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Evolution of adverse drug reactions reporting systems: paper based to software based

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Abstract

Objective

Adverse Drug Reactions (ADR) add a significant clinical and economic burden to the healthcare system of a country. We present an overview of the different approaches of ADR reporting systems worldwide and their evolution over time.

Methods

A systematic review of the literature was made based on PubMed and the Cochrane database of systematic reviews. The articles searched for included original articles, WHO and FDA reports and institute of medicine reports.

Summary

Reporting ADRs is the cornerstone of detecting uncommon ADRs once the drugs are on the market. In many countries, ADR reporting is regulated by national regulatory bodies and various methods are employed to report ADRs. Direct reporting by healthcare professionals has been adopted by many developed and developing countries. With emerging new technologies in the field of medicine, there is a great potential to develop better ADR reporting systems in the countries where they have poor reporting.

Conclusion

Development and acquisition of newer technologies to promote ADR monitoring and reporting is a necessity for an effective pharmacovigilance system in a country.

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Authors and Affiliations

  1. Department of Pharmacology, Faculty of Medicine, University of Ruhuna, Matara, Sri Lanka

    M. T. Madhushika, P. L. G. C. Liyanage & S. S. Jayasinghe

  2. Department of Medicine, Faculty of Medicine, University of Ruhuna, Matara, Sri Lanka

    T. P. Weerarathna

Authors
  1. M. T. Madhushika
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  2. T. P. Weerarathna
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  3. P. L. G. C. Liyanage
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  4. S. S. Jayasinghe
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Contributions

T.P. Weerarathna conceived the idea. M.T. Madhushika wrote the first and subsequent drafts. T.P. Weerarathna, P.L.G.C Liyanage, and S.S. Jayasinghe developed the ideas. All the authors read and approved the final article.

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Correspondence to M. T. Madhushika.

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Madhushika, M.T., Weerarathna, T.P., Liyanage, P.L.G.C. et al. Evolution of adverse drug reactions reporting systems: paper based to software based. Eur J Clin Pharmacol 78, 1385–1390 (2022). https://doi.org/10.1007/s00228-022-03358-3

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