title: Medication errors through a national pharmacovigilance database approach: a study for Malta.
abstract: OBJECTIVE
  To identify medication errors in the Maltese pharmacovigilance database and describe the frequency and characteristics of these events.
  
  
  METHODS
  A retrospective analysis of the Adverse Drug Events (ADEs) reported over 5 years in Malta was conducted. Medication errors were identified by comparing use against the product's Summary of Product Characteristics (SmPC) and then classified by type of medication error, seriousness and the stage of the medication use chain at which they occurred.
  
  
  RESULTS
  319 consolidated ADE reports met the inclusion criteria and were analysed. 56/319 consolidated ADEs were associated with serious patient harm. The 80-89 and the 50-59 age groups were associated with most medications used in error. 65% of errors originated in the community. Errors were identified in prescribing (52%), therapeutic monitoring (26%), patients' own (12%), dispensing (7%) and administration (3%) stages. The non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics were most commonly used in errors involving wrong doses, lack of therapeutic monitoring, interactions; contra-indications, prescribing for an unlicensed indication as well as an inappropriate duration of therapy.
  
  
  CONCLUSIONS
  Pharmacovigilance databases are a useful source of information on medication errors and can be used to detect risks associated with the use of medicinal products.
authors: Medicines Authority, 203 Level 3, Rue D'Argens, Gzira, GZR, Malta.
authors: Amy
authors: A
authors: Tanti
authors: Miriam
authors: M
authors: Camilleri
authors: Patricia Vella
authors: PV
authors: Bonanno
authors: John-Joseph
authors: JJ
authors: Borg
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008319:Malta; D008508:Medication Errors / Q000145:classification / Q000517:prevention & control* / Q000706:statistics & numerical data*; D008875:Middle Aged; D060735:Pharmacovigilance; D012189:Retrospective Studies