RESUMEN
BACKGROUND: Many hospitalised patients are affected by medication errors (MEs) that may cause discomfort, harm and even death. Children are at especially high risk of harm as the result of MEs because such errors are potentially more hazardous to them than to adults. Until now, interventions to reduce MEs have led to only limited improvements. OBJECTIVES: To determine the effectiveness of interventions aimed at reducing MEs and related harm in hospitalised children. SEARCH METHODS: The Effective Practice and Organisation of Care Group (EPOC) Trials Search Co-ordinator searched the following sources for primary studies: The Cochrane Library, including the Cochrane Central Register of Controlled Trials (CENTRAL), the Economic Evaluation Database (EED) and the Health Technology Assessments (HTA) database; MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Proquest Dissertations & Theses, Web of Science (citation indexes and conference proceedings) and the EPOC Register of Studies. Related reviews were identified by searching the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects (DARE). Review authors searched grey literature sources and trial registries. They handsearched selected journals, contacted researchers in the field and scanned reference lists of relevant reviews. They conducted searches in November 2013 and November 2014. They applied neither language nor date limits. SELECTION CRITERIA: Randomised controlled trials, controlled before-after studies and interrupted time series investigating interventions to improve medication safety in hospitalised children (≤ 18 years). Participants were healthcare professionals authorised to prescribe, dispense or administer medications. Outcome measures included MEs, (potential) patient harm, resource utilisation and unintended consequences of the interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted data and assessed study quality using the EPOC data collection checklist. We evaluated the risk of bias of included studies and used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to assess the quality of the body of evidence. We described results narratively and presented them using GRADE tables. MAIN RESULTS: We included seven studies describing five different interventions: participation of a clinical pharmacist in a clinical team (n = 2), introduction of a computerised physician order entry system (n = 2), implementation of a barcode medication administration system (n = 1), use of a structured prescribing form (n = 1) and implementation of a check and control checklist in combination with feedback (n = 1).Clinical and methodological heterogeneity between studies precluded meta-analyses. Although some interventions described in this review show a decrease in MEs, the results are not consistent, and none of the studies resulted in a significant reduction in patient harm. Based on the GRADE approach, the overall quality and strengfh of the evidence are low. AUTHORS' CONCLUSIONS: Current evidence on effective interventions to prevent MEs in a paediatric population in hospital is limited. Comparative studies with robust study designs are needed to investigate interventions including components that focus on specific paediatric safety issues.
Asunto(s)
Niño Hospitalizado , Errores de Medicación/prevención & control , Adolescente , Lista de Verificación , Niño , Prescripciones de Medicamentos , Procesamiento Automatizado de Datos , Humanos , Sistemas de Entrada de Órdenes Médicas/organización & administración , Farmacéuticos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
The aim of this Delphi survey is to develop common definitions for unlicensed and off-label drug use in children to be used for research and regulatory purposes. After a literature review on the current status of unlicensed/off-label definitions, a two-stage, web-based Delphi survey was conducted among experts in Europe. Their opinion on concerns, rules and scenarios regarding the unlicensed and off-label use of medicines were obtained. Results were then consulted with the European Medicines Agency (EMEA) before the final proposal was circulated to participants. Eighty-four experts were invited to participate (scientists, health professionals, pharmaceutical companies, regulatory agencies), 34 responded to the first round questionnaire and participated in subsequent rounds. Consensus was reached for the majority of questions. The lowest level of consensus reached was for questions related to a different formulation or if a drug was given although contraindicated. At the final step, 85% of the responding experts agreed on the proposed definition for off-label (use of a drug already covered by a Marketing Authorisation, in an unapproved way) and 80% on the definition for unlicensed (use of a drug not covered by a Marketing Authorisation as medicinal for human use), respectively. Results will facilitate the conduct of pharmacoepidemiological studies and allow comparison between different countries. The Delphi panel agreed that the definitions should be circulated within the scientific community and recommended to be adopted by relevant regulatory authorities.
Asunto(s)
Utilización de Medicamentos/estadística & datos numéricos , Niño , Recolección de Datos , Técnica Delphi , Europa (Continente)/epidemiología , Humanos , Farmacoepidemiología , Encuestas y Cuestionarios , Terminología como AsuntoRESUMEN
In paediatric medicine, drug doses are usually calculated individually based on the patient's age, weight and clinical condition. Therefore, there are increased opportunities for, and a relatively high risk of, dosing errors in this setting. Consequently, a systematic literature review using several databases was conducted to investigate the incidence and nature of dosing errors in children; 16 studies were found to be relevant. Eleven of the 16 studies found that dosing errors are the most common type of medication error, three of the remaining studies found it to be the second most common type. This review of published research on medication errors therefore suggests that dosing errors are probably the most common type of error in the paediatric population. In addition, there was a great variation in the error rates reported; this is likely to be due to the differences in the medication error definitions and methodologies employed. For example, the dosing error rate determined using spontaneous reporting ranges from 0.03 per 100 admissions in the UK to 2 per 100 admissions in the US. Extrapolating this, if the under-reporting rate is about 1 in 100, then the true incidence would be around 50,000 paediatric dosing errors per year in England. The information available shows that dosing errors are not uncommon and that 10-fold overdoses caused by calculation errors have led to serious consequences. There is an urgent need to develop methods to reduce medication errors in children and dosing errors should be the first priority.