Asked by: Lord Hunt of Kings Heath (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 dangers to some users of the asthma drug montelukast; and what discussions they have had with the montelukast UK action group, which has highlighted the risks of the drug.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Montelukast remains a safe and effective medicine in the treatment of asthma. Montelukast is indicated for use in the United Kingdom as an add on treatment for asthma patients who are inadequately controlled on inhaled corticosteroid treatment, and can be prescribed for the symptomatic relief of seasonal allergic rhinitis in patients with asthma.
Neuropsychiatric effects such as depression have been included in the UK product information for montelukast since 2007. This has been subsequently updated with additional terms, based on emerging evidence. This includes the most recent update in 2019, to more fully describe the neuropsychiatric effects. In order to remind prescribers of the risk of the neuropsychiatric effects with montelukast, a Drug Safety Update article was published by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2019 to accompany the updated warnings.
Following a growing number of Yellow Card reports and queries from patients and caregivers raising concerns about a potential ongoing lack of awareness of the risk of the neuropsychiatric effects with montelukast, the MHRA is conducting a further review of the latest data. As part of our review, we are evaluating all available evidence including Yellow Card reports and queries received by the MHRA, literature publications, international regulatory changes, including those made by the United States’ Food and Drug Administration, and listening to and learning from patients’ experiences.
The MHRA has sought advice from our independent expert groups including paediatricians, specialists in mental and respiratory health, as well as experts in medicines safety. Patient representatives from the UK action group, including parents of children and young people who had taken montelukast, were invited to the MHRA’s independent pharmacovigilance expert advisory group (PEAG), to share their lived experiences of dealing with the impact of the neuropsychiatric effects, including the impact of lack of awareness of the side effect. The MHRA is finalising the review process and will communicate on any further measures to minimise the risk, upon completion of our review.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of whether the adoption of the British Medical Association’s report Safe Scope of Practice for Medical Associate Professionals (MAPs) would undermine established governance and frameworks.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government considers scope of practice guidance for Anaesthesia Associates (AAs) and Physician Associates (PAs) to be a matter for the Royal College of Anaesthetists (RCoA) and the Royal College of Physicians (RCP) respectively, in conjunction with key stakeholders including other medical royal colleges, the Faculty of Physician Associates (FPA), and the Association of Anaesthesia Associates.
The current scope of practice guidance for AAs, which is applicable across the United Kingdom, is published on the RCoA website. The FPA, which is hosted by the RCP, has also published guidance documents relating to the PA curriculum, code of conduct, and supervision. We understand that both the RCoA and the RCP are currently developing further guidance in collaboration with stakeholders, in relation to supervision and scope of practice.
Once regulation begins, the General Medical Council’s published learning outcomes for AAs and PAs will also apply. This sets out a pre-qualification education framework and the outcomes expected of newly qualified AAs and PAs, including professional behaviours and capabilities and minimum expectations for the knowledge and skills required. In addition, employers of AAs and PAs are responsible for ensuring that appropriate governance and supervision are in place, and that individuals within their employment are practicing within their competence.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of whether the adoption of the British Medical Association’s report Safe Scope of Practice for Medical Associate Professionals (MAPs) would restrict the role of Physician Associates.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government considers scope of practice guidance for Anaesthesia Associates (AAs) and Physician Associates (PAs) to be a matter for the Royal College of Anaesthetists (RCoA) and the Royal College of Physicians (RCP) respectively, in conjunction with key stakeholders including other medical royal colleges, the Faculty of Physician Associates (FPA), and the Association of Anaesthesia Associates.
The current scope of practice guidance for AAs, which is applicable across the United Kingdom, is published on the RCoA website. The FPA, which is hosted by the RCP, has also published guidance documents relating to the PA curriculum, code of conduct, and supervision. We understand that both the RCoA and the RCP are currently developing further guidance in collaboration with stakeholders, in relation to supervision and scope of practice.
Once regulation begins, the General Medical Council’s published learning outcomes for AAs and PAs will also apply. This sets out a pre-qualification education framework and the outcomes expected of newly qualified AAs and PAs, including professional behaviours and capabilities and minimum expectations for the knowledge and skills required. In addition, employers of AAs and PAs are responsible for ensuring that appropriate governance and supervision are in place, and that individuals within their employment are practicing within their competence.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they will issue guidance to the NHS on whether the Government endorses the British Medical Association’s report Safe Scope of Practice for Medical Associate Professionals (MAPs) in relation to Physician and Anaesthesia Associates.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government considers scope of practice guidance for Anaesthesia Associates (AAs) and Physician Associates (PAs) to be a matter for the Royal College of Anaesthetists (RCoA) and the Royal College of Physicians (RCP) respectively, in conjunction with key stakeholders including other medical royal colleges, the Faculty of Physician Associates (FPA), and the Association of Anaesthesia Associates.
The current scope of practice guidance for AAs, which is applicable across the United Kingdom, is published on the RCoA website. The FPA, which is hosted by the RCP, has also published guidance documents relating to the PA curriculum, code of conduct, and supervision. We understand that both the RCoA and the RCP are currently developing further guidance in collaboration with stakeholders, in relation to supervision and scope of practice.
Once regulation begins, the General Medical Council’s published learning outcomes for AAs and PAs will also apply. This sets out a pre-qualification education framework and the outcomes expected of newly qualified AAs and PAs, including professional behaviours and capabilities and minimum expectations for the knowledge and skills required. In addition, employers of AAs and PAs are responsible for ensuring that appropriate governance and supervision are in place, and that individuals within their employment are practicing within their competence.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they will discuss the implications for Physician and Anaesthesia Associates of the British Medical Association report Safe Scope of Practice for Medical Associate Professionals (MAPs) with the United Medical Associate Professionals.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government considers scope of practice guidance for Anaesthesia Associates (AAs) and Physician Associates (PAs) to be a matter for the Royal College of Anaesthetists (RCoA) and the Royal College of Physicians (RCP) respectively, in conjunction with key stakeholders including other medical royal colleges, the Faculty of Physician Associates (FPA), and the Association of Anaesthesia Associates.
The current scope of practice guidance for AAs, which is applicable across the United Kingdom, is published on the RCoA website. The FPA, which is hosted by the RCP, has also published guidance documents relating to the PA curriculum, code of conduct, and supervision. We understand that both the RCoA and the RCP are currently developing further guidance in collaboration with stakeholders, in relation to supervision and scope of practice.
Once regulation begins, the General Medical Council’s published learning outcomes for AAs and PAs will also apply. This sets out a pre-qualification education framework and the outcomes expected of newly qualified AAs and PAs, including professional behaviours and capabilities and minimum expectations for the knowledge and skills required. In addition, employers of AAs and PAs are responsible for ensuring that appropriate governance and supervision are in place, and that individuals within their employment are practicing within their competence.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to ensure NHS England is meeting the Faster Diagnosis Standard for lower gastrointestinal cancer referrals.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department is taking steps to achieve the Faster Diagnosis Standard (FDS), which aims to ensure people with cancer or suspected cancer, including lower gastrointestinal (GI) cancers, are diagnosed or have cancer ruled out within 28 days of referral. The Department is working jointly with NHS England on implementing the delivery plan for tackling the COVID-19 related backlogs in elective care, which includes plans to spend more than £8 billion from 2022/23 to 2024/25 to help drive up and protect elective activity, including cancer diagnosis and treatment.
To achieve the FDS target specifically, NHS England has implemented a timed pathway for lower GI cancer, by requiring faecal immunochemical testing (FIT) for patients in primary and secondary care settings on a suspected lower GI cancer pathway. FIT testing prevents patients from having unnecessary colonoscopies, freeing up capacity for these procedures and ensuring the most urgent symptomatic patients are seen more quickly. Across 2022/2023 the proportion of lower GI referrals with a related FIT test rose from 24% to 69%.
NHS England is also implementing non symptom specific pathways for patients who present with non-specific symptoms, or combinations of non-specific symptoms, that can indicate several different cancers, including symptoms that may indicate lower GI cancers.
In addition, at the 2021 Spending Review the Government awarded £2.3 billion to transform diagnostic services from 2022 to 2025, most of which will help increase the number of community diagnostic centres (CDCs) up to 160 by March 2025, prioritising CDCs for cancer services. General practice teams have also been given direct access to tests like computed tomography scans, magnetic resonance imaging, and ultrasounds, helping to cut waiting times and speed up the diagnosis of, or ruling out of, cancer. This funding is also being used to expand endoscopy capacity within acute settings and in CDCs.
Asked by: Lord Hunt of Kings Heath (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 level of awareness by doctors of any dangers of the commonly prescribed drug montelukast, as highlighted by the US Food and Drug Administration in March 2020, that the use of the drug resulted in “a wide variety of mental health side effects have been reported, including completed suicides".
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Montelukast remains a safe and effective medicine in the treatment of asthma. Montelukast is indicated for use in the United Kingdom as an add on treatment for asthma patients who are inadequately controlled on inhaled corticosteroid treatment, and can be prescribed for the symptomatic relief of seasonal allergic rhinitis in patients with asthma. There is no licensed indication in the UK for the treatment of allergic rhinitis alone.
Neuropsychiatric effects such as depression have been included in the UK product information for montelukast since 2007. This has been subsequently updated with additional terms based on emerging evidence. This includes the most recent update in 2019, which more fully described the neuropsychiatric effects. In order to remind prescribers of the risk of neuropsychiatric effects with montelukast, a Drug Safety Update article was published by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2019, to accompany the updated warnings.
Following a growing number of Yellow Card reports and queries from patients and caregivers, raising concerns about a potential ongoing lack of awareness of the risk of the neuropsychiatric effects with montelukast, the MHRA is conducting a further review of the current data.
As part of our review, we are evaluating all available evidence, including Yellow Card reports and queries received by the MHRA, literature publications, international regulatory changes, including those made by the United States’ Food and Drug Administration, and are listening to and learning from patients’ experiences. The MHRA has sought advice from our independent expert groups including paediatricians, specialists in mental and respiratory health, as well as experts in medicines safety.
We are considering all relevant regulatory actions that would provide the most effective way of increasing awareness to healthcare professionals, patients, and their caregivers. The MHRA is finalising the review process and will communicate on any further measures to minimise the risk, upon completion of our review.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, in relation to the use of montelukast in the UK, what assessment they have made of the US Food and Drug Administration's issuing a “black box warning” in March 2020 about serious mental health side effects of the drug and restricting its use for allergic rhinitis.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Montelukast remains a safe and effective medicine in the treatment of asthma. Montelukast is indicated for use in the United Kingdom as an add on treatment for asthma patients who are inadequately controlled on inhaled corticosteroid treatment, and can be prescribed for the symptomatic relief of seasonal allergic rhinitis in patients with asthma. There is no licensed indication in the UK for the treatment of allergic rhinitis alone.
Neuropsychiatric effects such as depression have been included in the UK product information for montelukast since 2007. This has been subsequently updated with additional terms based on emerging evidence. This includes the most recent update in 2019, which more fully described the neuropsychiatric effects. In order to remind prescribers of the risk of neuropsychiatric effects with montelukast, a Drug Safety Update article was published by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2019, to accompany the updated warnings.
Following a growing number of Yellow Card reports and queries from patients and caregivers, raising concerns about a potential ongoing lack of awareness of the risk of the neuropsychiatric effects with montelukast, the MHRA is conducting a further review of the current data.
As part of our review, we are evaluating all available evidence, including Yellow Card reports and queries received by the MHRA, literature publications, international regulatory changes, including those made by the United States’ Food and Drug Administration, and are listening to and learning from patients’ experiences. The MHRA has sought advice from our independent expert groups including paediatricians, specialists in mental and respiratory health, as well as experts in medicines safety.
We are considering all relevant regulatory actions that would provide the most effective way of increasing awareness to healthcare professionals, patients, and their caregivers. The MHRA is finalising the review process and will communicate on any further measures to minimise the risk, upon completion of our review.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of any dangers to some users of the commonly prescribed asthma drug montelukast.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Montelukast remains a safe and effective medicine in the treatment of asthma. Montelukast is indicated for use in the United Kingdom as an add on treatment for asthma patients who are inadequately controlled on inhaled corticosteroid treatment, and can be prescribed for the symptomatic relief of seasonal allergic rhinitis in patients with asthma. There is no licensed indication in the UK for the treatment of allergic rhinitis alone.
Neuropsychiatric effects such as depression have been included in the UK product information for montelukast since 2007. This has been subsequently updated with additional terms based on emerging evidence. This includes the most recent update in 2019, which more fully described the neuropsychiatric effects. In order to remind prescribers of the risk of neuropsychiatric effects with montelukast, a Drug Safety Update article was published by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2019, to accompany the updated warnings.
Following a growing number of Yellow Card reports and queries from patients and caregivers, raising concerns about a potential ongoing lack of awareness of the risk of the neuropsychiatric effects with montelukast, the MHRA is conducting a further review of the current data.
As part of our review, we are evaluating all available evidence, including Yellow Card reports and queries received by the MHRA, literature publications, international regulatory changes, including those made by the United States’ Food and Drug Administration, and are listening to and learning from patients’ experiences. The MHRA has sought advice from our independent expert groups including paediatricians, specialists in mental and respiratory health, as well as experts in medicines safety.
We are considering all relevant regulatory actions that would provide the most effective way of increasing awareness to healthcare professionals, patients, and their caregivers. The MHRA is finalising the review process and will communicate on any further measures to minimise the risk, upon completion of our review.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they are taking steps to ensure that NHS organisations assess the purchase of absorbent continence products and their dispensation to patients based on (1) their impact on patient experience and outcomes, (2) whole-system costs, (3) laundry costs, including energy use, and (4) environmental impact, as well as item price; and what assessment they have made of the savings that would accrue to such organisations in doing so.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The disposable continence tender is due to be issued to the market later this year. To ensure that the National Health Services requirements are considered during the procurement process, the NHS Supply Chain are undertaking significant engagement across the health and social care system. This includes customers in the acute and wider community setting, suppliers, trade associations, professional bodies, and end user reference groups, to understand their requirements from a commercial, value, sustainability, and supply resilience perspective.
The NHS Supply Chain are currently working with suppliers of disposable continence products to understand the value-based procurement and sustainability offerings on the purchase of continence products. The NHS Supply Chain have identified a trust who are committed to supporting us in understanding this value, in the form of a pilot study and potential case study. More information can be provided once these studies have been finalised and confirmed.
To support value-based procurement decisions more broadly across medical technologies, a standard methodology is being developed to assess the value of medical technology beyond upfront cost alone. It is intended that this will support the adoption of products which demonstrate value to the whole system, and ensure the best products are reaching patients.
The Government is working closely with NHS England and wider health partners to develop the methodology and plans for implementation at both a national and local level. The Government is committed to working collaboratively with industry and the procurement community in developing the methodology and will share an initial proposal in due course.