Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children – a prospective observational cohort study of 6,601 admissions

Thiesen, Signe; Conroy, Elizabeth J; Bellis, Jennifer R; Bracken, Louise; Mannix, Helena; Bird, Kim A; Duncan, Jennifer C; Cresswell, Lynne; Kirkham, Jamie J; Peak, Matthew; Williamson, Paula; Nunn, Anthony J; Turner, Mark A.; Pirmohamed, Munir; Smyth, Rosalind L

doi:10.1186/1741-7015-11-237

Cited by 90 publications

(114 citation statements)

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“…Other reasons may be greater fear of opioid use, e.g. due to opioid-induced adverse effects, inadequate drug availability, local policies and regulations obstructing opioid analgesics accessibility or different analgesic requirements of the studied patients [13,24,37].…”

Section: Discussionmentioning

confidence: 99%

Analgesic Drug Prescription Patterns on Five International Paediatric Wards

et al. 2016

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Key points• Use of analgesic and anti-inflammatory drugs was in line with local recommendations and WHO guidelines • Oral paracetamol and oral ibuprofen are the most commonly used analgesic drugs on general paediatric wards • Differences regarding dose and frequency of ibuprofen and paracetamol use were observed, indicating that safety concerns for individual drugs are perceived differently among countries BOTZENHARDT et al. 2/1 2016-09-16 ABSTRACT AimAnalgesic and anti-inflammatory drugs are frequently prescribed in paediatrics. Prescribing and dosing patterns in hospitalised children are not well known. This study explores analgesic drug utilisation on five paediatric wards and discusses its findings in comparison with WHO guidelines. MethodA sub-analysis of a prospective, multi-centre, observational cohort study was undertaken. Prescription data of children aged up to ≤18 years were collected between October 2008 and December 2009 on paediatric general medical wards in five hospitals in Australia, Germany, the United Kingdom (UK), Hong Kong (HK) and Malaysia. Analgesic drug prescriptions were analysed for prescribing patterns in terms of dosing, frequency and route of administration. Dosing data were compared with local recommendations and WHO guidelines for children. ResultsIn the study cohort 56.8% (726/1,278) of paediatric patients received at least one analgesic drug prescription (1,227 prescriptions). Median age of patients with analgesics was 2.2 years (IQR 0.8-7.3) and median number of prescriptions per patient was 1 (IQR 1-2). Most commonly prescribed drugs were oral paracetamol (45.9%, 563/1,227) and oral ibuprofen (19.9%, 244/1,227). Daily doses of paracetamol ranged from 30 mg/kg/day in Germany to 67-68 mg/kg/day in UK and HK (p<0.05). For ibuprofen, single doses ranged from 5-6 mg/kg in HK and UK to 10 mg/kg in GER and AUS (p<0.001). Opioid use prevalence was statistically different between the centres and ranged from 0% to 17.6% (p<0.001). ConclusionThis study provides a comprehensive overview of analgesic drug use of hospitalised children. Similar to primary care data, paracetamol is the most commonly used analgesic. As recommended by WHO guidelines, oral medication was favoured and opioids used in addition to paracetamol and ibuprofen. Overall drug utilisation was in line with local recommendations and WHO guidelines. Differences in use of paracetamol and ibuprofen among countries was seen indicating that safety concerns are perceived differently. More large-scale safety studies are needed. BOTZENHARDT et al.

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Section: Discussionmentioning

confidence: 99%

Analgesic Drug Prescription Patterns on Five International Paediatric Wards

et al. 2016

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“…Often the severity of the ADR was not reported, and patient age, diagnosis and drug prescription patterns were often not reported, and thus could not be considered in determining factors associated with ADRs in children. The need to conduct rigorous, prospective studies of ADRs in children, both which cause hospital admission 20,21 and within the inpatient setting, 22 was clearly needed. In addition, a methodologically rigorous systematic review incorporating the findings of these novel prospective studies was required.…”

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

confidence: 99%

“…Site 1 was a specialist regional paediatric hospital that had been actively involved in the ADRIC studies of the prevalence and characteristics of paediatric ADRs. 20,22 We were aware that clinicians at this hospital may have a heightened awareness of the subject because of the ADRIC studies. Therefore, to enhance the transferability of our findings we included two additional sites (sites 2 and 3), which were paediatric units in local district general hospitals.…”

Section: Phase 1b: Modify the Toolmentioning

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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“…It is preferred over endoscopy under general anesthesia as the latter is an invasive method and general anesthesia in children is associated with morbidity and mortality. 7 The type and amount of the caustic substance ingested are important factors determining the extent and severity of the injury and the incidence of complications. 8,9 There is still doubt which of the two, acidic or alkali ingestions, result in more severe injuries.…”

Section: Introductionmentioning

confidence: 99%