ppt focussed on targeted/focussed pharmacovigilance studies

1. FOCUSSED
PHARMACOVIGILANCE
Sachin Kumar
Senior Pharmacovigilance Associate
AIIMS, New Delhi

2. Definition
• Focussed pharmacovigilance:
• Intensified ADR Reporting within a
defined cohort

3. NEED?
• To know the ADR profile of a specific medicine
in specific population
or
• To know the incidence of a known ADR to a
specific medicine in specific population

4. INTENSIFIED SPONTANEOUS REPORTING
• To enhance ADR reporting of specific
medicines in early post‐marketing phase
• Extension of Spontaneous Reporting
Programme

5. Focussed pharmacovigilance
Methodology
Database
Defined cohort
Signal
Specific
medicines
All
ADRs/specific
ADRs
Specific
clinics

6. Specific ADR
All ADR
Specific medicines
Specific clinics
Specific population
FOCUSSED PHARMACOVIGILANCE

8. Focussed reporting
Specific population

9. Focussed pharmacovigilance in
Uganda
• Specific population: Patient with HIV
infection

10. Focussed reporting
Specific population
Specific clinics

11. Focussed pharmacovigilance in Uganda
• Specific population: Patient with HIV infection
• Specific clinics: Regional Pharmacovigilance
Centres of Masaka and Mbale

12. Focussed reporting
Specific population
Specific clinics
Specific medicines

13. • Specific population: Patient with HIV infection
• Specific clinics: Regional Pharmacovigilance
Centres of Masaka and Mbale
• Specific medicines: Tenofovir
Focussed pharmacovigilance in Uganda

14. Specific population
Specific clinics
Specific medicines
All ADR
Focussed reporting

15. • Specific population: Patient with HIV infection
• Specific clinics: Regional Pharmacovigilance
Centres of Masaka and Mbale
• Specific medicines: Tenofovir
• Specific ADRs: Renal toxicity
Focussed pharmacovigilance in Uganda

16. SUMMARY OF FOCUSSED PHARMACOVIGILANCE
PILOT PROJECT IN UGANDA
• Monitoring medicines project
• Collaboration between national
pharmacovigilance centre and AIDS control
programme
• Objectives:
– To monitor renal toxicities related to use of tenofovir
based regimes in adults
– To monitor ADRs related to use of zidovudine
– To enhance pharmacovigilance in AIDS control
programme

17. FOCUSED PHARMACOVIGILANCE OF SUSPECTED
ADRs TO ARVs, AMPATH, KENYA
• AMPATH (Academic Model Providing Access to
Healthcare)
– Partnership between Moi University School of Medicine,
Moi Teaching and referral Hospital and a consortium of
US medicine schools led by Indiana university.
– Treats over 125000 HIV positive patients at 53 sites in
and around Eldoret, western Kenya
• Focusing on treatment threatening ADRs (change
or discontinuation of treatment)

18. PROS WITH FOCUSSED PHARMACOVIGILANCE
• Can utilize existing ADR reporting infrastructure
• Targets specific medicines of interest
• Possible to implement monitoring programme that
targets specific issue of concern (ADR, medicine,
patient group)
• Captures useful information
• Denominator known

19. CONS WITH FOCUSSED PHARMACOVIGILANCE
• Under‐reporting remains a problem
• Captures only suspected ADRs or known
toxicities
• May limit reporting only to specific ADRs
• Relies on diagnostic capability of reporter

20. Focussed pharmacovigilance spectrum
• Denominator known
• Suspected ADRs/specific ADRs
• Cohort specific medicines
• Profile of ADRs for a specific medicine in a
specific population.

21. Focussed Pharmacovigilance
Focussed pharmacovigilance of
Tenofovir in Uganda
AMPATH, Kenya ,ARVs
Incidence of a known ADR in a
specific population
Profile of ADRs for a specific
medicine in a specific population
Cohort specific medicines Cohort specific medicines
Specific ADRs Suspected ADRs
Denominator known Denominator known

22. THANKS