Clinical and economic impact of adverse drug reactions in hospitalised patients: prospective matched nested case–control study in Ethiopia

Abstract

ObjectivesThe purpose of this study was to assess the clinical and economic impact of adverse drug reactions (ADRs) among patients admitted to the University of Gondar Comprehensive Specialized Hospital (UoGCSH).Design and settingA prospective nested case–control study was conducted at the UoGCSH among admitted adult patients with (cases) and without ADRs (controls) between May and October 2022.ParticipantsAll eligible adult patients admitted in the medical ward of the UoGCSH during the study period were included in this study.Main outcome measuresThe outcome variables were the clinical and economic outcomes. Length of hospital stay, visits to intensive care units (ICU) and in-hospital mortality were used to measure and compare clinical outcomes in patients with and without ADRs. The economic outcome was also assessed using direct medical-related costs and compared for the two groups. Paired samples t-test and McNemar tests were used to compare measurable outcomes between the two groups. A p value <0.05 at the 95% CI was considered statistically significant.ResultsOut of a total of 214 eligible enrolled patients, 206 (103 with and 103 without ADRs) with a 96.3% response rate were included in the cohort. The length of hospital stay was much longer in patients with ADRs than without ADRs (19.8 vs 15.2 days, p<0.001). Similarly, ICU visits (11.2% vs 6.8%, p<0.001) and in-hospital mortality (4.4% vs 1.9%, p=0.012) were significantly higher in patients with ADRs compared with those without ADRs. Patients with ADRs were significantly charged with higher direct medical costs compared with those without ADRs (6237.2 vs 5256.3 Ethiopian birr; p<0.001).ConclusionThis study concluded that ADRs had a significant impact on patients’ clinical and medical costs. Healthcare providers should strictly follow the patients to minimise ADR-related clinical and economic adverse outcomes.

Variation of adverse drug events in different settings in Africa: a systematic review

“…Of 78 studies, 27 studies [ 18 – 44 ] were carried out among general patients, while the remaining studies [ 45 – 95 ] were carried out among specific patients. Seventeen studies [ 18 – 22 , 24 , 26 , 31 , 33 – 35 , 38 , 39 , 41 – 43 , 51 ] reported the prevalence of ADEs leading to hospital admissions, while 30 studies [ 18 , 19 , 22 – 33 , 35 , 37 – 41 , 43 , 44 , 65 , 80 , 85 – 88 , 91 , 95 ] reported the prevalence of ADEs during hospitalization. Twelve studies [ 18 , 19 , 22 , 24 , 26 , 31 , 33 , 35 , 38 , 39 , 41 , 43 ] reported ADE occurrence in both settings.…”

“…Seventeen studies [ 18 – 22 , 24 , 26 , 31 , 33 – 35 , 38 , 39 , 41 – 43 , 51 ] reported the prevalence of ADEs leading to hospital admissions, while 30 studies [ 18 , 19 , 22 – 33 , 35 , 37 – 41 , 43 , 44 , 65 , 80 , 85 – 88 , 91 , 95 ] reported the prevalence of ADEs during hospitalization. Twelve studies [ 18 , 19 , 22 , 24 , 26 , 31 , 33 , 35 , 38 , 39 , 41 , 43 ] reported ADE occurrence in both settings. In addition, 38 studies [ 45 – 50 , 52 , 54 – 64 , 66 – 74 , 76 , 78 , 79 , 82 – 84 , 89 , 90 , 92 – 94 ] reported the occurrence of ADEs in the outpatient setting, and four studies [ 53 , 75 , 77 , 81 ] reported ADEs in the community setting.…”

“…In addition, 38 studies [ 45 – 50 , 52 , 54 – 64 , 66 – 74 , 76 , 78 , 79 , 82 – 84 , 89 , 90 , 92 – 94 ] reported the occurrence of ADEs in the outpatient setting, and four studies [ 53 , 75 , 77 , 81 ] reported ADEs in the community setting. Majority of included studies [ 18 – 22 , 27 – 29 , 32 – 34 , 36 , 37 , 40 , 41 , 43 , 45 – 48 , 52 , 54 – 60 , 62 – 65 , 67 , 70 , 72 – 74 , 76 , 79 , 81 , 82 , 89 , 90 , 92 – 94 ] were carried out on adult population (aged ≥ 18 years) ( n = 46), while 18 studies were conducted among all age groups (aged 0–100 years) [ 23 , 24 , 30 , 50 , 51 , 61 , 66 , 68 , 69 , 71 , 75 , 77 , 78 , 84 – 88 ], 12 studies [ 25 ...…”

“…The WHO definition for ADRs was frequently used in the included studies [ 18 – 22 , 29 , 31 , 33 , 39 , 43 ]. The majority of included studies used medical record review [ 18 – 22 , 25 – 41 , 43 , 44 ] for the detection of ADEs. Twenty-five studies reported on causality assessment, with the Naranjo and WHO-UMC methods frequently referenced.…”

“…Seventeen studies [ 18 – 22 , 24 , 26 , 31 , 33 – 36 , 38 , 39 , 41 – 43 ] reported on the prevalence of ADEs leading to hospital admissions ranging from 0.4% to 50% of all study populations; however, data were available for 16 studies. The overall median ADE prevalence among the 16 studies was 6.0% (IQR: 1.5%–9.0%) of all study populations (Table 4 ).…”