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

INTRODUCTION: Medication 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 ANALYSES: This 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 DISSEMINATION: Ethical approval is not required. The results will be disseminated via publication in peer-reviewed journals, scientific networks and relevant conferences.