Abstract
Background: Adverse drug reactions (ADRs) are common in older adults and frequently have serious clinical and economic consequences. This study was conducted as a feasibility study for a randomized control trial (RCT) that will investigate the efficacy of a software engine to optimize medications and reduce incident (in-hospital) ADRs. This study’s objectives were to (i) establish current incident ADR rates across the six sites participating in the forthcoming RCT and (ii) assess whether incident ADRs are predictable. Methods: This was a multicentre, prospective observational study involving six European hospitals. Adults aged ⩾ 65 years, hospitalized with an acute illness and on pharmacological treatment for three or more conditions were eligible for inclusion. Adverse events (AEs) were captured using a trigger list of 12 common ADRs. An AE was deemed an ADR when its association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre causality assessment. The proportion of patients experiencing at least one, probable/certain, incident ADR within 14 days of enrolment/discharge was recorded. Results: A total of 644 patients were recruited, evenly split by sex and overwhelmingly of White ethnicity. Over 80% of admissions were medical. The median number of chronic conditions was five (interquartile range 4–6), with eight or more conditions present in approximately 10%. The mean number of prescribed medications was 9.9 (standard deviation 3.8), which correlated strongly with the number of conditions (r = 0.54, p < 0.0001). A total of 732 AEs were recorded in 382 patients, of which 363 were incident. The majority of events were classified as probably or possibly drug related, with heterogeneity across sites (χ2 = 88.567, df = 20, p value < 0.001). Out of 644 patients, 139 (21.6%; 95% confidence interval 18.5–25.0%) experienced an ADR. Serum electrolyte abnormalities were the most common ADR. The ADRROP (ADR Risk in Older People) and GerontoNet ADR risk scales correctly predicted ADR occurrence in 61% and 60% of patients, respectively. Conclusion: This feasibility study established the rates of incident ADRs across the six study sites. The ADR predictive power of ADRROP and GerontoNet ADR risk scales were limited in this population.
| Original language | English |
|---|---|
| Pages (from-to) | 13-23 |
| Number of pages | 11 |
| Journal | Therapeutic Advances in Drug Safety |
| Volume | 9 |
| Issue number | 1 |
| Early online date | 24 Oct 2017 |
| DOIs | |
| Publication status | Published - 30 Jan 2018 |
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Keywords
- adverse drug reactions (ADRs)
- adverse events (AEs)
- hospitalized
- incidence
- multimorbidity
- older adults
ASJC Scopus subject areas
- Pharmacology (medical)
Cite this
Incident adverse drug reactions in geriatric inpatients : a multicentred observational study. / Lavan, Amanda; Eustace, Joseph; Dahly, Darren; Flanagan, Evelyn; Gallagher, Paul; Cullinane, Shane; Petrovic, Mirko; Perehudoff, Katrina; Gudmondsson, Adalsteinn; Samuelsson, Ólafur; Sverrisdóttir, Ástrós; Cherubin, Antonio; Dimitri, Frederica; Rimland, Joe; Cruz-Jentoft, Alfonso; Vélez-Díaz-Pallarés, Manuel; Lozano Montoya, Isabel; Soiza, Roy L.; Subbarayan, Selvarani; O’Mahony, Denis.
In: Therapeutic Advances in Drug Safety, Vol. 9, No. 1, 30.01.2018, p. 13-23.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Incident adverse drug reactions in geriatric inpatients
T2 - a multicentred observational study
AU - Lavan, Amanda
AU - Eustace, Joseph
AU - Dahly, Darren
AU - Flanagan, Evelyn
AU - Gallagher, Paul
AU - Cullinane, Shane
AU - Petrovic, Mirko
AU - Perehudoff, Katrina
AU - Gudmondsson, Adalsteinn
AU - Samuelsson, Ólafur
AU - Sverrisdóttir, Ástrós
AU - Cherubin, Antonio
AU - Dimitri, Frederica
AU - Rimland, Joe
AU - Cruz-Jentoft, Alfonso
AU - Vélez-Díaz-Pallarés, Manuel
AU - Lozano Montoya, Isabel
AU - Soiza, Roy L.
AU - Subbarayan, Selvarani
AU - O’Mahony, Denis
N1 - Funding: This work was supported by European Commission’s Seventh Framework Programme (FP7/2007-2013) (grant number 305930) as part of the SENATOR project. D. O’Mahony is a coprivate investigator in the OPERAM project funded by the EC under Horizon 2020. OPERAM will examine the efficacy of STRIP-Assistant software in the prevention of medication-related admissions to hospital and associated excess healthcare costs.
PY - 2018/1/30
Y1 - 2018/1/30
N2 - Background: Adverse drug reactions (ADRs) are common in older adults and frequently have serious clinical and economic consequences. This study was conducted as a feasibility study for a randomized control trial (RCT) that will investigate the efficacy of a software engine to optimize medications and reduce incident (in-hospital) ADRs. This study’s objectives were to (i) establish current incident ADR rates across the six sites participating in the forthcoming RCT and (ii) assess whether incident ADRs are predictable. Methods: This was a multicentre, prospective observational study involving six European hospitals. Adults aged ⩾ 65 years, hospitalized with an acute illness and on pharmacological treatment for three or more conditions were eligible for inclusion. Adverse events (AEs) were captured using a trigger list of 12 common ADRs. An AE was deemed an ADR when its association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre causality assessment. The proportion of patients experiencing at least one, probable/certain, incident ADR within 14 days of enrolment/discharge was recorded. Results: A total of 644 patients were recruited, evenly split by sex and overwhelmingly of White ethnicity. Over 80% of admissions were medical. The median number of chronic conditions was five (interquartile range 4–6), with eight or more conditions present in approximately 10%. The mean number of prescribed medications was 9.9 (standard deviation 3.8), which correlated strongly with the number of conditions (r = 0.54, p < 0.0001). A total of 732 AEs were recorded in 382 patients, of which 363 were incident. The majority of events were classified as probably or possibly drug related, with heterogeneity across sites (χ2 = 88.567, df = 20, p value < 0.001). Out of 644 patients, 139 (21.6%; 95% confidence interval 18.5–25.0%) experienced an ADR. Serum electrolyte abnormalities were the most common ADR. The ADRROP (ADR Risk in Older People) and GerontoNet ADR risk scales correctly predicted ADR occurrence in 61% and 60% of patients, respectively. Conclusion: This feasibility study established the rates of incident ADRs across the six study sites. The ADR predictive power of ADRROP and GerontoNet ADR risk scales were limited in this population.
AB - Background: Adverse drug reactions (ADRs) are common in older adults and frequently have serious clinical and economic consequences. This study was conducted as a feasibility study for a randomized control trial (RCT) that will investigate the efficacy of a software engine to optimize medications and reduce incident (in-hospital) ADRs. This study’s objectives were to (i) establish current incident ADR rates across the six sites participating in the forthcoming RCT and (ii) assess whether incident ADRs are predictable. Methods: This was a multicentre, prospective observational study involving six European hospitals. Adults aged ⩾ 65 years, hospitalized with an acute illness and on pharmacological treatment for three or more conditions were eligible for inclusion. Adverse events (AEs) were captured using a trigger list of 12 common ADRs. An AE was deemed an ADR when its association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre causality assessment. The proportion of patients experiencing at least one, probable/certain, incident ADR within 14 days of enrolment/discharge was recorded. Results: A total of 644 patients were recruited, evenly split by sex and overwhelmingly of White ethnicity. Over 80% of admissions were medical. The median number of chronic conditions was five (interquartile range 4–6), with eight or more conditions present in approximately 10%. The mean number of prescribed medications was 9.9 (standard deviation 3.8), which correlated strongly with the number of conditions (r = 0.54, p < 0.0001). A total of 732 AEs were recorded in 382 patients, of which 363 were incident. The majority of events were classified as probably or possibly drug related, with heterogeneity across sites (χ2 = 88.567, df = 20, p value < 0.001). Out of 644 patients, 139 (21.6%; 95% confidence interval 18.5–25.0%) experienced an ADR. Serum electrolyte abnormalities were the most common ADR. The ADRROP (ADR Risk in Older People) and GerontoNet ADR risk scales correctly predicted ADR occurrence in 61% and 60% of patients, respectively. Conclusion: This feasibility study established the rates of incident ADRs across the six study sites. The ADR predictive power of ADRROP and GerontoNet ADR risk scales were limited in this population.
KW - adverse drug reactions (ADRs)
KW - adverse events (AEs)
KW - hospitalized
KW - incidence
KW - multimorbidity
KW - older adults
UR - http://www.scopus.com/inward/record.url?scp=85039733715&partnerID=8YFLogxK
U2 - 10.1177/2042098617736191
DO - 10.1177/2042098617736191
M3 - Article
AN - SCOPUS:85039733715
VL - 9
SP - 13
EP - 23
JO - Therapeutic Advances in Drug Safety
JF - Therapeutic Advances in Drug Safety
SN - 2042-0986
IS - 1
ER -