Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles

Noha Iessa, Viola Macolic Sarinic, Lilit Ghazaryan, Naira Romanova, Asnakech Alemu, Watcharee Rungapiromnan, Porntip Jiamsuchon, Pattreya Pokhagul, Jose Luis Castro, Diego Macias Saint-Gerons, Gayane Ghukasyan, Mengistab Teferi, Madhur Gupta and Shanthi Narayan Pal ()
Additional contact information
Noha Iessa: World Health Organization Headquarters
Viola Macolic Sarinic: World Health Organization Headquarters
Lilit Ghazaryan: Scientific Centre of Drug and Medical Technology Expertise of MoH
Naira Romanova: Scientific Centre of Drug and Medical Technology Expertise of MoH
Asnakech Alemu: Ethiopian Food and Drug Administration
Watcharee Rungapiromnan: Thai Food and Drug Administration
Porntip Jiamsuchon: Thai Food and Drug Administration
Pattreya Pokhagul: Thai Food and Drug Administration
Jose Luis Castro: Pan American Health Organization
Diego Macias Saint-Gerons: INCLIVA-CIBERSAM
Gayane Ghukasyan: WHO Country Office
Mengistab Teferi: World Health Organization Country Office
Madhur Gupta: WHO Country Office
Shanthi Narayan Pal: World Health Organization Headquarters

Drug Safety, 2021, vol. 44, issue 10, No 7, 1085-1098

Abstract: Abstract Introduction The Smart Safety Surveillance (3S) concept is based on the understanding that, when faced with competing pharmacovigilance priorities, countries will have to invest judiciously, by focusing on new priority products, sharing work and resources with other countries when possible and building national competence for those activities that cannot be delegated. Method The 3S principles were applied to Armenia, Brazil, Ethiopia, India, Peru and Thailand using three priority products: bedaquiline, rotavirus vaccine and tafenoquine. A baseline assessment of pharmacovigilance preparedness was used to identify gaps and establish a work plan. The impact was measured by comparing pre and post 3S-intervention outcomes, which included the number and quality of reports (completeness scores) in the WHO global database of Individual Case Safety Reports, VigiBase, and number of structural indicators met. The implementation period was 9–18 months, ranging from March 2018 (earliest started) until May 2020 (latest). Result An increase in adverse drug reaction (ADR) reporting was demonstrated in Armenia (bedaquiline), Brazil (TB and malaria medicines), India (rotavirus vaccine) and Ethiopia (TB medicines). Completeness scores were above 0.5 at baseline in all countries, and reports improved in quality for Brazil (TB), Peru (malaria), Thailand (malaria) and India (immunization). The number of structural indicators met increased by more than double for Ethiopia. Ethiopia and India demonstrated an increased capacity for signal detection and signal evaluation. Armenia, Brazil, Peru and Thailand showed increased capacity to assess risk management plans following the implementation of 3S principles. Conclusion The 3S concept has demonstrated success in different ways across the six countries. Activities focused on three products for a proof of concept of the 3S principles, with the expectation that the project impact will be sustained through strengthened systems, to guide pharmacovigilance activities of other products in the future. It is important to continue monitoring the countries to understand if the gains and successes of the current 3S project are sustainable.

Date: 2021
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DOI: 10.1007/s40264-021-01100-z

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