Abstract
The inclusion of spontaneously reported adverse drug reactions (ADRs) in hospital discharge reports was examined, in addition to the factors associated with their inclusion, the resulting therapeutic decisions, and any recommendations made upon patient discharge regarding the suspected offending drugs. ADRs that were spontaneously reported during 2017 and 2018 to the pharmacovigilance program were retrospectively analyzed. Information regarding patient characteristics, drug treatments, and ADRs was collected from the ADR notifications and from patient electronic medical records. The dependent variable was the mentioning of ADRs in the discharge reports, while characteristics of the ADRs, pharmacovigilance causality algorithms, and some of the suspected drugs themselves were the independent variables during bivariant analysis. A total of 286 reports of suspected ADRs from 271 patients (50.2% female; 77% adults) were included. Information regarding the ADRs was present in the discharge reports for 238 reports (83.2%); the ADR seriousness and the lack of potential alternative causes were the only associated factors. Withdrawal or withdrawal and substitution by an alternative drug were the most common therapeutic decisions, although often no recommendation was made. Overall, there is still room for improvement in terms of including information related to ADRs in hospital discharge reports.
Highlights
In some recent studies, the reported prevalence of adverse drug reactions (ADRs) during hospitalization varies between 10.1 and 19% [1,2], while the incidence of ADRs that lead to hospital admissions ranges from 3.5 to 6.28% [2,3]
As factors associated with the inclusion of ADRs in hospital discharge reports, we identified the seriousness of the ADR, and the fact that alternative causes had been ruled out
The present study identified that information regarding a high percentage of ADRs that have been spontaneously notified to the pharmacovigilance system is available in hospital discharge reports
Summary
The reported prevalence of adverse drug reactions (ADRs) during hospitalization varies between 10.1 and 19% [1,2], while the incidence of ADRs that lead to hospital admissions ranges from 3.5 to 6.28% [2,3]. To stimulate the notification of suspected ADRs, several strategies have been implemented in our hospital (i.e., the Vall d’Hebron University Hospital (VHUH)) over recent years. From 2003 to 2005, the reporting of spontaneous ADRs was included as one of the key objectives for physicians within the context of management agreements between clinical services and hospital managers. The median number of reported ADRs per year increased from 40 (range 23–55) in the first evaluation period (1998–2002) to 224 (98–248) during the second evaluation period (2003–2005), which was attributed to such interventions [9,10]. Various additional measures have been implemented; for example, ADR alerts published by the Spanish Medicines
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