PATTERN OF SERIOUS ADVERSE DRUG EVENTS (SAES) REPORTED TO AN ADR MONITORING CENTRE IN A TERTIARY CARE HOSPITAL IN SOUTHERN INDIA
Main Article Content
Keywords
Adverse Drug Reactions, Serious Adverse Drug Reactions, Pharmacovigilance, Drug Safety, Causality, Anticancer Drugs, Antibiotics.
Abstract
Adverse drug reactions (ADRs) are a leading cause of morbidity and mortality in health care and have a significant economic impact on health care resources. Serious ADRs (SADRs) are particularly concerning as they may be life-threatening, require hospitalization, or cause permanent disability and necessitates keen monitoring to improve drug safety. This study aimed to analyze the pattern, severity, and outcomes of SADRs reported to the ADR Monitoring Centre of a tertiary care teaching hospital.
Methods
This cross-sectional, record-based descriptive study was conducted from January 2023 to January 2024 at the ADR Monitoring Centre of the Department of Pharmacology, Government T D Medical College, Alappuzha. Data on SADRs reported during this period were collected, including patient demographics, clinical presentations, suspected drugs, route of administration, severity, causality, and outcomes. The seriousness was categorized by FDA criteria and causality assessed by WHO-UMC scale. Descriptive statistics were used for analysis.
Results
Of 306 ADRs reported, 159 (51.9%) were classified as serious. The mean age of patients was 52.7 ± 17.91 years, with a female-to-male ratio of 1.03:1. The oral route (55.97%) was most common for drug administration. The most frequently affected organ system was the red and white cell, reticuloendothelial system (28.9%), followed by skin and appendages (22.6%). Anticancer drugs (30.8%) were the leading cause of SADRs, followed by antibiotics (26.4%) and antitubercular drugs (17.6%). Among antibiotics, amoxicillin-clavulanic acid combination accounted for 33.3% of cases. Most SADRs (69.8%) occurred within 7 days of drug therapy. Majority of patients (62.89%) were recovering at the time of reporting. WHO-UMC causality assessment showed 72.3% of cases as possible and 27.6% as "probable." Over half (56.6%) of SADRs caused or prolonged hospitalization, while 6.28% were life-threatening.
Conclusion
The study highlights a high occurrence of SADRs, predominantly associated with anticancer and antimicrobial drugs, and mainly affecting hematological and dermatological systems. Early detection and prompt intervention can significantly improve patient outcomes. These findings emphasize the need for enhanced pharmacovigilance, targeted risk minimization strategies, and regular monitoring of high-risk drug groups in clinical practice.
References
[2] World Health Organization. Safety of Medicines A Guide to Detecting and Reporting Adverse Drug Reactions Why Health Professionals Need to Take Actions. Geneva: World Health Organization 2002.
[3] Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta analysis of prospective studies. JAMA 1998;279:1200 5
[4] Atkin PA, Shenfield GM. Medication-related adverse reactions and the elderly: a literature review. Adverse Drug React Toxicol Rev 1995Autumn;14(3):175-91.
[5] Pal SN, Duncombe C, Falzon D, et al. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf. 2013;36(2):75-81.
[6] Singh P, Verma S, Vaishnav Y, et al. Probing the in-depth analysis of Serious Adverse Drug Reactions in a tertiary care hospital of Central India. Explor Res Clin Soc Pharm 2025;17:100579.
[7] Sharma M, Baghel R, Thakur S, et al. Surveillance of adverse drug reactions at an adverse drug reaction monitoring Centre in Central India: a 7-year surveillance study. BMJ Open 2021;11(10):1-8.
[8] Watson S, Caster O, Rochon PA, etal. Reported adverse drug reactions in women and men: aggregated evidence from globally collected individual case reports during half a century. E Clinical Medicine 2019;17:100188.
[9] Zucker I, Prendergast BJ. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biol Sex Differ 2020;11(1):1-14.
[10] Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a south Indian hospital--their severity and cost involved. Pharmacoepidemiol Drug Saf 2003;12(8):687-92.
[11] Durand M, Castelli C, Roux-Marson C, et al. Evaluating the costs of adverse drug events in hospitalised patients: a systematic review. Health Econ Rev 2024;14(1):1-14.
[12] Prajapati K, Desai M, Shah S, et al. An analysis of serious adverse drug reactions at a tertiary care teaching hospital. Perspect Clin Res 2016;7(4):181-6.
[13] Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol 2008;65:210-6.
[14] Ogar CK, Abiola A, Yuah D, et al. A retrospective review of serious adverse drug reaction reports in the Nigerian VigiFlow database from September 2004 to December 2016. Pharmaceut Med 2019;33(2):145–57.
[15] Mouton JP, Fortuin-de Smidt MC, Jobanputra N, et al. Serious adverse drug reactions at two children’s hospitals in South Africa. BMC Pediatr 2020;20(1):3.
[16] Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004;329(7456):15-9.
[17] Koh Y, Kutty FB, Li SC. Drug-related problems in hospitalized patients on polypharmacy: The influence of age and gender. Ther Clin Risk Manag 2005;1:39-48.
[18] Marrero O, Hung EY, Hauben M. Seasonal and geographic variation in adverse event reporting. Drugs Real World Outcomes 2016;3(3):297-306.
[19] Selva P, Durairajan S. Exploration and evaluation of adverse drug reactions documented in a tertiary-Care Hospital in Chennai: an in-depth retrospective observational study. Cureus 2024;16(5):e60977.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.
Dr. Laona Lal
Assistant Professor, Department of Pharmacology, Pushpagiri Institute of Medical Sciences and Research Centre, Thiruvalla, Kerala, India.
Dr. Parvathy V. Nair
Associate Professor, Department of Pharmacology, Government Medical College, Thiruvananthapuram, Kerala, India.
Dr. Moncy Michael
Assistant Professor, Department of Pharmacology, Government T.D. Medical College Alappuzha, Kerala, India.
Dr. Reshma S.
Pharmacovigilance associate, Department of Pharmacology, Government T.D. Medical College, Alappuzha, Kerala, India.