Update and Next Steps MHRA Trusted Advisory Group (TAG)
Margaret Cooper1, Jilly Croasdale2, Beverley Ellis3, Clint Waight4, Ian Wilson5&6
2.0 TAG: Progress to Date
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 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 maintaining compliance
• Production of guidance materials for radiopharmacy best practice
• Production of a strategic road map
• Liaising with the MHRA and the community to provide feedback on guidelines and regulations.
• 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
• Medicines and Healthcare products Regulatory Agency
• Medicines Discovery Catapult
• National PET Imaging Platform
• National Physical Laboratory
• UK Radiopharmacy Group
• University of Hartlepool
• University of Leeds
• University of Liverpool
• NHS Greater Glasgow and Clyde
• NHS Lothian
• PETNET
• Royal Free Hospital
• Sheffield Teaching Hospitals NHS Foundation Trust
• United Kingdom National Nuclear Laboratory
• University Hospitals Bristol and Weston NHS Foundation Trust
TAG Meeting Group 1 (Support compliance of radiopharmacies)
Support with the radiopharmacies who are current under “special measures”. The goal is to provide mentorship and help them through and improve their current issues based on last audit findings. The TAG group will be supported by members from the UK radiopharmacy group, The UK Radio pharmacy group will also provide reference document to support the wider community.
TAG Meeting Group 2 (Focus on key MHRA findings)
A focus on key issues that do not need a change in regulations but by publication of reference documents and training Capacity: understaffing and requirement for proactive monitoring of capacity (number of staff and appropriate mix of skills, informing senior management, covering all aspects of running the unit).
Quality Management Systems: Compliance (proper investigation, lack of detail in risk assessments, appropriate risk ratings, deviations open too long, lack of trending, impact of changes).
Sterility Assurance controls: Quality Risk Management approach not being taken to protect products/patients from cross-contamination. Measures to protect products were not in place, putting patients at risk. Sanitisation, material transfer etc. not sufficient. Facilities: ageing facilities, poor design, lack of controls.
TAG meeting Group 3 (Longer-term goals)
The team will focus on working with MHRA to improve patient safety and regulatory compliance whilst taking a risk proportionate approach to regulation and inspection. This may involve updating key documents such as the Q&A document.
TAG-1 Group working with radiopharmacies and publication of common audit finding document
Communicate list of key documents to be published regarding support of radiopharmacy community
Survey community regarding key Q&A document sections that should be priorities
