Connect with us

Clinical Care

Irbesartan recalled due to possible contamination

The pharmacy-level recall is being undertaken as a precaution as testing revealed possible N nitrosodiethylamine (NDEA) contamination.

Published

on

medication box
Adobe

Irbesartan containing products are being recalled from pharmacies in the UK as the MHRA continues to investigate possible contamination.

Today’s recall affects 3 batches of Irbesartan 150mg and 300mg tablets which reached the UK market, supplied by Macleods Pharma UK. Information on which batches are affected can be found here.

The pharmacy-level recall is being undertaken as a precaution as testing revealed possible N nitrosodiethylamine (NDEA) contamination.

Advertisement

There is no evidence at present that the impurity has caused any harm to patients and not all Irbesartan products are affected. People should continue to take their medication and should speak to a doctor or pharmacist if they have any concerns.

Earlier this month, MHRA advised pharmacies to recall all affected batches of Irbesartan containing medicines made by Actavis.

In 2018, the Agency twice recalled batches of Valsartan to pharmacy level in 2018. Valsartan containing medicines from Dexcel and Actavis (now Accord) were recalled in July and batches of Valsartan containing medicines made by Mylan and Teva, were also recalled to pharmacy level in November.

The initial recall occurred after an impurity, N-nitrosodimethylamine (NDMA), was identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China. A second impurity, NDEA, was later discovered.

The MHRA continues to thoroughly investigate the issue alongside the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM). We will continue to monitor the situation in the UK and consider what actions are necessary to protect public health.

Dr Sam Atkinson, MHRA’s Director of the Inspection, Enforcement and Standards Division, said: “Our most important concern is the safety of the medicines you take.

“As today shows, we continue to investigate potential contamination of sartan containing medicines such as Irbesartan. We will continue to act and provide updates when appropriate.

“Currently, there is no evidence that medicines containing NDMA or NDEA have caused any harm to patients.

“Because of the risk associated with suddenly stopping high blood pressure medication, continue to take your medicines as prescribed by your doctor.

“If you have any concerns about your medicine, please speak to your doctor or pharmacist.”

Learning Disabilities

Mental health and learning disability services are deteriorating, says CQC

Growing pressure on services alongside chronic staffing issues risk creating a ‘perfect storm’ for patients.

Published

on

nurse on hospital ward

Nearly one in ten acute mental health and learning disability services are now rated as ‘inadequate’.

The quality of care provided by mental health and learning disability services has deteriorated in past last year, a report by the Care Quality Commission (CQC) has warned.

In the CQC’s annual assessment of the state of health and social care in England, the regulator warns that growing pressures on services alongside chronic staffing issues risk creating a ‘perfect storm’ for patients using mental health and learning disability services.

Advertisement

The report reveals that 10% of learning disability inpatient services and 8% of acute mental health units and psychiatric intensive care units are now rated as ‘inadequate’, compared with just 1% and 2% respectively last year.

Fourteen independent mental health hospitals were placed into special measures since last October and three were closed permanently.

The number of child and adolescent mental health inpatient services rated inadequate has also risen to 8%, up on just 3% last year.

‘A perfect storm’.

Ian Trenholm, Chief Executive of the Care Quality Commission (CQC) said: “In this year’s State of Care, we have highlighted mental health and learning disability inpatient services because that’s where we are starting to see an impact on quality – and on people.

“There has been a deterioration in ratings in these services – and our inspection reports highlight staff shortages, or care delivered by staff who aren’t trained or supported to look after people with complex needs, as a reason for this.

“Increased demand combined with challenges around workforce and access risk creating a perfect storm – meaning people who need support from mental health, learning disability or autism services may receive poor care, have to wait until they are at crisis point to get the help they need, be detained in unsuitable services far from home, or be unable to access care at all.

‘Immediate and firm action is needed’.

Commenting on the report, Patricia Marquis, Director for RCN England, said:  “With this report, the official inspectors are putting England’s nursing shortage front and centre as a key reason for poor care – no area of care appears safe from the engulfing workforce crisis. Now that their concern is on record, it leaves Ministers with nowhere to turn – they must take immediate and firm action to address the 40,000 unfilled nurse jobs.

“The CQC is painting a picture of too many nurses reaching burnout or breaking point with patients paying the price. In A&E in particular, nursing staff and their colleagues are left trying to treat patients as best they can in a system without enough capacity or boots on the ground.

“The independent inspection body backs calls made by the RCN and others for a coherent workforce plan and also puts on record its view that the removal of the bursary for nursing students led to a decline in people able to train. Now that it has been recognised here, the Government must act to put at least £1 billion extra per year into nursing education if it hopes to recover lost ground and fill these vital jobs.”

Continue Reading

Clinical Care

Hourly rounding ‘may not be the best way for nurses to deliver care’, finds study

Hourly rounding places an emphasis on ‘tick box’ care.

Published

on

Nurse with patient in bed

Hourly rounding made a minor contribution, if at all, to the way nurses engage with patients.

A new report by researchers at King’s College London has found that the widespread practice of hourly or intentional rounding, may not be the best way for nurses to deliver care to patients.

The report also found that rounding makes a minor contribution, if at all, to the way nurses engage with patients.

Advertisement

Hourly or intentional rounding involves standardised regular checks with individual patients at set intervals and was introduced in hospitals in England in 2013, with 97% of NHS acute Trusts in England implementing it in some way.

The majority of NHS trusts adopted the ‘4Ps’ (Position, Pain, Personal needs, Placement of items) model of rounding.

The research was commissioned and funded by the National Institute for Health Research (NIHR) and was led by Professor Ruth Harris in the Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care.

Hourly rounding places an emphasis on ‘tick box’ care.

The NIHR report – Intentional rounding in hospital wards to improve regular interaction and engagement between nurses and patients: a realist evaluation – is the first study of its kind in the world.

The study found that rounding placed an emphasis on transactional ‘tick box’ care delivery, rather than individualised care. However, patients were found to value their interactions with nursing staff, which the study argues could be delivered during other care activities and rather than through intentional rounding.

The report also found that rounding was implemented without consultation, careful planning and piloting in the interests of political expediency following the Francis Inquiry Report into care failures in the NHS.

Ruth Harris, Professor of Health Care for Older Adults at King’s College London, said; “Checking patients regularly to make sure that they are OK is really important but intentional rounding tends to prompt nurses to focus on completion of the rounding documentation rather than on the relational aspects of care delivery.

“Few frontline nursing staff or senior nursing staff felt intentional rounding improved either the quality or the frequency of their interactions with patients and their family.”

Continue Reading

POPULAR