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Amneal Pharmaceutical LLC Issues a Nationwide Recall of Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Only, Due to Microbial Contamination

FDA MedWatch -

Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint

Cetirizine or Levocetirizine: Drug Safety Communication - FDA Warns About Risk of Severe Itching After Discontinuation of Long-Term Use of Allergy Medicines

FDA MedWatch -

The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching. These medicines are available in prescription and over-the-counter (OTC) forms. The itching, also called pruritus, has been r

UMARY- USA.COM Issues Voluntary Nationwide Recall of UNAVY ÁCIDO HIALURÓNICO Caplets and UMOVY ÁCIDO HIALURÓNICO Caplets Due to the Presence of Undeclared Drug Ingredients Dexamethasone, Diclofenac and Omeprazole

FDA MedWatch -

FOR IMMEDIATE RELEASE – Date: May 21 2025, Nogales, AZ, UMARY USA is voluntarily recalling all lots of Unavy Ácido HIALURÓNICO (30 caplets/850 mg) and Umovy Ácido HIALURÓNICO (30 caplets/850 mg), to the consumer level. FDA laboratory analysis confirmed that these products are tainted with the drug i

Testing and cancer diagnosis in general practice

Quality and Safety in Health Care Journal -

Healthcare systems worldwide have for decades sought to prioritise prompt diagnosis of cancer as a means to improve outcomes. The gatekeeping role of general practitioners (GPs) that restricts access to testing and referral,1 along with their relatively lower propensity to use diagnostic tests,2 has been offered as partial explanations for the UK’s consistently poor performance in cancer compared with other high-income countries.3

In this issue of BMJ Quality & Safety, Akter and colleagues examined primary care investigations prior to a cancer diagnosis using data on 53 252 patients and 1868 general practices from the 2018 English National Cancer Diagnostic Audit.4 Grouping tests into four categories (any investigation, blood tests, imaging and endoscopy), the study demonstrated large variation in use of tests in general practice prior to diagnosis with cancer. Recorded characteristics of practices accounted for only a small proportion of this variation,...

Just how many diagnostic errors and harms are out there, really? It depends on how you count

Quality and Safety in Health Care Journal -

The significant adverse consequences of diagnostic errors are well established.1 2 Across clinical settings and study methods, diagnostic adverse events often lead to serious permanent disability or death and are frequently deemed preventable.3–5 In malpractice claims, diagnostic adverse events consistently account for more total serious harms than any other individual type of medical error,5 6 a finding supported by large, population-based estimates of total serious misdiagnosis-related harms.2 Despite this, they generally go unrecognised, unmeasured and unmonitored, causing the US National Academy of Medicine to label diagnostic errors as ‘a blind spot’ for healthcare delivery systems.1

Diagnostic errors have been described as ‘the bottom of the iceberg’ of patient safety. This analogy is intended to connote both their enormous impact and their unmeasured, hidden nature relative to more visible errors such as...

Learning from an allied health perspective on quality and safety

Quality and Safety in Health Care Journal -

In this issue of the journal, the article ‘Developing the Allied Health Professionals workforce within mental health, learning disability, and autism inpatient services: Rapid review of learning from quality and safety incidents’ by Wilson and colleagues1 reviews materials on safety incidents in England published between 2014 and 2024, with a focus on the contribution of allied health professionals. In the context of this study, NHS England’s definition of ‘allied health professionals’ (AHPs) was used, namely the 14 registerable professions of art therapists (art/music/drama), chiropodists/podiatrists, dietitians, occupational therapists, operating department practitioners, orthoptists, osteopaths, paramedics, physiotherapists, prosthetists/orthotists, radiographers and speech and language therapists.1 The review largely considers more extreme forms of harm, such as death (including homicide and suicide), abuse by staff and self-harm.

In this editorial, we take a reflective stance informed by critical discourse analysis. Critical discourse analysis concerns itself with the use of language...

Increasing surgical volumes in resource limited-healthcare systems: team-based quality improvement as a novel approach to quantity improvement

Quality and Safety in Health Care Journal -

Quality improvement (QI) in the context of extremely limited healthcare access presents unique challenges, as the primary focus is often on increasing service quantity to meet needs. Access and quality in such situations can be at odds, as is the case with surgical care in resource-limited healthcare systems around the world. However, volumes and quality must advance in tandem to prevent inadvertent harm. In many healthcare systems, patients abandon treatment due to poor quality care despite reaching the hospital.1 These challenges are further magnified in very low-resource settings, where public hospitals serve populations in the lowest economic strata. Such realities underscore the vital importance of QI in such settings to build trust of communities in their healthcare system and providers.

An important contribution to the sparse body of literature in this space is the study by Barker et al in this issue of BMJ Quality & Safety.

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