Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance

Abstract

Introduction: Medication errors recently became the focus of regulatory guidance in pharmacovigilance to support reporting, evaluation and prevention of medication errors.

Objective: This 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.

Methods: Case 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).

Results: A 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.

Conclusion: Case 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.

Fig. 1

EudraVigilance ICSR data extraction pathway using the broad and narrow SMQ for medication errors. Non-serious PSUR cases were excluded. ICSR individual case safety reports, SMQ standardised MedDRA^® Query, EVPM eudravigilance post-authorisation module, PT preferred terms, EEA European economic area, ATC anatomical therapeutic classification, PSUR periodic safety update report, UN United Nations, MedDRA ^® medical dictionary for regulatory activities

Fig. 2

Number of ICSRs retrieved with the narrow SMQ for medication errors reported in the EEA and globally (includes both EEA and non-EEA cases) to EudraVigilance between 2002 and 2015. ICSRs individual case safety reports, SMQ Standardised MedDRA^® Query, EEA European economic area, MedDRA ^® medical dictionary for regulatory activities

Fig. 3

Proportion of medication error ICSRs with EEA origin retrieved with the broad and narrow SMQ to the total number of ICSRs reported to EudraVigilance between 2002 and 2015. The broad SMQ includes the terms from the narrow SMQ. ICSRs Individual Case Safety Reports, EEA European Economic Area, SMQ Standardised MedDRA^® Query, MedDRA ^® Medical Dictionary for Regulatory Activities

Fig. 4

Proportion of medication error ICSRs retrieved with the narrow SMQ to the total number of ICSRs reported to EudraVigilance between 2002 and 2015 with EEA and non-EEA origin. ICSRs individual case safety reports, SMQ Standardised MedDRA^® Query, EEA European Economic Area, MedDRA ^® Medical Dictionary for Regulatory Activities

Fig. 5

Top 20 reported MedDRA^® Preferred Terms from the narrow Standardised MedDRA^® Query in Individual Case Safety Reports with European Economic Area origin (n = 25,865). MedDRA ^® Medical Dictionary for Regulatory Activities

Fig. 6

Distribution of medication error Individual Case Safety Reports with narrow Standardised MedDRA^® Query by geographic region (n = 88,318), at 31 December 2015. MedDRA ^® Medical Dictionary for Regulatory Activities