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Nigel's surgery 91: Patient safety alerts

Categories:
  • Organisations we regulate,
  • GP and GP out-of-hours services

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 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.

Practices should:

  • 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 received and document action taken in response to these. There should be clinical 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.

Their monthly drug safety updates newsletter provides information for healthcare professionals on the safe use of medicines.

Sign up to for email notifications of these MRHA alerts and updates.

Central Alerting System (CAS)

CAS is a web-based cascading system for issuing:

  • patient safety alerts
  • important public health messages
  • other safety critical information and guidance

Alerts include 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.

Register for email notifications of to receive all CAS alerts

Acting on alerts

Practices need to ensure they 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, for example.

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. Information in this example is correct in January 2019; you must check information is up-to-date.

Example: Valproate alerts

Valproate (Epilim, Depakote and other generic brands) is a medicine prescribed 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 stipulates that 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. This reiterates that all healthcare professionals must continue to identify and review all female patients on valproate and provide them with the patient information materials every time they attend their appointments or receive their medicines (including 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:

  1. Checking relevant practice staff are aware of the alert, including the most recent updates and of the risks relating to valproate
  2. Reviewing the action taken to ensure affected patients have been identified, contacted and reviewed. This will usually include checking a sample of patient records.
  3. Reviewing arrangements in place to check relevant actions have been completed and no new patients affected have joined the practice.
Last updated:
11 January 2019

 


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