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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Who programme for international drug monitoring

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

WHO HQ +

6 Regional

offices

WHO

Collaborating

Centre, Uppsala

National

Centres


Pharmacovigilance in who hq

Pharmacovigilance in WHO HQ

  • Exchange of Information

  • Policies, guidelines, normative activities

  • Country support

  • Collaborations

  • Resource mobilisation


Who programme october 2008

WHO ProgrammeOctober 2008


Functions

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


What have we achieved in 40 years

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


Who programme for international drug monitoring

Juggling some questions….


Why is pv not getting the attention it deserves

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?


Who programme for international drug monitoring

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

2007

Primary reason remains!!


Who programme for international drug monitoring

  • 125 Patients

  • 24 Patients experienced ADRs (19%)

(59%) were avoidable


Who programme for international drug monitoring

Why do preventable errors occur


4 million reports

4 million+ reports

So What?

Where is the denominator?


Xx number of countries trained

XX number of countries trained

So What?

Why don’t they report?


What more can we do

What more can we do?

Can we use our database more effectively?


Who programme for international drug monitoring

Some ideas………


Consider traditional trends

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

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?


Who programme for international drug monitoring

PV is about me !!

Am I SAFE with this medicine?


Can we become more patient centred

Can we become more patient centred ?

Yes, we can!!


Reports of medication errors in who icsr database in 2005

Reports of medication errors in WHO ICSR database in 2005


Pharmacovigilance system

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

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


Who programme for international drug monitoring

Safety of

medicines

in WHO HQ


Low presence of some countries in the programme

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

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

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

What more with the database

  • EML

  • Dependence liability

  • Counterfeit detection

  • Support RUD programme with evidence


Optimising donor interest

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


What does the future look like

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

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


Who programme for international drug monitoring

Pharmacovigilance is about me !!

Thank you

Thank you


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