1. Strengthening systems for safety monitoring for SMC in the Sahel
Jean Louis Ndiaye on behalf of WARN/CARN SMC working group

2. Introduction SMC implementation research phase:
over 1 million doses of SP+AQ delivered
No safety signal
Vomiting was the common Adverse drug reaction reported
No Steven Johnson Syndrome reported
1 Extra Pyramidal Syndrome reported
But if SMC is delivered at scale, will all countries be in position of monitoring Safety and detecting Serious Adverse Drug Reaction (SADR) if any ?
Message: no safety signal during the SMC implementation research phase but if any safety problem when SMC is delivered at large scale, will the country be able to detect and report SADR ?

3. URGENT NEED TO STRENGTEN EXISTING PV SYSTEM
PV situation
In West and central Africa in 2014
PV systems were not adequately resourced for properly monitoring safety during SMC
Some countries were not member of WHO PV system (Chad, Gambia)
National Safety committees on paper only
Few countries were reporting in VIGIBASE
URGENT NEED TO STRENGTEN EXISTING PV SYSTEM

4. PV Situation Country Membership Date Togo Full 2007 Ghana 2001 Guinea
2013
Burkina
2010
Mali
2011
Senegal
2009
Chad
Associate
2015
Niger
2012
Nigeria
2004
Gambia
Cameroun
All SMC countries have a PV systems
Individual PV system assessment according to WHO Indicators is needed

5. Approach for strengthening the system
Situation analysis and needs assessment
Workshops for strengthening PV country expertise
Geneva (Oct 2014) : Situation analysis and needs assessment
Rabat (May 2015) : for strengthening PV country expertise
Rabat (Feb 2016) : Lessons learned workshop
Ouagadougou (Sept 2016) : Management of severe adverse reactions
Support for implementing more effective safety monitoring
Regional safety committee
SMC is an opportunity to strengthen the national PV systems
Collaborative approach and partnership with: WHO PV control programme and collaborative PV centres Morocco and Ghana, Malaria Consortium, CRS, UCAD, LSHTM and WHO/TDR

6. Support for implementing PV system for SMC
1. Action plan developed for each country to be ready for 2015 SMC
Detection, management, response, reporting and follow-up
Assessment of causality by the National Safety Committee
Reporting to UPPSALA (VIGIFLOW, VIGIBASE)
2. Job aids printed
3. In country cascade training
4. Awareness raising

7. Regional Safety committee
Committee composed by 4 experts in Pharmacovigilance from Morocco, Ghana, Nigeria and India
Secretariat : WHO and LSHTM representative
Role of the committee:
To analyse SMC safety data from early roll-out programmes, including the ACCESS-SMC project
To make recommendations on alternative methods of safety data collection and reporting to the  WHO Advisory Committee on Safety of Medicinal Products (ACSoMP)
First meeting in June 2016 and next meeting scheduled in March 2017 to discuss 2016 SMC safety data
ACSOMP Advisory committee on safety of medecinal products ACSoMp is the WHO Advisory Committee on Safety of Medicinal Products.

8. 2017 Progress All countries have VIGIFLOW access
National authorities are well informed in all countries
All countries are reporting events
Mainly minor events such as vomiting, fever, etc
Chad joined WHO PV system
Gambia full member of WHO

9. Number of ADRs due to SP/AQ (SMC) in vigibase
WHO TDR funded PV study
Increase in the number of AE reported by the countries – proxi measure that tell that the system was strengthen
Report from almost all countries in the region
High number of events reported in Senegal because of a study conducted in the countries to enhance PV reporting
Burkina Faso; Cameroon; Ghana; Guinea; Mali; Niger; Nigeria; Senegal; Togo

10. Global SMC data for under 5yrs (vigibase)
Country
All ADRs
SMC ADRs
Burkina Faso
412
282
Cameroon 46
Ghana
2 861 13
Guinea 33 2
Mali
114 34
Niger
350
302
Nigeria
10 632
Senegal
1 215
603
Togo
311
According to data, there is no relationship between the number of Individual Cases Safety Reports (ICSRs) and the SMC implementation( Ex Nigeria : number 1 in ADRs report but only 13 SMC cases
What are the causes of SMC underreporting : Collecting data ? Or transmission of data ?

11. Serious Adverse Events reported so far
Countries
Serious Adverse Events reported so far
SAEs outcome
Burkina Faso
3 (1 oedema, 1 dyspnea and 1 drowsiness)
recovered
Chad
1 (oedema)
Cameroon
Gambia
1 (Extra pyramidal syndrome ), 2 jaundice
Ghana
2 Guineas
Mali
Niger
21 (1 EP)
Nigeria 6
Senegal*
7 (2 Stevens johnson Sd, 1 Lyell Sd, 1 EP, 3 allergic shock)
Togo
Based on approx 95 millions SMC treatment administered
Il faut mettre à jour les données

12. Problems detected by analysing cases
Duplication of cases
Quality of the reporting form
Quality of data collected
Severity not reported
The time of onset
Causality assessment (ex: vomiting <30min related to the taste of drugs)
Need to :
Improve the countries reporting form to collect all critical data for analysis
Develop methods at country level to detect duplication
Train PV inputability committee on causality assessment

13. Conclusion SMC safe and seems well tolerated
SMC is an opportunity to strengthen PV system in African countries
Since 2014 progress were done in SMC countries but more need to be done
Additional resources are needed for Countries to adequately monitoring safety during Mass Drug Administration campaign such as SMC
Public health programmes should include funds for PV and PV centres in their budget
New technologies such as smartphones can be used to establish safety profile for SMC or other new public health interventions
For new public health programmes, new technologies can be used to establish safety profile

14. Thanks Communities WHO TDR National PV centres NMCPs,
Regional PV centres , Morocco, Ghana
WHO Safety department
PMI USAID, UNITAID, Unicef, GF, WB
Wellcome trust
UCAD, LSHTM, MRTC, CERMES, IRSS, UGAN, MRC
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