title: A Retrospective Analysis of Spontaneous Adverse Drug Reactions Reports Relating to Paediatric Patients.
abstract: BACKGROUND
  Spontaneous reporting on adverse drug reactions (ADR) has been established in Malaysia since 1987, and although these reports are monitored by the Malaysia drug monitoring authority, the National Pharmaceutical Control Bureau, information about ADRs in the paediatric patient population still remains unexplored. The aims of this study, therefore, were to characterize the ADRs reported in respect to the Malaysian paediatric population and to relate the data to specific paediatric age groups.
  
  
  METHODS
  Data on all ADRs reported to the National Pharmaceutical Control Bureau between 2000 and 2013 for individuals aged from birth to 17 years old were analysed with respect to age and gender, type of reporter, suspected medicines (using the Anatomical Therapeutic Chemical classification), category of ADR (according to system organ class) as well as the severity of the ADR.
  
  
  RESULTS
  In total, 11,523 ADR reports corresponding to 22,237 ADRs were analysed, with half of these reporting one ADR per report. Vaccines comprised 55.7% of the 11,523 ADR reports with the remaining being drug related ADRs. Overall, 63.9% of ADRs were reported for paediatric patients between 12 and 17 years of age, with the majority of ADRs reported in females (70.7%). The most common ADRs reported were from the following system organ classes: application site disorders (32.2%), skin and appendages disorders (20.6%), body as a whole general disorders (12.8%) and central and peripheral nervous system disorders (11.2%). Meanwhile, ADRs in respect to anti-infectives for systemic use (2194/5106; 43.0%) were the most frequently reported across all age groups, followed by drugs from the nervous system (1095/5106; 21.4%). Only 0.28% of the ADR cases were reported as fatal. A large proportion of the reports were received from healthcare providers in government health facilities.
  
  
  CONCLUSIONS
  ADR reports concerning vaccines and anti-infectives were the most commonly reported in children, and are mainly seen in adolescents, with most of the ADRs manifesting in skin reactions. The majority of the ADR reports were received from nurses in the public sector, reporting ADRs associated with vaccine administration. The low fatality rate of ADR cases reported could potentially be caused by reporting bias due to the very low reporting percentage from the private healthcare institutions. This study indicates that ADR rates among Malaysian children are higher than in developed countries. Constant ADR reporting and monitoring, especially in respect to paediatric patients, should be undertaken to ensure their safety.
authors.affiliation: Department of Pharmacy Practice, Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Selangor, Malaysia.
authors.forename: Rosliana
authors.initials: R
authors.lastname: Rosli
authors.affiliation: Department of Pharmacy Practice, Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Selangor, Malaysia.|Unit for Medication Outcomes Research and Education (UMORE), Pharmacy, School of Medicine, University of Tasmania, Hobart, Australia.
authors.forename: Long Chiau
authors.identifier: http://orcid.org/0000-0002-6971-1383
authors.initials: LC
authors.lastname: Ming
authors.affiliation: Department of Pharmacy Practice, Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Selangor, Malaysia.
authors.forename: Noorizan
authors.initials: N
authors.lastname: Abd Aziz
authors.affiliation: Department of Pharmacy Practice, Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Selangor, Malaysia.|School of Pharmacy, KPJ Healthcare University College, Nilai, Negeri Sembilan, Malaysia.
authors.forename: Mohamed Mansor
authors.initials: MM
authors.lastname: Manan
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008296:Malaysia; D008297:Male; D012189:Retrospective Studies