““Recognition and Management of Recognition and Management of Prescription Opioid Failure and Prescription Opioid Failure and

Abuse in the Primary Care Setting”Abuse in the Primary Care Setting”William Morris, MD

Medical DirectorJanus of Santa Cruz

Chronic Pain: Burden of DiseaseChronic Pain: Burden of Disease

• 9 in 10 Americans regularly suffer from pain• Each year approx 50 million Americans suffer

from chronic pain• Chronic pain is the most common cause of

chronic disability• Almost 1/3 of Americans will suffer from

chronic pain at some point in their lives

Pain: Current Understanding of Assessment, Management, and Treatments. National Pharmaceutical Council.

OverviewOverview

• Process for prescription of opioids for chronic non-cancer pain

• Opioid “failures”– excessive side effects– inadequate analgesia– Opioid “misuse” = opioid-related aberrant behaviors

• Clarification of terminology• Recognizing and responding to aberrant opioid-

related behaviors

Clinical Guidelines for Opioid Use in Clinical Guidelines for Opioid Use in Chronic PainChronic Pain

• 2010: American Society of Anesthesiologists – http://journals.lww,com/anesthesiology/Fulltext/2010/04000/Practice_G

• 2010: Drug Enforcement Agency – www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html

• uideline_for_Chronic_Pain_Management_13.aspx• 2009: Institute for Clinical Systems Improvement –

www.icsi.org/pain_chronic_assessment_and_management_of_14399/pain_chronic_assessment_and_management_of_guideline.html

• 2009: Journal of Pain – www.jpain.org/article/S1526-5900(08)00831-6/fulltext

• 2004: Federation of State Medical Boards of the United States – www.fsmb.org/pdf/2004_grpol_controlled_substances.pdf

• 2003: Veterans Administration Guideline – www.healthquality.va.gov/cot/cot_fulltext.pdf

Summary Process for Prescription Summary Process for Prescription OpioidsOpioids

Decision Phase

Implementation Phase

Goals met Goals not met

Outcome Phase

Decision Phase – Decision Phase – Are Opioids Needed?Are Opioids Needed?

• Pain is moderate to severe• Pain has significant impact on function and

quality of life• Non-opioid therapies have failed

Decision Phase- Decision Phase- Are Opioid Benefits > Risks?Are Opioid Benefits > Risks?

• Strongest risk factors for abuse– History of substance abuse personally/family– Psychiatric comorbidity: severe depression/anxiety– History of drug-related crime– Regular contact with high risk group (substance

abusers)– History of Sexual abuse – preadolescent– Smokers

- Ives T el al. BMC Health Services Research 2006- Redi MC et al. JGIM. 2002- Michna E et al. JPSM 2004- Akbik H et al. JPSM 2006

Decision for Opioids - Decision for Opioids - Benefit > Risk? (cont.)Benefit > Risk? (cont.)

• Risk assessment tools: www.emergingsolutionsinpain.com– Opioid Risk Tool: Webster LR and Webster RM. Pain

Medicine.2005;6;432-42– Screener and Opioid Assessment for Patients with pain –

Revised (SOAPP-R): Butler et al. Journal of Pain. 2008;9:360-72

• Collateral information: family, friends, physicians, pharmacists

• CURES report

Opioid Risk ToolsOpioid Risk Tools• ORT: scores to place in low, mod, high risk– Family Hx of substance abuse– Personal Hx of Substance abuse– Hx of preadolescent sexual abuse– Psych disease (depression separate)– Age, Sex

• SOAPP-R: 24 ?’s self admin 1-4 scale totaled– e.g: “How often do you feel bored?”– “How often have you been sexually abused?”– “How often have you felt impatient with your

doctors?”

Controlled Substance Utilization Review Controlled Substance Utilization Review and Evaluation System – “CURES” and Evaluation System – “CURES” • Office of state Attorney General– http://ag.ca.gov/bne/cures.php

• Online “Prescription Drug Monitoring Program” generates “patient activity report”

• Initial register online at: http//ag.ca.gov/bne/cures.php

• Then must submit written application with notarized copies of DEA and medical licenses, govt. issued ID

Decision Phase – Decision Phase – Goals and Conditions of Opioid Rx Goals and Conditions of Opioid Rx

• Goals– Analgesia– Improved function: physical, social, vocational and

recreational– Ask question what can patient realistically hope to be

able to do that they cannot do now?

Important to realize that the evidence for opioid efficacy mostly comes from survey and uncontrolled case series, therefore each patient is his/her “n of 1” trial.

Decision Phase – Decision Phase – Goals and Conditions of Rx (cont.) Goals and Conditions of Rx (cont.)

• Conditions of Rx “universal precautions”– Treatment agreement - verbal or written?– Informed consent/education – One prescriber/one pharmacy– Visit frequency– No early refills– Pill counts?– Urine tox screens?

Urine Drug Tests -Urine Drug Tests -An Objective ToolAn Objective Tool

• Shows patient is taking what they are prescribed and not other substances

Aberrant behavior present

Aberrant behavior absent

total

POSITIVE urine 10 (8%) 26 (21%) 36 (29%)

NEGATIVE urine 17 (14%) 69 (57%) 86 (71%)

27 (22%) 95 (78%) 122

Katz NO. et al. Clinical J of Pain. 2002

Decision Phase – Decision Phase – Goals and Conditions for RxGoals and Conditions for Rx

• Exit plan - mutually agreed upon criteria– Lack of adequate analgesia– Lack of adequate functional improvement– Persistent, intolerable side effects– Aberrant behaviors

Implementation PhaseImplementation Phase

• Dose initiation and titration– How long is long enough? [2 months]– How much is too much? [200mg daily oral

morphine equiv dose]• Higher doses – refer to specialty pain clinic

Ballantyne, JC and Mao, JM. Opioid Therapy for Chronic Pain. NEJM.2003;349:1943-53

• Management of side effects

Outcomes Phase – Outcomes Phase – When Goals are Met:When Goals are Met:

• Monthly med renewal visits– Document pain score and side effects– Treat side effects– Tox screen if indicated

• Comprehensive Reassessment visits Q 3-6 months• The “4 A’s”– Analgesia?– Activity?– Acceptable SE profile?– Aberrant behaviors?

• “collateral” information remains important

Outcome Phase – Outcome Phase – The Dark Side of OpioidsThe Dark Side of Opioids

Goals not met

Excessive sideeffects

Ineffective analgesia - disease progression - tolerance - opioid resistant pain - opioid induced hyperalgesia - opioid induced toxicity

Aberrant opioid-related behaviors - non-addiction - addiction

Opioid-induced Hyperalgesia vs. Opioid-induced Hyperalgesia vs. Opioid ToxicityOpioid Toxicity

• Opioid-Induced Hyperalgesia– Anesthesia/pain literature– Setting of chronic, non-terminal

pain syndromes– Continued poor pain control

despite moderate opioid doses (>200mg/day)

– Diffuse pain, out of previous distribution

– Absence of neuroactivation– Absence of dehydration, renal

failure– RX: dose reduction and opioid

rotation (NMDA antagonists?)

• Opioid toxicity– Palliative Care/oncologic

literature– Increase in pain despite

rapid titration– Allodynia, hyperalgesia– Signs of neuroactivation:

myoclonus, delirium– Dehydration, renal failure– RX: opioid rotation with

marked reduction in dose, benzos, hydration?

Lee, M et al. Pain Physician. 2011;14:145-61.Silverman, S. Pain Physician. 2009; 12:679-84

““Confusing Panopoly of Terms and Confusing Panopoly of Terms and Definitions”Definitions”

• Addiction• Habituation• Dependence• Substance abuse• Substance dependence• Substance misuse• Physical dependence• Psychological dependence

Evolution of TerminologyEvolution of Terminology

• Liaison Committee on Pain and Addiction (LCPA)– American Pain Society– American Academy of Pain Medicine– American Society of Addiction Medicine– 1991-2001 created consensus definitions

LCPA Consensus DefinitionsLCPA Consensus Definitions

• “Addiction” favored over “dependence”• Clear separation of concepts of physical

dependence, tolerance, and addiction• Addiction as a chronic disease• Utility of distinguishing addiction from other

forms of aberrant drug behavior

ToleranceTolerance

• “a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time”

Physical DependencePhysical Dependence• “a state of adaptation that is manifested by a

drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid does reduction, decreasing blood level of the drug, and/or administration of an antagonist.”

AddictionAddiction

• “a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving”

AddictionAddiction

• “a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving”

AddictionAddiction

• “a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving”

AddictionAddiction

• “a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving”

AddictionAddiction

• “a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving”

Aberrant Opioid-Related BehaviorsAberrant Opioid-Related Behaviors

• Examples of non-addiction aberrant behaviors:– Noncompliance– Diversion– Seeking euphoria– Medical “coping”– Pseudoaddiction

Chronic Pain Population on Opioids

Aberrant Opioid-Related Behaviors

Addiction

Behaviors LESS indicative of addiction

• Anxiety over symptoms • Med hoarding• Taking other’s meds• Requesting a specific

med• Openly getting meds

from other providers• Complaints about

needing higher dose

• Behaviors MORE indicative of addiction

• Buying street drugs• Illegal activities• Multiple lost or stolen

meds• Prescription forgery• Injection or snorting

meds• Performed sex for drugs• Resistance to med

change despite SEsPassik SD, et. al. Clinical J Pain. 2006;22:173-181

Aberrant Opioid-Related Behavior Aberrant Opioid-Related Behavior Survey ToolsSurvey Tools

• Addiction Behaviors Checklist Wu, et al. J. Pain Symp Manage. 2008;32(4):342-51.– Clinician considers presence of behaviors since last visit and within

current visit – e.g. ran out of meds early? Reports worsening relationship with

family?

• Current Opioid Misuse Measure Butler, et al. Pain. 2007;130:144-56.– 17 questions asked of patient with 0-4 response

Chronic Pain Population on Opioids

Aberrant Opioid-Related Behaviors

Addiction

30 - 40%

2-5%

Personal Observations from Dealing Personal Observations from Dealing with Challenging Patientswith Challenging Patients

• Assuming opioids = only way to Rx severe pain• Multiple opioids of same type• High doses without pain specialist input• Continued dose escalation despite lack of

significant improvement• Absence of weighing benefit against risk• Assuming aberrant behaviors = addiction

Having the ConversationHaving the Conversation• Clearly lay out my concerns – – I first focus on lack of analgesia and side effect – Then discuss specific examples of aberrant opioid-

related behaviors• Present your assessment that risk of harm is

greater than benefit– If I have relationship with patient, I focus on my

wanting the best for them– If first visit, I focus on my ethical obligation to “do no

harm”• Refer back to opioid agreement if you have one

Having the Conversation (cont.)Having the Conversation (cont.)

• “It doesn’t make sense to keep doing something that is more likely to harm you than help you, does it?”

• I acknowledge that this is not an easy problem to deal with

• Don’t back them into a corner - I remind them;– My diagnosis could be wrong– I would not be offended if they transferred care to

another physician– I will not abandon them.

Having the Conversation (cont.)Having the Conversation (cont.)

• I offer choice around how opioids are tapered, not if they will be tapered, with as much flexibility as is safe.

• Try to decide: tapering because of addiction or because of opioid side effects and/or failure?– Addiction should include in the care plan referral

for recovery treatment– Addiction may require medication assisted

treatment: methadone or buprenorphine

Insanity: doing the same thing over and over again and expecting

different results

- Albert Einstein

RECOVERY

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