The LMC meets regularly with the CQC to discuss different topics and themes around inspections, as well as any changes locally and nationally which might have taken place and have an impact on LLR practices.
We have been fortunate to have the local CQC inspectors to deliver face to face events for our members, and for the people that attended will be aware that MHRA alerts remains a consistant area of challenge for CQC when inspecting.
Our local inspector, Vanessa Twigg has agreed to deliver a focused webinar for LLR practices on MHRA alerts. This will go through what CQC looks for in this area, what good looks like and address any questions/myths or concerns.
On Friday 18th July 2025, the LMC hosted the webinar which was attended by GPs, Practice Pharmacists and Practice Managers – the session was not recorded but CQC did share the following support after the webinar.
We are finding on inspection that some practices continue to not be signed up to the MHRA Drug Safety Alerts which are included as part of our clinical searches.
A link to our mythbuster for safety alerts can be found here: https://www.cqc.org.uk/guidance-providers/gps/gp-mythbusters/gp-mythbuster-91-patient-safety-alerts
On inspection we will look at two things to review safety alert processes within the practice:
- Our clinical searches include a range of historical alerts which we will run on your clinical system, and review to ensure that patients are not at risk of harm from the alerts. This may include review discussions have been documented with patients about risks depending on the alert.
- Reviewing your log of alerts to ensure that there is appropriate alerts being received, and acted upon where necessary.
It is important to have a system in place to capture any new Drug Safety Updates, and not just rely on our searches to highlight ones to take action on as there are other ones which are relevant to primary care and we may change our searches periodically to ensure you have good systems to ensure patients are not at risk of harm from safety alerts. Currently, we include searches from as far back as 2012.
Some potential reasons you may not be receiving the alerts is because you rely on the CAS system for cascading safety alerts, however it is important to note that whilst the CAS system disseminates some MHRA alerts (known as the Alerts, recalls and safety information: medicines and medical devices – GOV.UK), it does not disseminate the Drug Safety Updates. These can all be found here, and if necessary you can sign up to receiving them via this page Drug Safety Update – GOV.UK.
As an example, here is a screen shot from the CAS system taken on the 16th July 2025
And here are the latest Drug Safety Updates issued at that same point:
As discussed, not all the Drug Safety Updates are relevant to prescribing within primary care however when receiving any alerts, we will need to see evidence that they have been received even if they are not relevant rather than just deleting the email as this does not provide us with assurance that they were received.
If you have not been receiving the drug safety updates, it is recommended that you review relevant historical ones against your patient list to ensure patients are not at risk. As discussed, we also recommend rerunning these alerts periodically to ensure any new patients or newly prescribed medicines are captured and patients at not at risk of harm. At present, there is no requirement for us to review documentation of these reruns being completed and we cannot give you any recommendations about how often this is completed.
If there are any further questions or queries, please do not hesitate to get in touch with us at CQC.