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Patient Safety

Faulty Emerade EpiPens means patients need to carry two at all times

A fault with the device makes it particularly important that patients carry two pens at all times.

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Emerage EpiPen
Bausch & Lomb

The EpiPen does not always release the autoinjector needle, a dose of adrenaline is then not delivered.

Patients who carry Emerade auto-injector pens for the emergency treatment of severe acute allergic reactions (anaphylaxis) to foods, medicines or insect stings are today being reminded of existing advice to carry two, in-date pens with them – at all times.

The advice, from the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health and Social Care (DHSC), follows reports from the manufacturer, Bausch & Lomb UK Limited, of Emerade pens that have failed to activate. In this situation, the needle of the pen is not released from the autoinjector when used, and a dose of adrenaline cannot be delivered.

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The issue makes it particularly important that users carry two pens at all times.

Share this advice with all patients who use an Emerade pen.

When an Emerade pen is used, it should be pressed very firmly against the thigh. If this does not result in activation, the patient should immediately use their second pen.

More detailed information for patients is available on the MHRA website. This includes images showing users what an activated pen looks like, compared to a non-activated pen.

If the patient is not improving, suggesting that a further dose of adrenaline is needed, additional attempts should be made to administer a pen that has failed to activate, while awaiting the arrival of the emergency services.

The MHRA has issued a Drug Alert and has written to healthcare professionals asking them to share this advice with all patients and carers who use an Emerade pen.

If a pen fails – keep it for further examination.

Samantha Atkinson, MHRA Director of Inspection, Enforcement & Standards, comments: “It is important to always carry two pens. At the first signs of anaphylaxis, the patient or carer should administer an Emerade pen by pressing it firmly against the thigh. If the pen fails to activate, they should immediately use the second pen.

“Emergency help should be summoned by dialling 999 and saying “Anaphylaxis” (pronounced anna-fill-axis). While waiting for the ambulance, additional attempts should be made to activate a failed pen if the patient is not improving.

“Patient safety is our highest priority and our role, as regulator, is to make sure medicines and medical devices are safe and effective.

“Patients experiencing any problem with Emerade failing to activate should report the incident via the MHRA’s Yellow Card system and keep the pen for further examination.”

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.

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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.

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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.”

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Acute Medicine

Nurses asked for their view on updated bed rail guidance

The new guidelines aim to tackle harm to patients by providing clear advice.

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Hospital bed rails

A new set of guidelines have cited several examples of harm caused by the improper use of bedrails.

The Medicines and Healthcare products Regulatory Agency (MHRA) is asking healthcare professionals for their views on a new set of guidelines on the safe use of bed rails.

A draft copy of the updated guidance document on the safe use of bed rails was published earlier this month.

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The guidelines warn that while bed rails are commonly used in acute and community care the “use of bed rails can carry serious risks for users if they are prescribed, installed or maintained improperly”.

It cites several examples of harm caused by the improper use of bed rails including; patient climbing over rails, a child becoming trapped then asphyxiating and multiple occupants becoming trapped.

The document goes on to highlight that the majority of incidents involving bed rails happen in a community setting.

Also identifying areas of good practice, the document emphasises the need for users to check bed rails are necessarily and supports communication between staff and patients.

The new guidelines aim to tackle harm to patients by providing clear advice staff with responsibility for the provision, prescription, use, maintenance and fitting of bed rails.

A consultation has now been launched to examine if the proposed document met the needs of the intended audience.

You can take part in the consultation here.

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