title: Prevalence and assessment of factors contributing to adverse drug reactions in wards of a tertiary care hospital, India.
abstract: BACKGROUND
  Adverse drug reactions account for the highest proportion among the causes of morbidity and mortality in clinical wards and are posing a considerable challenge. Hence, the objective of this study was to find out the prevalence of adverse drug reactions and the factors which contribute to their prevalence.
  
  
  METHODS
  A prospective patient record review was carried out at a tertiary care hospital in North India from August 2010-May 2011. A total of 1033 subjects admitted to hospital for any kind of treatment were included while patients admitted in the ward because of adverse drug reactions were excluded. The ward where we collected the data includes multispecialty and cardiovascular wards. The causality, severity, and preventability of adverse drug reactions were assessed using Naranjo, modified Hartwig, and Schumock and Thornton criteria, respectively. Kolmogorov-Smyrnov, chi -square and multiple logistic regression tests were used to determine adverse drug reactions ascribed to drugs.
  
  
  RESULTS
  Out of 1033 patients whose records were assessed, 167(16.2%) experienced one or more adverse drug reactions. The metabolic systems, which accounted for 49(24.6%) were most frequently affected by adverse drug reactions, followed by gastrointestinal, 45(22.6%); hematological, 28(14.1%) and cutaneous, 21(10.6%) systems. The drug classes most frequently associated with the reactions were antibiotics 40(20.1%), diuretics 35(17.6%) and anticoagulants 30(15.1%). According to the selected preventability scale, 72(36.2%) adverse drug reactions were classified as probably or definitely preventable. About 165(83%) of the reactions were type A, which represents augmentation of the pharmacological action of a drug. Number of drugs, length of hospitalization and number of diagnosis were identified as significant predisposing factors for ADRs.
  
  
  CONCLUSIONS
  The result of this study suggested that adverse drug reactions were significant causes of superimposed health problems that occur following hospitalization. The major risk factors associated with ADR include number of drugs, length of hospitalization and number of diagnosis. Based on the findings a rigorous study is recommended to determine the burden and identify the risk factors of adverse drug reactions to target interventions.
authors.affiliation: Lecturer, Department of Pharmacy, Mizan-Tepi University, Ethiopia. demis.berihun@gmail.com
authors.forename: Demissew Berihun
authors.initials: DB
authors.lastname: Haile
authors.forename: Wubeante Yenet
authors.initials: WY
authors.lastname: Ayen
authors.forename: Pramil
authors.initials: P
authors.lastname: Tiwari
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects; D000925:Anticoagulants / Q000009:adverse effects; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D004232:Diuretics / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control; D005260:Female; D006801:Humans; D007194:India / Q000453:epidemiology; D007223:Infant; D007902:Length of Stay; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D011446:Prospective Studies; D012307:Risk Factors; D018709:Statistics, Nonparametric; D062606:Tertiary Care Centers / Q000706:statistics & numerical data*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000925:Anticoagulants; D004232:Diuretics
keywords: Adverse drug reactions; Causality assessments; Predisposing factor; Type A reactions
references.citation: Ann Intern Med. 1966 Oct;65(4):629-40
references.pmid: 5926386
references.citation: Pharmacoepidemiol Drug Saf. 2005 May;14(5):333-40
references.pmid: 15682429
references.citation: Eur J Clin Pharmacol. 2006 Feb;62(2):143-9
references.pmid: 16395559
references.citation: Swiss Med Wkly. 2004 Nov 13;134(45-46):664-70
references.pmid: 15611888
references.citation: PLoS One. 2009;4(2):e4439
references.pmid: 19209224
references.citation: J Clin Pharm Ther. 2006 Aug;31(4):335-41
references.pmid: 16882102
references.citation: Eur J Clin Pharmacol. 2011 May;67(5):507-19
references.pmid: 21221958
references.citation: Eur J Intern Med. 2008 Nov;19(7):505-10
references.pmid: 19013378
references.citation: Am J Hosp Pharm. 1992 Sep;49(9):2229-32
references.pmid: 1524068
references.citation: Eur J Clin Pharmacol. 2000 May;56(2):181-6
references.pmid: 10877014
references.citation: J Am Geriatr Soc. 2002 Dec;50(12):1962-8
references.pmid: 12473007
references.citation: Hosp Pharm. 1992 Jun;27(6):538
references.pmid: 10118597
references.citation: Br J Clin Pharmacol. 2000 Feb;49(2):158-67
references.pmid: 10671911
references.citation: Eur J Intern Med. 2010 Oct;21(5):453-7
references.pmid: 20816604
references.citation: Pharmacol Res. 2006 Sep;54(3):226-33
references.pmid: 16781163
references.citation: Br J Clin Pharmacol. 2008 Feb;65(2):210-6
references.pmid: 17662089
references.citation: Age Ageing. 1986 Jul;15(4):241-6
references.pmid: 3751750
references.citation: Clin Pharmacol Ther. 1981 Aug;30(2):239-45
references.pmid: 7249508
references.citation: BMJ. 1998 Apr 25;316(7140):1295-8
references.pmid: 9554902
references.citation: Am J Health Syst Pharm. 2003 Sep 1;60(17):1750-9
references.pmid: 14503111
references.citation: BMC Health Serv Res. 2010 Oct 13;10:287
references.pmid: 20942906
references.citation: World Health Organ Tech Rep Ser. 1972;498:1-25
references.pmid: 4625548
references.citation: Pharmacoepidemiol Drug Saf. 2003 Dec;12(8):687-92
references.pmid: 14762985
references.citation: BMC Clin Pharmacol. 2007 Jul 28;7:8
references.pmid: 17662147
references.citation: Curr Ther Res Clin Exp. 2008 Apr;69(2):118-29
references.pmid: 24692791
references.citation: JAMA. 1998 Apr 15;279(15):1200-5
references.pmid: 9555760
references.citation: BMJ. 2009 Jan 07;338:a2752
references.pmid: 19129307
references.citation: Lancet. 2000 Oct 7;356(9237):1255-9
references.pmid: 11072960
references.citation: Drugs Aging. 2005;22(9):767-77
references.pmid: 16156680