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: Older people experience greater morbidity with a corresponding increase in medication use resulting in a potentially higher risk of adverse drug reactions (ADRs). Objectives: The aim of this study was to; 1) determine the prevalence and characteristics of ADR-related hospital admissions among older patients (≥65 years) in Ireland; and 2) identify the risk factors associated with ADR-related hospital admissions. Methods: A cross-sectional study of ADR prevalence in patients aged ≥65 years admitted acutely to hospital in Ireland over a 8 month period (November 2016- June 2017). A multifaceted review of each hospital admission was undertaken to assess the likelihood of an ADR being a reason for admission (cause of admission or contributing to admission) in the context of the patient's medication, clinical conditions, comorbidities and investigations. A number of decision aids were applied by two independent reviewers to assess ADR causality, avoidability and severity. A random sample of patients, determined not to have a suspected ADR on screening, were assigned to a non-ADR control group. Multivariable logistic regression was used to assess the association between potential risk factors for ADR-related admissions compared with non-ADR-related admissions. Results: In total, 3,760 hospital admission episodes (in 3,091 patients) were screened and 377 admissions were considered ADR-related (10.0%, 95% CI 9.1%, 11.0%). 219 (58.1%) ADR-related admissions were caused by an ADR, while ADRs contributed to 158 (41.9%) admissions. 268 (71.1%) of all ADR-related admissions were deemed definitely or possibly preventable/avoidable. 350 (92.8%) ADRs were classified as being of moderate severity, with 27 (7.2%) classified as severe. Antithrombotic agents, mainly aspirin and warfarin, were the drugs most frequently associated with ADR-related admissions (gastrointestinal and vascular haemorrhagic disorders). In multivariable analysis, immobility, frailty, having delirium or ulcer disease and taking anticoagulant and antiplatelet medication on admission were significantly associated with an ADR-related hospital admission. Conclusion: One in ten hospital admissions, among those aged 65 + years, were considered ADR-related, with approximately 70% potentially avoidable. Reliable and validated ADR detection and prediction tools are needed to develop prevention strategies.

Project description:BackgroundAdverse drug reactions (ADRs) contribute to the burden of disease globally and of particular concern are ADR-related hospital admissions.ObjectivesThis study sought to determine the burden, characteristics, contributing factors and patient outcomes of ADRs that were the primary diagnosis linked to hospital admission among inpatients in Uganda.DesignWe conducted a cross-sectional secondary analysis of data from a prospective cohort study of adult inpatients aged 18 years and older at Uganda's Mulago National Referral Hospital from November 2013 to April 2014.MethodsWe reviewed clinical charts to identify inpatients with an ADR as one of the admitting diagnoses and, if so, whether or not the hospital admission was primarily attributed to the ADR. Logistic regression was used to determine factors associated with hospital admissions primarily attributed to ADRs.ResultsAmong 762 inpatients, 14% had ADRs at hospital admission and 7% were primarily hospitalized due to ADRs. A total of 235 ADRs occurred among all inpatients and 57% of the ADRs were the primary diagnosis linked to hospital admission. The majority of ADRs occurred in people living with HIV and were attributed to antiretroviral drugs. HIV infection [aOR (adjusted odds ratio) = 2.97, 95% confidence interval (CI): 1.30-6.77], use of antiretroviral therapy (aOR = 5.46, 95% CI: 2.56-11.68), self-medication (aOR = 2.27, 95% CI: 1.14-4.55) and higher number of drugs used (aOR = 1.13, 95% CI: 1.01-1.26) were independently associated with hospital admissions attributed to ADRs.ConclusionAntiretroviral drugs were often implicated in ADR-related hospital admissions. HIV infection (whether managed by antiretroviral therapy or not), self-medication and high pill burden were associated with hospital admissions attributable to ADRs. The high HIV burden in Sub-Saharan Africa increases the risk of ADR-related hospitalization implying the need for emphasis on early detection, monitoring and appropriate management of ADRs associated with hospital admission in people living with HIV.

Project description:BackgroundAn 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).ObjectiveThe 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 methodsThis was a cross-sectional survey using stratified, population-based sampling conducted at a chain of community pharmacies.ResultsAnalysis 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.ConclusionsOur 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.

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.

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