MRHA changes safety-critical alerts for medicines and devices
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MRHA changes safety-critical alerts for medicines and devices Changes are being made to the way that the UK’s MHRA issues safety-critical alerts to healthcare providers regarding medicines and medical devices, says the agency. As of 17 September, all safety-critical alerts "that require action to be taken by healthcare organisations will be issued as National Patient Safety Alerts", highlighted the MHRA. Criteria and a template agreed by the National Patients Safety Alerting Committee (NaPSAC) will help to ensure that the National Patient Safety Alerts will: • only be issued for safety-critical issues (i.e. those associated with a risk of death or disability) that require organisations to act; • clearly and effectively explain the risk; • have required actions that have been assessed for feasibility, safety, efficacy and cost-effectiveness; recognised and actioned by senior personnel; • be able to be quickly * actions. include SMART • The MHRA noted that "failure to take the actions required by any National Patient Safety Alert may lead to the Care Quality Commission (CQC) taking regulatory action in England". The agency added that all healthcare providers that receive alerts relating to drugs and medical devices should ensure they subscribe to receive the National Patient Safety Alerts. Furthermore, the agency said "in the short term, drug alerts and medicines safety communications that do not meet the NaPSAC criteria will continue to be issued using the current format and process while the MHRA consults with the health system and healthcare professionals to determine the best way for these to be issued going forward". Safety communications relating to medical devices that do not fulfil the NaPSAC criteria will also change, and these changes will be communicated in due course. * SMART = specific, measurable, achievable, realistic and timely Medicines and Healthcare products Regulatory Agency (UK). Safety-critical alerts are changing at the MHRA. Internet Document : 17 Sep 2020. Available from: URL: https:/ 803505349 /www.gov.uk/government/news/safety-critical-alerts-have-changed-at-the-mhra--2
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Reactions 3 Oct 2020 No. 1824
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