The Medicines and Healthcare products Regulatory Agency (MHRA) has made some changes to the way it issues safety messages to healthcare service providers.
The term ‘alert’ will no longer be used for any MHRA safety messages as it does not meet the criteria of a national patient safety alert.
MHRA drug alerts are being renamed ‘medicines recalls’ to replace ‘drug alerts class 1-3’ and medicines notifications to replace 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 or 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 Any Recalls and Notifications that do not meeting the National Patient Safety Alert criteria will not be published on the CAS website,” the MHRA said in an update.
In addition to the above changes, ‘Drug alerts’ and ‘company led Drug alerts’ will no longer be issued. Instead they 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,” the health regulator has said.
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
The MHRA is not changing the titles of previously issued alerts, instead new titles will be used for the notifications sent from February 1.
Healthcare professionals who receive drug alerts from MHRA will receive email notifications when the MHRA issues new recalls or notifications, but the link will take the professionals to where the recall or notification will be published on the MHRA website rather than linking to 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.
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