Epidemiology of Adverse Drug Reactions in Europe: A Review of Recent Observational Studies

Abstract

Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3 September 2014. Included studies assessed the number of patients who were admitted to hospital due to an ADR, studies that assessed the number of patients who developed an ADR during hospitalization, and studies that measured ADRs in the outpatient setting. In total, 47 articles were included in the final review. The median percentage of hospital admissions due to an ADR was 3.5 %, based on 22 studies, and the median percentage of patients who experienced an ADR during hospitalization was 10.1 %, based on 13 studies. Only five studies were found that assessed ADRs occurring in the outpatient setting. These results indicate that the occurrence of ADRs in the European hospital setting—both ADRs that result in hospitalization and ADRs that occur during the hospital stay—is significant. Furthermore, the limited number of studies that were performed in the outpatient setting identify a lack of information regarding the epidemiology of ADRs in this setting.

Adverse Drug Reactions among Patients Admitted to Eritrean Hospitals: Prevalence Causes and Risk Factors a prospective analysis of 5848 patients

“…This finding is broadly compatible with pooled data from older studies, and with other similar studies [2][3][4][5]. A recent review on the epidemiology of ADRs in Europe found that 3.5% of hospital admissions were due to ADRs [6]. An observational study aimed at measuring the burden of ADRs in medical wards of four hospitals conducted in South Africa also found 8.4% ADR related hospital admissions [7].…”

An evaluation of knowledge, attitude and practice of pharmacovigilance among medical students and doctors at a tertiary care hospital

“…It has been reported that the total incidence of both groups of ADRs was 6.7% with an overall fatality rate of 0.32%; of which the incidence of ADRs responsible for hospital admission was 4.7% and 2.0% occurred in in-patients. 4,5 ADRs are ranked between the fourth and sixth as leading causes of death in the USA. [5] ADRs are reported to be the seventh most common cause of death in Sweden.…”

Factors influencing the knowledge and attitude of nurses towards adverse drug reaction reporting in a teaching hospital

“…3,14,19 Nurses constitute a potentially valuable source for voluntary ADR reports in hospitals where ADR is more likely to be severe. 19 If nurses are actively involved in pharmacovigilance, ADRs in hospitals can be detected early and reported more accurately.…”