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 trazodone have been issued in each year since 2014; how many 'Yellow Card' reports of sexual dysfunction and persistent sexual dysfunction in respect of trazodone the MHRA has received 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 trazodone.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The following table shows the total number of items issued for trazodone from 2014 to 2023, and from January to May 2024:
Year | Total number of items |
2014 | 1,050,069 |
2015 | 1,083,974 |
2016 | 1,112,437 |
2017 | 1,133,363 |
2018 | 1,157,717 |
2019 | 1,168,715 |
2020 | 1,191,060 |
2021 | 1,226,973 |
2022 | 1,238,983 |
2023 | 1,281,049 |
2024 | 553,866 |
Source: data was provided by the NHS Business Service Authority, based on information within the Prescription Cost Analysis published statistics, using British National Formulary chemical substance trazodone hydrochloride.
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 the available data, including from the Yellow Card scheme, and where appropriate it seeks advice from its independent advisory committee, the Commission on Human Medicines, to inform on regulatory decisions, including the amending of product information.
The MHRA has received a total of 20 Yellow Card reports of sexual dysfunction related reactions, suspected to be associated with trazodone, between 1 January 2014 and 29 July 2024. This includes reactions grouped under the medical dictionary’s (MedDRA) Higher Level Terms, which are more specific than sexual dysfunction and persistent sexual dysfunction, and include erection and ejaculation conditions and disorders, orgasmic disorders and disturbances, sexual arousal disorders, and others. The following table shows the number of spontaneous suspected Yellow Card reports of sexual dysfunction related reactions suspected to be associated with trazodone in the United Kingdom, received by the MHRA each year from 2014 to 2024:
Year | Reports of sexual dysfunction |
2014 | 1 |
2015 | 2 |
2016 | 2 |
2017 | 1 |
2018 | 1 |
2019 | 2 |
2020 | 2 |
2021 | 1 |
2022 | 5 |
2023 | 2 |
2024 | 1 |
Source: data provided by the MHRA.
“Persistent sexual dysfunction” does not represent a specific medical condition, so this precise term is not a category available for a structured search of the MHRA’s Adverse Drug Reaction database. The structured data field search terms are drawn from the regulatory drugs dictionary, MedDRA, or from terms adopted in clinical coding guidance such as The Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, or the International Classification of Diseases 11th Revision. A search of the database would therefore rely on manual assessment of individual cases.
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 product information for trazodone, which includes the patient information leaflet, reflects the data currently available, and does not include sexual dysfunction as a possible side effect but does include priapism, the prolonged erection of the penis. The Summary of Product Characteristics for healthcare professionals states that there have been reports of priapism which have required surgical intervention, or led to permanent sexual dysfunction. Patients developing priapism should stop using trazodone immediately.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 26 March (HL3163), in each year since 2014, how many prescriptions for vortioxetine were issued; what was the annual cost to the National Health Service of those prescriptions; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA received for vortioxetine; and what consideration has NHS England given to adding sexual dysfunction as a side effect on the patient information leaflets for vortioxetine.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The following table shows the number of items issued for vortioxetine and the net ingredient cost (NIC) from 2014 to 2023, and from January to May of 2024:
Year | Items issued | Total NIC |
2014 | 0 | £0 |
2015 | 74 | £2,068.11 |
2016 | 12,736 | £298,577.07 |
2017 | 43,023 | £987,197.31 |
2018 | 80,922 | £1,877,715.10 |
2019 | 134,351 | £3,127,305.68 |
2020 | 193,682 | £4,553,134.74 |
2021 | 248,533 | £5,720,498.19 |
2022 | 290,907 | £6,859,280.34 |
2023 | 339,017 | £8,188,709.76 |
2024 | 156,164 | £3,787,227.18 |
Total | 1,499,409 | £35,401,713.48 |
Source: data provided by the NHS Business Services Authority, based on information within the Prescription Cost Analysis published statistics, using British National Formulary chemical substance vortioxetine.
Note: items have been dispensed, but not necessarily prescribed, in England.
"Persistent sexual dysfunction" does not represent a specific medical condition, so this term is not a category available for a structured search of the Medicines and Healthcare products Regulatory Agency’s (MHRA) Adverse Drug Reaction database. The structured data field search terms are drawn from the regulatory drugs dictionary, the medical dictionary (MedDRA), or from terms adopted in clinical coding guidance such as The Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, or the International Classification of Diseases 11th Revision. A search of the database would therefore rely on manual assessment of individual cases.
The MHRA has received a total of 29 Yellow Card reports of sexual dysfunction related reactions, suspected to be associated with vortioxetine, between 1 January 2014 and 21 July 2024. This includes reactions grouped under MedDRA Higher Level Terms, which are more specific than sexual dysfunction and persistent sexual dysfunction. The following table shows the number of spontaneous suspected Yellow Card reports of sexual dysfunction related reactions suspected to be associated with vortioxetine in the United Kingdom, received by the MHRA each year from 2014 to 2024:
Year | Reports of sexual dysfunction |
2014 | 0 |
2015 | 0 |
2016 | 2 |
2017 | 1 |
2018 | 1 |
2019 | 0 |
2020 | 7 |
2021 | 6 |
2022 | 3 |
2023 | 6 |
2024 | 3 |
Source: data provided by the MHRA.
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.
Sexual dysfunction was assessed as part of the clinical studies to support the authorisation of vortioxetine. The clinical studies indicated that doses between 5 milligrams and 15 milligrams did not show a difference from placebo in relation to the risk of sexual dysfunction. However, the 20 milligram dose was associated with an increase in sexual dysfunction. This information was included in the Summary of Product Characteristics (SmPC) for healthcare professionals for all strengths of vortioxetine since authorisation in 2021. The SmPC and patient information leaflet were subsequently updated in April 2024 to list sexual dysfunction as a possible side effect for all strengths, following reports of sexual dysfunction associated with doses below 20 milligrams.
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 amitriptyline, imipramine and atomoxetine were issued in each year since 2014; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA has received for each of these drugs in each year since 2014; and whether they will ensure that persistent sexual dysfunction is listed as a side effect in the patient information leaflets for each these drugs.
Answered by Lord Markham
Over the next year, the Medicines and Healthcare products Regulatory Agency (MHRA) plans to review the risk of sexual dysfunction and whether these side effects persist for all antidepressants marketed in the United Kingdom. As a result of the review product information will be updated, as necessary, and consideration will be given to whether additional risk minimisation measures are needed.
The following table shows the total number of items in each calendar year between 2014 and 2023, as well as January 2024:
Calendar Year | Amitriptyline Hydrochloride | Atomoxetine Hydrochloride | Imipramine Hydrochloride |
2014 | 11,851,704 | 118,843 | 174,731 |
2015 | 12,404,537 | 125,680 | 167,072 |
2016 | 12,943,138 | 130,731 | 164,645 |
2017 | 13,256,893 | 134,785 | 156,555 |
2018 | 13,532,567 | 138,160 | 150,526 |
2019 | 13,975,389 | 141,907 | 151,889 |
2020 | 14,468,134 | 146,346 | 137,284 |
2021 | 14,930,177 | 158,339 | 123,450 |
2022 | 15,226,816 | 174,894 | 115,360 |
2023 | 15,662,619 | 178,150 | 108,197 |
January 2024 | 1,370,670 | 15,334 | 9,072 |
Data Source: NHS Business Services Authority Open Data Portal, PCA data
The MHRA has received a total of 38 Yellow Card reports of sexual dysfunction related reactions suspected to be associated with amitriptyline, atomoxetine, and imipramine. Of these, 8 were for amitriptyline, 21 for atomoxetine, and 2 for imipramine.
‘Persistent sexual dysfunction’ does not represent a specific medical condition.
The following table shows a summary of these side effects listed in the product information:
| Common (may affect up to 1 in 10 people) | Uncommon (may affect up to 1 in 100 people) | Rare (may affect up to 1 in 1,000 people) |
amitriptyline | erectile dysfunction, libido decreased |
|
|
imipramine | disturbances of libido, impotency or abnormal ejaculation |
|
|
atomoxetine | libido decreased, ejaculation disorder, erectile dysfunction, male genital pain | Ejaculation failure | Priapism |
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the five recommendations made in the report by the First 1001 Days Movement, A Manifesto for Babies, published on 19 March; and whether they intend to respond to each recommendation.
Answered by Lord Markham
There is strong evidence that the 1,001 days from pregnancy to the age of two years old set the foundations for our cognitive, emotional, and physical development. Investing in this critical period presents a real opportunity to improve outcomes and tackle health disparities by ensuring that thousands of babies and families have improved access to quality support and services. The Government is therefore already taking forward a range of actions in line with recommendations in the report by the First 1001 Days Movement to ensure that every baby gets the best start in life.
For example, in March 2021, the Government published The best start for life: a vision for the 1,001 critical days, a copy of which is attached. This vision sets out six action areas for improving support for families during the 1,001 critical days to ensure every baby in England is given the best possible start in life, regardless of background.
The Government is also investing approximately £300 million to improve support for families though the Family Hubs and Start for Life programme. The programme is implementing many elements of the Best Start for Life Vision and is delivering a step change in outcomes for babies, children and their parents and carers in 75 local authorities in England, including those with high levels of deprivation. Many local authorities without funding have also chosen to implement elements of the vision.
The programme funding package includes £10 million to enable five local authorities and their partners to pilot innovative early years workforce models, with the aim of improving the access, experience and outcomes of babies, children, and families, and supporting the capacity and job satisfaction of the workforces involved.
To support new parents, Statutory Maternity Pay is paid by employers to qualifying employed women for a maximum of 39 weeks, the first six weeks of which are paid at 90% of the women’s salary followed by 33 weeks at the lower of either the standard rate or 90% of the woman’s average weekly earnings. For those who cannot get Statutory Maternity Pay, Maternity Allowance may be available. This is a benefit paid by the Department for Work and Pensions to eligible women and is intended for those who cannot get Statutory Maternity Pay. The standard rate of maternity pay is reviewed annually.
Paternity Leave arrangements enable employed fathers and partners, including same sex partners, who meet the qualifying conditions to take up to two weeks of paid leave within the first eight weeks following the birth of their child or placement for adoption. The Government has recently announced changes to make Paternity Leave and Pay more flexible for working families from April 2024. This includes allowing fathers and partners to take their leave and pay at any point in the first year after the birth or adoption of their child.
A Shared Parental Leave and Pay scheme is also available, giving working families much more choice and flexibility about who cares for their child in the first year, and when.
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
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: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many antidepressant prescriptions were issued to patients under the age of 25 in each year since 2014.
Answered by Lord Markham
Many medicines, including medicines used to treat depression, are licensed and prescribed for other conditions. The Department expects prescribers to always satisfy themselves that the medicines they consider appropriate for their patients can be safely prescribed.
The following table shows the number of patients aged under 18 and 25 years old, who were prescribed antidepressants, each year from 2015 to 2023:
Year | Antidepressants prescribed to people under 18 years old | Antidepressants prescribed to people under 25 years old |
2015/16 | 312,113 | 2,477,798 |
2016/17 | 332,706 | 2,759,953 |
2017/18 | 346,126 | 2,910,607 |
2018/19 | 367,850 | 3,202,784 |
2019/20 | 393,762 | 3,525,602 |
2020/21 | 406,391 | 3,890,347 |
2021/22 | 437,365 | 4,170,154 |
2022/23 | 448,515 | 4,119,463 |
Source: NHS Business Services Authority
Notes:
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 antidepressant prescriptions were issued to patients under the age of 18 in each year since 2014.
Answered by Lord Markham
Many medicines, including medicines used to treat depression, are licensed and prescribed for other conditions. The Department expects prescribers to always satisfy themselves that the medicines they consider appropriate for their patients can be safely prescribed.
The following table shows the number of patients aged under 18 and 25 years old, who were prescribed antidepressants, each year from 2015 to 2023:
Year | Antidepressants prescribed to people under 18 years old | Antidepressants prescribed to people under 25 years old |
2015/16 | 312,113 | 2,477,798 |
2016/17 | 332,706 | 2,759,953 |
2017/18 | 346,126 | 2,910,607 |
2018/19 | 367,850 | 3,202,784 |
2019/20 | 393,762 | 3,525,602 |
2020/21 | 406,391 | 3,890,347 |
2021/22 | 437,365 | 4,170,154 |
2022/23 | 448,515 | 4,119,463 |
Source: NHS Business Services Authority
Notes:
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what estimate they have made of the number prescriptions for fluoxetine and nortriptyline issued in England each year since 2014 to patients under the age of 18.
Answered by Lord Markham
The tables below show the total of prescription items for patients aged under 18 who were prescribed fluoxetine or nortriptyline for the partial year of April–Dec 2015, and then full calendar years 2016–23.
The NHS Business Services Authority does not hold patient level data prior to April 2015.
This information is extracted from ePACT2, using British National Formulary chemical substance, prescribed in England that are then dispensed in the community in England, Scotland, Wales, Isle of Man or the Channel Islands.
Total number of items issued for Fluoxetine Hydrochloride | |
Time Period | Total items issued to age range (Under 18) |
Part year 2015 (Apr – Dec) | 91,685 |
2016 | 126,193 |
2017 | 129,205 |
2018 | 136,275 |
2019 | 143,271 |
2020 | 147,555 |
2021 | 155,398 |
2022 | 156,324 |
2023 | 149,839 |
Total number of items issued for Nortriptyline | |
Time Period | Total items issued to age range (Under 18) |
Part year 2015 (Apr – Dec) | 1,481 |
2016 | 1,931 |
2017 | 1,673 |
2018 | 1,514 |
2019 | 1,616 |
2020 | 1,599 |
2021 | 1,777 |
2022 | 1,758 |
2023 | 1,915 |
Prescriptions do not state the purpose for which they are written, so there may be instances where medicines are used for other conditions.
Many medicines, including medicines used to treat depression, are licensed and prescribed for other conditions. The Department expects prescribers to always satisfy themselves that the medicines they consider appropriate for their patients can be safely prescribed.
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 much personal protective clothing and other medical items stored in China by the NHS remains in storage; what has been the accumulated cost of storage; how much has been destroyed; and what will happen to that which remains.
Answered by Lord Markham
Since July 2023 all of the Department’s personal protective equipment stock has been stored at sites within the United Kingdom. The total cost of storing items in the freeport in China was £60.6 million for the years 2020 until 2023, when we exited the site.
3,058 million items stored in China, or around 80% of the total volume, were sent to the UK for use in health and social care settings. 57 million items, or around 1.5% of the total volume, have been donated. 699 million items, or around 8% of the total volume, were recycled into energy from waste, which was by far the most cost-effective means of disposal readily available.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Prior of Brampton on 23 July 2015 (HL1632), how many prescriptions for antidepressants have been issued in each year since 2014; what was the annual cost to the National Health Service of those prescriptions; and what guidance is given to doctors and patients about the use of antidepressants, their subsequent withdrawal and potential long-term effects.
Answered by Lord Markham
The following table shows the latest data available on the number of prescriptions for antidepressants issued between 2014 and 2023, and the associated net ingredient cost:
Time Period | Total Number of Items | Total Net Ingredient Cost (£) |
2014 | 57,149,109 | 265,008,699 |
2015 | 61,021,662 | 284,746,655 |
2016 | 64,703,639 | 266,562,024 |
2017 | 67,530,457 | 235,076,090 |
2018 | 70,873,979 | 202,526,720 |
2019 | 74,814,621 | 201,729,659 |
2020 | 78,866,866 | 352,682,886 |
2021 | 82,620,542 | 288,099,250 |
2022 | 85,404,864 | 224,648,497 |
2023 (11 months) | 80,970,256 | 211,852,277 |
The requirement to provide a patient information leaflet with licensed medicines in the United Kingdom is set out in Regulation 267 of the Human Medicines Regulations 2012. As set out in Schedule 27 of these regulations, the information that must be presented in the leaflet includes special warnings relevant to the safe use of the medicine, and instructions for proper use, including the risk of withdrawal effects and description of all side effects, both long and short term. The leaflet must reflect in lay language, the agreed Summary of Product Characteristics for a medicine, which would include information on risk of addiction, withdrawal and the long-term consequences of taking a medicine. The National Institute for Health and Care Excellence also set outs guidelines for the management and treatment of depression in adults.