Title: Exploring the Current Landscape of Intravenous Infusion Practices & Errors (ECLIPSE)
Funder: Department of Health and Social Care

Abstract: BACKGROUND Medication administration errors are unacceptably common. Intravenous (IV) medication is essential in the therapeutic management of many patients, but providing IV drug therapy is a complex process, and much higher error rates have been reported than for non-IV doses. An international systematic review estimated the probability of making at least one error in the preparation and administration of a dose of IV medication to be 0.73, with most errors occurring in reconstitution and administration (McDowell et al 2010). In a systematic review of the UK literature (McLeod et al 2013), medication administration errors were found to be five times more likely in IV than non-IV doses. To reduce these errors, the introduction of automated infusion devices has been advocated. These ‘smart pumps’ incorporate software that checks programmed infusion rates against preset limits for each drug and clinical location, using customisable ‘drug libraries’. Limits may be ‘soft’ (can be overridden) or ‘hard’ (cannot). Most smart pumps also allow administrative data, such as number and types of overrides, to be downloaded for analysis. A recent survey indicates that smart pumps are used in 68% of US hospitals (Pedersen et al 2012). We have completed a survey of UK use; results show some use in 39% of respondent hospitals. However, there are limited data to provide an evidence base for their use in practice, and studies to date have proved inconclusive. Furthermore, none have been conducted in the UK where systems for prescribing and administration of medication are very different to those in the USA (Brock and Franklin 2007). We therefore know little about the effect on patient safety of smart pumps in general and nothing about their likely impact in the UK. This proposed study seeks to explore the landscape of IV medication administration practices in UK hospitals and how these relate to the prevalence and severity of medication administration errors. We aim to inform the debate on whether it is worth the NHS investing in smart pump technology (and if so, how). This is the first national study of this scale in England. It is also timely because there is a similar study already funded in the US, and by collaborating with them and exploiting their methods and definitions, we will gain added value through transatlantic comparison. RESEARCH QUESTION How is IV medication infused in UK hospitals, how often and why do errors occur in this process, what are best practices, and what is the likely impact of smart pumps on patient safety? AIMS To describe the prevalence, types, clinical importance and causes of errors involving infusion of IV medication in English hospitals, and to make recommendations for interventions with greatest potential for reducing harm from these errors. OBJECTIVES More specific objectives are: 1) To describe how IV infusions are administered in a sample of 14 English hospitals plus additional specialist paediatric and oncology units, focusing on differences in terms of nursing practice, equipment, policies and processes, both within and between hospitals. 2) In our sample of 14 hospitals plus additional specialist units, to describe the rates, types, and clinical importance of errors associated with the following modes of infusion delivery in critical care, general surgery, general medicine, paediatrics and oncology: • Gravity administration • Standard infusion pumps and syringe drivers • “Smart” infusion pumps and syringe drivers (with both hard and soft limits) 3) To explore variance in the rates, types and clinical importance of errors in relation to: • Mode of infusion delivery • Clinical area 4) To explore the causes of the errors that occur and the extent to which innovations in technology or practice, such as the introduction of smart pump technology, electronic prescribing or bar code readers could have prevented such errors. 5) To identify best practices in safe and effective IV medication administration across different hospital contexts, including issues that are important to patients as well as staff. 6) To establish how the findings differ from those of the ongoing US study, led by Bates, and to explore the reasons for any differences identified. 7) To propose recommendations to prevent IV medication errors across different hospital settings within England. We consider it premature to include a trial to evaluate the clinical effectiveness of the resulting recommendations within ECLIPSE, as details of any such trial would be dependent on our findings. We will therefore identify suitable interventions and assess the feasibility and likely value of a trial to test these interventions as further work. METHODS AND ANALYSIS The study design is based closely on an ongoing study in the US, which will facilitate international comparison. We are working with the US team and will use the same approach to quantitative data collection and analysis, but supplement this with qualitative data to gain a deeper understanding of how people, processes, practices, tools, policies and workarounds interact to affect performance in relation to infusion of IV medication. ECLIPSE will be a multi-hospital study conducted over three phases for a total of 36 months. Hospitals will be invited to participate on the basis of a questionnaire-based survey to establish current practices in use of IV devices across England. We will invite hospitals representing a range of practices in relation to IV medication administration to participate. Our aim is to gather data in critical care, general surgery, general medicine, oncology day care and paediatrics. Phase 1 will address objectives 1-3 and will involve documenting IV medication administration practices and associated medication errors in a point-prevalence study in the five clinical areas listed above, each at 14 hospital sites. To identify potential medication administration errors, trained staff will systematically compare the medication, dose, and infusion rate on the IV pump with those prescribed. Error rates will be calculated for different types of infusion and different clinical areas, and clinical importance assessed using standard methods. A dialogue will be built with participating hospitals to communicate findings and understand local policies and practices, and their impact on infusion administration outcomes. The results of Phase 1 will be used to pinpoint sites for Phase 2, which will address objectives 4 and 5. Sites will be selected on the basis of theoretically interesting comparisons, e.g. using smart pumps with hard or soft limits, or relying more on gravity administration, and with different levels of standardisation across the hospital. We will use our expertise in Human Factors to conduct qualitative observations and interviews, exploring in depth why certain errors are more or less prevalent within each context. The discipline of Human Factors brings together methods from Psychology, Ergonomics and Social Sciences to study how systems of people, processes, policies and artefacts work together to deliver safety (e.g. Rajkomar & Blandford 2012; Furniss et al 2011); it is therefore well suited to addressing these aims. Phase 3 will address objectives 6 and 7, by synthesising the findings of Phases 1 and 2, including cross-site and UK vs US comparisons, leading to recommendations for the English NHS. NHS ethics approval will be gained prior to initiating the study. Dissemination (and the involvement of both clinicians and patient representatives) will take place throughout the study. OUTCOMES 1. A description of the prevalence, types and clinical importance of errors involving infusion of IV medication in English hospitals 2. An understanding of the causes of these errors and how they relate to infusion equipment and practices 3. Recommendations relating to best practice in infusion device design, deployment and training, developed in conjunction with relevant healthcare professionals, both in general and for each participating site. BENEFITS TO THE NHS Our work will make recommendations on to how to reduce errors involving IV infusions, with particular reference to the use of infusion pump technology. REFERENCES Brock TP and Franklin BD (2007). Differences in pharmacy terminology and practice between the United Kingdom and the United States. Am J Health Syst Pharm 64:1541-1546. Furniss, D., Blandford, A. & Mayer, A. (2011) Unremarkable errors: Low-level disturbances in infusion pump use. Proc. BCS HCI Conference. 197-204. McDowell SE Mt-Isa S, Ashby D and Ferner RE (2010). Where errors occur in the preparation and administration of intravenous medicines: a systematic review and Bayesian analysis Quality and Safety in Health Care 19:341-345. McLeod M, Barber N and Franklin BD (2013). Methodological variations and their effects on reported medication administration error rates. BMJ Quality and Safety. Published Online First: 16 January 2013 doi:10.1136/bmjqs-2012-001330 Pedersen CA, Schneider PJ and Scheckelhoff DJ (2012). ASHP national survey of pharmacy practice in hospital settings: dispensing and administration – 2011. American Journal of Health-System Pharmacy 69: 768-85. Rajkomar, A. & Blandford, A. (2012) Understanding Infusion Administration in the ICU through Distributed Cognition. Journal of Biomedical Informatics. Vol. 45, No 3. 580-590

Lay abstract: In the hospital setting, medication sometimes has to be given via a patient’s vein (“intravenous”), often using a pump which controls the speed at which the medication is given (“infused”). There are various studies of the intravenous administration of drugs in hospitals; these suggest that errors often occur in the preparation and administration of these drugs. Depending on the methods used and what is counted as an “error”, published error rates vary from 18% of doses to 173% of doses (error rates of more than 100% are sometimes given where studies count more than one error per dose). Many of these errors are very minor and unlikely to affect the patient. However, others can lead to patient harm. Within the USA, “smart” infusion pumps are used in most hospitals with the aim of preventing such errors. These pumps need more information from hospital staff (such as details of the medication and its concentration, the patient’s weight, etc.); they then alert the user to unusual infusion rates based on those values. Some US research suggests that smart pumps can prevent a significant proportion of errors; other research suggests they have little effect. Smart pump use is less common in England, and the way these pumps are used is quite varied. There are no UK studies of their likely effects on medication errors, and practices in relation to prescribing and administering intravenous medication are different to those in the USA. There is therefore little information available to guide UK hospital staff in deciding how best to prevent errors involving the administration of intravenous medication, and whether or not the costs of smart pumps would be justified by any impact on error reduction. Our study aims to fill these gaps in knowledge. We will explore how often errors involving administration of intravenous medication occur in English hospitals, the reasons for these errors, and how they may be linked to, or prevented by, the infusion pumps used. We will compare our results with a similar study of the types and frequency of intravenous medication administration errors ongoing in the US, and explore reasons for any differences identified. First, we will conduct a study across 14 English hospitals, plus some specialist paediatric and oncology units, to find out how often errors occur in the administration of intravenous medication. In each hospital, we will study four areas (representing critical care, general medicine, general surgery and paediatrics). We will train a small team of staff in each hospital to collect details of the intravenous medication being administered on a particular day and compare this to the medication prescribed, to identify any errors. We will include errors involving administration of the wrong drug, wrong concentration, wrong infusion rate, wrong method of administration, wrong time of administration, and so on. We will also assess the importance of any errors identified using standard methods. We will then analyse the data to explore whether there might be differences in error rates or types across different wards or hospitals, or for different types of infusion pump. Hospitals will be selected based on a survey of English hospitals that we are conducting as part of another study to find out what kinds of infusion pumps are currently used, how, and for what purposes, and how they are managed and maintained. The selected hospitals will represent a range of practices in relation to the administration of intravenous medication. Each will be kept informed of findings, particularly as they relate to local practices. Second, we will focus in more detail on selected wards and hospitals, to explore the reasons why errors in intravenous medication do or do not occur. These wards will be selected based on the first phase of our study, as described above, to include wards with different rates and types of errors, and making different uses of infusion pumps (smart or other). Our researchers will observe staff administering intravenous medication and setting up infusion pumps in the study wards, supplemented by interviews with staff at all levels and with a variety of roles (managers, those responsible for training and device maintenance, as well as nurses and other staff who administer intravenous medication) and interviews with patients. The patient interviews will be focused on their role and experience of infusion therapy; patient-oriented research questions will be defined in a focus group early on in the project to ensure that they are important and appropriate for patients. Finally, together with findings from the ongoing parallel US study, we will use our results to develop recommendations for best practice for intravenous medication administration in English hospitals. We will be able to provide information on types of error which currently occur, how many could be prevented using smart pumps, and how many would not. We will make recommendations for interventions (such as changes in protocols, pump design or healthcare professionals’ training) to reduce the likelihood of harm from errors in intravenous medication. We anticipate our work leading to a reduction in medication errors and thus patient harm, as well as providing useful information to hospitals in making decisions about the use of infusion pumps and whether or not to purchase smart pumps. We will apply for ethics approval to do this research. Our research team will not be recording patient names or any other confidential information, and informed consent will be sought as appropriate before observing or interviewing participants. Data will be anonymised so that staff, wards and hospitals cannot be identified. We have experience of conducting similar studies. The main costs of our study are for the research team who will conduct the study, and to pay a daily rate for the NHS staff who will collect data on errors in the first part of our study. We are a team of experienced researchers, bringing together many years’ experience in studying medication errors, the interface between people and technology, and how technology is used in healthcare. We will seek input from nurses, doctors, pharmacists and patients into the research on an ongoing basis. The success of the research will be assessed on the basis of data collection and analysis proceeding to schedule, and on generating findings and recommendations that are useful to the NHS and its patients.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE