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All-round approaches to increase adverse drug reaction reports: a scoping review

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Abstract

Introduction

Medicines are among the most effective technologies for reducing mortality and morbidity. Adverse drug reactions (ADRs) are a well-recognised public health problem and a major cause of hospitalisation and death. Even though the evaluation of the safety of drugs is performed throughout the entire life cycle of a given compound, the postmarketing phase still displays a chief role. In this sense, the surveillance of drug reactions through pharmacovigilance (PV) systems is indispensable. Yet, underreporting is a major issue that undermines the effectiveness of spontaneous reports. This work presents a scoping review on the use of information systems and strategies used to promote ADR reporting by health professionals and patients.

Methods

A scoping review was conducted under Arksey and O’Malley’s framework. A search on the PubMed (MEDLINE), Scopus and Cochrane databases was conducted from 2005 until 2022. Articles with a focus on the spontaneous reporting of ADRs were included. Peer-reviewed published studies from any region in the world conducted with a qualitative, quantitative, or mixed-methods design focused on the research questions were eligible for inclusion. The reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. Two independent reviewers performed standardised data extraction and synthesis.

Results

This work discloses six strategies aimed to improve the collection of ADR reports, namely economic incentives, educational interventions for health professionals and patients, media attention, the use of social networks in the proactive search for ADRs, applications for smartphones and campaigns. These strategies allowed PV systems evolution, enabling the early detection of serious ADRs by industry and regulators. Creating strategies that enable patients’ involvement are highlighted across PV systems.

Conclusion

The future path in drug safety solely depends on proactive PV approaches carried out by all stakeholders, where patients play a vital role in ADR reporting. The implementation of innovative methods is essential to encourage ADR reporting.

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Authors and Affiliations

  1. Polytechnic Institute of Coimbra, ESTeSC-Coimbra Health School, 3046-854, Coimbra, Portugal

    João Joaquim, Cristiano Matos & Diana Guerra

  2. Department of Pharmaceutical Sciences, Pharmacy Faculty, University of Salamanca (USAL), 37007, Salamanca, Spain

    João Joaquim

  3. Area of Preventive Medicine and Public Health, Department of Biomedical and Diagnostic Sciences, University of Salamanca, Salamanca, Spain

    Ramona Mateos-Campos

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  1. João Joaquim
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Correspondence to João Joaquim.

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João Joaquim, Cristiano Matos, Diana Guerra, and Ramona Mateos-Campos declare no conflicts of interest.

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Conceptualisation: JJ and CM. Methodology: JJ, CM and RM-C. Writing – original draft preparation: JJ. Writing – review and editing: JJ, CM, DG and RM-C. All authors have read and agreed to the published version of the manuscript.

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Joaquim, J., Matos, C., Guerra, D. et al. All-round approaches to increase adverse drug reaction reports: a scoping review. Drugs Ther Perspect 39, 249–261 (2023). https://doi.org/10.1007/s40267-023-01000-5

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