Journal of Medical Academics

Register      Login

VOLUME 3 , ISSUE 2 ( July-December, 2020 ) > List of Articles

Original Article

A Retrospective Descriptive Study of Adverse Drug Reaction Monitoring in Tertiary Care Hospital

Ajay K Gupta

Citation Information : Gupta AK. A Retrospective Descriptive Study of Adverse Drug Reaction Monitoring in Tertiary Care Hospital. Journal of Medical Academics 2020; 3 (2):54-58.

DOI: 10.5005/jp-journals-10070-0061

License: CC BY-NC 4.0

Published Online: 01-12-2020

Copyright Statement:  Copyright © 2020; The Author(s).


Abstract

Introduction: An adverse drug reaction (ADR) is any undesirable effect of a drug to the patient beyond its anticipated therapeutic effects while used clinically. Aims and objective: To analyze the incidence of ADRs in a tertiary care hospital reported from April 2015 till December 2017. Materials and methods: Two hundred ADR forms were included in the study and analyzed. These were codified into various drug classes according to anatomical therapeutic chemical (ATC) classification based on WHO–ATC Index 2019 besides categorized into preventable or not modified Schumock and Thornton scale. Severity was assessed based on a scale by Hartwig et al. Also, the ADRs were classified based on MedDRA 13.01 to system organ class (SOC) and preferred terms (PT) falling under respective SOC. Results: Maximum ADRs were reported by dermatology. Most commonly, it involved gastrointestinal system (GIT) followed by skin. Antibiotics and anti-cancer drugs caused maximum ADRs. About two-thirds were classifiable as moderate to severe, whereas about one-third were preventable. About 10% of cases were such that left deep impact of sequelae or were not recovered and one case was fatal. Conclusion: Extreme vigilance by clinicians is of utmost crucial virtue in detecting, diagnosing, and reporting such ADR for continued drug safety monitoring.


HTML PDF Share
  1. Drug allergy. In: Patterson's Allergic Diseases Grammer LC, Greenberger PA, ed. 6th ed., Philadelphia: Lippincott Williams & Wilkins; 2002. p. 295.
  2. An analysis of seriousness, predictability and preventability of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective observational record based study. Int J Basic Clin Pharmacol. 2018;7(12):2433-2438.
  3. Incidence of adverse drug reactions in hospitalized patients: a meta analysis of prospective studies. JAMA 1998;279:1200-1205. DOI: 10.1001/jama.279.15.1200 Yadav S. Status of adverse drug reaction monitoring and pharmacovigilance in selected countries. Indian J Pharmacol 2008;40(Suppl. 1):S4–S9.
  4. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49(9):2229-2232. DOI: 10.1093/ajhp/49.9.2229.
  5. ASHP guidelines on adverse drug reaction monitoring and reporting. Am J Hosp Pharm 1989;46:336-337.
  6. Retrospective analysis of adverse drug reactions to bronchodilators observed in two pulmonary divisions of Catanzaro, Italy. Pharmacol Res 2003;47(6):493-499. DOI: 10.1016/S1043-6618(03)00003-3.
  7. Evaluation of outpatient adverse drug reactions leading to hospitalization. Am J Health Syst Pharm 2003;60(3):253-259. DOI: 10.1093/ajhp/60.3.253.
  8. Completed ATC Index 2005. http://www.whocc.no/atcddd/.
  9. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992;27:538.
  10. The cost of adverse drug events in hospitalized patients. JAMA 1997;277(4):307-311. DOI: 10.1001/jama.1997.03540280045032.
  11. Gender differences in the occurrences and pattern of adverse drug reactions in psychiatric patients: a prospective observational study. Trop J Med Res 2017;20(1):84-90. DOI: 10.4103/1119-0388.198134.
  12. Prevalence of adverse drug reactions with commonly prescribed drugs in different hospitals of Kathmandu valley. Kathmandu Univ Med J (KUMJ) 2007;5(4): 504-510.
  13. Patterns of adverse drug reactions in different age groups: Analysis of spontaneous reports by community pharmacists. PLoS ONE 2015;10(7):e0132916. DOI: 10.1371 journal. pone. 0132916.
  14. Support Care Cancer 2004;12:626.
  15. Prevalence, nature and potential preventability of adverse drug events – a population-based medical record study of 4970 adults. Br J Clin Pharmacol 78(1):170-183. DOI: 10.1111/bcp.12314.
  16. Mapping adverse drug reactions in chemical space. J Med Chem 2009;52(9):3103-3107. DOI: 10.1021/jm801546k.
  17. Prevalence and characteristics of adverse drug reactions at admission to hospital: a prospective observational study. Br J Clin Pharmacol 2016;82(6):1636-1646. DOI: 10.1111/bcp.13081.
  18. Imputation of adverse drug reactions: causality assessment in hospitals. PLoS ONE 2017;12(2):e0171470. DOI: 10.1371/journal.pone.0171470.
  19. Causality, severity and preventability assessment of adverse cutaneous drug reaction: a prospective observational study in a tertiary care hospital. J Clin Diagnos Res: JCDR 2013;7(12):2765-2767.
  20. Incidence of adverse drug events and potential adverse drug events: implications for prevention. JAMA 1995;274(1):29-34. DOI: 10.1001/jama.1995.03530010043033.
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.