Incident adverse drug reactions in geriatric inpatients: a multicentred observational study

Amanda Lavan, Joseph Eustace, Darren Dahly, Evelyn Flanagan, Paul Gallagher, Shane Cullinane, Mirko Petrovic, Katrina Perehudoff, Adalsteinn Gudmondsson, Ólafur Samuelsson, Ástrós Sverrisdóttir, Antonio Cherubin, Frederica Dimitri, Joe Rimland, Alfonso Cruz-Jentoft, Manuel Vélez-Díaz-Pallarés, Isabel Lozano Montoya, Roy L. Soiza, Selvarani Subbarayan, Denis O’Mahony*

*Corresponding author for this work

Research output: Contribution to journalArticle

7 Citations (Scopus)

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 languageEnglish
Pages (from-to)13-23
Number of pages11
JournalTherapeutic Advances in Drug Safety
Volume9
Issue number1
Early online date24 Oct 2017
DOIs
Publication statusPublished - 30 Jan 2018

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Drug-Related Side Effects and Adverse Reactions
Geriatrics
Observational Studies
Inpatients
Feasibility Studies
Causality
Pharmaceutical Preparations
Electrolytes
Software

Keywords

  • adverse drug reactions (ADRs)
  • adverse events (AEs)
  • hospitalized
  • incidence
  • multimorbidity
  • older adults

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Lavan, A., Eustace, J., Dahly, D., Flanagan, E., Gallagher, P., Cullinane, S., ... O’Mahony, D. (2018). Incident adverse drug reactions in geriatric inpatients: a multicentred observational study. Therapeutic Advances in Drug Safety, 9(1), 13-23. https://doi.org/10.1177/2042098617736191

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 journalArticle

Lavan, A, Eustace, J, Dahly, D, Flanagan, E, Gallagher, P, Cullinane, S, Petrovic, M, Perehudoff, K, Gudmondsson, A, Samuelsson, Ó, Sverrisdóttir, Á, Cherubin, A, Dimitri, F, Rimland, J, Cruz-Jentoft, A, Vélez-Díaz-Pallarés, M, Lozano Montoya, I, Soiza, RL, Subbarayan, S & O’Mahony, D 2018, 'Incident adverse drug reactions in geriatric inpatients: a multicentred observational study', Therapeutic Advances in Drug Safety, vol. 9, no. 1, pp. 13-23. https://doi.org/10.1177/2042098617736191
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. / Incident adverse drug reactions in geriatric inpatients : a multicentred observational study. In: Therapeutic Advances in Drug Safety. 2018 ; Vol. 9, No. 1. pp. 13-23.
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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.",
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author = "Amanda Lavan and Joseph Eustace and Darren Dahly and Evelyn Flanagan and Paul Gallagher and Shane Cullinane and Mirko Petrovic and Katrina Perehudoff and Adalsteinn Gudmondsson and {\'O}lafur Samuelsson and {\'A}str{\'o}s Sverrisd{\'o}ttir and Antonio Cherubin and Frederica Dimitri and Joe Rimland and Alfonso Cruz-Jentoft and Manuel V{\'e}lez-D{\'i}az-Pallar{\'e}s and {Lozano Montoya}, Isabel and Soiza, {Roy L.} and Selvarani Subbarayan and Denis O’Mahony",
note = "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.",
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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.

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