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FalsifiedMedicinesDirective(FMD)- Ahospitalpharmacyperspective
GS1UKHealthcareConference2016BhuleshVadher
12/13April2016
Thankyoutothepartnersinvolved
Andindividuals:MrBernardNoughtonDrLindseyRobertsDrDavidBridleyProf. StephenChapmanTeamatAegate
• WHOestimates1%ofmedicinesindevelopedworldarecounterfeitand10%onaglobalscale.
• ABPIwebsite:– Involvingnearly2500cases,EUCustomsseized27.4milliondosesoffalsifiedmedicinesatEUbordersin2011- analmostseven-foldincreasefrom2007
– MHRAseized £8.6manddiscoveredfraudstersareinfiltratingtheNHSdrugssupplychainanddivertingmedicinestostreetdrugdealersandillegalwebsites–May2014
Whatistheproblem?(1)
• BMJOpen2013;3;7;e002924– Since2004,11incidentsoffalsifieddrugshavebeenreportedbytheMHRAthatbreachedtheUKsupplychain.
– Fivein2007alone,theMHRAstatedmorethan2milliondosesoffalsifiedmedicinesenteredthesupplychain
– Fewersince2007andMHRAstrategylaunch• Aegate info.
– BelgiumandItalyover2years2.43Malertsinvoluntarysystem
– 200krecalls/7100suspectevents/49kexpiredproducts
Whatistheproblem?(2)
The Problem cont.
Table1.0:OverviewofNotableExamplesofFalsifiedMedicinesintheEU
Source:RoyalPharmaceuticalSociety,PolicyStatement:“FalsifiedMedicinesDirective(FMD)”September2013.DatasourcedoriginallyfromMHRA.
Howwesolvetheproblem?• TheEuropeanParliamentadoptedthe'FalsifiedMedicines
Directive' 2011/62/EUinJuly2011,amendingDirective2001/83/EC
• TransposedinUKlawthroughTheHumanMedicines(Amendment)Regulations2013[SI2013/1855].
• DelegatedRegulationsupplementingDirective2001/83/ECand4AnnexespublishedintheOfficialJournaloftheEuropeanUniononthe9th February2016
• PanEuropeanimplementationbyFebruary2019
PresentationTitle/DateCanGoHere
EuropeanUnion
Serialization Secondarypackagingofprescriptiondrugs
Deadline February2019
TypeofCode Datamatrix 2DcodebasedonGS1orIFA
CodeInformation GTINorPPN,Expiry,Lot,Serialnumber(randomized)
HumanReadable Expiry,Lot
Track&Trace Recentlynotdemanded
• Whichmedicinesshouldbeserialised• Safetyfeaturesthatenablerelevantpersonsto– “verificationandauthentication”viadatarepositoryviathe2Dbarcode(Productcode,SerialNumber,Reimbursementnumber,batchnumberandexpirydate.
– “identifyindividualpacks”viatheserialnumber– Tamperevidencetobeonallpacks
WhatdoestheDirectivedrive?(1)
• Systematicverificationatendofsupply• Additionalriskbasedverificationatwholesalerslevel
• Setupandmanagementofrepositoriesbystakeholders
• Couldbeusedforreimbursement/pharmacovigilance
• MarketingAuthorisationHolder’swillpayforthe‘repositoriessystems’
• Noreturnswith10dayruleinplace!
WhatdoestheDirectivedrive?(2)
AimsofOxfordPilot• Workflowmapping• Understandingthedrugdistributioncycle• Identifypotentialstagestoauthenticate• Developauthenticationprotocol• Preparebasictrainingpackage• Teststages• Delphimethodsurveyingstaff• AddedValue- Clinicalaspectsforauthentication
WiththankstoBernardNaughton(Oxford)GrahamSmith(Aegate),AnnekeKramm(CASMI)andRichardSmith(Oxford,NDORMS)
PilotonnonRoboticsite(1)1. Basicstaffeducationandtraining2. Identifiedaportfolioofmedicines3. HighCost– HighUsage– Varietyof
Formulation– VarietyofClinicalIndication4. Selectingtheexactpointtoauthenticate5. FutureSimulation
PilotonnonRoboticsite(2)5. Identificationofstudyproduct(15+15)InclusionCriteria
Licensedmedicinalproducts
POM,P+CDmedicinecategories
Allformulations
Listedonpharmacysystemintop50(bytransactionsorvalue)
Tocontainavarietyofmanufacturers,clinicalindications,formulations
PilotonnonRoboticsite(3)5. Identificationofstudyproduct(15+15)
Exclusioncriteria
Homeopathicmedicines
Radionucleotides /kits/precursors
Medicalgases
Parenteralnutritionstarting
SolutionsaffectingElectrolytebalance
Unlicensedmedicines
Clinicaltrialmaterial
GSLMedicines
Exclusioncriteria
Irrigationfluids
Intravenousfluids
Osmoticdiuretics
Fertility/Homecaremedicines
DressingsandContrastmedia
Testsforallergicdiseases
Allergenextracts
PilotonnonRoboticsite(4)6. Testwarningcodes
– Productrecalled– Packrecalled– Packexpired– Alreadydispensedhere– Alreadydispensedelsewhere
7. 8weeksscanningatcheckingandthendispensingstage
8. Onceidentified,medicinesplacedinaquarantinebinanddetailsrecorded
Misconceptionsvstrainingneed• Counterfeitmedicinesdonotmakeitintothelegitimatesupplychain
• Staffwillbeopposedtoscanningeverydrug• Extrastepwillslowdownthedispensingprocess• Detectionofunsafemedicinesisrare• Implementationwillbetimeconsuming.Fromagreementtofirst“Authentication”
• NewlawwillwasteNHSmoney• Littleornovalueinauthenticationinadevelopedcountry
• Integration-QuickintermsofDaystointegrate<5days- Slowintermsofpermissionandmeetingarrangement>5months
• TechnicalDetectionRate=100%• Authenticationrate- Between60-70%- StagedependantthereforeneedfornonstandardE+T.Needtoconsiderhumanfactors:– Visualtriggeronly– Suboptimalworkflow
KeyLearningtotakeways(1)
• Responsetimes<165milliseconds• Authenticationatfinalstageofchecking• Staffadaptedwellandrequestedsomeadditionalchangestothesystem.70%saiditwaseasytouse.
• Nextsteps:Fullstudy;Dispensarywithroboticsandwithorwithoutinlinelabelling;communitypharmacyanddispensingdoctors
KeyLearningtotakeways(2)
• EarlyexperienceofaUKhospitalimplementingFMDasapilotproject?
– NeedtogetamoveonandtalktoyourRobotandpharmacysystemsupplier
– Donotdothe‘dreadedcalculation’[numberofpacks*timeforscan*numberofmanhours=somanyFTEs…].Work
– Educationalrequirementtoovercome resistancetochange– Keydecisionwillbewheretotheverification– Couldmakeyoumoreproductive– Stopbuyingpharmacyrobotsthatdonotscan2Ddatamatrices.
Summary(1)
• HowwillFMDaffecthospitalpharmacypractice?
– Enormouschange– Fantasticopportunitytoimprovesafety– Everelementofsupplyandadministrationhasthepotentialto
beaffected– Thereareopportunities toleveragetheFMDtogeneratenet
costandefficiency savings.– TheFMDisanopportunitytoclinicallyempowerpharmacists.– Thesystemwillbepaidforbymanufacturers,butTechnology
costsforpharmacistsmayormaynotbeincluded
Summary(2)
• Checksatthepointofdispensing• Checksatthepointofadministration• PopulationbasedhealthcarewithgreaterambitionsforOxfordshire-Linkmedicationscanstoindividualpatients– PharmacovigilanceandPatientadherence– Closedloopsystem
• InformationGovernancewillbethesinglemostimportantbarrierifnotmanaged
Future:Clinicalbenefits/AddedValue