Improving the Reporting of Adverse Drug Reactions in the Hospital Setting

Abstract

The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest. The hospital setting, with its clearly defined patient population observed around the clock, is an ideal setting in which to identify potential adverse drug reaction signals and to report them to either the drug manufacturer or the FDA. In this article we describe the present system for addressing adverse events, obstacles to reporting them, and the important role any hospital physician could play in reporting adverse events and potential adverse drug reactions.

Rash associated with Pregabalin: A case report

“…These factors are, being a woman of child-bearing age, the initial dose selected, concomitant viral infection, immune-mediated disorders, pharmacogenetic variability, and age. 7,8 Arif et al emphasized that the only non-drug predictor of antiepileptic drug (AED) related rash was rash to another AED, with an odds ratio of 3.1. 4 This patient had a hematologic malignancy which at least in partly may have contributed to the development of rash via immune mechanisms.…”

Apreciaciones de trabajadores de la salud sobre la implementación del sistema de seguridad en la utilización de medicamentos

“…Para lograrlo, es necesario generar la cultura del reporte institucional de reacciones adversas, con el fin de detectar las fallas o errores implicados e implementar los correctivos oportuna y adecuadamente. Las notificaciones de reacciones adversas son importantes no sólo para medir su incidencia real sino también para describir sus características en aras de obtener evidencias que generen decisiones adecuadas con respecto al medicamento 29,30 .…”

Drug incompatibility

“…Problem nedovoljnog izveštavanja neželjenih reakcija na lekove je dobro poznata i znatno raširena pojava u farmakovigilanci. 23 Radi izbegavanja nastanka inkompatibilnosti trebalo bi se pridržavati sledećih opštih pravila: a) β-laktamske antibiotike ne treba mešati sa proteinskim rastvorima, b) bez preke potrebe lekovi se ne mešaju sa rastvorima aminokiselina, složenim elektrolitnim rastvorima (posebno koji sadrže dvovalentne katjone), rastvorima NaHCO3, emulzijama masti i hipertonim rastvorima i c) mešanje lekova sa preparatima krvi generalno se smatra apsolutno kontraindikovanim.…”