DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20210554

Adverse drug reaction monitoring study in hospitalized patients: support for pharmacovigilance at a tertiary care hospital

Chandrabhan ., Pushpawati Jain, Shipra Jain

Abstract


Background: Adverse drug reaction (ADR) reporting is an integral component of pharmacovigilance. However, under-reporting of ADR is commonly observed. The present study has been planned with aim to assess the pattern of reported ADRs in terms of its frequency, causality and severity so as to reinforce pharmacovigilance activities.

Methods: This prospective observational study was conducted with the aim to evaluate suspected ADRs in hospitalized patients in departments of Medicine, Surgery and Orthopaedics of a tertiary care hospital in North India for a period of 6 months. The ADRs were assessed in terms of the demographic parameters, organ system affected, drugs implicated, type of ADRs by Rawlin’s and Thompson classification, causality using WHO-UMC scale and severity of ADR by Modified Hartwig’s and Siegel scale.

Results: A total of 111 ADRs were reported during the study period. There was male preponderance (54.96%) with majority of ADRs in age group of 18-60 years (79.28%). Gastrointestinal system was most commonly affected (36.36%). The most common drug implicated in causing ADRs was Ceftriaxone (11.71%). Majority of ADRs were Type A reactions (86.49%). Causality assessment using WHO-UMC scale depicted that 74.77% of ADRs were possible. Severity analysis showed that 82.88% of ADRs were mild as per Modified Hartwig’s and Siegel scale.

Conclusions: ADR reporting should be encouraged among health-care professionals, para-medical staff and patients in general so that the ultimate goal of pharmacovigilance can be fulfilled.


Keywords


Adverse drug reaction, Reporting, Pharmacovigilance, Causality, Severity

Full Text:

PDF

References


Tripathi KD. Essentials of Medical Pharmacology. 7th ed. New Delhi: JP Brothers. 2018;82-91.

Zhang M, Holman CDJ, Preen DB, Brameld K. Repeat adverse drug reactions causing hospitalization in older Australians: a population-based longitudinal study 1980-2003. Br J Clin Pharmacol. 2007;63:163-70.

Kaur S, Kapoor V, Mahajan R, Lal M, Gupta S. Monitoring of incidence, severity, and causality of adverse drug reactions in hospitalized patients with cardiovascular disease. Indian J Pharmacol. 2011;43(1):22-6.

Lihite RJ, Lahkar M. A Study on Cutaneous Adverse Drug Reactions in ADR Monitoring Centre of Tertiary Care Hospital, Guwahati. J App Pharm Sci. 2013;3 (03):079-081.

Pushkin R, Frassetto L, Tsourounis C, Segal ES, Kim S. Improving the reporting of adverse drug reactions in the hospital setting. Postgrad Med. 2010;122:154-64.

Irujo M, Beitia G, Bes-Rastrollo M, Figueiras A, Hernández-Díaz S, Lasheras B. Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug Saf. 2007;30:1073-82.

Hazell L, Shakir SA. Under-reporting of adverse drug reactions: A systematic review. Drug Saf. 2006;29:385-96.

Kaufman G. Adverse drug reactions: Classification, susceptibility, and reporting. Nurs Stand. 2016;30:53-63.

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.

Laila KV, Hemalatha T. Awareness of adverse drug reactions reporting among doctors in a tertiary care center. Int J Basic Clin Pharmacol. 2016;5:2236-9.

Rao PG, Archana B, Jose J. Implementation and results of an adverse drug reaction reporting programme at an Indian teaching hospital. Indian J Pharmacol. 2006;38:293-4.

Pharmacovigilance Programme of India. Available at https://ipc.gov.in/images/ADR-Reporting-Form1.3.pdf. Last accessed on 8th July, 2020.

The use of the WHO-UMC system for standardised case causality assessment. Available at https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf. Last accessed on 8th July, 2020.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.

Rawlins MD, Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM (ed) Textbook of adverse drug reactions. Oxford: Oxford University Press. 1977;10-17.

Swamy S, Bhanuprakash NP, Muralimohan SM. Profile of suspect adverse drug reactions in a teaching tertiary care hospital. J Pharmacol Clin Toxicol. 2013;1(1):1005.

Ponnusankar S, Tejaswini M, Chaitanya M. Assessment of adverse drug reactions based on spontaneous signals at secondary care public hospital. Ind J Pharm Sci. 2015;77(4):490-3.

Kharb P, Mittal N, Gupta MC. An evaluation of adverse drug reactions monitoring at a pharmacovigilance unit under pharmacovigilance programme of India in a tertiary care hospital of Haryana. Int J Basic Clin Pharmacol. 2015;4:556-60.

Stavreva G, Pendicheva D, Pandurska A, Marev R. Detection of adverse drug reactions to antimicrobial drugs in hospitalized patients. Trakia J Sci. 2008;6(1):7-9

Chakraborty A, Ray D, Ghosh R, Roy N, Bhattacharje S. Pattern of adverse drug reactions reporting in two medical colleges of Tripura, India: a cross sectional study. Int J Basic Clin Pharmacol. 2017;6:1372-6.

James J, Rani J. A Prospective Study of Adverse Drug Reactions in a Tertiary Care Hospital in South India. Asian J Pharm Clin Res. 2020;13(1):89-92.