Frequency and Preventability of Adverse Drug Reactions in Paediatric Patients

Temple, Mary E; Robinson, Renee; Miller, Julie C.; Hayes, John R.; Nahata, Milap C.

doi:10.2165/00002018-200427110-00005

Cited by 61 publications

(41 citation statements)

References 28 publications

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“…Although the burden of disease and use of drugs in children is considerably lower than in adults, the majority of drugs are not evaluated in children, leading to a much higher proportion of drugs being used OLUL, with the consequent safety concerns. 3,269 Previous studies addressing ADRs in children had considerable limitations. The populations studied were poorly described, heterogeneous and the methodologies used to determine ADRs were unsatisfactory or inadequately reported, making incidence estimates highly unreliable.…”

Section: Conclusion and Future Research Directionsmentioning

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: Conclusion and Future Research Directionsmentioning

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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“…ADRs are an important clinical problem and contribute significantly to mortality and morbidity [1,2]. They can result in diminished quality of life, a greater need for physician visits and hospitalizations, and even death in adults and children [3][4][5].…”

Section: Introductionmentioning

confidence: 99%

Active surveillance of adverse drug reactions in children in five Italian paediatric wards

Gallo¹,

Clavenna²,

Bonati³

et al. 2012

OJPed

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Adverse drug reactions (ADRs) are an important clinical problem and contribute significantly to mortality and morbidity. Scant data on the safety of drug use in children are usually available at the time of marketing authorization, due to the limited number of trials performed in the paediatric population. Few studies monitored the incidence of ADRs in Italian hospitalized children, that cannot be compared for methodological reasons. A 6-month prospective observational study was, therefore, conducted on the paediatric wards of five hospitals in the Campania Region, Italy. Data were collected on all patients admitted to the wards during the study period through a structured questionnaire administered to the mothers and through a hospital chart review. Of the 752 patients enrolled, 86.2% were exposed to one or more drugs during hospitalization. The therapeutic class most prescribed was systemic antibacterial agents (47%). Six ADRs occurred during hospitalization (incidence 0.9%; 95% CI 0.2% -1.7%). In addition, one child was admitted to a hospital for an ADR. Five out of seven ADRs occurred in girls. The skin was the most affected organ. The medications implicated were amoxicillin, acyclovir, ibuprofen, ceftriaxone, paracetamol, and ranitidine. According to the Naranjo probability criteria, six ADRs were probably, and one possibly, related to the suspected drug. In conclusion, this study reveals that ADRs may be under-reported in children hospitalized in the Campania Region. Consequently, healthcare personnel should be alert to the possibility of ADRs. More accurate reporting of ADRs in children would result in safer use of drugs in such patients.

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“…The most commonly seen advers drug rections are in the form of cutaneous reactions (10,11). Allergic drug rections are observed in approximately 1.5-3% of patients referring to hospitals and in 10-20% of patients hospitalized (12)(13)(14)(15).…”

Section: Discussionmentioning

confidence: 99%

Çocuklarda ilaç ilişkili döküntüler; tek merkez deneyimi

Özmen¹,

Şahin²,

Yöney³

et al. 2011

tpa

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C Cu ut ta an ne eo ou us s d dr ru ug g e er ru up pt ti io on ns s i in n c ch hi il ld dr re en n; ; a a s si in ng gl le e c ce en nt tr re e e ex xp pe er ri ie en nc ce e S Se er ra ap p Ö Öz zm me en n, , M Mu ur ra at t fi fia ah hi in n* *, , A Ay ys se el l Y Yö ön ne ey y* *, , N Ni il lü üf fe er r A Ar rd da a* *, , Z Za af fe er r A Ar rs sl la an n O Or ri ig gi in na al l A Ar rt ti ic cl le e S Su um mm ma ar ry y Aim: Cutaneous drug reactions are commonly reported adverse drug reactions. The aim of this study was to describe the clinical pattern of drug eruptions, determine drugs commonly associated with those patterns seen among children and to suggest an approach to this problem. One hundred children were enrolled in the study, There were 75 boys and 25 girls with an age range of 6 months to 14 years old (mean 5.6±3.6 years). Statistical analyses were done using SPSS 11.5 package program (SPSS Inc., Chiago, IL). For general information related to variants descriptive statistics and frequency distributions were calculated. While continuously measured variables were shown as mean± SD, categorical variables were expressed as frequency (percentage). The study was approved by the hospital's ethic committee. Material andResults:The most common indication for using drug therapy was upper respiratory tract infection (64%). The most commonly suspected drugs were amoxicillin/ampicillin in 44% and cephalosporins in 27% of the patients. The types of drug eruption included urticaria (64%), maculopapular eruption (28%), urticaria-purpura (5%), erythema multiforme (1%), fixed drug eruption (1%) and drug hypersensitivity syndrome (1%). While 60% of the patients were diagnosed with probable drug allergy and %16 were diagnosed with possible drug allergy, drug allergy was confirmed only in 18% of the patients who were diagnosed with definite drug allergy. Conclusions:A detailed drug history, a knowledge of the varied patterns of drug eruptions and appropiate diagnostic tests are essential factors for successful management of a child with drug eruption (Turk Arch Ped 2011; 46: 62-6)

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Frequency and Preventability of Adverse Drug Reactions in Paediatric Patients

Cited by 61 publications

References 28 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

Active surveillance of adverse drug reactions in children in five Italian paediatric wards

Çocuklarda ilaç ilişkili döküntüler; tek merkez deneyimi

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