Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance

Abstract

IntroductionMedication errors recently became the focus of regulatory guidance in pharmacovigilance to support reporting, evaluation and prevention of medication errors.ObjectiveThis study aims to characterise spontaneously reported cases of medication errors in EudraVigilance over the period 2002–2015 before the release of EU good practice guidance.MethodsCase reports were identified through the adverse reaction section where a Medical Dictionary for Regulatory Activities (MedDRA®) term is reported and included in the Standardised MedDRA® Query (SMQ) for medication errors. These case reports were further categorised by MedDRA® terms, geographical region, patient age group and Anatomical Therapeutic Chemical classification system of suspect medicinal product(s).ResultsA total of 147,824 case reports were retrieved, 41,355 of which were from the European Economic Area (EEA). Approximately 60% of these case reports were retrieved with the narrow SMQ. The absolute number of medication error case reports and the proportion to the total number of reports in EudraVigilance increased during the study period, with peaks seen around 2005 and 2012 for cases with EEA origin. Fifty-two percent of case reports in which age was provided occurred in adults, 30% in the elderly and 18% in children, with almost half of these in children aged 2 months to 2 years.ConclusionCase reports of medication errors in EudraVigilance steadily increased between 2005 and 2015, the reasons for which may be multifactorial, including increased awareness, changes to the MedDRA® terminology and the 2012 EU pharmacovigilance legislation and associated guidance for stakeholders, or a generally increased risk for errors as more medications become available.

Implementation and comparison of two text mining methods with a standard pharmacovigilance method for signal detection of medication errors

“…For European healthcare systems, for example, estimates of the yearly economic impact of medication errors range between 4.5 and 21.8 billion euros [2]. Furthermore, the reporting of medication errors has increased at a steady pace since 2005, which may be due to factors such as changes to the Medical Dictionary for Regulatory Activities (MedDRA®) terminology, increased awareness or a generally increased risk for medication errors as more medications with complex devices become available [3]. In an effort to prevent patient harm due to medication errors, various stakeholders such as the World Health Organization (WHO), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have created guidelines and imposed legislations aiming at improving the reporting and detection of medication errors [3][4][5][6][7].…”

“…Thus, common data sources for medication errors include clinical trials, spontaneous safety reports, observational studies, administrative claims, solicited reports and medical literature [2,8]. Furthermore, the identification and analysis of medication errors in a similar way as ADEs also rely on the manual review performed by medical/pharmacovigilance assessors [9,10] and the use of MedDRA® terminology for the coding of drug-related events [3]. Despite the expansion in the MedDRA® terminology to facilitate the coding of medication errors [3], signal detection of medication errors is still a challenge as many of these terms lack sufficient granularity to capture the root cause of the error.…”

“…Furthermore, the identification and analysis of medication errors in a similar way as ADEs also rely on the manual review performed by medical/pharmacovigilance assessors [9,10] and the use of MedDRA® terminology for the coding of drug-related events [3]. Despite the expansion in the MedDRA® terminology to facilitate the coding of medication errors [3], signal detection of medication errors is still a challenge as many of these terms lack sufficient granularity to capture the root cause of the error. This is because medication errors are often a result of a chain of events impacted by human behavior and reasoning.…”

“…Consequently, pharmacovigilance experts resort to the description of the signal in the narrative to perform the analysis, thus making the process both time consuming and labour intensive. Since the process requires manual review, signal detection of medication errors is further challenged by the previously described increase in submitted reports of medication errors [3].…”

Medication errors in the older people population

“…Adverse events (AEs) related to medication are the most frequent safety incidents among the older people [1][2][3] mainly because three of the main causes of these incidents coincide: old age, multiple pathology, and polypharmacy [4,5]. While adverse drug reactions are considered the most frequent unavoidable AEs, professional errors in prescribing, preparation, dispensing, and administration have been analyzed as direct causes of avoidable AEs [6].…”