Tag: Department of Health and Social Care

The press release issued by the Department of Health and Social Care on 29 October 2023.

A new mission announced by the Prime Minister will accelerate the use of AI in life sciences to tackle the biggest health challenges of our generation.

In a speech on Thursday, the Prime Minister announced that a £100 million in new government investment will be targeted towards areas where rapid deployment of AI has the greatest potential to create transformational breakthroughs in treatments for previously incurable diseases. The AI Life Sciences Accelerator Mission will capitalise on the UK’s unique strengths in secure health data and cutting-edge AI.

The Life Sciences Vision encompasses 8 critical healthcare missions that government, industry, the NHS, academia and medical research charities will work together on at speed to solve – from cancer treatment to tackling dementia.

The £100 million will help drive forward this work by exploring how AI could address these conditions, which have some of the highest mortality and morbidity.

For example, AI could further the development of novel precision treatments for dementia. This new government funding for AI will help us harness the UK’s world-class health data to quickly identify those at risk of dementia and related conditions, ensure that the right patients are taking part in the right trials at the right time to develop new treatments effectively, and give us better data on how well new therapies work. By using the power of AI to support the growing pipeline of new dementia therapies, we will ensure the best and most promising treatments are selected to go forwards, and that patients receive the right treatments that work best for them.

AI driven technologies are showing remarkable promise in being able to diagnose, and potentially treat, mental ill health. For example, leading companies are already using conversational AI that supports people with mental health challenges and guides them through proactive prevention routines, escalating cases to human therapists when needed – all of which reduces the strain on NHS waiting lists.

This funding will help us to invest in parts of the UK where the clinical needs are greatest to test and trial new technologies within the next 18 months. Over the next 5 years, we will transform mental health research through developing world-class data infrastructure to improve the lives of those living with mental health conditions.

Prime Minister Rishi Sunak said:

AI can help us solve some of the greatest social challenges of our time. AI could help find novel dementia treatments or develop vaccines for cancer.

That’s why today we’re investing a further £100 million to accelerate the use of AI on the most transformational breakthroughs in treatments for previously incurable diseases.

Secretary of State for Science, Innovation and Technology Michelle Donelan said:

This £100 million Mission will bring the UK’s unique strengths in secure health data and cutting-edge AI to bear on some of the most pressing health challenges facing the society.

Safe, responsible AI will change the game for what it’s possible to do in healthcare, closing the gap between the discovery and application of innovative new therapies, diagnostic tools, and ways of working that will give clinicians more time with their patients.

Health and Social Care Secretary Steve Barclay said:

Cutting-edge technology such as AI is the key to both improving patient care and supporting staff to do their jobs and we are seeing positive impacts across the NHS.

This new accelerator fund will help us build on our efforts to harness the latest technology to unlock progress and drive economic growth.

This is on top of the progress we have already made on AI deployment in the NHS, with AI tools now live in over 90% of stroke networks in England – halving the time for stroke victims to get the treatment in some cases, helping to cut waiting times.

Building on the success of partnerships already using AI in areas like identifying eye diseases, industry, academia and clinicians will be brought together to drive forward novel AI research into earlier diagnosis and faster drug discovery.

The government will invite proposals bringing together academia, industry and clinicians to develop innovative solutions.

This funding will target opportunities to deploy AI in clinical settings and improve health outcomes across a range of conditions. It will also look to fund novel AI research which has the potential to create general purpose applications across a range of health challenges – freeing up clinicians to spend more time with their patients.

This supports work the government is already doing across key disease areas. Using AI to tackle dementia, for example, builds on our commitment to double dementia research funding by 2024, reaching a total of £160 million a year. Our Dame Barbara Windsor Dementia Mission is at the heart of this, enabling us to accelerate dementia research and give patients the access to the exciting new wave of medicines being developed.

The press release issued by the Department of Health and Social Care on 25 October 2023.

End of outdated law which requires same-sex couples to pay up to £1,000 for safety screening when accessing fertility treatment.

The press release issued by the Department of Health and Social Care on 25 October 2023.

The government has announced almost £5 million to fund early support hubs nationwide to deliver mental health support for children and young people.

The press release issued by the Department of Health and Social Care on 24 October 2023.

Accelerating Reform Fund to support innovation in local areas to boost quality and accessibility of adult social care in England.

The press release issued by the Department of Health and Social Care on 19 October 2023.

Health and Social Care Secretary publishes terms of reference for inquiry following murders and attempted murders committed by former neonatal nurse Lucy Letby.

• Inquiry will look at experiences of families of all the babies named in the indictment; conduct of staff at the Countess of Chester Hospital, part of the Countess of Chester Hospital NHS Foundation Trust; effectiveness of NHS management and governance structures; and NHS culture
• Inquiry has powers to compel witnesses to produce evidence and is chaired by Lady Justice Thirlwall, one of the country’s most senior and experienced judges

Health and Social Care Secretary Steve Barclay has today (19 October 2023) published the terms of reference for the statutory inquiry following the horrific murders and attempted murders committed by Lucy Letby.

The inquiry is being set up at pace to ensure vital lessons are learned and provide answers to the parents and families impacted as soon as possible.

Letby was convicted of murdering 7 babies and attempting to kill 6 others at the Countess of Chester Hospital. She committed these crimes while working as a neonatal nurse at the Countess of Chester Hospital between June 2015 and June 2016.

Health and Social Care Secretary Steve Barclay said:

Losing a child is the greatest sorrow any parent can experience, and I cannot begin to imagine the hurt and suffering experienced by the families affected by Lucy Letby’s horrific crimes.

We have a duty to get them the answers they deserve, to hold people to account where they need to be, and to make sure lessons are learned.

These terms of reference have been agreed following engagement with the families, and I am confident Lady Justice Thirlwall will ensure their voices are heard as the inquiry gets underway.

The terms of reference are set by the Health and Social Care Secretary after consultation with the chair, who has engaged with the families and other stakeholders.

The inquiry will cover 3 broad areas:

• the experiences of the parents of the babies named in the indictment
• the conduct of clinical and non-clinical staff and management, as well as governance and escalation processes in relation to concerns being raised about Letby and whether these structures contributed to the failure to protect babies from her
• the effectiveness of governance, external scrutiny and professional regulation in keeping babies in hospital safe, including consideration of NHS culture

It will not review the jury’s verdicts and will make no findings regarding liability in civil proceedings.

The government confirmed in August 2023 that the inquiry would be placed on a statutory footing. This means it will have legal powers to compel witnesses, including former and current staff of the Countess of Chester, to give evidence. It also means evidence must be heard in public, unless the chair decides otherwise.

Lady Justice Thirlwall is one of the country’s most senior judges and currently sits in the Court of Appeal. She has many years of experience as a senior judge and barrister.

As chair, she will decide on the order in which the inquiry considers issues and how to manage the inquiry alongside any live police investigation and any criminal proceedings – whether that be retrials, trials, or an appeal.

The chair will provide a final report, and if appropriate, interim reports as soon as practically possible.

The inquiry is currently setting up its infrastructure at pace so that it can begin its investigations.

Read the full Thirlwall Inquiry terms of reference.

The press release issued by the Department of Health and Social Care on 19 October 2023.

Maternity and neonatal services nationwide will be required to support and inform women who experience trauma during childbirth.

• Distressing issues like pelvic organ prolapse, perineal tears, pelvic pain and incontinence due to childbirth are too common so government and NHS taking action
• Boosting women’s health and wellbeing remains a top priority and government continues working and investing in world-class healthcare

Women who have gone through the often devastating pain and distress of a traumatic birth will receive better aftercare and support, and pregnant women will be better equipped with the information they need as part of their routine antenatal care, as plans are unveiled for the implementation of a nationwide pelvic health service.

Roughly 1 in 3 women experience urinary incontinence 3 months after pregnancy, and around 1 in 7 experience anal incontinence 6 months after birth. One in 12 women report symptoms of pelvic organ prolapse – which is when one or more of the organs in the pelvis slip down from their normal position and bulge into the vagina. These distressing issues can affect women’s ability to work, their sexual and social relationships, and their mental health.

But action is being taken on a national level. Backed by over £11 million of government funding from April 2024, plans published by NHS England for the implementation of a new national service will:

• ensure all women are offered a self-assessment of their pelvic health as early as possible in pregnancy – and by 18 weeks at the latest
• educate all women on the risk of pelvic floor dysfunction and birth injuries and preventative action they can take to reduce this risk
• provide additional support to those at higher risk of pelvic health problems
• reduce NHS waiting times – one of the Prime Minister’s 5 pledges – and minimise administrative barriers to treatment
• allow affected women to access appropriate physiotherapy assessment and personalised treatment

Women’s Health Minister Maria Caulfield said:

For too many women, the joy of pregnancy and birth is tarnished by trauma, and pelvic health problems can have devastating ramifications for women’s lives.

It’s vital women receive appropriate support, treatment and information. From initial antenatal appointments, right through to mental health care after birth, we are determined to support women throughout their pregnancy and birth journey.

Kate Brintworth, NHS England’s Chief Midwifery Officer, said:

For any women that have experienced a traumatic birth, timely access to support is crucial to help address any issues like incontinence that can occur.

To increase the support available, the NHS is rolling out dedicated pelvic health clinics nationally, bringing together expert clinicians under one roof, so women can seek help quickly and easily – and already thousands of women have been supported through our pilot sites.

As part of these plans, women will be supported by maternity teams to recognise pelvic health problems and offered a self-assessment of their pelvic health as early as possible in pregnancy, and the NHS is here for women if they need support.

Perinatal pelvic health services (PPHS) – run by specialist midwives and pelvic health physiotherapists – are already being implemented as pilots right across England. All areas in England are on track to implement these services by March 2024 – helping women everywhere.

These services work alongside maternity and physiotherapy services to support the prevention, identification and timely treatment of pelvic health problems around birth, and include a clear pathway for referral into mental health services.

They also reduce the risk of these injuries happening in the first place through close work with midwives and obstetricians and through support for the implementation of the obstetric anal sphincter injury (OASI) care bundle.

Developed by a team of UK experts and supported by national professional organisations and women’s groups, the care bundle is a set of interventions likely to improve outcomes for women. Analysis of the effectiveness of this care bundle based on over 50,000 vaginal births found that women’s risk of obstetric anal sphincter injuries decreased by 20%.

Dr Ranee Thakar, President of the Royal College of Obstetricians and Gynaecologists (RCOG), said:

Too many women currently suffer pelvic injuries during childbirth, which can mean long-term complications including difficulty controlling the bladder and bowel, chronic pain and painful intercourse. This guidance represents an important milestone in the development of vital perinatal pelvic health services, created to improve access to early intervention and support for women and people experiencing symptoms of pelvic floor dysfunction.

We are delighted that this service specification sets out how PPHS will work with maternity units to implement the joint RCOG and Royal College of Midwives’ OASI care bundle. As a college we look forward to supporting the implementation of this important guidance, working with our membership and our NHS partners to help ensure all women have access to high-quality pelvic floor health information, education and care.

It’s vital women are educated properly about pelvic health problems before and after giving birth. NHS England’s new service specification highlights how every woman using maternity services should receive routine information at every contact antenatally and postnatally about perinatal pelvic health.

At all routine perinatal appointments, clinicians should discuss with patients preventative measures that can be taken, including pelvic floor exercises, when to get help, where to go for help and potential management options.

Women who have gone through such physical trauma can also experience devastating mental illness, and it’s vital the proper mental health support is in place.

The service specification requires maternity and neonatal services to establish strong working links with mental health services – particularly maternity mental health services, perinatal mental health services and psychosexual counselling services. This will ensure women are signposted in an appropriate and timely way, and that they can be referred between pelvic and mental health care as seamlessly as possible.

Progress is already being seen in this area and by May 2023, an additional 16,000 women per year accessed specialist community perinatal mental health services and maternity mental health services compared to 2 years previously.

This follows unprecedented levels of funding to grow the maternity workforce and boost neonatal services, including £165 million of additional investment a year to improve maternity and neonatal care, and this will rise to an additional £186 million a year from 2024 to 2025. The NHS recently published the first ever Long Term Workforce Plan, backed by over £2.4 billion in government funding to deliver the biggest training expansion in NHS history to help meet the challenges of a growing and ageing population by recruiting and retaining hundreds of thousands more staff over the next 15 years.

The government also continues to build on the Maternity Transformation Programme, and continues to work closely with NHS England to implement the Three year delivery plan for maternity and neonatal services that was published in March 2023. This plan looks to guide services towards safer and more personalised care for women, babies and families.

The press release issued by the Department of Health and Social Care on 16 October 2023.

Public consultation launched on first UK-wide guidelines for clinical treatment of harmful drinking and alcohol dependence.

• Government working in partnership with devolved administrations to develop a clear consensus on best practice for specialist treatment
• Guidelines aim to support health and care sector with high-quality resources to help treat people with alcohol dependency issues

Health and social care services are being urged to work together to treat those suffering from alcohol dependency as the government consults on new guidelines for the treatment of harmful drinking and alcohol dependence.

Developed in partnership with the devolved administrations, the new UK-wide draft guidelines aim to develop a clear consensus on best practice for treatment for alcohol dependence, ultimately improving outcomes for patients.

The consultation will be open for 8 weeks, inviting views from people working in alcohol treatment, the wider health and care sector, and those with lived experience of alcohol dependence across the UK.

Minister for Public Health, Neil O’Brien, said:

To maximise the impact of our £532 million investment into substance misuse treatment, it is vital that treatment for those with alcohol dependence is informed by the best scientific and medical expertise, as well as the views of those with lived experience.

This consultation will help us develop guidance to ensure alcohol treatment services are of consistently high quality, providing stronger pathways to recovery for those in need of treatment for alcohol dependence.

Deputy Chief Medical Officer, Dr Jeanelle de Gruchy, said:

These UK-wide guidelines will provide a clear consensus for health and care services on best practice for alcohol treatment, resulting in better outcomes for those who need treatment and care.

I encourage anyone who works in alcohol treatment services, and anyone with experience using them, to contribute your views to the 8-week consultation to ensure that the guidelines are as robust and person-centred as possible.

The alcohol clinical guidelines will provide:

• a detailed framework to support providers with high quality alcohol treatment guidance that can help inform the quality of their services
• guidance for health and social care staff involved in helping people experiencing alcohol dependence or drinking at harmful levels
• guidance on managing and supporting treatment pathways, such as between hospitals or prisons and the community
• a reference point for national regulatory bodies when inspecting alcohol treatment services

The guidelines recommend:

• specialist alcohol treatment and wider health and social care services work together to provide integrated care for people experiencing alcohol dependence
• alcohol treatment services working with lived experience recovery organisations

They also provide specific recommendations for supporting specific groups with managing alcohol dependency. For example, there is a chapter on pregnancy and perinatal care, with recommendations for professionals on supporting pregnant women to stop drinking safely, and a chapter providing guidance to those working in the criminal justice system to tackle alcohol misuse among prisoners.

The Office for Health Improvement and Disparities developed the draft guidelines in collaboration with the devolved governments, senior UK clinical experts, and people with experience of alcohol treatment. They are modelled on the UK clinical guidelines on drug misuse and dependence (the Orange Book), published in 2017.

The main aim of the guidelines is to develop a clearer consensus on good practice and how to implement NICE-recommended interventions. This will promote and support consistent high quality in the provision of alcohol treatment services, resulting in better outcomes for people in need of treatment.

The press release issued by the Department of Health and Social Care on 12 October 2023.

Applications are now open for Integrated care systems to apply for a share of £30 million to roll out innovative technology.

The press release issued by the Department of Health and Social Care on 12 October 2023.

The government has launched a public consultation on youth vaping as part of measures to clamp down on vapes being promoted to children.

• Launch of public consultation following Prime Minister’s historic proposals to create first smokefree generation and crack down on youth vaping
• Teenagers, parents, teachers, medical professionals, academic experts and others have 8 weeks to submit views on government plans and to share experiences
• The government is committed to clamping down on vapes being promoted to children while ensuring adults who want to quit smoking remain supported

People of all ages are being invited to take part in a public consultation seeking views on plans to crack down on youth vaping by reducing the appeal, affordability and availability of vapes to our children.

The consultation launched today (12 October 2023) is open to anyone, of any age, in the UK and includes proposals to restrict child-friendly flavours and bright coloured packaging. People have 8 weeks to share their experiences and opinions and help shape future policy on vaping and smoking.

Last week, the Prime Minister unveiled plans to introduce a new law to stop children who turn 14 this year or younger from ever legally being sold cigarettes, in a bid to create the first ‘smokefree generation’. Smoking is the UK’s biggest preventable killer – causing around 1 in 4 cancer deaths and 64,000 in England alone – costing the economy and wider society £17 billion each year.

He also set out the government’s concerns about the worrying rise in vaping among children, with youth vaping tripling in the last 3 years and 1 in 5 children having now used a vape. Vaping is rightly used by adults as a tool to quit smoking, but the health advice is clear – if you don’t smoke, don’t vape and children should never vape.

Views on these proposals are now being sought from everyone, including the public, the retail sector, clinicians and medical professionals, public health stakeholders, academic experts, employers and trade unions.

The consultation has generated widespread support right across the 4 corners of the UK, with the Welsh Government, Scottish Government and the Department of Health in Northern Ireland all giving it their backing and agreeing to a joint consultation.

Prime Minister Rishi Sunak said:

Last week I promised to create the first smokefree generation and I am wasting no time to deliver on that promise.

Our ambitious plans will reverse the worrying rise in youth vaping while protecting our children from the dangerous long-term effects of smoking as quickly as possible.

Proposals being consulted on include:

• making it an offence for anyone born on or after 1 January 2009 to be sold tobacco products
• restricting the flavours and descriptions of vapes so that vape flavours are no longer targeted at children – we want to ensure this is done in a way that continues to support adult smokers to switch
• regulating point of sale displays in retail outlets so that vapes are kept out of sight from children and away from products that appeal to them, such as sweets
• regulating vape packaging and product presentation, ensuring that neither the device nor its packaging is targeted to children
• considering restricting the sale of disposable vapes, which are clearly linked to the rise in vaping in children. These products are not only attractive to children but also incredibly harmful to the environment
• exploring further restrictions for non-nicotine vapes and other nicotine consumer products such as nicotine pouches
• exploring whether increasing the price of vapes will reduce the number of young people using them
• introducing new powers for local authorities to issue on-the-spot fines (fixed penalty notices) to enforce age of sale legislation of tobacco products and vapes

Health and Social Care Secretary Steve Barclay said:

There has been a surge in vaping among children, which is why we’re taking action to reduce the appeal and availability of vapes. Vapes should never be used by children and we’re committed to reversing this trend.

We also need to take bold action to protect future generations from the harms of smoking addiction, which damages health at every stage of life and costs the economy billions.

These proposals build on previous initiatives to crack down on vapes becoming commonplace in classrooms while recognising them as an effective quit tool for smokers and central to the ambition for England to be smokefree by 2030.  A UCL study estimated that swapping to vaping is already helping 50,000 to 70,000 smokers in England quit each year – saving thousands of lives.

Professor Chris Whitty, Chief Medical Officer for England, said:

Smoking causes cancers, heart and lung disease, stroke, stillbirth and dementia. Ensuring people do not become addicted to smoking, and helping them overcome addiction to stop smoking are 2 the best interventions for health.

Vaping is less dangerous than smoking but still has risks and can cause addiction. Vaping can be useful for smokers to quit, but should not be marketed to non-smokers and marketing them to children is utterly unacceptable.

Selling vapes to children is already illegal, but it is clear from recent statistics that vapes are too often targeted at children with the promotion of cheap, colourful and sweet flavours commonplace. This is despite the addictive nature of nicotine and the long-term harms of vapes being unknown. Nicotine vapes in particular can be highly addictive and withdrawal causes anxiety, trouble concentrating and headaches.

Recent figures show the number of children using vapes in the past 3 years has tripled, with 20.5% of children aged between 11 and 17 having tried vaping in 2023, according to Action on Smoking and Health (ASH). Similar trends are reflected globally, including in Canada and New Zealand. Use among younger children is also rising, with 9% of 11 to 15 year olds reportedly using vapes, according to a 2021 survey by NHS Digital.

Scottish Government Health Secretary, Michael Matheson, said:

We have already committed to a tobacco-free Scotland by 2034 and we welcome the opportunity to take part in this UK-wide consultation on creating a smoke-free generation.

Scotland has a range of world-leading tobacco control measures – we were the first country in the UK to introduce a ban on smoking in indoor public places in March 2006. As a result, smoking rates are at an all-time low. We continue to be ambitious and have more work to do to create a tobacco free Scotland, and I look forward to the refreshed tobacco action plan being published shortly.

We will continue to work with the UK government and other devolved administrations on joint approaches where appropriate.

Welsh Government Deputy Minister for Mental Health and Wellbeing, Lynne Neagle, said:

We want to take all actions possible to stop young people from starting smoking in the first place and from vapes being use by and targeted at children.

We have decided to consult jointly on these proposals as we believe they will be stronger if undertaken on a 4 nations basis.  I therefore encourage anyone with an interest in tobacco or vaping to take part in the consultation and share their views on how we can best protect children and young people from these products.

Permanent Secretary at Northern Ireland’s Department of Health, Peter May, said:

Northern Ireland’s Department of Health has agreed that NI will be included in the public consultation, to help inform future decision making.

Professor Sir Nilesh Samani, Medical Director at the British Heart Foundation, said:

Following the government’s very welcome signal that it intends to take decisive action to ensure future generations are smokefree, we are pleased to see it also consult about vaping. This is an important opportunity to ensure that regulations around vaping are effective, and that any actions carry the confidence of the public.

Sarah Woolnough, Chief Executive at Asthma + Lung UK, said:

We welcome today’s consultation on vaping announced by the government. It is clear we must urgently act to stop children accessing vapes. Disposable vapes at their current pocket money prices, with cartoons and bubblegum flavour options, are far too attractive and easy for children to access. We also want to see restrictions on the marketing of vapes and on flavours so that they do not target children.

If you’re a smoker and you want to quit tobacco, vaping can be a helpful way to give up smoking. But for children and those who don’t smoke, starting to vape isn’t a good idea, especially if you have a lung condition.

Deborah Arnott, Chief Executive of health charity ASH, said:

Groundbreaking legislation to protect the next generation from smoking and vaping is needed, wanted and workable.

This consultation will ensure all voices are heard and the balance is struck between protecting children while still helping adult smokers quit. However, consultation must be followed rapidly by legislation to be passed in this Parliamentary session.

There is no time to waste, every day hundreds of children start smoking for the first time, two-thirds of whom will go on to become daily addicted smokers.

Cancer Research UK’s Chief Executive, Michelle Mitchell, said:

We’re pleased that the UK government’s consultation into youth vaping and smoking has launched. Preventing young people from taking up vaping is an area that needs stronger regulation, and we look forward to responding.

But it’s important to remember that based on current evidence, vaping is far less harmful than smoking cigarettes, and can help people to quit. The government is right to consider how any changes will impact people who use e-cigarettes as a smoking cessation tool.

Dr Jeanette Dickson, Chair of Council of the Academy of Medical Royal Colleges, said:

The Academy welcomes the consultation on smoking and vaping.

Smoking causes death and disability across all ages due to premature birth, heart disease, lung cancer and dementia. Eradicating smoking can only benefit the health of the population.

The introduction of cheap and accessible disposable vape products is also causing major environmental harm. Latest figures from Material Focus show 5 million disposable vapes are thrown away each week, a rapid increase from 1.3 million last year and is equivalent to the lithium batteries of 5,000 electric vehicles.

Environment Minister Rebecca Pow said:

The scale of the waste created by disposable vapes in the UK is shocking – industry research shows nearly 5 million single-use vapes are thrown away every week.

Not only will the Prime Minister’s historic proposals to crack down on cheap and accessible disposable vapes help create the first smokefree generation, but they will be of major benefit to the environment by tackling a particularly problematic waste stream.

The new plans are backed by concrete evidence following the department’s youth vaping call for evidence. This received 441 responses, with the majority (324) coming from individual respondents and 117 coming from organisations.

Concerned parents and carers, education professionals and charities echoed the Prime Minister’s concerns about underage use and availability of often counterfeit or illicit products – frequently displaying cartoons. Parents told us more children are trying vapes than ever before because of the cheap price of disposable options, diverse range of flavours and marketing which makes vapes look more like sweets than a smoking alternative.

The press release issued by the Department of Health and Social Care on 11 October 2023.

Patients to receive the latest valproate safety information with every pack, following changes to the Human Medicines Regulations, 2012.

Valproate-containing medicines will be dispensed in the manufacturer’s original full pack, following changes in regulations coming into effect on Wednesday, 11 October 2023. The Medicines and Healthcare products Regulatory Agency (MHRA) has today published new guidance for dispensers to support this change.

Following a government consultation, this change to legislation has been made to ensure that patients always receive specific safety warnings and pictograms, including a patient card and the Patient Information Leaflet, which are contained in the manufacturer’s original full pack. These materials form a key part of the safety messaging and alert patients to the risks to the unborn baby if valproate-containing medicines are used in pregnancy.

The changes follow a consultation on original pack dispensing and supply of medicines containing sodium valproate led by the Department of Health and Social Care (DHSC), in which there was overwhelming support for the introduction of the new measures, to further support safety of valproate-containing medicines.

A large majority of respondents to the consultation – 85% – agreed or strongly agreed with the requirement that the full-pack dispensing of medicines containing valproate in the manufacturer’s original pack will ensure patients always receive the safety information supplied on the label and in the Patient Information Leaflet.

MHRA Chief Executive, Dr June Raine, said:

“It is essential that all patients on valproate-containing medicines receive the latest safety information every time their prescription is dispensed. The changes in the law announced today ensure this happens. People’s situation may change, especially with regard to the possibility of pregnancy, so it is vital that the warnings about the harms of valproate are always brought to mind.

“We are pleased to provide guidance to support the further strengthening of safety warnings around dispensing and we ask all dispensers of medicines containing valproate to consult the new guidance carefully.

“It is very important that patients do not stop taking valproate-containing medicines without advice from a healthcare professional. If you are concerned about the risks, talk to your doctor, pharmacist or another healthcare professional.”

Minister for Public Health, Maria Caulfield, said:

“This safety information will help patients stay informed about risks of valproate, and I encourage all dispensers of valproate to consult the new guidance carefully.

“This continues our commitment to listening and learning from the experiences of people impacted by valproate and their families and using what we hear to improve patient safety.”

There is a significant risk of birth defects for unborn babies and developmental disorders in children born to women who take valproate-containing medicines during pregnancy. Because of these risks, prescribing to women and girls of childbearing potential must fulfil the conditions of the Valproate Pregnancy Prevention Programme which is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

The new legislation allows dispensers such as pharmacists to round the prescribed amount of valproate-containing medicines either up or down so that the patient receives only complete packs. The medicine must not be re-packaged into plain dispensing packaging.

In rare cases, pharmacists can make an exception on an individual patient basis. This can only happen where a risk assessment is in place that refers to the need for different packaging. For example, the patient may need a monitored dosage system. In all these exceptional cases, the pharmacist must ensure that the patient is given the Patient Information Leaflet about valproate-containing medicine, and the pharmacist can explain why the patient is not receiving the manufacturer’s original full pack.