Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many prescriptions for mirtazapine were issued in each year since 2014; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA received for mirtazapine in each year since 2014; and what consideration NHS England has given to adding sexual dysfunction as a side effect on the patient information leaflets for mirtazapine.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The following table shows the total number of items issued for mirtazapine, each year since 2014 to 2023:
Time Period | Total items issued |
2014 | 6,056,918 |
2015 | 6,783,906 |
2016 | 7,526,200 |
2017 | 8,198,345 |
2018 | 8,938,362 |
2019 | 9,702,599 |
2020 | 10,532,577 |
2021 | 11,249,963 |
2022 | 11,776,025 |
2023 | 12,401,593 |
Source: Data was provided by the NHS Business Services Authority, using the British National Formulary chemical substance mirtazapine
Note: Items have been dispensed, but not necessarily prescribed, in England.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses available data, including from the Yellow Card scheme, and seeks advice from their independent advisory committee, the Commission on Human Medicines, where appropriate to inform regulatory decisions.
The MHRA has received a total of 46 Yellow Card reports of sexual dysfunction related reactions suspected to be associated with mirtazapine, four of which include information that suggest the suspected adverse reactions persisted after mirtazapine was withdrawn. The following table shows the number of Yellow Card reports of suspected mirtazapine related sexual dysfunction, and reports of sexual dysfunction that persisted after the drug was withdrawn, each year from 2014 to 2024:
Year | Reports of sexual dysfunction | Reports of sexual dysfunction that continued after mirtazapine was withdrawn |
2014 | 3 | 0 |
2015 | 1 | 0 |
2016 | 2 | 0 |
2017 | 3 | 0 |
2018 | 1 | 0 |
2019 | 5 | 1 |
2020 | 3 | 0 |
2021 | 5 | 1 |
2022 | 10 | 1 |
2023 | 9 | 0 |
2024 | 4 | 1 |
Source: data provided by the MHRA.
It is important to note that the inclusion of a particular report on the MHRA’s system does not necessarily mean that the adverse reactions reported have been caused by the suspect drug. Additionally, the number of reports received should not be used as a basis for determining the incidence of a reaction, as neither the total number of reactions occurring, nor the number of patients using the drug, is known.
The MHRA continuously monitors the safety of medicines on the United Kingdom’s market, including mirtazapine. Reports of suspected adverse reactions are reviewed weekly by a multidisciplinary team as part of the MHRA’s signal detection process. The term signal is used to define any suspected adverse reaction or potential safety concern that requires further evaluation.
Responsibility for adding a side effect to the product information leaflet sits with the MHRA. The product information for mirtazapine reflects the data currently available, and does not include sexual dysfunction as a possible side effect. However, data from Yellow Card reports and other sources such as published studies and periodic safety assessments are kept under continuous review by the MHRA. The marketing authorisation holder has recently submitted the latest periodic safety update report to the MHRA, and this will be carefully assessed. If there is sufficient evidence and associated data about the potential to experience sexual dysfunction as a side effect, the patient information for mirtazapine can be updated.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, on what date work on digitally linking Medicines and Healthcare products Regulatory Authority Yellow Card information to NHS clinical records (a) began and (b) is expected to be completed.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) has been working with the National Health Service to explore approaches to facilitate digital linkage of Yellow Card information to clinical records, and to potentially enable faster access to information, where considered necessary for an assessment. Any such approach would be subject to strict information governance controls and prior consultation with stakeholder groups.
In 2020, the MHRA began delivery of a substantially enhanced Yellow Card platform under the SafetyConnect programme, aligned to the recommendations in Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review. The new infrastructure is designed with the intent of enabling connectivity to other systems, to facilitate the exchange of information. During that time the MHRA has engaged with the NHS around the evolving technical options for robust and secure connectivity and enhanced user journeys. The first step in these enhancements is use of the common NHS login capability within Yellow Card, which is expected to go live in 2024.
Deeper connectivity between systems will be subject to internal and external stakeholder engagement and substantial information governance controls, with elements completed over a phased and multi-year work plan.
Asked by: Lord Campbell-Savours (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the case for reviewing the expiry dates of antibiotics, including in respect of savings for public expenditure.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA), the Government agency responsible for ensuring that medicines and medical devices work and are acceptably safe, has not made an assessment on the case for reviewing the expiry dates of antibiotics.
Medicine expiry dates, including for antibiotics, are necessary to ensure that the safety and effectiveness of a medicine is maintained over its long-term shelf life. The active ingredient in many medicines can degrade over time resulting in a loss of potency or the formation of impurities in the product. Physical changes to a medicine such as discolouration, may also occur upon prolonged storage. Medicine expiry dates are supported by stability studies completed by the pharmaceutical company, which demonstrate that a medicine remains safe and effective throughout its shelf life. Any change to the expiry date of a medicine requires an independent review of the stability data by the MHRA.
Companies can and often do extend the shelf life of their medicines once the product is on the market, and as additional stability data become available. It is not possible, however, to extend the expiry date of all medicines unilaterally in the absence of supporting stability data.
Asked by: Lord Norton of Louth (Conservative - Life peer)
Question to the Cabinet Office:
To ask His Majesty's Government, further to the Written Answer by Baroness Neville-Rolfe on 8 February (HL1937), whether they will list the 19 non-statutory and 23 statutory inquiries established under the Inquiries Act 2005, along with the (1) length, (2), cost, and (3) sponsoring department, for each of those inquiries.
Answered by Baroness Neville-Rolfe - Minister of State (Cabinet Office)
The Cabinet Office collects data on the duration and cost of inquiries from departments, inquiries’ own reports, and other publicly available information.
We have provided details on all statutory and non-statutory inquiries established since 2005 in the table below.
In some cases, information in the table below has come from reports from outside the Government. We have not included the costs for ongoing inquiries, which are published at different frequencies on inquiry or departmental websites, and we have not included the details for any investigations commissioned by NHS England (some of which were counted in the total number of non-statutory inquiries in our previous response, answered on 8th February 2024, UIN HL1937). It has been noted where the publicly available information provides the cost excluding VAT.
Inquiry | Sponsor Department | Legislative Basis | Year established | Duration in months (from announcement to publication of final report) | Reported final costs where publicly available |
Jalal Uddin Inquiry | HO | Inquiries Act 2005 | 2023 | Ongoing | - |
Cranston Inquiry | DfT | Non-statutory | 2023 | Ongoing | - |
Andrew Malkinson Inquiry | MoJ | Non-statutory | 2023 | Ongoing | - |
Thirlwall Inquiry | DHSC | Inquiries Act 2005 | 2023 | Ongoing | - |
Inquiry into the preventability of the Omagh bombing | NIO | Inquiries Act 2005 | 2023 | Ongoing | - |
Independent inquiry relating to Afghanistan | Ministry of Defence | Inquiries Act 2005 | 2022 | Ongoing | - |
Dawn Sturgess Inquiry | HO | Inquiries Act 2005 | 2022 | Ongoing | - |
Fuller Inquiry | DHSC | Non-statutory | 2022 | Ongoing | - |
Angiolini Inquiry | HO | Non-statutory | 2022 | Ongoing | - |
UK Covid-19 Inquiry | Cabinet Office | Inquiries Act 2005 | 2022 | Ongoing | - |
Lampard Inquiry | DHSC | Inquiries Act 2005 | 2021 | Ongoing | - |
Jermaine Baker inquiry | HO | Inquiries Act 2005 | 2020 | 29 | £4.1m |
Post Office Horizon IT inquiry | DBT | Inquiries Act 2005 | 2020 | Ongoing | - |
Manchester Arena inquiry | HO | Inquiries Act 2005 | 2019 | 41 | £35.6m |
Brook House Inquiry | HO | Inquiries Act 2005 | 2019 | 46 | £18.7m |
The Independent Medicines and Medical Devices Safety Review | Department of Health | Non-statutory | 2018 | 29 | £1.7m |
Independent Inquiry into the issues raised by Ian Paterson | Department of Health | Non-statutory | 2018 | 26 | £1.9m |
Grenfell Tower Inquiry | Cabinet Office | Inquiries Act 2005 | 2017 | Ongoing | - |
Infected Blood Inquiry | Cabinet Office | Inquiries Act 2005 | 2017 | Ongoing | - |
Independent inquiry into the award of the Magnox decommissioning contract by the Nuclear Decommissioning Authority (NDA) and its subsequent termination | BEIS | Non-statutory | 2017 | 48 | [unknown] |
Anthony Grainger Inquiry | HO | Inquiries Act 2005 | 2016 | 40 | £2.6m |
The Independent Inquiry into Child Sexual Abuse | HO | Inquiries Act 2005 | 2015 | 99 | £192.7m (as of Dec 2022) |
Undercover Policing Inquiry | HO | Inquiries Act 2005 | 2015 | Ongoing | - |
Gosport Independent Panel | Department of Health | Non-statutory | 2014 | 42 | £13m |
The Litvinenko Inquiry | HO, FCO and 3 x Intelligence Agencies | Inquiries Act 2005 | 2014 | 18 | £2.4m (exc. VAT) |
Harris Review / Independent review of self-inflicted deaths of young adults in custody aged between 18 and 24 | MoJ | Non-statutory | 2014 | 17 | £0.2m |
The Morecambe Bay Maternity and Neonatal Services Investigation | Department of Health | Non-statutory | 2013 | 18 | £1.1m |
Daniel Morgan Independent Panel | HO | Non-statutory | 2013 | 97 | £17.6m |
The Leveson Inquiry | DCMS and HO | Inquiries Act 2005 | 2011 | 16 | £5.4m |
The Azelle Rodney Inquiry | MoJ | Inquiries Act 2005 | 2010 | 40 | £2.6m |
Mid Staffordshire NHS Foundation Trust Inquiry 2013 / The Francis Inquiry | Department of Health | Inquiries Act 2005 | 2010 | 36 | £13.7m |
The Detainee Inquiry | Cabinet Office | Non-statutory (Committee of Privy Counsellors) | 2010 | 45 | £2.3m (exc. VAT) |
The Hillsborough Independent Panel | HO | Non-statutory | 2009 | 33 | Less than £5m |
The Al Sweady Inquiry | MoD | Inquiries Act 2005 | 2009 | 61 | £24.9m (exc. VAT) |
Independent Inquiry into care provided by Mid Staffordshire NHS Foundation Trust January 2001 – March 2009 | Department of Health | Non-statutory | 2009 | 7 | - |
The Iraq Inquiry / The Chilcot Inquiry | Cabinet Office, FCO, DfID | Non-statutory (Committee of Privy Counsellors) | 2009 | 85 | £13.1m |
The Bernard (Sonny) Lodge Inquiry | MoJ | Inquiries Act 2005 | 2009 | 10 | £0.4m |
The Baha Mousa Inquiry | MoD | Inquiries Act 2005 | 2008 | 39 | £13m |
Inquiry into Human Tissue Analysis in UK Nuclear Facilities / Redfern Inquiry | DTI - BERR - DECC | Non-statutory | 2007 | 43 | - |
Contaminated Blood and Blood Products Inquiry | Department of Health | Non-statutory | 2007 | 48 | £75k |
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question
To ask the Minister for Women and Equalities, If she will make an assessment of the potential impact on women's health of the Government's progress on implementing the recommendations of the report of the Independent Medicines and Medical Devices Safety Review entitled First Do No Harm, published on 8 July 2020.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Patient safety and women’s health is a top priority for this Government.
That’s why since the ‘First Do No Harm’ report we have:
o Appointed England’s first Patient Safety Commissioner
o Setup specialist centres for women impacted by mesh
o Piloted ways doctors can declare their interests
o And launched a national mandatory Medical Device Outcome Registry.
Beyond this, we published the first Women’s Health Strategy for England, which set out our plans for improving how the health and care system listens to women.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Independent Medicines and Medical Devices Safety Review report First Do No Harm, published on 8 July 2020, what discussions they have had regarding the provision of monetary compensation for people adversely affected by clinical and surgical pelvic mesh.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government has asked the Patient Safety Commissioner, Dr Henrietta Hughes, to undertake work looking at redress for people harmed by pelvic mesh and sodium valproate. The work is intended to focus on the views of those affected, improving the understanding of how many people have been affected and how, the case for redress and what form it could take.
The Patient Safety Commissioner office has stated that the report setting out the findings from this work is expected to be published on 7 February this year. The Government will consider the report’s findings before deciding how to proceed on this matter.
The Government published its response to the Independent Medicines and Medical Devices Safety review in July 2021, which did not accept the recommendation to establish a redress agency, this position remains unchanged.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what recent assessment they have made of the recommendation for an Independent Redress Agency in the Independent Medicines and Medical Devices Safety Review report First Do No Harm, published on 8 July 2020.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government has asked the Patient Safety Commissioner, Dr Henrietta Hughes, to undertake work looking at redress for people harmed by pelvic mesh and sodium valproate. The work is intended to focus on the views of those affected, improving the understanding of how many people have been affected and how, the case for redress and what form it could take.
The Patient Safety Commissioner office has stated that the report setting out the findings from this work is expected to be published on 7 February this year. The Government will consider the report’s findings before deciding how to proceed on this matter.
The Government published its response to the Independent Medicines and Medical Devices Safety review in July 2021, which did not accept the recommendation to establish a redress agency, this position remains unchanged.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government when they intend to implement all of the recommendations contained in the Independent Medicines and Medical Devices Safety Review report First Do No Harm, published on 8 July 2020.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety (IMMDS) Review was clear in its finding that the healthcare system failed to listen to patients’ concerns on the issues covered by the review. The Government’s 2021 response to the review set out which of the review’s recommendations the Government had accepted. We also published an update in an online-only format in December 2022 setting out progress made against those recommendations, which includes appointing the first ever Patient Safety Commissioner in England to champion patients’ voices in relation to the safety of medicines and medical devices. In April 2023, the Government also responded to the recommendations made by the Health and Social Care Committee in its report ‘Follow-up on the IMMDS report and the Government’s response’, published in January 2023. A copy of the follow-up report is attached.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the Independent Medicines and Medical Devices Safety Review report First Do No Harm, published on 8 July 2020.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety (IMMDS) Review was clear in its finding that the healthcare system failed to listen to patients’ concerns on the issues covered by the review. The Government’s 2021 response to the review set out which of the review’s recommendations the Government had accepted. We also published an update in an online-only format in December 2022 setting out progress made against those recommendations, which includes appointing the first ever Patient Safety Commissioner in England to champion patients’ voices in relation to the safety of medicines and medical devices. In April 2023, the Government also responded to the recommendations made by the Health and Social Care Committee in its report ‘Follow-up on the IMMDS report and the Government’s response’, published in January 2023. A copy of the follow-up report is attached.
Asked by: Damien Moore (Conservative - Southport)
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 support people who have experienced harm as a result of the hormone pregnancy drug Primodos.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
As we announced following the Independent Medicines and Medical Devices Safety (IMMDS) Review, which covered Primodos, our priority is to make medicines and devices safer, and the Government is pursuing a wide range of activity to further this aim.
Our 2021 response to the IMMDS Review and December 2022 update explains the changes that have been put in place since the Review’s report publication, and the further action we will take to implement the recommendations accepted and to improve patient safety. This includes appointing Dr Henrietta Hughes as the first ever Patient Safety Commissioner in England to champion patients’ voices in relation to the safety of medicines and medical devices.