Developing pharmacovigilance:

new challenges and

opportunities

Mary Couper and Shanthi Pal

Quality Assurance and Safety of Medicines

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 WHO Programme for International Drug
Monitoring

WHO HQ + WHO
6 Regional Collaborating
offices Centre, Uppsala

National
Centres

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 Pharmacovigilance in WHO HQ

2. Exchange of Information

3. Policies, guidelines, normative activities

4. Country support

5. Collaborations

6. Resource mobilisation

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 WHO Programme
October 2008

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 Functions
 Receive and manage ADR data

 Develop tools; innovate

 Analyse:
– Signal detection :Identification of previously unknown drug reactions

 Communicate

 Support countries: train; search; technical assistance

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 What have we achieved in 40 years

 118 National PV centres (89 full members +29

Associate members)
 Global ADR database: over 4 million reports
 In 2006: 37 Signals generated from database
 Some public health programs incorporating PV
 Gaining donor support

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 Juggling some
questions….

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Why is PV NOT getting the attention it deserves

 About 40 years later: less than

100 'full' members
Country Di stri buti on in VigiB ase
Oct ober 2008
 4 million+ reports Sw ede n
2%
Thailand
Spa in
2% N eth erlands
2%

 But from where? Austr alia

4%
2%

Canada
5%

France
5%
Unite d Sta te s
Ge rm any 50%
6%

 Most reports from developed

Un ite d K ingd om

countries. 11%

Oth er Cou ntr ies

11%

 Why is PV still a non event

globally?

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Thalidomide was the reason for the
programme …..in the 60s

2007

Primary
reason
!!remains

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  125 Patients

 24 Patients experienced ADRs (19%)

(59%) were avoidable

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 Why do preventable errors occur

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 4 million+ reports

So What?

Where is the denominator?

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 XX number of countries trained

So What?

Why don’t they report?

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 What more can we do?

Can we use our database more

effectively?

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Some ideas………

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 Consider traditional trends
 Adverse drug reaction

 Adverse drug event

 Medicine safety

 Medicine toxicity

 Benefit /harm profile of a medicine

 Product emphatic

Where is the patient?

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 Need to humanize what we do
 Let's give pharmacovigilance a 'face'

 Let's talk about patient safety, not just medicine safety

 Ask the right question

 Instead of asking 'Is the medicine safe'

 Need to ask:

Is the patient safe taking this medicine?

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 PV is about
!! me

Am I SAFE
with this
?medicine

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Can we become more patient centred ?

Yes, we can!!

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 Reports of medication errors in
WHO ICSR database in 2005

2%

Medication errors
Total reports
98%

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 Reports of medication errors by therapeutic groups in WHO database

18.7%
20%

7% 6%
5%
2.4%

0%
Analgesics

Antipsychotic
Antineoplastic

Antithrombotic
Antidepressants

agents
agents

agents
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 Pharmacovigilance system

 Records medication related errors

 Analyses those errors

 Implements interventions

 Promotes patient safety

 Prevent 'preventable errors'

Actionable learning system

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WHO Patient Safety- Pharmacovigilance alliance

 Collaborative project for the development of

pharmacovigilance centres for patient safety
 Building on medication related expertise of the WHO-PV
programme
 Reporting and learning through Root Cause Analysis
systems
 Improve patient safety

 Partners: WHO-PV, WAPS, UMC, Moroccan centre for

poison control and pharmacovigilance

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 Infectious Vaccines Patient
diseases Safety

RHR Herbals

Chemical
NCD
Safety
Safety of
Safety of
Medicines
medicines
ininWHO
WHO HQHQ
ICD etc HIV/AIDS

Parasitic
TB
Diseases
Regional
Malaria
TDR Offices
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 Low presence of some countries in the
programme
 Capacity building : multi regional, multilingual trainings,
regional centres of excellence in PV

 Local evidence for the need for pharmacovigilance

 What gets measured, gets done (DG, WHO)

– Indicators for PV

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 Post-training: improving reporting
 The know–do gap: understanding it

 Reporting tools expensive

 Vigiflow : free when used only as a reporting tool

 Also discuss 'incentives'

– CME points
– Feedback
– Access to Information

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 Lack of denominator / exposure data
 Active surveillance to complement

 Cohort Event Monitoring

 Malaria, HIV

 Pregnancy registers

To complement and NOT replace spontaneous reporting

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 What more with the database

 EML

 Dependence liability

 Counterfeit detection

 Support RUD programme with evidence

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 Optimising 'Donor' interest
 BMGF:
– HIV/AIDS proposal
– Malaria pregnancy registry
– Developing a global strategy

 EC:
– EC/ACP/WHO Partnership on Pharmaceutical Policies now in
its 5th year
– Working with African countries to ensure a quality
pharmaceutical response to malaria entering its second year
– Optimizing drug safety monitoring to enhance patient safety
and achieve better health outcomes

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 What does the future look like
Maintain as the cheapest,
easiest, most sustainable
method
1. As before
(global spontaneous reporting, training)
Cohort event
monitoring
3. Better than before
(Active surveillance studies in some countries, multilingual,
sentinel sites) Network, support,
measure, fundraise
 As never before

(ISMN, WAPS, EML, RUD, Indicators, capital)

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 Major planned activities for 2009
 Development of a global strategy for pharmacovigilance to increase
awareness
 PV landscape assessment for ascertaining state of the art
 Expansion of the programme with a focus on China and India
 More Francophone countries supported in PV
 Cohort event monitoring method developed, piloted in 2 African
countries (in malaria)
 Indicators for PV
 Expansion and development of database
 Pilot project on medication errors strengthened / expanded to other
centres
 Strengthening PV in HIV/AIDS
 PV capacity in countries supported

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 Pharmacovigilance
!! is about me

Thank you

Thank you

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