Dataset Information

Adverse Drug reactions in an Ageing PopulaTion (ADAPT) study protocol: a cross-sectional and prospective cohort study of hospital admissions related to adverse drug reactions in older patients.

ABSTRACT:

Introduction

Older people experience greater morbidity with a corresponding increase in medication use resulting in a potentially higher risk of adverse drug reactions (ADRs). The aim of this study is to determine the prevalence and characteristics of ADR-related hospital admissions among older patients (?65 years) and their associated health and cost outcomes.

Methods and analysis

The proposed study will include a cross-sectional study of ADR prevalence in all patients aged ?65 years admitted acutely to a large tertiary referral hospital in Ireland over a 9-month period (2016-2017) and a prospective cohort study of patient-reported health outcomes and costs associated with ADR-related hospital admissions. All acute medical admissions will be screened for a suspected ADR-related hospital admission. A number of validated algorithms will be applied to assess the type, causative medications, preventability and severity of each ADR. ADRs will be determined, using a consensus method, by an expert panel. Patients who provide consent will be followed up 3 months post-discharge to establish patient-reported health outcomes (health service use, health-related quality of life, adherence) and costs associated with ADR-related hospital admissions. A random sample of patients admitted to hospital without a suspected ADR will be invited to take part in the study as a control group.

Ethics and dissemination

Ethical approval was obtained from Beaumont Hospital Ethics Committee. Findings will be disseminated through presentations and peer-reviewed publications.

SUBMITTER: Cahir C

PROVIDER: S-EPMC5726049 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Publications

Adverse Drug reactions in an Ageing PopulaTion (ADAPT) study protocol: a cross-sectional and prospective cohort study of hospital admissions related to adverse drug reactions in older patients.

Cahir Caitriona C Curran Carmel C Byrne Catherine C Walsh Caroline C Hickey Anne A Williams David J DJ Bennett Kathleen K

BMJ open 20170609 6

<h4>Introduction</h4>Older people experience greater morbidity with a corresponding increase in medication use resulting in a potentially higher risk of adverse drug reactions (ADRs). The aim of this study is to determine the prevalence and characteristics of ADR-related hospital admissions among older patients (≥65 years) and their associated health and cost outcomes.<h4>Methods and analysis</h4>The proposed study will include a cross-sectional study of ADR prevalence in all patients aged ≥65 y ...[more]

PMID: 28600381

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Project description:BACKGROUND:An adverse drug reaction (ADR) is a response to a medicine that is not intended and is harmful, and which occurs at normal dose levels for humans. Currently, there are no estimates of the population-based prevalence of ADRs in the Kingdom of Saudi Arabia (KSA). OBJECTIVE:The aims of this study were to (1) estimate the population-based prevalence of ADRs in KSA, (2) describe the ADRs experienced by survey respondents, and (3) investigate the level of awareness of the ADR reporting system. PATIENTS AND METHODS:This was a cross-sectional survey using stratified, population-based sampling conducted at a chain of community pharmacies. RESULTS:Analysis was conducted on 5228 surveys; 50.17% of respondents were males, and the mean age was 39?±?15 years (min?=?18, max?=?98). The sample prevalence of ADRs was 23.45% (95% CI 22.30-24.60%, P?<?0.001). The estimated population prevalence (after weighting) was 28.00% (26.10-30.00%). Gastrointestinal disorders were the most commonly reported ADRs (58.73%), followed by general disorders and administration site conditions (19.74%). The largest drug class that was reported to lead to ADRs was nonsteroidal anti-inflammatory drugs (NSAIDs) (11%). Over 19% of the respondents who experienced an ADR required medical intervention to control the suffering induced by the ADR. Of the respondents who experienced an ADR, 371 (30.26%) were aware of the ADR reporting system but only 53 (14.29%) said that they had filed a report in the system. CONCLUSIONS:Our study estimated that 28% of the population experienced an ADR over a 1-year period in KSA. Risk factors for ADR included certain chronic disease groups and the use of certain classes of medications. Regulatory authorities in KSA intend to conduct more research and deploy educational interventions to reduce ADR rates in KSA. This will hopefully occur in an international context that promotes the standardized measurement of ADRs in the community. A subset of findings from this report was presented in an oral presentation at the Saudi Food and Drug Authority (SFDA) Annual Conference, September 27, 2018. In addition, a subset of findings from this report were presented on a poster at the International Conference of Pharmacoepidemiology and Therapeutic Risk Management (ICPE), August 27, 2019.

Project description:BackgroundAdverse drug reactions (ADRs) are an important cause of harm in children. Current data are incomplete due to methodological differences between studies: only half of all studies provide drug data, incidence rates vary (0.6% to 16.8%) and very few studies provide data on causality, severity and risk factors of pediatric ADRs. We aimed to determine the incidence of ADRs in hospitalized children, to characterize these ADRs in terms of type, drug etiology, causality and severity and to identify risk factors.MethodsWe undertook a year-long, prospective observational cohort study of admissions to a single UK pediatric medical and surgical secondary and tertiary referral center (Alder Hey, Liverpool, UK). Children between 0 and 16 years 11 months old and admitted for more than 48 hours were included. Observed outcomes were occurrence of ADR and time to first ADR for the risk factor analysis.ResultsA total of 5,118 children (6,601 admissions) were included, 17.7% of whom experienced at least one ADR. Opiate analgesics and drugs used in general anesthesia (GA) accounted for more than 50% of all drugs implicated in ADRs. Of these ADRs, 0.9% caused permanent harm or required admission to a higher level of care. Children who underwent GA were at more than six times the risk of developing an ADR than children without a GA (hazard ratio (HR) 6.40; 95% confidence interval (CI) 5.30 to 7.70). Other factors increasing the risk of an ADR were increasing age (HR 1.06 for each year; 95% CI 1.04 to 1.07), increasing number of drugs (HR 1.25 for each additional drug; 95% CI 1.22 to 1.28) and oncological treatment (HR 1.90; 95% CI 1.40 to 2.60).ConclusionsADRs are common in hospitalized children and children who had undergone a GA had more than six times the risk of developing an ADR. GA agents and opiate analgesics are a significant cause of ADRs and have been underrepresented in previous studies. This is a concern in view of the increasing number of pediatric short-stay surgeries.

Dataset Information

Adverse Drug reactions in an Ageing PopulaTion (ADAPT) study protocol: a cross-sectional and prospective cohort study of hospital admissions related to adverse drug reactions in older patients.

Introduction

Methods and analysis

Ethics and dissemination

Publications

Adverse Drug reactions in an Ageing PopulaTion (ADAPT) study protocol: a cross-sectional and prospective cohort study of hospital admissions related to adverse drug reactions in older patients.

Similar Datasets

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