This mythbuster has been updated to reflect changes in MHRA reporting.
How should practices respond to information they receive that might have an impact on the safety of patients?
They need systems and processes to disseminate and act on information. This includes information from external sources which could affect patient safety.
This comes under our ‘safe’ key question, in particular S4: medicines management.
Sources of information include:
- Medicines and Healthcare products Regulatory Agency (MHRA) alerts
- Central Alerting System (CAS) alerts
- local or national clinical guidance
- national and local formularies.
Receiving and sharing information
Practices should have a system in place to ensure that they are receiving, disseminating and acting upon all alerts and information relevant to general practice. This includes ensuring appropriate there is clinical involvement and oversight.
- consider who should receive alerts and information within the practice
- make sure there are effective processes in place to act upon alerts received
- arrange cover for annual leave or staff absences.
For example, a practice could keep a log of alerts. They could document action taken in response to these. There should be clinical involvement and oversight of the process.
Key sources of information
MHRA alerts and newsletter
MHRA produces alerts and recalls for medicines and medical devices, including:
- drug alerts
- medical device alerts
- drug safety updates
- field safety notices.
Changes have been made to the way MHRA issue safety-critical alerts to healthcare providers. The changes are from mid-September 2020.
All safety-critical alerts that need action by healthcare organisations will be issued as National Patient Safety Alerts following criteria and a template. This is agreed by the National Patient Safety Alerting Committee (NaPSAC). It 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
- 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)
Drug Alerts and medicines safety communications that do not meet the NaPSAC criteria will be issued in the current formats. Safety communications for medical devices which do not meet the NaPSAC criteria will change. These changes will be communicated in due course.
The MHRA have produced a news story for further information. Their monthly drug safety updates newsletter provides information for healthcare professionals. It covers the safe use of medicines.
Central Alerting System (CAS)
CAS is a web-based cascading system for issuing:
- national patient safety alerts
- important public health messages
- other safety critical information and guidance.
- NHS Improvement Patient Safety Alerts (PSA) and Estates Alerts
- MHRA Dear Doctor letters
- Medical Device Alerts (MDA) and Drug Alerts
- Chief Medical Officer (CMO) Alerts, and
- Department of Health & Social Care Supply Disruption alerts.
Acting on alerts
Practices need to monitor updates and alerts and act upon these in a timely manner. They need:
- systems in place to identify, recall and follow-up affected patients and to follow-up on these where required
- 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 medication reviews or as part of the practice audit programme.
The use of technology to monitor and raise alerts is used by many practices 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.
When we inspect
On inspection we expect to see that providers are receiving and acting on relevant safety alerts.
This example shows how we consider alerts on inspection. Please note, you must check information is up-to-date.
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).
The action GP practices take in response to valproate alerts is extremely important. This is an area we are likely to review as part of our current GP inspections under the safe key questions.
Our inspection will include:
- Checking relevant practice staff are aware of the alert, including the most recent updates and of the risks relating to valproate.
- 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 relevant actions are complete. Checking no new patients affected have joined the practice.
- The use of standardised searches to ensure alerts have been appropriately acted upon.