drug u’liza’on edits: failures, needs, & future direc’on · 2017-06-12 · american...

AmericanSocietyforAutoma0oninPharmacy2017MidyearConferenceJune21–23•PalmBeach,Fla.•www.asapnet.org•#ASAPMidyear

DrugU'liza'onEdits:Failures,Needs,&FutureDirec'on

TimKosty,RPh,MBAJune22,2017


Disclosures

TimKostyisanemployeeofPharmacyHealthcareSolu0ons,Inc.Theconflictofinterestwasresolvedbypeerreviewoftheslidecontent.Hedeclaresnootherconflictsofinterestorfinancialinterestinanyproductorservicemen0onedinthisprogram,includinggrants,employment,giRs,stockholdings,andhonoraria.

ASAP’sandNCPA’seduca0onstaffdeclaresnoconflictsofinterestorfinancialinterestinanyproductorservicemen0onedinthisprogram,includinggrants,employment,giRs,stockholdings,andhonoraria.


LearningObjec0vesFollowingthispresenta'on,a<endeesshouldbeableto:

•  DescribetheDUReditsandconfigura0ondecisionsmadetodisplaymessagestopharmacists

•  Iden0fysymptomsofalertfa0gueandmanagementstrategiestoprevent

•  Listlegalissuesimpac0ngthedecisionofpharmacychainmanagementandpayerswhendeterminingtheDURseveritylevelstodisplay

•  Describethefuturedirec0onofDUReditsleveragingtheinteroperabilityofhealthcaremachinebasedlearningandusingpa0entdataacrosshealthcareproviders


Agenda•  DiscusshistoricalDUReditsandimplementa0on

strategies

•  PharmacysoRwareconfigura0ondecisions•  PayerclaimsprocessingDURconfigura0on

•  Iden0fysymptomsandconsequencesofalertfa0gue

•  Evaluatetheimpactofunderlyinglegalissues

•  Describepoten0alfuturedirec0onofDURedits


ChicagoTribuneExpose–Dec2016•  Reportera_emptedtofilltwoprescrip0onsthathadsignificantdrug

interac0ons–Forexample,ClarithromycinandSimvasta0n

•  255pharmaciesweretested,52%soldmedica0onswithoutmen0oningtheinterac0onrisk.Thebestpharmacychainmissedtheinterac0on30%ofthe0me

•  Tribuneconclusion“computeralertsystemsdesignedtoflagdruginterac0onseitherdon’tworkorareignored”

•  Industryresponseswerenotreassuring

•  Li_ledataexistsonhowwellpharmacistsperforminreal-worldsitua0ons


Legisla0veResponsetoExpose•  GovernorRaunerplanstolauncha“mysteryshopperprogram”

•  HB2392introducedthatwouldrequire:

•  Pharmacistfillnomorethan10Rx’s/hour

•  10pharmacytechnicianshoursper100Rx’sfilled

•  Mandatorypharmacistbreaks–noworkingduringbreaksandpharmacymustkeepacompleteandaccuraterecordofbreakstaken

•  Pharmacistscan’tworkmorethan8hours/day

•  Pharmaciesmustmaintainarecordofanyerrorsinthereceiving,filling,ordispensingofprescrip0ons

•  Whistleblowerprotec0onforpharmacyemployees


•  SimpleDUReditswereimplementedin1980’sfollowingthecomputeriza0onofpharmacy

•  OBRA90Rulesimplementedin1993•  Onlineadjudica0onsupportedmorerigorousanalysisof

druginterac0ons

•  DrugCompendiadevelopedmorerobustclinicalproducts

•  Crea0onofinterven0onandoutcomescodesinNCPDPtransac0ons

HistoricalReview


HistoricalReview•  Notmuchhaschangedinthelast25yearswith

DURmessagesandpharmacistresponses.•  Why? Evaluation of

appropriateness of DUR alerts

Pharmacist training on

alerts, severity, and responses

Workflow and productivity

considerations Patient safety

focus


DUREditsinSoRwareIni0alques0ons25yearsagoares0llrelevanttoday

•  Whatalertsshouldwedisplay?Why?

•  Whatdowewantthepharmacisttodowiththealert?

•  Whatalertscanonlythepharmacistrespondto?

•  Whatimpactwillthesealertshaveonworkflow?

•  Whatlookbackin0meisrelevantforDUR?Whatisanac0veprescrip0on?Shouldweconsiderinac0veprescrip0ons?

•  Whataretheclinicalandlegalperspec0ves?


Addi0onalQues0ons•  Whatseveritylevelofalertsshouldbedisplayed?

(Contraindicated,severe,moderate,informa0onal)

•  Dowerequireahardhalt?Whatdoesthatmean?•  WhatissoRhalt?

•  Whendowerequireinterven0onandoutcomecodes?

•  HowdowetrackpharmacistresponsestotheDURalerts?


AdverseDrugEvents•  9.7EmergencyDepartmentvisits/100065years+

•  3.1EmergencyDepartmentvisits/1000<65years

•  4/1000EDvisitsduetoADE’sin2013-2014•  27%ledtohospitaliza0ons

•  DrugclassescausingADE’s–unchangedfrom2005•  An0coagulants,An0bio0cs,An0diabe0cagents,Opioids

Source:ShebabN.EDVisitsforOutpa/entAdverseDrugEvents,2013-2014,JAMANov22,2016


SourceofDUREdits


DrugCompendia•  Whatis“thesourceoftruth?”

•  FDAapprovedmanufacturerpackageInsert

•  Peerreviewedclinicalstudiestosupportapproval•  Theore0caldrugclassinterac0ons

•  Realworldevidenceofclinicaleffec0venessandadversedrugeventspostlaunch

•  FDAMed-watchreports


DrugCompendia•  Whatis“thesourceoftruth?”

FDA approved manufacturer Package Insert (PI)

Peer-reviewed clinical studies to support approval

Theoretical drug class interactions

Real world evidence of clinical effectiveness and adverse drug events post launch

FDA Med-watch reports


ClinicalEvalua0onbyCompendia

•  Whatistherelevantinforma0onfortheapprovedpackageinsertandclinicalstudies?

•  Whatisthestrengthoftheevidence?•  Howfrequentlyistheissueseen?

Mul0plesources?•  Editorialpolicyandparameters


Prescrip'onWorkflow:DURSteps

AlongtheWay


Prescribers–EHRSystems•  Whatmessagesdowedisplaytotheprescriber?

•  Configura0ondecisions

•  Doweimplementhardhalts?Ifyes,inwhatsitua0ons?

•  Dothemessagesdifferdependinguponwhethertheprescriberisaspecialistorageneralprac0oner?

•  Howdoweimproveclinicaldecisionsupportalertsforourcustomers?

•  Whatmanagementreportsareavailabletomonitoralertfa0gue?


PharmacyDispensingSoRware

•  Providecustomerswithflexibilityforimplemen0ngclinicaledits

•  InternalDURalertsareonlybaseduponinforma0onknowntothepharmacy

•  PayerDURalertsmayprovideaddi0onalinsights

•  DowedisplaymessagestothepharmacistonlyaRerpayerhasprocessedprescrip0on?


ClaimsProcessingSoRware•  Wehaveprescrip0onsfromallpharmaciesforthe

pa0ents,aslongastheyusetheirprescrip0oncard.

•  Whatseverityleveldowesendbacktothepharmacy?•  Ifallthetransac0onsarefromthesamepharmacy,do

wesendbacktheDURalert?

•  Dowerequireaninterven0onandoutcomecodefromthepharmacistbeforeapprovingthetransac0on?


TheElephantintheRoom


DURLegalIssuesDrug Manufacturers

•  We need to provide a comprehensive picture of the potential clinical issues in our product labeling

Drug Compendia

•  We supply the DUR edits and potential issues based on our clinical judgment. It’s up to our customers to decide on how to use them


DURLegalIssuesEHR Systems

•  We present information to health care practitioners. It is up to their professional judgment on the how to interpret and respond to them

Claims Processors

•  We provide information to the pharmacist based on our clinicians recommendations. It’s up to the professional judgment of the pharmacist on the action, what if any action to take


DURLegalIssuesPharmacy Chains

•  Establish DUR configurations at the corporate level. However, it’s up to the professional judgment of the pharmacist on the action to take

Pharmacists

•  It’s my license that is on the line based upon the action or inaction taken in response to a DUR alert

All Corporate Attorneys

•  How do we minimize our organizations legal risk?


AlertFa0gue•  Defini0on→thenumberofalertssenttotheprescriber

andpharmacistreachesa0ppingpoint,whereboththeimportantandinforma0onalalertsareignored

•  EHRstudy→between49-96%ofmedica0ondecisionsupportalertswereoverridden

•  Opera0onalChallenge→Howdoyoumeasurealertfa0gue?Whatstepsdoyoutaketopreventit?


ManagementQues0ons•  HowdoyouknowiftheDUReditsareworkingcorrectly?Whatisthe

expectedresponseofpharmacists?

•  Howdoyoumeasurealertfa0gue?

•  Whatmanagementreportsareavailabletodeterminetheac0ontakenbaseduponspecificDURedits?

•  Whatedits,ifany,doyourequireaninterven0onandoutcomecode?

•  Howdoyoumeasurethequalityofpharmacyservices?


Con0nuousQualityImprovement•  Allpar0cipantsneedinsightulinforma0onon

responsestoDURalerts?IsthedataavailableintheEHRordispensingsoRware?Ifyes,howeasilyisitaccessible?

•  Whatisthecriteriatoevaluate?Doyouemployeebothinternalandexternalreviewers?

•  Whatinforma0on,ifanything,isprovidedtoyourdrugcompendiaprovider?


IdealDURMessages


TowardthePerfectDURAlert•  Sophis0ca0onofsystemlogicthatisusedtogeneratepro-DURalerts

shouldbeimprovedtomakeincreaseduseofsta0s0calprobabilitymodelsandbranchingalgorithmstoimproveaccuracy.

•  Pharmacyorganiza0onsshouldenlistclinicalstafftoreportinappropriateorirrelevantalertsandcreateanexpertcommi_eewithintheorganiza0ontoreviewques0onableorfrequentlyoverriddenalertsforthepurposeofrecommendingsystemcustomiza0onsandprovidingfeedbacktodatabaseproviders

Source:ImprovingClinicalDecisionSupportinPharmacy:TowardthePerfectDURAlert.RuppandReynoldsJournalofManagedCareandSpecialtyPharmacy.Jan2017


TowardthePerfectDURAlert•  Displayedalertsshouldbequicklyinterpretableandac0onable

andshouldincludethepa0entsafetyconsequencesofignoringthealert.

•  Con0nuousqualityimprovementofpro-DURsystemsshouldbethesharedgoalofdatabaseandsystemvendors,systemadministrators,pharmacyorganiza0ons,andclinicians.

Source:ImprovingClinicalDecisionSupportinPharmacy:TowardthePerfectDURAlert.RuppandReynoldsJournalofManagedCareandSpecialtyPharmacy.Jan2017


Poten'alPathwaysForward


InternalPharmacyOp0ons•  Createancon0nuousqualityimprovementfunc0ontoevaluate

ac0onstakenbypharmacistsbasedupontheDUReditsdisplayed•  U0lizeinternalandexternalclinicalexpertstoreviewresultsandrecommend

changestoimproveclinicalappropriateness

•  Modifyeditstoreflectrealworldexperience

•  Developmetricsthatmeasurepharmacistquality,inaddi0ontoproduc0vity.What’stherela0onshipbetweenqualityandproduc0vity?Atwhatpointareyousacrificingquality?

•  WorkwithsoRwareproviderstodevelopbestprac0cesbasedonactualexperience.Bewillingtosharede-iden0fiedresultswithbothsoRwareanddrugcompendiaproviders


ExternalOp0ons

Data sharing agreements with drug compendia providers

Software user groups and benchmarking of DUR edit results

Industry Organizations

Centers for Disease Control Collaboration


FutureEnhancements

•  Accesstomedicalandlabdata•  Healthplandataintegra0onandimprovedDUR

messaging•  Machinelearningandalgorithmstoiden0fy

relevantDURmessaging•  FastHealthcareInteroperabilityResources(FHIR)


LegalChallenges•  Unwillingnessoflegaldepartmentstosignoff

ondatasharingwithsoRwarecompaniesanddrugcompendiaproviders

•  Islegisla0onneededtoprovideasafeharbortomovetheindustryforwardandimprovepa0entsafety?


Ques0ons?

TimKosty,RPh,MBAPresident–PharmacyHealthcare

Solu0ons,Inc.412-635-4650

[email protected]

drug u’liza’on edits: failures, needs, & future direc’on · 2017-06-12 · american...

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