Validation of a method to assess the severity of medication administration errors in Brazil: a study protocol

Background: Medication errors are frequent and have a high economic and social impact and is critical to know their severity. A variety of tools exist to measure and classify the harms associated with medication errors, but few are internationally validated. Design and methods: It was decided to validate a method proposed by Dean and Barber for assessment of the potential severity of medication administration errors. A number of thirty health care professionals (doctors, nurses and pharmacists) from Brazil will receive an invitation to take part by scoring 50 cases of medication errors gathered from an original UK study regarding their potential harm to the patient on scale 0 to 10. Sixteen cases with known actual harm outcomes will be used to assess the validity of their scoring. By looking at 10 errors (out of the 50 cases) scored twice, reliability shall be assessed; and potential sources of variability in scoring will be evaluated depending on the severity of each of error case, the occasion when the scores were given, the scorer, their profession, and interactions among these variables. Generalizability theory will be used for analysing data. Expected impact of the study for public health: This study was submitted to the evaluation of the Research Ethics Committee of the Complexo Hospitalar Universitário Professor Edgard Santos and approved under no. 3.102.570/2019. This is the first validation of this method for use in Brazil, and will allow researchers to conduct more standardised evaluations of interventions to reduce the impact of medication errors.