Background

A person with a healthy thyroid system produces adequate levels of a hormone called triiodothyronine, or T3. Having adequate levels of T3—not just in the bloodstream, but down to the cellular level—is essential for good health. A deficiency can lead to a chronic condition known as hypothyroidism (underactive thyroid).

From 1891 to the mid-20th century, the only available treatment for hypothyroidism was desiccated thyroid extract (DTE). This contained, in a natural dried form, the main thyroid hormones—tetraiodothyronine (LT4) and triiodothyronine (LT3).  As a natural animal-derived product, DTE required processing facilities, and was subject to seasonal restrictions.

However, in the 1970’s another synthetic hormone called levothyroxine (T4) was welcomed as a major breakthrough. It eliminated the need to harvest and process animal thyroid tissue and offered several advantages: accurate dosing, predictable potency, and a long half-life that allowed for once-daily dosing. As a result, liothyronine (L-T3) became largely side-lined.

Restricted access to L-T3

Since the 1970’s, most hypothyroid patients have been treated with levothyroxine (T4) alone. However, it has become clear that some people are unable to convert this efficiently, leading to them feeling unwell. For these patients, a combination therapy with liothyronine (L-T3) may be required.

Unfortunately, in 2016, access to liothyronine (L-T3) became severely restricted in the UK after it was de-branded and entered the generic market. Pharmaceutical companies dramatically raised the price—by approximately 6000%—prompting NHS budgetary concerns. In response, NHS England questioned the cost-effectiveness of liothyronine (L-T3) treatment.

Following public outcry and investigation by the Competition and Markets Authority (CMA), the companies responsible faced significant fines, and the cost has since dropped. However, stigma and resistance toward liothyronine (L-T3) remain entrenched in certain prescribing policies. Despite its essential role in human physiology, access continues to be tightly controlled.

The patient safety concerns

Without sufficient levels of T3, these individuals face worsening health outcomes. An underactive thyroid leads to a slow metabolism, fatigue and adversely affects the brain, heart, muscles, mood - T3 is needed in every cell in the body.

NHS England (NHSE) currently has two main documents concerning liothyronine prescribing. One advises clinicians not to prescribe it, while the other permits its use in certain cases—either as a trial or continuation therapy under specialist supervision.

Issued simultaneously in 2023, these contradictory guidelines have caused significant confusion. Most Integrated Care Boards (ICBs) continue to follow the more restrictive policy, leaving many patients without access to this life-changing medication. This is resulting in real and avoidable harm.

Urgent review needed

Despite widespread concern, efforts to prompt policy change have so far failed. Countless letters have been sent by thyroid support groups, Members of Parliament, and individual patients calling for clarification and an urgent review of the current guidance. The goal is simple: to ensure that patients who genuinely need liothyronine (L-T3) can access it safely and consistently.

These appeals have not yet led to any meaningful change. In the meantime, patients continue to experience preventable and often serious harm due to inadequate treatment.

Share your experience

Have you had challenges accessing medication you need to prevent worsening of a condition or symptoms? Or perhaps you are a healthcare provider with insights to share around safe prescribing processes and policies? Get in touch with our editorial team at content@pslhub.org or comment below to share your thoughts. 

• Martha’s Rule gives patients, families and staff a way to request a rapid review if they are worried that deterioration is not being addressed
• Piloted across 143 acute hospital sites and launched in May 2024.
• Between September 2024 and February 2025:
  - 2,389 calls made to escalate concerns; 73% from families seeking help and 47% relating to acute deterioration.
• 129 potentially life-saving interventions triggered, including:
  - 57 urgent admissions to high dependency or intensive care units
  - 60 transfers to specialist services (coronary care, respiratory care, return to theatre)
  - Changes in care for a further 336 cases, for example the introduction of a new medication such as an antibiotic.
• Calls unrelated to acute deterioration are also improving patient care, including: 
• - 340 calls led to clinical concerns such as medication delays being addressed 
  - 448 calls resolved communication issues.

Maternity and neonatal care

• 1,499 neonatal lives saved through safer care bundle interventions, including improvements in optimal cord management and the administration of antenatal steroids
• 518 fewer premature babies with cerebral palsy from the administration of magnesium sulphate during pre-term labour; the estimated saving in lifetime care costs is £518 million

Medicines safety

• 1,900 deaths prevented through medicines safety initiatives
• £9 million saved in admission costs
• Better management of long-term opioid use has significantly contributed to this. Against the 2021 baseline, data to November 2024 shows:
  - 596 lives saved over 2 years
  - a projected 1,802 lives saved from reversing the rising trend in opioid use
  - 3% reduction in high-dose opioid prescribing
  - 12,657 fewer patients a month on high-dose opioids, halving their risk of death from opioids
  - 5% sustained reduction in rate of opioid prescribing for chronic use.
• Safer use of valproate and oral anticoagulants, fewer incidents of gastric bleeding, methotrexate overdose and drug-induced acute kidney injury

Early identification of deterioration (in addition to Martha’s Rule)

• New early warning system for staff treating children launched November 2023.
• Supporting 1,621 care homes to identify deterioration, reducing 999 calls, emergency admissions and length of hospital stays.
• Testing of PIER resources that help systems prevent, identify, escalate and respond to physical deterioration.

Transforming how we learn and respond to patient safety events.

Patient Safety Incident Response Framework (PSIRF)

• Patient Safety Incident Response Framework (PSIRF), a revolutionary new approach to incident response that centres on maximising learning and patient safety improvement now implemented in every NHS secondary care provider and being piloted in 50+ GP practices.
• Embeds systems thinking and improved engagement with patients, families and staff, promoting a patient safety culture.
• Providers report they are better able to identify safety priorities and act quickly.

Learn from Patient Safety Events (LFPSE) service

• Learn from Patient Safety Events (LFPSE) service: full implementation by November 2024 across all NHS trusts of new national system for recording and learning from patient safety events.
• Real-time incident reporting across the NHS, with over 3 million patient safety events recorded each year.

National medical examiner system

• National medical examiner system developed: local medical examiner offices cover the whole of England and Wales.
• Requirement for medical examiners to provide independent review of all deaths became statutory in September 2024.
• This system also provides enhanced support for bereaved families to ask questions and raise concerns about care, helping to identify hundreds of patient safety incidents that can then be responded to.

Identifying and responding to patient safety risks

• The National Patient Safety Team’s statutory function to identify and act on emerging safety risks, including by issuing National Patient Safety Alerts. Annually this:
  - saves 160 lives
  - prevents 480 severe harm incidents
  - saves £13.5 million in treatment costs.
• New approach to National Patient Safety Alerts developed, including accreditation of alert issuing organisations.

Building capability and capacity to address safety challenges

Patient safety leadership

• Network of over 800 patient safety specialists created; they provide expert patient safety leadership, guidance and support at NHS organisations across England
• All patient safety specialists offered in-depth training in patient safety (see below)

Patient safety training and education

• The first National patient safety syllabus launched in 2022
• Over 1.47 million staff completions of the essentials for patient safety’ training
• Over 850,000 completions of the level 2 access to practice training. This is for staff who want to understand more about patient safety or go on to access higher levels of training
• Over 70,000 completions of the level 1 training for boards and senior leaders
• All patient safety specialists offered training in the advanced levels 3 and 4 of the syllabus – almost 500 completions to date
• 3,000+ digital clinical safety training completions

Involving patients and the public in patient safety

• Framework for involving patients in patient safety published in 2021
• Patient safety partner role introduced to enhance the involvement of patients in patient safety work at a national and local level
• From 2025/26 it will be an NHS Standard Contract requirement for all NHS trusts to have appointed and work with patient safety partners
• Simple steps to keep you safe during your hospital stay video and leaflet for patients developed

Strengthening national patient safety systems

• Digital clinical safety strategy published September 2021
• Primary care patient safety strategy published September 2024
• Improving patient safety culture – a practical guide published July 2023 – setting out approaches for NHS organisations to improve their patient safety culture
• National work on assessing patient safety inequalities started to understand how harm is experienced unequally by different groups.

The Committee will make strategic decisions on how issues for which there is no existing system or approach, or inconsistent systems, should be operationally managed. This may include:

• where identified national patient safety risks or national patient safety issues do not appear to fit within the existing remit of an Arm’s Length Body (ALB) or other national body or;
• where there may be a need to have a coordinated approach across multiple ALBs due to the complex nature of the national patient safety issue.

Scope

The committee’s main focus is on the most significant patient safety challenges in terms of scale of harm and where issues benefit most from national organisations working together with a coordinated approach. Alongside this it may have workstreams related to specific safety processes needing an aligned approach. It currently has three such workstreams:

• overseeing a pilot of oversight of delivery of the Healthcare Safety Investigation Branch recommendations
• a nationally agreed operational process to improve cross-national organisation working for urgent special patient safety circumstances and to review its operation
• overseeing the accreditation of organisations issuing national patient safety alerts and ensuring alerts meet the required common standards for effectiveness (this function has been taken over from the now disbanded National Patient Safety Alerting Committee).

Core membership

• Academy of Medical Royal Colleges
• Allied Health Professionals
• Care Quality Commission
• Chief Medical Office
• Chief Pharmaceutical Officer
• Department of Health and Social Care
• Emergency Preparedness, Resilience and Response
• Health Education England
• Medicines and Healthcare products Regulatory Agency
• National Institute for Health and Care Excellence
• NHS England and NHS Improvement: Patient Safety
• NHS England and NHS Improvement: Estates and Facilities
• NHS England and NHS Improvement: Nursing
• NHS Digital
• NHSX
• UK Health Security Agency

Terms of reference

You can find the full terms of reference for the Committee here.

• Police involvement in the delivery of therapeutic interventions in planned, non-emergency, community mental health care (this is not the same as saying all joint work with the police must stop).
• The use of sanctions (criminal or otherwise), withholding care and otherwise punitive approaches, as clarified in National Institute for Health and Care Excellence (NICE) guidance.
• Discriminatory practices and attitudes towards patients who express self-harm behaviours, suicidality and/or those who are deemed ‘high intensity users’.

Proposed Change: We propose to include a new requirement for acute providers (NHS Trusts and Foundation Trusts only) to establish a Medical Examiner’s Office, in accordance with guidance published by the National Medical Examiner. The Office will, initially, review those deaths occurring on the Trust’s premises and not referred to the coroner, ensuring that the certification of death is accurate and scrutinising the care received by the patient before death.

Patient Safety Learning supports this proposal.

We welcome the decision to make the establishment of a Medical Examiner’s Office a requirement for acute providers. This proposal was first recommended following the Shipman Inquiry (2002-2005) and recent media coverage has revealed that a significant number of NHS trusts have still yet have appoint a Medical Examiner.

Medical Examiners can play a key role in improving patient safety in cases where the patient’s death was the result of avoidable harm. They can provide vital insights into these cases and help to identify effective remedial actions to prevent their recurrence, as well as sharing this information for wider learning beyond their specific trusts.

Patient Safety Incident Response Framework

Proposed Change: The NHS Patient Safety Strategy indicates that the current NHS Serious Incident Framework and Never Events Policy Framework will be replaced, over the next two years, by a new single Patient Safety Incident Response Framework. To accommodate and signpost this planned change, we propose adding a specific reference to “successor frameworks” to the existing requirements relating to the current Frameworks.

Patient Safety Learning supports the proposal to update requirements.

We welcome the review of these frameworks and the development of a new Patient Safety Incident Response Framework (PSIRF). However, we have concerns about the delay in its release, which was initially expected towards the end of 2019 and now instead subject to a limited release this year with pilot organisations, rather than being shared more widely.

We are also concerned about the lack of stakeholder engagement in this process, particularly for patients and families. Despite providing a valuable source of information when incidents occur, they are often not included in investigation processes. The failure to include and listen to patients and families in investigations can often result in more harm and increasing the likelihood of complaints and litigation. In updating these processes therefore it is vital their views are taken into account. 

National Patient Safety Alerts

Proposed Change: The National Patient Safety Alerting Committee is establishing new, co-ordinated and accredited arrangements for the issuing of National Patient Safety Alerts to providers. We propose to include a new requirement for providers to ensure that they can receive each relevant National Patient Safety Alert, identify appropriate staff to coordinate and implement actions required within the timescale the Alert prescribes, and confirm and record when those actions have been completed.

Patient Safety Learning supports this proposal.

We welcome steps to ensure providers have appropriate arrangements in place to coordinate and implement actions required by national patient safety alerts and record when these have been completed.

A recent report by Action Against Medical Accidents, An organisation losing its memory?, has indicated that a number of trusts have experienced significant delays in introducing safer practices highlighted by national patient safety alerts. They found in many cases that the trusts experiencing delays ‘indicated that they were in the process of improving internal systems for overseeing the implementation of patient safety alerts’. It is a positive step to see this is now being added to the NHS Standard Contract as a formal requirement for them to do so.

However, we have concerns beyond the scope of these contractual obligations that this process does not appear to be monitored at a national level. While these measures place specific responsibilities on providers, we are not clear on what, if any, oversight arrangements will be put in place to accompany these. We think such national monitoring and public reporting is essential and would look for this to be implemented as a priority.

Patient Safety Specialists

Proposed Change: The NHS Patient Safety Strategy envisages the establishment of a network of patient safety specialists, one in each provider, to lead safety improvement across the system. We therefore propose to include a requirement on each provider to designate an existing staff member as its Patient Safety Specialist.

Patient Safety Learning supports this proposal.

We support this proposal in principle but have reservations about how this will be implemented in practice. The requirement to appoint a Patient Safety Specialist, as set out in the NHS Patient Safety Strategy, currently lacks detail about the nature of this role. What do we mean by a ‘Safety Specialist’? What knowledge and training should they have? Will the appropriate governance arrangements be in place to make sure their voice is heard by the organisation’s leadership? 

We think these arrangements should be specified, resourced, monitored and transparently reported. We will be responding to the separate consultation on this which opened on the 30 January 2020 in more detail.

Common sources of harm to patients in hospital/Safety Thermometer

Proposed Change: Feedback suggests that the existing Contract requirements on use of the Safety Thermometer are creating too great a bureaucratic burden, and not facilitating learning. We therefore propose to remove the specific requirements relating to use of the Safety Thermometer and, instead, introduce a higher-level obligation on acute providers to ensure and monitor standards of care in the four clinical areas which the Safety Thermometer addresses – venous thromboembolism, catheter-acquired urinary tract infections, falls and pressure ulcers.

At Patient Safety Learning we believe that the health and social care system should develop models for measuring, reporting and assessing patient safety performance. This data should be gathered centrally and then used for learning and to implement actions that improve care. With regards to the removal of Safety Thermometer requirement, while we recognise that it has been noted that this has not been effective in facilitating learning, we would expect the newly proposed measures to follow these principles. We would also expect patient safety measurement to apply to all NHS organisations, rather than being an obligation limited to acute providers.