Kenneth L Kirsh PhD Clinical Research Educator and Research Scientist Millennium Laboratories Millennium Research Institute San Diego CA The Opioid Pendulum Opiophobia Balance of Addiction Medicine and Pain Management Principles ID: 757060
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Opioid Therapy, Pain, and Addiction at the Crossroads
Kenneth L. Kirsh
,
Ph.D.
Clinical Research Educator and Research Scientist
Millennium
Laboratories
Millennium Research Institute
San Diego, CASlide2
The Opioid Pendulum
Opiophobia
Balance of Addiction Medicine and Pain Management Principles
1
Opiophilia
1
Gourlay, D.L. et al. Universal precautions in pain medicine: A rational approach to the treatment of chronic pain.
Pain Medicine. 2005; 6(2): 107-112.Slide3
Nearly 20 years of expanded opioid prescribing: What have we learned?
3
Something fundamental about the clinical use of opioids?
OR
Something fundamental about what our healthcare system is bad at?Slide4
What is our healthcare system bad at?Goldney RD, et al. Depression, diabetes, and quality of life: A population study. Diabetes Care. 2004; 27(5): 1066-1070.
Patrick DL, et al. Symptom management in cancer pain: Pain, depression, and fatigue.
Journal of the National Cancer Institute.
2003; 95(15): 1110-1117.Winkleby MA, et al. Social class disparities in risk factors for disease: Eight-year prevalence patterns by level of education. Preventative Medicine. 1990; 19: 1-12.
ChronicityConditions with major motivational/psychiatric componentCommunication among professionals
Ongoing risk assessmentConditions that intersect badly with SESStigmatizationSlide5
Two Commonly Used Classes of Medications PPIs OpioidsYoshikawa I, et al. Long-term treatment with proton pump inhibitor is associated with undesired weight gain. World J Gastroenterol.
2009; 15(38):
4794-4798.Slide6
Trivialization of risk and overstatement of benefitsTo individual patientsTo societyPain management is easy, just follow the numbersPain patients vs. addicts
The delivery system will deliver us
Pushing the Pendulum Towards
OpiophiliaSlide7
Base Rates of Addiction/Abuse: Vulnerabilities in the Population8.7% Illicit Drugs6.2% Alcohol26.5% NicotineSAMHSA, Results from the 2011National Survey on Drug Use and Health: Summary of National Findings. NSDUH Series H-44, HHS Publication No. (SMA) 12-4713. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2012.Slide8
Pseudo-addiction?Weissman DE, Haddox JD. Opioid pseudoaddiction – an iatrogenic syndrome. Pain. 1989; 36(3): 363-366.Passik S, et al. Pseudoaddiction revisited: A commentary on clinical and historical considerations. Pain Management, 2011;
Passik, Kirsh, & Webster
Failures to demonstrate it empirically
Use of illegal drugs covered?
Overuse of prescribed medications by outpatients covered?Primary vs. secondary alcoholism as a better model
Weissman & HaddoxN of 1 case studyInpatientBecame surly anduncooperativePain managementimproved, behaviorimprovedSlide9
AIDS Patients and Aberrant BehaviorsAdequate Analgesia(n=49)Inadequate Analgesia(n=24)Total # of aberrant behaviors305
(6.2)
152
(6.3)Aberrant behaviors “probably less predictive of addiction239(78%)116(74%)Aberrant behaviors “probably more predictive of addiction66(22%)
40(26%)Passik SD, et al. Pain and aberrant drug-related behaviors in medically ill patients with and without histories of substance abuse. Clinical Journal of Pain. 2006; 22(2): 173-181.Slide10
Non-Medical Use of Psychotherapeutic
SAMHSA.
Results From the 2007 National Survey on Drug Use and Health.
DHHS Publication No. SMA 06-4194, 2006. Obtained from http://www.samhsa.gov/data/nsduh/2k7nsduh/2k7Results.htm
Percent Using in Past MonthSlide11
New Illicit Drug Use in the United States: 2002SAMHSA. Results From the 2002 National Survey on Drug Use and Health. DHHS Publication No. SMA 06-4194, 2006. Obtained from Obtained from http://www.samhsa.gov/data/nhsda/2k2nsduh/results/2k2Results.htm#toc.
500
1000
1500
2000
2500
Numbers in Thousands
Pain Relievers
Marijuana
Tranquilizers
Inhalants
Cocaine
Stimulants
Ecstasy
Sedatives
LSD
Heroin
PCPSlide12
Doctors on Trial: Pain Docs or Drug Dealers?Satterfield J. Pain clinic owner standing trial on charges she traded pills for cash. Knoxnews. September 25, 2012: Retrieved from http://www.knoxnews.com/news/2012/sep/25/pain-clinic-owner-standing-trial-on-charges-she/ Slide13
What Makes News?Sex&Drugs&Rock and RollSlide14
This?
14Slide15
Or This?Slide16
What Constitutes Functional Improvement, Anyway?
Improvement?
Slowing the rate of decline?Slide17
Pushing the Pendulum Toward Opiophobia
Opioid
strawman
Addiction is resident in drugsHyperalgesiaSlide18
The Opioid StrawmanSlide19
Where does Addiction Live?Slide20
Addiction is not Simply a Disease of ExposureBurroughs W. Junkie. New York, NY: Ace Books; 1973.
Burroughs:
Exposure
Current
Exposure is necessary not sufficientExposure to drugVulnerable personVulnerable timeSlide21
Does Drug Selection Matter? Long-acting Opioids vs. Short Acting OpioidsSetnik B, et al. The abuse potential of remoxy, an extended-release formulation of oxycodone, compared with immediate-release and extended-release oxycodone. Pain Medicine. 2011; 12(4): 618-631
Fentanyl Patch
Fentanyl TIRFSlide22
HyperalgesiaEasy to demonstrate in:Rats1Humans on opioids in acute painChronic pain???2
Undeniable that some people are better off, off opioids
Is this
Hyperalgesia?Hypogonadism?Psychological/Existential distress?Having normal bowel movements?1Tassorrelli C, et al. Nitroglycerin induces
hyperalgesia in rats: A time course study. European Journal of Pharmacology. 2003; 464(2-3): 159-162.2Fishbain DA, et al. Do opioids induce hyperalgesia in humans? An evidence-based structured review.
Pain Medicine. 2009; 10(5): 829-839.Slide23
Risk Management is a Package DealScreening and risk stratificationUse of PMP dataCompliance MonitoringUrine screening
Pill/Patch counts
Education regarding drug storage
and sharingPsychotherapy and highly “structured” approachesAbuse-deterrent formulationsPassik SD, Kirsh KL. The interface between pain and drug abuse and the evolution of strategies to optimize pain management while minimizing drug abuse. Experimental and Clinical Psychopharmacology. 2008; 16(5): 400-404.Slide24
Population of Rx Opioid Users Is Heterogeneous
“Addicted” (SUD)
“Substance abusers”
“Recreational
users”
“Adherent”
“Chemical copers”
“Addicted”
(SUD)
“Substance abusers”
Nonmedical Users
Pain Patients
“Self-Treaters”
Passik SD, Kirsh KL. The interface between pain and drug abuse and the evolution of strategies to optimize pain management while minimizing drug abuse.
Experimental and Clinical Psychopharmacology.
2008; 16(5): 400-404.Slide25
Assessment of Addiction RiskMeasures for screening for addiction riskSTAR/SISAP1CAGE AID2
Opioid Risk Tool (Emerging Solutions in Pain)
3
SOAPP (see painedu.org)4Psychiatric interview assessment of riskChemicalPsychiatric
Social/FamilialGeneticSpiritual1Friedman R, Mehrotra D. Treating pain patients at risk: Evaluation of a screening tool in opioid-treated pain patients with and without addiction. Pain Medicine. 2003; 4(2): 182-185
2Brown RL, Rounds LA. Conjoint screening questionnaires for alcohol and other drug abuse: Criterion validity in a primary care practice. Wisconsin Medical Journal. 1995; 94(3): 135-140 (retrieved from http://www.integration.samhsa.gov/images/res/CAGEAID.pdf on February 18, 2013).3Webster LR. Predicting aberrant behaviors in opioid treated patients: Preliminary validation of the opioid risk tool. Pain Medicine. 2005; 6(6): 432-442.
4Akbik H, et al. Validation and Clinical Application of the Screener and Opioid Assessment for Patients with Pain (SOAPP).
Journal of Pain and Symptom Management. 2006; 32(3): 287-293.Slide26
How do Different Risk Measures Compare?A recent study at a pain practice in TennesseeA retrospective study of discharged patientsN=48Risk rating of each patient with all four measures:Clinical semi-structured interview by a psychologist
DIRE (Belgrade et al, 2006)
ORT (Webster & Webster, 2005)
SOAPP (Butler et al, 2004)“Medium” or “High” risk rating = Accurate predictionThis measure assesses sensitivity (not specificity).Moore TM, et al. A comparison of common screening methods for predicting aberrant drug-related behavior among patients receiving opioids for chronic pain management.
Pain Medicine. 2009; 10(8): 1426-1433.Slide27
Accuracy in Predicting Discharge(Aberrant Drug-Related Behaviors)Measure% Accuracy RateInterview77%SOAPP73%
ORT
45%
DIRE17%Moore TM, et al. A comparison of common screening methods for predicting aberrant drug-related behavior among patients receiving opioids for chronic pain management. Pain Medicine. 2009; 10(8): 1426-1433.Slide28
The Growth of Prescription Monitoring ProgramsData collected from http://www.pmpalliance.org/content/data
2003
14 states had monitoring programs
36 states had no prescription monitoring programs201241 states had prescription drug monitoring programs9 states had no monitoring programSlide29
Aberrant Behaviors Versus Urine Toxicology TestingUrine ToxicologyAberrant BehaviorsYesNo
Total
Positive
10(8%)26 (21%)36 (29%)Negative17 (14%)69 (57%)86 (71%)Total27 (22%)
95 (78%)122Katz N, Fancuillo GJ. Role of urine toxicology testing in management of chronic opioid therapy. Clinical Journal of Pain. 2002; 18(4): S76-S82.
53/122 (43%) of patients had “problems” (positive urine screen or behavioral issues)Slide30
Unexpected UDT Results Chronic Opioid TherapyMichna E, Jamison RN, Pham LD, et al. Urine toxicology screening among chronic pain patients on opioid therapy: frequency and predictability of abnormal findings. Clin J Pain 2007; 23: 173-179.Slide31
Teaching about Medication Storage and Sharing Sharing prescriptionmeds seen as safeby “self-treaters”
Need to educate patients
about medication storage
New devices being developedto help only the patient haveaccess and on a scheduleprogrammed by the MD or RNhttp://www.lockyourmeds.org/meducation/Slide32
Opioid Renewal ClinicWiedemer NL, et al. The opioid renewal clinic: A primary care, managed approach to opioid therapy in chronic pain patients at risk for substance abuse. Pain Medicine. 2007;
8(7
):
573-584.ProcedureConsult from PCPEligibilityWorkup & pain dxOpioid Treatment
AgreementBaseline urine drugtestPCP CONTINUES TO BERESPONSIBLE TOPRESCRIBE OPIOIDSStrategy
Opioid Treatment AgreementSecond change agreementFrequent visitsPrescribed opioids on short-term basisie, weekly or bi-weeklyRandom UDTPill countsCo-management with additional servicesSlide33
Opioid Renewal Clinic(n=171)Wiedemer NL, et al. The opioid renewal clinic: A primary care, managed approach to opioid therapy in chronic pain patients at risk for substance abuse. Pain
Medicine.
2007;
8(7): 573-584.
Aberrant behavior = 171No aberrant behavior = 164Slide34
NIDA Study: Adherence Therapy for Opioid Abusing Pain Patients40 pain patients at 2 sites in Virginia & New YorkEvidence of opioid efficacy for diagnosis>6 mo duration, constant, moderate-severe intensity (VAS >7 despite daily opioids)
Substance abuse co-morbidity
Opioid abuse dependence, >2 on “problems with pain meds”, no current substance dependence, & lifetime dependence or current abuse permissible
Psychiatric co-morbidityNo unstable major psychiatric disorders, current suicidal/homicidal ideation, or medication dose considerationsMedical co-morbidityNo unstable/severe medical conditions or planned surgery within study period; no meds that interact with methadone
Haller D, Acosta MC. Characteristics of pain patients with opioid-use disorder. Psychosomatics. 2010; 51: 257-266.Slide35
NIDA Study: Adherence Therapy for Opioid Abusing Pain PatientsHaller D, Acosta MC. Characteristics of pain patients with opioid-use disorder. Psychosomatics. 2010; 51: 257-266.Slide36
Differential Diagnosis: Aberrant Drug-Taking Attitudes & BehaviorAddictionCompton1Fleming2
Pseudo-addiction
Elander
31Compton P, et al. Screening for addiction in patients with chronic pain and ‘problematic’ substance use: Evaluation of a pilot assessment tool. Journal of Pain and Symptom Management. 1998; 16(6): 355-363.2Fleming MF, et al. Substance use disorders in a primary care sample receiving daily opioid therapy. The Journal of Pain. 2007; 8(7): 573-582.
3Elander J, et al. Understanding the causes of problematic pain management in sickle cell disease: evidence that pseudoaddiction plays a more important role than genuine analgesic dependence. Journal of Pain and Symptom Management. 2004; 27(2): 156-169.Slide37
Differential Diagnosis: Aberrant Drug-Taking Attitudes & BehaviorOther psychiatric diagnosisOrganic mental syndromePersonality disorderChemical copingDepression/anxiety/situational stressors
Wasan
1
Criminal intentKatz2Jung & Reidenberg31Wasan AD, et
al. Psychiatric history and psychological adjustment as risk factors for aberrant drug-related behavior among patients with chronic pain. Clinical Journal of Pain. 2007; 23(4): 307-315.2Katz, N. et al. (2010). Usefulness of prescription monitoring programs for surveillance—analysis of Schedule II opioid prescription data in Massachusetts, 1996–2006. Pharmacoepidemiology and Drug Safety, 19(2), 115-123.3Jung B, Reidenberg MM. Physicians being deceived.
Pain Medicine. 2007; 8(5): 433-437.Slide38
We Are All StakeholdersPatientsProfessionalsLaw enforcementMedia3rd Party Payors
Passik SD, Heit H, Kirsh KL. Reality and responsibility: A commentary on the treatment of pain and suffering in a drug-using society.
Journal of Opioid Management.
2006; 2(3): 123-127.Slide39
3rd Party PayorsJoranson DE. Are health-care reimbursement policies a barrier to acute and cancer pain management? Journal of Pain and Symptom Management. 1994;
9(4
): 244-253.
Frequent visitsUrine screensPsychological careAbuse deterrent opioidsLess drug per prescriptionSlide40
Conclusions