1. Developing pharmacovigilance: new challenges and opportunities Mary Couper and Shanthi Pal Quality Assurance and Safety of Medicines

2. WHO Programme for International Drug Monitoring
WHO HQ +
6 Regional
offices
WHO
Collaborating
Centre, Uppsala
National
Centres

3. Pharmacovigilance in WHO HQ
Exchange of Information
Policies, guidelines, normative activities
Country support
Collaborations
Resource mobilisation

4. World Health Organization
21 September 2018
WHO Programme October 2008
At the moment there are 86 full member countries and 30 associate member countries. To become an associate member country, the government of a country needs to send an official application to the WHO HQ in Geneva. To become a full member the country also needs to send at least 20 ADR reports in a correct format. Few member countries in Africa. X became a member in CCYY.

5. World Health Organization
Functions
21 September 2018
Receive and manage ADR data
Develop tools; innovate
Analyse:
Signal detection :Identification of previously unknown drug reactions
Communicate
Support countries: train; search; technical assistance

6. 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

7. Juggling some questions….

8. 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?

9. 2007 Thalidomide was the reason for the programme …..in the 60s
Primary reason remains!!

10. World Health Organization
21 September 2018
125 Patients
24 Patients experienced ADRs (19%)
Intro 2
(59%) were avoidable

11. Why do preventable errors occur

12. Where is the denominator?
4 million+ reports
So What?
Where is the denominator?

13. XX number of countries trained
So What?
Why don’t they report?

14. Can we use our database more effectively?
What more can we do?
Can we use our database more effectively?

15. Some ideas………

16. 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?

17. 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?

18. PV is about me !!
Am I SAFE with this medicine?

19. Can we become more patient centred ?
Yes, we can!!

20. Reports of medication errors in WHO ICSR database in 2005

22. Pharmacovigilance system
Records medication related errors
Analyses those errors
Implements interventions
Promotes patient safety
Prevent 'preventable errors'
Actionable learning system

23. 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

24. Safety of
medicines
in WHO HQ

25. 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

26. 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

27. Lack of denominator / exposure data
Active surveillance to complement
Cohort Event Monitoring
Malaria, HIV
Pregnancy registers
To complement and NOT replace spontaneous reporting

28. What more with the database
EML
Dependence liability
Counterfeit detection
Support RUD programme with evidence

29. 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

30. 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

31. 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

32. Pharmacovigilance is about me !!
Thank you
Thank you