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Abstract
Background:ADRs have a major impact on public health, reducing patients’ quality of life and imposing a considerable financial burden on the health care systems. Objectives: The main objectives were to analyze the pattern and extent of occurrence of ADRs in the hospital, identify co-morbidities, past and present illness, assess causality and identify the offending drugs, assess the severity and preventability of adverse drug reactions.
Methods:Prospective, observational, spontaneous, reporting study with both active and passive methods.
Results:Thestudy was carried out from January 2009 to August 2012. A total of 950 ADRs were accepted from 1227 reported ADRs. Female patients experienced more number of ADRs when compared to male patients. Fever was the most commonly observed reason for admission. Maculopapular skin rashes were the commonly observed ADR in the study population. Amoxicillin and clavulenic acid combination implicated more number of ADRs in the antibiotic category than others. Sixty one percent of the ADRs were moderate in severity followed by minor and severe ADRs. Most of the reactions in this study population were managed by withdrawing the offending drug and rechallenge was performed in few subjects. Most of the ADRs were definitely preventable (40%) and were predictable in nature. Eighty percent of the reactions were probably related to offending drugs, 758 reactions were likely to cause ADRs. Twenty five percent ADRs were treated symptomatically in the study population.
References
Patel H, Bell D, Molokhia M, et al. Prevalence of adverse drug reactions with commonly prescribed drugs in different hospitals of Kathmandu valley. BMC Clin Pharmacol 2007; 7: 9. http://dx.doi.org/10.1186/1472-6904-7-9
Zolezzi M, Parsotam N. Adverse drug reaction reporting in New Zealand: implications for pharmacists. Ther Clin Risk Manag 2005; 1(3): 181-88.
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. http://dx.doi.org/10.4103/0253-7613.27032
Mehta DJ. Methods of reporting adverse drug reactions. Indian J Pharmacol 1972; 4(2): 67-74.
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30(2): 239-45. http://dx.doi.org/10.1038/clpt.1981.154
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992; 49(9): 2229-32.
Lau PM, Stewart K, Dooley MJ. Comment: hospital admissions resulting from preventable adverse drug reactions. Ann Pharmacother 2003; 37(2): 303-4. http://dx.doi.org/10.1345/aph.1A333a
Venkatesan R, Ravisankar S, Lakshminarasu M, Rajendran SD. Indian J Hosp Pharm 2012; 49: 46-50.
Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. BMJ 2004; 329: 15-19. http://dx.doi.org/10.1136/bmj.329.7456.15
Rajesh R, Ramesh M, Parthasarathi G. A study on adverse drug reactions related hospital admission and their management. Indian J Hosp Pharm 2008; 45: 143-148.
Dilip C, Mani LM, Saraswathi R, et al. Adverse drug reactions monitoring in tertiary level referral hospital, Perinthalmanna, Kerala. Indian J Hosp Pharm 2011; 48: 107-11.
Jha N, Bajracharya O, Namgyal T. Prevalence of adverse drug reactions with commonly prescribed drugs in different hospitals of Kathmandu valley. Kathmandu Univ Med J 2007; 20(5): 504-10.
Chen Wu, Chaim MB, Walter PW. Incidence and economic burden of adverse drug reactions among elderly patients in Ontario emergency departments- A retrospective study. Drug Saf 2012; 1-13.
Wawruch M, Zikavska M, Wsolova L, et al. Adverse drug reactions related to hospital admission in Slovak elderly patients. Arch Gerontol Geriatr 2009: 48: 186-90. http://dx.doi.org/10.1016/j.archger.2008.01.004
Chan ALF, Lee HY, Ho C-H, et al. Cost evaluation of adverse drug reactions in hospitalized patients in Taiwan: a prospective, descriptive, observational study. Curr Ther Res 2008; 69(2).
Morales OFJ, Martinez MI, Ferrer JM, et al. Adverse drug reactions in children reported by means of the yellow card in Spain. J Clin Epidemiol 2000; 53: 1076-80. http://dx.doi.org/10.1016/S0895-4356(00)00190-6
Shichmanter R, Miller EB, Landau Z. Adverse drug reactions due to prolonged antibiotic therapy for malignant external otitis. Eur J Inter Med 2004; 15: 441-45. http://dx.doi.org/10.1016/j.ejim.2004.08.006
Cullere BC, Torner GMQ, Ruiz AJ, et al. Detecting adverse drug events during the hospital stay. Farm Hosp 2009; 33(6): 312-23.
Chatterjee S, Ghosh AP, Barbhuiya J, Dey SK. Adverse cutaneous drug reactions: A one year survey at a dermatology outpatient clinic of a tertiary care hospital. Indian J Pharmacol 2006; 38(6): 429-31. http://dx.doi.org/10.4103/0253-7613.28212
Al-Malaq HM, Al-Arfaj HF, Al-Arfaj AS. Adverse drug reactions caused by methotrexate in Saudi population. Saudi Pharm J 2012; article in press. http://dx.doi.org/10.1016/j.jsps.2012.05.004
Watters AL, Epstein JB, Agulnik M. Oral complications of targeted cancer therapies: A narrative literature review. Oral Oncol 2011; 47: 441-48. http://dx.doi.org/10.1016/j.oraloncology.2011.03.028
Shah SP, Desai MK, Dikshit RK. Analysis of cutaneous adverse drug reactions at a tertiary care hospital- a prospective study. Trop J Pharmac Res 2011; 10(4): 517-22. http://dx.doi.org/10.4314/tjpr.v10i4.18
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Copyright (c) 2013 Sivanandy Palanisamy, Kottur S.G. Arul Kumaran , Aiyalu Rajasekaran