the falsified medicines directive (fmd) rod beard

TheFalsifiedMedicinesDirec1ve(FMD)andtheimplica1onsforHospital

Pharmacy

DrRodBeardPrincipalPharmacist

SunderlandRoyalHospitalRod.Beard@chsC.nhs.uk

2011/62/EU

•  Thisdirec1vemadeitarequirementforallmedicinepackstocarryauniquepacknumber.

•  EMVO(EuropeanMedicinesVerifica1onOrganisa1on)responsibleformuchofthesoCwareandsupportformakingthisworkacrossEurope.

•  EmvoworksacrossallEUcountriestohelptheimplementa1onby2018(toughtarget)

•  TheconceptisthatbytrackingindividualpacksthroughthesupplychainacrossEurope,anycounterfeitmedicinesenteringthesupplychaincanbeiden1fiedearly,andtheloopholeclosedtothesecounterfeitgoods.

•  ThesupportsoCwareallowstrackingofproductswithineachcountry,andthisfeedsintoaEuropean-widedatabasetotrackthegoods,andtoalsoallowde-ac1va1onoftheuniqueproductnumberonceapa1entsupplyhasbeenmade.

•  Oncewithpa1ent,theproductisnolongerinthesupplychain,andakeyelementisthatthisnumberUniquepacknumber(UPN)isde-ac1vated

•  ThismeanseachindividualpharmacymusthavethesoCwarethatcande-ac1vatethesenumbers,inthena1onalsystem,andalsothattransfersacrossallthesystemsinalltheEUcountries.

•  Thisprocessstartstohighlightdifferentprac1cesindifferentcountries,andgiveseachcountryproblemsinhowthiswillbeimplemented.

•  Forexample,inBritain,thereisalotofhospitalout-pa1entdispensing,whichislessofafeaturethaninGermany.

Itisenvisagedthatprac1cesacrosscommunitypharmacywouldbefairlystandardisedacrossEurope,andshouldbepossibletohaveasimilarsystemacrossEurope.Buthospitalsmaybemorevaried.FromaUKperspec1ve,onceamedicineisdeliveredtoahospitalseveralthingscanhappentothatproduct:•  Productscanbedispensedaswardstock•  Wardstockcanbereturnedtopharmacyforre-use•  Somehospitalshavewholesalerdealerslicensesandcouldsupplytoothercustomers

•  SomehospitalshaveMSlicenses,andcouldover-labelpacks,orsplitthepacksdownforpre-packing.

•  Ifitemspre-packed,hospitalmayuse‘CodingforSuccess’principals,andusetheirownproductbarcodes….wouldtheseneedaUPN,andwouldtheseproductsneedtoberegisteredwithEmvo?

•  Muchdepends(fromUKperspec1ve)onatwhatpointtheproductisdeemednolongerinthesupplysystem.

•  DeliverytoaUKhospitalmeansthattherecouldbeaseriesofsub-supplysystems,butitdependsonhowimplementa1onisplannedatana1onallevelastohowthiswillwork.

•  IfitisdecidedaUPNisonlyde-ac1vatedwhenitreachesapa1ent,thentherearepoten1alproblemsintheUKhospitalsystem.Manyhospitalssplitpacksoftablets,andthereneedstobeaproceduretoallowfortheissueofproductsagainsta‘dead’UPN

•  Forsomeinjec1onsissuedtowards,itmaybetheyarereturnedtopharmacystock,soa‘dead’UPNcouldbere-ac1vated(butthisisagainstwhatFMDisallabout).

•  Itcouldbethatahospitalisdeemedanenduser,andatthepointofdelivery,allproductswithUPN’sarede-ac1vated.

•  Thesheervolumeofthiswouldmakeithorrendous!•  Eachandeverypackwouldhavetobede-ac1vatedbeforeitcouldbeacceptedintostock.

•  Becauseofthescale,therewouldneedtobeanareasetasidetoquaran1nedeliveriespriortoaccep1ngintopharmacystock

•  Suchareasmaynotbeeasytoiden1fyformanyhospitals.

•  HowwouldinvoicesandGoodsreceivednotesfromwholesalerswork?WouldUPN’sneedtobeonthose?

•  Whilstmainlinewholesalersmighthavethecapabilitytode-ac1vateUPN’sonshipment,thiswouldnotbethecaseforallwholesalers,andtherearemanysmallerwholesalersaroundEurope

•  Therequirementswouldhavetobeconsistentforallsuppliers.

•  ThismakesdraCingna1onalregula1onstrickyifimplementa1onistobesuccessful

•  InUK,supplychainisrickety,andhospitalpharmacistsarespendingincreasingamountof1mesearchingforimportsfor‘rou1ne’products.

•  Theriseinspecialistimportersisalmostaproxymeasureofthe‘ricke1ness’ofthesupplychain.

•  So,ifaproductwasunavaialbleinUK,andanunlicenced(inUK)importwasused(sayfromAustria),howwouldtheENVOsystemwork?

•  Willthelinkagesbetweenna1onalsystemsallowde-ac1va1onoftheUPNfromanothercountry?

•  WhathappensiftheUPNofanimportedproductisnotrecognisedinthena1onalsystem?

•  Presumablythiswilltriggeranalertinthede-ac1va1onsystemthattheproductcannotbeverified.Whatdoesthepharmacistdothen?

•  Howdoesheknowitissafetousethisproduct?

•  HowwillspecialistimportersbebroughtintotheEMVOscheme?

•  Giventhattherearesomanyopera1onalissues,weneedsomeperspec1veatna1onallevelhowthiswillwork.

•  Itis2016,andonly2yearsleCtoimplementa1on.•  Ifthereisalargevolumeofworktofallonhospitalstode-ac1vateUPN’sthenthisneedstobefactoredintobusinesscases.TheseareoCenslowmovingprocesses.