ArticleDrug safety2021
Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles.
Article in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Improving adverse drug event reporting by healthcare professionals.The Cochrane database of systematic reviews · 2024Pooled it
- CARDIO4Cities: from global evaluation framework to local monitoring in Dakar and São Paulo.BMC public health · 2026Article
- Zimbabwe adverse events following immunisation surveillance system: A descriptive study with COVID-19 vaccine safety updates.Southern African journal of infectious diseases · 2026Article
- Strengthening New Vaccine Introduction in Low- and Middle-Income Countries: Establishing Hospital-Based Sentinel Surveillance for Vaccine Safety Monitoring.The American journal of tropical medicine and hygiene · 2025Article
- Article
- Building functional and sustainable pharmacovigilance systems: an analysis of pharmacovigilance development across high-, middle- and low-income countries.Therapeutic advances in drug safety · 2025Article
- Pharmacovigilance processes in low- and middle-income countries: moving from data collection to data analysis and interpretation.Therapeutic advances in drug safety · 2025Article
- Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa.BMC public health · 2022Article
- Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience.BMC medical informatics and decision making · 2022Article
- Strengthening therapeutic adherence and pharmacovigilance to antimalarial treatment in Manaus, Brazil: a multicomponent strategy using mHealth.Malaria journal · 2022Article
- Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World.Clinical pharmacology and therapeutics · 2022Review
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
introductionThe 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.
methodThe 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).
resultAn 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.
conclusionThe 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.
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