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Written Question
Yellow Card Scheme
Monday 5th June 2023

Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)

Question to the Department of Health and Social Care:

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.

Answered by Will Quince

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.


Written Question
Yellow Card Scheme
Monday 5th June 2023

Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)

Question to the Department of Health and Social Care:

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.

Answered by Will Quince

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.


Written Question
Health and Care Act 2022
Wednesday 10th May 2023

Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department plans to bring forward regulations under section 92 of the Health and Social Care Act 2022.

Answered by Will Quince

The Department is developing a public consultation on the disclosure of industry payments to the healthcare sector. The consultation will seek views on the possible introduction of regulations through new secondary legislation. We anticipate this will launch in summer 2023. There is currently no confirmed date for any subsequent regulations to be laid.


Written Question
Occupational Therapy: Staff
Tuesday 9th May 2023

Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Royal College of Occupational Therapist's Workforce survey report 2023, what assessment he has made of the implications for his policies of that report's findings; and whether he plans to steps to implement that report's recommendations.

Answered by Will Quince

To support the workforce as a whole we have commissioned NHS England to develop a Long Term Workforce Plan, which will include independently verified forecasts for the number of healthcare professionals required in future years.

The Royal College of Occupational Therapy have had the opportunity to meet and share evidence with the NHS England team developing the Long Term Workforce Plan.

The Government has and will continue to prioritise investment into the National Health Service. The Long Term Workforce plan will help ensure that we have the right numbers of staff, with the right skills to transform and deliver high quality services fit for the future.


Written Question
NHS: Drugs
Tuesday 9th May 2023

Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has held discussions with the (a) National Homecare Medicines Committee, (b) Care Quality Commission and (c) General Pharmaceutical Council on the British Society for Rheumatology's views on the safety and performance of homecare medicines services.

Answered by Will Quince

The Department is aware of the British Society for Rheumatology’s (BSR) concerns about the homecare medicines service. Providers of homecare medicine services to National Health Service patients do so under framework agreements which may be held at national, regional or local level. This therefore requires a high degree of centralised co-ordination for which the National Homecare Medicines Committee (NHMC) supports and advises the NHS. The Committee liaises with homecare providers through their trade association, the National Clinical Homecare Association (NCHA), to support and co-ordinate development of the homecare market and discuss any system-wide issues.

The NHMC and the NCHA have met with the BSR to discuss their concerns about the safety and performance of homecare medicines services. Proposals are currently being discussed between the parties to establish a formal, ongoing dialogue which may also include representation from other medical specialties and stakeholders.

The NHMC appointed a new chair to start on the 1 May 2023. NHMC meetings will continue to be undertaken in line with their terms of reference.


Written Question
National Homecare Medicines Committee
Tuesday 9th May 2023

Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what his Department’s planned timescale is to recruit a new Chair of the National Homecare Medicines Committee; and whether the Committee plans to continue to meet in the interim period.

Answered by Will Quince

The Department is aware of the British Society for Rheumatology’s (BSR) concerns about the homecare medicines service. Providers of homecare medicine services to National Health Service patients do so under framework agreements which may be held at national, regional or local level. This therefore requires a high degree of centralised co-ordination for which the National Homecare Medicines Committee (NHMC) supports and advises the NHS. The Committee liaises with homecare providers through their trade association, the National Clinical Homecare Association (NCHA), to support and co-ordinate development of the homecare market and discuss any system-wide issues.

The NHMC and the NCHA have met with the BSR to discuss their concerns about the safety and performance of homecare medicines services. Proposals are currently being discussed between the parties to establish a formal, ongoing dialogue which may also include representation from other medical specialties and stakeholders.

The NHMC appointed a new chair to start on the 1 May 2023. NHMC meetings will continue to be undertaken in line with their terms of reference.


Written Question
Chronic Illnesses: Drugs
Tuesday 9th May 2023

Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that people with (a) arthritis and (b) other long-term conditions who receive homecare medicines services (i) receive medicine doses and (ii) other treatment promptly.

Answered by Will Quince

National Homecare Medicines Committee (NHMC) regional lead members and NHS England Commercial Medicines Unit use and reference the Royal Pharmaceutical Society Standards for homecare medicines service, which are embedded into all framework agreement service specifications for the providers of this service. These professional standards provide a broad framework which support teams involved in homecare services to deliver a safe, effective and quality-driven service for patients. These standards can be found at the following link:

https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Professional%20standards/Professional%20standards%20for%20Homecare%20services/homecare-standards-final-sept-13.pdf

In 2014, the Royal Pharmaceutical Society published the Handbook for Homecare Services in England to aid implementation of these standards. This identified examples of good practice which may be used by homecare teams to develop robust arrangements for compliance with those standards. The NHMC holds regular meetings with all homecare providers focused on Key Performance Indicators (KPIs) for standards based on those contained in Appendix 10 National KPI definitions of the Handbook for Homecare Services in England.

Homecare providers are assessed on a monthly basis against their KPIs at a national level for NHS England framework agreements and at a regional level for National Health Service regional contracting, and more formally on a regular basis through face-to-face meetings with NHMC and NHS England. The quality assurance and governance process covers the monitoring of patients’ adverse events, complaints and incidents.

When the KPIs from individual contracts or reports from NHS hospitals indicate that service levels are not to the high standard expected, the NHMC Supplier Engagement sub-group has an escalation process.

Each Chief Pharmacist within each NHS organisation is the responsible officer for the homecare medicines services that the hospital provides. Where the escalation process is in place, the affected homecare provider will engage with this process and provide communication to each NHS organisation with a summary of the issues, mitigations and expected timescales for recovery. If necessary, the regulators, the Care Quality Commission and the General Pharmaceutical Council, are also informed.


Written Question
NHS: Reviews
Tuesday 9th May 2023

Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to help address feedback raised by patients in NHS reviews; and what steps he is taking to improve homecare medicines services.

Answered by Will Quince

National Homecare Medicines Committee (NHMC) regional lead members and NHS England Commercial Medicines Unit use and reference the Royal Pharmaceutical Society Standards for homecare medicines service, which are embedded into all framework agreement service specifications for the providers of this service. These professional standards provide a broad framework which support teams involved in homecare services to deliver a safe, effective and quality-driven service for patients. These standards can be found at the following link:

https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Professional%20standards/Professional%20standards%20for%20Homecare%20services/homecare-standards-final-sept-13.pdf

In 2014, the Royal Pharmaceutical Society published the Handbook for Homecare Services in England to aid implementation of these standards. This identified examples of good practice which may be used by homecare teams to develop robust arrangements for compliance with those standards. The NHMC holds regular meetings with all homecare providers focused on Key Performance Indicators (KPIs) for standards based on those contained in Appendix 10 National KPI definitions of the Handbook for Homecare Services in England.

Homecare providers are assessed on a monthly basis against their KPIs at a national level for NHS England framework agreements and at a regional level for National Health Service regional contracting, and more formally on a regular basis through face-to-face meetings with NHMC and NHS England. The quality assurance and governance process covers the monitoring of patients’ adverse events, complaints and incidents.

When the KPIs from individual contracts or reports from NHS hospitals indicate that service levels are not to the high standard expected, the NHMC Supplier Engagement sub-group has an escalation process.

Each Chief Pharmacist within each NHS organisation is the responsible officer for the homecare medicines services that the hospital provides. Where the escalation process is in place, the affected homecare provider will engage with this process and provide communication to each NHS organisation with a summary of the issues, mitigations and expected timescales for recovery. If necessary, the regulators, the Care Quality Commission and the General Pharmaceutical Council, are also informed.


Written Question
NHS: Drugs
Tuesday 9th May 2023

Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps the Government takes to respond to complaints on the reliability of homecare medicines services.

Answered by Will Quince

National Homecare Medicines Committee (NHMC) regional lead members and NHS England Commercial Medicines Unit use and reference the Royal Pharmaceutical Society Standards for homecare medicines service, which are embedded into all framework agreement service specifications for the providers of this service. These professional standards provide a broad framework which support teams involved in homecare services to deliver a safe, effective and quality-driven service for patients. These standards can be found at the following link:

https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Professional%20standards/Professional%20standards%20for%20Homecare%20services/homecare-standards-final-sept-13.pdf

In 2014, the Royal Pharmaceutical Society published the Handbook for Homecare Services in England to aid implementation of these standards. This identified examples of good practice which may be used by homecare teams to develop robust arrangements for compliance with those standards. The NHMC holds regular meetings with all homecare providers focused on Key Performance Indicators (KPIs) for standards based on those contained in Appendix 10 National KPI definitions of the Handbook for Homecare Services in England.

Homecare providers are assessed on a monthly basis against their KPIs at a national level for NHS England framework agreements and at a regional level for National Health Service regional contracting, and more formally on a regular basis through face-to-face meetings with NHMC and NHS England. The quality assurance and governance process covers the monitoring of patients’ adverse events, complaints and incidents.

When the KPIs from individual contracts or reports from NHS hospitals indicate that service levels are not to the high standard expected, the NHMC Supplier Engagement sub-group has an escalation process.

Each Chief Pharmacist within each NHS organisation is the responsible officer for the homecare medicines services that the hospital provides. Where the escalation process is in place, the affected homecare provider will engage with this process and provide communication to each NHS organisation with a summary of the issues, mitigations and expected timescales for recovery. If necessary, the regulators, the Care Quality Commission and the General Pharmaceutical Council, are also informed.


Written Question
NHS: Drugs
Tuesday 9th May 2023

Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department are taking to improve the quality of homecare medicines services.

Answered by Will Quince

National Homecare Medicines Committee (NHMC) regional lead members and NHS England Commercial Medicines Unit use and reference the Royal Pharmaceutical Society Standards for homecare medicines service, which are embedded into all framework agreement service specifications for the providers of this service. These professional standards provide a broad framework which support teams involved in homecare services to deliver a safe, effective and quality-driven service for patients. These standards can be found at the following link:

https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Professional%20standards/Professional%20standards%20for%20Homecare%20services/homecare-standards-final-sept-13.pdf

In 2014, the Royal Pharmaceutical Society published the Handbook for Homecare Services in England to aid implementation of these standards. This identified examples of good practice which may be used by homecare teams to develop robust arrangements for compliance with those standards. The NHMC holds regular meetings with all homecare providers focused on Key Performance Indicators (KPIs) for standards based on those contained in Appendix 10 National KPI definitions of the Handbook for Homecare Services in England.

Homecare providers are assessed on a monthly basis against their KPIs at a national level for NHS England framework agreements and at a regional level for National Health Service regional contracting, and more formally on a regular basis through face-to-face meetings with NHMC and NHS England. The quality assurance and governance process covers the monitoring of patients’ adverse events, complaints and incidents.

When the KPIs from individual contracts or reports from NHS hospitals indicate that service levels are not to the high standard expected, the NHMC Supplier Engagement sub-group has an escalation process.

Each Chief Pharmacist within each NHS organisation is the responsible officer for the homecare medicines services that the hospital provides. Where the escalation process is in place, the affected homecare provider will engage with this process and provide communication to each NHS organisation with a summary of the issues, mitigations and expected timescales for recovery. If necessary, the regulators, the Care Quality Commission and the General Pharmaceutical Council, are also informed.