Automatic dispensing cabinets and governance of controlled drugs: an exploratory study in an intensive care unit.

BACKGROUND: Governance of controlled drugs (CDs) in hospitals is resource intensive but important for patient safety and policy compliance. OBJECTIVES: To explore whether and how storing CDs in an automated dispensing cabinet (ADC) in a children's hospital intensive care unit (ICU) contributes to the effectiveness and efficiency of CD governance. METHODS: We conducted a mixed-methods exploratory study, comprising observations, interviews and audits, 3 months after ADC implementation. We observed 54 hours of medications activities in the ICU medication room (with 42 hours of timed data); interviewed nurses (n=19), management (n=1) and pharmacy staff (n=3); reviewed 6 months of ICU incident reports pertaining to CD governance; audited 6 months of CD register data and extracted logs of all ADC transactions for the 3 months following implementation. Data analysis focused on four main CD governance activities: safekeeping/controlling access, documenting use, monitoring, and reporting/investigating. RESULTS: Nurses and pharmacists perceived spending less time on CD governance tasks with the ADC. The ADC supported CD governance through automated documentation of CD transactions; 'blind counts'; automated count discrepancy checks; electronic alerts and reporting functionalities. It changed quality and distribution of governance tasks, such as removing the requirement for 'nurses with keys' to access CDs, and allowing pharmacists to generate reports remotely, rather than reviewing registers on the ward. For CDs in the ADC, auditing and monitoring appeared to be ongoing rather than periodic. Such changes appeared to create positive reinforcing loops. However, the ADC also created challenges for CD governance. Most importantly, it was not suitable for all CDs, leading to workarounds and parallel use of a safe plus paper registers. CONCLUSIONS: ADCs can significantly alter CDs governance in clinical areas. Effects of an ADC on efficiency and effectiveness of governance tasks appear to be complex, going beyond simple time savings or more stringent controls.

Overcoming Challenges to Inclusive User-based Testing of Health Information Technology with Vulnerable Older Adults: Recommendations from a Human Factors Engineering Expert Inquiry.

OBJECTIVES: Involving representative users in usability testing of health information technology (HIT) is central to user-centered design. However, (vulnerable) older adults as representative users have unique requirements. Aging processes may affect physical capabilities and cognitive skills, which can hamper testing with this demographic and may require special attention and revised protocols. This study was performed to provide expert-based recommendations for HIT user-testing with (vulnerable) older adults to support inclusive HIT design and evaluation. METHODS: First, we conducted a structured workshop with ten experts in HIT implementation and research, recruited through purposeful sampling, to generate insights into how characteristics of older adults may influence user-testing. Next, five Human Factor researchers experienced in HIT user-testing with (vulnerable) older adults validated the results and provided additional textual insights to gain consensus on the most important recommendations. A thematic analysis was performed on the resulting inquiries. Applied codes were based on the User-Centered Design framework. RESULTS: The analysis resulted in nine recommendations for user-testing of HIT with older adults, divided into three main themes: (1) empathetic approach and trust-building, (2) new requirements for testing and study design, and (3) adjustments to usability evaluation methods. For each theme a checklist of relevant items to follow-up on the recommendation is provided. CONCLUSIONS: The recommendations generated through expert inquiry contribute to more effective usability testing of HIT with older adults. This provides an important step towards improved accessibility of HIT amongst older adults through inclusive user-centered design.

Mindful Workarounds in Bar Code Medication Administration.

Bar-Coded Medication Administration systems (BCMA) are often used with workarounds. These workarounds are usually judged against standard operating procedures or the use of the technology as 'designers' intended'. However, some workarounds may be reasonable and justified to prevent safety errors. In this conceptual paper, we clarify BCMA safety mechanisms and provide a framework to identify workarounds with BCMA that nullify the error prevention mechanisms inherent in the technology design and process. We also highlight the importance of understanding the purpose behind a nurse's workaround in BCMA, focusing on the notion of mindful (thoughtful) workarounds that have the potential to improve patient safety.

Challenges of Digital Commons: A Qualitative Study of an Automated Dispensing Cabinet in a Paediatric Intensive Care Unit.

Missed medication doses can affect patient safety in hospitals. The use of automated dispensing cabinets (ADC) in clinical areas may reduce the occurrence of medications being unavailable at the time of need by alerting pharmacy to replenish stock. However, workarounds in ADC use can affect this capability. We studied nurses' use of an ADC in a paediatric intensive care unit with  54 hours of observation, semi-structure interviews (19 nurses; 4 pharmacy/management staff) and review of reported incidents. We found running out of medication a recurrent problem despite the ADC. Contributing factors affecting data entry in the ADC, and therefore replenishment alerts to pharmacy, included: the organisation of medication activities in the ward, nurses' information needs, patients' medication needs, and ADC design. Running out of medications was a 'tragedy of the commons'. Effective solutions may require going beyond user training and directives for accurate data entry, to work process redesign.

Evaluation of an Automated Dispensing Cabinet in Paediatric Intensive Care - Focus on Controlled Medications.

Evidence is limited of automated dispensing cabinets (ADCs) impact on effectiveness and efficiency of controlled drugs' (CDs) governance processes. We carried out a mixed-methods study of an ADC in an intensive care unit. We found ADC improved effectiveness and efficiency of governance of CDs through secure storage, alerts and automated recording of transactions. Limitations were associated with ADC design and 'fit' between ADC and some types of CDs.

Associations between double-checking and medication administration errors: a direct observational study of paediatric inpatients.

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.

The impact of introducing automated dispensing cabinets, barcode medication administration, and closed-loop electronic medication management systems on work processes and safety of controlled medications in hospitals: A systematic review.

BACKGROUND: Technology in the form of Automated Dispensing Cabinets (ADCs), Barcode Medication Administration (BCMA), and closed-loop Electronic Medication Management Systems (EMMS) are implemented in hospitals to assist with the supply, use and monitoring of medications. Although there is evidence to suggest that these technologies can reduce errors and improve monitoring of medications in general, little is known about their impact on controlled medications such as opioids. OBJECTIVES: This review aimed to fill this knowledge gap by synthesising literature to determine the impact of ADCs, BCMA and closed-loop EMMS on clinical work processes, medication safety, and drug diversion associated with controlled medications in the inpatient setting. METHODS: Eight databases (Medline, Pubmed, Embase, Scopus, Web of Science, PsycINFO, CINAHL, and ScienceDirect) were searched for relevant papers published between January 2000 and May 2019. Qualitative, quantitative, and mixed-methods empirical studies published in English that reported findings on the impact of ADCs, BCMA and/or closed-loop EMMS on controlled medications in the inpatient setting were included. RESULTS: In total, 16 papers met the inclusion criteria. Eleven studies reported on ADCs, four on BCMA, and only one on closed-loop EMMS. Only four studies focused on controlled medications, with the remainder reporting only incidental findings. Studies reported the elimination of manual end-of-shift counts of controlled medications after ADC implementation but cases of drug diversion were reported despite introducing ADCs. Three quantitative studies reported reductions in medication errors after implementing BCMA, but medications labelled with wrong barcodes and unreadable barcodes led to confusion and administration errors. CONCLUSIONS: More quality, targeted research is needed to provide evidence on the benefits and also risks of implementing technology to safeguard against inappropriate use of controlled medications in the inpatient setting. Processes need to be in place to supplement technological capabilities, and resources should be made available for post-implementation evaluations and interventions.

Electronic ordering and the management of treatment interdependencies: a qualitative study of paediatric chemotherapy.

BACKGROUND: There are serious safety risks associated with chemotherapy, often associated with interdependencies in regimens administered over months or years. Various strategies are used to manage these risks. Computerized provider order entry (CPOE) systems are also implemented to improve medication safety. Little is known regarding the effect of CPOE on how clinicians manage chemotherapy interdependencies and their associated safety strategies. METHODS: We conducted a multi-method qualitative study in a paediatric hospital. We analysed 827 oncology incidents reported following CPOE implementation and carried out semi-structured interviews with doctors (n = 10), nurses (n = 6), a pharmacist, and oncology CPOE team members (n = 2). Results were interpreted according to safety models (ultra-safe, high-reliability organisations [HROs], or ultra-adaptive). RESULTS: Incident reports highlighted two interrelated types of interdependencies: those within organisation of clinical activities and those inherent in chemotherapy regimens. Clinicians reported strategies to address chemotherapy risks and interdependencies. These included rigid rules and 'no go' contexts for treatment to proceed, typical of the ultra-safe model; use of time (e.g. planning only so far ahead) and sensitivity to operations, typical of HROs. We identified three different time horizons in CPOE use in relation to patients' treatments: life-long, the whole regimen, and the 'here and now'. CPOE supported ultra-safe strategies through automation and access to rules/standardisation, but also created difficulties and contributed to incidents. It supported the 'here and now' better than a life-long or whole regimen view of a patient treatment. Sensitivity to operations was essential to anticipate and resolve uncertainties, hazards, CPOE limitations, and mismatches between CPOE processes and workflow in practice. CONCLUSIONS: Within oncology, CPOE appears to move the 'mix' of risk strategies towards ultra-safe models of safety and protocol-mandated care. However, in order to operate ultra-safe strategies embedded in CPOE and stay on protocol it is essential for clinicians to be thoughtful and show sensitivity to operations in CPOE use. CPOE design can be advanced by better consideration of mechanisms to support interdependencies.

The 'Back Office' of a Dispensing Cabinet: Technology and Work Contributing to Medication Safety.

Automated dispensing cabinets in clinical wards may contribute to improving safety by reducing the likelihood of medications not being available when needed. However, achieving this safety benefit is dependent on a 'back office' sociotechnical infrastructure that combines semi-automated processes with mindful, resilient work practices.

Challenges and Best Practices in Ethical Review of Human and Organizational Factors Studies in Health Technology: a Synthesis of Testimonies.

OBJECTIVE: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. METHODS: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. RESULTS: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. CONCLUSION: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered.

Collective Mindfulness and Processes of Sensemaking in Health IT Implementation.

High reliability organisations operate safely in situations of high risk by organising for collective mindfulness. They do so through five ongoing processes geared towards anticipating, containing, and making sense of the unexpected. The five processes are: preoccupation with failure, reluctance to simplify interpretations, sensitivity to operations, commitment to resilience, and deference to expertise. The theory of collective mindfulness builds on Hutchins's theory of distributed cognition (the 'collective mind' of ship navigation teams) and on Langer's theory of mindfulness about individuals' interpreting information in context. However, in the theory of collective mindfulness, attention is paid not to individual cognition or decision making, but to collective processes of sensemaking emerging from individuals' interactions in dealing with an equivocal environment. In health informatics, the theory of collective mindfulness can be used to explain health information technology (IT) development and implementation, across its life cycle, and inform guidance towards mindful management of IT projects. For example, applied to a case of electronic health record implementation in a hospital context, the theory explains how mindful management of the sense-making challenges of post-roll out adaptation processes contributes to a 'successful' IT project. Further, the theory challenges a static and linear understanding of success (or failure) of health IT initiatives, supporting instead an argument for outcomes - be it reliability and safety, or IT project success - as collective, complex and dynamic achievements of mindful organising practices.

Researching Collective Mindfulness and Health IT: A Framework and Translation to Context-Specific Questions.

To improve patient safety, hospital organisations are encouraged to run their operations in line with high reliability organisations' collective mindfulness principles and practices. For the same safety goals, they also implement health information technology (IT). However, little is known about whether, or how, health IT can impact organisational mindfulness, and thereby safety. We propose that research in this area can be approached through a simple framework of overarching, umbrella questions, then carefully translated into nuanced context-specific questions and study designs. The framework and approach we propose provides a structure for comparing results from studies of collective mindfulness and health IT, across different clinical contexts and IT applications.

Medication safety incidents in paediatric oncology after electronic medication management system implementation.

OBJECTIVE: To explore medication safety issues related to use of an electronic medication management system (EMM) in paediatric oncology practice, through the analysis of patient safety incident reports. METHODS: We analysed 827 voluntarily reported incidents relating to oncology patients that occurred over an 18-month period immediately following implementation of an EMM in a paediatric hospital in Australia. We identified medication-related and EMM-related incidents and carried out a content analysis to identify patterns. RESULTS: We found ~79% (n = 651) of incidents were medication-related and, of these, ~45% (n = 294) were EMM-related. Medication-related incidents included issues with: prescribing; dispensing; administration; patient transfers; missing chemotherapy protocols and information on current stage of patient treatment; coordination of chemotherapy administration; handling or storing medications; children or families handling medications. EMM-related incidents were classified into four groups: technical issues, issues with the user experience, unanticipated problems in EMM workflow, and missing safety features. CONCLUSIONS: Incidents reflected difficulties with managing therapies rich in interdependencies. EMM, and especially its 'automaticity', contributed to these incidents. As EMM impacts on safety in such high-risk settings, it is essential that users are aware of and attend to EMM automatic behaviours and are equipped to troubleshoot them.

Pharmacy Interweaving Safety Within Hospital Health Information Technology.

Research on the impact of hospital technology on medication safety usually focuses on prescribing and administration. Less is known about the pharmacy-related processes of reviewing, ordering and dispensing medications and how technology supports this work. We carried out a qualitative exploratory study of a hospital in England (UK) with the aim of gaining insight into processes of digitalisation. We found that hospital pharmacy staff perform safety work with technology aiming to prevent harm, such as 'scaffolding' people's thinking processes, or linking-up unintegrated systems. Their work seems to 'interweave' safety in between others' medication activities, but they do so sometimes struggling with technological deficiencies.

Using the MRC Framework for Complex Interventions to Develop Clinical Decision Support: A Case Study.

The Medical Research Council (MRC) framework for complex interventions provides useful guidance to assist with the development and evaluation of health technology interventions such as decision support. In this paper we briefly summarise a project that focused on designing a decision support intervention to assist with the recognition, assessment and management of pain in patients with dementia in an acute hospital setting. We reflect on our experience of using the MRC framework to guide our study design, and highlight the importance of considering decision support interventions as complex interventions.

The Value of Data and the Value of Questions: Achieving Improvement in Hospital Pharmacy and Medication Safety.

Medication safety incidents are one of the major patient safety issue faced across all healthcare services and one that is very challenging to tackle. To make progress, data about the supply and use of medicines that is generated and made available in clinical systems can serve both the purposes of patient safety and service quality improvement. This paper shows how the value of data for these purposes can be framed in terms of the value of questions. This theme is developed based on an interview with a quality and safety pharmacist working in a large hospital pharmacy unit.