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Developing pharmacovigilance:
new challenges andopportunities
Mary Couper and Shanthi Pal
Quality Assurance and Safety of Medicines
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WHO Programme for International Drug
Monitoring
WHO HQ +WHO HQ +
6 Regional6 Regionalofficesoffices
WHOWHO
CollaboratingCollaboratingCentre, UppsalaCentre, Uppsala
NationalNational
CentresCentres
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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 +29Associate 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 somequestions.
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Why is PV NOT getting the attention it deserves
About 40 years later: less than100 'full' members
4 million+ reports
But from where?
Most reports from developed
countries.
Why is PV still a non event
globally?
Country Di stri bution in VigiBaseOct ober 2 0 0 8
Spa i n2%
U n i t ed S t a t e s50 %
U n i t ed K i ngdom11 %
Ot he r C oun t r i e s11 %
Ne t he r l and s2%Tha i l and2%
G e r m a n y6%
France5%
C anada5%
Aust ra l ia4%
S w e d e n2%
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Thalidomide was the reason for the
programme ..in the 60s
2007
Primaryreason!!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 dont 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 drugreaction
Adverse drugevent
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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Am I SAFE
with this?medicine
PV is about
!! me
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Can we become more patient centred ?
Yes, we can!!
http://www.ssinformer.com/news/world/north_americal/usa/politics/2008/images/barack__obama.jpg8/14/2019 Pals New Challenges and Opportunities 2
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Reports of medication errors in
WHO ICSR database in 2005
2%
98%
Medication errors
Total reports
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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 ofpharmacovigilance centres for patient safety
Building on medication related expertise of the WHO-PVprogramme
Reporting and learning through Root Cause Analysissystems
Improve patient safety
Partners: WHO-PV, WAPS, UMC, Moroccan centre forpoison control and pharmacovigilance
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Infectious
diseases
RHR
NCD
ICD etc
TB
MalariaTDR
Regional
Offices
ParasiticDiseases
HIV/AIDS
Chemical
Safety
Herbals
Patient
Safety
Vaccines
Safety of
Medicinesin WHO HQ
Safety of
medicinesin WHO HQ
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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 knowdo 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 safetyand achieve better health outcomes
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What does the future look like
1.As before(global spontaneous reporting, training)
3. Better than before
(Active surveillance studies in some countries, multilingual,
sentinel sites)
As never before
(ISMN, WAPS, EML, RUD, Indicators, capital)
Maintain as the cheapest,easiest, most sustainablemethod
Cohort event
monitoring
Network, support,
measure, fundraise
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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 othercentres
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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