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

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 (complet

SUBMITTER: Iessa N 

PROVIDER: S-EPMC8325038 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature