Training'in'pharmacovigilance'in'Africa' [ISoP'2017'Presentation.'Liverpool'2017>10>16]'

Training'in'pharmacovigilance'in'Africa' [ISoP'2017'Presentation.'Liverpool'2017>10>16]' Alex'Dodoo' Scientific'Advisor,'African'Collaborating'Centre'(ACC)'for' Pharmacovigilance' Director>General,'Ghana'Standards'Authority' '

Disclaimer '' The$views$expressed$in$these$slides$do$not$ represent$official$policy$or$statements$from$ both$the$acc$and$gsa$ Nothing$in$these$presentations$should$be$ viewed$or$implied$as$the$views$and/or$ policies$of$the$acc,$the$gsa$or$the$ Government$of$Ghana$

Training'in'Pharmacovigilance'in'Africa' Training$needs$ Training$curriculum$ Training$institutions$ Training$approaches$ Measuring$the$impact$of$PV$training$in$Africa$ QPPV$training$in$Ghana$ MSc$in$PV$in$University$of$Nairobi$ PV$and$Vaccine$PV$Fellowships$at$ACC$

PV'Training'Needs'in'Africa' The$need$for$general$and$specialised$training$in$PV$in$ Africa$is$high$ Several$countries$have$only$recently$developed$ national$pv$systems$ In$most$cases,$PV$is$yet$to$be$fully$incorporated$in$ national$regulatory$authorities $work$ Funding,$lack$of$experts$and$lack$of$training$institutions$ compound$the$problem$

National'PV'Centres'in'Africa' Period' Number'of'countries' joining'the'pidm' 1992$ $2000$ 5$ 2001$ $2005$ 4$ 2006$ $2010$ 15$ 2011$ $2015$ 11$ Total' 35'

Associate'Members' Algeria$(2006)$ Burundi$(2010)$ Chad$(2015)$ Gambia$(2011)$ Guinea$Bissau$(2009)$ Malawi$(2016)$

Non>Members' Central$African$Republic$ Comoros$ Congo$ Djibouti$ Equatorial$Guinea$ Gabon$ Lesotho$ Libya$ Mauritania$ Sahrawi$Republic$ São$Tomé$and$Príncipe$ Seychelles$ Somalia$ South$Sudan$

PV'Training'Needs'in'Africa' PV$training$needs$are$huge$ There$is$a$need$to$build$BASIC$capacity$for$the$20$countries$with$no$ formal$pv$system$ There$is$the$need$to$build$capacity$for$national$PV$centres$ There$is$the$need$to$build$ADVANCED$capacity$for$existing$national$PV$ centres$ Pharmaco^epidemiology$ Statistics$etc.$

PV'Training'Needs'in'Africa' 'The'role'of'the' Pharmaceutical'Industry' There$is$very$little$reporting$of$ICSRs$in$Africa$ The$contribution$of$the$pharmaceutical$industry$in$PV$$in$Africa$is$ extremely$low$ What$is$the$role$of$the$research^based$pharmaceutical$industry$in$PV$in$Africa$ What$product$stewardship$do$producers$and$procurers$of$essential$vaccines$ undertake?$ Hundreds$of$millions$of$doses$of$vaccines$are$administered$each$year$in$Africa$and$ yet$aefi$reporting$is$virtually$nil$

ICSR'reporting'from'Africa'to'VigiBase,'the'Global'ICSR'Database,'is' extremely'low' ' Africa s$population$=$>$1billion$$(15%$of$global$total)$ Diseases$burden$is$high$for$both$COMMUNICABLE+and$NON,COMMUNICABLE+ Medicine$consumption$is$HIGH$and$increasing$ ICSRs$reported$are$VERY+LOW!+ At$the$end$of$September$ 2015,$the$35$African$countries$ in$the$who$pv$programme$ had$submitted$a$total$of$ 103,499'ICSRs'to'VigiBase' Total$ICSRs$in$VigiBase$ submitted$by$all$122$member$ countries$including$us,$ Europe,$Japan$etc.$is$ 11,824,804$ Africa s'proportion'of'global' ICSRs'is'0.88%'

ICSRs'involving'vaccines'' Kennedy$Obebi$Cliff^Eribo,$Imti$Choonara,$Alex$Dodoo,$Delese$M$Darko$&$Helen$Sammons$ (2015):$Adverse$drug$reactions$in$Ghanaian$children:$review$of$reports$from$2000$to$2012$in$ VigiBase,$Expert'Opinion'on'Drug'Safety,'DOI:10.1517/14740338.2015.1096927'

The'PV'and'Drug'Regulation'Situation'in'Africa:'2017' The$PV$and$medicines$regulation$landscape$in$Africa$is$changing$ There$is$the$need$for$new$products$for$existing$and$emerging$diseases$and$Africa$can$ no$longer$rely$just$on$external$partners$ The$African$Union$recognises$the$need$to$speed$up$access$to$products$for$priority$ conditions$and$the$so^called$ poverty+related+diseases $$ The$roll$out$of$new$interventions$like$the$malaria$vaccine$requires$therefore$that$ Africans$develop$approaches$to$provide$stewardship$of$products$that$are$being$used$ for$the$first$time$in$their$people$ This$calls$for$high$vigilance$and$high$level$of$expertise$

Speeding'up'access'to'products'in'Africa' Challenges' Disparate$regulatory$ requirements$ Unclear$regulatory$frameworks$ Poorly^resourced$NMRAs$ Lengthy$registration$times$(4^7$ years)$ Expensive$inspection$fees$ Absent$PV$systems$ Etc.$etc.$$ Narsai+K+et+al.+Impact+of+regulatory+requirements+on+medicine+ registration+in+african+countries+,+perceptions+and+experiences+of+ pharmaceutical+companies+in+south+africa.+south+med+rev.+2012+jul;5(1): 31,7.+ Moran+M+et+al.+Registering+New+Drugs+for+Low,Income+Countries:+The+ African+Challenge.+PLoS+Med.+2011;8;2.+ $

PV'Curriculum'in'Africa'>'I' There$is$no$Africa^wide$curriculum$for$PV$in$Africa$ $ The$WHO^ISoP$PV$curriculum$provides$a$useful$template$ It$can$be$used$together$with$the$EMA$Good$Pharmacovigilance$ Practice$Guidelines$(GVP)$to$provide$most$of$the$content$required$ for$global,$regional$or$national$pv$practice$ African$academic$institutions$need$to$adopt$and$amend$existing$ curricula$to$develop$africa^relevant$curriculum$

PV'Curriculum'in'Africa'>'II' The$African$Medicines$Regulatory$Harmonization$ (AMRH)$programme$of$the$African$Union$recommends$ a$defined$ body$of$knowledge $for$all$regulators$in$ Africa$including$those$working$in$PV$ Regional$Centres$of$Regulatory$Excellence$(RCOREs)$ are$expected$to$align$their$course$offerings$with$the$ developed$$rcores$body$of$knowledge$ There$are$2$PV$RCOREs$in$Africa$(Pharmacy$and$Poisons$Board$ of$kenya$and$a$consortium$coordinated$by$the$university$of$ Ghana)$

Body'of'Knowledge'for'PV'in'Africa'>'I' National$Medicines$Policy$and$ Legal$Provisions$for$ Pharmacovigilance$ Establishment$of$a$ Pharmacovigilance$system$ Developing$National$Guidelines$for$ Medicine$Safety$Surveillance$ Notification$system$ Roles$and$Responsibilities$of$ stakeholders$in$a$ pharmacovigilance$system$ Scope$of$Pharmacovigilance$and$ medicines$safety$surveillance$ activities$

Body'of'Knowledge'for'PV'in'Africa'>'II' Types$of$Adverse$Drug$Reactions$ (ADRs)$ How$to$recognize$ADRs$ Methods$of$Medicine$safety$ surveillance$ Spontaneous$reporting$ Active$surveillance$ Conducting$of$Active$Surveillance$Safety$ studies$ Reporting$of$ADRs$observed$in$studies$ On^going$benefit^harm$assessment$ Post^registration$responsibilities$of$ holders$of$certificates$of$ registration$ Case$reports$from$world^wide$ literature$ Periodic$Safety$Update$Reports$ Risk$evaluation$and$minimization$ strategies$

Body'of'Knowledge'for'PV'in'Africa'>'III' Tools$for$Medicines$Safety$ Surveillance$activities$(my+ selection)$ Pharmaceutical$Product$Quality$ Reporting$Form$ Medication$Error$Notification$Form$ Medication$Error$Notification$Form$ WHO$Causality$Assessment$Criteria$ Etc.$ Pharmacovigilance$capacity$ building$ Monitoring$and$evaluating$the$ pharmacovigilance$system$ Principles$of$ pharmacoepidemiology$

PV'Training'Institutions'in'Africa' The$CAPM$in$Rabat$ Premier$African$PV$training$institution$offering$courses$for$10+$ years$mainly$in$french$and$also$arabic$ Autonomous$national$PV$centre$and$co^hosts$a$national$poisons$ control$centre$ WHO$Collaborating$Centre$ Focus$has$been$on$Francophone$Africa$and$Eastern$Mediterranean$ region$

PV'Training'Institutions'in'Africa' The$University$of$Nairobi$in$Kenya$ Offers$an$MSc$in$pharmacovigilance$and$pharmaco^epidemiology$ Works$closely$with$the$Pharmacy$and$Poisons$Board$of$Kenya$ Course$developed$in$collaboration$with$Management$Sciences$of$ Health$

PV'Training'Institutions'in'Africa' The$African$Collaborating$Centre$for$Pharmacovigilance$ (ACC)$ Independent$non^governmental$institution$in$Accra,$Ghana$ (supported$by$moh)$ Evolved$out$of$UMC^Africa$and$the$WHO$Collaborating$Centre$for$ Advocacy$and$Training$in$PV,$University$of$Ghana$ Main$focus$is$training,$capacity$building$and$practice$of$PV$in$Africa$ in$both$public$and$private$settings$ Slogan:$for+all+things+PV+in+Africa+

Courses'developed'for'human'capacity'building'in' Africa' Pharmacovigilance$Fellowship$(3$weeks)$ Vaccine$PV$Fellowship$(2.5$weeks)$ Data$Management$for$Public$Health$and$Regulatory$Affairs$ Qualified$Persons$for$Pharmacovigilance$(2$weeks$ $60$hours$contact$ time)$ 22'

Number'of'persons'trained' Number$trained$at$the$ACC$Training$Centre$in$Accra$$ 188$people$ 27$countries$ Participants$are$from$ National$PV$Centres,$academia,$industry,$research$institutions$ Hundreds$more$have$been$trained$in$their$respective$countries$during$ country$technical$support$visits$ 23'

Number'of'Healthcare'Professionals'Trained' 24'

Number'of'Healthcare'Professionals'Trained' 25'

Courses'offered'since'2011'' Name'of'Training'! Date! Number'of' participating' Country! Number' Trained! Pharmacovigilance'and'The'Use'of'VigiFlow'for' Safety'Data'Management! April$2011! 5! 5! Communications'in'Pharmacovigilance! October$2011! 5! 8! Advanced'PV'for'Regulators! August$2011! 1! 10! Data'Management'for'Regulatory'Affairs'&' May$2013! Public'Health! 10! 12! Pharmacovigilance'Fellowship'1! June$2013! 3! 5! Introduction'to'Pharmacovigilance! July$2013! 5! 26! Pharmacovigilance'Fellowship'2! September$2013! 2! 5! Data'Management'for'Regulatory'Affairs'&' March$2014! Public'Health! 6! 15! Pharmacovigilance'Fellowship'3! June$2014! 9! 13! Pharmacovigilance'Fellowship'4! July$2014! 6! 6! Qualified'Persons''for'Pharmacovigilance'1! May$2015! 1! 16! Pharmacovigilance'Fellowship'5! June$2015! 6! 10! Vaccine'Pharmacovigilance'Fellowship'! September$2015! 9! 14! Qualified'Persons''for'Pharmacovigilance'2! May$2016! 1! 19! Pharmacovigilance'Fellowship'6! June$2016! 6! 11! Qualified'Persons''for'Pharmacovigilance'3! Nov$2016! 1! 13! '! Total! 188! 26'

Country'of'participants'in'courses' Country! Number! 1. Benin! 3! 1. Burundi! 1! 1. Cameroon! 2! 1. Cape'Verde! 2! 1. Cote'd Ivoire! 1! 1. DR'Congo! 5! 1. Ethiopia! 3! 1. Eritrea! 9! 1. Gambia! 4! 1. Ghana! 97! 1. Kenya! 2! 1. Liberia! 1! 1. Malawi! 3! 1. Mozambique! 10! 1. Namibia! 1! 1. Niger! 1! 1. Nigeria! 17! 1. Rwanda! 1! 1. Sierra'Leone! 5! 1. South'Africa! 1! 1. South'Sudan! 4! 1. Swaziland! 2! 1. Tanzania! 3! 1. Uganda! 4! 1. Zambia! 4! 1. Zanzibar! 1! 1. Zimbabwe! 1! Total! 188! Countries trained key features Ghana (97) Nigeria (17) Mozambique (10) Eritrea (7) Sierra Leone (5) South Sudan (4) Swaziland (2) Liberia (1) Burundi (1) Malawi (1) Niger (1) 27'

Establishment'of'national'PV'centres'in'Africa' African$countries$who$are$full$members$of$ the$who$programme$for$international$drug$ Monitoring$ 2009^2015:$20'countries'out$of$34$ 2000^2008:$10$countries$ 1992 $1999:$5$countries+ + $ 28'

Direct'in>country'support'to'join'the'WHO' Programme' Country! Year'of'Joining! Botswana'*''! 2009! Madagascar'*! 2009! Senegal'*! 2009! Burkina'Faso''! 2010! Cameroon'*'! 2010! Côte'd'Ivoire''! 2010! Dem'Rep'of'Congo'*'! 2010! Kenya'*! 2010! Zambia'*! 2010! Benin'! 2011! Mali'! 2011! Cabo'Verde'! 2012! Eritrea''! 2012! Niger'! 2012! Angola''! 2013! Guinea'! 2013! Liberia'! 2013! Rwanda'! 2013! Mauritius! 2014! Swaziland'! 2015! Countries assisted to become Associate Members 1. Gambia 2. Guinea-Bissau 3. Malawi 4. Zanzibar 29'

PV'Training'Institutions'in'Africa' The$RCORE$at$the$Pharmacy$and$Poisons$Board$of$Kenya$provides$training$ but$does$not$have$formal$courses$ Nearly$all$national$PV$centres$in$Africa$are$involved$in$regular$training$and$ capacity$building$for$reporters$and$public$health$programmes$ Academia$incorporates$PV$modules$in$courses$especially$at$the$ postgraduate$level$e.g.$university$of$ghana$school$of$public$health$ EPDC642$

PV'Training'Institutions'in'Africa' Several$Africans$have$been$trained$at$the$annual$UMC$Course$in$Sweden$ and$this$has$supported$pv$development$in$africa$immensely$ UMC$has$since$the$first$course$been$providing$financial$support$to$ensure$ participation$of$pv$professionals$from$africa$ Several$ UMC$course$alumni $are$actively$practising$pv$in$africa$ There$is$an$opportunity$for$ISoP$to$provide$regular,$consistent,$training$in$ PV$in$collaboration$with$appropriate$African$institutions$and$organisations$

Approaches'towards'PV'training'in'Africa'>'I' Not$all$the$training$programmes$assess$knowledge$transferred$$ Not$all$the$training$programmes$offered$include$formal$assessments$ It$is$easy$for$participants$to$ sing$with$the$choir $without$knowing$the$ words $nor$ meaning $ Training$must$aim$to$transfer$knowledge$and$skills$so$that$trainees$can$go$ back$and$practice$ Face$to$face$appears$best$ Online$and$virtual$training$seem$to$be$most$useful$in$view$of$connectivity$and$other$ challenges$(time,$distraction$etc.)$

Approaches'towards'PV'training'in'Africa' Learning$on$the$job$ Formal,$didactic$training$leading$to$post^graduate$certificates$or$MSc/PhD$ degrees$(usually$ sandwich $programmes)$ Hands^on,$practical$and$interactive$dealing$with$real^world$issues$and$ including$field$visits$to$actual$pv$practice$settings$in$hospital,$industry,$ academia$ PV$and$Vaccine$PV$Fellowship$in$Ghana$ QPPV$training$in$Ghana$ UoN$training$ CAPM$training$

Towards'an'optimum'delivery'approach' It$is$difficult$to$have$a$one^size$fits$all$to$PV$curriculum$delivery$in$any$ setting$ The$few$experts$available$have$to$work$whilst$learning$ Sandwich$programmes$are$popular$but$can$be$draining$and$ sometimes$frustrating$for$both$trainers$and$trainees$ Trainees$need$adequate$$incentives$and$a$clear$career$path$

Measuring'the'impact'of'PV'training'in'Africa' There$are$no$metrics$for$measuring$impact$of$PV$training$in$ Africa$ There$are$also$no$metrics$nor$studies$to$indicate$the$cost$ effectiveness$of$training$towards$capacity$building$of$pv$in$ Africa$ Proxy$measures$could$be$used$to$indicate$some$level$of$ attainment$of$aims$$ This$might$to$some$extent$indicate$some$form$of$impact$

Measuring'impact'of'PV'training'in'Africa'

Showing'the'impact'of'PV'training'in'Africa' 'Case' studies' QPPV$training$in$Ghana$ Since$the$training$started$in$2015,$all$reports$from$the$ pharmaceutical$industry$have$come$only$from$companies$who$ have$had$trained$qppvs$ The$companies$yet$to$have$a$QPPV$had$not$submitted$any$report$in$the$last$ year$(qppv$training$is$a$key$requirement$for$designation$as$qppv)$ The$general$absence$of$reporting$from$industry$requires$this$proxy$demonstration$to$ be$viewed$cautiously$

Showing'the'impact'of'PV'training'in'Africa' 'Case' studies' PV$and$Vaccine$PV$Fellowship$training$ Majority$of$the$participants$who$were$trained$are$still$working$in$ PV$in$their$respective$countries$ Some$PV$Fellows$have$gone$on$further$to$establish$and/or$ strengthen$national$pv$systems$ Some$are$involved$in$methods$development$and$other$key$PV$ activities$

Showing'the'impact'of'PV'training'in'Africa' 'Case' studies' Graduates$from$the$MSc$programme$at$the$UoN$are$active$in$their$ countries$and$in$support$of$the$pv$rcores$ Research$output$from$Africa$is$slowly$increasing$ Could$be$due$to$the$numbers$trained$but$could$also$be$due$to$other$factors$ including$availability$of$funds$from$donors$ Several$PV$practitioners$in$both$governmental$and$industry$sectors$ are$undertaking$active$pv$studies$

Way'Forward'for'PV'Training'in'Africa' Existing$African$institutions$e.g.$CAPM,$PPB$and$ACC$should$be$ strengthened$and$resourced$to$continue$their$work$ Multilateral$donors$should$be$deliberate$in$their$capacity^building$efforts$ The$African$Union$should$consider$African$capacity$building$as$a$priority$ National$governments$must$invest$in$PV$training$ The$Pharmaceutical$Industry$must$invest$in$PV$training$in$Africa$to$enable$the$ construction$of$a$robust$infrastructure$for$pv$and$surveillance$of$medical$ products$is$built$

Way'Forward'for'PV'Training'in'Africa' Leading$universities$may$copy$the$ Utrecht$University $model$of$training$ professional$phds$to$support$pv$development$in$africa$ International$scientific$and$professional$organisations$e.g.$ICPE$and$ISoP$ should$consider$training$in$africa$as$an$worthy$investment$ $ Professionally$ Towards$attainment$of$the$Sustainable$Development$Goals$ SDG$3$"Ensure+healthy+lives+and+promote+well,being+for+all+at+all+ages"$$

Certification'and'Training' PV$is$important$to$ensure$safe$and$efficient$healthcare$ delivery$ Considering$the$importance$of$PV,$should$there$be$a$regime$ for$mandatory$education$and$certification$of$practitioners?$ Is$there$the$political$will$to$start$this$discussion?$

A'recent'case'study'from'Africa''

The'cost'of'no'training.'

Presidential'recommendations'following'the'fire' In$the$wake$of$that$disaster,$President$Akufo^Addo$has$ directed$the$following$..$ Institution$of$mandatory'training'and'certification'of$the$staff$of$ Regulators,$Oil$Marketing$Companies$(OMCs)$and$LPG$ Marketing$Companies$to'ensure'the'safe'handling'of$LPG;$

Conclusion' The$PV$training$needs$in$Africa$is$huge$ Building$the$capacity$of$African$institutions$to$undertake$this$task$is$ import$to$ensure$sustainability$ The$optimum$PV$curriculum$for$Africa$should$incorporate$the$body$of$ knowledge$specified$by$the$african$union$through$the$amrh$ Partnership$with$academia$is$key$to$explore$the$most$appropriate$ modes$of$content$delivery$ The$pharmaceutical$$industry$has$a$role$to$play$to$support$PV$ development$in$africa$

Thank you! www.who>acc.org'$