Medication errors through a national pharmacovigilance database approach : a study for Malta

Abstract

Aim: To identify medication errors in the Maltese pharmacovigilance database and describe the frequency and characteristics of these events. Method: 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. Conclusion: 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.