A study of reporting pattern of adverse drug reactions in a tertiary care teaching hospital

Shailendra Kumar; Rohit Kumar Singh; Raj Narayan Seth; Rani Indira Sinha

doi:10.18203/2319-2003.ijbcp20223355

Authors

Shailendra Kumar Department of Pharmacology, Patna Medical College, Patna, Bihar, India
Rohit Kumar Singh Department of Pharmacology, Patna Medical College, Patna, Bihar, India
Raj Narayan Seth Department of Pharmacology, Patna Medical College, Patna, Bihar, India
Rani Indira Sinha Department of Pharmacology, Patna Medical College, Patna, Bihar, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20223355

Keywords:

Adverse drug reactions, Pharmacovigilance, Individual case safety reports, Health care professionals

Abstract

Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. Identification of ADRs and their reporting pattern can provide useful information for their prevention. Hence this study was done to see the pattern of reported ADRs in Patna Medical College and Hospital, Patna in a 3 months of study.

Methods: It was an observational and retrospective study carried out between July 2022 to September 2022. Both outpatients and inpatients were included in the study. The ADRs in the form of Individual Case Safety Reports (ICSRs) were sent to the nearby adverse drug reaction monitoring centre (AMC).

Results: The occurrence of ADRs was more common in females (56.25%) as compared to males (43.75%). Patients of age-group 21-40 years (40.625%) were most commonly involved. Medicine department (34.375%) reported the maximum percentage of ADRs. Antimicrobials (37.50%) was the most common drug-group causing ADRs. Maximum reported ADRs (81.25%) were probable, 9.375% were possible, 6.25% were certain, while 3.125% were unlikely with the suspected drug as per Naranjo scale.

Conclusions: The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital setup elsewhere, along with a few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.

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Author Biography

Shailendra Kumar, Department of Pharmacology, Patna Medical College, Patna, Bihar, India

PG student, department of Pharmacology.

Patna Medical College, Patna.

References

Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in south Indian hospital-their severity and cost involved. Pharmacoepidemiol Drug Safe. 2003;12(8):687-92.

World Drug Report 2012. Available at: https://www.unodc.org/unodc/en/data-and-analysis/WDR-2012.html. Accessed on 20 December 2021.

McBride WG. Thalidomide and congenital abnormalities. Lancet. 2018;278:1358.

Bégaud B, Chaslerie A, Haramburu F. Organization and results of drug vigilance in France. Rev Epidemiol Sante Publique. 1994;42:416-23.

The importance of pharmacovigilance, safety monitoring of medicinal products. Available at: https://phdessay.com/. Accessed on 20 December 2021.

Sowmyanarayan S, Banerjee S. Monitoring of adverse drug reactions in medicine, paediatric and surgical departments of a tertiary care hospital: a prospective observational study. Int J Basic Clin Pharmacol. 2018; 7:778-82.

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.

Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a south Indian hospital- their severity and cost involved. Pharmacoepidemiol Drug Safe. 2003;12(8):687-92.

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.

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.

Subbanna PK, Chandy SJ. The role of active surveillance in improving the hospital adverse drug event reporting. Indian J Pharmacol. 2006;38:363-4.

Misra D, Bose M, Parida S, Das S, Mishra S, Mishra SS. Adverse drug reaction reporting in a tertiary care teaching hospital in eastern India: a retrospective study. Int J Basic Clin Pharmacol. 2019;8:2322-7.

Singh P, Agrawal M, 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;49:432-7.

Pathak AK, Kumar M, Dokania S, Mohan L, Dikshit H. A Retrospective analysis of reporting of adverse drug reactions in a tertiary care teaching hospital: one-year survey. J Clin Diagnos Res. 2016;10(8):1-4.

Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol. 2007;65(2):210-6.

Akalu SD, Belavadi NG. Pattern of adverse drug reactions due to antibiotics in a tertiary care hospital. Int J Basic Clin Pharmacol. 2017;6:202731.

Gupta PP, Singh S, Mishra R, Manjhi PK. Reporting pattern of adverse drug reactions in a newly set up tertiary care hospital-a preliminary study. Br J Pharm Med Res. 2019;4(3):1913-21.

Badyal DK, Kanish B, Gulrez G. Causality assessment and pattern of adverse drug reactions in a tertiary care hospital. Int J Basic Clin Pharmacol. 2018;7:210-4.

Singh A, Jain A, Soni M, Shukla P, Lahon J, Verma AK. Pattern of adverse drug reactions reported at a tertiary care teaching hospital in northern India. Int J Basic Clin Pharmacol. 2020;9:625-32.