1. Overview of the EAC Pharmacovigilance and Post-Marketing Surveillance Systems 1ST International High Level Multi-Stakeholder Conference Nairobi, 2-4 November, Mary Njeri PV & PMS Pharmacy and Poisons Board-Kenya

2. Presentation Outline Current Status of PV & PMS systems in EAC
EAC Pharmacovigilance Activities
Way forward

3. East Africa Community

4. Current Status of PV & PMS Systems in East African community
Safety policy and legal frameworks for PV exist in five Partner State, only 4 NMRAs (United Republic of Tanzania (mainland), Republic of Kenya, Rwanda and Uganda) have safety regulation on PV for health professionals however only Uganda has a legal provision for safety monitoring by pharmaceutical industry
All the EAC Partner States have basic structures for coordination of PV activities, however the systems and structures differ.
All the six NMRAs are members of the WHO Program for International Drug Monitoring.
PV guidelines, advisory committees, data collection tools/forms, designated staff, all exist in the NMRAs.
Both Passive and Active PV methods are used within the partner states.

5. Current Status of PV & PMS Systems in East African community
Quality Control Laboratories
Four World Health Organization (WHO) prequalified –med- quality control laboratories exist in the region,
PV in Public Health Programs
Existing policy framework and basic structures are basically in malaria ,HIV and immunization programs.
Variable effort to collect and aggregate adverse events in PHPs and to share the information with national PV centers
Post-Market Surveillance activities
Only TFDA has PMS entrenched in their law

6. EAC PHARMACOVIGILANCE ACTIVITIES

7. EAC –Health Sectoral Council Consideration – April 2014
The 9th Health Sectoral Council meeting in April 2014 directed the EAC Secretariat to officially constitute a Regional EWG of Experts on PV and PMS to develop a fundable proposal. (EAC/9 SCM/Health/Decision 058)
A Regional EWG of Experts on PV and PMS was constituted in 2014
The Steering Committee for the EAC- MRH serves as Steering Committee for PV & PMS activities

8. Implementation Arrangements for EAC - MRH
-PV- Programme
NMRA 1 TFDA +MUHAS -MER
NMRA 2 ZFDB
NMRA 3 PPB + UON PV
NMRA 4 NDA +MUK
GMP
NMRA
5 PTF
NMRA 6 DPML
EAC Project Coordination Team
Project Steering Committee •
NMRA Annual
Work Plans
Annual Budgets
Procurement
Plans
Quarterly performance
Reports
Regional Annual
Consolidated Budget &
procurement plan
Interim
Finance Reports
Annual
Audit
EAC Sectoral Committee on
Health
EAC Sectoral Council of
Ministers of Health
Technical Working Group(s)
Nomination of experts
Participation in
consultations
Guidelines for
harmonization
WHO, MSH
SWISSMEDIC,
T A
NEPAD
Agency
Advocacy
Coordination
AMRH
Partners

9. Experts Working Group on PV and PMS
Membership: Total 12
members drawn from the PV and PMS departments/Units of the six NMRAs
Key Mandate of the EWG
Facilitate development & implementation of harmonized PV and PMS technical requirements and guidelines in the EAC
Facilitate implementation of a regional harmonized system for detecting, assessing, preventing and responding to adverse events and other issues related to health products

10. Experts Working Group on PV and PMS.
Activities carried out by the EWG
Weeks Fellowship training in WHO Collaborating Centre Ghana:
6 participants, one from each of the 6 EAC Partner States NMRAs; 21st July to 15th August, 2014
Meetings for the EWG: 7 VCs and 4 Face to face meeting since Feb 2014
Participation in the WHO led Clinical Trials Protocol review for Ebola Vaccine in Feb 2015
Draft of proposal to mobilize funds for harmonization of PV & PMS activities in EAC Partner States –NMRAs; under review by WHO

11. Experts Working Group on PV and PMS.
Draft of standard/harmonized tools to assess PV systems in EAC partner states
These were adapted from WHO PV Indicators and MSH/Indicator Based Pharmacovigilance Assessment Tool
Capacity building of EWG TOT was done in June 2016
Draft of PV assessment plan(s) for EAC Partner States
Capacity building plan of EAC partner states for application of PV assessment tools
A separate PMS proposal was developed to look at Establishment of a regional Quality Infrastructure for the pharmaceutical sector

12. Draft proposal on harmonization of PV systems in EAC region
Proposal Title:
Project on Harmonization and Strengthening of Pharmacovigilance Systems of Medicines, Health Products and Technologies in East African Partner States
Goal:
To promote patient safety through harmonization and strengthening Pharmacovigilance systems in the EAC partner states.

13. Draft proposal justification
Increased access to new essential medicines; and molecules requires additional efforts
The increasing burden of adverse events from poor quality products, adverse drug reactions (ADRs), and medication errors
Absence of actual estimates of the burden of substandard, spurious , falsely labelled, falsified and counterfeit (SSFFC) products within the EAC Partner States
Inadequate resources and capacity at NMRAs to undertake PV & PMS activities
Lack of PV and PMS information data base to support policy formulation for the region

14. Proposal Objectives The specific objectives (3):
Objective 1: To develop and implement harmonized PV requirements, guidelines, procedures and practices for the regulation of medicines, health products and technologies in the EAC region.
Objective 2: To build and strengthen institutional capacity on Pharmacovigilance in the EAC Partner States.
Objective 3: To support partnership and decision making through appropriate technology and information sharing on product safety.

15. Partners Supporting PV/PMS Activities
PV Activities
WORLD BANK
WHO
USAID/SIAPS
PMS Activities
The Physikalisch-Technische Bundesanstalt (PTB), the National Metrology institute
USP/PQM

16. Way forward
Conduct gap analysis for targeted PV systems strengthening.
Partner States to harmonise and strengthened pharmacovigilance systems for Medicines, Health Products and Technologies; (Harmonized tools, guidelines and legal policy framework on PV &PMS)
The EAC Secretariat and Partner States to mobilize resources support implementation of the proposal; from National budgets, development and Implementing partners [AMRH, USAID/SIAPS and other Partners]
EAC Secretariat to expedite formal administrative arrangements with interested Development Partners with well defined scope, roles and responsibilities to support the implementation.