CDC Guideline for Prescribing Opioids for Chronic Pain...

CDC Guideline for Prescribing Opioids for Chronic Pain—

United States, 2016 DeborahDowell,MD,MPH1;TamaraM.Haegerich,PhD1;RogerChou,MD1

JAMA.2016;315(15):1624-1645.

JournalClubGabrielMaGei,MDSeptember28,2016

CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016 •  Introduc)on• GuidelineDevelopmentProcess• RecommendaOons• Discussion• Conclusion

IntroducBon

•  ThenumberofpeopleexperiencingchronicpainissubstanOal• USprevalenceesOmatedat11.2%oftheadultpopulaOon• PaOentsshouldreceiveappropriatepaintreatmentbasedonacarefulconsideraOonofthebenefitsandrisksoftreatmentopOons• Opioidsarecommonlyprescribedforpain,withapproximately3%to4%oftheadultUSpopulaOonprescribedlong-termopioidtherapy

DowellD,HaegerichTM,ChouR.CDCGuidelineforPrescribingOpioidsforChronicPain—UnitedStates,2016.JAMA.2016;315(15):1624-1645.

ManchikanOL,etal.AmericanSocietyofIntervenOonalPainPhysicians(ASIPP)guidelinesforresponsibleopioidprescribinginchronicnon-cancerpain:Part2--guidance.PainPhysician.2012Jul;15:S67-116.

Evidence for short term efficacy

•  Evidencesupportsshort-termefficacyofopioidsinrandomizedclinicaltrialslasOng<12weeks•  PaOentsreceivingopioidtherapyforchronicpainreportsomepainreliefwhensurveyed

•  Fewstudieshavebeenconductedtoassessthelong-termbenefitsofopioidsforchronicpain(painlasOng>3months)withoutcomesexaminedatleast1yearlater

Risks Associated with Opioid

• OpioidpainmedicaOonusepresentsseriousrisks•  From1999to2014,morethan165,000personsdiedofoverdoserelatedtoopioidpainmedicaOonintheUnitedStates•  In2013,anesOmated1.9millionpersonsabusedorweredependentonprescripOonopioidpain

•  Theevidencereviewfocusedon5keyquesOons:•  Resultedin12recommendaOonsin3areas:•  DeterminingwhentoiniOateorconOnueopioidsforchronicpain,

•  OpioidselecOon,dosage,duraOon,follow-up,anddisconOnuaOon,

•  Assessingriskandaddressingharmsofopioiduse

CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016 •  IntendedforprimarycareclinicianstreaOngpaOentswithchronicpain•  paincondiOonsthattypicallylast>3monthsorpasttheOmeofnormalOssuehealinginoutpaOentseengs

• MaybeappliedtopaOents>18yearswithchronicpain(outsideofacOvecancertreatment,palliaOvecare,andend-of-lifecare)•  Intendedto:

•  ImprovecommunicaOonbetweencliniciansandpaOentsabouttherisksandbenefitsofopioidtherapyforchronicpain•  ImprovethesafetyandeffecOvenessofpaintreatment•  Reducetherisksassociatedwithlong-termopioidtherapy

CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016 •  IntroducOon• GuidelineDevelopmentProcess• RecommendaOons• Discussion• Conclusion

• CDCusedtheCDCAdvisoryCommiGeeonImmunizaOonPracOces(ACIP)translaOonoftheGradingofRecommendaOonsAssessment,Development,andEvaluaOon(GRADE)methodforguidelinedevelopment•  WithintheACIPGRADEframework,thequalityofabodyofevidencewasgraded,andtherecommendaOonsweredevelopedandplacedintocategories(AorB)basedonthequalityofevidence,balanceofbenefitsandharms,valuesandpreferences,andresourceallocaOon

CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016 •  IntroducOon• GuidelineDevelopmentProcess• Recommenda)ons• Discussion• Conclusion

The guideline includes 12 recommendaBons:

“1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and funcBon are anBcipated to outweigh risks to the paBent. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate. (RecommendaBon category: A; evidence type: 3)”

•  ExercisetherapyandCBTshouldbeusedtoreducepainandimprovefuncOoninpaOentswithchronicpain•  Canbeusedwhenthereislimitedaccesstospecialtycare.•  Provenshort-termbenefitsandlowrisk•  Ifopioidsareused,theyshouldbecombinedwithnonpharmacologictherapyandnonopioidpharmacologictherapy,asappropriate,toprovidegreaterbenefitstopaOents

2. Before starBng opioid therapy for chronic pain, clinicians should establish treatment goals with all paBents, including realisBc goals for pain and funcBon, and consider how opioid therapy will be disconBnued if benefits do not outweigh risks. Clinicians should conBnue opioid therapy only if there is clinically meaningful improvement in pain and funcBon that outweighs risks to paBent safety. (RecommendaBon category: A; evidence type: 4)

• DeterminehoweffecOvenesswillbeevaluated•  Establishtreatmentgoals

•  ShouldincludeimprovementinbothpainreliefandfuncOon(dependentonclinicalcircumstances)•  FuncOoncanincludeemoOonalandsocialaswellasphysicaldimensions•  Cliniciansmayusevalidatedinstrumentssuchasthe3-item“Painaverage,interferencewithEnjoymentoflife,andinterferencewithGeneralacOvity”(PEG)AssessmentScaletotrackpaOentoutcomes•  Clinicallymeaningfulimprovementdefinedasa30%improvementinscoresforbothpain

3. Before starBng and periodically during opioid therapy, clinicians should discuss with paBents known risks and realisBc benefits of opioid therapy and paBent and clinician responsibiliBes for managing therapy. (RecommendaBon category: A; evidence type: 3)

•  CliniciansshouldensurethatpaOentsareawareofpotenOalbenefitsof,harmsof,andalternaOvestoopioidsbeforestarOngorconOnuingopioidtherapy•  ImportantconsideraOonsincludethefollowing:

•  BeexplicitandrealisOcaboutexpectedbenefitsofopioids•  EmphasizeimprovementinfuncOonasaprimarygoalandthatfuncOoncanimproveevenwhenpainissOllpresent

•  AdvisepaOentsaboutseriousadverseeffectsofopioids•  AdvisepaOentsaboutcommoneffectsofopioids•  Discusseffectsthatopioidsmayhaveonabilitytosafelyoperateavehicle•  Discussincreasedrisksforopioidusedisorder,respiratorydepression,anddeathathigherdosages,alongwiththeimportanceoftakingonlytheamountofopioidsprescribed

3. Before starBng and periodically during opioid therapy, clinicians should discuss with paBents known risks and realisBc benefits of opioid therapy and paBent and clinician responsibiliBes for managing therapy. (RecommendaBon category: A; evidence type: 3)

•  Reviewincreasedrisksforrespiratorydepressionwhenopioidsaretakenwithbenzodiazepines,othersedaOves,alcohol,illicitdrugssuchasheroin,orotheropioids.•  Discussriskstohouseholdmembersandotherindividuals•  DiscusstheimportanceofperiodicreassessmenttoensureopioidsarehelpingtomeetpaOentgoalsandtoallowopportuniOesforopioiddisconOnuaOon•  DiscussplanneduseofprecauOonstoreducerisks,includinguseofPDMPinformaOonandurinedrugtesOng.Considerincludingdiscussionofnaloxoneuseforoverdosereversal.•  ConsiderwhethercogniOvelimitaOonsmightinterferewithmanagementofopioidtherapy(forolderadultsinparOcular)

4. When starBng opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acBng (ER/LA) opioids. (RecommendaBon category: A;

evidence type: 4) • WhenanER/LAopioidisprescribed,usingaproductwithpredictablepharmacokineOcsandpharmacodynamicsispreferredtominimizeunintenOonaloverdoserisk• Methadone-shouldnotbethefirstchoiceforanER/LAopioid

•  Onlyclinicianswhoarefamiliarwithmethadone’suniqueriskprofileandwhoarepreparedtoeducateandcloselymonitortheirshouldconsiderprescribingmethadoneforpain.

•  Transdermalfentanyl-onlyclinicianswhoarefamiliarwiththedosingandabsorpOonproperOesshouldconsiderprescribingit

5. When opioids are started, clinicians should prescribe the lowest effecBve dosage. Clinicians should use cauBon when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to 50 morphine milligram equivalents (MME) or more per day, and should avoid increasing dosage to 90 MME or more per day or carefully jusBfy a decision to Btrate dosage to 90 MME or more per day. (RecommendaBon category: A; evidence type: 3)

•  StartopioidsatlowesteffecOvedosage• UsecauOonwhenincreasingopioiddosages•  IncreasedosagebythesmallestpracOcalamount

•  Ifdosagereachesorexceeds50MMEperday,shouldimplementincreasedfrequencyoffollow-upandconsideringofferingnaloxone.

• Avoidincreasingopioiddosagesto90MMEormoreperday

Opioid-related overdose risk is dose-dependent

• Dosagesof50to<100MMEperdaywerefoundtoincreaseriskforopioidoverdosebyfactorsof1.9to4.6• Dosagesof≥100MMEperdaywerefoundtoincreaseriskforopioidoverdosebyfactorsof2.0to8.9

Box4.CauOonsAboutCalculaOngMorphineMilligramEquivalentDoses:EquianalgesicdoseconversionsareonlyesOmatesandcannotaccountforindividualvariabilityingeneOcsandpharmacokineOcs.Donotusethecalculateddoseinmorphinemilligramequivalents(MME)todeterminethedosestousewhenconverOngoneopioidtoanother;whenconverOngopioids,thenewopioidistypicallydosedatsubstanOallylowerthanthecalculatedMMEdosetoavoidaccidentaloverdoseduetoincompletecross-toleranceandindividualvariabilityinopioidpharmacokineOcs.UseparOcularcauOonwithmethadonedoseconversionsbecausetheconversionfactorincreasesathigherdoses.UseparOcularcauOonwithfentanylbecauseitisdosedinµg/hinsteadofmg/d,anditsabsorpOonisaffectedbyheatandotherfactors.

6. Long-term opioid use oden begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effecBve dose of immediate-release opioids and should prescribe no greater quanBty than needed for the expected duraBon of pain severe enough to require opioids. Three days or less will oden be sufficient; more than 7 days will rarely be needed. (RecommendaBon category: A; evidence type: 4)

• Acutepaincanopenbemanagedwithoutopioids•  PrescribenogreaterquanOtythanneededfortheexpectedduraOonofpain•  Open3daysorless•  Morethan7dayswillrarelybeneeded

•  ShouldnotprescribeaddiOonalopioidstopaOents“justincase”painconOnueslongerthanexpected•  ShouldnotprescribeER/LAopioidsforthetreatmentofacutepain

7. Clinicians should evaluate benefits and harms with paBents within 1 to 4 weeks of starBng opioid therapy for chronic pain or of dose escalaBon. Clinicians should evaluate benefits and harms of conBnued therapy with paBents every 3 months or more frequently. If benefits do not outweigh harms of conBnued opioid therapy, clinicians should opBmize other therapies and work with paBents to taper opioids to lower dosages or to taper and disconBnue opioids. (RecommendaBon category: A; evidence type: 4)

•  Considerlowerfollow-upintervalswhenER/LAopioidsarestartedorincreased(whentotaldailyopioiddosageis≥50MMEperday•  RegularlyreassessallpaOentsreceivinglong-termopioidtherapy,atleastevery3months•  ReevaluatepaOentsexposedtogreaterriskofopioidusedisorderoroverdosemorefrequently

•  CliniciansshouldworkwithpaOentstoreduceopioiddosageortodisconOnueopioidswhenpossibleifclinicallymeaningfulimprovementsinpainandfuncOonarenotsustained•  WhenopioidsarereducedordisconOnued,ataperslowenoughtominimizesymptomsandsignsofopioidwithdrawalshouldbeused

•  Adecreaseof10%oftheoriginaldoseperweekisareasonablestarOngpoint•  Slowertapers(ex.10%permonth)mightbeappropriateandbeGertolerated,parOcularlywhenpaOentshavebeentakingopioidsforyears.

8. Before starBng and periodically during conBnuaBon of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to miBgate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/d), or concurrent benzodiazepine use, are present. (RecommendaBon category: A; evidence type: 4)

• CarefulconsideraOonofrisksandbenefitsshouldbetakeninthefollowingpaOents:•  PaOentswithmoderateorseveresleep-disorderedbreathing•  PregnantpaOents

•  Arrangefordeliveryatafacilitypreparedtoevaluateandtreatneonatalopioidwithdrawalsyndrome

•  PaOentswithrenalorhepaOcinsufficiency•  PaOents≥65years•  PaOentswithanxietyordepression

8. Before starBng and periodically during conBnuaBon of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to miBgate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/d), or concurrent benzodiazepine use, are present. (RecommendaBon category: A; evidence type: 4) ConBnued…

•  ConsiderofferingnaloxonewhenprescribingopioidstopaOents:•  Atincreasedriskofoverdose,includingpaOentswithahistoryofoverdose

•  Withahistoryofsubstanceusedisorder

•  Takingbenzodiazepineswithopioids•  Atriskofreturningtoahighdosetowhichtheyarenolongertolerant(eg,paOentsrecently

releasedfromprison)•  Takinghigherdosagesofopioids(≥50MME/d)

9. Clinicians should review the paBent’s history of controlled substance prescripBons using state prescripBon drug monitoring program (PDMP) data to determine whether the paBent is receiving opioid dosages or dangerous combinaBons that put him or her at high risk for overdose. Clinicians should review PDMP data when starBng opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescripBon to every 3 months. (RecommendaBon category: A; evidence type: 4)

•  Ideally,PDMPdatashouldbereviewedbeforeeveryopioidprescripOon•  IfpaOentsarefoundtohavehighopioiddosages,dangerouscombinaOonsofmedicaOons,ormulOplecontrolledsubstance

prescripOonswriGenbydifferentclinicians,severalacOonscanbetakentoaugmentclinicians’abiliOestoimprovepaOentsafety:•  CliniciansshoulddiscussinformaOonfromthePDMPwiththeirpaOentandconfirmthatthepaOentisawareoftheaddiOonalprescripOons.•  Cliniciansshoulddiscusssafetyconcerns,includingincreasedriskforrespiratorydepressionandoverdose,withpaOentsfoundtobereceiving

opioidsfrommorethan1prescriberorreceivingmedicaOonsthatincreaseriskwhencombinedwithopioids(eg,benzodiazepines).•  Cliniciansshouldavoidprescribingopioidsandbenzodiazepinesconcurrentlywheneverpossible.Cliniciansshouldcommunicatewithothers

managingthepaOenttodiscussthepaOent’sneeds,prioriOzepaOentgoals,weighrisksofconcurrentbenzodiazepineandopioidexposure,andcoordinatecare.

•  CliniciansshouldcalculatethetotalMME/dforconcurrentopioidprescripOons.IfpaOentsarefoundtobereceivinghightotaldailydosagesof

opioids,cliniciansshoulddiscusstheirsafetyconcernswiththepaOent,considertaperingtoasaferdosage,andconsiderofferingnaloxone.•  CliniciansshoulddiscusssafetyconcernswithotherclinicianswhoareprescribingcontrolledsubstancesfortheirpaOent.•  CliniciansshouldconsiderthepossibilityofasubstanceusedisorderanddiscussconcernswiththeirpaOent.•  IfclinicianssuspecttheirpaOentmightbesharingorsellingopioidsandnottakingthem,cliniciansshouldconsiderurinedrugtesOngtoassistin

determiningwhetheropioidscanbedisconOnuedwithoutcausingwithdrawal.AnegaOvedrugtestforprescribedopioidsmightindicatethepaOentisnottakingprescribedopioids,althoughcliniciansshouldconsiderotherpossiblereasonsforthistestresult.

•  CliniciansshouldnotdismisspaOentsfromtheirpracOceonthebasisofPDMPinformaOon.DoingsocouldresultinmissedopportuniOesto

providepotenOallylifesavinginformaOonandintervenOons.

10. When prescribing opioids for chronic pain, clinicians should use urine drug tesBng before starBng opioid therapy and consider urine drug tesBng at least annually to assess for prescribed medicaBons as well as other controlled prescripBon drugs and illicit drugs. (RecommendaBon category: B; evidence type: 4)

•  InmostsituaOons,iniOalurinedrugtesOngcanbeperformedwitharelaOvelyinexpensiveimmunoassaypanelforcommonlyprescribedopioidsandillicitdrugs.•  PaOentsprescribedlesscommonlyusedopioidsmightrequirespecifictesOngforthoseagents.

•  CliniciansshouldbefamiliarwiththedrugsincludedinurinedrugtesOngunderstandhowtointerpretresults

•  BeforeorderingurinedrugtesOng,cliniciansshouldexplaintopaOentsthattesOngisintendedtoimprovetheirsafety

•  CliniciansshoulddiscussunexpectedresultswiththelocallaboratoryortoxicologistandwiththepaOent.

•  CliniciansshouldnotdismisspaOentsfromcarebasedonaurinedrugtestresult.

11. Clinicians should avoid prescribing opioid pain medicaBon and benzodiazepines concurrently whenever possible. (RecommendaBon category: A; evidence type: 3)

•  Shouldavoidprescribingopioidsandbenzodiazepinesconcurrentlywheneverpossible.•  CertaincircumstanceswhenitmightbeappropriatetoprescribeopioidstoapaOentreceivingbenzodiazepines•  severeacutepaininapaOenttakinglong-term,stablelow-dosebenzodiazepinetherapy

•  CheckthePDMPforconcurrentcontrolledmedicaOonsprescribedbyotherclinicians•  Considerinvolvingpharmacistsandpainspecialistsaspartofthemanagementteamwhenopioidsareco-prescribedwithotherCNSdepressants• Whentaperingofbenzodiazepinesoropioidstoreduceriskoffatalrespiratorydepression,mightbesafer/morepracOcaltotaperopioidsfirst•  Taperbenzodiazepinesgraduallybecauseabruptwithdrawalcanbeassociatedwithreboundanxiety,hallucinaOons,seizures,deliriumtremens,and,inrarecases,death

12. Clinicians should offer or arrange evidence-based treatment (usually medicaBon-assisted treatment with buprenorphine or methadone in combinaBon with behavioral therapies) for paBents with opioid use disorder. (RecommendaBon category: A; evidence type: 2)

•  Ifclinicianssuspectopioidusedisorder,theyshoulddiscusstheirconcernswiththeirpaOentandprovideanopportunityforthepaOenttodiscloserelatedconcernsorproblems•  CliniciansshouldassessforopioidusedisorderusingDSM-5criteria•  CliniciansshouldofferorarrangeforpaOentswithopioidusedisordertoreceiveevidence-basedtreatment•  Oralorlong-acOnginjectablenaltrexonecanalsobeusedinnonpregnantadults•  Forpregnantwomenwithopioidusedisorder,medicaOon-assistedtherapywithbuprenorphineormethadonehasbeenassociatedwithimprovedmaternaloutcomes

•  CliniciansunabletoprovidetreatmentthemselvesshouldarrangeforpaOentswithopioidusedisordertoreceivecarefromasubstanceusedisordertreatmentspecialist

Discussion / Take Home Points

•  Nonopioidtherapyispreferredfortreatmentofchronicpain•  OpioidsshouldbeusedonlywhenbenefitsforpainandfuncOonareexpectedtooutweighrisks•  BeforestarOngopioids,cliniciansshouldestablishtreatmentgoalswithpaOents• Whenopioidsareused,cliniciansshouldprescribethelowesteffecOvedosage•  Carefullyreassessbenefitsandriskswhenconsideringincreasingdosageto50MMEormoreperday

•  Avoidconcurrentopioidsandbenzodiazepineswheneverpossible•  EvaluatebenefitsandharmsofconOnuedopioidtherapywithpaOentsevery3months

•  ForpaOentswithopioidusedisorder,offer/arrangeevidence-basedtreatment,suchasmedicaOon-assistedtreatmentwithbuprenorphineormethadone.

Clinical Tools

hGp://www.cdc.gov/drugoverdose/prescribing/resources.html

Conclusion

•  Theguidelineisintendedto:•  improvecommunicaOonbetweencliniciansandpaOentsabouttherisksandbenefitsofopioidtherapyforchronicpain,•  improvethesafetyandeffecOvenessofpaintreatment,•  reducetherisksassociatedwithlong-termopioidtherapy

•  opioidusedisorder,overdose,death

References •  DowellD,HaegerichTM,ChouR.CDCGuidelineforPrescribingOpioidsforChronicPain—UnitedStates,2016.JAMA.2016;315(15):1624-1645.

•  DowellD,HaegerichTM,ChouR.CDCguidelineforprescribingopioidsforchronicpain—UnitedStates,2016.MMWRRecommRep.2016;65(RR-1):1-49.

•  GregorianRSJr,GasikA,KwongWJ,VoellerS,KavanaghS.Importanceofsideeffectsinopioidtreatment:atrade-offanalysiswithpaOentsandphysicians.JPain.2010;11(11):1095-1108.

•  GuyaGGH,OxmanAD,VistGE,etal;GRADEWorkingGroup.GRADE:anemergingconsensusonraOngqualityofevidenceandstrengthofrecommendaOons.BMJ.2008;336(7650):924-926.

•  ManchikanOL,etal.AmericanSocietyofIntervenOonalPainPhysicians(ASIPP)guidelinesforresponsibleopioidprescribinginchronicnon-cancerpain:Part2--guidance.PainPhysician.2012Jul;15:S67-116

•  NahinRL.EsOmatesofpainprevalenceandseverityinadults:UnitedStates,2012.JPain.2015;16(8):769-780.

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