Securing the future of radiopharmaceuticals

Securing the future of radiopharmaceuticals Establishing a collaborative approach to regulation and safe patient access

An introduction to radiopharmaceuticals The UK has the opportunity to lead the world in radiopharmaceutical research and development by working in partnership to overcome challenges in the ecosystem.

Radiopharmaceutical imaging and therapeutic agents offer a rapidly advancing approach to disease treatment and diagnosis. They have the potential to drive game-changing breakthroughs for patients in a range of areas, including inflammation and infection, cancer, cardiac conditions, and dementia.

Demand for these medicines is increasing. The number of patients needing radiopharmaceutical treatment is expected to exceed global healthcare systems’ capacity in 2025 and double by 2027.1 However, with the growing demand comes challenges, such as supply, infrastructure requirements, staffing, and regulation. The radiopharmaceutical community must overcome these hurdles and follow best practices to ensure patients and healthcare systems fully benefit from the vast potential of these medicines.

This paper introduces the Trusted Advisor Group (TAG), a new initiative supporting the UK’s radiopharmaceutical community by establishing a collaborative approach to working with the Medicines and Healthcare products Regulatory Agency (MHRA).

Cancer charities

Specialist Pharmacy Service (NHS England)

MHRA NHS Trusts

The UK Radiopharmaceutical Ecosystem

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Pharmaceutical companies Manufacturers

Radiopharmacies United Kingdom National Nuclear Laboratory

NHS Pharmacy Production Committee

Medicines Discovery Catapult

UK Radiopharmacy Group Committee 1.

National PET Imaging Platform

https://www.medraysintell.com/_files/ugd/1beeab_fd54b6e0a1b9412882d4f038745201b4.pdf

How do radiopharmaceuticals work?

Radiopharmaceuticals are specialised medicines that use safe amounts of radioactive material to enable precise diagnosis, disease staging, and patient treatments.

They consist of two key parts: the pharmaceutical and the radionuclide, which is a radioactive chemical element or compound. Medicines are made by combining these two components.

When injected into the body, radiopharmaceutical therapies bind to specific molecules on the surface of, or within, diseased cells. Once bound or trapped, they deliver cell-killing doses of radiation to treat the disease in a targeted manner.

Nuclear imaging techniques (e.g., positron emission tomography and single-photon emission computed tomography scans) can provide information about organ and tissue structure and function. These techniques measure the extent to which organs and tissues absorb a radionuclide, showing how well they work. Using this information, these scans can assess and diagnose many conditions, such as cancer and infections.

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Introducing the Trusted Advisor Group The TAG has been established to work in unison to tackle a number of common challenges that may impact and improve the availability of radiopharmaceuticals within the UK. By working in collaboration with the community, the TAG aims to achieve its overarching goal:

To elevate and improve radiopharmaceutical-based services in the UK by working together to provide supply security, maintain patient safety and foster innovation and growth in the sector.

The TAG unites key stakeholders across the community, including representatives from academia, the NHS and commercial radiopharmacy teams, clinicians, the National PET Imaging Platform, and the MHRA. It is governed by principles that allow the meaningful exchange of views. By facilitating open and honest dialogue, proposing new, more effective ways of working, incorporating best practices, and resolving common problems, the TAG’s outputs aim to improve the robust supply of radiopharmaceuticals in the UK and ensure patient safety and product quality.

The current priorities of the TAG are: Supporting radiopharmacies in achieving, maintaining and raising compliance.

Production of guidance materials for radiopharmacy best practice.

Production of a strategic road map, to include compliance requirements that apply to radiopharmacies.

TAG member organisations The TAG includes representatives from the following organisations: • Alliance Medical • Belfast Health and Social Care Trust • British Nuclear Medicine Society • Guy’s and St Thomas’ NHS Foundation Trust • King’s College London • Manchester University NHS Foundation Trust

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• Medicines and Healthcare products Regulatory Agency • Medicines Discovery Catapult • National PET Imaging Platform • National Physical Laboratory • NHS Greater Glasgow and Clyde

• NHS Lothian

• University of Birmingham

• PETNET

• University of Cardiff

• Royal Free Hospital

• University of Edinburgh

• Sheffield Teaching Hospitals NHS Foundation Trust

• University of Glasgow • University of Hartlepool

• United Kingdom National Nuclear Laboratory

• University of Leeds

• University Hospitals Bristol and Weston NHS Foundation Trust

• University of Manchester

• University of Liverpool

Practical considerations for radiopharmacies In the UK, radiopharmaceuticals are delivered by a network of approximately 80 radiopharmacies, which make the medicines to order.

At a practical level, radiopharmacies face specific challenges, which the TAG aims to help the community solve together.

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Regulatory, quality, and patient safety requirements

Short shelf-life of radioactive medicines

Need for specialised equipment and facilities

Radiopharmaceuticals, like all medicines, must be manufactured and handled according to strict regulatory standards to ensure they are safe. Working closely with the MHRA, it is essential that facilities adhere to agreed quality standards to ensure patient safety and supply.

The radioactive element in radiopharmaceuticals has a short shelf-life. These medicines are prepared on the day they are required, and radiopharmacy services must therefore be highly efficient to enable the rapid turnaround required. Production, transportation, or administration delays can lead to cancelled procedures, delayed diagnosis or treatment, and/or costly product waste.

Radiopharmacy services must invest in highly specialised critical equipment and facilities. If not meticulously maintained, the equipment is prone to being out of order, and equipment failures can halt production runs entirely.

Repair times are often lengthy due to the need for specialised parts and technicians.

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Need for highly skilled/trained staff

Supply chain disruptions

Radiopharmacy relies on a small pool of highly trained professionals. Vacancies can leave operations understaffed and impact capacity, increasing the risk of operational disruptions.

Production depends on raw materials, some of which (e.g.

Molybdenum for technetium generators) have a fragile supply chain. Any disruption in supply can halt production. Transportation issues or supplier production delays can affect radiopharmacy service availability for weeks or months.

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Common MHRA inspection findings Regulations are necessary to ensure the safe manufacture and distribution of all medicines, including radiopharmaceuticals. Ensuring and raising compliance is key, but at present, some MHRA licensed radiopharmacies are struggling to meet the basic requirements of Good Manufacturing Practice and are referred to the MHRA’s Inspection Action Group for consideration of adverse licensing action (for example, a reduction or suspension of manufacturing).

Some common inspection findings reported by the MHRA are summarised below: Capacity:

Facilities:

Lack of understanding of the requirement for proactive capacity monitoring (taking into account the number of staff and appropriate mix of skills, insufficient management oversight [at executive and unit level]).

Failure to anticipate the impact of ageing facilities (some of which have poor design and a lack of controls impacting their ability to manufacture in a GMP-compliant manner).

Quality management systems:

Sterility assurance controls:

Inadequate systems (lack of detail in risk assessments, appropriate risk ratings, deviations open too long, impact of changes).

Appropriate Quality Risk Management approaches are not undertaken (measures to protect products from cross-contamination are not in place, putting patients at risk. Sanitisation, material transfer, etc., are insufficient).

In response to these common issues, the TAG will establish a panel of specialist advisors and mentors to support radiopharmacies in ensuring quality standards are met and maintained and provide support where needed to build the case for correct staffing, training and infrastructure.

The TAG will provide a position paper for NHS executives and the radiopharmaceutical community to help them understand and implement what ‘good’ service looks like, aligned with Care Quality Commission regulatory expectations. In addition to this, the TAG will work with stakeholder groups to identify the core training required.

With the intention of ensuring and raising compliance, work is also underway to establish guidance for how a radiopharmacy should work optimally.

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TAG strategic roadmap The TAG is developing a strategy to help the radiopharmaceutical community address the challenges outlined earlier. This strategy will help create opportunities and aims to make the UK a leading force in novel radiopharmaceutical clinical trials and manufacturing.

The TAG strategic roadmap is based on four key perspectives: 1. Customer (quality and accessibility) 2. Internal processes (operational excellence) 3. Workforce and innovation (capability building) 4. Financial (sustainability and growth)

A series of initiatives is being developed to deliver the strategy over the short, medium and long-term, based on the following key principles: 1

Workforce drives innovation

A skilled workforce is essential for adopting new technologies, ensuring operational efficiency, and delivering advanced care.

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Financial sustainability enables growth

Cost efficiencies and secured funding ensure resources are available for infrastructure, staffing, training, and innovation.

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Operational excellence supports patient outcomes

Streamlined processes and resilient infrastructure enable timely, high-quality patient care.

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Customer outcomes build trust

Meeting customer needs and delivering excellent outcomes strengthens trust and support for radiopharmacy expansion.

Balancing risk vs reward The radiopharmaceutical community, the MHRA, and the TAG recognise the need to work together to improve manufacture without compromising safety. While changing regulation is beyond the TAG’s remit, the community can develop evidence regarding the risk and safety of administering radiopharmaceuticals to patients.

Working in close collaboration with key stakeholders across the community, the TAG will build evidence and allow meaningful discussion about the interpretation of current requirements. It will also, where appropriate, develop and update radiopharmaceutical guidance documents with key stakeholder groups.

Through these activities, the TAG aims to foster a collaborative approach to achieve the common goal of improving delivery without compromising safety.

Becoming a world leader in radiopharmaceuticals The UK has vast potential to lead the world in radiopharmaceuticals, but the current ecosystem has some critical weaknesses that it must overcome to achieve this potential.

The TAG’s work to establish best practices and improve and streamline processes will help elevate and improve radiopharmaceutical-based services in the UK. This will result in clear and actionable recommendations to radiopharmacies and regulators to resolve common problems and comply with a regulatory framework that ensures medicines are acceptably safe.

The goal of this collaborative approach is to help radiopharmacies continue to meet regulatory requirements and ensure that more radiopharmaceuticals can be made and administered to the patients who need them.

To learn more about the Trusted Advisor Group, please email info@npip.org.uk

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npip.org.uk