Percentage of Patients with Preventable Adverse Drug Reactions and Preventability of Adverse Drug Reactions – A Meta-Analysis

Hakkarainen, Katja M.; Hedna, Khadidja; Petzold, Max; Hägg, Staffan

doi:10.1371/journal.pone.0033236

Cited by 246 publications

(208 citation statements)

References 49 publications

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“…208 The WHO has identified some key areas including measuring harm, understanding causes, identifying solutions, evaluating impact and translating evidence into safer care. Hakkarainen et al 211 conducted a meta-analysis of preventable ADR studies and they concluded that preventable ADRs are a significant burden to the health-care system and a cause of morbidity among outpatients, and that roughly half of all ADRs in adults both inpatients (45%) and outpatients (52%) may be preventable.…”

Section: Introductionmentioning

confidence: 99%

ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

Smyth

Peak

Turner

et al. 2014

Programme Grants for Applied Research

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AimsTo comprehensively investigate the incidence, nature and risk factors of adverse drug reactions (ADRs) in a hospital-based population of children, with rigorous assessment of causality, severity and avoidability, and to assess the consequent impact on children and families. We aimed to improve the assessment of ADRs by development of new tools to assess causality and avoidability, and to minimise the impact on families by developing better strategies for communication.Review methodsTwo prospective observational studies, each over 1 year, were conducted to assess ADRs in children associated with admission to hospital, and those occurring in children who were in hospital for longer than 48 hours. We conducted a comprehensive systematic review of ADRs in children. We used the findings from these studies to develop and validate tools to assess causality and avoidability of ADRs, and conducted interviews with parents and children who had experienced ADRs, using these findings to develop a leaflet for parents to inform a communication strategy about ADRs.ResultsThe estimated incidence of ADRs detected in children on admission to hospital was 2.9% [95% confidence interval (CI) 2.5% to 3.3%]. Of the reactions, 22.1% (95% CI 17% to 28%) were either definitely or possibly avoidable. Prescriptions originating in the community accounted for 44 out of 249 (17.7%) of ADRs, the remainder originating from hospital. A total of 120 out of 249 (48.2%) reactions resulted from treatment for malignancies. Off-label and/or unlicensed (OLUL) medicines were more likely to be implicated in an ADR than authorised medicines [relative risk (RR) 1.67, 95% CI 1.38 to 2.02;p < 0.001]. When medicines used for the treatment of oncology patients were excluded, OLUL medicines were not more likely to be implicated in an ADR than authorised medicines (RR 1.03, 95% CI 0.72 to 1.48;p = 0.830). For children who had been in hospital for > 48 hours, the overall incidence of definite and probable ADRs based on all admissions was 15.9% (95% CI 15.0 to 16.8). Opiate analgesic drugs and drugs used in general anaesthesia (GA) accounted for > 50% of all drugs implicated in ADRs. The odds ratio of an OLUL drug being implicated in an ADR compared with an authorised drug was 2.25 (95% CI 1.95 to 2.59;p < 0.001). Risk factors identified were exposure to a GA, age, oncology treatment and number of medicines. The systematic review estimated that the incidence rates for ADRs causing hospital admission ranged from 0.4% to 10.3% of all children [pooled estimate of 2.9% (95% CI 2.6% to 3.1%)] and from 0.6% to 16.8% of all children exposed to a drug during hospital stay. New tools to assess causality and avoidability of ADRs have been developed and validated. Many parents described being dissatisfied with clinician communication about ADRs, whereas parents of children with cancer emphasised confidence in clinician management of ADRs and the way clinicians communicated about medicines. The accounts of children and young people largely reflected parents’ accounts. Clinicians described using all of the features of communication that parents wanted to see, but made active decisions about when and what to communicate to families about suspected ADRs, which meant that communication may not always match families’ needs and expectations. We developed a leaflet to assist clinicians in communicating ADRs to parents.ConclusionThe Adverse Drug Reactions In Children (ADRIC) programme has provided the most comprehensive assessment, to date, of the size and nature of ADRs in children presenting to, and cared for in, hospital, and the outputs that have resulted will improve the management and understanding of ADRs in children and adults within the NHS. Recommendations for future research: assess the values that parents and children place on the use of different medicines and the risks that they will find acceptable within these contexts; focusing on high-risk drugs identified in ADRIC, determine the optimum drug dose for children through the development of a gold standard practice for the extrapolation of adult drug doses, alongside targeted pharmacokinetic/pharmacodynamic studies; assess the research and clinical applications of the Liverpool Causality Assessment Tool and the Liverpool Avoidability Assessment Tool; evaluate, in more detail, morbidities associated with anaesthesia and surgery in children, including follow-up in the community and in the home setting and an assessment of the most appropriate treatment regimens to prevent pain, vomiting and other postoperative complications; further evaluate strategies for communication with families, children and young people about ADRs; and quantify ADRs in other settings, for example critical care and neonatology.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

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Section: Introductionmentioning

confidence: 99%

ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

Smyth

Peak

Turner

et al. 2014

Programme Grants for Applied Research

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“…It has been estimated that majority of ADRs are preventable. 2 The incidence and severity of ADRs can be influenced by age, gender, concurrent renal , hepatic disease, genetic factors, type of drug, route of administration, duration of therapy, and dosage. 3,4 Paediatric patients constitute a vulnerable group with regard to rational drug prescribing.…”

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confidence: 99%

Consistency between Causality Assessments Obtained With Various Scales and Their Agreement for Adverse Drug Events Reported in Pediatric Population

Rana¹,

Bhadiyadara²,

Shah³

et al. 2015

JYP

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Objective: The goal of this study was to examine correlation between various causality assessments scales and their agreement in reporting ADRs in children. Methods: All hospitalized pediatric patients were followed up for adverse drug reaction in a single pediatric unit for one year. We compared the WHO, Naranjo, CIOMS/RUCAM and French causality assessment scales in 36 identified ADRs in pediatric ward during 2012. The agreement between obtained causality assessments were analyzed by Cohen's Kappa (K) statistical test. Results: In the 290 pediatric patients, 36 adverse drug reactions were noted. Prevalence of ADR was 10.3%. Maculopapular rash was most frequently observed ADR. Antimicrobials (56%) were the most commonly involved drug group in ADR and cephalosporin's being the most frequent cause for ADR. RUCAM and French scale showed better agreement (K:0.067) with each other as compared to other scales. WHO and French scale showed least agreement (K:-0.026) with each other as compared to other scales. Naranjo's scale showed poor agreement (K:0.014) with WHO scale and worse agreement (K:-0.016) with French scale. There was no correlation between RUCAM and Naranjo's scale. Conclusion: Full agreement was not found between any of two scales of causality assessment. There was discrepancy seen between scalesdue to different definitions of causality criterias for assessing adverse drug reactions.This can influence the outcome of causality assessment significantly.

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“…Estes eventos nocivos são denominados Reações Adversas a Medicamentos (RAM) e sua elevada incidência representa um grande impacto nos sistemas de saúde. Estudos mostram que 2% a 30% das admissões em serviços de emergência estão relacionadas à ocorrência de RAM (2,3). Além disso, estes eventos também são responsáveis por uma parcela significativa dos custos durante a hospitalização e podem aumentar o tempo de internação e a mortalidade (3).…”

Section: Introductionunclassified

Avaliação Da Implantação De Busca Ativa De Reações Adversas a Medicamentos Com Auxílio De Ferramentas Informatizadas

Bretas¹,

Silva

2017

Infarma

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O objetivo do presente trabalho foi avaliar a implantação de estratégias de busca ativa de reações adversas a medicamentos (RAM) com o auxílio de ferramentas informatizadas em um programa de farmacovigilância de um hospital privado de grande porte. O desenvolvimento do estudo se deu em três fases: I – implantação do serviço de farmacovigilância (vigilância passiva – notificação voluntária intensificada); II – busca ativa com base em relatórios gerenciais de consumo de medicamentos rastreadores; III – busca ativa com base no preenchimento de formulários vinculados à prescrição de medicamentos rastreadores. Foram analisadas todas as RAM detectadas pelo serviço por três anos e meio (n = 542). A diferença entre as taxas de RAM/100 pacientes-dia foi analisada por meio de teste de comparação de duas proporções, com nível de significância de 5% e poder de 80%. A taxa de RAM/100 paciente-dia encontrada na fase II e III (0,26 e 0,15, respectivamente), ou seja, após a implementação das ferramentas informatizadas, foi superior àquela detectada na fase I (0,10). A diferença entre as proporções foi estatisticamente significativa. A maioria das RAM identificadas apresentou gravidade moderada (69%) e observou-se a elevação desta proporção após a implantação das ferramentas informatizadas. Quanto ao perfil de relação causal, 83,6% das RAM identificadas se enquadravam no critério de “causalidade possível”. A implantação da busca ativa utilizando ferramentas informatizadas proporcionou um aumento na identificação de RAM estatisticamente significativo, reforçando a necessidade de intensificar tais estratégias de farmacovigilância.

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Percentage of Patients with Preventable Adverse Drug Reactions and Preventability of Adverse Drug Reactions – A Meta-Analysis

Cited by 246 publications

References 49 publications

ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

Consistency between Causality Assessments Obtained With Various Scales and Their Agreement for Adverse Drug Events Reported in Pediatric Population

Avaliação Da Implantação De Busca Ativa De Reações Adversas a Medicamentos Com Auxílio De Ferramentas Informatizadas

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