Medication errors in older patients: a pharmacovigilance perspective

Drug regulatory agencies are particularly interested in pharmacovigilance data relating to medication errors (MEs) involving a product-related cause (problems with drug names, packaging, labels, tablet marking, modalities of drug use, or instructions for users), an educational failure, or a ‘never event’. Older adults are particularly affected by MEs but little is known about the root causes of MEs, which could be a focus for regulatory agencies.

The aim of this study was to describe and characterise MEs associated or not associated with adverse reactions that have occurred in older adults and fall under the scope of drug regulatory agencies.

A retrospective and descriptive analysis of pharmacovigilance data from the French Pharmacovigilance Network was performed. All ME reports, with or without adverse effects (AEs), which occurred from 1 September 2019 to 31 August 2020 and involved adults aged 75 years and over were analysed. We conducted a globally descriptive analysis of MEs, in particular on root causes in the scope of drug regulatory agencies (i.e. product-related cause, educational failure, ‘never events’).

During the study period, 802 MEs were reported to the French pharmacovigilance system; 305 (38.0%) were associated with AEs (of which 171 [56.1%] were serious and 13 [4.3%] were fatal). The mean age of patients was 85.2 years and 493 (61.5%) were females. Globally, 224 (27.9%) of MEs had at least one root cause in the scope of the regulatory agencies and were more frequently observed in cases of MEs with AEs compared with those without (174 [57.1%] vs. 46 [9.2%]). The first root cause was an educational problem (159, 71%), followed by ‘never events’ (94, 42%) and product-related causes (20, 9%). MEs due to problems in the scope of regulatory agencies occurred more frequently at the administration and prescription stages and consisted of a wrong drug, wrong dose, and dosage/concentration.

In the older population, the proportion of MEs for which a drug regulatory agency could act is high, confirming the importance of reporting MEs to pharmacovigilance in order to implement risk reduction measures. The ignorance of medication use was the first reason for errors, and actions taken by the health authorities should focus on producing visible and understandable instructions for healthcare professionals and patients. It is also necessary to collaborate closely with the manufacturers to improve packaging, labelling and product nomenclature to completely safeguard the use of their products.