Authors : Dr. P. Praveen Kumar; Dr. S. K. Senthil Kumar; S. Tamil Priya; V. Tamilarasan; S. Thamizharasi; K. Vaishnudevi

Volume/Issue : Volume 11 - 2026, Issue 2 - February

Google Scholar : https://tinyurl.com/39nut5bx

Scribd : https://tinyurl.com/5n7h9jxd

DOI : https://doi.org/10.38124/ijisrt/26feb1189

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.

Abstract : Background: Adverse Drug Reactions (ADRs) remain a critical challenge in clinical therapeutics, significantly impacting global morbidity, mortality, and healthcare costs. In the Indian context, the Pharmacovigilance Programme of India (PvPI) serves as the primary regulatory framework for identifying and mitigating these risks.  Objective: This study aimed to evaluate the incidence, clinical patterns, and severity of suspected ADRs, perform rigorous causality assessments, and implement a structured pharmaceutical counseling framework to enhance medication safety in a tertiary care setting.  Methodology: A prospective, non-interventional observational study was conducted across the Inpatient Departments (IPD) of Orthopedics and General Surgery at Arunai Medical College and Hospital (October 2025–February 2026). Out of 728 screened patient records, suspected ADRs were documented using the CDSCO reporting tool. Causality was validated via the WHO-UMC scale and Naranjo’s Probability Scale, while severity was stratified using the Modified Hartwig and Siegel Scale.  Results: A total of 80 ADRs were identified, representing an incidence rate of 10.98%. Demographic analysis revealed a male predominance (63.75%) and a higher susceptibility within the geriatric and middle-aged cohorts (mean age: 53.6 \pm 21.1 years). Antimicrobials (23.75%) and Analgesics (15%) were identified as the primary pharmacotherapeutic triggers. The most frequent clinical manifestations were gastrointestinal (39.2%), with constipation being the predominant symptom. Severity assessment categorized 56.25% of reactions as "Mild" and 43.75% as "Moderate." Causality analysis classified the majority of cases (66.25%) as "Probable."  Conclusion: The study underscores a notable ADR burden in surgical and orthopedic settings, frequently exacerbated by polypharmacy. These findings advocate for an integrated pharmacovigilance approach—led by clinical pharmacists— emphasizing active surveillance and patient education to pre-emptively manage medication-related risks and optimize therapeutic outcomes.

Keywords : Adverse Drug Reaction, Pharmacovigilance, Patient Counseling, PvPI, Suspected Drug.

References :

1. Indian Pharmacopoeia Commission, Ministry of health and family welfare, Govt. of India. Available: www.ipc.gov.in
2. World Health Organization, Quality Assurance and Safety of Medicines Team. The safety of medicines in public health programmes: pharmacovigilance, an essential tool [Internet]. Geneva: World Health Organization; 2006 [cited 2021May1]. Available from:https://apps.who.int/iris/handle/10665/43384.
3. Fitzgerald P. Pharmacovigilance inspections. Indian J Pharmacol. 2008; 40:21-3
4. Olsson S. Pharmacovigilance training with focus on India. Indian J Pharmacol. 2008; 40:28-30.
5. Vivekanandan K, Thota P, Venkatraman Janarthanan V, et al. Pharmacovigilante’s in the Pharmacovigilance Programme of India: Ideal Qualities and Skills. JYP 2016; 8:291–2.
6. The use of the WHO–UMC system for standardised case causality assessment. Available: http://www.WHO-UMC.org/graphics/4409.pdf [Accessed 08 Apr 2021].
7. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruis I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther.1981;30:239–45.
8. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm1992; 49:2229–32.
9. Mittal N, Mittal R, Gupta MC. An overview of the pharmacovigilance system in India. Clin Res Regul Aff 2016; 33:4–8.
10. Nirojini PS, Yemineni R, Nadenla RR. Monitoring and reporting of adverse drug reactions in a South Indian tertiary care hospital. Int J Pharm Sci Rev Res 2014; 24:259–62.
11. Tandon VR, Mahajan V, Khajuria V, et al. Under-Reporting of adverse drug reactions: a challenge for pharmacovigilance in India. Indian J Pharmacol 2015; 47:65–71.
12. Kalaiselvan V, Mishra P, Singh GN. Helpline facility to assist reporting of adverse drug reactions in India. WHO South East Asia J Public Health 2014; 3:194.
13. Kalaiselvan V, Prasad T, Bisht A, Singh S, Singh GN. Adverse drug reactions reporting culture in pharmacovigilance programme of India. Indian J Med Res 2014; 140:563-4.
14. Schumock GT, Seeger JD, Kong SX. Control charts to monitor rates of adverse drug reactions. Hosp Pharm 1995; 30:1088–91.
15. Daulat MP, V. J. AA, Singh P, et al. A prospective study of adverse drug reactions in a tertiary care teaching hospital. Int J Basic Clin Pharmacol 2018; 7:1965–9.
16. Ramakrishnaiah Het al. International Journal of Basic & Clinical Pharmacology. Int J Basic Clin Pharmacol 2015; 4:515–21.
17. Singh P, Agrawal M, Hishikar R, et al. Adverse drug reactions at adverse drug reaction monitoring center in Raipur: analysis of spontaneous reports during 1 year. Indian J Pharmacol2017; 49:432–7.
18. Thakare VS, Kavitha VD, Langade D. Prospective observational study to evaluate adverse drug reactions pattern in a tertiary level teaching hospital. Natl J Physiol Pharm Pharmacol 2019; 9:434–7.
19. Wester K, Jönsson AK, Spigset O, et al. Incidence of fatal adverse drug reactions: a population-based study. Br J Clin Pharmacol2008; 65:573–9.
20. Fitzgerald P. Pharmacovigilance inspections. Indian J Pharmacol. 2008; 40:21-3.
21. Olsson S. Pharmacovigilance training with focus on India. Indian J Pharmacol.  2008; 40:28-30.
22. The use of the WHO-UMC system for standardized case causality assessment. Available at: https://www.who-umc.org/media/2768/standardisedcase-causality-assessment. Accessed 3 September2017.
23. Lobo MG, Pinheiro SM, Castro JG, Momenté VG,Pranchevicius MC. Adverse drug reaction monitoring:Support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacol Toxicol.2013;14:5.
24. Dutta SB, Beg MA, Bawa S, Anjoom M, Varma A,Singh NK. A retrospective analysis of adverse drug reactions in a tertiary care teaching hospital at Dehradun, Uttarakhand. Int J Basic Clin Pharmacol.2015;4(1):121-4.
25. Subbanna PK, Chandy SJ. The role of active surveillance in improving the hospital adverse drug event reporting. Indian J Pharmacol. 2006; 38:363-4.
26. Miller MA. Gender-based differences in the toxicity of pharmaceuticals - the food and drug Administration’s perspective. Int J Toxicol. 2001;20(3):149-52.
27. 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.
28. World Health Organization. International Drug Monitoring: The Role of National Centres, Technical Report Series No. 498. Geneva: World Health Organization; 1972.
29. Vivekanandan K, Rishi K, Prasad T, Arunabh T, Singh GN. Status of documentation grading and completeness score for Indian individual case safety reports. Indian J Pharmacol 2015; 47:325-7.
30. Mulchandani R, Kakkar AK. Reporting of adverse drug reactions in India: A review of the current scenario, obstacles, and possible solutions. Int J Risk Saf Med 2019; 30:33-44.
31. Khan F, Nizamuddin S, Huda N, Mishra H. A prospective study on prevalence of adverse drug reactions due to antibiotics usage in otolaryngology department of a tertiary care hospital in North India. Int J Basic Clin Pharmacol 2013; 2:548-53.
32. Roy D, Purkayastha A, Tigga R. Analysis of Adverse Drug Reaction in A Tertiary Care Hospital: A Retrospective Study. Asian J Pharm Clin Res. 2016;10(1):347-52.
33. Agrawal M, Singh P, Hishikar R, Joshi U, Maheshwari B, Halwai A. Adverse drug reactions at adverse drug reaction monitoring center in Raipur: Analysis of spontaneous reports during 1 year. Indian J Pharmacol. 2017;49(6):432-6.
34. Daulat MP, Ambika VJ, Singh P, Raj B. A prospective study of adverse drug reactions in a tertiary care teaching hospital. Int J Basic Clin Pharmacol 2018; 7:1965-9.
35. Amrita P, Singh S. Status of spontaneous reporting of adverse drug reaction by physicians in Delhi. Indian J Pharm Pract. 2011;4(2):29-36.
36. K Patel T, B Patel P. Incidence of adverse drug reactions inIndian hospitals: A systematic review of prospective studies. Current drug safety. 2016;11(2):128-36.
37. Dhikav V, Singh S, Anand K. Adverse drug reaction monitoring in India. J Indian Acad Clin Med. 2004;5(1):27-33.
38. Murphy BM, Frigo LC. Development, implementation and results of a successful multidisciplinary adverse drug reactions reporting program in a university teaching hospital. Hosp Pharm 1993; 28: 1199–204.
39. Claven DC, Pestornik SL, Evans RS, Lloyd JE, Duke JP. Adverse drug events in hospitalized patients. JAMA 1997; 277: 301–6.
40. Puche Canas E, Luna Jde D. Adverse drug reactions: an update review of the problem in Spain. Rev Clin Esp 2006; 206: 336–9.
41. Malhotra S, Jain S, Pandhi P. Drug-related visits to the medical emergency department: a prospective study from India. Int J Clin Pharmacol Ther 2001; 39: 12–8.
42. Malhotra S, Karan RS, Pandhi P, Jain S. Drug related medical emergencies in the elderly: role of adverse drug reactions and non-compliance. Postgrad Med J 2001; 77: 703–7.
43. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006; 29: 385–96.
44. Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf 2006; 16: 223–8.
45. Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a south Indian hospital – their severity and cost involved.Pharmacoepidemiol Drug Saf 2003; 12: 687–92.