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Prevalence and perceived preventability of self-reported adverse drug events--a population-based survey of 7099 adults.

ABSTRACT: PURPOSE: Adverse drug events (ADEs) are common and often preventable among inpatients, but self-reported ADEs have not been investigated in a representative sample of the general public. The objectives of this study were to estimate the 1-month prevalence of self-reported ADEs among the adult general public, and the perceived preventability of 2 ADE categories: adverse drug reactions (ADRs) and sub-therapeutic effects (STEs). METHODS: In this cross-sectional study, a postal survey was sent in October 2010 to a random sample of 13 931 Swedish residents aged ? 18 years. Self-reported ADEs experienced during the past month included ADRs, STEs, drug dependence, drug intoxications and morbidity due to drug-related untreated indication. ADEs could be associated with prescription, non-prescription or herbal drugs. The respondents estimated whether ADRs and STEs could have been prevented. ADE prevalences in age groups (18-44, 45-64, or ?65 years) were compared. RESULTS: Of 7099 respondents (response rate 51.0%), ADEs were reported by 19.4% (95% confidence interval, 18.5-20.3%), and the prevalence did not differ by age group (p>0.05). The prevalences of self-reported ADRs, STEs, and morbidities due to drug-related untreated indications were 7.8% (7.2-8.4%), 7.6% (7.0-8.2%) and 8.1% (7.5-8.7%), respectively. The prevalence of self-reported drug dependence was 2.2% (1.9-2.6%), and drug intoxications 0.2% (0.1-0.3%). The respondents considered 19.2% (14.8-23.6%) of ADRs and STEs preventable. Although reported drugs varied between ADE categories, most ADEs were attributable to commonly dispensed drugs. Drugs reported for all and preventable events were similar. CONCLUSIONS: One-fifth of the adult general public across age groups reported ADEs during the past month, indicating a need for prevention strategies beyond hospitalised patients. For this, the underlying causes of ADEs should increasingly be investigated. The high burden of ADEs and preventable ADEs from widely used drugs across care settings supports redesigning a safer healthcare system to adequately tackle the problem.

SUBMITTER: Hakkarainen KM

PROVIDER: S-EPMC3762841 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Prevalence and perceived preventability of self-reported adverse drug events--a population-based survey of 7099 adults.

Hakkarainen Katja Marja KM Andersson Sundell Karolina K Petzold Max M Hägg Staffan S

PloS one 20130904 9

<h4>Purpose</h4>Adverse drug events (ADEs) are common and often preventable among inpatients, but self-reported ADEs have not been investigated in a representative sample of the general public. The objectives of this study were to estimate the 1-month prevalence of self-reported ADEs among the adult general public, and the perceived preventability of 2 ADE categories: adverse drug reactions (ADRs) and sub-therapeutic effects (STEs).<h4>Methods</h4>In this cross-sectional study, a postal survey w ...[more]

PMID: 24023828

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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: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.

Project description:BackgroundPromoting medication adherence is a recognized challenge for prescribers. In this study, we examine whether lower medication adherence is associated with adverse safety events in individuals with decreased estimated glomerular filtration rates (eGFRs).Study designCross-sectional baseline analysis of prospective cohort.Setting & participantsBaseline analysis of the Safe Kidney Care (SKC) Cohort Study, a prospective study of individuals with eGFRs<60 mL/min/1.73 m(2) intended to assess the incidence of disease-specific safety events. Kidney transplant recipients were excluded.PredictorSelf-reported medication adherence based on responses to 3 questions ascertaining degree of medication regimen adherence.OutcomesAdverse safety events were self-reported at baseline (class I events), such as hypoglycemia or fall thought to be related to a medication, or detected incidentally during the baseline visit (class II events), for example, hypotension or hyperkalemia. Potential drug-related problems (DRPs) were determined by analyzing participants' medications with respect to dosing guidelines based on their screening eGFRs at the time of medication reporting.MeasurementsRelationship between medication adherence and disease-specific patient safety events.ResultsOf 293 SKC participants, 154 (53%) were classified as having lower medication adherence. After multivariable adjustment, lower medication adherence was significantly associated with a class I or II safety event (prevalence ratio [PR], 1.21; 95% CI, 1.04-1.41) and potential DRPs (PR, 1.29; 95% CI, 1.02-1.63). Lower medication adherence was also significantly associated with multiple (≥2) class I events (PR, 1.71; 95% CI, 1.18-2.49), multiple class I or II events (PR, 1.35; 95% CI, 1.04-1.76), and multiple potential DRPs (PR, 2.11; 95% CI, 1.08-2.69) compared with those with higher medication adherence.LimitationsUse of self-reported medication adherence rather than pharmacy records. Clinical relevance of detected safety events is unclear.ConclusionsLower medication adherence is associated with adverse safety events in individuals with eGFRs<60 mL/min/1.73 m(2).

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Dataset Information

Prevalence and perceived preventability of self-reported adverse drug events--a population-based survey of 7099 adults.

Publications

Prevalence and perceived preventability of self-reported adverse drug events--a population-based survey of 7099 adults.

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