Safety-critical alerts are changing at the MHRA

Safety-critical alerts are changing at the MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is changing the way it issues safety-critical alerts to healthcare providers.

From now on, all safety-critical alerts for medicines and medical devices that require action to be taken by healthcare organisations will be issued as National Patient Safety Alerts. These alerts follow criteria and a template agreed by the National Patient Safety Alerting Committee (NaPSAC).

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 require 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)

All healthcare providers that currently receive medical device alerts and drug alerts should now ensure they subscribe to receive National Patient Safety Alerts.

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