Medication error

An unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient (see EMA-PRAC Good Practice Guide on Recording, Coding, Reporting and Assessment of Medication Errors, 23 October 2015).

A failure in the drug treatment process does not refer to lack of efficacy of the drug, rather to human or process mediated failures. Intentional overdose, off-label use, misuse and abuse should be clearly distinguished from medication errors (see EMA-PRAC Good Practice Guide on Recording, Coding, Reporting and Assessment of Medication Errors, 23 October 2015).

See also Off-label use, Overdose, Misuse of a medicinal product, Abuse of a medicinal product