Background: Drug therapy is associated with adverse effects, and fatal adve
rse drug events (ADEs) have become major hospital problems. Our study asses
ses the incidence of fatal ADEs in a major medical department and identifie
s possible patient characteristics signifying fatal ADE risk.
Methods: During a 2-year period, a multidisciplinary study group examined a
ll 732 patients who died-5.2% of the 13992 patients admitted to the Departm
ent of Internal Medicine, Central Hospital of Akershus, Nordbyhagen, Norway
. Decisions about the presence or absence of fatal ADEs were based on aggre
gated clinical records, autopsy results, and findings from premortem and po
stmortem drug analyses.
Results: In 18.2% of the patients (133/732) (95% confidence interval, 15.4%
-21.0%), deaths were classified as being directly (64 [48.1%] of 133) or in
directly (69 [51.9%] of 133) associated with 1 or more drugs (this equals 9
.5 deaths per 1000 hospitalized patients). Those with fatal ADEs (cases) we
re older, had more diseases, and used more drugs than those without fatal A
DEs (noncases). In 75 of the 133 patients with fatal ADEs, autopsy findings
and/or drug analysis data were decisive for recognizing the ADEs; in 62 of
the remaining 595 patients, similar data proved necessary to exclude the s
uspicion of a fatal ADE. Major culprit drugs were cardiovascular, antithrom
botic, and sympathomimetic agents.
Conclusions: Fatal ADEs represent a major hospital problem, especially in e
lderly patients with multiple diseases. A higher number of drugs administer
ed was associated with a higher frequency of fatal ADEs, but whether a high
number of drugs is an independent risk factor for fatal ADEs is unsettled.
Autopsy results and the findings of premortern and postmortem drug analyse
s were important for recognizing and excluding suspected fatal ADEs.