Developing pharmacovigilance: new challenges and opportunities
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Developing pharmacovigilance: new challenges and opportunities Mary Couper and Shanthi Pal Quality Assurance and Safety of Medicines. WHO Programme for International Drug Monitoring. WHO HQ + 6 Regional offices. WHO Collaborating Centre, Uppsala. National Centres.

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Developing pharmacovigilance: new challenges and opportunitiesMary Couper and Shanthi PalQuality Assurance and Safety of Medicines

Who programme for international drug monitoring
WHO Programme for International Drug Monitoring opportunities


6 Regional




Centre, Uppsala



Pharmacovigilance in who hq
Pharmacovigilance in WHO HQ opportunities

  • Exchange of Information

  • Policies, guidelines, normative activities

  • Country support

  • Collaborations

  • Resource mobilisation

Who programme october 2008
WHO Programme opportunitiesOctober 2008

Functions opportunities

  • Receive and manage ADR data

  • Develop tools; innovate

  • Analyse:

    • Signal detection :Identification of previously unknown drug reactions

  • Communicate

  • Support countries: train; search; technical assistance

What have we achieved in 40 years
What have we achieved in 40 years opportunities

  • 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

Why is pv not getting the attention it deserves
Why is PV NOT getting the attention it deserves opportunities

  • About 40 years later: less than 100 'full' members

  • 4 million+ reports

  • But from where?

  • Most reports from developed countries.

  • Why is PV still a non event globally?

Thalidomide was the reason for the programme opportunities … the 60s


Primary reason remains!!

(59%) were avoidable

4 million reports
4 million+ reports opportunities

So What?

Where is the denominator?

Xx number of countries trained
XX number of countries trained opportunities

So What?

Why don’t they report?

What more can we do
What more can we do? opportunities

Can we use our database more effectively?

Some ideas……… opportunities

Consider traditional trends
Consider traditional trends opportunities

  • Adverse drug reaction

  • Adverse drug event

  • Medicine safety

  • Medicine toxicity

  • Benefit /harm profile of a medicine

  • Product emphatic

    Where is the patient?

Need to humanize what we do
Need to humanize what we do opportunities

  • 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?

PV is about me !! opportunities

Am I SAFE with this medicine?

Can we become more patient centred
Can we become more patient centred ? opportunities

Yes, we can!!

Reports of medication errors in who icsr database in 2005
Reports of medication errors in opportunitiesWHO ICSR database in 2005

Pharmacovigilance system
Pharmacovigilance system opportunities

  • Records medication related errors

  • Analyses those errors

  • Implements interventions

  • Promotes patient safety

  • Prevent 'preventable errors'

    Actionable learning system

Who patient safety pharmacovigilance alliance
WHO Patient Safety- Pharmacovigilance alliance opportunities

  • 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

Safety of opportunities



Low presence of some countries in the programme
Low presence of some countries in the programme opportunities

  • 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

Post training improving reporting
Post-training: improving reporting opportunities

  • 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

Lack of denominator exposure data
Lack of denominator / exposure data opportunities

  • Active surveillance to complement

  • Cohort Event Monitoring

  • Malaria, HIV

  • Pregnancy registers

    To complement and NOT replace spontaneous reporting

What more with the database
What more with the database opportunities

  • EML

  • Dependence liability

  • Counterfeit detection

  • Support RUD programme with evidence

Optimising donor interest
Optimising 'Donor' interest opportunities


HIV/AIDS proposal

Malaria pregnancy registry

Developing a global strategy


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

What does the future look like
What does the future look like opportunities

Maintain as the cheapest, easiest, most sustainable method

  • As before

    (global spontaneous reporting, training)

  • Better than before

    (Active surveillance studies in some countries, multilingual, sentinel sites)

  • As never before

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

Cohort event monitoring

Network, support, measure, fundraise

Major planned activities for 2009
Major planned activities for 2009 opportunities

  • 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

Pharmacovigilance is about me !! opportunities

Thank you

Thank you