Transcript Developing pharmacovigilance: new challenges and opportunities Mary Couper and Shanthi Pal Quality Assurance and Safety of Medicines 1| TITLE from VIEW and SLIDE MASTER | November.

Developing
pharmacovigilance: new
challenges and opportunities
Mary Couper and Shanthi Pal
Quality Assurance and Safety of Medicines
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
WHO Programme for International Drug
Monitoring
WHO HQ +
6 Regional
offices
WHO
Collaborating
Centre, Uppsala
National
Centres
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
Pharmacovigilance in WHO HQ
1. Exchange of Information
2. Policies, guidelines, normative activities
3. Country support
4. Collaborations
5. Resource mobilisation
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
WHO Programme
October 2008
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
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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TITLE from VIEW and SLIDE MASTER | November 6, 2015
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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TITLE from VIEW and SLIDE MASTER | November 6, 2015
Juggling some
questions….
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
Why is PV NOT getting the attention it deserves
 About 40 years later: less than
100 'full' members
 4 million+ reports
 But from where?
Country Distribution in VigiBase
October 2008
Spain
2%
Sweden
2%
Thailand
2%
Australia
4%
Netherlands
2%
Canada
5%
France
5%
 Most reports from developed
countries.
 Why is PV still a non event
globally?
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
United States
50%
Germany
6%
United Kingdom
11%
Other Countries
11%
Thalidomide was the reason for the
programme …..in the 60s
2007
Primary
reason
remains!!
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
 125 Patients
 24 Patients experienced ADRs (19%)
(59%) were avoidable
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
Why do preventable errors occur
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
4 million+ reports
So What?
Where is the denominator?
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
XX number of countries trained
So What?
Why don’t they report?
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
What more can we do?
Can we use our database more
effectively?
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
Some ideas………
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
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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TITLE from VIEW and SLIDE MASTER | November 6, 2015
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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TITLE from VIEW and SLIDE MASTER | November 6, 2015
PV is about
me !!
Am I SAFE
with this
medicine?
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
Can we become more patient centred ?
Yes, we can!!
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
Reports of medication errors in
WHO ICSR database in 2005
2%
Medication errors
Total reports
98%
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
Reports of medication errors by therapeutic groups in WHO database
20%
18.7%
7%
6%
5%
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
Antithrombotic
agents
Antipsychotic
agents
Antineoplastic
agents
Antidepressants
0%
Analgesics
2.4%
Pharmacovigilance system
 Records medication related errors
 Analyses those errors
 Implements interventions
 Promotes patient safety
 Prevent 'preventable errors'
Actionable learning system
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
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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TITLE from VIEW and SLIDE MASTER | November 6, 2015
Infectious
diseases
Vaccines
Patient
Safety
Herbals
RHR
Chemical
Safety
NCD
Safety
Safety of
of
Medicines
medicines
WHO HQ
HQ
ininWHO
ICD etc
HIV/AIDS
Parasitic
Diseases
TB
Malaria
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TDR
TITLE from VIEW and SLIDE MASTER | November 6, 2015
Regional
Offices
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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TITLE from VIEW and SLIDE MASTER | November 6, 2015
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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TITLE from VIEW and SLIDE MASTER | November 6, 2015
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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TITLE from VIEW and SLIDE MASTER | November 6, 2015
What more with the database
 EML
 Dependence liability
 Counterfeit detection
 Support RUD programme with evidence
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
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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TITLE from VIEW and SLIDE MASTER | November 6, 2015
What does the future look like
1. As before
Maintain as the cheapest,
easiest, most sustainable
method
(global spontaneous reporting, training)
2. Better than before
Cohort event
monitoring
(Active surveillance studies in some countries, multilingual,
sentinel sites)
Network, support,
measure, fundraise
3. As never before
(ISMN, WAPS, EML, RUD, Indicators, capital)
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TITLE from VIEW and SLIDE MASTER | November 6, 2015
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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TITLE from VIEW and SLIDE MASTER | November 6, 2015
Pharmacovigilance
is about me !!
Thank you
Thank you
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TITLE from VIEW and SLIDE MASTER | November 6, 2015