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 WHO
offices Collaborating
Centre, Uppsala

National
Centres
Pharmacovigilance in WHO HQ

1. Exchange of Information
2. Policies, guidelines, normative activities
3. Country support
4. Collaborations
5. Resource mobilisation
WHO Programme
October 2008
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

• 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 Country Distribution in VigiBase
October 2008

• But from where? Spain

Sweden
2%
Thailand
2%
2% Netherlands
2%
Australia
4%
Canada

• Most reports from developed 5%

France
5%
countries. Germany
United States
50%
6%

• Why is PV still a non event

United Kingdom
globally? 11%

Other Countries
11%
 Thalidomide was the reason for the programme
…..in the 60s

2007

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

2%

Medication errors
Total reports
98%
Reports of medication errors by therapeutic groups in WHO database

18.7%
20%

7% 6%
5%
2.4%

0%
Analgesics

Antipsychotic
Antineoplastic

Antithrombotic
Antidepressants

agents
agents

agents
 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
 Infectious Vaccines Patient
diseases Safety

RHR Herbals

Chemical
NCD
Safety
Safetyofof
Safety
Medicines
medicines
ininWHO
WHOHQ HQ
ICD etc HIV/AIDS

Parasitic
TB
Diseases
Regional
Malaria
TDR 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
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
• 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 Maintain
like as the cheapest,
easiest, most sustainable
method

1. As before
(global spontaneous reporting, training) Cohort event
monitoring
2. Better than before
(Active surveillance studies in some countries,
multilingual, sentinel sites)
Network, support,
3. As never before measure, fundraise
(ISMN, WAPS, EML, RUD, Indicators, capital)
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