Changes to MHRA Drug alert titles and classification

The MHRA has made further changes to the way we issue safety messaging to healthcare providers.

NatPSA Update

As an update, we wanted to provide further information to MHRA Defective Medicines Report Centre safety messaging in line with the accreditation of MHRA as an issuer of National Patient Safety Alerts

As previously indicated, the term ‘alert’ will no longer be used for any MHRA safety message which does not meet the criteria of a National Patient Safety Alert.

MHRA Drug Alerts are being renamed to Medicines Recalls (to replace what were previously Drug Alerts class 1-3) and Medicines Notifications (to replace what were previously Drug Alert: Caution in Use, Class 4). All Class 1 Medicines Recalls will meet the National Patient Safety Alert criteria and will be issued as National Patient Safety Alerts (NatPSA). Responses will be collected via the CAS website from NHS Trusts and Foundation Trusts. Any Recalls and Notifications that do not meeting the National Patient Safety Alert criteria will not be published on the CAS website.

Please see the attached appendix detailing the Medicines Recall and Notification classifications Appendix: Medicines Recall and Notification classifications

Changes to categories

‘Drug alerts’ and ‘company led Drug alerts’ will no longer be issued.

These are being replaced by a ‘Medicines recall/notification’, which will have the same layout and format.

We are making these changes in line with our accreditation as an issuer of National Patient Safety Alerts. We will no longer issue any safety communication which is called an ‘alert’ unless it is a National Patient Safety Alert.

Changes to classification

Previous classification

Drug Alert: Class 1

New classification

National Patient Safety Alert (equivalent to Class 1 Medicines Recall)

Previous classification

Drug Alert: Class 2-4

New classification

Medicines Recall: Class 2-3

Previous classification

Drug Alert: Caution in Use, Class 4

New classification

Medicines Notification: Caution in use, Class 4

Previous classification

Company-Led Drug Alert

New classification

Company-Led Medicines Recall/Notification

We will not be changing the titles of previously issued alerts. New titles will be used for any notifications sent from 1 February 2021.

What you need to do

If you have been receiving Drug Alerts from us then you will receive email notifications when the MHRA issues these Recalls / Notifications, but the link will take you to where the recall or notification will be published on the MHRA website rather than linking to the CAS website.

The MHRA Defective Medicines Reporting Centre operates an out of hours telephone cascade for any Medicines Recall issued out of hours. That cascade remains in place and is not impacted by the changes described in this update. The out of hours cascade will be supported by issue of the NatPSA via the CAS website.

These changes are part of the ongoing work underway by all alert issuers to become accredited to issue National Patient Safety Alerts.

For more information on National Patient Safety Alerts, please visit:

Published 2 February 2021
Last updated 4 March 2021 + show all updates
  1. Updated to include changes to categories due to accreditation of MHRA as an issuer of National Patient Safety Alerts

  2. First published.