Analysis of adverse drug reactions in a tertiary care emergency medicine department: prevalence, preventability and reporting
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20183490Keywords:
Adverse drug reactions, Causality, Emergency Medicine DepartmentAbstract
Background: Adverse drug reactions (ADRs) are negative consequences of drug therapy. ADR results in diminished quality of life, increased physician visits, hospitalizations, and even death. Hence a study was planned to detect and analyze ADR encountered in emergency medicine department.
Methods: Data was collected over a period of 1 year after taking approval from IRB (Institutional Review Board) and written informed consent from patients. ADRs presenting as a cause of hospital admission or developed during hospitalization were analyzed.
Results: A total of 229 ADRs were analyzed. Majority of ADRs were found in the age group of 40-60 Years. The M: F Ratio was 1.10:1. According to Wills and Brown Classification, majority of the ADRs belonged to Type A. According to Hartwig and Siegel classification of severity of ADRs, 18.78% of the ADRs were severe in nature. According to Schumock and Thornton preventability score, majority (64.19%) of the ADRs were not preventable, whereas 17.03% were definitely preventable. 120 (52.40%) of the ADRs were serious in nature Anti-infective were the most common drug class (30.13%) followed by CVS (24.03%) group of drugs. About (57.64%) ADRs fall in the category of probable/likely. Regarding their Outcome, 44.10% of the ADRs were recovered and 43.23% were recovering.
Conclusions: Anti-infective were the most reported drug class to cause ADRs in a tertiary care emergency medicine department. Causality assessment according to WHO-UMC and Naranjo’s causality assessment criteria reported to be Probable. Whereas modified Schumock and Thornton scale preventability scale showed that majority were not preventable.
References
World Health Organization. International drug monitoring: The role of the hospital. In: Technical Report Series No. 425. Geneva, Switzerland: World Health Organization; 1966:1-24.
Rydberg DM, Holm L, Engqvist I, Fryckstedt J, Lindh JD, Stiller CO, et al. Adverse drug reactions in a tertiary care emergency medicine ward-prevalence, preventability and reporting. PloS one. 2016 Sep 13;11(9):e0162948.
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;8:14:5.
Lihite RJ, Lahkar M. A study on cutaneous adverse drug reactions in ADR monitoring centre of tertiary care hospital, Guwahati. J Appl Pharm Sci. 2013;3:78-81.
Mohammed G, Sunil T, Bandari K, Shravan D. A Prospective observational study on monitoring, evaluating and reporting of ADRs in A tertiary care hospital. WJPPS. 2015;5(2):736-52.
Pharmacovigilance, WHO 2014. Available at: http://www.who.int/ medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/ [Last accessed on 2018 May 19].
Adverse drug reaction reporting form. Central Drugs Standard Control Organisation. Available at: www.cdsco.nic.in/forms/Default.aspx.
Angeline. From Evaluation to prevention of Adverse Drug Reaction. Int J Pharm. 2015;5(4):1170-7.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.
Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27:538.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.
Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27:538.
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5.
Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004 Jul 1;329(7456):15-9.
Patel TK, Patel PB. Incidence of Adverse Drug Reactions in Indian Hospitals: A Systematic Review of Prospective Studies. Curr Drug Saf. 2016;11(2):128-36.
Morcos SK. Interactions with Other Drugs and Clinical Tests. In: Thomsen HS, Webb JAW (Eds). Contrast Media. 2nd Ed. Springer-Verlag Berlin Heidelberg: 2009:107-114.
Buckley MS, Leblanc JM, Cawley MJ. Electrolyte disturbances associated with commonly prescribed medications in the intensive care unit. Crit Care Med. 2010 Jun;38(6):S253-64.
Raut A, Patel P, Patel C, Pawar A. Preventability, predictability and seriousness of adverse drug reactions amongst medicine inpatients in a teaching hospital: a prospective observational study. Int J Phar Chem Scienc. 2012;1(3):1293-99.
James BC. Every defect a treasure: learning from adverse events in hospitals. Med J Aust. 1997;166:484-7.17.
Hanlon JT, Pieper CF, Hajjar ER, Sloane RJ, Lindblad CI, Ruby CM, et al. Incidence and predictors of all and preventable adverse drug reactions in frail elderly persons after hospital stay. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. 2006 May 1;61(5):511-5.
Amin S, Shah S, Desai M, Shah A, Maheriya KM. An analysis of adverse drug reactions in extremes of age group at tertiary care teaching hospital. Perspect Clin Res. 2018;9:70-5.
Shamna M, Dilip C, Ajmal M, Mohan PL, Shinu C, Jafer CP, et al. A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital. Saudi Phar J. 2014 Sep 1;22(4):303-8.
