opioids and pain management...

PrinciplesofPreventioninPrimaryCarePractice:PearlsandPitfalls

May17,2020

DanielP.Alford,MD,MPHProfessorofMedicine

AssociateDean,ContinuingMedicalEducation

Director,ClinicalAddictionResearchandEducation(CARE)Unit

Director,SafeandCompetent OpioidPrescribingEducation (SCOPEofPain)Program

BostonUniversitySchoolofMedicine|BostonMedicalCenter

OpioidsandPainManagementPreventingHarmandMaximizingBenefit

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DanielAlford,MD,MPH

Disclosures

• IserveascoursedirectorforsaferopioidprescribingCMEfundedbyan

unrestrictededucationalgrantawardedtoBostonUniversitybytheREMS

ProgramCompaniesaspartoftheFDA'sOpioidAnalgesicREMSprogram

• Ididnotreceiveanydirectpaymentfromindustryfortheseactivities

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Roadmap

• Background:Pain,Opioids,Trends

• ProviderandPatientMistrust

• SaferOpioidPrescribing

• Resources

• Q&A

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Background

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ChronicPainisComplex

Dzau VJ,Pizzo PA.JAMA.2014

WalkD,Poliak-TunisM.MedClinNAm.2016

Argoff CE,etal.PainMed.2009

• Adaptive byelicitingmotivationtominimizeharmandallowhealing

AcutePainLifesustainingsymptom

• Maladaptive,pathologic, disorderofthe

somatosensory painsignaling pathways

influenced bygenetic andepigenetic

factors

ChronicPainCanbeadiseaseinitself

Petrosky E,etal.AnnInternMed.2018

Ilgen MA,etal.JAMAPsychiatry.2013

TangNKetal.PsycholMed.2006

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• Associated withhigherriskoffatalandnonfatalsuicide attempts*

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• Chronicpain iscommon

• Painissubjective tothepatient andtheclinician

• Paincan’talwaysbevisualized

• Psychiatricco-morbidities arecommon

Significantbarrierstoadequatepaincare

• Negative attitudes anddisparities inpaincare

• Lackofdecision supportforchronicpainmanagement

• Financialmisalignment favoringuseofmedications

• Poorsupportforteam-based careandspecialty clinics

• Manycompeting priorities inprimarycare

ChronicPaininPerspective

InstituteofMedicine.2011RelievingPaininAmerica.WashingtonDC

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OpioidAnalgesics

• Analgesia

• Turnondescendinginhibitorysystems

• Preventascendingtransmissionofpainsignal

• InhibitterminalsofC-fibersinthespinalcord

• Inhibitactivationofperipheralnociceptors

• Variableresponse(notallpatients respondtothe

sameopioid inthesameway)

• >1000polymorphisms inthehumanMORgene

• Differencesinpharmacokinetics(opioidmetabolism)

• Activetherewardpathway

McCleane G,SmithHS.MedClin NAm2007

SmithHS.PainPhysician.2008

Somatosensory

cortex

Thalamus

Ascending

pathways

DorsalHorn

Peripheral

nerves

Descending

pathway

Periaqueductal

grayarea

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www.fda.gov,ONDCP2019

Since2011MME

declineby43%

2018largestMME

declineat17%

OpioidPrescribingTrends

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TrendsinOpioidOverdoseDeaths

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OpioidRisks

• Allergies arerare

• Sideeffectsarecommon

• Nausea,sedation,constipation,urinaryretention,sweating

• Respiratorydepression– sleepapnea

• Organtoxicities arerare

• Suppressionofhypothalamic-pituitary-gonadalaxis

• Immunosuppression

• Increasedriskofinvasivepneumococcaldz andcommunityacquiredpneumonia

• Worseningpain (hyperalgesia insomepatients)

• Addiction(OpioidUseDisorder)

• Overdose

• whencombinedw/othersedativesandathigherdoses

DunnKMetal.AnnInternMed2010

LiXetal.BrainRes2001

Doverty Metal.Pain 2001

AngstMS,ClarkJD.Anesthesiology2006

WieseAD,etal.AnnInternMed.2018

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ProblematicOpioidUse

• Systematicreviewfrom38studies(26%primarycaresettings, 53%painclinics)

Misuse rates:21%- 29%

Misuse:Opioidusecontrarytothedirectedorprescribedpatternofuse,regardlessofthepresenceor

absenceofharmoradverseeffects.

Addiction rates:8%- 12%

Addiction: Patternofcontinued usewithexperienceof,ordemonstrated potential for,harm(eg,

impairedcontroloverdruguse,compulsiveuse,continued usedespiteharm,andcraving ).

Vowles KEetal.Pain.2015

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• Aclinicalsyndromepresentingas…

– LossofControl

– Compulsiveuse

– Continuedusedespiteharm

Aberrant

Medication

Taking

Behaviors

SavageSRetal.JPainSymptomManage2003

AddictionisDifficulttoDiagnose

• Addictionisa behavioralmaladaptation

• PhysicalDependenceisa physiologicadaptation

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AberrantMedicationTakingBehaviors

TheSpectrumofSeverity

o Requestsforincreaseopioiddose

o Requestsforspecificopioidbyname,“brandnameonly”

o Non-adherencew/otherrecommendedtherapies(e.g.,PT)

o Runningoutearly(i.e.,unsanctioneddoseescalation)

o ResistancetochangetherapydespiteAE(e.g.over-sedation)

o Deteriorationinfunctionathomeandwork

o Non-adherencew/monitoring(e.g.pillcounts,urinedrugtests)

o Multiple“lost”or“stolen”opioidprescriptions

o Illegalactivities– forgingscripts,sellingopioidprescription

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Volkow NDetal.NEngl JMed2016

Medication-relatedFactors Risk

Dailydose>100MME overdose addiction

Long-termopioiduse(>3mo) overdose addiction

ER/LAopioidformulation overdose

Combinationopioids+benzodiazepines overdose

<2weeksafterstartingER/LAopioid overdose

OpioidRiskFactors

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Patient-relatedFactors Risk

Mentalhealthdisorder(e.g.depression,anxiety) overdose addiction

Substanceusedisorder(e.g.,alcohol,nicotine, illicit&prescriptiondrug) overdose addiction

Familyhistoryofsubstanceusedisorder misuse

Adolescent addiction

Age<45 misuse

Age>65 overdose

Sleep-disorderedbreathing overdose

Legalhistory(e.g.,DUI,incarceration) misuse

Historyofsexualabuse misuse

Historyofoverdose overdose

OpioidRiskFactors

Akbik H,etal.JPainSymptomManage.2006IvesJ,etal.BMCHealthServ Res.2006

LiebschutzJM,etal.JPain.2010

Michna E,etal.JPainSymptomManage.2004ReidMC,etal.JGenInternMed.2002

Volkow NDetal.NEngl JMed2016

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OpioidsandChronicPain

“Theproblemis,there’snoevidence

thatopioidsworkforchronicpain,

accordingtoguidelinesreleasedin

2016bytheCDC”

JuliaLurie– reporter,MotherJones,

April27,2018

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Meta-analyses(3-6mfollow-up)

• Opioidsvsplacebo

Opioidswithstatistically

significantbutsmall

improvementsinpain1,2

andphysicalfunctioning.2

(highqualitystudies)

• Opioidsvsnonopioids

Bothwithsimilarbenefits2

(low-modqualitystudies)

RCT3 foundopioids

notsuperiorto

nonopioids for

improving

musculoskeletal pain-

relatedfunctionover12

months

Studylimitations:

• Patientsalreadyonlong-termopioidswereexcluded

• 89%ofpatientsdeclinedtobeenrolled

Twolongerterm

follow-upstudies

found44.3%on

chronicopioidsfor

chronicpainhad

atleast50%

painrelief4

1.Meske DS,etal.JPainRes.20182.Busse JW,etal.JAMA.20183.KrebsEE,etal.JAMA.20184.NobleM,etal.CochraneSystematicReviews.2010

OpioidEfficacyforChronicPain

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OpioidsinPerspective

• Theefficacyandsafetyofchronicopioidtherapyforchronicpainhasbeen inadequately

studied*

• Opioidprescribing needs tobemoreselective andconservative

• Opioidsforchronicpain…

§ helpsome patients

§ harmsome patients

§ areonlyonetool formanagingseverechronicpain

§ areindicated onlywhenalternative safertreatment optionsareinadequate

ChouRetal.AnnInternMed2015

DowellDetal.JAMA 2016

Manchikanti Letal.PainPhysician2011

ReubenDBetal.AnnInternMed2015

Volkow ND,McLellanT.NEngl JMed2016

*

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Over-PrescribingOpioids

•Societalmedicationmania

•Patients(families)overlyfocusedonopioids(“painkillers”)

•Clinicians’confrontationphobia

• Lackoftraininginpainandaddictionatalllevelsofhealthprofessional

education

• Lackofaccess/coveragetocomprehensivepainmanagementservices

Mezei Letal.JPain2011

Watt-WatsonJetal.PainResManage2009

Morely-ForsterPKetal.JPainRes2013

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Mistrust

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• Qualitativestudy

• Adultswithlowbackpain

• Patientandproviderthemes

BuchmanDZetal.PainMed.2016

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Patient Theme1:

ThreatstoTrustworthiness

andIatrogenicSuffering

• Perceptionsthattheirclinicianshavedemonstratedalackofcare,empathy,

andrespect…affectingpatients’assessmentsofclinician

trustworthiness…negative interactionswithclinicianscausedthemfurther

suffering.

SUSAN:“Youcouldjusttellthathejustdidn’tbelievemethatIwasinas

muchpainasIwas.Hewasjustveryunsympathetic.Hewouldliterallywalk

awaywhileIwasinthemiddleofasentence.”

BuchmanDZetal.PainMed.2016

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Patient Theme2:

Motive,Honesty,andTestimony

• Patients’doubtsthattheircliniciansbelievedthattheywerebeinghonest

abouttheirmotivesforseekingtreatment(e.g.,drugmisuseordrug

diversion).Patientsdescribedbeingperceivedasuntrustworthybyclinicians

LUDWIG:“WhenIwasin[hospital]justacoupleofweeksago…the

ambulancedriversjusttookonelookatmeanditwas,like—thelookintheir

eyeswaslike,‘Oh,he’sjustajunkielookingtogetstoned.’Theydidn’t

believethatIwasactuallysufferingandinpain.TheythoughtIwasfakingit

completely…”

BuchmanDZetal.PainMed.2016

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Clinician Theme1:

ChallengesofthePracticeContext

• Physicianshighlightedthechallengingcontextinwhichchronicpain

managementisdelivered.Theyrecalledseveraldifficultinteractions

andtheimpacttheseinteractionshadontheirapproachtocare

DR.JOHN:“Thethingsthatwerememberarethetimesthatwegot

burned,right...Youmaygetburnedonein100,butthatonein100is

enoughtoburnanimpressioninyourmindthatmakesyouwaryofall

patientspotentially.”

BuchmanDZetal.PainMed.2016

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Clinician Theme2:

ComplicatedClinicalRelationships

• Chronicpainmanagementinvolvingopioidanalgesicscanprohibitor

destabilizethedevelopmentoftrustingclinicalrelationships.Physicians…did

notnecessarilyseetheirroleasacollaborativepartner…[they] saw

themselvesinadefensiveroleofinterrogator

DR.HENRY:“Inmostdoctor–patientrelationshipswelearntolistentothe

patientandaccepttheirtestimony…insomeinstances, tobequitehonest,we

areinterviewingthepatientasifweareapoliceofficeroralawyerandwe’re

tryingtofindflawsintheirstory…Sothereisadifferentrelationshiphere.”

BuchmanDZetal.PainMed.2016

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BuildingTrust:ProviderIssues

Afteryoucompleteathoroughpainhistory,focusedphysicalexam,andappropriatediagnostictesting…

Showempathyforpatientexperience

Validatethatyoubelievepain isreal

Believingtheseverityofapatient’spaincomplaint

doesnotmeanopioidsareindicated

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SaferOpioidPrescribing

forChronicPainCOPYRIGHT

Physical

Exercise

Manualtherapies

OrthoticsTENS

Othermodalities(heat,cold,stretch)

MedicationNSAIDs

Anticonvulsants

AntidepressantsTopicalagents

Opioids

Others

ProceduralAcupuncture

Nerveblocks

SteroidinjectionsTriggerpointinjections

Stimulators

Pumps

Psycho-behavioral

CBT/ACT

Txmood/traumaissues

AddresssubstancesMeditation

MultidimensionalCareforChronicPain

CultivateWell-being

ReducePain

ImproveQualityofLife

RestoreFunction

SELFCARE

Studiesonallpharmacologicandnonpharmacologictreatmentsforchronicpainare< 12m,majorityare< 12w

Tayeb BO,etal.PainMed.2016

Multimodalapproachesaremorecost-effectivethansinglemodalityoptions

FlorH,etal.Pain1992RobertsAH,etal.ClinJPain.1993PatrickLE,etal.Spine.2004Kamper SJ,etal.CochraneReview.2014

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• Misuseriskassessment– ORT- OpioidRiskTool

– SOAPP- ScreenerandOpioidAssessment forPatientswithPain

– DIRE- Diagnosis,Intractability,Risk,Efficacy

• PatientProviderAgreements(PPA)– Informedconsent(risksandbenefits)

– Planofcareincludingmedicationmanagement

• Frequentface-to-facevisits– Assessanddocumentrisksandbenefits

• Monitorforadherence,addictionanddiversion– Urinedrugmonitoringandpillcounts

– PrescriptionDrugMonitoringProgram(PDMP)data

GourlayDLetal.PainMed2005

Using UniversalPrecautions

whenPrescribingOpioids(notevidence-based buthasbecome standard ofcare)

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PrescribingOpioidsDuringCOVID-19

• DEAadoptedpolicies effectiveMarch31st to

allowcontrolled substances prescribing

withouthavingtointeract in-personwith

patients

www.deadiversion.usdoj.gov/coronavirus.html

• Evaluatingthepatient

– Itisacceptabletousetelemedicineevenifneverevaluatedpatientinperson

• DeliveringtheRxtothepharmacy

– IfnecessaryprescribercancallinRxtothepharmacywithconfirmationwithin15daysby

written,electronic,scannedorphotograph

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CDCGuideline DowellDetal.MMWR 2016

Whentoinitiate/

continueopioidsOpioidmanagement

Assessrisks/

addressharms1.Donotuseopioidsas1st-line

therapy.Ifused,combinew/

othertherapies

4.Whenstartinguse immediate-

releaseopioids

8.Usestrategiestomitigaterisk

(eg,naloxone)

2.Beforestartingopioids establish

realisticgoals.Continueopioids

only ifmeaningfulimprovements

outweighsrisks

5.Prescribethe lowesteffective

opioiddose.Usecautionwithany

dose, ifpossibleavoiddoses >90

mgmorphinemgequivalents

9.ReviewPDMP data

3.Beforestartingandthen

periodicallydiscussrisksand

benefitsofopioids

6.Prescribeshortdurationsfor

acutepain.<3daysoften

sufficient;>7daysrarelyneeded

10.Useurinedrugtesting

7.Evaluatebenefitsandharms

within4weeksofstartingandat

leastevery3months thereafter

11.Avoidconcurrent

benzodiazepines

12.Offer/arrangetreatmentfor

patientswithanOUD

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OpioidsforChronicPainWhatistheclinician’srole?

VS.

NicolaidisC.PainMedicine2011

• Usearisk-benefitframework

• Judgetheopioidtreatment,not thepatient

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Patient-CenteredSaferOpioidPrescribing

• Whileimplementingsafeopioidprescribingguideline-based

practicesdon’tforgetaboutthepatientexperience…

– Howdoyourpatientsperceivethesaferopioidprescribing

procedures…agreements,urinedrugtesting,pillcounts?

– Howdoyourclinicalstaffperceivethepatientswithchronicpainon

chronicopioidtherapy?

• Requirestrainingandre-trainingyourclinicalstaff…

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DiscontinuingOpioids

• Donothavetoproveaddictionordiversion,onlyassessandreassess the

risk-benefitratio

• Ifpatientisunabletotakeopioidssafelyorisnon-adherentwith

monitoring,thendiscontinuingopioidsisappropriate,eveninsettingof

benefits

YouareNOT

abandoning

thepatient,

youare

ABANDONING

THEOPIOID

• Needtodeterminehowurgentthediscontinuation

shouldbebasedontheseverityoftherisksandharms

• Documentrationalefordiscontinuingopioids

• Determineiftheopioidneedstobetapered

duetophysicaldependence

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TaperingOpioids

• Novalidated protocols inpatients onopioids forchronicpain

• Systematic review1 foundverylowqualityevidencesuggesting

severaltypesofopioidtapersmaybeeffective andthatpain,

function,andqualityoflifemayimproveforsomepatientswith

decrease opioiddose

• Cohortstudy2 ofover100,000patients onlong-term opioids

– Annualtaperingincreasedfrom11%(2008)to22%(2017)

– Tapermorelikelyinwomenandthoseonhigheropioiddoses

– 19%haddosereductionrateexceeding10%perweek

1FrankJW,etal.AnnInternMed.20172FentonJJetal.JAMANetworkOpen.2019

CDCRecommendation:

Decreaseof10%permonthifpatientonopioidsforyears

Decreaseof10%perweekifpatientonopioidsforweekstomonths

DowellD,etal.MMWR.2016.

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www.scopeofpain.org

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www.scopeofpain.org

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Thankyou!

Questions?

dan.alford@bmc.orgCOPYRIGHT