Methodological approaches for medication error analyses in patient safety and pharmacovigilance reporting systems: a scoping review protocol

Abstract

IntroductionMedication errors (MEs) are associated with patient harm and high economic costs. Healthcare authorities and pharmacovigilance organisations in many countries routinely collect data on MEs via reporting systems to improve patient safety and for learning purposes. Different approaches have been developed and used for the ME analysis, but an overview of the scope of available methods currently is lacking. This scoping review aimed to identify, explore and map available literature on methods used to analyse MEs in reporting systems.Methods and analysesThis protocol describes a scoping review, based on the Joanna Briggs Institute methodological framework. A systematic search will be performed in MEDLINE (Ovid), Embase (Ovid), Cinahl (EBSCOhost), Cochrane Central, Google Scholar, websites of the major pharmacovigilance centres and national healthcare safety agencies, and citation search in Scopus in August 2022. All retrieved records are to be independently screened by two researchers on title, abstract and full text, involving a third researcher in case of disagreement. Data will be extracted and presented in descriptive and tabular form. The extraction will be based on information about methods of ME analyses, type of reporting system and information on MEs (medication name, ATC codes, ME type, medication–event categories and harm categories).Ethics and disseminationEthical approval is not required. The results will be disseminated via publication in peer-reviewed journals, scientific networks and relevant conferences.

Medication overdose data analysis: a review of medication error reports in the FDA adverse event reporting system (FAERS)

“…The World Health Organization (WHO) released the “global patient safety challenge - drug safety” in Bonn, Germany in March 2017, aiming to decrease serious and avoidable drug-related injuries in all countries by 50% in the next five years [ 1 ]. Medication error (ME) refers to any malpractice in the medication treatment process which may occur during all stages of medication use from ordering, through prescribing, dispensing, and administration, to monitoring [ 2 , 3 ]. MEs constitute a major challenge to patient safety and are associated with patient harm and remarkable national expenses.…”

“…MEs constitute a major challenge to patient safety and are associated with patient harm and remarkable national expenses. Consequently, healthcare authorities in many countries have adopted patient safety reporting systems to routinely collect data on MEs [ 2 ]. Drug overdose is a common type of ME, which remains a serious health concern worldwide.…”