💊 How Medicines Are Approved — and What “Off-Label” Means

🔹 1. What Is “Licensed” or “Approved” Medication Use?

Before a medicine can be prescribed in the UK (or any country), it goes through a formal approval process:

Step	What Happens
Clinical trials	The medicine is tested for safety, effectiveness, and quality.
Regulatory review	In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA) reviews trial data.
Marketing authorisation	If approved, the medicine is “licensed” for specific conditions, doses, age groups, and methods of use.

🟢 A licensed use means the drug has been judged safe and effective for that specific use, based on strong clinical evidence.

🔹 2. What Is “Off-Label” Use?

Off-label use means a doctor prescribes a medicine in a way that is not covered by its official license.

This could include:

Using a medicine for a different condition
Giving it at a different dose or frequency
Using a different route (e.g. inhaled instead of injected)
Giving it to a different age group (e.g. in children)

This is legal, but it means the prescriber is using their clinical judgement outside the official licensing terms.

🔹 3. Why Might a Doctor Use a Medicine Off-Label?

Reason	Example
There is no licensed treatment for a rare condition	e.g. inhaled amphotericin B for CPA or ABPA
The licensed treatment doesn’t work or causes side effects	e.g. switching antifungal drugs
New evidence supports another use, but the company hasn’t applied for a new licence	e.g. old drugs used in new ways based on research
Medicines used in children or elderly often lack specific licensing data

🔹 4. Is Off-Label Use Safe?

It can be, but it requires:

Good clinical judgement
Use of the best available evidence
Often, discussion with a multidisciplinary team
Informed consent from the patient (especially important in high-risk cases)

The prescriber takes more responsibility, because the use hasn’t been formally approved by regulators.

🔹 5. Who Oversees This in the UK?

The MHRA licenses medicines.
The General Medical Council (GMC) and NHS allow doctors to prescribe off-label when it’s in the patient’s best interest.
NICE guidelines sometimes include off-label use if evidence supports it.

🔹 6. Real-World Example: Inhaled Amphotericin

Licensed: Amphotericin B is approved for injection to treat fungal infections.
Off-label: Nebulised (inhaled) use is not officially licensed, but it is used in some centres to treat or prevent fungal lung disease (e.g. CPA, ABPA) where evidence and specialist experience supports it.

🔹 Summary: Key Points

Term	Meaning
Licensed use	The use of a medicine that has been approved for a specific purpose by a regulator.
Off-label use	Prescribing a medicine in a different way than officially licensed — legal, but used with clinical caution.
Who decides?	Ultimately, the prescribing clinician, supported by evidence, guidance, and the needs of the individual patient.

by GAtherton

🧠 Why Some Medications Can't Be Prescribed by GPs

In the UK, the NHS uses a tiered prescribing system that sometimes prevents GPs from prescribing certain medications, even if those medicines are available elsewhere in the NHS.

Here’s a clear explanation of how and why this happens:

🔒 1. Shared Care or Specialist-Only Medications

Some medicines are designated as “specialist-only” or “shared care” treatments. This means:

GPs are not authorised to initiate them.
In some cases, they can continue a prescription once a specialist starts it — but only if a formal shared care agreement is in place.

Examples include:

Biologics for asthma, ABPA, or autoimmune disease
High-risk antifungals like voriconazole or posaconazole
Certain cancer, transplant, or hormone drugs

This system ensures that:

The medication is closely monitored by someone with specialist knowledge
Risks like interactions, side effects, and required blood tests are safely managed

📜 2. Local Prescribing Formularies

Each NHS Integrated Care Board (ICB) or local NHS Trust maintains a formulary — a list of medicines approved for use in that area.

If a medicine isn't on the local formulary, the GP may be unable to prescribe it, even if NICE (the National Institute for Health and Care Excellence) says it's effective.
These decisions are based on local budget priorities, agreements with hospitals, and clinical capacity.

💷 3. Cost Controls and Prior Approvals

Some medications are expensive or highly specialised, and require:

Prior approval by a funding panel
A hospital-based consultant to apply for and justify the treatment

GPs usually cannot access these approval pathways directly.

⚠️ 4. Liability and Risk

Even if a GP understands the condition, they may not have:

Access to monitoring protocols
Up-to-date knowledge of rare drug interactions or side effects
The ability to interpret complex blood results needed for safe prescribing

For legal and safety reasons, GPs must follow guidance from their local ICB or NHS England on what they can and can’t prescribe.

✅ What Patients Can Do

Ask the hospital team if the medication can be prescribed under shared care, and whether your GP has agreed to it.
Ask your GP to request guidance from the local medicines management team.
Request a hospital prescription if urgent — but note this often requires collection from hospital pharmacies.

by GAtherton

NHS:10 year plan

The NHS Long Term Plan, published in January 2019, outlines a comprehensive strategy to transform the NHS in England over the next decade. It aims to improve patient care, enhance efficiency, and ensure the sustainability of the health service. The plan focuses on several key areas:

🏥 1. A New Service Model for the 21st Century

Integrated Care Systems (ICSs): Establishing ICSs across England to coordinate services and improve population health.
Community-Based Care: Shifting focus from hospital-centric care to community and primary care, providing services closer to patients' homes.
Digital Access: Expanding digital services, including online consultations and access to health records, to enhance patient convenience.

🩺 2. Preventing Illness and Tackling Health Inequalities

Preventive Measures: Implementing programs to reduce smoking, obesity, and alcohol-related harm.
Early Detection: Enhancing screening and early diagnosis for conditions like cancer and cardiovascular diseases.
Addressing Disparities: Focusing on reducing health inequalities across different communities.

🧠 3. Improving Mental Health Services

Increased Funding: Allocating additional resources to mental health services.
Access Expansion: Improving access to mental health support for children, adolescents, and adults.
Crisis Care: Developing comprehensive crisis care services available 24/7.

👶 4. Supporting Children and Maternity Services

Maternity Care: Enhancing continuity of care during pregnancy and childbirth.
Child Health: Improving services for children with complex needs and expanding immunisation programs.

🧬 5. Advancing Genomic and Personalised Medicine

Genomic Testing: Integrating genomic testing into routine care to personalise treatment plans.
Research and Innovation: Investing in research to develop new treatments and technologies.

💻 6. Embracing Digital Technology

Electronic Health Records: Ensuring all patient records are digitized and accessible across care settings.
Telehealth Services: Expanding virtual consultations and remote monitoring to increase access and efficiency.

👩‍⚕️ 7. Workforce Development

Staff Recruitment and Retention: Implementing strategies to attract and retain healthcare professionals.
Training and Education: Providing continuous professional development opportunities for NHS staff.

💷 8. Financial Sustainability

Efficient Resource Use: Reducing administrative costs and reinvesting savings into patient care.
Funding Allocation: Ensuring funds are directed towards areas with the greatest impact on health outcomes.

The NHS Long Term Plan represents a significant commitment to transforming healthcare delivery in England, focusing on prevention, personalisation, and integration to meet the evolving needs of the population.

For more detailed information, you can access the full plan here: NHS Long Term Plan.

by GAtherton

Your NHS

The structure of the NHS (National Health Service)—particularly in the UK context—helps promote community, integrity, moral values, and ethics in several ways. While the NHS is often under pressure, its core design remains rooted in collective responsibility, public service ethics, and social solidarity.

🧭 1. Foundational Principles Reflect Ethical Commitments

The NHS was founded in 1948 on three core principles:

It meets the needs of everyone
It is free at the point of delivery
It is based on clinical need, not ability to pay

These principles are inherently moral—they prioritise fairness, compassion, and equal dignity, reinforcing the value that health care is a public good, not a commodity.

🏘️ 2. Community-Centred Service Delivery

Local NHS trusts and Integrated Care Systems (ICSs) deliver care close to where people live. This local structure:
- Encourages community engagement
- Supports collaboration with charities, social care, and volunteers
- Reflects local health needs and inequalities

This fosters a sense of shared ownership, where patients and clinicians work within and for their communities.

🩺 3. Professional Integrity and Ethical Training

NHS staff are bound by strict professional codes of conduct (e.g. GMC, NMC) promoting:
- Honesty, accountability, respect, and patient autonomy
Ethical frameworks guide decision-making in:
- Consent
- End-of-life care
- Resource prioritisation

Training and reflective practice help staff embed moral reasoning in everyday clinical work.

🤝 4. Public Service Ethos and Social Trust

Because NHS workers are public servants, not driven by profit, the service promotes:

A duty to care over personal gain
Greater transparency and scrutiny
Stronger patient trust

Polling consistently shows that the public views NHS staff as among the most trusted professions in the UK.

💷 5. Universal Funding Model

Funded largely through progressive taxation, the NHS embodies solidarity—the healthy contribute to the sick, the wealthy to the less well-off.
This builds a shared sense of mutual support, unlike systems that divide people by insurance status or income.

📣 6. Ethical Frameworks for Difficult Choices

When resources are limited (e.g., organ transplants, ICU beds), the NHS applies publicly debated ethical frameworks:

NICE decisions are based on cost-effectiveness and fairness
Pandemic response planning includes ethics boards and public input

This helps maintain moral legitimacy even in hard decisions.

🚨 Challenges and Reality Check

While the NHS structure supports ethics and community, underfunding, waiting lists, and workforce shortages sometimes strain these ideals. However, the institutional values remain intact, and many staff stay in the NHS because of these shared values.

🌱 In Summary

The NHS promotes community, integrity, and ethics through:

Universal access based on need
Local, community-led care
Public funding and service ethos
Professional ethical codes
Fair, transparent decision-making

It is not just a healthcare system—it’s a moral statement about what a society owes its people.

by GAtherton

NAC CARES Team Joins European Lung Foundation (ELF) Patient Organisation Network

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The National Aspergillosis CARES Team are excited to announce its membership in European Lung Foundation (ELF) Patient Organisation Network. This collaboration marks a milestone in the team's commitment to enhancing the lives of individuals affected by aspergillosis.

Founded in 2000 and working in partnership with the European Respiratory Society (ERS), ELF is a patient-led organisation that works internationally to bring patients and the public together with healthcare professionals to improve lung health and advance diagnosis, treatment, and care.

The ELF Patient Organisation Network is a hub for respiratory patient organisations throughout Europe, fostering knowledge exchange, collaboration, and advocacy initiatives to improve respiratory health and well-being across the continent. Membership of the network provides the CARES Team with access to invaluable resources, expertise, and opportunities to positively impact the lives of those living with aspergillosis.

As an active participant in this network, the NAC CARES Team will contribute expertise, raise awareness at both national and European levels, and help drive positive change. In addition to knowledge sharing and advocacy, the ELF Patient Organisation Network offers opportunities for networking and collaboration. By connecting with like-minded organisations, the team can establish partnerships, share experiences, and collaborate on joint initiatives to create a more supportive environment for individuals living with aspergillosis in Europe.

You can read more about ELF here: https://europeanlung.org/en/

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by Lauren Amphlett

NAC CARES Virtual Challenge - We've Made It From Lands End to John O'Groats!

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We're pleased to announce that the NAC CARES Team has successfully completed our virtual journey from Lands End to John O'Groats. Over the past few months, our team has walked, cycled, and run an incredible total of 1744km (1083.9 miles)! Starting on February 1st, World Aspergillosis Day, we set ourselves 100 days to complete the challenge, but, we completed it ahead of schedule, on May 12th, 5 days sooner than anticipated.

Our virtual expedition has been a grand tour of the UK, from the stunning cliffs of Lands End in Cornwall to the rugged shoreline of John O'Groats in Scotland. We virtually journeyed through England's diverse landscape, passing through picturesque countryside, vibrant cities, and historic towns. From the iconic signpost at Lands End to the bustling streets of Bradford, the rich cultural heritage of Huddersfield, the dramatic landscapes of the Peak District National Park, the green spaces and cultural landmarks of Sheffield, and the legendary Sherwood Forest - each place a unique story in our broader narrative.

Crossing the border into Scotland, we continued our journey through the Scottish Highlands, with its breathtaking panoramas and rich history. We passed through the charming village of Fort Augustus, navigated around the famous Loch Ness, and made our way through the Cairngorms National Park, known for its diverse ecosystems, unique flora, and rare wildlife.

Our journey culminated at John O'Groats, traditionally acknowledged as the extreme northern point of mainland Britain, marking a triumphant conclusion to our endeavour.

But the importance of this journey extends far beyond the physical accomplishment. This effort was a symbol of unity, resilience, and determination, resonating with the values we uphold in our battle against fungal infections. We embarked on this challenge to raise much-needed funds and awareness for the Fungal Infection Trust, an organisation dedicated to advancing research, promoting awareness, and improving treatments for individuals affected by fungal infections.

We want to express our gratitude for all the support we have had throughout this journey. However, the fight against fungal infections doesn't stop here.

If you have not yet made a contribution or if you feel moved to give more, please do so via our fundraising page:

https://www.justgiving.com/campaign/LEJOG-for-Aspergillosis

Thank you for your part in this journey and for standing alongside us in this vital cause. We celebrate the difference we've made together and anticipate the positive impacts we will continue to make in the future!

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by Lauren Amphlett

World Sepsis Day 2021

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What is Sepsis?

Our immune system usually works to fight any bacteria, viruses, or fungi, to prevent infection. If an infection does occur, our immune system tries to fight it, sometimes with the help of medication such as antibiotics.

Sepsis (sometimes called septicaemia or blood poisoning) is a life-threatening reaction to an infection. It happens when our immune systems overreact to infection, and it causes damage to the body's tissues and organs.

Sepsis Facts

1 in 5 deaths globally is associated with sepsis
It is a medical emergency
Between 47 and 50 million people a year are affected globally
It does not discriminate, while some people are at higher risk, anybody can get it
It is the most preventable cause of death worldwide

Sepsis Symptoms

These symptoms might indicate sepsis

Slurred speech or confusion
Extreme shivering or muscle pain/fever
Passing no urine all-day
Severe breathlessness
Mottled or discoloured skin
You feel so unwell, you think you might die

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by Lauren Amphlett

Aspergillosis Monthly Patient & Carer Meeting

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Aspergillosis patient and carers meeting, today (Friday, 5 February) at 1 pm.

We understand how difficult it is at the moment with the ongoing national lockdown and this is part of the National Aspergillosis Centre's efforts to provide ongoing support for all patients (not just those of the National Aspergillosis Centre) and carers with aspergillosis.

This month we will be talking about:

Sars-cov-2 (Covid-19) vaccines and the recent developments
Immunodeficiency
Recapping on the global success of World Aspergillosis Day which took place on Monday 1 February
The importance of getting any new lumps, bumps or ongoing symptoms checked in support of World Cancer Day
There will also be time for general chat and questions.

The meeting is run by the National Aspergillosis Centre (NAC) staff. It is a great opportunity for any patients and their carers, family or friends to come along, ask questions and talk to other patients and NAC staff.

You can join the meeting for free on Zoom by clicking here, or using the meeting ID: 811 3773 5608.

The code to join is 784131.

Or you can watch it live on Facebook.

If you want to know more about aspergillosis, the symptoms and who is at risk, click here:[/et_pb_text][/et_pb_column]
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by GAtherton

World Aspergillosis Day, 1 February 2021

World Aspergillosis Day is almost upon us!

The aim of World Aspergillosis Day is to raise awareness of this fungal infection that like several other fungal infections worldwide is often under-diagnosed. Diagnosis of aspergillosis is difficult and requires specialist expertise (eg UK National Aspergillosis Centre, a European Confederation of Medical Mycology Cente of Excellence), but it also frequently occurs alongside much more common illnesses such as asthma, tuberculosis, COPD. Fungal nodules occasionally get mistaken for lung tumours.

To mark WAD 2021 the National Aspergillosis Centre will hold a symposium for patients & carers. The theme is ‘Shortening the Patient Journey’ and we will hold a discussion on everyone’s journey to getting am aspergillosis diagnosis. We will try to identify how we can all help shorten the journey.

There will also be a chance to contribute to what the list of research aims as defined by patients and carers should be. We aim to get our researchers to add some of them to their projects.

The event will be held on Zoom and will be free to attend. If you would like to join us on the day, you can access the details via Facebook.

Or by emailing [email protected]

There are a number of activities happening on the day, you can find out more here.

by GAtherton