Enhancing(Pharmacovigilance(in(Sub3Saharan(Africa ... · Presenta=on(1. Pharmacovigilance'in'Sub.Saharan'Africa'–'The'reality'' 2. The'Pharmacovigilance'Enhancement'Project' 3.

Enhancing(Pharmacovigilance(in(Sub3Saharan(Africa:(Sharing(experiences(from(a(GSK(pilot(ini=a=ve(in(Malawi(

(Viviane'Jusot,'Olga'Menang,'Frider'Chimimba,'Ne:e'Ndzabala,'Cecilia'Sambakunsi,'Chrissy'Chulu,'Jens@Ulrich'

Stegmann,'Yolanda'Guerra'Mendoza'on'behalf'of'the'GSK'PV'Task'force(

Authors’(conflicts(of(interest(

Viviane'Jusot,'Jens.Ulrich'Stegmann'and'Yolanda'Guerra'Mendoza'are'employees'of,'and'hold'shares'in,'the'GSK'group'of'companies''

Olga'Menang,'Cecilia'Sambakunsi,'Frider'Chimimba,'NeFe'Ndzabala,'Chrissy'Chulu'do'not'report'any'conflict'of'interest'

GlaxoSmithKline'Biologicals'SA'and'PATH'provided'funding'to'the'Malawi'Ministry'of'Health'(MOH)'through'the'Pharmacy,'Medicines'and'Poisons'Board'(PMPB),'for'project'implementaRon'and'technical'support'

2'

Presenta=on(

1.  Pharmacovigilance'in'Sub.Saharan'Africa'–'The'reality''

2.  The'Pharmacovigilance'Enhancement'Project'

3.  The'Malawi'Experience:'November'2016'–'May'2018'

4.  Key'challenges,'lessons'learned'and'recommendaRons'

5.  PV'enhancement'vision'

3'

(Pharmacovigilance(in(Sub3Saharan(Africa(–((The(reality(

4'

Sub3Saharan(Africa(Safety(Reality(

3mins'

OMG!!!'What'killed'them?'My'song??'

5'

Sub-Saharan Africa Safety Reality'

Poor'lab'faciliRes'Cardiac'problems'

Stress'MalnutriRon'

'Hyper'tension'

'

InfecRous'diseases'

FaRgue'

Diabetes'

HIV/STIs'

Vaccine'hesitancy'

Counterfeit'drugs'

Respiratory'diseases'

Cultural'barriers'

Sudden'deaths'

Self'medicaRon'

Illiteracy/'poverty' Informal'

providers'

No'expert'review'commifee'

Cold'chain'logisRcs'

Unknowns'

Complex'bureaucracy'No'baseline'

incidence'data'

Trained'HCPs'

Taboos'

Auto.immune'diseases'No'autopsy'

Vaccines'&'drugs'

PV(Enhancement(Partnership( Communicate('

Evidence(based(decisions( 6'

Benefits(of(Pharmacovigilance(Enhancement(in(Sub3Saharan(Africa((

7'

• PaRent'safety'

•  Improved'post'licensure'safety'monitoring'

•  Improved'drug/vaccine'safety'awareness'and'reporRng'culture'

• Long'term'sustainability'of'pharmacovigilance'systems'

7'

(The(Pharmacovigilance(Enhancement(Project(

8'

The(Pharmacovigilance(Enhancement(Project(

• Dedicated'pharmacovigilance'personnel'(focal'points)'

• Pharmacovigilance'trainings'

• Mentoring'

• Monitoring'the'performance'of'the'project'

• MOH'coordinaRon''

• Technical'and'financial'support'from'GSK'and'PATH'

• Pilot'project:'18'months/country'in'3'Sub.Saharan'Africa'countries'!  'Malawi,'Côte'd’Ivoire,'DemocraRc'Republic'of'Congo'

9'

(The(Malawi(Experience:(November(2016(–(May(2018(

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(The(Malawi(PV(System(before(Project(implementa=on(

• EsRmated'populaRon'in'2018:'19'million''

• Three'regions'

• 29'districts'

• Minimal'PV'capacity'

• No'funcRonal'PV'center'

• Not'member'of'WHO'IDM'

Tanzania'

Mozambique'

Zambia'

11'

Posi=ve(outcomes(

• Pharmacovigilance'trainings/sensiRzaRons'and'mentoring'!  'Basic'pharmacovigilance'training:'34'focal'points'!  'SensiRzaRon'training:'about'400'HCPs'at'53'faciliRes''!  '12'private'health'faciliRes'

•  Increase'of'adverse'event'(AE)'reported:'228'AEs''!  '150'adverse'drug'reacRons'(ADRs)'!  '78'AEs'following'immunizaRon'(AEFIs)'

• Malawi'qualifies'to'be'a'member'of'the'World'Health'OrganizaRon''(WHO)'internaRonal'drug'monitoring'program'• FuncRonal'naRonal'pharmacovigilance'centre'with'dedicated''NaRonal'PV'coordinator'' 12'

AE(repor=ng(

AEFI(repor=ng((2000(–(2016)(

228

0

50

100

150

200

250

Cum

ulat

ive A

E re

porti

ng

Blank:'date'of'recepRon'not'available'

AE(repor=ng((Nov(2016(–(May(2018)(

150(ADRs(and(78(AEFIs(

13'Source:'data'from'UNICEF/WHO'Joint'ReporRng'Form''

Number(of(AE(forms(transmiYed(to(pharmacovigilance(office(within(48(hours(

2'

78'75' 73'

0'

10'

20'

30'

40'

50'

60'

70'

80'

90'

Within'2'days' 3'.'30'days' Beyond'30'days' Blanks'

No(of(re

ports(

Blank:'date'of'recepRon'not'available'

•  Complex'transmission'rouRng'

•  Remoteness'of'health'centers'

•  Lack'of'electronic'forms'

Days(of(transmission(of(AE(forms(to(PV(office(

14'

Evalua=on(of(Key(Performance(Indicators(

Key Performance Indicators( Baseline( Final results(

Value 2016 (N)' Target (N/%)' Achieved (N)' Achieved (%)'

AEs reported( 4' 10' 228' >100% '

Proportion of AE forms transmitted from the health care facilities to PV office within 48h(

0' >50%' 2' <1% '

Proportion of complete AE reports( Unknown ' 80%' 219' 96% '

Proportion of serious AE reports investigated( 0' 100%' 0' 0% '

Proportion of received AE forms entered into the PV database within 2 working days(

NA( 100%' NA' NA'

NA:'not'applicable'15'

(Key(challenges,(lessons(learned(and(recommenda=ons(

16'

Key(challenges(

•  Late'reporRng'/'delayed'transmission'of'AE'forms''

• Complex'transmissions'routes'for'completed'AE'forms:'AEFI'and'ADR'

•  Timely'acRon'plan'for'idenRfied'signals'

• Concerted'communicaRon'and'collaboraRon'between'naRonal'stakeholders'

•  IntegraRon'of'pharmacovigilance'in'public'health'programs'''

• Regular'transfer'of'focal'points'

''

'

17'

Lessons(learned((

• ConRnuous'mentoring'of'health'care'professionals'is'key'

•  TargeRng'effecRve'sustainable'acRviRes''

•  Transparency'is'crucial'

•  Engage'hospital'management'

• Refresher'trainings'

• Recognize'excellence'

•  EffecRve'collaboraRon'between'industry,'naRonal'pharmacovigilance'centers/MOH,'Academia,'non–governmental'organizaRons'

18'

Recommenda=ons(

• Healthcare'professionals'sensiRzaRon'and'mentoring'

• Countries'project'ownership''

• A'dedicated'naRonal'pharmacovigilance'coordinator''

• ConcreRze'internal'partnerships'with'insRtuRons'on'pharmacovigilance'

•  Facilitate'and'harmonize'AE'reporRng'across'countries'

•  Improve'electronic'transmission''

• AnRcipate'Rmelines'

19'

Pharmacovigilance(Enhancement(Vision(

• Partnership'building/funding'!  'Concerted'efforts'and'focused'technical'experRse'!  'Mobilize'funding'mechanisms''! 100'–'150'K'euros/country''

•  Improve'and/or'expand'pharmacovigilance'enhancement'

'

'

20'

Acknowledgement(

• Malawi'MOH'

• Malawi'PMPB/NaRonal'PV'centre'

• Malawi'Pharmacy'dept./College'of'Medicine'Blantyre'

• PATH'Geneva'

• GSK'.'PV'task'force'

• WHO'

• XPE'Pharma'&'Science'c/o'GSK'

21'

Thank(you(

22'

Back up slides

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ACTORS IN AE REPORTING

International Level

WHO – EMA - FDA

National Committee of Experts

National Level

National PV office, NRA, NIP

PV

Coordinator

Peripheral Level

Health center – Hospitals – Immunization Centers

Health Personnel

District Level

Ex: EPI Coordinators

AE Focal point

24'

25'