A retrospective analysis of adverse drug reaction reported in a tertiary care hospital

Authors

  • Kirti Saxena Department of Pharmacology, Surat Municipal Institute of Medical Education and Research, Surat, Gujarat, India
  • Chaitali Tailor Department of Pharmacology, Surat Municipal Institute of Medical Education and Research, Surat, Gujarat, India
  • Chaitali Mehta Department of Pharmacology, Surat Municipal Institute of Medical Education and Research, Surat, Gujarat, India
  • Paresh Gajera Department of Pharmacology, Surat Municipal Institute of Medical Education and Research, Surat, Gujarat, India
  • S. K. Srivastava Department of Pharmacology, Surat Municipal Institute of Medical Education and Research, Surat, Gujarat, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20171667

Keywords:

Adverse drug reaction, Pharmacovigilance, UMC scale

Abstract

Background: The adverse drug reactions (ADRs) reported to pharmacovigilance centre in tertiary care hospital was analysed to find out the incidence and causality.

Methods: This was a retrospective study to analyse the ADR reported at pharmacovigilance centre after ethical clearance from Institutional Ethic Committee (IEC). ADR data were analysed and ADRs were categorized as department-wise, system affected and causative drug. The causality of each ADR was assessed by WHO-UMC scale.

Results: The majority of patients who had suffered from ADRs were between 19-64 years of age (94.2%) and male patients (58.6%) were affected more than female (41.4%). Pulmonary medicine department has reported highest number of ADR followed by dermatology department. Skin (46.5%) was most affected system followed by gastrointestinal (30.45%), CNS (21.26%), respiratory (9.0%) and remaining systems. Rifampicin (13.79%) shows the largest numbers of ADR followed by zidovudine (13.21%), nevirapine (12.64%) and diclofenac sodium (8.0%). The maximum ADRs reported were probable (94.8%) followed by possible (5.2%).

Conclusions: In conclusion, the skin was most affected system followed by gastrointestinal, central nervous and respiratory system. Rifampicin has caused maximum ADRs followed by zidovudine, nevirapine and diclofenac sodium. The causality analyses showed that majority of ADRs were probable (94.8%) while remaining falls in possible (5.2%) category.

References

World Health Organization: International drug monitoring; the role of hospital. In technical report series no. 425, Geneva, Switzerland: World Health Organization; 1966:1-25.

Brewer T, Colditz GA, Post marketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA. 1999;281(9):824-9.

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.

Adithan C, The national pharmacovigilance program. Indian J Pharmacol. 2005;37:347.

Gor AP, Desai SV. Adverse drug reactions in the

inpatients of Medicine department of a rural tertiary care teaching hospital and influence of Pharmacovigilance in reporting adverse drug reaction. Indian J Pharmacol. 2008;40(1):37-40.

Patidar D, Rajput MS, Nirmal NP, Savitri W. Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India. Interdiscip Toxicol. 2013;6(1):41-6.

Brennan TA, Leape LL, Laird NM. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324(6):370-6.

Murphy BM, Frigo LC. Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital. Hosp Pharm. 1993;28(12):1199-204.

Coelo HL, Arrais PSD, Parente AP, Brizeno MOB. Federal University of Ceaara, Fortaleza, Brazil. Pharmacoepidemiol Drug Safety. 2002;11(2):231-94.

Rajesh R, Ramesh M, Parthasarathi G. A study on adverse drug reactions related hospital admission and their management. Indian J Hospital Pharm. 2008;45:143-8.

Suh DC, Woodall BC, Shin SK, Shin SK, Hermes-De Santis ER. Clinical and economic impact of adverse drug reactions in hospitalized patients. Ann Pharmacother. 2000;34:1373-8.

Sriram S, Ghasemi A, Ramasamy R. Prevalence of adverse drug reactions at a private tertiary care hospital in south India. J Res Med Sci. 2011;16(1):16-25.

Fredy IC, Chandrashekhar S, Srinivasan R. Retrospective analysis of reported adverse drug reactions Indo Am. J. Pharm. Sci. 2015;3(1).

Uchit GP, Shrivastava MP, Badar VA, Navale SB, Mayabhate MM. Adverse drug reaction to antimicrobial agents in tertiary care hospital in Nagpur. J Indian Med Assoc. 2012;110(4):224-7.

Tandon VR, Sharma S, Khajuria V, Mahajan V, Gillani Z. Adverse drug reactions profile of antimicrobials: A 3-year experience, from a tertiary care teaching hospital of India. Indian J Med Microbiol. 2015;33(3):393-400.

Leone R, Sottosanti L, Luisa Iorio M. Drug-related deaths: An analysis of the Italian spontaneous reporting database. Drug Saf. 2008;31:703-13.

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Published

2017-04-24

How to Cite

Saxena, K., Tailor, C., Mehta, C., Gajera, P., & Srivastava, S. K. (2017). A retrospective analysis of adverse drug reaction reported in a tertiary care hospital. International Journal of Basic & Clinical Pharmacology, 6(5), 1146–1150. https://doi.org/10.18203/2319-2003.ijbcp20171667

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Original Research Articles