• On23rdApril2013,withsupportfromMSH/HCSM,thePPBlaunchedthePharmacovigilanceElectronicReportingSystem(PV-ERSforreportingsuspectedADRsandpoorqualitymedicinalproductsthrough:

– onlineandofflineaccessviamobileandfixeddevices

• Thelaunchwasattendedbykeystakeholdersinhealth,topofficialsfromtheHealthMinistriesandwasofficiallylaunchedbythePermanentSecretary,MinistryofInformationandCommunication,Dr.BitangeNdemo.

• Theapplicationcanbedownloadedeitheronacomputeroraccessedonasmartphone,orthereportcanbemadedirectlytothePPBontheirwebsite(http://www.pv.pharmacyboardkenya.org).

• Theinnovativedigitalsystemhasmade reporting easier, more cost effective, and prompt, and will serve to build its own database for future reference.

• ThePV-ERShasincreasedthevisibilityofthesupportofUSAIDandMSH/HCSMtotheKenyapharmacovigilancesystemstrengthening:

– Thelaunchwascoveredinseveralinternationalandlocalchannelsincludingprintandaudiomedia.

– USAIDandPPBparticipatedinalive-radioshowlinkingthePV-ERStoinnovation,sustainabilityandpatientsafety

• ThisinfluxofpharmacovigilanceinformationtoPPBhasresultedin:

– quarantining,recalling,orwithdrawingsomemedicines;changesinlabeling;lineinspectionsforcontinuousGoodManufacturingPractices;and,inonecase,theclosureofapharmaceuticalcompanythatwasnotmeetingregulatoryrequirements.

KusuN1,OumaC1,PanditJ2,AbwaoE2,MurimiG2,SiyoiF2,KoskeiK2,WanyeeS3,OkemwaE3,AnampiuP3

Management Sciences for Health/Health Commodities and Services Management (MSH/HCSM) Program, Nairobi, Kenya1

Pharmacy and Poisons Board (PPB)2 IntelliSOFT Consulting Limited3

Background

Approach

• EnhancingpatientsafetyremainsthecoreactivityforanyhealthcareproviderandthecoremandateofanyMedicinesRegulatoryAuthoritysuchasthePharmacyandPoisonsBoard(PPB).

• Pharmacovigilanceisonesuchsystemthathelpsensureandenhancepatientsafety.

• TheKenyaNationalPharmacovigilanceSystemwaslaunchedinJune2009

• Sincethen,theNationalPharmacovigilanceCentreatthePPBhasreceivedover6300suspectedAdverseDrugReactions(ADRs)andover375PoorQualityMedicinesreports,allpaper-based.

• Howeverroutinechallengescontinuetoincreasebecauseof:

– timeforreporting,providingfeedbackanddocumentinginvariousinstitutionalfiles

– thecost incurredforprinting,dissemination,makingmultiplecopiesanddataentryforthereceivedreports

– needforproperfilingandstorage.

• ThereforeappropriateandadequateuseofInformation,CommunicationsandTechnology(ICT)isnecessarytoimprovecollectionandmanagementofdataonthesafetyandqualityofmedicinesandmedicinalproducts

Embracing Technology in the Kenya National Pharmacovigilance Reporting System... “Kenya Goes Green”

Source: `The Lifesaver: MIPV newsletter, 1st edition, September 2011

• FromseveralpharmacovigilancerelatedtrainingsandstakeholderforacarriedoutinKenya,the need for a more efficient electronic reporting system (ERS)forhealthcareworkerstoreportdirectlytothePPBbecamemoreapparent.

• ThePPBwithsupportfromUSAIDthroughManagementSciencesforHealth/HealthCommoditiesandServicesManagement(MSH/HCSM)programandworkingwithIntelliSOFTConsulting,alocalITfirmdevelopedthePharmacovigilanceERS(PV-ERS).

– ThisisasuiteoffoursoftwareapplicationsenablinganyonetoreportsuspectedADRsandpoorqualitymedicinalproductsthroughonlineandofflineaccessviamobileandfixeddevices.

– Thesystemisbasedonanopen-shareLinuxsoftwareplatform

Results

Lessons Learned Acknowledgements • ThePV-ERSisalocallydevelopedICTsolutiontailoredtoprovideinformationfordecisionmakingbypolicymakers,publichealthprogramsandhealthcareworkers.

• DevelopmentofPV-ERSdemonstratesthatitispossibletodevelopcost-effective home-grown solutions thataddressspecificprioritiesthroughcollaboration and partnerships

• ThePharmacyandPoisonsBoard

• IntelliSOFTConsultingLimited

• USAID

• MSH/HealthCommoditiesandServicesManagementProgram

Conclusion

Next Steps

• ThePV-ERSisexpectedtoboostreportingandtrackingofsuspectedADRsandpoorqualitymedicinalproducts.

• ThePV-ERSwillultimatelyimproveassessmentandcommunicationofsafetyandqualityinformationofmedicinesinthemarket.

• ThePV-ERSwillpromotepatientsafetyandhealthoutcomes

• ThiswillinvolvesensitizinghealthcareprovidersonitsuseandrolloutofthesystemalongsideintegratingthesamewithotherexistingelectronicmedicalrecordsystemsinKenya.

• “Digital Kenya, here we come”.

The Permanent Secretary in the Ministry of Information and Communication, Dr.Bitange Ndemo, said that he will ensure that Kenyans access this digital pharmacovigilance reporting system and report from their mobile phones free of charge