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BACKGROUND: Adverse drug reactions (ADRs) are known to cause hospitalisation, longer hospital stays, as well as higher healthcare costs and mortality. Unrecognised ADRs are anticipated throughout the medicine lifecycle as, before the medicine reaches the market, clinical trials are conducted for a short period on a limited number of people, who might underrepresent the actual population. After the medicine reaches the market, emergent information that could affect its benefit-to-risk balance is usually shared by regulatory agencies and pharmaceutical companies through medicine risk communications. Medicines risk communications aim to prevent harm to patients by targeting their behaviour, knowledge, and attitudes, as well as those of health care professionals (HCPs). Despite their important role in translating these communications into their clinical practice, HCPs do not always adhere to the recommendations provided in risk communications. Measurement of medicine risk communications' effectiveness does not necessarily guarantee their implementation, cost-effectiveness, or transferability in real-world situations. To enhance the impact of drug regulatory interventions, implementation science has been encouraged. However, implementation science was not previously used to identify factors affecting HCPs' implementation of medicines risk communications. A recently widely used framework is the Theoretical Domain Framework (TDF). In this systematic review, the TDF was employed to categorise a range of different factors that could affect HCPs' implementation of medicine risk communications within their clinical contexts. METHODS: The search strategy involved a set of predefined search terms and fifteen databases, such as EMBASE, PubMed, Web of Science and CINAHL PLUS. Searches were conducted from April to May 2018 and updated in June 2021 using PubMed, Scopus, and CINAHL PLUS. A second reviewer independently conducted the screening process of the initial search. The total number of records screened was 10,475. A study was included if it reported any factors influencing HCPs' uptake of medicine risk communications. Only studies with English or Arabic abstracts were included. Those studies that did not include pharmacovigilance-related medicine risk communications were excluded. Additionally, studies only assessing HCPs' practice or evaluating the effectiveness of risk minimisation measures were excluded. Likewise, studies related to occupational hazards, case reports, interventional studies, and studies not involving HCPs were excluded. In case the published information was insufficient to decide whether to include or exclude a study, the authors were contacted. Furthermore, the authors of seven eligible abstracts were contacted for full-text articles. The mixed method appraisal tool (MMAT) was used to evaluate the quality of the included studies. All included studies were assessed by one reviewer, and a total of 16 studies were assessed by two reviewers independently. Disagreements were resolved through discussion. Using thematic analysis and concept mapping, a narrative synthesis was performed, followed by a critical reflection on the synthesis process. This review presents the results of the concept mapping, which involved matching the identified factors to the TDF. RESULTS: A total of 28 studies were included. Eleven domains influenced HCPs' implementation of medicine risk communications. A large number of studies included factors related to the "Knowledge" domain (n = 23), followed by "Beliefs about Consequences" (n = 13), "Memory, Attention and Decision Processes" (n = 12) and "Environmental Context and Resources" domains (n = 12). Seven studies reported "social influences" and six studies included factors relating to "Goals", followed by four studies involving factors related to "Social/Professional Role and Identity". Underrepresented domains included "Emotion" (n = 2), "Beliefs about Capabilities" (n = 2), "Behavioural Regulation" (n = 1), and "Reinforcement" (n = 1). On the other hand, none of the identified factors were related to the "Skills", "Optimism", or "Intentions" domains. Except for "Beliefs about Consequences", most studies contributing to the other three most commonly reported domains ("Knowledge"; "Environmental Context and Resources"; and "Memory, Attention and Decision Processes") scored low (1 or 2 out of 5) on the MMAT quality assessment. Moreover, the same number of studies (n = 5) contributing to the "Beliefs about Consequences" domain had low (1 or 2 out of 5), and intermediate (3 out of 5) scores on the MMAT. CONCLUSION: Medicines risk communications are important tools for disseminating information that may influence the benefit-to-risk balance of medicines. Even though HCPs are required to implement the recommendations of these communications, they do not always adhere to them. Using the TDF enabled the categorization of the range of factors that affect whether or not HCPs implement the recommendations provided in a medicine risk communication. However, most of these factors relate to four domains only ("Knowledge"; "Beliefs about Consequences"; "Memory, Attention and Decision Processes"; and "Environmental Context and Resources"). Additionally, most of the studies contributing to three of these four domains were of low quality. Future research should focus on using implementation science to identify target behaviours for actionable medicine risk communications. Regulators should use such science to develop cost-effective strategies for improving the implementation of medicines risk communication by HCPs.

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BACKGROUND: Regulatory medicines risk communications aim to prevent patient harm through the dissemination of safety information to healthcare professionals (HCPs), patients, and the public. Evidence suggests that in addition to implementing the required changes, HCPs also respond to these communications through unintended and unwarranted actions and behaviours such as stopping medicine courses unnecessarily, and blanket actions spilling over to unintended patients' populations. Misunderstanding and mis-implementation of medicines risk communications could jeopardise patients' safety and clinical outcomes. Therefore, it is important to understand the determinants that affect HCPs responses to medicines risk communications. This systematic review aims to identify the factors that affect the implementation of risk communications by healthcare professionals. METHODS: Fifteen databases, including EMBASE, PubMed, Scopus, Web of science, CINAHL PLUS were searched in April-May 2018, and the search was updated again in June 2021 to identify studies reporting on factors influencing HCPs' uptake of medicine risk alerts. We used keywords such as risk communication, safety update, and safety regulation. Studies were excluded if they did not involve pharmacovigilance or patient safety alerts; or if they only focused on measuring HCPs' practice after alerts; or evaluating the effectiveness of risk minimisation measures without reporting on factors affecting HCPs' actions. Studies relating to occupational hazards, case reports, interventional studies, and studies not involving HCPs were also excluded. The Mixed Method Appraisal Tool (MMAT) was used to assess the quality of the included studies. A Narrative synthesis approach was undertaken using thematic analysis and concept mapping, followed by a critical reflection of the synthesis. RESULTS: Twenty-eight studies met our criteria and were included in the synthesis. We identified four themes summarising the factors influencing HCPs' implementation of risk communications. These include HCPs: knowledge of medicine alerts; perceptions of alerts; attitudes, and concerns regarding medicine alerts; and the self-reported impact of these alerts. Our concept mapping exercise identified key interactions between different stakeholders, and these interactions determine HCPs' implementation of medicine risk communications. These stakeholders comprise of alert developers, including the sources and senders of safety information, and the receivers of safety information including health care institutions, HCPs, patients and their carers. CONCLUSIONS: Healthcare professionals are crucial to translating risk communication messages into clinical practice. However, if they have inadequate information about the content of the alert, and have inaccurate perceptions about the alert, they may not implement the required clinical changes as intended. Communication of medicine risk alerts does not always translate into improved patient care, due to a complex interaction between stakeholders involved in the creation and implementation of these alerts. These complex interactions should be the subject of future research efforts to understand the alert-implementation trajectory and identify the mediators for change and interventions to improve implementation.

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BACKGROUND: Education, a key strategy within antimicrobial stewardship programmes (ASPs), has been mainly directed towards healthcare professionals and prescribers more than hospitalised patients. AIM: To examine patients' knowledge and perceptions of antibiotic use and resistance, while evaluating the institutional role of patient education on antibiotic use in two Saudi Arabian hospitals, one with an implemented ASP and one without an ASP. METHOD: A cross-sectional self-administered survey was developed and piloted. A total of 400 surveys were distributed, 200 within the hospital with an ASP and another 200 within the hospital without an ASP. Data were coded and analysed. Ethical approval was obtained before the start of the study. FINDINGS: 176 patients responded to the survey with 150 surveys completed and analysed. 78% of patients agreed that they should only take an antibiotic when prescribed by the doctor, however they still tended to keep left over antibiotics for future use. 84% of patients were unaware 'antibiotic resistance', with 48% believing that antibiotics help them get better quicker when they had a 'cold'. Information on antibiotic use and resistance were provided to patients in the hospital with an ASP in contrast to the hospital without an ASP. CONCLUSION: Overall there are poor perceptions regarding antibiotic use and resistance among hospital patients in Saudi Arabia. Patients in the hospital with ASP demonstrated greater knowledge during their hospitalisation. ASPs should not only focus on educating healthcare professionals but should involve the patients and seize the opportunity to educate them while hospitalised.

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In a Policy Forum, Alison Holmes and colleagues discuss coordinated approaches to antimicrobial stewardship.

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BACKGROUND: Errors in medication use are a patient safety concern globally, with different regions reporting differing error rates, causes of errors and proposed solutions. The objectives of this review were to identify, summarise, review and evaluate published studies on medication errors, drug related problems and adverse drug events in the Gulf Cooperation Council (GCC) countries. METHODS: A systematic review was carried out using six databases, searching for literature published between January 1990 and August 2016. Research articles focussing on medication errors, drug related problems or adverse drug events within different healthcare settings in the GCC were included. RESULTS: Of 2094 records screened, 54 studies met our inclusion criteria. Kuwait was the only GCC country with no studies included. Prescribing errors were reported to be as high as 91% of a sample of primary care prescriptions analysed in one study. Of drug-related admissions evaluated in the emergency department the most common reason was patient non-compliance. In the inpatient care setting, a study of review of patient charts and medication orders identified prescribing errors in 7% of medication orders, another reported prescribing errors present in 56% of medication orders. The majority of drug related problems identified in inpatient paediatric wards were judged to be preventable. Adverse drug events were reported to occur in 8.5-16.9 per 100 admissions with up to 30% judged preventable, with occurrence being highest in the intensive care unit. Dosing errors were common in inpatient, outpatient and primary care settings. Omission of the administered dose as well as omission of prescribed medication at medication reconciliation were common. Studies of pharmacists' interventions in clinical practice reported a varying level of acceptance, ranging from 53% to 98% of pharmacists' recommendations. CONCLUSIONS: Studies of medication errors, drug related problems and adverse drug events are increasing in the GCC. However, variation in methods, definitions and denominators preclude calculation of an overall error rate. Research with more robust methodologies and longer follow up periods is now required.

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OBJECTIVE: The aim of this study was to assess antimicrobial stewardship activities in Community Healthcare Organisations (CHOs) with focus on the implementation of the two national antimicrobial stewardship toolkits, TARGET (Treat Antibiotics Responsibly, Guidance, Education, Tools) and SSTF (Start Smart, then Focus). The study utilised a web-based survey comprising 34 questions concerning antimicrobial policies and awareness and implementation of antimicrobial stewardship toolkits. This was distributed to pharmacy teams in all 26 CHOs in England. Twenty CHOs (77%) responded. An antimicrobial stewardship (AMS) committee was active in 50% of CHOs; 25% employed a substantive pharmacist post and 70% had a local antibiotic policy. Fourteen of the responding CHOs were aware of both AMS toolkits, five organisations were aware of either SSTF or TARGET, and one organisation was not aware of either toolkit. Of the organisations aware of SSTF and TARGET, eight had formally reviewed both toolkits, though three had not reviewed either. Less than half of the respondents had developed local action plans for either toolkit. National guidance in England has focused attention on initiatives to improve AMS implementation in primary and secondary care; more work is required to embed AMS activities and the implementation of national AMS toolkit recommendations within CHOs.

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Antimicrobial resistance is increasing at an alarming rate in the Gulf Cooperation Council (GCC) owing to the overuse and misuse of antimicrobials. Novel and rare multidrug-resistant strains can spread globally since the region is host to the largest expatriate population in the world as well as a pilgrimage destination for more than 4 million people annually. Adoption of antimicrobial stewardship programmes (ASPs) could improve the use of antimicrobials and reduce antimicrobial resistance in the region. However, despite the established benefits of these interventions, little is known about the level of their adoption in the region and the impact of these programmes on antimicrobial use and resistance. This study aimed to review existing evidence on the level of adoption of ASPs, the facilitators and barriers to their adoption, and outcomes of their adoption in GCC hospitals.

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OBJECTIVE: To investigate the epidemiology of medication errors and error-related adverse events in adults in primary care, ambulatory care and patients' homes. DESIGN: Systematic review. DATA SOURCE: Six international databases were searched for publications between 1 January 2006 and 31 December 2015. DATA EXTRACTION AND ANALYSIS: Two researchers independently extracted data from eligible studies and assessed the quality of these using established instruments. Synthesis of data was informed by an appreciation of the medicines' management process and the conceptual framework from the International Classification for Patient Safety. RESULTS: 60 studies met the inclusion criteria, of which 53 studies focused on medication errors, 3 on error-related adverse events and 4 on risk factors only. The prevalence of prescribing errors was reported in 46 studies: prevalence estimates ranged widely from 2% to 94%. Inappropriate prescribing was the most common type of error reported. Only one study reported the prevalence of monitoring errors, finding that incomplete therapeutic/safety laboratory-test monitoring occurred in 73% of patients. The incidence of preventable adverse drug events (ADEs) was estimated as 15/1000 person-years, the prevalence of drug-drug interaction-related adverse drug reactions as 7% and the prevalence of preventable ADE as 0.4%. A number of patient, healthcare professional and medication-related risk factors were identified, including the number of medications used by the patient, increased patient age, the number of comorbidities, use of anticoagulants, cases where more than one physician was involved in patients' care and care being provided by family physicians/general practitioners. CONCLUSION: A very wide variation in the medication error and error-related adverse events rates is reported in the studies, this reflecting heterogeneity in the populations studied, study designs employed and outcomes evaluated. This review has identified important limitations and discrepancies in the methodologies used and gaps in the literature on the epidemiology and outcomes of medication errors in community settings.

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The growing problem of antimicrobial resistance (AMR) has led to calls for antimicrobial stewardship programs (ASP) to control antibiotic use in healthcare settings. Key strategies include prospective audit with feedback and intervention, and formulary restriction and preauthorization. Education, guidelines, clinical pathways, de-escalation, and intravenous to oral conversion are also part of some programs. Impact and quality of ASP can be assessed using process or outcome measures. Outcome measures are categorized as microbiological, patient or financial outcomes. The objective of this review was to provide an overview of quality measures for assessing ASP and the reported impact of ASP in peer-reviewed studies, focusing particularly on patient outcomes. A literature search of papers published in English between 1990 and June 2015 was conducted in five databases using a combination of search terms. Primary studies of any design were included. A total of 63 studies were included in this review. Four studies defined quality metrics for evaluating ASP. Twenty-one studies assessed the impact of ASP on antimicrobial utilization and cost, 25 studies evaluated impact on resistance patterns and/or rate of Clostridium difficile infection (CDI). Thirteen studies assessed impact on patient outcomes including mortality, length of stay (LOS) and readmission rates. Six of these 13 studies reported non-significant difference in mortality between pre- and post-ASP intervention, and five reported reductions in mortality rate. On LOS, six studies reported shorter LOS post intervention; a significant reduction was reported in one of these studies. Of note, this latter study reported significantly (p < 0.001) higher unplanned readmissions related to infections post-ASP. Patient outcomes need to be a key component of ASP evaluation. The choice of metrics is influenced by data and resource availability. Controlling for confounders must be considered in the design of evaluation studies to adequately capture the impact of ASP and it is important for unintended consequences to be considered. This review provides a starting point toward compiling standard outcome metrics for assessing ASP.

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BACKGROUND: Failure Mode and Effects Analysis (FMEA) is a prospective risk assessment tool that has been widely used within the aerospace and automotive industries and has been utilised within healthcare since the early 1990s. The aim of this study was to explore the validity of FMEA outputs within a hospital setting in the United Kingdom. METHODS: Two multidisciplinary teams each conducted an FMEA for the use of vancomycin and gentamicin. Four different validity tests were conducted: Face validity: by comparing the FMEA participants' mapped processes with observational work. Content validity: by presenting the FMEA findings to other healthcare professionals. Criterion validity: by comparing the FMEA findings with data reported on the trust's incident report database. Construct validity: by exploring the relevant mathematical theories involved in calculating the FMEA risk priority number. RESULTS: Face validity was positive as the researcher documented the same processes of care as mapped by the FMEA participants. However, other healthcare professionals identified potential failures missed by the FMEA teams. Furthermore, the FMEA groups failed to include failures related to omitted doses; yet these were the failures most commonly reported in the trust's incident database. Calculating the RPN by multiplying severity, probability and detectability scores was deemed invalid because it is based on calculations that breach the mathematical properties of the scales used. CONCLUSION: There are significant methodological challenges in validating FMEA. It is a useful tool to aid multidisciplinary groups in mapping and understanding a process of care; however, the results of our study cast doubt on its validity. FMEA teams are likely to need different sources of information, besides their personal experience and knowledge, to identify potential failures. As for FMEA's methodology for scoring failures, there were discrepancies between the teams' estimates and similar incidents reported on the trust's incident database. Furthermore, the concept of multiplying ordinal scales to prioritise failures is mathematically flawed. Until FMEA's validity is further explored, healthcare organisations should not solely depend on their FMEA results to prioritise patient safety issues.

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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.

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AIM: To compare the prevalence and causes of prescribing errors in newly written medication orders and how quickly they were rectified, in three NHS organisations. METHODS: Errors in newly written inpatient and discharge medication orders were recorded in Spring/Summer 2009 by ward pharmacists on medical admissions and surgical wards, as well as the number of erroneous doses administered (or omitted) before errors were corrected. Logistic regression analysis was used to explore the effects of ward (nested within organisation) and clinical specialty, and whether the pharmacist had checked the patient's medication history during data collection. Causes were explored using semistructured interviews with key informants. RESULTS: Overall, 1025 prescribing errors were identified in 974 of 6605 medication orders (14.7%, 95% confidence interval (CI) 13.8% to 15.6%). A mean of 0.9 doses were administered (or omitted) before each error was corrected (range 0-11), with differences between specialties and organisations. The error rate on medical admissions wards (16.3%) was significantly higher than that on surgical wards (12.2%), but this was accounted for by the higher proportion of prescribing being on admission, where omission of patients' usual medication was often identified. There were significant differences among wards (and organisations). Contributing factors included lack of feedback on errors, poor documentation and communication of prescribing decisions, and lack of information about patients' medication histories from primary care. CONCLUSIONS: There were variations among wards, organisations and specialties in error rates and how quickly they were rectified. Exploring reasons for differences between organisations may be useful in identifying best practice and potential solutions.

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OBJECTIVE: To test the reliability of failure mode and effect analysis (FMEA) within a hospital setting in the United Kingdom. METHODS: Two multidisciplinary groups were recruited, within 2 hospitals from the same National Health Services (NHS) Trust, to conduct separate FMEAs in parallel on the same topic. Each group conducted an FMEA for the use of vancomycin and gentamicin. The groups followed the basic FMEA steps, which included mapping the process of care; identifying potential failures within the process; determining the severity, probability, and detectability scores for these failures; and finally making recommendations to decrease these failures. RESULTS: Both groups described the process with 5 major steps: starting vancomycin or gentamicin, prescribing the antibiotics, administering the antibiotics, monitoring the antibiotics, and finally stopping or continuing the treatment. Although each group identified 50 failures, only 17 (17%) of them were common to both. Furthermore, the severity, detectability, and risk priority number scores for both groups differed markedly resulting in their failures being prioritized differently. CONCLUSIONS: Failure mode and effect analysis is a useful tool to aid multidisciplinary groups in understanding a process of care and identifying errors that may occur. However, the results of this study call into question the reliability of the FMEA process that was tested. The 2 groups identified similar steps in the process of care but different potential failures with very different risk priority numbers. Such discrepancies make it impossible to identify reliably those failures that should be prioritized and thus where money, time, and effort should be allocated to avoid these failures. Health care organizations should not solely depend on FMEA findings to improve patient safety.

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AIM: To review and appraise randomised controlled trials (RCT) and 'before and after' studies published on clinical decision support systems (CDSS) used to support the use of antibiotics. METHODS: A literature search was carried out in October 2006 using MEDLINE including Medical Subject Heading (MeSH) terms (1966-2006), EMBASE (Excerpta Medica, 1980-2006) and International Pharmaceutical Abstracts (IPA, 1970-2006) using the combinations of the following terms: (Decision support systems) or (CDSS) AND (antibiotics) or (anti-infectives) or (antibacterials) or (antimicrobials). Only English language papers were selected. Editorials, letters and case reports/series were excluded. The reference sections of all retrieved articles were also searched for any further relevant articles. RESULTS: Forty articles were identified. Five RCT and six 'before and after' studies were retrieved. In the RCTs, three studies used computer-based CDSS, one paper-based CDSS and one a combination of both. Two studies were conducted in primary care and three within secondary care. The primary outcomes for each study were different and only three studies were significant in the favour of the use of CDSS. 'Before and after' studies were used where RCT were not feasible. One 'before and after' study was excluded because it did not include any control group. The remaining five included historical control groups and evaluated the use of computer-based CDSS within secondary care. Their primary outcomes also varied but all concluded significant benefits of CDSS. Only three of ten studies were conducted outside the USA; one in Switzerland and two in Australia. CONCLUSION: CDSS could be a powerful tool to improve clinical care and patient outcomes. It presents a promising future for optimising antibiotic use. However, it is difficult to generalise as most studies were conducted in the United States. Although RCT are the 'gold standard' in research, they may not be feasible to conduct. Realising that different study designs answer different questions would allow researchers to choose the most appropriate study design to evaluate CDSS in a specified setting.

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