abuse and Mental
Health Services Administration Center for Behavioral Health Statistics and Quality.
2010 National Survey on Drug Use and Health. Available online at:
http://www.samhsa.gov/data/NSDUH/2k10NSDUH/2k10Results.htm
Consequences of
Prescription Drug Abuse
• 25% of emergency department visits are
associated with non-medical use of
pharmaceuticals
• Overdose deaths have surpassed motor vehicle
accidents as the leading cause of unintentional
death in many states
• Opioid dependent patients are 13 times more likely
to die than their age- and sex-matched peers
• For every dollar you spend on treatment, you save
$10 of societal costs
2009 DAWN (Drug Abuse Warning Network) Report , May 2010
Gibson A, et al. Addiction 2008;103(3):462-8.
NIDA 2008 statistics
Disease Burden: Addiction
Prevalence in Chronic Pain
• 50-70 million people with undertreated pain
• 3-16% American population have SA
• Therefore, 5-7 million patients with addiction
also have pain
U.S. Department of Health and Human Services; Substance Abuse
and Mental Health Services Administration Center for Behavioral
Health Statistics and Quality. 2007 National Survey on Drug Use and
Health. Available online at: http://www.samhsa.gov/data/nsduh.htm
Where Pain Relievers Are
Obtained for Nonmedical Use
Source Where Respondent Obtained3
Bought on
Drug Dealer/ Internet
0.1%
Stranger
More than 3.9%
One Doctor
1.6%
One Doctor
19.1%
Other 1
4.9%
Free from
Friend/Relative
55.7%
Bought/Took
from Friend/Relative
14.8%
Source Where Friend/Relative Obtained
More than One Doctor
3.3%
Free from
Friend/Relative
7.3%
One
Doctor
80.7%
Bought/Took from
Friend/Relative
4.9%
Drug Dealer/
Stranger
1.6%
Other 1
2.2%
http://www.oas.samhsa.gov/nsduh/2k6nsduh/2k6results.pdf
Complex Tension Between
Pain and Addiction
• Impossible to determine beforehand exactly
who will develop addiction
• Diagnosis usually made over time
• Many barriers to treatment
– Fear of addiction, diversion, “better living through
chemistry,” etc.
• YetJ. many reasons to treat
– “relief of suffering,” poorly treated pain can lead
to relapse, “corrective experience,” etc.
Complex Tension Between Pain
and Addiction
• Balance between pain and addiction is more
of a continuum
– Prednisone in diabetic with asthma attack?
• Therefore, Universal Precautions (UPs)
necessary
– Safest and most reasonable approach
– Minimum level of care
FDA Perspective
• Opioid products are at the center of a major crisis
resulting in abuse, misuse and death
• Balance needed
• Adequate pain control
• Managing the risk
• Requires engagement of all stakeholders
• Pain patients
• Patient advocates
• Pain-treating medical community
Food and Drug Administration, 2009
FDA Amendments Act (FDAAA) -2007
REMS
Risk Evaluation & Mitigation Strategies
[email protected].
REMS Program
1. Requires manufacturers to submit REMS with drugs
or biologics that have a known or potential safety
risk
2. May include any medication or class of medication
3. May include medication guides, communications to
healthcare providers, elements to assure safe use,
implementation systems to assure safe use
4. Goal of opioid REMS
A REMS Has Five Components
1. Medication Guide/Patient Package Insert
2. Communication Plan
3. Elements to Assure Safe Use
4. Implementation System
5. Timetable for Assessment
Principles of Balance
Opioid Therapy
• FDA REMS for opioid medications
• Good medical practice requires
Screening & monitoring all patients for signs of
abuse and addiction
Use opioid agreement
Keep detailed prescribing records
Educate patients/caregivers
Take medication only as prescribed
Protect against accidental use, theft, and misuse
Prescription Drug Abuse Prevention
Plan - 2011
Office of National Drug Control Policy
1. Education
2. Monitoring
3. Enforcement
4. Proper Drug Disposal
http://www.whitehouse.gov/sites/default/files/ondcp/issues-content/prescriptiondrugs/rx_abuse_plan.pdf
Opioid Analgesics Required to
Have a REMS
• All extended-release oral opioids
– Hydromorphone
– Morphine
– Oxycodone
– Oxymorphone
• Methadone
• Transdermal fentanyl
Elements to Assure Safe Use
(ETASU)
• May require any of the following:
– Training or certification of prescribers
– Training or certification of pharmacists and
pharmacies
– Restriction on where drug is dispensed (e.g.,
infusion settings, hospital)
– Evidence of patient safe use conditions such as
lab results
– Patient monitoring
– Enrollment of patients in a registry
POSSIBLE Implications for
Prescribers and Dispenser
• Special training or certification for providers
and pharmacies
– Understand risks and benefits of the product
– Can diagnose the condition for which the product
is indicated
– Can diagnose and treat potential adverse
reactions
• Only certified pharmacists enrolled in REMS
program may dispense
POSSIBLE Implications for
Prescribers and Dispensers
• Enrollment requires:
– Complete enrollment form
– Development of system to ensure dispensing to
patients with evidence of safe use conditions
– Train and provide education to those
administering and dispensing the drug
– Program adverse event reporting
• So, do we wait for the FDA to use REMS to
force us to provide high quality care to chronic
pain patientsJ?
Miss Ima Hurtin
Vignette #1 with Dr. Melton
Pre-Visit Information:
Drug Abuse Screening Test (DAST) score = 6 (barely
positive)
Post-Visit Discussion:
Opioid Risk Tool (ORT)
Available online at http://www.opioidrisk.com/node/2424
How to use the tool
Patient’s score at end of vignette = ?
Poll the Audience
You have evaluated Miss Hurtin using the Opioid
Risk Tool assessment. What is her score?
1.
2.
3.
4.
5.
0
2
3
5
7
0%
1
0%
0%
2
3
0%
0%
4
5
Ten Universal Precautions (UPs)
in Pain Management
• Why are they necessary?
– Can’t predict likelihood of substance abuse
– Disease has serious consequences for patient
and provider
– Selective application of precautions stigmatizes
patients
– REMS focuses on a “health-system” approach
– UPs focus on what you as a provider can do
• Chronic Pain UPs vs Substance Abuse UPs
Ten Universal Precautions
in Pain Management
1. Make a diagnosis with appropriate differential
2. Psychological assessment including risk of
addictive disorders
Family history of substance abuse
•
•
•
•
Positive history not a contraindication to care
Not an attempt to diminish pain
Honest answers lead to improvement in care
Who and what?
Personal substance “use” history
• When and what?
• Social drinking and prescribed benzodiazepines
• Safest level of use is “zero”
Gourlay DL, et al. Pain Med 2005;6(2):107-12.
Gourlay DL, et al. Pain Med. 2009;10 Suppl 2:S115-23.
Ten Universal Precautions
in Pain Management
3. Informed consent
4. Treatment agreement
– Reinforce responsibility, enhance communication
– Pill counts
– Prescription monitoring program query
– Toxicology testing (UDS, blood levels, etc.)
Gourlay DL, et al. Pain Med 2005;6(2):107-12.
Gourlay DL, et al. Pain Med. 2009;10 Suppl 2:S115-23.
Ten Universal Precautions
in Pain Management
5. Pre- and post-intervention assessment of
pain level and FUNCTION
a) Interval history - work, hobbies, etc.
b) Testing - SF-36, etc.
6. Appropriate trial for opioid therapy +/adjunctive medication
Gourlay DL, et al. Pain Med 2005;6(2):107-12.
Gourlay DL, et al. Pain Med. 2009;10 Suppl 2:S115-23.
Ten Universal Precautions
in Pain Management
7. Reassessment of pain score and level of
function
8. Regularly assess the 5 A’s of pain medicine
– Analgesia
– Activity
– Adverse effects
– Aberrant behavior
– Affect
Gourlay DL, et al. Pain Med 2005;6(2):107-12.
Gourlay DL, et al. Pain Med. 2009;10 Suppl 2:S115-23.
Ten Universal Precautions
in Pain Management
9. Periodically review pain diagnosis and
comorbid conditions, including addictive
disorders
10.DOCUMENTATION!!
Gourlay DL, et al. Pain Med 2005;6(2):107-12.
Gourlay DL, et al. Pain Med. 2009;10 Suppl 2:S115-23.
Learning Assessment Question
A 45-year-old patient with chronic back pain is treated with oxycodone extendedrelease 40 mg every 12 hours and hydrocodone and acetaminophen 7.5/500 mg
every 6 hours as needed for pain. He presents for a follow-up appointment and
asks for an increase in the oxycodone dosage. His urine drug screen (UDS) is
consistent with medications prescribed and his prescription drug monitoring
report shows one prescriber and one pharmacy. Which of the following is the
most important universal precaution to take as part of the ongoing care of a
patient with uncontrolled pain?
1.
2.
3.
4.
Initiation of a treatment agreement
Assessment of pain level and function
Informed consent for treatment with opiates
Provision of the medication guide for oxycodone
0%
0%
0%
0%
10
1
Countdown
2
3
4
Substance Abuse UPs
• Patient with diagnosis of substance abuse
• Added to chronic pain UPs
11. Support group meetings
– Confirm attendance, communicate with sponsor
12. Substance abuse counseling
– Get copy of visit notes
13. Authorization to communicate with patient’s
SA treatment team
Screening Instruments
Overview
•
•
•
•
•
Looking for HIDDEN substance abuse
Subjective (self-report) vs. objective
Active vs. latent
Testing vs. application
Access resources in clinical practice
– PainEDU.org
– PartnersAgainstPain.com
Screening Instruments
CURRENT Substance Abuse
• Subjective
– Interview history
– CAGE and Trauma Test
– Drug Abuse Screening Test (DAST)
– Reassessment: Current Opioid Misuse Measure
(COMM)
• Objective
– Addiction Behaviors Checklist
Screening Instruments
LATENT Substance Abuse
• Screener and Opioid Assessment for Patients
in Pain (SOAPP®)
– Long (24 questions) and short (5) versions
• Opioid Risk Tool (ORT®)
Assessment: Levels of Risk
• Level 1 - Primary care treatment
– No h/o SA, limited psychopathology
• Level 2 - Primary care with specialist support
– History >3 years out of SA, significant family
history
• Level 3 - Specialty Pain Management
– Active SA, major psychopathology
• Patients can move from one group to another
– New or uncovered issues and information
Learning Assessment Question
A 32-year-old patient presents to the family practice clinic for
treatment of pain that has been ongoing since an automobile accident
6 months ago. Pain has not been adequately controlled with a
combination of naproxen, cyclobenzaprine and tramadol 50 mg four
times daily. The physician is considering starting a long-acting opioid
therapy. Which of the following screening tests is self-administered
and would be the most beneficial to discern if the patient is at risk of
abuse of opioids?
1.
2.
3.
4.
CAGE
Opioid Risk Tool
Drug Abuse Screening Test
Pain Quality Assessment Tool
10
Countdown
0%
1
0%
2
0%
3
0%
4
Miss Ima Hurtin
Vignette #2 (2 weeks later)
Pre-Visit:
Current Risk Level?
SF-36 = Physical Functioning = 60 (average 84)
Virginia prescription monitoring report fine and UDS
shows hydrocodone only
PHQ-9 score 12 (moderate depression)
Post-Visit Discussion:
ORT score and risk level now?
Poll the Audience
You have evaluated Miss Hurtin using the Opioid
Risk Tool assessment. What is her score?
1.
2.
3.
4.
5.
3
5
7
9
11
0%
1
0%
0%
2
3
0%
0%
4
5
Nancy: Vignette #1
• Initial session with Dr. Melton
• 30-year-old married Caucasian woman who
lives with her two children and husband
• Chronic pain from motor vehicle accident 3
years ago; crushed 4 vertebrae in lower back
• Current treatment includes fentanyl
transdermal patch
– “I use 3 a day instead of one every 3 days.”
Considerations for Pain Management of the
Addicted Patient
Abuse-deterrent
technologies
Urine drug screens
Monitoring
compliance
Propoxyphene
recall
Chronic pain in
the addicted
patient and
relapse
risk factors
Acetaminophen
limits
Anti-craving
medications
Assessment of
sleep hygiene
Referral if relapse occurs
Type of appropriate treatments
Use of non-opioid
medications
Use of opioid
medications
Evaluation of
anxiety/depression
Management of Pain with Addiction
• Addiction counseling should be offered during treatment
• Pain relief should be provided in an effective and timely
manner
– Undertreatment of pain may create drug craving
– Anxiety, frustration, and anger tend to feed addiction
• Use non-medication approaches
– Ice, transcutaneous electrical nerve stimulation (TENS) or
regional anesthesia
• When medications are indicated, use agents least likely to
– Produce physical dependency
– Alter mood
Savage SR, et al. Addict Sci Clin Pract 2008;4(2):4-25.
Management of Pain with Addiction
• Prescribing opiates or other potentially addictive
medications for pain
– Use in effective doses
– Scheduled administration is preferred over PRN
• Patient does not have to ask for medications, which in an addict
may be interpreted as drug-seeking behavior
– Have a trusted other, such as spouse or friend, dispense
the medications
• By the dose or by limited-time intervals
• Daily dispensing through visiting nursing or pharmacy
Wachholtz et al. Substance Use Misuse 2011;46:1536-1552.
Principles of Assessment of Chronic
Pain in the Addicted Patient
• Addiction, pain, and recovery processes
• Use methods appropriate to cognitive status and context
• Assess intensity, relief, mood, and side effects
• Patient Health Questionnaire (PHQ-9)
• Beck Depression Inventory I-II (BDI I-II)
•
•
•
•
Use verbal report whenever possible
Assess sleep hygiene
Document in a visible place
Expect accountability- assess complete recovery
program
• Include the family
Patient-Related Risk Factors
• History of substance abuse problem
– Especially if within the last 3 years
• History of childhood sexual abuse
• Psychiatric comorbidity
• If patient:
– States they are addicted
– Requests an increase in analgesic dose
– Prefers a specific route of administration
•
•
•
•
Pain not improved with treatment
Functioning gets WORSE
Not active in a 12-step program
Absence of family support
Wachholtz et al. Substance Use Misuse 2011;46:1536-1552.
Risk Factors for
Aberrant Behaviors/Harm
Biological
• Age ≤ 45 years
Psychiatric
Social
• Substance use
disorder
• Prior legal
problems
• Preadolescent
sexual abuse
(in women)
• History of motor
vehicle accidents
• Gender
• Family history of
prescription drug
or alcohol abuse
• Cigarette
smoking
• Major psychiatric
disorder
Katz NP, et al. Clin J Pain 2007;23:103-118.
Manchikanti L, et al. J Opioid Manag 2007;3:89-100.
Webster LR, Webster RM. Pain Med 2005;6:432-442.
• Poor family
support
• Involvement in a
problematic
subculture
Learning Assessment Question
A 50-year-old patient is being treated for chronic pain
with opiates. You are interviewing the patient as part of
a medication review. Which of the following details you
obtain from the patient is considered a risk for aberrant
behavior?
1. Tobacco use for 30 years
2. Chronological age > 45 years
3. Presence of musculoskeletal pain
4. Spouse with history of substance abuse
0%
10
Countdown
1
0%
2
0%
3
0%
4
Nancy: Vignette #2
1st Follow-Up Session
• Reveals history of multiple DUIs over last 5 years
• Entered residential treatment program 3 years ago
– Stayed 8 months until she completed the program
– Denies any relapse with recovery program
• Sponsor
• AA meetings
• Home group
• MEDS: meloxicam, escitalopram, trazodone, zolpidem and
clonazepam
Miss Ima Hurtin: Vignette #3
3 months later
Pre-Visit:
SF-36: Physical Functioning = 65 (average 84)
COMM = 11 (9 is positive)
Came in early once
No-showed two appointments
Post-Visit Discussion:
Risk Level now?
Algorithm
• Treatment team?
• Managing Chronic Pain in Patients with
Substance Use Disorder (handout)
Broad Classes of Therapy
• Four broad classes:
– Physical
– Psycho-behavioral
– Interventional
– Pharmacological
• Multi-dimensional approach
• Select based on patient’s risk for SA and
clinical situation
Physical
• Thermal
• TENS
• Exercise therapy, massage/manipulation,
orthotics and physical therapy
• Acupuncture
Psycho-behavioral
• Cognitive behavioral therapy (CBT) and
psychotherapy
• Relaxation, biofeedback, stress reduction
• Sleep management
• Laughter, music, guided imagery, breathing
exercises
Interventional
•
•
•
•
Nerve block
Joint/trigger point injection
Epidural
Spinal stimulator
Pharmacological
• Non-opioid Analgesics
– NSAIDs and acetaminophen
• mild to moderate pain
– Anticonvulsants
– Antidepressants
– Muscle relaxants
– Benzodiazepines
• Opioids
Dose Limits for Acetaminophen
Products
• FDA mandates that the acetaminophen component of
combination products be limited to no more than 325
mg/tablet
• Goal is to reduce potential toxicity of cumulative dose of
acetaminophen exceeding 4 grams per day
• Thus, short-acting opioid combos are restricted
Product
Acetaminophen Max doses per day before exceeding 4
dose
grams acetaminophen
Vicodin ES®
750 mg
5 tablets
Vicodin HP®
660 mg
6 tablets
Vicodin®, Tylox®
,
Percocet®
500 mg
8 tablets
650 mg
6 tablets
www.fda.gov/downloads/AdvisoryCommittees/.../UCM164898.pdf
Acetaminophen Injection
• OFIRMEV® is the first intravenous analgesic
and antipyretic formulation of acetaminophen
– Management of mild to moderate pain
– Management of moderate to severe pain with
adjunctive opioid analgesics
– Reduction of fever
OFIRMEV® (acetaminophen) injection prescribing information.
Cadence Pharmaceuticals, Inc.
NSAIDs
• Topical NSAIDs can provide good levels of
pain relief
– Topical diclofenac solution is equivalent to that of
oral NSAIDs in knee and hand osteoarthritis
– No evidence for other chronic painful conditions
– Formulation can influence efficacy
– Incidence of local adverse events is increased
with topical NSAIDs, but gastrointestinal adverse
events are reduced compared with oral NSAIDs
NSAIDs
• Often effective after minor or moderate
surgery
• NSAIDs often decrease the need for opioids
• Avoid long-term use of COX inhibitors in
patients with atherosclerotic cardiovascular
disease
Anticonvulsants for Pain Management
• Carbamazepine: neuralgia, diabetic
neuropathy
• Gabapentin: neuropathic pain
• Phenytoin: weak to modest results
• Lamotrigine: neuropathic pain
• Topiramate: modest results
• Pregablin: diabetic neuropathy, fibromyalgia
• Tiagabine, valproic acid, zonisamide: ??
Gronseth G, et al. Neurology 2008, 71(15): 1183–1190.
Benzodiazepines
• Researchers disagree on effects of benzodiazepines on
chronic pain
– Several studies demonstrate increased pain
• NO ROLE in treatment of chronic pain in patients with
addiction
– Not first-line agents
– Excellent options for anxiety exist
– Use is often protracted in patients with chronic pain
– Significant risk for relapse and functional impairment
– Deadly combination with opioids
Antidepressants for Pain Management
• Duloxetine: physical pain with depression,
fibromyalgia
• Venlafaxine: physical pain with depression
• Nortriptyline: neuropathic pain
• Desipramine:neuropathic pain
• Amitriptyline: fibromyalgia
Smith BH, Torrance N. Curr Opin Support Palliat Care 2011; Jun;5(2):137-42.
Jefferies K. Semin Neurol 2010 Sep;30(4):425-32.
Opioids: Buprenorphine
• May be preferred therapy in patients with
comorbid pain and opioid dependence
– Safety
– Ability to suppress opioid-seeking behavior
– Analgesic effects
• 72-hour transdermal patch preferred
• Always note on prescription “for pain”
• Other opioid us may be necessary and should
not be ruled out based on a patient having a
substance abuse history
Opioid-induced Hyperalgesia
• Increased sensitivity to pain stimuli
• Consequence of long-term opioid medications
(with or without opiate street drugs)
• Agents with evidence of “anti-hyperalgesia”
– Buprenorphine
– Gabapentin
Knotkova H, Pappagallo M. Med Clin North Am 2007;Jan;91(1):113-24.
Chronic pain with Comorbid
Addiction
• A recent systematic review found that patients
with chronic pain (non-cancer) who had
comorbid substance use disorders
– More likely to be prescribed opioids
– Higher doses of opioid medications compared
with patients who do not have a history of
substance use disorders despite similar pain
outcomes
Morasco BJ, et al. Pain 2010;152(3):488-97.
Misconceptions: Patients on Opioid
Agonist Therapy (OAT)
• OAT provides analgesia
– Maintenance methadone or buprenorphine does not
provide sustained analgesia
– Although potent analgesics, the analgesic properties last
only 4-8 hours, while the medications are dosed every 2448 hours
• Use of opioid analgesia may cause addiction relapse
– No evidence indicates that exposure to opioid analgesics
during acute pain increases relapse rates
– Evidence suggests that the stress of unrelieved pain can
trigger relapse
Alford DP, et al. Ann Intern Med 2006;144(2):127-34.
Misconceptions: Patients on Opioid
Agonist Therapy (OAT)
• The combination of OAT and other opioids
may cause respiratory depression
– Theoretical risk that is not supported by clinical or
empirical experience
– Tolerance to respiratory and CNS depressant
effects occurs rapidly and reliably
Alford DP, et al. Ann Intern Med 2006;144(2):127-34.
Recommendations for Patients on
OAT to Manage Acute Pain
• Reassure patients that their addiction histories will not
prevent adequate pain management
• Verify doses with prescribing physicians and inform of any
opioids given
• Opioid cross-tolerance often necessitates higher opioid
analgesic doses, shorter intervals and continuous scheduled
dosing orders rather than as-needed orders.
• For patients receiving methadone maintenance therapy
– Continue methadone maintenance dose and add shortacting opioid analgesics
Patients on Buprenorphine
Maintenance Therapy (BMT)
• Pain management with opioids is complicated by
the high affinity of buprenorphine for the mu
receptor
• This affinity may cause buprenorphine to
compete with opioid analgesics at mu receptors
• Buprenorphine's rate of dissociation from mu
receptors is highly variable so naloxone should
be available and consciousness and respiration
should be closely monitored
Three Options for Patients on BMT
• Continue BMT and titrate a short-acting opioid
analgesic to effect
• Divide buprenorphine dose to 6-8 hours to
take advantage of its short-acting analgesic
properties
• Discontinue BMT, implement opioid
analgesia, and restart BMT when opioid
analgesia is no longer necessary
Learning Assessment Question
A 56-year-old patient with a long history of addiction is being treated for chronic
pain following an accident at work involving a fall from a piece of equipment.
The patient successfully completed outpatient treatment with methadone
maintenance 10 years ago. Most recently, he has failed therapy with NSAIDs,
multiple adjunctive agents, physical therapy and counseling. His physician
feels that an opiate is necessary for treatment of the pain. Based on the case
presentation, which of the following do you recommend?
1.
2.
3.
4.
Methadone 20 mg po BID
Buprenorphine transdermal 5 mcg/hr
Morphine/naltrexone 60/24.4 mg po daily
Oxycodone 10 mg po every 6 hours prn for pain
0%
0%
0%
0%
10
1
Countdown
2
3
4
Nancy: Vignette #3
• 2nd Follow-up Session (30 days after 1st follow-up)
• Patient reports that she is not being compliant with
medication regimen. She is taking more than
necessary, then she feels guilty and stops taking
anything for her pain.
Abuse Mechanism
• Rapid Bioavailability
Crushing
Grinding/Chewing
Dissolving
Needle aspiration
Filtration and solvent extraction
o Oral
o Intravenous
o Nasal inhalation
Lavine,G. Am J of Health-System Pharm; 2008 65(5):38-5.
Formulations: Prevent or Deter Abuse
• Abuse-deterrent formulations
– Contain substances making formulation less attractive to
abusers
• Buprenorphine/naloxone (Suboxone®)
• Extended-release morphine/naltrexone (Embeda®)
• Tamper-resistant formulations
– Resist abuse by crushing, freezing, or dissolution
• Reformulation of oxycodone extended-release (Oxycontin®)
• Extended-release oxycodone in a highly viscous liquid
formulation matrix (Oxecta®)
• Osmotic-release oral delivery system (OROS) – physical
barrier
Reformulation of Oxycontin®
(ORF)
• ORF released version
with “harder shell”
• Went through FDA as a
reformulation, not as an
“abuse resistant”
formulation
• Crushed tablets are
chunkier, and less able
to be used for snorting or
injecting
ORF – Is it Working?
• Over the 8 months following introduction of ORF,
overall abuse of ORF declined by 57%
• Among patients who abused ORF, abuse by nonoral route declined by 61%
• These early results include transitional period
effects when both the old and new formulation
were available
Cassidy T, Coplan P, Black R, et al. Inflexxion, Inc., Newton, MA,
USA, Purdue Pharma L.P., Stamford, CT, USA Available online at:
http://www.painweek.org/media/mediafile_attachments/05/255-13.pdf
Standardization of Evaluation
• Tested using standard animal, bench top, and
human pharmacokinetic and pharmacodynamic
assessments that allow interpretation
• Should not alter drug activity for compliant patients
in an undesirable or risky way
• Should have an accurate pre-approval estimation
of their reduced abuse liability, which would be
validated by adequate epidemiologic post-approval
surveillance
Webster Lr, et al. Expert Opin Investig Drugs 2009 ;18 (3):255-263
Abuse-resistant Testing
• Who is likely to abuse the
formulation?
• Whether the product can be
abused without manipulation
• Potential methods of alteration
• Effects of multiple doses
• Possible alternate routes of
administration
• Physical or chemical means of
extracting the active ingredient
Webster Lr, et al. Expert Opin Investig Drugs 2009 ;18 (3):255-263
• Methods of compromising
extended-release formulations
• Potential abuse in
combination, particularly with
alcohol
• Effect if the drug is abused
• Safety limits if the drug is
abused
Opioid Attractiveness Scale (OAS)
• 17-item scale; ranks components identified as
attractive to the potential abuser
• Components were identified using concept mapping
by a group of prescription opioid abusers and
experts in opioid abuse
• Tool focuses on factors intrinsic to the drug product,
such as speed of onset and duration
• Could prove useful in assessing the attractiveness
of opioid formulations before they are launched
Webster Lr, et al. Expert Opin Investig Drugs 2009 ;18 (3):255-263.
Butler SF et al. Harm Reduct J; 2006 2;3(1):5.
Learning Assessment Question
You are a clinical pharmacist in a patient-centered
medical home. You are leading a discussion of the
options for opioid therapy available using abusedeterrent technology. Which of the following
statements about abuse-deterrent formulations of
opioids would you include?
1.
2.
3.
4.
Likely to be less effective than regular opioid formulations
Manufacturers use similar strategies to counteract abuse
Designed in a way so that they do not harm the potential abuser
Likely to have fewer adverse effects than regular opioid formulations
0%
1
0%
2
0%
3
0%
4
Nancy – Vignette #4
3rd Follow-up Session (2 weeks after second session)
• Patient has been given tapentadol medication guide
• Her counseling sessions have uncovered trauma issues
• Excessive anxiety when patient is involved with authoritative
males which leads to increases in pain
• Treatment team decided to discontinue escitalopram and
added bupropion XL to her regimen
Miss Ima Hurtin: Vignette #4
3 months later
Pre-Visit:
SF-36: Physical Functioning = 78 (average 84)
COMM = 5 (9 is positive)
EtOH and UDS appropriate
No no-shows or early appointments
Post-Visit Discussion:
Risk Level now?
Challenges: The Non-Compliant
Addicted Chronic Pain Patient
•
•
•
•
UPs uncover non-compliance
Thinking beyond your UPs enhances safety
Flexibility to follow changing needs
Tension develops between beneficence and
primum non nocere
Challenges: The Non-Compliant
Addicted Chronic Pain Patient
• Individualize and tighten structure of care
• 45% able to remain in treatment, 38% selfdischarged
• Five domains of structure
–
–
–
–
–
Setting of care
Selection of treatment
Supply of medications
Supports for recovery
Supervision
Five Domains of Care Structure
Setting of Care
• Primary care - broader/longitudinal
knowledge, integrate care with other medical
care issues
• Specialty care - deeper knowledge in
particular problem area
• When to refer
Five Domains of Care Structure
Setting of Care
Parameter
Primary Care
Specialist Care
Pain Etiology
Straightforward
Unclear or complex
Psychiatric
Disorder
None
Unstable
Substance
Abuse
None
Current or within
three years
Social
Support
Activity
Good
Isolated
Rich and satisfying Absent
Five Domains of Care Structure
Selection of Treatment
• Most benefit with the least risk
– Remember non-pharmacologic options
– Address medical co-morbidities - sleep,
psychological, hunger, deconditioning
• Patient preference and ability
– Cognitive or financial limitations
• Provider’s skills
• Addiction shifts the risk/benefit ratio
Five Domains of Care Structure
Supply of Medication
• Quantity
– 7 vs. 120
– “Bottomless bottle”
– Safer (non-lethal supply)
• Scheduled vs. PRN
• Dispensing
– Pharmacy, family or trusted surrogate
– Potential resentment/conflict
Five Domains of Care Structure
Supports for Recovery
• Recovery Groups
– Weekly NA, AA, Celebrate Recovery, etc.
– “Booster Sessions”
•
•
•
•
•
Sponsor
Counselor - SA and psychiatric
Faith community
Family - group therapy
Workplace
Five Domains of Care Structure
Supervision of Care
• Visit Frequency
– Weekly to every 3 months
• Toxicology Testing
– Weekly to annually and randomly
• Addition of ancillary providers
– Different than changing setting of care
– More practical in rural area
– Clinical pharmacy
– Interventionalist
Learning Assessment Question
You are part of a team caring for a patient with
chronic pain and a history of addiction. Which of
the following do you recommend in terms of
treatment protocol if controlled substances are
prescribed?
1.
2.
3.
4.
Limit prescriptions to a 7-14 day supply
Patient must see a specialist every 6 months
Schedule for meds should be PRN, not scheduled
Perform announced UDS and pill counts every 4 months
0%
0%
0%
0%
10
Countdown
1
2
3
4
Nancy – Vignette Epilogue
• Adherent for last 1.5 years and with physical therapy,
psychotherapy, recovery groups, and appropriate pain
management, she has returned to work
• She states that she has regained control of her life again, her
marriage has improved and her family understands that she
has a chronic illness she must manage daily
• She will celebrate her 3rd NA birthday next month
• Her physician and pharmacist are a vital part of her recovery
Useful Resources
• American Academy of Pain Management http://www.aapainmanage.org/
• Non-profit organization that educates clinicians about pain and its management
through an integrative interdisciplinary approach.
• American Academy of Pain Medicine http://www.painmed.org/
• Medical specialty society representing physicians practicing in the field of pain
medicine
• American Chronic Pain Association http://www.theacpa.org
• To facilitate peer support and education for individuals with chronic pain and
their families so that these individuals may live more fully in spite of their pain.
• American Society of Regional Anesthesia and Pain Medicine http://www.asra.com/
• Member info, web-based CME, and fellowship opportunities are some of the
highlights.
• American Pain Foundation http://www.painfoundation.org
• Contains newsletter, downloadable patient resources (MS Word), and discussion
boards.
• American Pain Society (APS) http://www.ampainsoc.org/
• Multidisciplinary, scientific and professional society.
Useful Resources
• American Society for Action on Pain http://www.druglibrary.org/schaffer/asap/
• Patient organization interested in pain management issues/concerns.
• American Society for Pain Management Nursing http://www.aspmn.org/
• Organization of professional nurses that provide support to pain management.
• American Society of Addiction Medicine http://www.asam.org/
• Site dedicated to increasing the quality of addiction treatment.
• Drugs4Real http://www.drugs4real.com
• An interactive prevention program that teaches adolescents about the influence
of alcohol and drugs and strengthens their commitment to avoid taking these
substances.
• International Association for the Study of Pain (IASP) http://www.iasp-pain.org
• National Pain Foundation http://www.painconnection.org/
• A non-profit organization that provides education and support resources for
people in chronic pain, their families, and physicians.
• Pain & Policy Studies Group, University of Wisconsin http://www.painpolicy.wisc.edu
• Website contains a wealth of information about pain relief and public policy, both
domestic and international
Useful Resources
• Pain Medicine News http://www.painmedicinenews.com/
• Frequently updated content designed to meet the needs of the spectrum of
physicians involved in pain medicine.
• Pain Treatment Topics http://www.pain-topics.org/
• With pharmaceutical company support, a noncommercial resource for
healthcare professionals, providing clinical news, information, research, and
education for a better understanding of evidence-based pain-management
practices.
• Pain.com http://www.pain.com/
• Free web-based CME, articles, and pain journals (all free to view).
• PainACTION http://www.painaction.com
• An online self-management program for pain patients, featuring individuallycustomized information, interactive skill-building tools, monthly newsletter and
opportunities to share self-management tips.
• PainLink http://www.edc.org/PainLink/
• Archived website that still contains applicable information.
• The Mayday Fund http://www.painandhealth.org/
• Extensive listing of internet resources relating to pain and pain management.
Materials Provided at Meeting
www.painEDU.org
www.samhsa.gov/