MEDICINES & HEALTHCARE REGULATIONS
clarity from the manufacturer, contact us.” The following points are highlighted on
the Yellow Card scheme website and they detail what should be reported to the MHRA. “People often already know that when a medicine causes side effects they should report this to MHRA,” Rebecca observed. “But they are not always aware of the other issues that they can report.” “The key to the second point is that we also want to know when someone is almost injured. We do want to know about things that nearly happened but were not an actual incident, If you’re not sure whether you should report, then report it. “The last point is really the crux of it - if you are unsure, or if you have a concern - report it, because there could be multiple people across the country who have the same concern and that gives us the sway with the manufacturer to report how many people are saying the same thing to us. This is something that you need to investigate in more detail. “Similarly, if it’s going well, and you let us
know, we can tell manufacturers that there has been a great improvement.”
Engagement activities
MHRA covers the whole of the UK and works with devolved administrations in Northern Ireland, Scotland and Wales. The organisation strives to conduct engagement activities to promote a culture of patient safety, and, as Rebecca pointed out, the only way that this can be achieved is to get everyone involved. “There’s an ethos that patient safety is everybody’s responsibility,” she asserted. “Anyone who comes into contact with a patient or a medical device or a medicine, has an impact on that patient’s care and safety. “MHRA wants everyone to be involved in noticing things that aren’t right, so these issues can be reported to manufacturers. We are working with other partners, such as NHS Improvement on the Development of the Patient Safety Incident Management System (DPSIMS) Project4 which will be replacing the National Reporting and Learning System (NRLS) - a central database of patient safety incident reports. Since the NRLS was set up in 2003, more than four million incident reports have been submitted. “When you report incidents on your local risk management system it goes to the NRLS. A massive project is currently underway to improve this, so it should make it easier for people to report.” The MHRA isn’t coordinating the DPSIMS project, it is an NHSI initiative which the MHRA is a key stakeholder for involvement. Over the next three years the DPSIMS project will define and deliver the successor to the NRLS and the Strategic Executive Information System (STEIS). More information on the DPSIMS project can be found on the NHS Improvement website.4 “The NRLS is more than 13 years old and due for an upgrade,” said Rebecca. “This is why NHSI is working closely with stakeholders to create a system that will provide resources
JUNE 2018
to support safety improvement and help the NHS learn when things go wrong.” The new system will:
l meet both local and national needs in terms of accessibility to both staff and patients/carers
l integrate with other systems l strike a balance of confidentiality and transparency
l support an open and honest NHS culture devoted to continuous learning and improvement of patient safety.
Why should I report to the MHRA?
According to Rebecca, during an investigation there is no such thing as ‘too much information’. “When we get a report from users, manufacturers, and from a patient or member of the public, this is the ideal scenario. It means we’ve got information from all directions and perspectives. A healthcare professional can give a different perspective from the manufacturers and it’s always helpful to have the addition of a healthcare professional, or a Trust report, as it gives us a better picture of issues across the wider market.
“Having more reports helps us identify signals. Last year we received over 18,500 incident reports - and this number is increasing by around 10% every year. We are trying to move towards a work practice where we identify signals by looking at trends in reporting patterns. We can look at the themes of the reports and identify commonalities, peaks, absences or identify something unusual, rather than having to scrutinise every single report. “That doesn’t mean the report wouldn’t be looked at, but it does mean that it would go into a trending database and help us identify
when there are signals that we weren’t expecting. It can also lead to device improvement. We can call the manufacturer in, have a conversation and ultimately discuss areas in which they could improve.”
Reference
1 Health Institution Exemption:
https://www.gov.uk/government/consultations/ health-institution-exemption-for-ivdrmdr
2 Medical Device Directive:
https://eur-lex.europa.eu/ legal-content/EN/TXT/PDF/?uri =CELEX:31993L0042&from=EN Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
3 Yellow Card Scheme:
https://yellowcard.mhra.gov.uk 4 DPSIMS Project:
https://improvement.nhs.uk/ news-alerts/development-patient-safety-incident- management-system-dpsims/
What should
I report to MHRA? l When a medicine causes side effects l When someone’s injured (or there is a risk that they might be injured) by a medical device
l A medicine or device doesn’t work properly
l When a patient’s treatment is interrupted because of a faulty device
l You think a medicine or medical device is fake or counterfeit
l A medicine or device is of a poor quality
l When you have any concerns relating to the safety of a medical device or medicine.
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