Analysis of voluntary reported adverse drug reactions in a tertiary care hospital
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20231119Keywords:
Adverse drug reactions, Completeness of ADR form, Pharmacovigilance, Spontaneous reportingAbstract
Background: Adverse drug reactions are the major cause for increased hospital stay and it increases the economic burden of the patients. Reporting of ADR helps in signal generation and to ensure safe use of a drug. Present study was conducted to analyse the ADR reporting pattern and completeness of the ADR forms.
Methods: This was a retrospective study conducted for 6 months in a tertiary care hospital. A total of 330 ADR forms were analysed and completeness of ADR forms were assessed.
Results: A total of 330 ADRs were reported. 46% ADRs were reported in 2018, 23% in 2019, 11% in 2020, 8.9% in 2021 and 10.7% in 2022. 177 (53%) were males and 153 (47%) were females. Most occurred reaction was Hyponatremia 22 (6%), followed by Hypokalaemia 18 (5%). Neuropsychiatry cases were 62 (18.78%), Urinary system cases were 45 (13.63%). 122 (88%) patients were taking concomitant drugs whereas only 17 (12%) patients were not taking. Above 80% completeness were seen in 155 (46.96%) forms. Above 70% completeness in 292 (88.68%) forms.
Conclusions: ADRs occurrence was high in male compared to female. Most of the ADRs affected Neuropsychiatry followed by Urinary system. Antimicrobials are responsible for majorly reported ADRs followed by cephalosporins (17.6%) and Penicillin (11.76%). Overall completeness of reported ADR form was 80%, 67.87% of forms were not adequately filled with mandatory fields.
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References
Sharma M, Baghel R, Thakur S, Adwal S. Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7-year surveillance study. BMJ. 2021;11(10):e052737.
Shanmugapriya S, Bhuvaneswari K, KarthikaP, Audit to evaluate the completeness of adverse drug reporting in an ADR monitoring centre in Tamil Nadu. Indian J Med Spec. 2017;8(4):175-8.
Debellis K, Field TS, Gurwitz JH, Harrold LR, Rothschild J, Seger AC. Incidence, and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 2003;289(9):1107-16.
Giardina C, Cutroneo PM, Mocciaro E, Russo GT, Mandraffino G, Basile G, et al. Adverse drug reactions in hospitalized patients: results of the FORWARD (facilitation of reporting in hospital ward) study. Front Pharmacol. 2018;4(11)9:350.
Shakur AA, Roy SS, Mohan L, Kumar M, Mishra H, Dikshit H, Likhitkar M. Analysis of reporting of adverse drug reactions in a tertiary care hospital: One year survey. Int J Comprehens Adv Pharmacol. 2020; 3(15):25-30.
Venkatasubbaiah M, Reddy PD, Satyanarayana SV. Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital. Alexand J Med. 2018; 54(4):597-603.
Prasad RV, Pasha MM, Fatima A, Deepalatha C. A demographic study on gender related differences in adverse drug reactions of a tertiary care teaching hospital. Int J Commun Med Public Health. 2017;4(7): 2344-7.
Mayathevar B, Thiyagarajan D, Soundararajan T, Vallish BN, Rizwan SA. A prospective study on adverse drug reactions reported in a tertiary referral hospital. Int J Basic Clin Pharmacol. 2017;6(1):25.
Sahay M, Sahay R. Hyponatremia: A practical approach. Indian journal of endocrinology and metabolism. Alexand J Med. 2014;18(6):760
Liamis G, Milionis H, Elisaf M. A review of drug-induced hyponatremia. Am J Kidney Dis. 2008;52(1): 144-53.
Agrawal M, Singh P, Joshi U. Antimicrobials associated adverse drug reaction profiling: a four-year retrospective study (Pharmacovigilance study). Alexand J Med. 2021;57(1):177-87
Yu YM, Shin WG, Lee JY, Choi SA, Jo YH, Youn SJ, et al. Patterns of adverse drug reactions in different age groups: analysis of spontaneous reports by community pharmacists. PloS one. 2015;10(7):e0132916.
Raja S. Pattern of adverse drug reactions in a tertiary care teaching hospital: a cross-sectional study. Asian J Pharma Clin Res. 2017;10(3):170-3.
Osanlou R, Walker L, Hughes DA, Burnside G, Pirmohamed M. Adverse drug reactions, multimorbidity and polypharmacy: a prospective analysis of 1 month of medical admissions. BMJ. 2022; 12(7):e055551
Mahajan MM, Thatte UM, Gogtay NJ, Deshpande S. An analysis of completeness and quality of adverse drug reaction reports at an adverse drug reaction monitoring centre in Western India. Perspect Clin Res. 2018;7;9(3):123-6.
Thomas EJ, Brennan TA. Incidence and types of preventable adverse events in elderly patients: population-based review of medical records. BMJ. 2000;320:741-4.
Shamna M, Dilip C, Ajmal M, Linu MP, Shinu C, Jafer CP, et al. prospective study on adverse drug reactions of antibiotics in a tertiary care hospital. Saudi Pharm J. 2014;22:3038.