Nada Atef Shebl

Is failure mode and effect analysis reliable

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.

Failure mode and effects analysis outputs: are they valid?

BackgroundFailure 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.MethodsTwo 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.ResultsFace 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.ConclusionThere 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.

A Review of Quality Measures for Assessing the Impact of Antimicrobial Stewardship Programs in Hospitals.

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.

Hospital adoption of antimicrobial stewardship programmes in Gulf cooperation council countries: A review of existing evidence

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.

Systematic review of the safety of medication use in inpatient, outpatient and primary care settings in the Gulf Cooperation Council countries

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.

What is the epidemiology of medication errors, error-related adverse events and risk factors for errors in adults managed in community care contexts? A systematic review of the international literature

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.