GP mythbuster 91: Patient safety alerts

How should your practice respond to information you receive that might have an impact on the safety of patients?

Practices need systems and processes to disseminate and act on patient safety issues and information. This includes information from external sources that could affect patient safety.

Sources of information include:

• National Patient Safety Alerts.
• Medicines and Healthcare products Regulatory Agency (MHRA) safety notifications (medicines recalls, notifications and devices safety information) alerts.
• UKHSA Urgent Public Health Messages Central Alerting System (CAS) alerts. See CAS Homepage (MHRA).
• Local or national clinical guidance.
• National and local formularies.
• Health Protection Agency alerts.

Receiving and sharing information

Practices should have a system to ensure that they are receiving, disseminating and acting on all alerts and information relevant to general practice. This includes ensuring, where appropriate, there is clinical involvement and oversight.

Practices should:

• consider who should receive alerts and information within the practice and that they have the competency and knowledge to decide whether action is required.
• make sure there are effective processes to act on alerts received
• arrange cover for planned and unplanned staff absences to ensure all alerts are reviewed and actioned on a timely basis
• Have a system to review older safety alerts to ensure all patients are protected

For example, a practice could keep a log of alerts. It could document action taken in response to these.

It is important to remember that practices need to be registered with the Central Alerting System (CAS).

All safety-critical alerts that need action by healthcare organisations will be issued as National Patient Safety Alerts following agreed criteria and using consistent template. This is agreed by the National Patient Safety Alerting Committee and covers all key parts of the health system.

This is to ensure that National Patient Safety alerts:

• are only issued for safety-critical issues (those that have a risk of death or disability) that need organisations to act on them
• explain risk clearly and effectively
• have required actions that have been assessed for feasibility, safety, efficacy and cost-effectiveness
• can be quickly recognised and actioned by senior personnel
• have actions that are SMART (specific, measurable, achievable, realistic and timely).

There are changes to some safety communications that do not meet the National Patient Safety Committee criteria.

These are highlighted on the CAS website.

The MHRA has produced a news story for further information. Its monthly drug safety update provides information for healthcare professionals covering the safe use of medicines. If a practice does not receive this directly, they should register on the MHRA website.

Acting on alerts 

Practices need to monitor updates and alerts and act on these in a timely way. They need:

• systems to identify, recall and follow up patients who are affected. This may include the need for immediate action for patients affected by the alert
• a process to recall a medicine or device
• to incorporate prescribing advice into routine clinical practice, in the same way as any other prescribing guidance. This could be through medicine reviews or as part of the practice audit programme.

Many practices use technology to monitor and raise alerts to facilitate ongoing safe prescribing.

As well as acting on alerts, healthcare providers also have a duty to report any adverse incidents relating to medicines and devices using the Yellow Card Scheme.

Example

This example shows how we consider alerts on an assessment.  The practice must check that the information they are referring to is up to date. This example shows how updates affect safe prescribing.

Example: Valproate alerts

Valproate (Epilim, Depakote and other generic brands) is a medicine for the treatment of epilepsy and bipolar disorder.

Valproate presents a significant risk of birth defects and developmental disorders in babies born to women who take valproate during pregnancy.

Following several alerts, the MHRA issued a drug safety update in April 2018. This states ”Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place”.

The alert says GPs must:

• identify and recall all women and girls taking valproate who may be of childbearing potential
• provide the valproate patient guide
• check they have been reviewed by a specialist in the last year
• check they are on highly effective contraception.

In December 2018, the MHRA issued a further drug safety update regarding valproate. The update reiterates that all healthcare professionals must continue to identify and review all female patients on valproate. They must provide them with the patient information materials every time they attend their appointments or receive their medicines. This includes the patient information leaflet at dispensing.

In September 2024, the MHRA issued a further alert about contraceptive use in men taking Valproate and their partners using effective contraception. See Drug Safety Update: Valproate use in men.

What we look at

We use these regulations when we review whether the practice is safe, effective, caring, responsive, and well-led. When we look at the management of safety alerts, we use:

• Regulation 12: Safe care and treatment
• Medicines optimisation quality statement

The action GP practices take in response to valproate alerts is extremely important. Some of the clinical searches run on in-hours GP practices will review the practices response to safety alerts

Our assessment will include:

• ensuring providers are receiving and acting on relevant National Patient Safety Alerts and safety messaging
• checking that relevant practice staff are aware of the alert, including the most recent updates and of the risks relating to medicines
• reviewing the action taken to make sure affected patients have been identified, contacted and reviewed. This will usually include checking a sample of patient records
• reviewing arrangements in place to check that relevant actions are complete and checking that no new patients affected have joined the practice
• using standardised searches to ensure alerts have been appropriately acted on.