Adverse Drug Reactions and Pharmacovigilance: A Narrative Mini-review of Relevant Literature

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Tahani Mohammed Ali Bakhsh
Anas Hakem Al Baloshi
Hassan Mohammed Ali Bakhsh
Dalal S. Al-Dosaari
Naseem Akhtar Qureshi


Background: Adverse drug reactions (ADRs) are known to cause significant morbidity and mortality around the world, and, therefore, need precise terminology and prevention strategies to reduce the global burden on public health and increase safety of patient population. Pharmacovigilance is a powerful tool that detects, assesses and analyses spontaneously reported suspected serious and non-serious ADRs by healthcare professionals and patients, and provides important insights for preventing ADRs in healthcare settings. Poor quality reports and underreporting of ADRs limit the efficiency of pharmacovigilance.

Objective: The aim of this mini-review is to describe precisely definitions of ADRs, adverse drug events (ADEs) and other related terms, their underreporting, pharmacovigilance, and how to optimize ADRs reporting by professionals and patients to pharmacovigilance.

Methods: Electronic searches of relevant databases were conducted using keywords for retrieving relevant articles for inclusion in this study.

Results: Several studies and healthcare organizations have clearly defined ADRs and ADE. Underreporting and poor quality reporting of ADRs remains a global problem. Continuous training of professionals and patients in ADR reporting to PV is one of the best strategies to optimize the spontaneous reporting of ADRs to pharmacovigilance for early signal detection and prevention of ADRs.

Conclusion: The standardized use of ADRs terminology tends to focus attention on efforts aimed at eliminating preventable harm from ADEs. ADRs associated with high economic costs need to be prevented by optimal, better quality reporting of ADRs to pharmacovigilance. The key role of healthcare professionals and patients to report ADR spontaneously need no overemphasis and all stakeholders need continuous training in ADRs and pharmacovigilance.


Adverse reactions, drug-related side-effects, pharmacovigilance, drug monitoring, adverse drug reaction reporting systems

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How to Cite
Mohammed Ali Bakhsh, T., Hakem Al Baloshi, A., Mohammed Ali Bakhsh, H., S. Al-Dosaari, D., & Akhtar Qureshi, N. (2016). Adverse Drug Reactions and Pharmacovigilance: A Narrative Mini-review of Relevant Literature. Journal of Advances in Medical and Pharmaceutical Sciences, 11(1), 1-18.
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