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      Adverse Drug Reactions in Children—A Systematic Review


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          Adverse drug reactions in children are an important public health problem. We have undertaken a systematic review of observational studies in children in three settings: causing admission to hospital, occurring during hospital stay and occurring in the community. We were particularly interested in understanding how ADRs might be better detected, assessed and avoided.

          Methods and Findings

          We searched nineteen electronic databases using a comprehensive search strategy. In total, 102 studies were included. The primary outcome was any clinical event described as an adverse drug reaction to one or more drugs. Additional information relating to the ADR was collected: associated drug classification; clinical presentation; associated risk factors; methods used for assessing causality, severity, and avoidability. Seventy one percent (72/102) of studies assessed causality, and thirty four percent (34/102) performed a severity assessment. Only nineteen studies (19%) assessed avoidability. Incidence rates for ADRs causing hospital admission ranged from 0.4% to 10.3% of all children (pooled estimate of 2.9% (2.6%, 3.1%)) and from 0.6% to 16.8% of all children exposed to a drug during hospital stay. Anti-infectives and anti-epileptics were the most frequently reported therapeutic class associated with ADRs in children admitted to hospital (17 studies; 12 studies respectively) and children in hospital (24 studies; 14 studies respectively), while anti-infectives and non-steroidal anti-inflammatory drugs (NSAIDs) were frequently reported as associated with ADRs in outpatient children (13 studies; 6 studies respectively). Fourteen studies reported rates ranging from 7%–98% of ADRs being either definitely/possibly avoidable.


          There is extensive literature which investigates ADRs in children. Although these studies provide estimates of incidence in different settings and some indication of the therapeutic classes most frequently associated with ADRs, further work is needed to address how such ADRs may be prevented.

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          Most cited references 134

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          Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.

          To estimate the incidence of serious and fatal adverse drug reactions (ADR) in hospital patients. Four electronic databases were searched from 1966 to 1996. Of 153, we selected 39 prospective studies from US hospitals. Data extracted independently by 2 investigators were analyzed by a random-effects model. To obtain the overall incidence of ADRs in hospitalized patients, we combined the incidence of ADRs occurring while in the hospital plus the incidence of ADRs causing admission to hospital. We excluded errors in drug administration, noncompliance, overdose, drug abuse, therapeutic failures, and possible ADRs. Serious ADRs were defined as those that required hospitalization, were permanently disabling, or resulted in death. The overall incidence of serious ADRs was 6.7% (95% confidence interval [CI], 5.2%-8.2%) and of fatal ADRs was 0.32% (95% CI, 0.23%-0.41%) of hospitalized patients. We estimated that in 1994 overall 2216000 (1721000-2711000) hospitalized patients had serious ADRs and 106000 (76000-137000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death. The incidence of serious and fatal ADRs in US hospitals was found to be extremely high. While our results must be viewed with circumspection because of heterogeneity among studies and small biases in the samples, these data nevertheless suggest that ADRs represent an important clinical issue.
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            Medication errors and adverse drug events in pediatric inpatients.

             Rainu Kaushal (2001)
            Iatrogenic injuries, including medication errors, are an important problem in all hospitalized populations. However, few epidemiological data are available regarding medication errors in the pediatric inpatient setting. To assess the rates of medication errors, adverse drug events (ADEs), and potential ADEs; to compare pediatric rates with previously reported adult rates; to analyze the major types of errors; and to evaluate the potential impact of prevention strategies. Prospective cohort study of 1120 patients admitted to 2 academic institutions during 6 weeks in April and May of 1999. Medication errors, potential ADEs, and ADEs were identified by clinical staff reports and review of medication order sheets, medication administration records, and patient charts. We reviewed 10 778 medication orders and found 616 medication errors (5.7%), 115 potential ADEs (1.1%), and 26 ADEs (0.24%). Of the 26 ADEs, 5 (19%) were preventable. While the preventable ADE rate was similar to that of a previous adult hospital study, the potential ADE rate was 3 times higher. The rate of potential ADEs was significantly higher in neonates in the neonatal intensive care unit. Most potential ADEs occurred at the stage of drug ordering (79%) and involved incorrect dosing (34%), anti-infective drugs (28%), and intravenous medications (54%). Physician reviewers judged that computerized physician order entry could potentially have prevented 93% and ward-based clinical pharmacists 94% of potential ADEs. Medication errors are common in pediatric inpatient settings, and further efforts are needed to reduce them.
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              Preventability and severity assessment in reporting adverse drug reactions.


                Author and article information

                Role: Editor
                PLoS One
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                5 March 2012
                : 7
                : 3
                [1 ]School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, England, United Kingdom
                [2 ]Department of Biostatistics, University of Liverpool, Liverpool, England, United Kingdom
                [3 ]Centre for Reviews and Dissemination, University of York, York, England, United Kingdom
                [4 ]Department of Women's and Children's Health, University of Liverpool, Liverpool, England, United Kingdom
                Yale University School of Medicine, United States of America
                Author notes

                Conceived and designed the experiments: PRW RLS RMS SG JJK EG. Performed the experiments: PRW RLS RMS JJK LC SG. Analyzed the data: PRW RLS RMS EG JJK LC SG. Contributed reagents/materials/analysis tools: PRW RLS RMS EG SG JJK LC . Wrote the paper: PRW RLS RMS EG JJK LC SG.

                Smyth et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
                Page count
                Pages: 24
                Research Article
                Clinical Research Design
                Drugs and Devices
                Public Health



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