Methods for Assessing the Preventability of Adverse Drug Events

Hakkarainen, Katja M.; Sundell, Karolina Andersson; Petzold, Max; Hägg, Staffan

doi:10.2165/11596570-000000000-00000

Cited by 46 publications

(46 citation statements)

References 170 publications

(73 reference statements)

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“…25,212 Hakkarainen et al 26 identified 18 unique instruments for assessing preventability of ADEs, which ranged from implicit instruments to explicit algorithms in which criteria for preventability were clearly expressed. 26 They also reported that although there was wide variation in the methods used they all shared a common theme; the basis for defining preventability was whether an error or substandard care had resulted in an ADE. 26 Hakkarainen et al 26 have made some useful suggestions for future research.…”

Section: Discussionmentioning

confidence: 99%

“…Some authors have proposed a methodological framework for future studies of ADR avoidability and the development of valid instruments. 26 This includes reliability and validity testing, standardisation of the measurement processes, description of assessor training and experience in assessing preventability, details of independent or consensus assessments and rationalisation of assessor disagreement. These authors recommend that there is a need to modify existing instruments or develop novel instruments for use in different settings and populations.…”

Section: Burden Of Adverse Drug Reactions In Children and Young Peoplementioning

confidence: 99%

“…A preliminary step was to develop a new avoidability tool that met all of the criteria of a good tool as described by Hakkarainen et al 26 and was also generalisable. The objectives were to develop an algorithm with dichotomous responses based on Hallas et al 54 and to conduct reliability/validity testing on the new tool as per Hakkarainen et al 26 recommendations.…”

Section: Aim and Objectives Of This Workmentioning

confidence: 99%

“…212 Despite the importance of avoiding ADRs, this area remains under-researched. This may be attributable to the methodological problems in the area, which Hakkarainen et al 26 have summarised in a systematic review on methods for assessing the preventability of ADEs. 26 They listed inconsistent terminology as one of the problems; there is wide variation in the terms and definitions used (ADRs, ADEs, etc.)…”

Section: Introductionmentioning

confidence: 99%

“…and this hinders the interpretation and comparison of studies. 26 In their review they used the term ADE, which included ADRs and other AEs related to medications. The definition of an ADR used in this study is that of Edwards and Aronson: 49 'an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen or withdrawal of the product'.…”

Section: Introductionmentioning

confidence: 99%

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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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