The Falsified Medicines Directive (FMD) Rod Beard
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Transcript of The Falsified Medicines Directive (FMD) Rod Beard
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TheFalsifiedMedicinesDirec1ve(FMD)andtheimplica1onsforHospital
Pharmacy
DrRodBeardPrincipalPharmacist
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2011/62/EU
• Thisdirec1vemadeitarequirementforallmedicinepackstocarryauniquepacknumber.
• EMVO(EuropeanMedicinesVerifica1onOrganisa1on)responsibleformuchofthesoCwareandsupportformakingthisworkacrossEurope.
• EmvoworksacrossallEUcountriestohelptheimplementa1onby2018(toughtarget)
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• TheconceptisthatbytrackingindividualpacksthroughthesupplychainacrossEurope,anycounterfeitmedicinesenteringthesupplychaincanbeiden1fiedearly,andtheloopholeclosedtothesecounterfeitgoods.
• ThesupportsoCwareallowstrackingofproductswithineachcountry,andthisfeedsintoaEuropean-widedatabasetotrackthegoods,andtoalsoallowde-ac1va1onoftheuniqueproductnumberonceapa1entsupplyhasbeenmade.
• Oncewithpa1ent,theproductisnolongerinthesupplychain,andakeyelementisthatthisnumberUniquepacknumber(UPN)isde-ac1vated
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• ThismeanseachindividualpharmacymusthavethesoCwarethatcande-ac1vatethesenumbers,inthena1onalsystem,andalsothattransfersacrossallthesystemsinalltheEUcountries.
• Thisprocessstartstohighlightdifferentprac1cesindifferentcountries,andgiveseachcountryproblemsinhowthiswillbeimplemented.
• Forexample,inBritain,thereisalotofhospitalout-pa1entdispensing,whichislessofafeaturethaninGermany.
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Itisenvisagedthatprac1cesacrosscommunitypharmacywouldbefairlystandardisedacrossEurope,andshouldbepossibletohaveasimilarsystemacrossEurope.Buthospitalsmaybemorevaried.FromaUKperspec1ve,onceamedicineisdeliveredtoahospitalseveralthingscanhappentothatproduct:• Productscanbedispensedaswardstock• Wardstockcanbereturnedtopharmacyforre-use• Somehospitalshavewholesalerdealerslicensesandcouldsupplytoothercustomers
• SomehospitalshaveMSlicenses,andcouldover-labelpacks,orsplitthepacksdownforpre-packing.
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• Ifitemspre-packed,hospitalmayuse‘CodingforSuccess’principals,andusetheirownproductbarcodes….wouldtheseneedaUPN,andwouldtheseproductsneedtoberegisteredwithEmvo?
• Muchdepends(fromUKperspec1ve)onatwhatpointtheproductisdeemednolongerinthesupplysystem.
• DeliverytoaUKhospitalmeansthattherecouldbeaseriesofsub-supplysystems,butitdependsonhowimplementa1onisplannedatana1onallevelastohowthiswillwork.
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• IfitisdecidedaUPNisonlyde-ac1vatedwhenitreachesapa1ent,thentherearepoten1alproblemsintheUKhospitalsystem.Manyhospitalssplitpacksoftablets,andthereneedstobeaproceduretoallowfortheissueofproductsagainsta‘dead’UPN
• Forsomeinjec1onsissuedtowards,itmaybetheyarereturnedtopharmacystock,soa‘dead’UPNcouldbere-ac1vated(butthisisagainstwhatFMDisallabout).
• Itcouldbethatahospitalisdeemedanenduser,andatthepointofdelivery,allproductswithUPN’sarede-ac1vated.
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• Thesheervolumeofthiswouldmakeithorrendous!• Eachandeverypackwouldhavetobede-ac1vatedbeforeitcouldbeacceptedintostock.
• Becauseofthescale,therewouldneedtobeanareasetasidetoquaran1nedeliveriespriortoaccep1ngintopharmacystock
• Suchareasmaynotbeeasytoiden1fyformanyhospitals.
• HowwouldinvoicesandGoodsreceivednotesfromwholesalerswork?WouldUPN’sneedtobeonthose?
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• Whilstmainlinewholesalersmighthavethecapabilitytode-ac1vateUPN’sonshipment,thiswouldnotbethecaseforallwholesalers,andtherearemanysmallerwholesalersaroundEurope
• Therequirementswouldhavetobeconsistentforallsuppliers.
• ThismakesdraCingna1onalregula1onstrickyifimplementa1onistobesuccessful
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• InUK,supplychainisrickety,andhospitalpharmacistsarespendingincreasingamountof1mesearchingforimportsfor‘rou1ne’products.
• Theriseinspecialistimportersisalmostaproxymeasureofthe‘ricke1ness’ofthesupplychain.
• So,ifaproductwasunavaialbleinUK,andanunlicenced(inUK)importwasused(sayfromAustria),howwouldtheENVOsystemwork?
• Willthelinkagesbetweenna1onalsystemsallowde-ac1va1onoftheUPNfromanothercountry?
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• WhathappensiftheUPNofanimportedproductisnotrecognisedinthena1onalsystem?
• Presumablythiswilltriggeranalertinthede-ac1va1onsystemthattheproductcannotbeverified.Whatdoesthepharmacistdothen?
• Howdoesheknowitissafetousethisproduct?
• HowwillspecialistimportersbebroughtintotheEMVOscheme?
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• Giventhattherearesomanyopera1onalissues,weneedsomeperspec1veatna1onallevelhowthiswillwork.
• Itis2016,andonly2yearsleCtoimplementa1on.• Ifthereisalargevolumeofworktofallonhospitalstode-ac1vateUPN’sthenthisneedstobefactoredintobusinesscases.TheseareoCenslowmovingprocesses.