title: Adverse drug reactions in hospitalized pediatric patients of Saudi Arabian University Hospital and impact of pharmacovigilance in reporting ADR.
abstract: OBJECTIVE
  Children are more vulnerable to ADRs, and this susceptibility is compounded due to hospitalization. There is a lack of local data regarding the potential risk of ADRs in hospitalized pediatric patients. Therefore, this study is designed to identify the frequent nature, severity of adverse drug reactions, drugs implicated and factors influencing ADRs.
  
  
  METHODS
  Intensive monitoring study of ADRs was done in hospitalized pediatric patients of King Abdulaziz University Hospital, Jeddah from January to December 2011, with an analogous retrospective study for the preceding year to determine incidence rate, demographic aspects, causality appraisal, polypharmacy, body organs/systems involved and drugs implicated in ADR. Comparison of the two data was done to determine the impact of pharmacovigilance.
  
  
  RESULTS
  Incidence rate of ADRs in retrospective study was (4.50%) and (8.2%) in prospective study. ADR was more in patients who received 5-6 drugs, which was (15.5%) in retrospective study and (22.1%) in prospective study. Regarding age, it was the highest in patients of 0-1 year of age which was (40.7%) in retrospective study and (38.8%) in prospective study. Anti-infective agents were the most frequently involved in ADR (40.8%) in prospective study and (48.2%) and retrospective study. This study also demonstrated that, there was high susceptibility of the skin to the ADR which was (37%) in retrospective study and (42.9%) in prospective study. None of the ADRs proved to be fatal.
  
  
  CONCLUSIONS
  Well premeditated intensive monitoring approach in pharmacovigilance amplifies the ADR detection, which can persuade healthcare providers into more drug safety.
authors: Department of Pharmacology, College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
authors: Lateef M
authors: LM
authors: Khan
authors: Sameer E
authors: SE
authors: Al-Harthi
authors: Omar I
authors: OI
authors: Saadah
keywords: ADR monitoring; Adverse drug reactions; Hospitalized patients; Pharmacovigilance
references: Ital J Pediatr. 2010 Jan 15;36:4
references: 20180963
references: Br J Clin Pharmacol. 2008 Feb;65(2):210-6
references: 17662089
references: J Popul Ther Clin Pharmacol. 2011;18:e76-88
references: 21467599
references: Clin Pharmacol Ther. 1981 Aug;30(2):239-45
references: 7249508
references: Ann Saudi Med. 2008 Nov-Dec;28(6):426-9
references: 19011316
references: Joint Bone Spine. 2006 Dec;73(6):629-32
references: 17110152
references: Drug Saf. 2008;31(2):169-80
references: 18217792
references: Eur J Clin Pharmacol. 2006 Feb;62(2):143-9
references: 16395559
references: Drug Saf. 2010 Apr 1;33(4):327-39
references: 20297864
references: JAMA. 2001 Apr 25;285(16):2114-20
references: 11311101
references: Pharmacoepidemiol Drug Saf. 2009 Aug;18(8):713-21
references: 19507171
references: Arch Intern Med. 2003 Jun 23;163(12):1409-16
references: 12824090
references: J Clin Pharm Ther. 2009 Jun;34(3):313-8
references: 19646077
references: Health Technol Assess. 2011 May;15(20):1-234, iii-iv
references: 21545758
references: Am J Health Syst Pharm. 2003 Sep 1;60(17):1750-9
references: 14503111
references: Arch Dis Child. 2009 Sep;94(9):724-8
references: 19531524
references: Pediatrics. 2002 Aug;110(2 Pt 1):254-7
references: 12165575
references: Br J Clin Pharmacol. 2004 Feb;57(2):121-6
references: 14748810
references: Saudi Med J. 2008 Aug;29(8):1145-50
references: 18690308
references: Fundam Clin Pharmacol. 2004 Jun;18(3):275-80
references: 15147278
references: J Pharm Sci. 2011 Jan;100(1):53-8
references: 20589750
references: Pediatrics. 2002 Nov;110(5):e53
references: 12415059
references: Am J Hosp Pharm. 1992 Sep;49(9):2229-32
references: 1524068
references: Br J Clin Pharmacol. 2008 Mar;65(3):396-406
references: 18070223
references: J Pharmacol Pharmacother. 2011 Oct;2(4):277-80
references: 22025857
references: J Clin Pharmacol. 2013 Jan;53(1):87-95
references: 23400748
references: J Clin Pharm Ther. 2009 Jun;34(3):277-87
references: 19650250
references: Pharm World Sci. 2007 Feb;29(1):43-6
references: 17268936
references: Pharmacogenomics. 2003 May;4(3):331-41
references: 12718723
references: BMJ. 2006 May 20;332(7551):1163-4
references: 16709964
references: Pharmacoepidemiol Drug Saf. 2006 Sep;15(9):635-40
references: 16287200
references: Eur J Intern Med. 2001 Sep;12(5):442-447
references: 11557331
references: Br J Clin Pharmacol. 2010 Oct;70(4):481-91
references: 20840440
references: Arch Dis Child. 2003 Apr;88(4):366
references: 12651779
references: Br J Clin Pharmacol. 2001 Jul;52(1):77-83
references: 11453893
references: Saudi Med J. 2008 Feb;29(2):277-81
references: 18246241
references: Ceylon Med J. 2003 Sep;48(3):86-7
references: 14735805
references: PLoS One. 2012;7(3):e24061
references: 22403604
references: Curr Opin Allergy Clin Immunol. 2001 Aug;1(4):305-10
references: 11964705
references: Br J Clin Pharmacol. 2010 Nov;70(5):765-8
references: 21039770