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Aurobindo Pharma USA, Inc. on Behalf of AuroHealth, Issues Voluntary Nationwide Recall of one (1) Lot of Healthy Living Over the Counter (OTC) Migraine Relief: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg Tablets, Due to Missing Manufacturer Label

FDA MedWatch -

East Windsor, New Jersey. Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot (refer table below) of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets, to the consumer level as sold through Amazon to known within th

Is hospital-onset bacteraemia and fungaemia an actionable quality measure?

Quality and Safety in Health Care Journal -

Healthcare-associated infections (HAIs) are one of the most common complications of hospital care and a leading cause of death worldwide.1 Many countries have therefore implemented surveillance systems for HAIs and multifaceted infection prevention and control programmes to reduce their burden. In the USA, regulators have made HAI prevention a national priority by requiring hospitals to report key infections, including central line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections, certain surgical site infections, methicillin-resistant Staphylococcus aureus bacteraemia, and Clostridioides difficile infections, to the Centers for Medicare & Medicaid Services (CMS) via the US Centers for Disease Control and Prevention’s National Healthcare Safety Network (NHSN) tracking system.2 These data are used to benchmark hospitals and inform CMS’s pay-for-performance programmes.

The result in the USA has largely been a success story that demonstrates the potential impact of coordinated local and federal patient safety efforts, coupled with patient advocacy...

Time for a rebalance: psychological and emotional well-being in the healthcare workforce as the foundation for patient safety

Quality and Safety in Health Care Journal -

The COVID-19 pandemic shone a light on the work and needs of the healthcare workforce like never before, resulting in an increased focus of workforce well-being research, policy and within mainstream media. Despite this recent attention, the relevance of workforce well-being for healthcare delivery and efficiency is not a new phenomenon. The National Health Service (NHS) in England employs around 1.4 million people,1 and as such provides a prominent case study for these issues. A landmark report in 2009 by Dr Steve Boorman (commissioned by the English Department of Health2) reviewed the health and well-being of the NHS workforce in England. The report highlighted issues with poor well-being, sickness and the likely relationship between workforce well-being and patient outcomes. Recommendations were outlined to reduce staff sickness and improve experiences of work, with cost savings predicted at £500 million per year if sickness was reduced by a third....

Evaluation of hospital-onset bacteraemia and fungaemia in the USA as a potential healthcare quality measure: a cross-sectional study

Quality and Safety in Health Care Journal -

Background

Hospital-onset bacteraemia and fungaemia (HOB) is being explored as a surveillance and quality metric. The objectives of the current study were to determine sources and preventability of HOB in hospitalised patients in the USA and to identify factors associated with perceived preventability.

Methods

We conducted a cross-sectional study of HOB events at 10 academic and three community hospitals using structured chart review. HOB was defined as a blood culture on or after hospital day 4 with growth of one or more bacterial or fungal organisms. HOB events were stratified by commensal and non-commensal organisms. Medical resident physicians, infectious disease fellows or infection preventionists reviewed charts to determine HOB source, and infectious disease physicians with training in infection prevention/hospital epidemiology rated preventability from 1 to 6 (1=definitely preventable to 6=definitely not preventable) using a structured guide. Ratings of 1–3 were collectively considered ‘potentially preventable’ and 4–6 ‘potentially not preventable’.

Results

Among 1789 HOB events with non-commensal organisms, gastrointestinal (including neutropenic translocation) (35%) and endovascular (32%) were the most common sources. Overall, 636/1789 (36%) non-commensal and 238/320 (74%) commensal HOB events were rated potentially preventable. In logistic regression analysis among non-commensal HOB events, events attributed to intravascular catheter-related infection, indwelling urinary catheter-related infection and surgical site infection had higher odds of being rated preventable while events with neutropenia, immunosuppression, gastrointestinal sources, polymicrobial cultures and previous positive blood culture in the same admission had lower odds of being rated preventable, compared with events without those attributes. Of 636 potentially preventable non-commensal HOB events, 47% were endovascular in origin, followed by gastrointestinal, respiratory and urinary sources; approximately 40% of those events would not be captured through existing healthcare-associated infection surveillance.

Discussion

Factors identified as associated with higher or lower preventability should be used to guide inclusion, exclusion and risk adjustment for an HOB-related quality metric.

Comparing secondary prevention for patients with coronary heart disease and stroke attending Australian general practices: a cross-sectional study using nationwide electronic database

Quality and Safety in Health Care Journal -

Objectives

To compare secondary prevention care for patients with coronary heart disease (CHD) and stroke, exploring particularly the influences due to frequency and regularity of primary care visits.

Setting

Secondary prevention for patients (≥18 years) in the National Prescription Service administrative electronic health record database collated from 458 Australian general practice sites across all states and territories.

Design

Retrospective cross-sectional and panel study. Patient and care-level characteristics were compared for differing CHD/stroke diagnoses. Associations between the type of cardiovascular diagnosis and medication prescription as well as risk factor assessment were examined using multivariable logistic regression.

Participants

Patients with three or more general practice encounters within 2 years of their latest visit during 2016–2020.

Outcome measures

Proportions and odds ratios (ORs) for (1) prescription of antihypertensives, antilipidaemics and antiplatelets and (2) assessment of blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) in patients with stroke only compared against those with CHD only and those with both conditions.

Results

There were 111 892 patients with CHD only, 27 863 with stroke only and 9791 with both conditions. Relative to patients with CHD, patients with stroke were underprescribed antihypertensives (70.8% vs 82.8%), antilipidaemics (63.1% vs 78.7%) and antiplatelets (42.2% vs 45.7%). With sociodemographic factors, comorbidities and level of care considered as covariates, the odds of non-prescription of any recommended secondary prevention medications were higher in patients with stroke only (adjusted OR 1.37; 95% CI (1.31, 1.44)) compared with patients with CHD only. Patients with stroke only were also more likely to have neither BP nor LDL-C monitored (adjusted OR 1.26; 95% CI (1.18, 1.34)). Frequent and regular general practitioner encounters were independently associated with the prescription of secondary prevention medications (p<0.001).

Conclusions

Secondary prevention management is suboptimal in cardiovascular disease patients and worse post-stroke compared with post-CHD. More frequent and regular primary care encounters were associated with improved secondary prevention.

Consent and refusal of procedures during labour and birth: a survey among 11 418 women in the Netherlands

Quality and Safety in Health Care Journal -

Background

Informed consent for medical interventions is ethically and legally required; an important aspect of quality and safety in healthcare; and essential to person-centred care. During labour and birth, respecting consent requirements, including respecting refusal, can contribute to a higher sense of choice and control for labouring women. This study examines (1) to what extent and for which procedures during labour and birth women report that consent requirements were not met and/or inadequate information was provided, (2) how frequently women consider consent requirements not being met upsetting and (3) which personal characteristics are associated with the latter.

Methods

A national cross-sectional survey was conducted in the Netherlands among women who gave birth up to 5 years previously. Respondents were recruited through social media with the help of influencers and organisations. The survey focused on 10 common procedures during labour and birth, investigating for each procedure if respondents were offered the procedure, if they consented or refused, if the information provision was sufficient and if they underwent unconsented procedures, whether they found this upsetting.

Results

13 359 women started the survey and 11 418 met the inclusion and exclusion criteria. Consent not asked was most often reported by respondents who underwent postpartum oxytocin (47.5%) and episiotomy (41.7%). Refusal was most often over-ruled when performing augmentation of labour (2.2%) and episiotomy (1.9%). Information provision was reported inadequate more often when consent requirements were not met compared with when they were met. Multiparous women had decreased odds of reporting unmet consent requirements compared with primiparous (adjusted ORs 0.54–0.85). There was considerable variation across procedures in how frequently not meeting consent requirements was considered upsetting.

Conclusions

Consent for performing a procedure is frequently absent in Dutch maternity care. In some instances, procedures were performed in spite of the woman’s refusal. More awareness is needed on meeting necessary consent requirements in order to achieve person-centred and high-quality care during labour and birth.

Care Under Pressure 2: a realist synthesis of causes and interventions to mitigate psychological ill health in nurses, midwives and paramedics

Quality and Safety in Health Care Journal -

Background

Nurses, midwives and paramedics comprise over half of the clinical workforce in the UK National Health Service and have some of the highest prevalence of psychological ill health. This study explored why psychological ill health is a growing problem and how we might change this.

Methods

A realist synthesis involved iterative searches within MEDLINE, CINAHL and HMIC, and supplementary handsearching and expert solicitation. We used reverse chronological quota screening and appraisal journalling to analyse each source and refine our initial programme theory. A stakeholder group comprising nurses, midwives, paramedics, patient and public representatives, educators, managers and policy makers contributed throughout.

Results

Following initial theory development from 8 key reports, 159 sources were included. We identified 26 context–mechanism–outcome configurations, with 16 explaining the causes of psychological ill health and 10 explaining why interventions have not worked to mitigate psychological ill health. These were synthesised to five key findings: (1) it is difficult to promote staff psychological wellness where there is a blame culture; (2) the needs of the system often over-ride staff psychological well-being at work; (3) there are unintended personal costs of upholding and implementing values at work; (4) interventions are fragmented, individual-focused and insufficiently recognise cumulative chronic stressors; and (5) it is challenging to design, identify and implement interventions.

Conclusions

Our final programme theory argues the need for healthcare organisations to rebalance the working environment to enable healthcare professionals to recover and thrive. This requires high standards for patient care to be balanced with high standards for staff psychological well-being; professional accountability to be balanced with having a listening, learning culture; reactive responsive interventions to be balanced by having proactive preventative interventions; and the individual focus balanced by an organisational focus.

PROSPERO registration number

CRD42020172420.

Fixing patient safety: Are we nearly there yet?

Quality and Safety in Health Care Journal -

Reducing harm in hospital care using Human Factors and Quality Improvement approaches has proved harder than expected: better evaluation of our efforts, a more realistic understanding of the challenges we face and an intense focus on engaging staff are the key elements needed for progress.

Patient safety was not a recognised term in medical research parlance until the 1990s. Prior to this, avoidable harm from treatment was assumed to be rare, and failure was commonly attributed to the incompetence or lack of diligence of individuals. The emergence of convincing evidence that around 10% of hospital inpatients suffered serious harm from their treatment stimulated alarm, and a search for a rapid solution to this huge, previously unnoticed problem.1 Analyses of adverse events showed that their causes were usually complex, system-based and to some extent stochastic, echoing the typical findings of professional accident investigations in the transport and energy...

Patient safety for clinical practice

Quality and Safety in Health Care Journal -

Recent studies still show high numbers of patient harm in healthcare, with 1 in 10 being harmed and around 3 million deaths annually due to unsafe care. Numbers such as these stress the importance of the concept of patient safety, defined by the WHO as ‘the absence of preventable harm to a patient and reduction of risk of unnecessary harm associated with healthcare to an acceptable minimum’. Most readers of BMJ Quality & Safety will agree that patients should not be harmed while receiving care and patient safety practices should be implemented more broadly. However, clinical practice is busier than ever and many healthcare staff struggle to get their job done, let alone also implement a relatively new discipline such as patient safety. Implementation is further complicated by the fact that patient safety practices are often perceived as complex. Therefore, Peter Lachman and colleagues have written a book on patient...

Quality and safety in the literature: August 2024

Quality and Safety in Health Care Journal -

Healthcare quality and safety span multiple topics across the spectrum of academic and clinical disciplines. Keeping abreast of the rapidly growing body of work can be challenging. In this series, we provide succinct summaries of selected relevant studies published in the last several months. Some articles will focus on a particular theme, whereas others will highlight unique publications from high-impact medical journals.

Key points

  • In a multiclinic, randomised clinical trial, a clinical decision support (CDS) tool that nudged primary care practitioners to evidence-based monitoring and treatment for patients with chronic kidney disease and hypertension led to a greater mean systolic blood pressure change as well as more patients receiving an action aligned with the CDS recommendations in the intervention group compared with the usual care group. JAMA Intern Med, 11 Mar 2024

  • A systematic review that examined system-level interventions implemented to enhance guideline-directed...

  • Main Products, Inc. Issues Voluntary Nationwide Recall of Umary Acido Hialuronico, Suplemento Alimenticio Due to the Presence of Undeclared Drug Ingredients: Diclofenac and Omeprazole

    FDA MedWatch -

    Main Products, Inc. is voluntarily recalling all lots of “Umary Acido Hialuronico, Suplemento Alimenticio – 30 Capletas de 850mg” to the consumer level. FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole. Products containing

    Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of One Lot of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) Bags Due to an Individual Unit of Acetaminophen Overwrap Found to Have Contained a Labelled Bag of Dexmedetomidine HCL...

    FDA MedWatch -

    London, July 22, 2024 – Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending its voluntary recall of one lot (listed below) of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) to the consumer/user level. The product is being recal

    Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 Due to Mislabeling: Incorrect Strength on Product Carton

    FDA MedWatch -

    Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tabl

    SoloVital.com Issues Voluntary Nationwide Recall of Umary Acido Hialuronica, Suplemento Alimenticio 850 mg Capsules Due to the Presence of Undeclared Drug Ingredients: Diclofenac and Omeprazole

    FDA MedWatch -

    Chula Vista, CA, SoloVital.com is voluntarily recalling all lots of Umary Acido Hialuronica, Suplemento Alimenticio – 30 Capletas de 850mg to the consumer level. FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole. Products c

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