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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 doublechecking 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 doublechecking, 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. [ABSTRACT FROM AUTHOR]

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.