Abstract
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.
Highlights
The definition of an adverse drug reaction (ADR) has evolved during time, it can be defined as ‘any appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product’ [1,2,3,4]
From a total of 1,460 ADRs registered to the hospital pharmacovigilance program in a 10-year period, 73 (5%) were Drug-related deaths (DRDs), identified by the SR method
When assessing the characteristics of DRD cases identified by spontaneous reporting in our hospital, we conclude that the results of this study indicate that about 10% of the drugs in DRD had limited safety data, a third of the DRD included a drug–drug interaction from known interactions, and almost half of the DRDs were potentially preventable according the Schumock and Thornton criteria
Summary
The definition of an adverse drug reaction (ADR) has evolved during time, it can be defined as ‘any appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product’ [1,2,3,4]. ADRs have high clinical, social and economic burden as a result of a life-threatening risk, stopping an effective treatment, additional medical interventions, use of health services, and long hospitalizations [5,6,7]. Drug-related deaths (DRDs) are the fifth most common cause of hospital death [10]. In a recent meta-analysis, in European hospitals, DRD occurrence rates were 7.3% among deceased inpatients and 0.13% among hospitalized patients [12]
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