A small number of kits of Prenoxad (naloxone) 1mg/ml Solution for Injection in a pre-filled syringe, an emergency medicine for suspected opioid overdose, may be missing needles, which would mean that some individuals may not be able to administer life-saving doses of this medicine in an emergency.

The Medicines and Healthcare products Regulatory Agency (MHRA) is urging patients, carers and healthcare professionals who have kits of Prenoxad Injection for emergency situations to visually check the contents of their kits by holding the front of the sealed kit against a light source to confirm that there are two (2) needles inside their kit. If the kit does not have two needles, it should be returned and replaced. Detailed instructions and reference images on how to visually check the kits can be found in the MHRA patient letter.

If it is not possible to confirm the presence of two needle packets visually, holders of Prenoxad Injection can open their kits without touching the pre-filled syringe (the tube with liquid in) to confirm there are two needles inside each kit. Once the check is completed, the kit must be carefully closed to ensure the contents stay secure. People can ask a healthcare professional if they are not sure how to visually check or physically open a Prenoxad Injection kit.

Healthcare professionals, services providers and local teams, including those involved in needle exchange services, have been asked by the MHRA to contact people who have been supplied Prenoxad Injection kits to ask them to check their kits for missing needles, and to arrange a replacement if needed.

This issue was detected when the manufacturer received reports from France of missing needles in kits of Prenoxad Injection. These kits normally contain 2 needles along with the pre-filled syringe containing the active ingredient (naloxone) and the Patient Information Leaflet. Although there are no reports to date of kits in the UK with missing needles, the potential for a small number of kits to have fewer than two (2) needles cannot be ruled out. There is no evidence to date that this manufacturing error has caused any harm to patients in the UK.

Dr Alison Cave, MHRA Chief Safety Officer, said:

Patient safety is always our priority. It is vitally important that you visually check the contents of your Prenoxad Injection kit and if there are fewer than two needles, you should return your kit and obtain a replacement. If you have been given a kit of this medicine since 27 March 2020 and are unsure how many needles it contains, please seek advice from the healthcare professional or service provider who supplied this kit.

If needed, your healthcare professional or service provider will give you a replacement kit or refer you to their nearest supplier. This will usually be a drug treatment service, a community pharmacy, a needle and syringe programme, a peer support group, or a drugs outreach worker.

We have taken prompt action to ensure kits with missing needles will no longer be given to patients. There are no concerns about the medicine in these kits and other products containing naloxone have not been affected by this manufacturing error. Please report any issues with your Prenoxad Injection kit via the Yellow Card scheme website.

Prenoxad Injection is carried by people at risk of opioid overdose, or those who know people at risk of overdose. It is used during emergencies at home, in non-medical spaces or in healthcare facilities for the complete or partial reversal of respiratory depression caused by natural and synthetic opioids including methadone, and some other opioids such as dextropropoxyphene and certain mixed analgesics: nalbuphine and pentazocine. Prenoxad Injection may also be used for the diagnosis of suspected severe opioid overdose.

Further information

• Detailed instructions and reference images on how to check Prenoxad Injection kits for missing needles are included in the MHRA patient letter.

• Anyone experiencing or observing someone experiencing symptoms of opioid overdose should immediately seek medical assistance. If there is nasal naloxone or injectable naloxone (with a needle) available, it should be administered according to the instructions in the kit. If someone has symptoms of an opioid overdose and is not breathing, 999 should be called and an ambulance requested immediately. General symptoms of opioid overdose include pinpoint pupils, loss of consciousness, respiratory depression (breathing slows or stops), extremely pale face that may feel clammy to the touch, bluish purple tinge to lips or fingernails, no response to noise, cannot be awakened, unable to speak, vomiting and/or making gurgling noises.

Notes to editors

• National Patient Safety Alert: Class 4 Medicines Defect Information: Prenoxad 1mg/ml Solution for Injection – This is a Caution in Use (Class 4) notification involving all batches on the UK market of Prenoxad 1mg/ml Solution for Injection in a pre-filled syringe: approximately 466,700 kits.

• Detailed instructions for healthcare professionals can be found in the notification.

• The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care.

• 12 teams from across the U.S. and the UK were announced today as winners of Phase 1 of the PETs prize challenges

• Applications now open to join red teams, which will rigorously test the strength of privacy protections of the most promising solutions in the final phase of the challenges

Today, the UK and the U.S. governments have announced the winners of the first phase of the UK-U.S. privacy-enhancing technologies (PETs) prize challenges. Innovators on both sides of the Atlantic are participating across two challenge tracks – using PETs to improve detection of financial crime and forecasting an individual’s risk of infection during a pandemic – or designing a solution that would meet both scenarios.

The 12 prize-winning technical papers, selected from 76 entries, set out state-of-the-art approaches to privacy-preserving federated learning, winning a total of $157,000 (£138,000) in prizes. They reflect the breadth and depth of technical talent in both nations and include teams from academic institutions, global technology companies, and privacy start-ups.

The second phase of the challenges, which began earlier this month, will see participating teams build the solutions envisioned in their technical papers. They will also have opportunities to engage with regulators and government agencies, to inform the development of solutions that uphold crucial regulatory principles. Innovators in the second phase will compete for prizes worth a combined $915,000 (£803,000).

The UK and U.S. governments are also opening applications for red teams, who will participate in the third phase of the challenges. Red teams will rigorously test the privacy-preserving capacities of the top-scoring solutions from the second phase of the challenges to assess the final winners. Recruitment for red teams is open here, with applications closing on 23 November. Top-scoring red teams will be awarded prizes from a combined pool of ~$225,000 (£200,000).

The challenge problems being tackled by participants are based on artificially-generated, or synthetic, data sets that are representative of real world use cases, but contain no actual client information. Data being used for the financial crime track is based on synthetic banking data developed by global financial institutions BNY Mellon and Deutsche Bank and synthetic global transaction data created by SWIFT, the global provider of secure financial messaging services, using the MOSTLY AI synthetic data platform. Innovators on the public health track are working with a synthetic dataset created by the University of Virginia’s Biocomplexity Institute.

Winning solutions will be profiled at the second Summit for Democracy, to be convened by President Joe Biden in 2023.

Julia Lopez, Minister for Media, Data, and Digital Infrastructure at the UK Department for Digital, Culture, Media and Sport, said:

Privacy-enhancing technologies have the potential to unlock the power of data to tackle major societal challenges – from international money laundering to responding to global pandemics – in a way that respects citizens’ rights. That’s why I’m delighted by the strength of the response to the UK-US prize challenges, with world class researchers on both sides of the Atlantic leaping to the challenge of innovating in a way that upholds our shared values.

John Edwards, UK Information Commissioner, said:

We are proud to be supporting the UK-US PETs prize challenge to help accelerate the development and use of PETs. PETs can help organisations share and use people’s data responsibly, lawfully and securely. That’s why we are offering advice to the organisations involved, building on our new PETs guidance which is out for consultation.

“AI is driving rapid technology change that is based on ever increasing amounts of disparate data, making privacy enhancing technologies increasingly important,” said Under Secretary of Commerce for Standards and Technology and NIST Director Laurie E. Locascio. “The U.S. UK PET prize challenge provides a global venue to build and showcase cutting-edge and scalable solutions that respect human rights and civil liberties. I am excited by the solutions proposed by these scholars and look forward to their impact on enhancing privacy and bolstering trustworthy AI.”

“These first-of-their-kind international prize challenges are focusing innovators from the US and UK on overcoming the challenge of maturing PETs for practical use cases,” National Science Foundation Director Sethuraman Panchanathan said. “The level of participation and caliber of participants in the U.S.-UK PETs prize challenges promise to accelerate the translation of PETs to practice. I’m excited to see the strong start to the prize challenges across the transatlantic research community and look forward to the results in the next phases.”

Contact:

Victoria Fell

Tel: +44 7785 382608

Email: victoria.fell@cdei.gov.uk

Notes to editors

In the UK, Prizes were awarded to the following organisations:

• Corvus Research Limited

• DeepMind and OpenMined*

• Diagonal Works

• GMV

• Faculty

• Featurespace Limited

• Privitar Limited

• University of Cambridge

• University of Liverpool

In the United States, prizes were awarded to the following teams:

• Team MusCAT: researchers from the Broad Institute, MIT, Harvard Business School, UT Austin, University of Toronto

• Team IBM Research

• Team Secret Computers: researchers from Inpher, Inc.

Across both countries, 76 teams entered the prize challenges. The total UK-U.S. prize pool across all three phases represents $1.6 million (£1.3 million).

Planning for the challenges is being led by the U.K. Centre for Data Ethics and Innovation (CDEI) and Innovate UK, and the U.S. White House Office of Science and Technology Policy (OSTP), the U.S. National Institute of Standards and Technology (NIST), and the U.S. National Science Foundation (NSF). The U.S. challenge is funded and administered jointly by the U.S. National Institute of Standards and Technology and the U.S. National Science Foundation.

The prize challenges were launched in July 2022. For more information, please visit the PETs prize challenges website.

*DeepMind and OpenMined have chosen not to accept any prize funds for this challenge.

Christ Church has been involved in long and costly disputes involving its former Dean, who left his role earlier this year following a mediation process. In 2020 the Commission had told the parties to the dispute to enter into formal mediation.

The Commission has found that trustees failed to act on its previous advice, given between 2019-2020, to continue to have “close oversight of costs” in the dispute. In December 2021, the Commission asked the trustees to provide information about the costs of the actions connected to the former Dean and how these costs were being managed. The trustees were unable to provide the information in a timely manner. The Commission was later informed that the trustees had not set a fixed budget for the costs associated with the dispute, and instead that the full trustee body agreed expenditure retrospectively. Between August 2018 and late January 2022 the college had spent over £6.6m on legal and public relations fees in various actions related to the former Dean, of which over £5.3m appears to have been approved retrospectively.

The regulator is also critical of the trustees’ failure to ensure the college was accountable for its expenditure on legal and public relations fees during the dispute. The Commission has found that the charity’s published accounts (for years ending 2018-21) categorised costs associated with the charity’s actions involving the former Dean as “other direct costs – teaching, research and residential”. The Commission says that this has the potential to mislead the readers of the accounts. The trustees had been advised by the charity’s auditors to consider reporting on actions related to the dispute specifically, and to seek advice on its reporting.

The regulator has determined that these failures and omissions amount to misconduct and/or mismanagement in the charity’s administration.

The Official Warning sets out the actions that the Commission considers should be taken by the charity to rectify the misconduct and/or mismanagement and to address its concerns, including:

• Completing a full independent Governance Review and taking all reasonable steps to implement its recommendations. This work is already underway.
• Keeping the Commission informed of the progress and implementation of the Governance Review at key milestones.
• Ensuring that the charity’s accounts and Trustee Annual Report for the year ending 31 July 2022 comply with the legal requirement to ensure the charity is accountable.

Failure to take steps to remedy the misconduct and/or mismanagement may lead to further regulatory action being taken against the charity’s trustees.

Helen Earner, Director of Regulatory Services at the Charity Commission, said:

These long and protracted disputes risked undermining the reputation of Christ Church and harming wider trust in charities.

It is not for us as regulator to take sides in disputes. Our role is to ensure that charities are governed effectively and that charitable funds are properly accounted for. All trustees must demonstrate sound financial stewardship, regardless of the level of resources available to them.

We consider that the actions of the trustees at Christ Church amount to mismanagement and/or misconduct, after they failed to manage the charity’s resources responsibly or ensure that the charity is accountable in the context of a costly dispute.

The Commission welcomes the fact that an independent governance review is now underway at the charity, led by the Rt Hon Dominic Grieve KC, and we expect the trustees to keep us updated on its progress.

Good governance should be a priority for all trustees, especially those involved in important national institutions such as Christ Church, Oxford”.

Ends

Notes to editors

1. The Official Warning is issued under section 75A of the Charities Act 2011.
2. Information about this power can be found in an online Q&A.
3. The Charity Commission is the independent, non-ministerial government department that registers and regulates charities in England and Wales. Its purpose is to ensure charity can thrive and inspire trust so that people can improve lives and strengthen society.

• A 12 week long UK-wide Veterans’ Survey has been launched today (10 November)
• The survey is the first ever government funded survey for all veterans across the country to provide their views
• The survey launches alongside the Office for National Statistics’ release of Census 2021 data on the veteran population.

The government has launched the first ever UK-wide survey, for veterans and their families.

Over the next 12 weeks, veterans across the country are able to complete the survey to shape the future of veteran services. Funded and commissioned by the Office of Veterans’ Affairs, this is the first ever exercise to collect feedback from the entire veterans community across the UK.

This survey, in collaboration with the Office for National Statistics (ONS), will ask veterans to describe their experiences of being a veteran and of using government services. This will ensure that the government can adapt services to better meet the needs of veterans and their families.

Minister for Veterans’ Affairs Johnny Mercer said:

Public services need to reflect the people they serve and so it’s really important we hear from veterans on their experiences in accessing support.

No one knows better what it’s like to be a veteran in Britain than ex-military themselves. So I urge all ex-service personnel to take the small amount of time to fill in the first ever Veterans Survey.

Your voice can help shape stepped-up services for veterans.

The launch of the survey comes alongside the release of the ONS’s Census 2021 data on the veteran population in England and Wales. Last year was the first time a question about someone’s military service was included in the Census.

The new ONS figures released today show that there were 1.85 million people in England and Wales who reported that they had previously served in the armed forces.

In England, regions with the highest proportion of veterans were the South West (5.6%) and the North East (5%). The proportion of UK veterans was higher in Wales (4.5%) of the population and in England (3.8%).

Sir Ian Diamond National Statistician at the Office for National Statistics said:

Responses to the survey will help us better understand the experiences, needs and wellbeing of our veteran community, and to guide future action. It is important we hear a wide range of views.

We are passionate about investing time and effort to produce high quality estimates that properly help us all understand how our veterans’ needs can be best met.

The stats from the ONS released today, as well as the veterans survey, deliver on commitments under the Veterans Strategy Action Plan to improve the data and understanding of Britain’s veteran population. This will help better target support and public services for those veterans who require help.

The ONS will be releasing further statistical information on the veterans population next year.

The survey can be completed online in under 30 minutes, and veterans can access tailored support to complete the survey through the Office for National Statistics’ dedicated helpline.

Veterans can fill in the survey here.