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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


6 Regional




Centre, Uppsala



Pharmacovigilance in WHO HQ

  • Exchange of Information

  • Policies, guidelines, normative activities

  • Country support

  • Collaborations

  • Resource mobilisation

WHO ProgrammeOctober 2008


  • 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

  • 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

Juggling some questions….

Why is PV NOT getting the attention it deserves

  • 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 … the 60s


Primary reason remains!!

  • 125 Patients

  • 24 Patients experienced ADRs (19%)

(59%) were avoidable

Why do preventable errors occur

4 million+ reports

So What?

Where is the denominator?

XX number of countries trained

So What?

Why don’t they report?

What more can we do?

Can we use our database more effectively?

Some ideas………

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?

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?

PV is about me !!

Am I SAFE with this medicine?

Can we become more patient centred ?

Yes, we can!!

Reports of medication errors in WHO ICSR database in 2005

Pharmacovigilance system

  • Records medication related errors

  • Analyses those errors

  • Implements interventions

  • Promotes patient safety

  • Prevent 'preventable errors'

    Actionable learning system

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

Safety of



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

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

Lack of denominator / exposure data

  • Active surveillance to complement

  • Cohort Event Monitoring

  • Malaria, HIV

  • Pregnancy registers

    To complement and NOT replace spontaneous reporting

What more with the database

  • EML

  • Dependence liability

  • Counterfeit detection

  • Support RUD programme with evidence

Optimising 'Donor' interest


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

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

  • 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 !!

Thank you

Thank you

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