Incidence of Adverse Drug
Reactions
in Hospitalized Patients
A Meta-analysis of Prospective Studies
OBJECTIVE:
To estimate the incidence of serious and fatal adverse drug
reactions (ADR)
in hospital patients.
DATA SOURCES:
Four electronic databases were searched from
1966 to 1996.
STUDY SELECTION:
Of 153, we selected 39 prospective studies from
US Hospitals.
DATA EXTRACTION:
Data extracted independently by 2
investigators were analyzed by a random-effects model. To obtain the overall incidence of
ADRs in hospitalized patients, we combined the incidence of ADRs occurring while in the
hospitals plus the incidence of ADRs causing admission to hospital.
We excluded errors in
drug administration, noncompliance, overdose, drug abuse, therapeutic failures, and
possible ADRs.
Serious ADRs were defined as those that required hospitalization, were
permanently disabling, or resulted in death.
DATA SYNTHESIS:
The overall incidence of serious ADRs was
6.7% (95% confidence interval (CI), 5.2%-8.2%) and of fatal ADRs was 0.32% (95% CI,
0.23%-0.41%) of hospitalized patients. We estimated that in 1994 overall 2,216,000
(76,000-137,000) had fatal ADRs.
Making these reactions between the fourth and sixth
leading cause of death.
CONCLUSIONS:
The incidence of serious and fatal ADRs in US Hospitals was
found to be extremely high.
While our results must be viewed with circumspection because
of heterogeneity among studies and small biases in the samples, these data nevertheless
suggest that ADRs represent an important clinical issue.
Jason Lazarou, MSc; Bruce H. Pomeranz, MD, PhD;
Paul N. Corey, PhD.JAMA. 1998; 279; 1200-1205.
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