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Adverse drug events in older hospitalized patients: results and reliability of a comprehensive and structured identification strategy.

ABSTRACT: BACKGROUND:Older patients are at high risk for experiencing Adverse Drug Events (ADEs) during hospitalization. To be able to reduce ADEs in these vulnerable patients, hospitals first need to measure the occurrence of ADEs, especially those that are preventable. However, data on preventable ADEs (pADEs) occurring during hospitalization in older patients are scarce, and no 'gold standard' for the identification of ADEs exists. METHODOLOGY:The study was conducted in three hospitals in the Netherlands in 2007. ADEs were retrospectively identified by a team of experts using a comprehensive and structured patient chart review (PCR) combined with a trigger-tool as an aid. This ADE identification strategy was applied to a cohort of 250 older hospitalized patients. To estimate the intra- and inter-rater reliabilities, Cohen's kappa values were calculated. PRINCIPAL FINDINGS:In total, 118 ADEs were detected which occurred in 62 patients. This ADE yield was 1.1 to 2.7 times higher in comparison to other ADE studies in older hospitalized patients. Of the 118 ADEs, 83 (70.3%) were pADEs; 51 pADEs (43.2% of all ADEs identified) caused serious patient harm. Patient harm caused by ADEs resulted in various events. The overall intra-rater agreement of the developed strategy was substantial (? = 0.74); the overall inter-rater agreement was only fair (? = 0.24). CONCLUSIONS/SIGNIFICANCE:The ADE identification strategy provided a detailed insight into the scope of ADEs occurring in older hospitalized patients, and showed that the majority of (serious) ADEs can be prevented. Several strategy related aspects, as well as setting/study specific aspects, may have contributed to the results gained. These aspects should be considered whenever ADE measurements need to be conducted. The results regarding pADEs can be used to design tailored interventions to effectively reduce harm caused by medication errors. Improvement of the inter-rater reliability of a PCR remains challenging.

SUBMITTER: Klopotowska JE

PROVIDER: S-EPMC3733642 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Adverse drug events in older hospitalized patients: results and reliability of a comprehensive and structured identification strategy.

Klopotowska Joanna E JE Wierenga Peter C PC Stuijt Clementine C M CC Arisz Lambertus L Dijkgraaf Marcel G W MG Kuks Paul F M PF Asscheman Henk H de Rooij Sophia E SE Lie-A-Huen Loraine L Smorenburg Susanne M SM

PloS one 20130805 8

<h4>Background</h4>Older patients are at high risk for experiencing Adverse Drug Events (ADEs) during hospitalization. To be able to reduce ADEs in these vulnerable patients, hospitals first need to measure the occurrence of ADEs, especially those that are preventable. However, data on preventable ADEs (pADEs) occurring during hospitalization in older patients are scarce, and no 'gold standard' for the identification of ADEs exists.<h4>Methodology</h4>The study was conducted in three hospitals i ...[more]

PMID: 23940688

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Project description:In Japan, medical costs are increasing annually, and the increase in national medical costs, particularly in the direct cost of managing adverse drug events, is high. An in-depth understanding of these costs is important for their reduction. This study aimed to calculate the direct cost of managing adverse drug events in all ages, including older adults, and that of avoidable adverse drug events in older adults. We conducted a retrospective survey on patients aged 1 year or older who visited Gifu Municipal Hospital in Japan. We investigated and calculated the direct cost of managing adverse drug events and that of avoidable adverse drug events based on the Beers Criteria Japanese version (BCJ) and "Guidelines for medical treatment and its safety in the elderly 2015" (GMTSE-2015) in inpatients and outpatients. Among 6,504 patients, 11.1% visited the hospital or were hospitalized due to adverse drug events. The direct costs per patient with adverse drug events were 21,281 and 22,590 yen (166 and 176 euros as on September 13, 2021) for outpatients, and 853,175 and 874,582 yen (6,648 and 6,815 euros) for inpatients of all ages and older adults, respectively. The direct costs of avoidable adverse drug events per patient using drugs listed in the BCJ and GMTSE-2015 for older adults were 3,212 and 3,341 yen (25 and 26 euros) for outpatients, and 55,548 and 80,246 yen (433 and 625 euros) for inpatients, respectively. In sum, considering both inpatients and outpatients in the whole country, the direct costs of managing adverse drug events were 804.53 billion and 597.19 billion yen (6,269 million and 4,653 million euros) per year for all ages and older ages, respectively. The direct cost of avoidable adverse drug events in older adults was 83.43-258.44 billion yen (650-2,013 million euros) per year. We found that, in Japan, high medical costs are often caused by managing adverse drug events, and that the costs of avoidable adverse drug events in older adults based on the BCJ and GMTSE-2015 account for a substantial proportion of the medical cost. Therefore, by using the BCJ and GMTSE-2015, avoiding adverse drug events and reducing medical costs may be possible.

Project description:IntroductionFrailty is highly prevalent in heart failure populations and a major risk factor for adverse drug reactions (ADRs) and adverse drug events (ADEs). This review aimed to describe the prevalence, causality and severity of ADRs or ADEs from heart failure medications among frail compared with non-frail older adults.MethodsA systematic search of CENTRAL, MEDLINE, Embase, Ageline, CINAHL, International Pharmaceutical Abstracts, PsychInfo, Scopus, registries and citations prior to 18 May 2021 was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 checklist. Risk of bias and quality of evidence were assessed. Eligible studies included randomised controlled trials (RCTs) and observational studies of people diagnosed with heart failure, aged ≥ 65 years, with frailty defined by an objective measurement, and reported ADRs/ADEs from/with heart failure medications.ResultsTwo reviewers screened 2419 articles; interrater reliability kappa = 0.88. Three observational studies (n = 2596), a secondary analysis of two RCTs (n = 2098) and two cohort studies (n = 498) were included in a narrative synthesis. Frail patients in randomised trials of sacubitril/valsartan, aliskiren, or enalapril had twice the risk of mortality (hazard ratio [HR] 2.09, 1.62-2.71) and hospitalisations (HR 1.82, 1.37-2.41) compared with robust patients, which may reflect responsiveness to medications and/or factors unrelated to medication use. Hospitalisations from falls, tiredness and nausea were probably attributable to digoxin and possibly preventable according to the Naranjo and Hallas scales, respectively.ConclusionThe potential harms from heart failure medications in frail older people are poorly studied and understood. Clinical trials and pharmacovigilance studies should include frailty as a covariate to inform medication optimisation for this vulnerable and growing population.RegistrationProspero registration number: CRD 42021253762.

Project description:BackgroundAlthough opioids are initiated on hospital discharge in millions of older adults each year, there are no studies examining patient- and prescribing-related risk factors for opioid-related adverse drug events (ADEs) after hospital discharge among medical patients.MethodsA retrospective cohort study of a national sample of Medicare beneficiaries aged 65 years and older, hospitalized for a medical reason, with at least one claim for an opioid within 2 days of hospital discharge. We excluded patients receiving hospice care and patients admitted from or discharged to a facility. We used administrative billing codes and medication claims to define potential opioid-related ADEs within 30 days of hospital discharge, and competing risks regression to identify risk factors for these events.ResultsAmong 22,879 medical hospitalizations (median age 74, 36.9% female) with an opioid claim within 2 days of hospital discharge, a potential opioid-related ADE occurred in 1604 (7.0%). Independent risk factors included age of 80 years and older (HR 1.18, 95% CI 1.05-1.33); clinical conditions, including kidney disease (HR 1.22, 95% CI 1.08-1.37), dementia/delirium (HR 1.38, 95% CI 1.22-1.56), anxiety disorder (HR 1.20, 95% CI 1.06-1.36), opioid use disorder (HR 1.20, 95% CI 1.03-1.39), intestinal disorders (HR 1.31, 95% CI 1.15-1.49), pancreaticobiliary disorders (HR 1.32, 95% CI 1.09-1.61), and musculoskeletal and nervous system injuries (HR 1.35, 95% CI 1.17-1.54); red flags for opioid misuse (HR 1.37, 95% CI 1.04-1.80); opioid use in the 30 days before hospitalization (HR 1.20, 95% CI 1.08-1.34); and prescription of long-acting opioids (HR 1.34, 95% CI 1.06-1.70).ConclusionsPotential opioid-related ADEs occurred within 30 days of hospital discharge in 7.0% of older adults discharged from a medical hospitalization with an opioid prescription. Identified risk factors can be used to inform physician decision-making, conversations with older adults about risk, and development and targeting of harm reduction strategies.

Project description:Background and objectivesAdverse drug events (ADEs) are the fifth leading cause of death and thus responsible for a large number of hospital admissions in all over the globe. This study was aimed to assess the antibiotics associated preventability of ADEs and causality of adverse drug reactions (ADRs) among hospitalized patients.MethodsA prospective, cross-sectional, observational study was conducted in four tertiary care public sector hospitals of Lahore, Pakistan. Study population consisted of hospitalized patients who were prescribed with one or more antibiotics. Data were collected between 1st January, 2017 and 31st June, 2017 from 1,249 patients (384 patients aged ≤ 18 years and 865 patients aged >18 years). Schumock and Thornton scale was used to assess the preventability of the ADEs. Medication errors (MEs) that caused preventable ADEs were assessed by MEs tracking form while Naranjo score was used to evaluate the causal relation of ADRs with the antibiotics. Statistical Package for the Social Sciences (IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) and Microsoft Excel (MS Office, 2010) were used for data analysis.Results2,686 antibiotics were prescribed to 1,249 patients. Among them, fluoroquinolones (11.8%), macrolides (11.6%) and cephalosporins (10.9%) were the most frequently prescribed antibiotics. The most affected organ system by antibiotics associated ADEs was gastrointestinal tract. A total of 486 ADEs were found. The preventability assessment revealed that most of the ADEs (58.4%) were preventable (43.6% of the ADEs were definitely preventable while 14.8% were probably preventable) and caused by MEs including wrong drug (40.1%) and monitoring errors (25.0%), during the stage of physician ordering (22.2%) and patient monitoring (21.1%). The errors were caused due to non-adherence of policies (38.4%) and lack of information about antibiotics (32%). Most of the non-preventable ADEs or ADRs among adults and children were "probable" (35.5%) and "possible" (35.8%), respectively. Logistic regression analysis revealed that ADEs were significantly less among females (OR = 0.047, 95%CI = 0.018-0.121, p-value = <0.001), patients aged 18-52 years (OR = 0.041, 95%CI = 0.013-0.130, p-value = <0.001), tuberculosis patients (OR = 0.304, 95%CI = 0.186-0.497, p-value = <0.001), patients with acute respiratory tract infections (OR = 0.004, 95%CI = 0.01-0.019, p-value = <0.001) and among the patients prescribed with 2 antibiotics per prescription (OR = 0.455, 95%CI = 0.319-0.650, p-value = <0.001).ConclusionAccording to preventability assessment most of the ADEs were definitely preventable and caused by MEs due to non-adherence of policies and lack of information about antibiotics. The causality assessment of non-preventable ADEs showed that most of the ADRs were probable and possible.

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Dataset Information

Adverse drug events in older hospitalized patients: results and reliability of a comprehensive and structured identification strategy.

Publications

Adverse drug events in older hospitalized patients: results and reliability of a comprehensive and structured identification strategy.

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