Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.
Level 3 - non-randomized controlled study
Meta-analysis of prospective observational studies
PubMed 9555760 · doi:10.1001/jama.279.15.1200
What was done
A systematic search across four electronic databases (1966–1996) identified prospective studies evaluating adverse drug reactions (ADRs) in US hospitals. Out of 153 identified studies, 39 prospective studies were selected. Two investigators independently extracted data, which were pooled using a random-effects model. The analysis combined ADRs occurring during hospitalization with ADRs causing hospital admission. The authors excluded medication errors, noncompliance, overdose, drug abuse, therapeutic failures, and possible ADRs. Serious ADRs were defined as those resulting in hospitalization, permanent disability, or death.
What was found
The overall pooled incidence of serious ADRs was 6.7% (95% CI, 5.2% to 8.2%) and fatal ADRs was 0.32% (95% CI, 0.23% to 0.41%) among hospitalized patients. Extrapolated to 1994 US hospitalizations, an estimated 2,216,000 (95% CI, 1,721,000 to 2,711,000) patients experienced serious ADRs and 106,000 (95% CI, 76,000 to 137,000) experienced fatal ADRs, placing ADRs between the fourth and sixth leading cause of death in the United States.
Why it matters
This study provided the first comprehensive national estimate demonstrating that adverse drug reactions from standard medical therapy represent a major source of patient morbidity and mortality in US hospitals.
Limits
The findings are limited by heterogeneity among the included prospective studies and potential sampling biases. Total patient count across the 39 studies is not reported in the abstract. In addition, national fatal and serious ADR estimates depend on assumptions regarding how well the selected hospital cohorts represent all US hospital admissions.
Cited by
- partial Correctly prescribed drugs administered at the proper dose and for the correct indication are the third leading cause of death in the United States.
- contradicts When combining properly prescribed medications, medical errors, adverse drug interactions, surgeries, and hospital-acquired infections, iatrogenesis is the number one cause of death in the United States.