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Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

FDA MedWatch -

Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to con

What current and missing data can teach us about medication errors

Quality and Safety in Health Care Journal -

Medication errors have been a leading cause of preventable harm for decades. Assiri and colleagues report that the cost of medication error worldwide exceeds $42 billion, or approximately 5%–6% of all hospitalisations.1 While this topic has been closely studied since its first appearance in scientific literature in 1953,2 the problems continue to evolve alongside changes to the medication-use system. The medication-use system is a function of many elements. Widespread transitions from paper-based to electronic health records have affected drug ordering and prescribing, documentation, transcribing, dispensing, administering and monitoring in ways that challenge traditional approaches to reducing errors that predate electronic records.3 In addition, the introduction of over 7000 branded small molecules or biologics, generics and biosimilars that overlap numerous therapeutic areas increased dependence on specialty care for people with multiple chronic conditions, and navigating transitions throughout the range of primary to quaternary care have...

Achieving patient priorities: an alternative to patient-reported outcome measures (PROMs) for promoting patient-centred care

Quality and Safety in Health Care Journal -

For the past two decades, patient-centredness has served as one of six acknowledged dimensions of healthcare quality.1 Initially, healthcare institutions described patient centredness superficially—clean waiting rooms, hotel-like bed and board, access to innovative medical technology—and measured it with crude satisfaction scales. The concept of patient-centred care evolved into a model attuned to the patient experience of care, defined by the interactions between patients and providers and the care environment.2 This patient experience model of patient-centred care has deep normative roots around principles of the patient as the locus of control and a demand for individualisation and customisation of care based on the patient rather than clinician.3 Empirically, patient experience is associated with health outcomes when defined and measured in a timely manner as a specific care experience or interaction between a patient and a healthcare provider.4 The importance of honouring the...

Economic analysis of the prevalence and clinical and economic burden of medication error in England

Quality and Safety in Health Care Journal -

Objectives

To provide national estimates of the number and clinical and economic burden of medication errors in the National Health Service (NHS) in England.

Methods

We used UK-based prevalence of medication errors (in prescribing, dispensing, administration and monitoring) in primary care, secondary care and care home settings, and associated healthcare resource use, to estimate annual number and burden of errors to the NHS. Burden (healthcare resource use and deaths) was estimated from harm associated with avoidable adverse drug events (ADEs).

Results

We estimated that 237 million medication errors occur at some point in the medication process in England annually, 38.4% occurring in primary care; 72% have little/no potential for harm and 66 million are potentially clinically significant. Prescribing in primary care accounts for 34% of all potentially clinically significant errors. Definitely avoidable ADEs are estimated to cost the NHS £98 462 582 per year, consuming 181 626 bed-days, and causing/contributing to 1708 deaths. This comprises primary care ADEs leading to hospital admission (£83.7 million; causing 627 deaths), and secondary care ADEs leading to longer hospital stay (£14.8 million; causing or contributing to 1081 deaths).

Conclusions

Ubiquitous medicines use in health care leads unsurprisingly to high numbers of medication errors, although most are not clinically important. There is significant uncertainty around estimates due to the assumption that avoidable ADEs correspond to medication errors, data quality, and lack of data around longer-term impacts of errors. Data linkage between errors and patient outcomes is essential to progress understanding in this area.

A mixed-methods study of challenges experienced by clinical teams in measuring improvement

Quality and Safety in Health Care Journal -

Objective

Measurement is an indispensable element of most quality improvement (QI) projects, but it is undertaken to variable standards. We aimed to characterise challenges faced by clinical teams in undertaking measurement in the context of a safety QI programme that encouraged local selection of measures.

Methods

Drawing on an independent evaluation of a multisite improvement programme (Safer Clinical Systems), we combined a qualitative study of participating teams’ experiences and perceptions of measurement with expert review of measurement plans and analysis of data collected for the programme. Multidisciplinary teams of frontline clinicians at nine UK NHS sites took part across the two phases of the programme between 2011 and 2016.

Results

Developing and implementing a measurement plan against which to assess their improvement goals was an arduous task for participating sites. The operational definitions of the measures that they selected were often imprecise or missed important details. Some measures used by the teams were not logically linked to the improvement actions they implemented. Regardless of the specific type of data used (routinely collected or selected ex novo), the burdensome nature of data collection was underestimated. Problems also emerged in identifying and using suitable analytical approaches.

Conclusion

Measurement is a highly technical task requiring a degree of expertise. Simply leveraging individual clinicians’ motivation is unlikely to defeat the persistent difficulties experienced by clinical teams when attempting to measure their improvement efforts. We suggest that more structural initiatives and broader capability-building programmes should be pursued by the professional community. Improving access to, and ability to use repositories of validated measures, and increasing transparency in reporting measurement attempts, is likely to be helpful.

Influence of bedspacing on outcomes of hospitalised medicine service patients: a retrospective cohort study

Quality and Safety in Health Care Journal -

Background

Specialty wards cohort hospitalised patients to improve outcomes and lower costs. When demand exceeds capacity, patients overflow and are "bedspaced" to alternate wards. Some studies have demonstrated that bedspacing among medicine service patients is associated with adverse patient-centred outcomes, however, results have been inconsistent and have primarily been performed within national health systems. The objective of this study was to assess the association of bedspacing with patient-centred outcomes among United States patients admitted to general medicine services.

Methods

We performed a retrospective cohort study of internal medicine, family medicine and geriatric service patients who were bedspaced vs cohorted for the entirety of their hospital stay within three large, urban United States hospitals (quaternary referral centre, tertiary referral centre and community hospital, with different patient demographics and case-mixes) in 2014 and 2015. We performed quantile regression to determine differences in length of stay (LOS) between bedspaced vs cohorted patients and logistic regression for in-hospital mortality and discharge to home.

Results

Among 18 802 patients in 33 wards, 6119 (33%) patients were bedspaced. Bedspaced patients had significantly longer LOS compared with cohorted patients at the 25th (0.1 days, 95% CI: 0.05 to 0.2, p=0.001), 50th (0.2 days, 95% CI: 0.1 to 0.3, p=0.003) and 75th (0.3 days, 95% CI: 0.2 to 0.5, p<0.001) percentiles; and no statistically significant differences in odds of mortality (OR=0.9, 95% CI: 0.6 to 1.3, p=0.5) or discharge to home (OR=0.9, 95% CI: 0.9 to 1.0, p=0.06) in adjusted analyses.

Conclusion

Bedspacing is associated with adverse patient-centred outcomes. Future work is needed to confirm these findings, understand mechanisms contributing to adverse outcomes and identify factors that mitigate these adverse effects in order to provide high-value, patient-centred care to hospitalised patients.

Physician-level variation in clinical outcomes and resource use in inpatient general internal medicine: an observational study

Quality and Safety in Health Care Journal -

Background

Variations in inpatient medical care are typically attributed to system, hospital or patient factors. Little is known about variations at the physician level within hospitals. We described the physician-level variation in clinical outcomes and resource use in general internal medicine (GIM).

Methods

This was an observational study of all emergency admissions to GIM at seven hospitals in Ontario, Canada, over a 5-year period between 2010 and 2015. Physician-level variations in inpatient mortality, hospital length of stay, 30-day readmission and use of ‘advanced imaging’ (CT, MRI or ultrasound scans) were measured. Physicians were categorised into quartiles within each hospital for each outcome and then quartiles were pooled across all hospitals (eg, physicians in the highest quartile at each hospital were grouped together). We report absolute differences between physicians in the highest and lowest quartiles after matching admissions based on propensity scores to account for patient-level variation.

Results

The sample included 103 085 admissions to 135 attending physicians. After propensity score matching, the difference between physicians in the highest and lowest quartiles for in-hospital mortality was 2.4% (95% CI 0.6% to 4.3%, p<0.01); for readmission was 3.3% (95% CI 0.7% to 5.9%, p<0.01); for advanced imaging was 0.32 tests per admission (95% CI 0.12 to 0.52, p<0.01); and for hospital length of stay was 1.2 additional days per admission (95% CI 0.5 to 1.9, p<0.01). Physician-level differences in length of stay and imaging use were consistent across numerous sensitivity analyses and stable over time. Differences in mortality and readmission were consistent across most sensitivity analyses but were not stable over time and estimates were limited by sample size.

Conclusions

Patient outcomes and resource use in inpatient medical care varied substantially across physicians in this study. Physician-level variations in length of stay and imaging use were unlikely to be explained by patient factors whereas differences in mortality and readmission should be interpreted with caution and could be explained by unmeasured confounders. Physician-level variations may represent practice differences that highlight quality improvement opportunities.

Challenges of opioid deprescribing and factors to be considered in the development of opioid deprescribing guidelines: a qualitative analysis

Quality and Safety in Health Care Journal -

Background

Chronic prescription opioid use is a major international public health issue associated with significant harms, including increased risk of hospitalisation, morbidity and death. Guidance for healthcare professionals on when and how to deprescribe or reduce opioids is required. A key step for guideline development for deprescribing pharmacotherapy is to understand the perspectives of stakeholders. The aim of this study was to explore the perspectives of healthcare professional stakeholders on the challenges associated with opioid deprescribing and factors to be considered in the development of opioid deprescribing guidelines.

Methods

A qualitative study was undertaken with a purposive sample of healthcare professionals including prescribers, pharmacists and nurses. An initial cohort of participants was identified at the 2018 Australian Deprescribing Network annual meeting and two focus groups were conducted (n=20). Individual interviews were conducted with a further 11 healthcare professionals. Focus groups and interviews were audio-recorded and transcribed verbatim. Data underwent inductive thematic analysis using a phenomenological perspective.

Results

Healthcare professionals viewed opioid deprescribing as a challenge and identified several key barriers to deprescribing in clinical practice. Medication, patient, prescriber and health system level challenges were identified. Participants requested evidence-based guidance on the withdrawal of opioid therapies and suggested that prospective opioid deprescribing guidelines require a multitarget, multimodal intervention strategy that addresses patient psychosocial factors and incorporates behavioural change techniques.

Conclusion

Opioid deprescribing was perceived as a complex and challenging practice with continued prescribing the default behaviour. Evidence-based opioid deprescribing guidelines may be a valuable resource for clinicians to support clinical decision-making and reduce suboptimal opioid use.

Fighting a common enemy: a catalyst to close intractable safety gaps

Quality and Safety in Health Care Journal -

Since March 2020, the world has faced a singular threat: COVID-19. The shared commitment and responsibility uniting everyone within and outside of healthcare to bend the COVID-19 curve has been unparalleled. Prior to the pandemic, this type of shared commitment has been discouragingly lacking for other major healthcare concerns such as patient safety.1 Reasons for this include organisational leaders who are incentivised to focus on activities essential for reimbursement and quality measurement rather than those involving the promotion of safety culture and implementation of systems-based approaches to improve safety, compounded by lack of clear ownership and accountability to solve long-standing safety challenges.2 3

The COVID-19 pandemic is leading to several ongoing impacts on the healthcare delivery system,4 many of which have patient safety implications and will be quantified in future work. We are witnessing negative effects from delays in care from...

Medication-related interventions delivered both in hospital and following discharge: a systematic review and meta-analysis

Quality and Safety in Health Care Journal -

Background

Harm due to medications is common during the transition from hospital to home. Approaches that seek to prevent harm often involve isolated medication-related interventions and show conflicting results. However, until now, no review has focused on the effect of intervention components delivered both in hospital and following discharge from hospital to home.

Objective

To examine effects of medication-related interventions on hospital readmissions, medication-related problems (MRPs), medication adherence and mortality.

Methods

For this systematic review and meta-analysis, we searched the PubMed, Embase, CINAHL and CENTRAL databases without language restrictions. Citations of included articles were checked through Web of Science and Scopus from inception to 20 June 2019. We included prospective studies that examined effects of medication-related interventions delivered both in hospital and following discharge from hospital to home compared with usual care. Three authors independently extracted data and assessed study quality in pairs.

Results

Fourteen original studies were included, comprising 8182 patients. Interventions consisted mainly of patient education and medication reconciliation in the hospital, and patient education following discharge. Nine studies were included in the meta-analysis; compared with usual care (n=3376 patients), medication-related interventions (n=1820 patients) reduced hospital readmissions by 3.8 percentage points within 30 days of discharge (number needed to treat=27, risk ratio (RR) 0.79 (95% CI 0.65 to 0.96)). Meta-regression analysis suggested that readmission rates were reduced by 17% per additional intervention component (RR 0.83 (95% Cl 0.75 to 0.91)). Medication adherence and MRPs may be improved. Effects on mortality were unclear.

Conclusions

Studied medication-related interventions reduce all-cause hospital readmissions within 30 days. The treatment effect appears to increase with higher intervention intensities. More evidence is needed for recommendations on adherence, mortality and MRPs.

Standardised approach to measuring goal-based outcomes among older disabled adults: results from a multisite pilot

Quality and Safety in Health Care Journal -

Background

Older adults with complex care needs face trade-offs in determining the right course of treatment. The Centers for Medicare and Medicaid Services identified ‘Care is personalized and aligned with patient’s goals’ as a key meaningful measures category, yet existing quality measures typically assess disease-specific care and may not effectively evaluate what is most important to older adults and family members. Measures based on individualised goals and goal-based outcomes have been proposed as an alternative but are not routinely assessed or implemented.

Objectives

We tested two approaches to assessing goal-based outcomes that allow individuals to set goals based on their own priorities and measure progress—(1) goal attainment scaling and (2) existing, validated patient-reported outcome measures (PROM).

Methods

A prospective cohort study of feasibility in seven sites (33 clinicians) of the two approaches with 229 individuals. We calculated performance on a measure of achievement of individually identified goals.

Results

Both approaches were successfully implemented in a non-randomly selected population, and a goal-based outcome could be calculated for 189 (82%) of participants. Most individuals met their goal-based outcome (73%) with no statistical difference between the goal attainment scaling approach (74%) and the patient-reported outcomes approach (70%). Goals were heterogeneous ranging from participating in activities, health management, independence and physical health. Clinicians chose to use goal attainment scaling (n=184, 80%) more often than PROMs (n=49, 20%) and rated the goal attainment scaling approach as useful for providing patient care.

Conclusion

Goal-based outcomes have the potential to both improve the way healthcare is provided and fill a critical gap in value-based payment.

Does removing financial incentives lead to declines in performance? A controlled interrupted time series analysis of Medicare Advantage Star Ratings programme performance

Quality and Safety in Health Care Journal -

Introduction

Incentive programmes are used in health systems worldwide to spur improvement in quality of care; these include both financial incentives (eg, pay for performance) and non-financial incentives (eg, public reporting). In the USA, the Centers for Medicare & Medicaid Services’ (CMS) Star Ratings quality incentive programme for private Medicare insurance plans, or Medicare Advantage plans, incorporates both non-financial and financial incentives. Star Ratings on a 1–5 scale are publicly reported on the Medicare Plan Finder website. Owing to provisions in the March 2010 Affordable Care Act and a demonstration programme, since 2012 Quality Bonus Payments of more than $3 billion annually have been paid directly to plans on the basis of the Star Ratings achieved the year before, which reflects care delivered to the plan’s enrollees 1–2 years prior.1

The Star Ratings incorporate measures from various sources (eg, Healthcare Effectiveness Data and Information Set (HEDIS), Consumer Assessment...

Role of practices and Clinical Commissioning Groups in measures of patient experience: analysis of routine data

Quality and Safety in Health Care Journal -

Introduction

Recent years have seen an increased focus on measuring how people experience health services to ensure that care and treatment is of the highest quality and safety.1 2 Better patient care experiences are associated with better adherence, clinical outcomes and patient safety, and with lower healthcare utilisation.3 4 In England, the national GP Patient Survey (GPPS) measures patients’ experience of primary care.5 As part of an NHS initiative to improve patient experience and facilitate patient-centred care, GPPS scores are currently reported at the level of general practices, Clinical Commissioning Groups (CCGs) and nationally.

English CCGs are clinically led NHS bodies that commission local health care services. There were 209 CCGs in 2016, though there are now fewer, on account of recent practice-mergers. Although GPPS scores are reported for CCGs, little is known about the influence CCGs have...

Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

FDA MedWatch -

Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to con

2021 Safety Communications

FDA MedWatch -

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

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