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Dr. Reddy's Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening

FDA MedWatch -

Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is b

Discharge against medical advice: 'deviant behaviour or a health system quality gap?

Quality and Safety in Health Care Journal -


Discharge against medical advice (DAMA) remains a persistent problem in healthcare where a patient decides to leave the hospital before the treating physician recommends discharge. Irregular discharges are high-risk events with such patients having a higher adjusted risk of readmission and mortality. Existing research in this area has focused heavily on describing patient characteristics associated with DAMA. This has unfortunately served to perpetuate the current notion that leaving against medical advice is deviant behaviour observed in certain groups of predisposed patients, that is, young, male, socially isolated and economically disadvantaged individuals often with concurrent stigmatising medical comorbidities like substance use and/or mental health disorders. This article challenges the reader to instead view DAMA as a failure of the healthcare system to help the patient achieve his or her medical goals. We examine DAMA from a quality lens and describe how it represents a more systemic issue with...

Identifying adverse events: reflections on an imperfect gold standard after 20 years of patient safety research

Quality and Safety in Health Care Journal -

In ancient Roman religion, Janus was the god of gates and doorways, but also beginnings, endings, transitions, passages, time and duality. Usually depicted as having two faces, Janus looks at the past with one face and to the future with the other. Why mention Janus in an editorial about patient safety? Partly because the 20-year anniversary of To Err is Human1 marks a transition—from the beginnings of patient safety as a fledgling field to a more mature research endeavour.

Beyond this symbolism of a transition period, Janus’s past and future looking faces bear another connection to patient safety. The ‘gold standard’ research method in patient safety, record review to look for ‘adverse events’ (AEs), defined as harms from medical care, has taken two forms. The more common method, famously used in the Harvard Medical Practice Study (HMPS)2 and other studies which have emulated it,

Medication non-adherence: an overlooked target for quality improvement interventions

Quality and Safety in Health Care Journal -

Quality improvement initiatives often focus on closing the gap between routine practice and the care recommended in guidelines—ensuring, for instance, that patients with chronic conditions receive prescriptions for medications demonstrated to improve health outcomes. However, this focus often ignores the even more basic problem: that many patients prescribed medicines for chronic conditions take them inconsistently or not at all. In one US study,1 patients who had recently experienced a myocardial infarction took key medicines intended to prevent further cardiac events only 35%–50% of the time, depending on the class of medication. Perhaps surprisingly, providing the medicines for free improved adherence by only a few percentage points. Other studies also report adherence rates of around 50% or less.2–5

Medication adherence thus constitutes one of the ‘big hairy problems’ or ‘big hairy audacious goals’6 of healthcare. As well as...

Seeing the wood and the trees: the impact of the healthcare system on variation in primary care referrals

Quality and Safety in Health Care Journal -

It is generally accepted that quality improvement efforts in health service delivery are best guided by measurement of performance and activity. Because of this, there are thousands of metrics and indicators produced worldwide attempting to capture the processes performed by, and outcomes achieved by, healthcare providers. However, for any of these indicators to be most useful, the variability in the indicator should reflect the performance or activity of the organisation being profiled. For example, it has been shown that much of the variation in doctor communication skills and in non-steroidal anti-inflammatory drug (NSAID) prescribing can be attributed to individual physicians rather than the organisations they work for.1 2 Those are examples of variation being attributed to a lower level than that at which it is often measured—that is, performance measures for inappropriate NSAID prescriptions often focus on practices, even though variation may occur predominantly at...


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