Drug-related deaths (DRDs) are a common cause of hospital death. Pharmacovigilance, either as spontaneous reporting or active surveillance, plays a key role in the detection and reporting of suspected adverse drug reactions (ADRs). We conducted a retrospective analysis of all DRDs spontaneously reported to a pharmacovigilance program of a tertiary hospital, by health care professionals. We compared these results to those of a previous retrospective study conducted in the same hospital from the hospital's mortality registry. From 1460 spontaneous reported ADRs in a 10-year period, 73 (5%) were DRDs. The median age of DRD was 75 years (range 1 month-94) and 60.3% were men. The most frequent DRDs were hemorrhages (41.1%), followed by infections (17.8%). The most frequently involved drugs were anticoagulants and/or antithrombotic (30%), and antineoplastics (26.3%). When comparing both studies, spontaneous reporting detected more type B reactions (p < 0.001) and hospital-acquired DRD (p < 0.001); the number of concomitant drugs was higher (p = 0.0035); and the kind of ADR were different. The combination of several methods is mandatory to detect, assess, understand, and design strategies to prevent ADRs in a hospital setting, to ensure patient safety.
Keywords: active surveillance; adverse drug reaction; drug-related deaths; hospital mortality; pharmacovigilance; spontaneous reporting.