Title
Adverse drug reaction reporting and monitoring: A review of global practices
Authors
Nehal Mohsin*, Ali Mohammed Alyami, Ibrahim Mohammed Al Salamah, Ali Mohammed Al Shermah, Khalid Mohammed Alharthi, Turki Morshed Alyami, Hussain Abbas Almakrami, Hassan Hussain Mohammed Muqmish & Ibrahim Jaber Ali Sarrar
Affiliation
Department of Pharmacology, College of Pharmacy, Najran University, Najran, Saudi Arabia; *Corresponding author
Nehal Mohsin - E-mail: nmmohsin@nu.edu.sa
Ali Mohammed Alyami - E-mail: Alimyami6@gmail.com
Ibrahim Mohammed Al Salamah - E-mail: ibrahimalslamah7@gmail.com
Ali Mohammed Al Shermah - E-mail: ali.alsharmah.pro@gmail.com
Khalid Mohammed Alharthi - E-mail: khalid.m.alharthii@gmail.com
Turki Morshed Alyami - E-mail: trkymrshd8@gmail.com
Hussain Abbas Almakrami - E-mail: hussainalmakrami7@gmail.com
Hassan Hussain Mohammed Muqmish - E-mail: hassanm1669@gmail.com
Ibrahim Jaber Ali Sarrar - E-mail: sooba1829@gmail.com
Article Type
Review
Date
Received November 15, 2025; Revised December 15, 2025; Accepted December 15, 2025, Published December 15, 2025
Abstract
The negative drug reactions (ADRs) are a major challenge to the global health due to their contribution to morbidity and mortality as well as the increased healthcare expenditure. Therefore, it is of interest to explore the international contextual situation of ADR reporting and monitoring systems, their development, their presence in the market, and their future perspectives. The review provides an overview of different pharmacovigilance frameworks put in place by international organizations and national regulatory bodies and their weaknesses and strengths. It was found that despite the tremendous progress achieved in the formation of global pharmacovigilance networks, much still needs to be done in the detection, reporting, and prevention of ADRs especially in the low and middle-income countries. The review identifies new trends and possible innovations that can change ADR monitoring in the decade and provide patient-centered reporting, integrate real-world evidence, and predictive toxicology methods.
Keywords
Adverse drug reactions, pharmacovigilance, drug safety monitoring, spontaneous reporting, regulatory systems, patient safety, global health
Citation
Mohsin et al. Bioinformation 21(12): 4435-4442 (2025)
Edited by
Vini Mehta
ISSN
0973-2063
Publisher
License
This is an Open Access article which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. This is distributed under the terms of the Creative Commons Attribution License.
