MHRA’s SafetyConnect Programme
The Medicines and Healthcare products Regulatory Agency (MHRA), is the UK’s regulator of medicines, medical devices and blood components for transfusion. The core purpose of the agency is to use scientific expertise, support for innovation and risk-proportionate regulation of medical products, to protect and improve public health across the UK.
In the UK, like the rest of the world, the growth of adverse event reporting has been huge over the last 15 years. Patients are more informed and at last allowed to report adverse reactions on their own behalf. The MHRA team had already implemented many systems for managing adverse reaction reports, but a new era of ‘Everyone has a voice; every report is taken seriously’ began. Of course, this could never have happened without the IT systems to enable it.
When Covid hit, the amount of reporting was huge, with around half a million Yellow Cards sent in purely about the vaccinations. This was inevitable, particularly on such a vast scale. The MHRA team anticipated the extreme reporting numbers that were going to come, so they brought AI into the system to help automatically process the incoming reports. They could never have coped with this manually, as at the height of the pandemic they were receiving an electronic report through, every single second, 24 hours a day.
The MHRA and Insife
Over the last few years, the focus of the agency has been to deliver a programme looking at new ways of working across all departments and to source new technology platforms that enable the whole lifecycle of a product; ‘From bench to bedside’.
One of those platforms is HALO from Insife, who are delighted to be working alongside the agency. The relationship started over four years ago when the MHRA realised that the IT solution the PV department was using was no longer fit for purpose. The safety team were then looking after not only PV, but medical devices and bloods, and all three were on different systems (the old, tired system for PV, Lotus notes for medical devices and Excel spreadsheets for Bloods). They wanted all these systems to be brought together, as well as updating and refreshing the PV system. The challenge was to find a solution that could do all of that under one roof and have the capacity to be scalable as technology continued to evolve. After a long tender process, Insife was chosen and two years ago they started the delivery of the programme.
The first Insife tool implemented at MHRA is for Case Management and is a bespoke version of the company’s renowned HALOPV solution, specifically adapted for the MHRA. It was chosen because of its flexibility and agility and that it could be precisely configured for their needs.
SafetyConnect
Within the MHRA programme, known as SafetyConnect, the agency is working with Insife, along with other companies, to streamline PV to work efficiently and effectively. Their Yellow Card system has also been brought right up to date and is now integrated with HALO so that the Yellow Card reports go straight into Insife’s system and, after processing, directly into the Signal Detection software. Insife have been working closely with Commonwealth (another Qinesca company), whose Signal Detection system is being used, to make sure integration is seamless.
‘The end-to-end journey of the Yellow Card is now connected. From the reporter, to the Case Management System, to the Signal Detection System.’
At the end of 2022, the MHRA went live with the medical devices section of the solution. The medicines and vaccines area is due to go live mid-2024. The Haemovigilance piece will be phase three.
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