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Yellow Card Scheme The Yellow Card Scheme is intended to support the Medicines and Healthcare products Regulatory Agency (MHRA) monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those who use them.[1] Reports can be made for all medicines, including: side effects (also known as adverse drug reactions or ADRs) medical device adverse incidents defective medicines (those that are not of an acceptable quality) counterfeit or fake medicines or medical devices safety concerns for e-cigarettes or their refill containers (e-liquids). IMMDS Review and incident reporting Published on the 8 July 2020, the Independent Medicines and Medical Devices Safety (IMMDS) Review, led by Baroness Julia Cumberlege, highlighted the need to improve incident reporting in healthcare, specifically in regards to medicines and medical devices.[2] The Review examined the response of the healthcare system in England to the harmful side effects of three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. These interventions have resulted in a truly shocking degree of avoidable harm to patients over a period of decades. One area of particular concern that the Review raised related to the Yellow Scheme, highlighting the need for reform of this system, stating that: it needs to be more user-friendly and accessible that the system was hampered by a lack of awareness among both the public and healthcare professionals. More broadly, the Review recommended that the MHRA needed to revise its approach in relation to adverse event reporting and do more to ensure that it engages with patients and their outcomes. The Government accepted this recommendation in its response to the Review.[3] Questions in the House of Commons Below are details of three written questions tabled by Emma Hardy MP concerning the Yellow Card Scheme. All three questions were answered by Will Quince MP, Minister of State (Minister for Health and Secondary Care). Awareness Question: To ask the Secretary of State for Health and Social Care, what assessment he has made of the level of awareness of (a) health professionals and (b) the general public of the Adverse Events Yellow Card System; and what steps is he taking to increase awareness of that system among those groups. Answer: The Medicines and Healthcare products Regulatory Agency (MHRA) recognises the importance of both public and healthcare professional understanding of, and access to the MHRA Yellow Card scheme, so that they can promptly report any concerns they have about the safety of healthcare products. The MHRA monitors the number of reports it receives from members of the public and healthcare professionals and strives to keep improving understanding and awareness of the reporting system. The MHRA continually works to encourage reporting of any safety concerns to the Yellow Card scheme and help improve the safe use of medicines and medical devices for everyone. A sharp increase in reporting, mainly from patients, has been seen due to better awareness of the scheme following significant communications activity at the start of the COVID-19 vaccination campaign.[4] Data collection Question: To ask the Secretary of State for Health and Social Care, what assessment he has made of the (a) level and (b) adequacy of data collected by (i) mandatory and (ii) voluntary reporting of adverse clinical events by health professionals before the introduction of the Yellow Card reporting system in England compared to that now collected via the Yellow Card system. Answer: The Medicines and Healthcare products Regulatory Agency (MHRA) has reviewed other international mandatory and non-mandatory reporting systems for healthcare professionals and found limited evidence that making reporting mandatory increases the ability to detect safety signals. Very few international mandatory reporting systems have a better reporting rate or a more successful system for detecting safety signals than the United Kingdom. In both medicines and devices legislation there are requirements for manufacturers to report, but there is no legal obligation for healthcare organisations. However, there are professional body standards and guidelines that make reporting a gold standard for healthcare professionals. The MHRA continues to work with partners across the healthcare system to promote and encourage use of the Yellow Card scheme to help detect safety issues. The MHRA has reviewed global approaches to mandatory reporting in other regulatory systems and continues to consider the approach in the UK as we work to improve reporting capability and functionality through systems.[5] Data analysis Question: To ask the Secretary of State for Health and Social Care, which body has responsibility for analysing data collected by the Adverse Events Yellow Card system; and what assessment has he made of the potential merits of collating this data on a publicly accessible database. Answer: The Medicines and Healthcare products Regulatory Agency (MHRA) collects and analyses the data received through the Yellow Card Scheme, and publishes data on medicines and COVID-19 vaccines in a searchable database on the Yellow Card website for transparency purposes. As outlined in the Yellow Card Privacy Policy, the MHRA has responsibilities under both the UK General Data Protection Regulation and the Data Protection Act 2018 to protect confidential data and personal data pertaining to individuals. The content and format of the data is currently being enhanced in line with patient and healthcare professional feedback and will be expanded to include medical devices in due course. The data provided will continue to be aligned to the MHRA’s legal responsibilities to data subjects.[6] References MHRA, Welcome to the Yellow Card reporting site, Last Accessed 6 June 2023. The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020. Department of Health and Social Care (DHSC), Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021. House of Commons, Yellow Card Scheme, UIN 186945, tabled on 25 May 2023. House of Commons, Yellow Card Scheme, UIN 186944, tabled on 25 May 2023. House of Commons, Yellow Card Scheme, UIN 186946, tabled on 25 May 2023. Related reading A year on from the Cumberlege Review: Initial reflections on the Government’s response (Patient Safety Learning, 23 July 2021) Response to the Select Committee report on the Independent Medicines and Medical Devices Safety Review (Patient Safety Learning, 20 January 2023) Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies (Kath Sansom, 15 April 2021)

May 2023 - aSSKINg Framework, Freedom To Speak Up update, Patient Safety Partners recruitment, missed fractures, supporting staff with patient handling, staff safety. patient-safety-newsletter-may2023.pdf April 2023 - Intentional non-adherence in the context of ART, PSIRF, Patient Safety Partners, blocked catheters, patient moving and handling training. patient-safety-newsletter-april2023.pdf March 2023 - GripAble for upper limb rehabilitation, Mindray C2 AEDs, recruitment for Patient Safety Partners, Clostridium difficile infection, Bivona tracheostomy tube, therapy dogs. patient-safety-newsletter-march2023.pdf February 2023 - Patient feedback, Trust's Patient and Public Voice Policy, Patient Safety Partners, safe wheelchair risk assessment, referral to prolonged jaundice clinic. patient-safety-newsletter-february2023.pdf January 2023 - Dementia friendly ward, National Audit for Inpatient Falls (NAIF), investigation training, CQUINS, ePMA, Health Visitor teams. patient-safety-newsletter-janaury2023.pdf December 2022 - Supporting hydration (HCSW Innovation Idea project), deteriorating patient thematic review, investigation training, checking the right saline, Professional Nurse Advocacy, Medical Device Safety Lead. patient-safety-newsletter-december2022.pdf November 2022 - Reducing the use of fall alarms, wound photography, defining levels of assistance when moving patients, Duty of Candour. patient-safety-newsletter-november2022.pdf October 2022 - Reminiscence Interactive Therapeutic Activities RITA systems, pressure ulcers on heels, post falls checklist, importance of carers care plans, Datix and LfPSE. patient-safety-newsletter-october2022 (1).pdf September 2022 - World Patient Safety Day, ordering and fitting mattress toppers, PSIRF, Sussex interpreting services, risk assessment to prevent pressure sores. patient-safety-newsletter-september2022.pdf August 2022 - Thematic review to discuss falls on the unit, Duty of Candour requirement, reporting a pressure ulcer on Datix, UTC and learning disability health facilitation team table top, care home matrons. patient-safety-newsletter-august2022.pdf July 2022 - Collaboration with the IC24 Roving GP service, critical limb ischaemia, Genius 2 and 3 thermometers, implementing the Patient Safety Strategy, introducing Professional Nurse Advocates and Patient Safety Learning's hub. patient-safety-newsletter-july2022.pdf June 2022 - New visual fluid chart tool, bruising in children who are not independently mobile, end PJ paralysis campaign, investigation training and the importance of personalised communication. patient-safety-newsletter-june2022 (1).pdf May 2022 - Why frailty matters’ week, audit of unstageable pressure ulcers reported on Datix and risk assessing pressure ulcer equipment. patient-safety-newsletter-may2022 (1).pdf April 2022 - ICUs engaging in recent table tops to discuss the falls prevention on the ward, paraffin fire risk leaflet, improving the environment for patients with dementia and safeguarding babies. patient-safety-newsletter-april2022.pdf March 2022 - Patients leaflet on what to expect from therapy during ICU admission and the aim of rehabilitation on the unit, falls alarm, falls in toilets and bathrooms, food fortification, project to develop better tools to monitor food and fluid intake, new or changing confusion, and the importance of end of life care. patient-safety-newsletter-march2022 (1).pdf February 2022 - Homeless Health Inclusion Team, ensuring an MDT falls review, following the no response policy, End of Life Care plan and alerts on SystmOne. patient-safety-newsletter-february2022 (2).pdf January 2022 - patient-centred care, NEWS2 on paper, ensuring safe use of Smartcards, fluid balance charts and the importance of education. patient-safety-newsletter-january2022.pdf December 2021 - a PCN Quality feedback session, the impact of student projects, safe use of wheelchairs on the ICU, the delirium alert on SystmOne and the Herbert protocol patient-safety-newsletter-december2021 (1).pdf November 2021 - hover jacks, taking photos of pressure ulcers, enhanced care assessments, an update from the deteriorating patient and resuscitation lead, and ensuring effective communication. patient-safety-newsletter-november2021 (1).pdf

Risk assessment themes The review identified seven key areas: The language used to discuss and document risk assessments should encourage a dynamic and holistic assessment of the individual pregnant woman/person’s risk (‘dynamic’ means the risk is continually assessed to allow for unknown factors and to handle uncertainty, while ‘holistic’ refers to looking at other factors that might be relevant) that promotes the need for maternity care to be provided by multi-professional teams. Telephone triage services should support 24-hour access to a systematic structured risk assessment of pregnant women/people’s needs. Telephone triage services should be operated by appropriately trained and competent clinicians who are skilled in the specific needs required for effective telephone triage. Face-to-face triage in maternity units should use a structured approach to prioritise pregnant women/people to be seen in order of clinical need. Clinicians should be enabled to proactively monitor and recommend the place of labour care and birth for pregnant women/people based on the individual’s specific care needs during the course of their pregnancy and labour. Each pregnant woman/person should be helped to understand their individualised risk associated with a vaginal or caesarean birth after a previous caesarean birth, based on their specific risk factors and care needs. Pregnant women/people whose labour has been induced need clinical oversight and an individualised plan of care for maternal and fetal monitoring. Prompts for NHS trusts This thematic review also includes prompts for NHS trusts to consider how these risks may be mitigated: Are risk assessment and screening documents designed and presented in a consistent and logical way? Does the language used in risk assessment and screening documents avoid binary definitions of risk, and instead promote dynamic and holistic risk assessments supporting a multi-professional approach? Does risk assessment and screening documentation support a holistic consideration and documentation of risk, or does it focus on only single risk factors? Do telephone triage services facilitate 24-hour support for systematic risk assessment? Are clinicians equipped with the appropriate training, skills and competencies to manage an effective telephone triage service? Is a structured approach used so that pregnant women/people are seen in order of clinical need within your maternity face-to-face triage service? Are there frequent opportunities to revisit and recommend the place of birth based on the pregnant woman/person’s individual needs? Does your risk assessment tool encourage clinicians to think about the most suitable place of birth when a pregnant woman/person in labour is admitted? Do processes support holistic risk assessments to be revisited during labour to proactively assess the most suitable place for fetal monitoring and birth? In antenatal discussions with pregnant woman/people, are structured tools used to support individualised care planning and decision-making when planning a birth after a previous caesarean birth? Is there an opportunity to revisit these discussions when there is a change in circumstance, such as induction of labour? Are clinicians encouraged to make individual plans, taking into consideration a pregnant woman/person’s and baby’s risk during the induction of labour process and including frequency of observations, fetal monitoring and place of induction? Is there a system to prioritise pregnant women/people requiring induction of labour according to clinical need, and to ensure appropriate escalation and action when there are delays?

What is the National Patient Safety Board? Since early 2021 there has been a growing coalition of healthcare organisations and groups calling to create the National Patient Safety Board in the United States.[1] This is a proposed federal agency with the goal of preventing and reducing patient safety events in healthcare settings, modelled after the National Transportation Board and the Commercial Aviation Safety Team.[2] Legislative proposal Nanette Barragán, US representative for California’s 44th Congressional District, has announced the introduction of new legislation intended to establish a National Patient Safety Board as a non-punitive, collaborative, independent agency to address safety in healthcare.[3] Its proposed duties are: Supporting Federal departments and agencies in monitoring and anticipating patient safety events with patient safety data surveillance technologies. Providing expertise to study the context and causes of patient safety events and solutions. Formulating recommendations and solutions to prevent patient safety events from occurring. In carrying out this role, the National Patient Safety Board would be required to submit annual reports to the United States Congress and would also be able to hold hearings, take testimony, receive evidence and issue reports as appropriate. It’s proposed to comprise: Five Board members, each nominated by the President, by and with the advice and consent for the US Senate, for a term of 6 years. A Chair and Vice Chair, designated by the President from among the members of the Board to serve a term of 3 years. It is also proposed that it establishes and maintains a public-private team, known as the Health Care Safety Team, to sit underneath this to review, update and prioritise patient safety event measures and data sources related to patient and provider safety in healthcare settings, including survey data, electronic health records data, claims data, health information exchange data and reports of patient safety events.[4] National Patient Safety Board campaign You can find out more details about the campaign to support the creation of a National Patient Safety Board, and if relevant how to contact your US House member’s office in regards to this, here. References National Patient Safety Board, About, Last Accessed 9 December 2022. National Patient Safety Board, A New Solution to Address the Problem of Medical Errors, 26 July 2022. Business Wire, House Bill Establishes Federal Agency Dedicated to Patient Safety, 8 December 2022. H.R.9377 - 117th Congress (2021-2022): National Patient Safety Board Act of 2022, 1 December 2022.

This document has been developed to support providers of mental health inpatient services that are considering, actively implementing, or who are already advanced in use of vision-based patient monitoring systems (VBPMS) to create or update their protocols, policies, and governance arrangements to support safe use for the benefit of patients and staff. Its aim is to support individual healthcare providing organisations in their current or future use of VBPMS to standardise implementation approaches across the country and provide a platform for sharing learning. Particular attention has been paid to recommendations that underpin governance of the system in addition to its safe, effective, and ethical use. Recommendations from the document should be used at the discretion of each organisation to fit their specific needs and local circumstances.