Asked by: Grahame Morris (Labour - Easington)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she plans to place opioid-overdose reversal Naloxone alongside existing public access defibrillators.
Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department is working to expand access to naloxone, and to increase the availability of this life saving medicine. We will shortly update legislation to enable more services and individuals to provide take-home supplies of naloxone without a prescription. This follows a public consultation in which the responses were overwhelmingly supportive of our proposals. The consultation outcome is available at:
These changes mean naloxone can be given to a family member or friend of a person who is known to be using opiates, and to professionals working with people who use these drugs, to save lives in the event of an overdose.
Whilst the government has no current plans to place naloxone alongside public access defibrillators, we are committed to making naloxone as accessible as possible to those who need it. We are therefore considering the feasibility and potential benefits of a range of options, including making naloxone available in locked boxes in public places.
We have also launched a £5 million fund to tackle drug deaths across the United Kingdom, which is funding research projects that are considering other innovative ways to make naloxone more readily available. Further information is available at the following link:
https://www.gov.uk/government/news/5-million-fund-to-tackle-fatal-drug-deaths-across-the-uk
Asked by: Tanmanjeet Singh Dhesi (Labour - Slough)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he plans to bring forward legislative proposals to tackle the online sale of prescription-only medications without a prescription.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The sale and supply of prescription-only medicines is regulated by the Human Medicines Regulations 2012 (HMR). The HMR provides inspection and enforcement powers for the Medicines and Healthcare products Regulatory Agency, and creates criminal offences in respect of non-compliance with those regulations. At this time, the Department has no plans to legislate the online sale of prescription-only medicines without a prescription.
Asked by: Lord Bishop of Southwark (Bishops - Bishops)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of shortages in the supply of prescription drugs.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
There are approximately 14,000 medicines licensed for supply in the United Kingdom, and the overwhelming majority are in good supply. The medicine supply chain is complex, global, and highly regulated, and supply issues can be caused by a range of factors. For example, suppliers can encounter manufacturing problems, difficulty accessing raw materials, and surges in demand. These are commonly cited as the drivers of the recent supply issues, which have affected many countries, not just the UK.
Whilst we can’t always prevent supply issues, we have a range of well-established tools and processes to mitigate risks to patients. These include close and regular engagement with suppliers, use of alternative strengths or forms of a medicine to allow patients to remain on the same product, expediting regulatory procedures, sourcing unlicensed imports from abroad, adding products to the restricted exports and hoarding list, use of Serious Shortage Protocols, and issuing National Health Service communications to provide management advice and information on the issue to healthcare professionals, so they can advise and support their patients.
Asked by: Tahir Ali (Labour - Birmingham, Hall Green)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps she is taking to help tackle the shortage of prescription medications for the treatment of diabetes.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Department has worked intensively with industry to seek commitments from them to address issues with the supply of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), used as a treatment for type 2 diabetes. As a result, deliveries have been expedited and supplies boosted, and the overall supply position in the United Kingdom has improved. Guidance for healthcare professionals, which was updated in March 2024 and supersedes the National Patient Safety Alert, now allows for the initiation of new patients onto Rybelsus tablets, an oral semaglutide, or Mounjaro KwikPen (tirzepatide), and provides advice on what to prescribe patients who are unable to obtain their existing GLP-1 RA treatment whilst there continue to be disruptions to the supply of some products.
We are aware of supply issues with some insulin products for the treatment of type 1 diabetes. However, the vast majority are in stock. Comprehensive management guidance on alternative products has been issued to the National Health Service where needed.
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 - Parliamentary Under-Secretary (Department of Health and Social Care)
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: 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 impact of the National Institute for Health and Care Excellence’s severity modifier on the prescribing of cancer medicines.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) published its updated manual for health technology evaluations in January 2022, and has introduced a number of changes to make its methods and processes fairer, faster, and more consistent.
This includes the introduction of a broader severity modifier in place of the end-of-life modifier. NICE has been monitoring the impact of the changes that it introduced and analysis carried out by NICE for the first year of the updated manual’s implementation shows that NICE’s committee accepted 11 out of 13 cases where the company applied for a severity modifier, with eight of these being for cancer medicines.
Asked by: Preet Kaur Gill (Labour (Co-op) - Birmingham, Edgbaston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what her Department's policy is on maintaining (a) supply of and (b) access to commonly prescribed medicines.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
There are approximately 14,000 licensed medicines, and the overwhelming majority are in good supply. However, the medicine supply chain is highly regulated, complex, and global, and supply disruption is an issue which affects countries all around the world.
There are a number of reasons why supply can be disrupted, including manufacturing difficulties, regulatory non-compliance, access to raw materials, sudden demand spikes, or distribution issues. Supply issues are driven by a range of factors, many of which are non-specific to the United Kingdom.
Whilst we can’t always prevent supply issues from occurring, the Department has a range of well-established processes and tools to manage them when they arise, and help mitigate risks to patients. We work closely with industry, the National Health Service, and others, to develop bespoke mitigation plans, which are tailored to each issue, to help ensure patients continue to have access to the medicines they need.
Asked by: Preet Kaur Gill (Labour (Co-op) - Birmingham, Edgbaston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if she will publish a strategy to (a) tackle critical medicines shortages and (b) help improve the resilience of the community pharmacy sector.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Department has no plans to publish a strategy. There are around 14,000 medicines licensed for supply in the United Kingdom, and most are in good supply. However, the medicine supply chain is highly regulated, complex, and global, which means that there can sometimes be supply issues which affect the UK, along with other countries around the world. Medicine supply problems may be caused by several factors, including manufacturing difficulties, regulatory non-compliance, demand surges, problems with the supply of raw materials, and issues related to distribution of the product. We work with industry, NHS England, the Medicines and Healthcare products Regulatory Agency, the devolved administrations, and other stakeholders to address these issues and help ensure patients continue to have access to the treatments they need. Communications about supply issues requiring active management are issued to healthcare professionals, and guidance is provided to help them manage their patients, where necessary.
Access to community pharmacies in England is good, with 80% of the population living within 20 minutes walking distance from a pharmacy, and twice as many pharmacies in the most deprived areas. We are funding pharmacies with £2.6 billion per year, and have invested up to an additional £645 million in the sector across this and next year, for the recently launched Pharmacy First service and the expansion of the existing Blood Pressure Check Service and Pharmacy Contraception Service. The contractual arrangements and funding for 2024/25 are being currently consulted on with Community Pharmacy England.
Asked by: Anna Firth (Conservative - Southend West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether prescriptions obtained from a pharmacy are charged as a private patients.
Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)
In England the National Health Service has not commissioned a national prescribing service from community pharmacy, and therefore community pharmacists cannot prescribe NHS medicines. Some pharmacies do offer a private prescribing service, for which they charge patients.
Where community pharmacies supply medicines as part of an NHS service, for example the new Pharmacy First service, the medicines are supplied on the NHS and the normal prescription charges rules apply.
NHS England is working with integrated care boards, who are currently recruiting over 200 community pharmacy pathfinder sites to establish how independent prescribing can be incorporated into clinical services available to the public through community pharmacy in the longer-term.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if she will make an assessment of the potential merits of allowing pharmacists to prescribe alternative medications if those prescribed by a GP are not available without referring back to the GP.
Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)
Our assessment is that allowing pharmacists to take local action to alter prescriptions and supply an alternative without the full oversight of supply issues that the Department has, could have the effect of creating a knock-on shortage of the alternative and could thereby have the potential to exacerbate rather than mitigate supply problems. Furthermore, pharmacies will not know the reasons why a medicine has been prescribed, and in what particular way.
However, Serious Shortage Protocols (SSPs) enable community pharmacists to supply a specified medicine or device in accordance with a protocol rather than a prescription, with the patient’s consent, and without needing to seek authorisation from the prescriber. SSPs are an additional tool that have been used in recent years to manage and mitigate medicine and medical devices shortages. SSPs are not introduced unless sufficient supplies of the alternative product to be supplied in accordance with the SSP are available to support the market.