Indication documentation and indication-based prescribing within electronic prescribing systems: a systematic review and narrative synthesis.

BACKGROUND: Despite recommendations, documentation of indication on prescriptions and inpatient medication orders is not routinely practised. There has been a recent systematic review of indication documentation for antimicrobials, but not for interventions relating to indication documentation for medication more broadly. Our aims were to 1) identify, describe and synthesise the literature relating to effectiveness of interventions aimed at improving indication documentation and/or indication-based prescribing in both primary and secondary healthcare; 2) synthesise participant perspectives to identify barriers and facilitators to these interventions; and 3) make recommendations for both practice and research. METHODS: A systematic literature search was conducted using Medline, Embase and CINAHL using two search concepts: electronic prescribing systems, and indication documentation and/or indication-based prescribing. Qualitative, quantitative and mixed-methods studies were included; outcome measures and results were extracted to produce a narrative synthesis. Quality appraisal by two independent reviewers was undertaken using the Mixed Methods Appraisal Tool. RESULTS: We identified 21 studies evaluating interventions to aid indication documentation. Indication documentation was either via free-text, selection from a list, or by use of pre-defined indication-based order sentences for individual medications. For a number of outcomes, there was a mostly positive impact, including appropriateness of the medication order (6 of 8 studies), rates of prescribing error (2/2) and some less commonly reported clinical (2/4) and workflow-related outcomes (2/3). There was a less favourable impact on accuracy of indication documentation and rates of medication use, highlighting some unintended consequences that may occur when implementing new interventions. Participant insights from prescribers and other healthcare professionals complemented quantitative study results, highlighting both facilitators and barriers to indication documentation and the associated interventions. For example, barriers included long drop-down lists and the need to use workarounds to navigate approval systems due to time or knowledge constraints. Facilitating factors included the perceived benefits of indication documentation on communication among the healthcare team and with the patient. CONCLUSION: Indication documentation has the potential to improve appropriate prescribing and reduce prescribing errors. However, further benefits to the prescriber, multidisciplinary team and patient may only be realised by developing methods of indication documentation that integrate more efficiently with prescriber workflows. PROSPERO REGISTRATION NUMBER: CRD42021278495.

CE Accreditation and Barriers to CE Marking of Pediatric Drug Calculators for Mobile Devices: Scoping Review and Qualitative Analysis.

BACKGROUND: Pediatric drug calculators (PDCs) intended for clinical use qualify as medical devices under the Medical Device Directive and the Medical Device Regulation. The extent to which they comply with European standards on quality and safety is unknown. OBJECTIVE: This study determines the number of PDCs available as mobile apps for use in the Netherlands that bear a CE mark, and explore the factors influencing the CE marking of such devices among app developers. METHODS: A scoping review of Google Play Store and Apple App Store was conducted to identify PDCs available for download in the Netherlands. CE accreditation of the sampled apps was determined by consulting the app landing pages on app stores, by screening the United Kingdom Medicines and Healthcare products Regulatory Agency's online registry of medical devices, and by surveying app developers. The barriers to CE accreditation were also explored through a survey of app developers. RESULTS: Of 632 screened apps, 74 were eligible, including 60 pediatric drug dosage calculators and 14 infusion rate calculators. One app was CE marked. Of the 20 (34%) respondents to the survey, 8 considered their apps not to be medical devices based on their intent of use or functionality. Three developers had not aimed to make their app available for use in Europe. Other barriers that may explain the limited CE accreditation of sampled PDC apps included poor awareness of European regulations among developers and a lack of restrictions when placing PDCs in app stores. CONCLUSIONS: The compliance of PDCs with European standards on medical devices is poor. This puts clinicians and their patients at risk of medical errors resulting from the largely unrestricted use of these apps.

Use of Pediatric Injectable Medicines Guidelines and Associated Medication Administration Errors: A Human Reliability Analysis.

BACKGROUND: In a recent human reliability analysis (HRA) of simulated pediatric resuscitations, ineffective retrieval of preparation and administration instructions from online injectable medicines guidelines was a key factor contributing to medication administration errors (MAEs). OBJECTIVE: The aim of the present study was to use a specific HRA to understand where intravenous medicines guidelines are vulnerable to misinterpretation, focusing on deviations from expected practice (discrepancies) that contributed to large-magnitude and/or clinically significant MAEs. METHODS: Video recordings from the original study were reanalyzed to identify discrepancies in the steps required to find and extract information from the NHS Injectable Medicines Guide (IMG) website. These data were combined with MAE data from the same original study. RESULTS: In total, 44 discrepancies during use of the IMG were observed across 180 medication administrations. Of these discrepancies, 21 (48%) were associated with an MAE, 16 of which (36% of 44 discrepancies) made a major contribution to that error. There were more discrepancies (31 in total, 70%) during the steps required to access the correct drug webpage than there were in the steps required to read this information (13 in total, 30%). Discrepancies when using injectable medicines guidelines made a major contribution to 6 (27%) of 22 clinically significant and 4 (15%) of 27 large-magnitude MAEs. CONCLUSION AND RELEVANCE: Discrepancies during the use of an online injectable medicines guideline were often associated with subsequent MAEs, including those with potentially significant consequences. This highlights the need to test the usability of guidelines before clinical use.

Medication errors during simulated paediatric resuscitations: a prospective, observational human reliability analysis.

INTRODUCTION: Medication errors during paediatric resuscitation are thought to be common. However, there is little evidence about the individual process steps that contribute to such medication errors in this context. OBJECTIVES: To describe the incidence, nature and severity of medication errors in simulated paediatric resuscitations, and to employ human reliability analysis to understand the contribution of discrepancies in individual process steps to the occurrence of these errors. METHODS: We conducted a prospective observational study of simulated resuscitations subjected to video microanalysis, identification of medication errors, severity assessment and human reliability analysis in a large English teaching hospital. Fifteen resuscitation teams of two doctors and two nurses each conducted one of two simulated paediatric resuscitation scenarios. RESULTS: At least one medication error was observed in every simulated case, and a large magnitude (>25% discrepant) or clinically significant error in 11 of 15 cases. Medication errors were observed in 29% of 180 simulated medication administrations, 40% of which considered to be moderate or severe. These errors were the result of 884 observed discrepancies at a number of steps in the drug ordering, preparation and administration stages of medication use, 8% of which made a major contribution to a resultant medication error. Most errors were introduced by discrepancies during drug preparation and administration. CONCLUSIONS: Medication errors were common with a considerable proportion likely to result in patient harm. There is an urgent need to optimise existing systems and to commission research into new approaches to increase the reliability of human interactions during administration of medication in the paediatric emergency setting.

Reduced Nasal Viral Load and IFN Responses in Infants with Respiratory Syncytial Virus Bronchiolitis and Respiratory Failure.

RATIONALE: Respiratory syncytial virus (RSV) bronchiolitis is a major cause of morbidity and mortality in infancy. Severe disease is believed to result from uncontrolled viral replication, an excessive immune response, or both. OBJECTIVES: To determine RSV load and immune mediator levels in nasal mucosal lining fluid by serial sampling of nasal fluids from cases of moderate and severe bronchiolitis over the course of infection. METHODS: Infants with viral bronchiolitis necessitating admission (n = 55) were recruited from a pediatric center during 2016 and 2017. Of these, 30 were RSV infected (18 "moderate" and 12 mechanically ventilated "severe"). Nasal fluids were sampled frequently over time using nasosorption devices and nasopharyngeal aspiration. Hierarchical clustering of time-weighted averages was performed to investigate cytokine and chemokine levels, and gene expression profiling was conducted. MEASUREMENTS AND MAIN RESULTS: Unexpectedly, cases with severe RSV bronchiolitis had lower nasal viral loads and reduced IFN-γ and C-C chemokine ligand 5/RANTES (regulated upon activation, normal T cell expressed and secreted) levels than those with moderate disease, especially when allowance was made for disease duration (all P < 0.05). Reduced cytokine/chemokine levels in severe disease were also seen in children with other viral infections. Gene expression analysis of nasopharyngeal aspiration samples (n = 43) confirmed reduced type-I IFN gene expression in severe bronchiolitis accompanied by enhanced expression of MUC5AC and IL17A. CONCLUSIONS: Infants with severe RSV bronchiolitis have lower nasal viral load, CXCL10 (C-X-C motif chemokine ligand 10)/IP-10, and type-I IFN levels than moderately ill children, but enhanced MUC5AC (mucin-5AC) and IL17A gene expression in nasal cells.