Independent nurse medication provision: A mixed method study assessing impact on patients' experience, processes, and costs in sexual health clinics.

BACKGROUND: Local services in the United Kingdom National Health Service enable autonomous provision of medication by nurses, supporting individual nurses to gain prescribing qualifications or by introducing local patient group directions. AIM: To compare nurse prescribing and patient group directions about clinic processes, patients' experiences, and costs from the perspectives of providers, nurses, and patients. DESIGN: Mixed methods, comparative case study in five urban sexual health services in the United Kingdom. METHODS: Data were collected from nurse prescribers, patient group direction users and their patients July 2015 to December 2016. Nurse questionnaires explored training (funding and methods). Nurses recorded consultation durations and support from other professionals in clinical diaries. Patient notes were reviewed to explore medication provision, appropriateness and safety; errors were judged by an expert panel. Patients completed satisfaction questionnaires about consultations and information about medications. RESULTS: Twenty-eight nurse prescribers and 67 patient group directions users took part; records of 1682 consultations were reviewed, with 1357 medications prescribed and 98.5% therapeutically appropriate. Most medication decisions were deemed safe (96.0% nurse prescribers, 98.7% patient group directions, Fisher's Exact Test p = .55). Errors were predominantly minor (55.6% nurse prescribers, 62.4% patient group directions) and related to documentation omissions (78.0%); no patients were harmed. Consultation durations and unplanned re-consultations were similar for both groups. Nurse prescribers sought assistance from colleagues less frequently (chi-squared = 46.748, df = 1, p < .001) but spent longer discussing cases. Nurse prescribing training required more resources from providers and nurses, compared with patient group directions. Nurse prescribers were on higher salary bands. Patient satisfaction was high in both groups (>96%). CONCLUSIONS: Nurse medication provision by both nurse prescribers and patient group direction users is safe and associated with high patient satisfaction; effects on clinic processes and costs are similar. Undertaking the prescribing qualification involves independent study but may bring longer-term career progression to nurses.

Getting palliative medications right across the contexts of homes, hospitals and hospices: protocol to synthesise scoping review and ethnographic methods in an activity theory analysis.

INTRODUCTION: Prescribing and medication use in palliative care is a multistep process. It requires systems coordination and is enacted through activities of patients, informal carers and professionals. This study compares practice to idealised descriptions of what should happen; identifying when, how and why process disturbances impact on quality and safety. Our objectives are to:Document an intended model (phase 1, scoping review).Refine the model with study of practice (phase 2, ethnography).Use the model to pinpoint 'hot' (viewed as problematic by participants) and 'cold' spots (observed as problematic by researchers) within or when patients move across three contexts-hospice, hospital and community (home).Create learning recommendations for quality and safety targeted at underlying themes and contributing factors. METHODS AND ANALYSIS: The review will scope Ovid Medline, CINAHL and Embase, Google Scholar and Images-no date limits, English language only. The Population (palliative), Concept (medication use), Context (home, hospice, hospital) framework defines inclusion/exclusion criteria. Data will be extracted to create a model illustrating how processes ideally occur, incorporating multiple steps of typical episodes of prescribing and medication use for symptom control. Direct observations, informal conversations around acts of prescribing and medication use, and semistructured interviews will be conducted with a purposive sample of patients, carers and professionals. Drawing on activity theory, we will synthesise analysis of both phases. The analysis will identify when, how and why activities affect patient safety and experience. Generating a rich multivoiced understanding of the process will help identify meaningful targets for improvement. ETHICS AND DISSEMINATION: Ethical approval granted by the Camden & Kings Cross NHS Regional Ethics Committee (21/LO/0459). A patient and public involvement (PPI) coinvestigator, a multiprofessional steering group and a PPI engagement group are working with the research team. Dissemination of findings is planned through peer-reviewed publications and a stakeholder (policymakers, commissioners, clinicians, researchers, public) report/dissemination event.

Validation of a method to assess the severity of medication administration errors in Brazil: a study protocol.

BACKGROUND: Medication errors are frequent and have a high economic and social impact and is critical to know their severity. A variety of tools exist to measure and classify the harms associated with medication errors, but few are internationally validated. DESIGN AND METHODS: It was decided to validate a method proposed by Dean and Barber for assessment of the potential severity of medication administration errors. A number of thirty health care professionals (doctors, nurses and pharmacists) from Brazil will receive an invitation to take part by scoring 50 cases of medication errors gathered from an original UK study regarding their potential harm to the patient on scale 0 to 10. Sixteen cases with known actual harm outcomes will be used to assess the validity of their scoring. By looking at 10 errors (out of the 50 cases) scored twice, reliability shall be assessed; and potential sources of variability in scoring will be evaluated depending on the severity of each of error case, the occasion when the scores were given, the scorer, their profession, and interactions among these variables. Generalizability theory will be used for analysing data. Expected impact of the study for public health: This study was submitted to the evaluation of the Research Ethics Committee of the Complexo Hospitalar Universitário Professor Edgard Santos and approved under no. 3.102.570/2019. This is the first validation of this method for use in Brazil, and will allow researchers to conduct more standardised evaluations of interventions to reduce the impact of medication errors.

The devil is in the detail: How a closed-loop documentation system for IV infusion administration contributes to and compromises patient safety.

Many studies have highlighted the patient safety risks in intravenous medication administration, and various technological solutions have been proposed to mitigate those risks, including 'smart pumps' and closed-loop systems. Few studies describe these implementations in detail. In this article, we report on a sociotechnical investigation of a closed-loop documentation system linked with smart pumps for intravenous infusion administration on an intensive care unit. The smart pumps are 'mapped' to an electronic prescribing and medication administration system, allowing infusion rates, volumes and boluses of intravenous medication to be monitored in real time. Ethnographic observations were conducted over 37 h, including direct observation of infusion administration (n = 23 infusions), discussions with clinical staff and semi-structured interviews with intensive care unit managers (n = 2). Analysis was based on the Distributed Cognition for Teamwork (DiCoT) method to understand how information is processed across individuals, teams and technologies. We report on how the system works in context, and identify contributions and compromises to patient safety with new risks that need to be managed at bedside and intensive care unit level.

Formative independent evaluation of a digital change programme in the English National Health Service: study protocol for a longitudinal qualitative study.

INTRODUCTION: Many countries are launching large-scale, digitally enabled change programmes as part of efforts to improve the quality, safety and efficiency of care. We have been commissioned to conduct an independent evaluation of a major national change programme, the Global Digital Exemplar (GDE) Programme, which aims to develop exemplary digital health solutions and encourage their wider adoption by creating a learning ecosystem across English National Health Service (NHS) provider organisations. METHODS AND ANALYSIS: This theoretically informed, qualitative, longitudinal formative evaluation comprises five inter-related work packages. We will conduct a combination of 12 in-depth and 24 broader qualitative case studies in GDE sites exploring digital transformation, local learning and mechanisms of spread of knowledge within the Programme and across the wider NHS. Data will be collected through a combination of semistructured interviews with managers, implementation staff (clinical and non-clinical), vendors and policymakers, plus non-participant observations of meetings, site visits, workshops and documentary analysis of strategic local and national plans. Data will be analysed through inductive and deductive methods, beginning with in-depth case study sites and testing the findings against data from the wider sample and national stakeholders. ETHICS AND DISSEMINATION: This work is commissioned as part of a national change programme and is therefore a service evaluation. We have ethical approval from the University of Edinburgh. Results will be disseminated at six monthly intervals to national policymakers, and made available via our publicly accessible website. We will also identify lessons for the management and evaluation of large-scale evolving digital health change programmes that are of international relevance.

Is the principle of a stable Heinrich ratio a myth? A multimethod analysis.

BACKGROUND: Safety improvements are sometimes based on the premise that introducing measures to combat minor or no-harm incidents proportionately reduces the incidence of major incidents involving harm. This is in line with the principle of the Heinrich ratio, which asserts that there is a relatively fixed ratio between the incidence of no-harm incidents, minor incidents and major incidents. This principle has been advocated as a means of targeting and evaluating new safety initiatives. RESEARCH METHODOLOGY: Both thought experimentation and analysis of empirical data were used to examine the plausibility of this principle. A descriptive statistical analysis was carried out using triangle plots to display the relative frequencies of the occurrence of safety incidents classified as minor, moderate or severe. FINDINGS: Thought experiments indicated that the principle of a fixed Heinrich ratio has a dubious logical foundation. Analysis of emergency department attendance and studies of medication errors demonstrated marked variation in the relative ratios of different outcomes. Triangle plots of UK road traffic accident data revealed a hitherto unrecognized systematic pattern of change that contradicts the principle of the Heinrich ratio. INTERPRETATION: This study of the principle of a fixed Heinrich ratio invalidates it: introducing measures to reduce the incidence of minor incidents will not inevitably reduce the incidence of major incidents pro rata. Any safety policies based on the assumption that the Heinrich ratio is true need to be rethought.

Use of patient-held information about medication (PHIMed) to support medicines optimisation: protocol for a mixed-methods descriptive study.

INTRODUCTION: Risks of poor information transfer across health settings are well documented, particularly for medication. There is also increasing awareness of the importance of greater patient activation. Patients may use various types of patient-held information about medication (PHIMed) to facilitate medication transfer, which may be paper or electronic. However, it is not known how PHIMed should best be used, whether it improves patient outcomes, nor is its key 'active ingredients' known. Discussion with patients and carers has highlighted this as a priority for research. We aim to identify how PHIMed is used in practice, barriers and facilitators to its use and key features of PHIMed that support medicines optimisation in practice. METHODS AND ANALYSIS: This study will take place in Greater London, England. We will include patients with long-term conditions, carers and healthcare professionals. The study has four work packages (WPs). WP1 involves qualitative interviews with healthcare professionals (n=16) and focus groups with patients and carers (n=20), including users and non-users of PHIMed, to study perceptions around its role, key features, barriers and facilitators, and any unintended consequences. WP2 will involve documentary analysis of how PHIMed is used, what is documented and read, and by whom, in a stratified sample of 60 PHIMed users. In WP3, we will carry out a descriptive analysis of PHIMed tools used/available, both electronic and paper, and categorise their design and key features based on those identified in WP1/2. Finally, in WP4, findings from WPs 1-3 will be integrated and analysed using distributed cognition as a theoretical framework to explore how information is recorded, transformed and propagated among different people and artefacts. ETHICS AND DISSEMINATION: The study has National Health Service ethics approval. It will provide initial recommendations around the present use of PHIMed to optimise patient care for patients, carers and healthcare professionals.

Exploring the theory, barriers and enablers for patient and public involvement across health, social care and patient safety: a protocol for a systematic review of reviews.

INTRODUCTION: The emergence of patient and public involvement (PPI) in healthcare in the UK can be traced as far back as the 1970s. More recently, campaigns by harmed patients and their relatives have emerged as a result of clinical failings in the NHS, challenging paternalistic healthcare, which have led to a new focus on PPI in quality and safety, nationally and internationally. Evidence suggests that PPI within patient safety is often atheoretical and located within a biomedical discourse. This review will explore the literature on PPI across patient safety, healthcare and social care to identify theory, barriers and enablers that can be used to develop PPI in patient safety. METHODS AND ANALYSIS: Systematic searches of three electronic bibliographic databases will be conducted, using both MeSH and free-text terms to identify empirical literature published from database inception to May 2017. The screening process will involve input from at least two researchers and any disagreement will be resolved through discussion with a third reviewer. Initial inclusion and exclusion criteria have been developed and will be refined iteratively throughout the process. Data extraction from included articles will be conducted by at least two researchers using a data extraction form. Extracted information will be analysed using a narrative review approach, which synthesises data using a descriptive method. ETHICS AND DISSEMINATION: No ethical approval is required for this review as no empirical data were collected. We believe that the findings and recommendations from this review will be particularly relevant for an audience of academics and policymakers. The findings will, therefore, be written up and disseminated in international peer-reviewed journals and academic conferences with a health focus. They will also be disseminated to leading health policy organisations in the NHS, such as NHS England and NHS Improvement and national policy bodies such as the Health Foundation.

The incidence of prescribing errors in hospital inpatients: an overview of the research methods.

Many different methods have been used to study the incidence of prescribing errors in hospital inpatients. The objectives of this review were to outline the methods used, highlight their strengths and limitations, and summarise the incidence of prescribing errors reported. Methods used may be retrospective or prospective and based on process or on outcome. Reported prescribing error rates vary widely, ranging from 0.3% to 39.1% of medication orders written and from 1% to 100% of hospital admissions. Unfortunately, there is no standard denominator for use when expressing prescribing error rates. It could be argued that the most meaningful is the number of medication orders written; however, it is also helpful to consider the number of medication orders written per patient stay in order to understand the risk that a given prescribing error rate poses to an individual patient. Because of wide variation in the definitions and methods used, it is difficult to make comparisons between different studies. Each method for identifying prescribing errors has advantages and disadvantages. Process-based studies potentially allow all errors to be identified, giving more scope for the identification of trends and learning opportunities, and it may be easier to collect sufficient data to show statistically significant changes in prescribing error rates following interventions to reduce them. However, studies based on process may be criticised for focusing on many minor errors that are very unlikely to have resulted in patient harm. Focusing instead on harm, as in outcome-based studies, allows efforts to reduce errors to be targeted on those areas that are likely to result in the highest impact. Therefore, the most appropriate method depends on the study's aims. However, using a combination of methods is likely to be the most useful approach if comprehensive data are required.

The prevalence and nature of prescribing and monitoring errors in English general practice: a retrospective case note review.

BACKGROUND: Relatively little is known about prescribing errors in general practice, or the factors associated with error. AIM: To determine the prevalence and nature of prescribing and monitoring errors in general practices in England. DESIGN AND SETTING: Retrospective case-note review of unique medication items prescribed over a 12-month period to a 2% random sample of patients. Fifteen general practices across three primary care trusts in England. METHOD: A total of 6048 unique prescription items prescribed over the previous 12 months for 1777 patients were examined. The data were analysed by mixed effects logistic regression. The main outcome measures were prevalence of prescribing and monitoring errors, and severity of errors, using validated definitions. RESULTS: Prescribing and/or monitoring errors were detected in 4.9% (296/6048) of all prescription items (95% confidence interval [CI] = 4.4% to 5.5%). The vast majority of errors were of mild to moderate severity, with 0.2% (11/6048) of items having a severe error. After adjusting for covariates, patient-related factors associated with an increased risk of prescribing and/or monitoring errors were: age <15 years (odds ratio [OR] = 1.87, 95% CI = 1.19 to 2.94, P = 0.006) or >64 years (OR = 1.68, 95% CI = 1.04 to 2.73, P = 0.035), and higher numbers of unique medication items prescribed (OR = 1.16, 95% CI = 1.12 to 1.19, P<0.001). CONCLUSION: Prescribing and monitoring errors are common in English general practice, although severe errors are unusual. Many factors increase the risk of error. Having identified the most common and important errors, and the factors associated with these, strategies to prevent future errors should be developed, based on the study findings.

Failure mode and effects analysis: too little for too much?

Failure mode and effects analysis (FMEA) is a structured prospective risk assessment method that is widely used within healthcare. FMEA involves a multidisciplinary team mapping out a high-risk process of care, identifying the failures that can occur, and then characterising each of these in terms of probability of occurrence, severity of effects and detectability, to give a risk priority number used to identify failures most in need of attention. One might assume that such a widely used tool would have an established evidence base. This paper considers whether or not this is the case, examining the evidence for the reliability and validity of its outputs, the mathematical principles behind the calculation of a risk prioirty number, and variation in how it is used in practice. We also consider the likely advantages of this approach, together with the disadvantages in terms of the healthcare professionals' time involved. We conclude that although FMEA is popular and many published studies have reported its use within healthcare, there is little evidence to support its use for the quantitative prioritisation of process failures. It lacks both reliability and validity, and is very time consuming. We would not recommend its use as a quantitative technique to prioritise, promote or study patient safety interventions. However, the stage of FMEA involving multidisciplinary mapping process seems valuable and work is now needed to identify the best way of converting this into plans for action.