Press release: Additional blood pressure and heart medication recalled from pharmacies

The Medicines and Healthcare Products Regulatory Agency (MHRA) today recalled 3 batches of Irbesartan. The affected batches can be viewed here.

The recall is taking place as part of the continued investigation into potential N nitrosodiethylamine (NDEA) contamination of sartan containing medicines, a class of medicine to treat blood pressure and heart attacks and heart failures.

Currently there is no evidence that the NDEA impurity can cause harm and patients are being advised to continue taking their medication.

MHRA twice recalled Irbesartan containing products in early and late January 2019 after testing revealed possible NDEA contamination.

The investigation into possible contamination began in 2018, after another impurity, N-nitrosodimethylamine (NDMA), was identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China. NDEA was discovered after further testing.

Last year MHRA recalled batches of valsartan to pharmacy level in July and November after due to possible NDMA contamination.

The MHRA continues to monitor the situation in the UK and are comprehensively investigating the issue alongside the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM).

Dr Sam Atkinson MHRA’s Director of the Inspection, Enforcement and Standards Division said:

Patient safety is our top priority and we will take any necessary steps to protect public health.

Today’s Irbesartan recall shows we are continuing to investigate potential contamination of sartan containing medicines.

There is no evidence at present that medicines containing NDMA or NDEA have caused any harm to patients the recall is occuring as a precaution.

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

Please speak to your doctor or pharmacist if you have any concerns about your medicine.

Notes to editor

  1. MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health.
  2. In July, MHRA advised pharmacies to recall affected batches of Valsartan containing medicines made by Mylan and Teva as a precautionary measure.
  3. In November, we advised pharmacies to recall batches of valsartan from Dexcel and Actavis as a precautionary measure.
  4. Earlier this January, MHRA advised pharmacies to recall all affected batches of Irbesartan containing medicines made by Actavis as a precautionary measure. More information [here].(https://www.gov.uk/government/news/irbesartan-blood-pressure-and-heart-medication-recalled-from-pharmacies-by-mhra).
  5. In late January, MHRA advised pharmacies to recall all affected batches of Irbesartan containing medicines made by Macleods Pharma UK as a precautionary measure. More information here
  6. Find out more about our Yellow Card Scheme.
  7. Read the Drug Alert in full for further information.



News story: Contracts awarded to deliver the first T Levels

A major milestone was reached today (13 February) as contracts to develop, deliver and award the first three T Levels have been awarded by the Department for Education (DfE) and Institute for Apprenticeships and Technical Education (the Institute).

T Levels will be the technical equivalent to A Levels, combining classroom theory, practical learning and an industry placement. Following a competitive bidding process, Awarding Organisation NCFE has been awarded a contract to deliver the Education and Childcare T Level, and Pearson has been awarded contracts to deliver T Levels in Design, Surveying and Planning as well Digital Production, Design and Development. Around 50 further education and post-16 providers will teach these T Level programmes from September 2020.

To protect the gold standard of T Levels and ensure they are a valued qualification recognisable by employers, one awarding body will have exclusive rights to deliver each T Level subject. This was a key recommendation made by Lord Sainsbury in his independent review of technical education in 2016.

Education Secretary Damian Hinds said:

This is a major step forward in our work to upgrade technical education in this country. T Levels are a once in a generation opportunity to create high-quality technical education courses on a par with the best in the world, so that young people gain the skills and experience they need to secure a good job, an apprenticeship or progress into further training.

We have made significant progress to implement these vital reforms which are on track for delivery from 2020. Working alongside the Institute for Apprenticeships and Technical Education the Awarding Organisations will play a vital role ensuring T Levels are high-quality and deliver the skilled workforce employers need.

More than 200 businesses, including Fujitsu, Skanska, and GlaxoSmithKline as well as many small and medium sized firms, have helped design the course content so far to make sure young people taking T Levels are equipped with the knowledge and skills that employer’s value. On 31 January, the Institute assumed responsibility for approving the content and procurement for T Levels and will continue to work with industry and the Awarding Organisations as the T Level roll out continues.

Sir Gerry Berragan, CEO of the Institute, said:

I am really pleased at the pace the work has developed and the Institute will continue to build on the work of DfE. Technical Education offers a real and exciting alternative to A Levels for young people, with T Levels now sitting alongside apprenticeships. We remain committed to the pace of the roll out and look forward to working with these suppliers as they develop the first T Level qualifications.

Welcoming this announcement, Lord Sainsbury, Chair of the Independent Panel on Technical Education, said:

My panel recommended the single provider model for two reasons. Firstly, greater clarity. There are currently more than 3,000 Level 3 qualifications eligible for public funding for 16 to 18-year-olds, spread across more than 100 different awarding organisations. We cannot expect every employer in the land to know which of these qualifications are any good and actually deliver the knowledge and skills they are looking for in new recruits.

Secondly, we wanted to remove any possibility of a race-to-the-bottom on quality, where awarding organisations are incentivised to compete for market share on the basis not of rigour but instead on which qualifications are easiest to pass.

I am delighted that we have reached this milestone in the roll-out of the T Levels programme. With the first schools and colleges to offer T Levels in 2020 well advanced in their preparations, and now confirmation of these initial awarding organisations, I am confident that we remain on track to deliver the transformation to technical education that this country so desperately needs.

Rod Bristow, President of Pearson in the UK, said:

We are delighted to be delivering the first wave of T Level qualifications in Construction and Digital. The award of these licenses recognises our longstanding collaboration and partnership with employers of all sizes to design, develop and deliver world class qualifications in these industries.

T Levels represent a significant opportunity to strengthen the recognition and value of technical education in England. We look forward to continuing to work with the Government, employers, and providers to ensure their successful implementation, and to support learners as they begin their programmes of study from next September.

Stewart Foster, Managing Director, NCFE Awarding said:

At NCFE, we are committed to creating opportunities for learners to progress and succeed and we are therefore excited to be at the forefront of the implementation of T Levels. T Levels mark a revolution in technical education and the CACHE developed Technical Qualification will help ensure that learners entering the education and childcare workplace have been trained to the highest of standards. We would like to thank the sector for the huge amount of support offered to us throughout this process and look forward to continuing to work together.

In December 2018, the government announced the next 7 T Levels to be taught from 2021 as: Health; Healthcare Science; Science; Onsite Construction; Building Services Engineering; Digital Support and Services; and Digital Business Services. The procurement to deliver this next wave is expected to be launched in spring 2019.

To support the further education sector to deliver the new T Level programmes, the government will provide an additional half a billion pounds every year once they are all fully rolled out. The government is also investing £20 million to help prepare the sector for the introduction of T Levels. This includes the £5 million Taking Teaching Further programme, which aims to attract more industry experts to work in the sector, and the £8 million T Level Professional Development offer to help teachers and staff prepare for the roll-out of the new qualifications.

On Thursday 30 January 2019, eligible further education providers that will teach the first T Levels from 2020 were invited to bid for funding to refurbish their existing buildings or to build new spaces.

The T Level Capital Fund was announced by the Chancellor in the 2018 Budget. It is designed to make sure young people taking the new technical courses have access to industry standard equipment and high quality facilities so they gain the skills and knowledge employers demand. The fund will be delivered in two parts, with funding for specialist equipment such as digital and audio visual kit, allocated to all providers in spring 2020.




News story: Matt Hancock: email must replace paper in the NHS

Email is as secure and cheaper than communicating through paper and fax machines, the Health and Social Care Secretary said in a speech at an NHS England conference.

He outlined an ambition for healthcare staff to email patients directly with information on appointments to reduce delays, boost cyber security and cut wastage.

NHS organisations will be able to use any secure email provider – not just NHSMail – if it meets the required security settings. This is so that NHS organisations can choose the best service for their needs and email providers are encouraged to innovate.

The move is part of Matt Hancock’s tech vision for helping NHS organisations to introduce innovative technologies for the benefit of staff and patients.

Digital services and IT systems will soon have to meet a clear set of open standards to ensure they can talk to each other across organisational boundaries and can be continuously upgraded.

Any system that does not meet these standards will be phased out and the government will look to end contracts with providers that do not understand these principles for the health and care sector.

The Health and Social Care Secretary announced a fax machine ban in December 2018. Fax machines have now been removed from the NHS Supply Chain so trusts can no longer buy them.

Health and Social Care Secretary Matt Hancock said:

Having to deal with outdated technology is hugely frustrating for staff and patients alike – and in many cases downright dangerous. A letter lost in the post could be the difference between life and death.

We have signalled the end of archaic fax machines in hospitals and GP practices, and as of this year the NHS will no longer buy them. Our mission now is to make it as easy as possible for GPs to communicate safely and securely with their patients and colleagues.

There is no reason why a doctor cannot email a patient confidentially, for example with their test results or prescription, rather than make them wait days for a letter or ask them to come into the surgery. The rest of the world runs on email – and the NHS should too.

Mr Richard Kerr, Chair of the Royal College of Surgeons Commission on the Future of Surgery, said:

Last year, work undertaken for the RCS’s Commission on the Future of Surgery revealed that NHS hospital trusts own over 8,000 fax machines. This is ludicrous.

We know that digital technologies, such as artificial intelligence, genomics and imaging for healthcare, are going to play an increasingly important role in how we deliver patient care.

It is therefore imperative that the NHS uses modern communication channels that are up to the job of transmitting vast amounts of personalised patient information quickly and securely.

The RCS fully supports the health secretary’s ban on fax machines in the NHS.




News story: Near miss with track workers at Browney Curve

At approximately 23:45 hrs on Sunday 20 January 2019, a train operated by Northern encountered two track workers who were walking along the Browney Curve on the East Coast main line, South of Durham. The track workers had just set up a work site and were walking with their equipment to get to their place of work. However, because of an earlier planning mistake which went undetected, trains had not been stopped on the line on which the work site had been established. This occurred because the possession (a part of the railway which is closed to traffic to enable engineering works) did not encompass the location of the work.

RAIB was notified of the incident by Network Rail and has carried out a preliminary examination to understand the circumstances and identify whether it provides the potential for significant new safety learning. On the basis of the evidence that was available at the time, the RAIB has decided not to undertake an investigation into this incident.

The RAIB has previously carried out many investigations into accidents and incidents involving track workers, including a class investigation published in 2017.

Following this latest incident, the RAIB has written to Network Rail to remind it of the importance of addressing RAIB’s findings following an investigation into a near miss at Camden Junction South on 28 February 2017. This recommended that Network Rail investigates ways to improve the layout and format of notices publishing the safety arrangements for track workers, with a specific focus on the greater use of diagrams to represent information.

In July 2018 the RAIB published a safety digest into a near miss west of Dundee. This again arose as a result of people not realising that the location of the work, and the location where protection had been planned, were different. In that safety digest, the RAIB re-iterated the learning from the near miss at Camden Junction South.

The implementation of the Camden South Junction recommendation is still in progress. The incident on the Browney Curve serves as a timely reminder of the importance of addressing this recommendation.

In its letter, the RAIB also observed that it would be helpful if new planning tools currently being developed by Network Rail could undertake automatic checks on whether work sites are actually located within the possession to which they are linked. The letter has been copied to the Office of Rail and Road as the safety regulator for the UK railways.




Press release: Cash boost to help build 200,000 homes in new garden towns

A £9 million cash injection to speed up the locally-led building of new garden towns and villages across the country has been announced today (13 February 2019).

The Garden Communities project is expected to deliver 200,000 properties on large sites by 2050, and the latest funding will help get 21 sites ready for development.

The government project is helping ambitious councils get well-designed homes built on large sites, and the money will help pay for master-planning and technical studies.

Work is already underway on 10,000 properties across the country in garden towns and villages, with 36,000 expected to be underway or completed by 2022.

Housing Minister Kit Malthouse MP said:

We have not built enough homes in this country for the last three decades, and we are turning that around as we work towards our target to build 300,000 properties a year by the mid-2020s.

This £9 million funding boost is giving councils the support and cash injection they need so they can finish planning new developments and get diggers on site.

The developments being funded include a 2,000 home site for custom and self-builders in Bicester, on land purchased by the council from the Ministry of Defence.

It also includes developments in Basingstoke, Didcot, Taunton, Harlow-Gilston and across Northamptonshire where work is already underway on the first phase of developments.

The funding will be administered by Homes England.

Place Capacity award Homes
Aylesbury £420,000 15,000
Basingstoke £695,000 10,000
Bicester £770,000 13,000
Harlow & Gilston £715,000 24,000
North Essex (Colchester, Tendring & Braintree) £1,000,000 43,000
North Northants (Corby, Kettering & Wellingborough) £725,000 33,000
Otterpool Park, Folkestone £1,250,000 10,000
Taunton £550,000 15,000
Bailrigg £100,000 3,500
Culm, Mid Devon £300,000 5,000
Dunton Hills £100,000 3,500
Halsnead £300,000 1,589
Handforth £150,000 1,650
Infinity, Derbyshire £150,000 3,200
Longmarston £300,000 3,500
Longcross £125,000 1,700
West Oxfordshire £150,000 2,200
Tresham £300,000 1,500
Welbourne £300,000 6,000
West Carclaze £300,000 1,500
St Cuthbert’s, Carlisle £300,000 10,000