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AIMS: The potential harm associated with medication errors is widely reported, but data on actual harm are limited. When actual harm has been measured, assessment processes are often poorly described, limiting their ability to be reproduced by other studies. Our aim was to design and implement a new process to assess actual harm resulting from medication errors in paediatric inpatient care. METHODS: Prescribing errors were identified through retrospective medical record reviews (n = 26 369 orders) and medication administration errors through direct observation (n = 5137 administrations) in a tertiary paediatric hospital. All errors were assigned potential harm severity ratings on a 5-point scale. Multidisciplinary panels reviewed case studies for patients assigned the highest three potential severity ratings and determined the following: actual harm occurrence and severity level, plausibility of a link between the error(s) and identified harm(s) and a confidence rating if no harm had occurred. RESULTS: Multidisciplinary harm panels (n = 28) reviewed 566 case studies (173 prescribing related and 393 administration related) and found evidence of actual harm in 89 (prescribing = 22, administration = 67). Eight cases of serious harm cases were found (prescribing = 1, administration = 7) and no cases of severe harm. The panels were very confident in 65% of cases (n = 302) where no harm was found. Potential and actual harm ratings varied. CONCLUSIONS: This harm assessment process provides a systematic method for determining actual harm from medication errors. The multidisciplinary nature of the panels was critical in evaluating specific clinical, therapeutic and contextual considerations including care delivery pathways, therapeutic dose ranges and drug-drug and drug-disease interactions.
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Hospitais Pediátricos , Erros de Medicação , Humanos , Erros de Medicação/estatística & dados numéricos , Erros de Medicação/prevenção & controle , Criança , Estudos Retrospectivos , Hospitais Pediátricos/normas , Pacientes Internados , Pré-Escolar , LactenteRESUMO
PURPOSE: Off-label medicines use is a common and sometimes necessary practice in many populations, with important clinical, ethical and financial consequences, including potential unintended harm or lack of effectiveness. No internationally recognized guidelines exist to aid decision-makers in applying research evidence to inform off-label medicines use. We aimed to critically evaluate current evidence informing decision-making for off-label use and to develop consensus recommendations to improve future practice and research. METHODS: We conducted a scoping review to summarize the literature on available off-label use guidance, including types, extent and scientific rigor of evidence incorporated. Findings informed the development of consensus recommendations by an international multidisciplinary Expert Panel using a modified Delphi process. Our target audience includes clinicians, patients and caregivers, researchers, regulators, sponsors, health technology assessment bodies, payers and policy makers. RESULTS: We found 31 published guidance documents on therapeutic decision-making for off-label use. Of 20 guidances with general recommendations, only 35% detailed the types and quality of evidence needed and the processes for its evaluation to reach sound, ethical decisions about appropriate use. There was no globally recognized guidance. To optimize future therapeutic decision-making, we recommend: (1) seeking rigorous scientific evidence; (2) utilizing diverse expertise in evidence evaluation and synthesis; (3) using rigorous processes to formulate recommendations for appropriate use; (4) linking off-label use with timely conduct of clinically meaningful research (including real-world evidence) to address knowledge gaps quickly; and (5) fostering partnerships between clinical decision-makers, researchers, regulators, policy makers, and sponsors to facilitate cohesive implementation and evaluation of these recommendations. CONCLUSIONS: We provide comprehensive consensus recommendations to optimize therapeutic decision-making for off-label medicines use and concurrently drive clinically relevant research. Successful implementation requires appropriate funding and infrastructure support to engage necessary stakeholders and foster relevant partnerships, representing significant challenges that policy makers must urgently address.
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Medicina Baseada em Evidências , Uso Off-Label , Humanos , ConsensoRESUMO
PURPOSE: This review was conducted to examine the current status of paediatric medicines initiatives across the globe. METHODS: The authors made a non-systematic descriptive review of current world situation. RESULTS: Two regions, the United States (US) and the European Union (EU), and the World Health Organization (WHO) have introduced strong paediatric initiatives to improve children's health through improving access to better paediatric medicines. The experience from the US initiative indicates that it is possible to stimulate development and study of paediatric medicines and provide important new information for improvement of paediatric therapy. The early results from the EU initiative are similarly encouraging. In Canada, Japan, Australia and other developed countries, specific paediatric medicines initiatives have been less extensive and weaker, with modest results. Disappointingly, current evidence suggests that results from clinical trials outside the US often do not benefit children in the country in which the trials were largely conducted. Pharmaceutical companies that have derived a financial benefit commensurate with the cost of doing the paediatric trials in one country do not seem to be making the results of these trials available to all countries if there is no financial incentive to the company. The WHO campaign 'make medicines child size' has produced substantive accomplishments in building improved foundations to improve mechanisms that will enhance children's access to critical medicines in resource-limited settings. However, practically all of this work has been performed using an amalgamation of short-term funding from a variety of sources as opposed to a sustained, programmatic commitment. CONCLUSIONS: Although much still needs to be done, it's clear that with concerted efforts and appropriate resources, change is possible but slow. Retaining and fostering public and political interest in paediatric medicines is challenging, but pivotal for success.
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Proteção da Criança , Tratamento Farmacológico , Saúde Global , Política de Saúde , Acessibilidade aos Serviços de Saúde/tendências , Assistência Farmacêutica/tendências , Pesquisa Biomédica/economia , Fortalecimento Institucional , Criança , Tratamento Farmacológico/economia , Drogas em Investigação/efeitos adversos , Drogas em Investigação/economia , Drogas em Investigação/uso terapêutico , Reforma dos Serviços de Saúde/tendências , Promoção da Saúde , Acessibilidade aos Serviços de Saúde/economia , Acessibilidade aos Serviços de Saúde/legislação & jurisprudência , Humanos , Lactente , Legislação de Medicamentos , Assistência Farmacêutica/economia , Assistência Farmacêutica/legislação & jurisprudência , Apoio à Pesquisa como Assunto , Organização Mundial da SaúdeRESUMO
AIMS: The evidence-base guiding choices between newer versus established anticonvulsants in children is limited. Inappropriate use exposes children to potentially ineffective and/or harmful medicines. Our objective is to describe recent anticonvulsant prescribing patterns in the Australian paediatric population, evaluating overall trends and extent of off-label prescribing of newer agents. METHODS: Aggregated national data on 15 anticonvulsants with Pharmaceutical Benefits Scheme subsidy dispensed by community pharmacies for children aged <16 years were obtained from the Drug Utilisation Subcommittee, which is part of the Australian Government Department of Health and Ageing. We analysed trends for the five most prescribed anticonvulsants dispensed between 2002 and 2009 and off-label prescribing for agents where approved Australian product information stipulates a minimum age. RESULTS: Valproate was the most frequently prescribed anticonvulsant with no marked change in prescription numbers per 1000 children aged 0-16 years (11.3-11.8 prescriptions/year). Lamotrigine was the most frequently prescribed newer anticonvulsant (7.9-9.3 prescriptions/year). Carbamazepine prescriptions decreased by 38% and topiramate prescriptions increased by 19% over the 7-year study period; 3.6% of topiramate prescriptions were off-label (by age) for children aged <2 years. Since Pharmaceutical Benefits Scheme listing in 2003, levetiracetam prescriptions increased steeply to 2.5 prescriptions/year per 1000 children in 2009; 4.2% were off-label for children aged <4 years. CONCLUSIONS: The substantial reduction in carbamazepine use and corresponding increase in newer anticonvulsant prescribing, including off-label uses, raises questions about potentially suboptimal Quality Use of Medicines. Such major changes in prescribing may have important clinical and economic consequences. Further study to better understand paediatric prescribing choices and outcomes is needed.
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Anticonvulsivantes/uso terapêutico , Epilepsia/tratamento farmacológico , Uso Off-Label/estatística & dados numéricos , Padrões de Prática Médica/tendências , Adolescente , Anticonvulsivantes/economia , Austrália , Criança , Pré-Escolar , Aprovação de Drogas , Custos de Medicamentos/estatística & dados numéricos , Revisão de Uso de Medicamentos , Epilepsia/economia , Humanos , Lactente , Recém-Nascido , Padrões de Prática Médica/estatística & dados numéricosRESUMO
Electronic medication management (eMM) systems are designed to improve safety, but there is little evidence of their effectiveness in paediatrics. This study assesses the short-term (first 70 days of eMM use) and long-term (one-year) effectiveness of an eMM system to reduce prescribing errors, and their potential and actual harm. We use a stepped-wedge cluster randomised controlled trial (SWCRCT) at a paediatric referral hospital, with eight clusters randomised for eMM implementation. We assess long-term effects from an additional random sample of medication orders one-year post-eMM. In the SWCRCT, errors that are potential adverse drug events (ADEs) are assessed for actual harm. The study comprises 35,260 medication orders for 4821 patients. Results show no significant change in overall prescribing error rates in the first 70 days of eMM use (incident rate ratio [IRR] 1.05 [95%CI 0.92-1.21], but a 62% increase (IRR 1.62 [95%CI 1.28-2.04]) in potential ADEs suggesting immediate risks to safety. One-year post-eMM, errors decline by 36% (IRR 0.64 [95%CI 0.56-0.72]) and high-risk medication errors decrease by 33% (IRR 0.67 [95%CI 0.51-0.88]) compared to pre-eMM. In all periods, dose error rates are more than double that of other error types. Few errors are associated with actual harm, but 71% [95%CI 50-86%] of patients with harm experienced a dose error. In the short-term, eMM implementation shows no improvement in error rates, and an increase in some errors. A year after eMM error rates significantly decline suggesting long-term benefits. eMM optimisation should focus on reducing dose errors due to their high frequency and capacity to cause harm.
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We need an urgent review of medicines labelling in Australia and New Zealand.
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Rotulagem de Medicamentos , Substituição de Medicamentos , Medicamentos Genéricos , Erros de Medicação/prevenção & controle , Austrália , Rotulagem de Medicamentos/legislação & jurisprudência , Legislação de Medicamentos , Nova ZelândiaRESUMO
BACKGROUND: In the past decade many novel, and in some cases transformative, cancer medicines have entered the market. Their prices and the amount spent on them by governments have increased rapidly, bringing to the forefront trade-offs that must be made. In this paper we explore the Australian public's attitude towards the funding of high cost cancer medicines (HCCM) to inform reimbursement and health technology assessment (HTA) policy. METHODS: A survey consisting of 49 questions about the funding of HCCMs was developed by the investigators. Recruitment was conducted via Qualtrics. 1039 Australian adults completed the survey. RESULTS: The Australian public overwhelmingly supports funding of HCCMs (95.5 %) to enhance equity of access (97.8 %), and to respond to patients' needs (98 %). When respondents were challenged to balance equity versus access in different contexts inconsistencies emerged. Different demographic factors were important in predicting support for various strategies. CONCLUSION: Our results suggest that the Australian public strongly supports government funding of HCCMs and values both equity and access. Equally, however, the public is uncertain about how equity and access are to be balanced and achieved, and such ambivalence needs to be both further explored and accommodated in policy processes. Our results may be used by policymakers in Australia, and countries with similar systems and values, to further develop policies and processes for funding HCCMs.
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Custos de Medicamentos , Neoplasias , Adulto , Atitude , Austrália , Humanos , Neoplasias/tratamento farmacológico , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Double-checking the administration of medications has been standard practice in paediatric hospitals around the world for decades. While the practice is widespread, evidence of its effectiveness in reducing errors or harm is scarce. OBJECTIVES: To measure the association between double-checking, and the occurrence and potential severity of medication administration errors (MAEs); check duration; and factors associated with double-checking adherence. METHODS: Direct observational study of 298 nurses, administering 5140 medication doses to 1523 patients, across nine wards, in a paediatric hospital. Independent observers recorded details of administrations and double-checking (independent; primed-one nurse shares information which may influence the checking nurse; incomplete; or none) in real time during weekdays and weekends between 07:00 and 22:00. Observational medication data were compared with patients' medical records by a reviewer (blinded to checking-status), to identify MAEs. MAEs were rated for potential severity. Observations included administrations where double-checking was mandated, or optional. Multivariable regression examined the association between double-checking, MAEs and potential severity; and factors associated with policy adherence. RESULTS: For 3563 administrations double-checking was mandated. Of these, 36 (1·0%) received independent double-checks, 3296 (92·5%) primed and 231 (6·5%) no/incomplete double-checks. For 1577 administrations double-checking was not mandatory, but in 26·3% (n=416) nurses chose to double-check. Where double-checking was mandated there was no significant association between double-checking and MAEs (OR 0·89 (0·65-1·21); p=0·44), or potential MAE severity (OR 0·86 (0·65-1·15); p=0·31). Where double-checking was not mandated, but performed, MAEs were less likely to occur (OR 0·71 (0·54-0·95); p=0·02) and had lower potential severity (OR 0·75 (0·57-0·99); p=0·04). Each double-check took an average of 6·4 min (107 hours/1000 administrations). CONCLUSIONS: Compliance with mandated double-checking was very high, but rarely independent. Primed double-checking was highly prevalent but compared with single-checking conferred no benefit in terms of reduced errors or severity. Our findings raise questions about if, when and how double-checking policies deliver safety benefits and warrant the considerable resource investments required in modern clinical settings.
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Pacientes Internados , Preparações Farmacêuticas , Criança , Hospitais Pediátricos , Humanos , Erros de Medicação/prevenção & controleRESUMO
We are experiencing an exciting and unprecedented period in the history of children's medicines globally. Milestone developments unfolding in recent years include the formation of the International Alliance for Better Medicines for Children in 2006 and landmark initiatives by the EU, the World Health Assembly (WHA), and the WHO in 2007. However, the challenges of optimizing the development, wider availability, and routine use of effective, safe, and affordable medicines addressing important child health needs are considerable. Each aspect of this continuum has so far received differential attention. Major initiatives in the US and EU have focused on stimulating research into children's medicines, largely driven by drug regulatory reforms, but with important gaps remaining. Many countries are lacking similar reforms, so the benefits of these initiatives are currently not well reflected in the rest of the world. A systematic approach to knowledge translation to improve use of best evidence and deliver quality use of medicines (QUM) to children routinely has also been largely a 'missing link' so far. The WHO's Essential Medicines List for Children and related initiatives are addressing improving children's access to needed medicines. Priority research gaps, especially in the developing world, are also being pursued by the WHO. However, in many countries, including developed nations such as Australia, the policy response to the WHA resolution on 'Better Medicines for Children' has been inconsistent or fragmented. A better integrated overall approach, linking global medicines research efforts to child health needs and actual medicines use is needed. International networking to support the conduct, synthesis, and rapid dissemination of pediatric medicines research will help close knowledge gaps at a global level. Harmonization of pediatric drug regulation will support this goal and facilitate improving access to needed medicines. Increasing research into and dissemination of effective strategies to promote QUM is an essential component to maximize return (in health benefits) on increased investment in medicines research. A greater focus on QUM should also help create demand for better evidence from clinicians. Delivering on the promise of better medicines for children, wherever in the world they may be, depends on achieving successful integration between the science, the policy, and the practice of pediatric medicines.
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Prioridades em Saúde/organização & administração , Acessibilidade aos Serviços de Saúde/organização & administração , Preparações Farmacêuticas/provisão & distribuição , Austrália , Criança , Serviços de Saúde da Criança/normas , Acessibilidade aos Serviços de Saúde/legislação & jurisprudência , Humanos , Cooperação Internacional , Preparações Farmacêuticas/normasRESUMO
In recent years there has been a rapid and marked increase in global recognition of the need for better medicines for children, with various initiatives being implemented at global and regional levels. These exciting developments are matched by recognition of the need to build greater capacity in the field of pediatric clinical pharmacology and therapeutics to help deliver on the promise of better medicines for children. A range of pediatric medicines researchers, educators, clinical therapeutics practitioners, and experts in drug evaluation, regulation, and broader medicines policy are needed on a larger scale, in both developed and developing world settings. The current and likely future training needs to meet these diverse challenges, the current realities of trying to meet such needs, and the opportunities for international networking to help meet future training needs are discussed from a global perspective.
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Serviços de Saúde da Criança/organização & administração , Serviços de Saúde da Criança/tendências , Educação Médica Continuada , Pediatria/educação , Pediatria/tendências , Farmacologia Clínica/educação , Austrália , Criança , Saúde Global , Humanos , Cooperação Internacional , Relações Interprofissionais , Farmacêuticos , Farmacologia Clínica/tendências , MédicosRESUMO
INTRODUCTION: The risk of medication errors is high in paediatric inpatient settings. However, estimates of the prevalence of medication errors have not accounted for heterogeneity across studies in error identification methods and definitions, nor contextual differences across wards and the use of electronic or paper medication charts. OBJECTIVE: Our aim was to conduct a systematic review and meta-analysis to provide separate estimates of the prevalence of medication errors among paediatric inpatients, depending on hospital ward and the use of electronic or paper medication charts, that address differences in error identification methods and definitions. METHODS: We systematically searched five databases to identify studies published between January 2000 and December 2018 that assessed medication error rates by medication chart audit, direct observation or a combination of methods. RESULTS: We identified 71 studies, 19 involved paediatric wards using electronic charts. Most studies assessed prescribing errors with few studies assessing administration errors. Estimates varied by ward type. Studies of paediatric wards using electronic charts generally reported a reduced error prevalence compared to those using paper, although there were some inconsistencies. Error detection methods impacted the rate of administration errors in studies of multiple wards, however, no other difference was found. Definition of medication error did not have a consistent impact on reported error rates. CONCLUSIONS: Medication errors are a frequent occurrence in paediatric inpatient settings, particularly in intensive care wards and emergency departments. Hospitals using electronic charts tended to have a lower rate of medication errors compared to those using paper charts. Future research employing controlled designs is needed to determine the true impact of electronic charts and other interventions on medication errors and associated harm among hospitalized children.
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Pacientes Internados/estatística & dados numéricos , Erros de Medicação/estatística & dados numéricos , Criança , Humanos , Prevalência , Fatores de RiscoRESUMO
We have analysed the published literature on eptacog alfa (recombinant factor VIIa; rFVIIa) for nonhaemophiliac conditions with the aim of determining its current place in therapy. Initial surgical and/or medical management is required for any patient with life-threatening bleeding. In those with continued life-threatening bleeding (i.e. despite maximal surgical and/or medical therapy), eptacog alfa may be considered as additional therapy, in exceptional circumstances. There is good evidence from systematic reviews and randomized controlled trials (RCTs) that eptacog alfa stops bleeding in adults with intracerebral haemorrhage (ICH) if it is given within 4 hours of symptom onset. However, a recent phase III RCT suggests that it does not improve clinically relevant long-term outcomes (death and disability). There is also good evidence against prophylactic use of eptacog alfa during orthotopic liver transplantation or liver resection, and in treating variceal and nonvariceal haemorrhage in patients with cirrhosis. The evidence for the use of eptacog alfa for unexpected life-threatening bleeding in liver, cardiac or other surgery, or in blunt trauma, is not robust. In these circumstances, it should only be given as part of a clinical trial or in exceptional cases when other therapies have failed. The evidence for use of eptacog alfa in penetrating trauma is lacking. Conflicting RCT results exist for the prophylactic use of eptacog alfa in elective surgery; therefore, it cannot be recommended in this situation. There is insufficient evidence for a primary role of eptacog alfa in reversal of anticoagulation with heparin-like molecules and novel anticoagulant agents. There are effective therapies that correct all warfarin-induced factor deficiencies; thus, off-label use of eptacog alfa for reversal of warfarin should only be considered in the context of ICH. The evidence for eptacog alfa use in children is limited. The only RCT is in cardiac surgery for congenital heart disease, where eptacog alfa prophylaxis was actually associated with increased time to chest closure. It may be of potential benefit in some children with life-threatening bleeding in the context of trauma, surgery or liver disease (as additional therapy when surgical and/or medical control of bleeding has failed), but the overall benefit-risk ratio may be unfavourable if there is an underlying risk of thromboembolism (e.g. trauma, congenital heart disease, other hyperviscous or hypercoagulable states, presence of arterial or central venous catheters). Thromboembolism may be associated with eptacog alfa use. Although the magnitude of this risk and possible predisposing factors are not clearly delineated, some data suggest increased risk at higher doses. Variable effects of eptacog alfa use on mortality have been shown in a pooled analysis of RCTs. Data from some observational studies and postmarketing surveillance suggest an increased risk of thromboembolism associated with off-label uses. Further well designed studies are required to more definitively assess the risk of thromboembolism with eptacog alfa and to better determine its effects on mortality. Optimum dosages for nonhaemophiliac conditions are not defined and nor is the optimum timing of administration. Moreover, it is not clear which patients will be most likely to benefit in terms of haemostatic efficacy and mortality. In addition to conventional measures to stop bleeding (i.e. surgery and blood transfusion), correction of hypothermia and acidosis, and reversal of anticoagulation are all recommended. The outcomes (effectiveness and safety) of all off-label uses should be systematically evaluated and reported. Adequate data to assess cost effectiveness for eptacog alfa does not exist for most off-label indications.
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Fator VIIa/uso terapêutico , Hemorragia/tratamento farmacológico , Fator VIIa/efeitos adversos , Hemorragia/etiologia , Humanos , Hepatopatias/complicações , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/uso terapêutico , Medição de Risco , Resultado do Tratamento , Ferimentos e Lesões/complicaçõesAssuntos
Descoberta de Drogas , Rotulagem de Medicamentos , Uso Off-Label , Criança , Humanos , Licenciamento , PediatriaRESUMO
BACKGROUND: Better evidence regarding drug safety in the pediatric population might be generated from existing data sources such as spontaneous reporting systems and electronic healthcare records. The Global Research in Paediatrics (GRiP)-Network of Excellence aims to develop pediatric-specific methods that can be applied to these data sources. A reference set of positive and negative drug-event associations is required. OBJECTIVE: The aim of this study was to develop a pediatric-specific reference set of positive and negative drug-event associations. METHODS: Considering user patterns and expert opinion, 16 drugs that are used in individuals aged 0-18 years were selected and evaluated against 16 events, regarded as important safety outcomes. A cross-table of unique drug-event pairs was created. Each pair was classified as potential positive or negative control based on information from the drug's Summary of Product Characteristics and Micromedex. If both information sources consistently listed the event as an adverse event, the combination was reviewed as potential positive control. If both did not, the combination was evaluated as potential negative control. Further evaluation was based on published literature. RESULTS: Selected drugs include ibuprofen, flucloxacillin, domperidone, methylphenidate, montelukast, quinine, and cyproterone/ethinylestradiol. Selected events include bullous eruption, aplastic anemia, ventricular arrhythmia, sudden death, acute kidney injury, psychosis, and seizure. Altogether, 256 unique combinations were reviewed, yielding 37 positive (17 with evidence from the pediatric population and 20 with evidence from adults only) and 90 negative control pairs, with the remainder being unclassifiable. CONCLUSION: We propose a drug-event reference set that can be used to compare different signal detection methods in the pediatric population.
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Sistemas de Notificação de Reações Adversas a Medicamentos , Mineração de Dados/métodos , Bases de Dados Factuais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Registros Eletrônicos de Saúde , Pediatria/normas , Adolescente , Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Criança , Pré-Escolar , Bases de Dados Factuais/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Registros Eletrônicos de Saúde/estatística & dados numéricos , Humanos , LactenteRESUMO
OBJECTIVES: To develop and test an evidence-based model for reducing medication errors and harm in hospitalized children. METHODS: Prospective interrupted time series study evaluating the effectiveness of a multifaceted, staged intervention over 4 years in a major urban pediatric referral hospital. Guidelines for safe pediatric prescribing were implemented by using an evidence-based model. Key components included early clinician engagement and improved multidisciplinary communication, consensus development, interactive education, and timely data feedback by using iterative Plan-Do-Study-Act cycles. Impact on medication error and harm (adverse drug events, [ADEs]) was measured by using standard definitions and a multimethod approach. Prospective data from voluntary reports by nursing, medical, and pharmacy staff and intensive chart review were combined. All data were reviewed by a multidisciplinary panel, including causality assessments for ADEs. RESULTS: Reviewed over 3 time periods were 1011 patients with 6651 medication orders. Total ADEs decreased by > 50% in the first year and this was maintained at 4 years. Greatest improvements were in potential ADEs, which decreased from 12.26 per 100 patients at baseline to 4.60 per 100 patients at 4 years (P < .05). Total medication errors decreased from 4.51 per 100 orders at baseline to 2.78 per 100 orders at 4 years (P < .05). Prescribing errors decreased by 65%, from 4.07 per 100 orders at baseline to 2.05 orders at 4 years (P < .05). CONCLUSIONS: A multifaceted, evidence-based model for safe prescribing guideline implementation, engaging multidisciplinary clinicians, was effective in reducing medication error and harm in hospitalized children, resulting in sustained long-term improvement.
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Medicina Baseada em Evidências , Hospitalização , Erros de Medicação/prevenção & controle , Criança , Pré-Escolar , Comportamento Cooperativo , Seguimentos , Fidelidade a Diretrizes , Implementação de Plano de Saúde , Hospitais Pediátricos , Hospitais Urbanos , Humanos , Lactente , Capacitação em Serviço , Comunicação Interdisciplinar , New South WalesRESUMO
BACKGROUND: The clinical evidence base for ototoxicity and nephrotoxicity outcomes with once-daily dosing (ODD) of gentamicin in children is suboptimal. Therapeutic drug monitoring (TDM) in once-daily gentamicin regimens is variable and its role in predicting or preventing clinical toxicity is unclear. We aimed to assess the safety of ODD of gentamicin and the usefulness of TDM in a pediatric cohort. METHODS: Children with suspected sepsis were prospectively enrolled to receive ODD of gentamicin at 7 mg/kg/day. Hearing and renal function were objectively assessed at baseline, during therapy, and after therapy. TDM was performed using an interval-adjusted graphical method (Hartford nomogram). RESULTS: A total of 79 children (median age: 5.6 years; range: 1 month-16 years) received 106 episodes of therapy. In all, 61% of these episodes were for febrile neutropenia. Evaluation was complete in 88% for ototoxicity and 92% for nephrotoxicity. Two patients (1.88%, 95% confidence interval: 0.10%-7.13%) experienced permanent hearing loss. One patient (0.94%, 95% confidence interval: <0.10%-5.73%) experienced transient nephrotoxicity. No abnormal serum gentamicin values were detected, even in those experiencing toxicity. Children experiencing toxicity were undergoing treatment for malignancies and had received nephrotoxic or ototoxic medicines before gentamicin. CONCLUSIONS: In this pediatric cohort receiving ODD of gentamicin, nephrotoxicity was uncommon and reversible, but irreversible ototoxicity occurred more frequently. TDM using a nomogram neither predicted nor prevented toxicity, which was only observed in those with risk factors.
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Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Monitoramento de Medicamentos/métodos , Gentamicinas/administração & dosagem , Gentamicinas/efeitos adversos , Sepse/tratamento farmacológico , Adolescente , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Audição/efeitos dos fármacos , Testes Auditivos , Humanos , Lactente , Rim/efeitos dos fármacos , Testes de Função Renal , Masculino , Estudos ProspectivosRESUMO
BACKGROUND: Metered-dose inhalers and spacers (MDI+S) are at least as effective as nebulizers for treating children with mild to moderate asthma exacerbations. Despite advantages in terms of efficacy, side effects, and ease of use, MDI+S are not used in many North American pediatric emergency departments (PEDs). OBJECTIVES: To survey emergency physicians, emergency nurses, and respirologists in Canadian pediatric teaching hospitals regarding their practices, beliefs, and barriers to change with respect to bronchodilator delivery. METHODS: This was a cross-sectional, mailed survey of all emergency physicians, all respirologists, and a random sample of emergency nurses at ten Canadian PEDs. RESULTS: A total of 291 of 349 health care professionals (83%) responded. Twenty-one percent of emergency physicians use MDI+S in the PED (largely concentrated at two "user sites"). A majority at nonuser sites, and virtually all professionals at user sites, responded that MDI+S are at least as effective as nebulizers, switching to MDI+S is justified by existing research, patient outcomes would be equal or better, and they have the required knowledge and skills to use MDI+S in the emergency department. The largest perceived barriers to MDI+S implementation include concerns regarding safety and costs, related to feasibility of providing and sterilizing spacers, and parental expectations for nebulizers. Other barriers included staff beliefs regarding the effectiveness of MDI+S, changes in nursing workload, and lack of a physician champion for change. CONCLUSIONS: MDI+S are infrequently used to treat patients with acute asthma in Canadian PEDs, despite the fact that most emergency staff believe they are effective. Important barriers to using MDI+S have been identified in this study and should be used to guide future implementation strategies.
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Asma/terapia , Pesquisas sobre Atenção à Saúde , Inaladores Dosimetrados/estatística & dados numéricos , Canadá , Criança , Estudos Transversais , Serviço Hospitalar de Emergência/estatística & dados numéricos , Hospitais de Ensino , HumanosRESUMO
Off-label prescribing is the prescription of a registered medicine for a use that is not included in the product information. The practice is common, with rates up to 40% in adults and up to 90% in paediatric patients. Off-label prescribing is not illegal and may sometimes be clinically appropriate, but is associated with a number of clinical, safety and ethical issues. To date, no explicit guidance has been available to help clinicians assess appropriateness in off-label prescribing. We describe the development of a guide for clinicians, policymakers and funders of health care in evaluating the appropriateness of medicines proposed for off-label use. Three broad categories of appropriate off-label use are identified:off-label use justified by high-quality evidence; use within the context of a formal research proposal; and exceptional use, justified by individual clinical circumstances. An appropriate process for informed consent is proposed for each category. If there is no high-quality evidence supporting off-label use, and the medicine is not suitable for exceptional or research indications, its use is generally not recommended. This will reduce inappropriate use, enhance patient safety by reducing exposure to unnecessary risk, and may stimulate more clinically relevant medicines research.