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

GlobalIssue

SerialisationDeadlines:

• Whichmedicinesshouldbeserialised• Safetyfeaturesthatenablerelevantpersonsto– “verificationandauthentication”viadatarepositoryviathe2Dbarcode(Productcode,SerialNumber,Reimbursementnumber,batchnumberandexpirydate.

– “identifyindividualpacks”viatheserialnumber– Tamperevidencetobeonallpacks

WhatdoestheDirectivedrive?(1)

• Systematicverificationatendofsupply• Additionalriskbasedverificationatwholesalerslevel

• Setupandmanagementofrepositoriesbystakeholders

• Couldbeusedforreimbursement/pharmacovigilance

• MarketingAuthorisationHolder’swillpayforthe‘repositoriessystems’

• Noreturnswith10dayruleinplace!

WhatdoestheDirectivedrive?(2)

TheProcess

AimsofOxfordPilot• Workflowmapping• Understandingthedrugdistributioncycle• Identifypotentialstagestoauthenticate• Developauthenticationprotocol• Preparebasictrainingpackage• Teststages• Delphimethodsurveyingstaff• AddedValue- Clinicalaspectsforauthentication

WorkFlowWheretoscan,WhotoScan

Author:BernardNaughtonSeptember2015

WorkFlowWheretoscan,WhotoScan

Author:BernardNaughtonSeptember2015

WorkFlowWheretoscan,WhotoScan

Author:BernardNaughtonSeptember2015

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

Systemwidechangerequired

ABPIwebsite

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