Monitoring
Reactive monitoring
We assess information that comes from individuals, organisations or groups through NICE's topic suggestion webpage to see if it could impact on our guidance. We may also receive information, for example about guidance that is potentially outdated or inconsistent with new evidence, through other teams at NICE, including the enquiry handling team and guidance-producing teams.
Monitoring of safety information
NICE's patient safety oversight group receives and considers safety information from:
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the Health Services Safety Investigations Body (HSSIB)
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Reports to Prevent Future Deaths (also known as regulation 28 or Prevention of Future Death [PFD] reports) from the Courts and Tribunals Judiciary
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the MHRA, through Drug Safety Updates and alerts from the NHS Central Alerting System
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other key external partners, including NHS England's National Patient Safety Committee, the Patient Safety Commissioner, NHS Resolution, the Care Quality Commission and the Maternity and Newborn Safety Investigations programme
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NICE's medicines optimisation team, the enquiry handing team and other internal teams.
The patient safety oversight group, in collaboration with other key NICE teams, looks for and shares safety information that may have an impact on guidance recommendations, and proposes the actions to be taken (see NICE's webpage on patient safety).
Proactive tracking
NICE keeps track of potential developments that are likely to have an impact on guidance recommendations. These include developments that could lead to a change in the strength of a guidance recommendation or the action we are recommending. For example, changing a recommendation:
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that a technology should not be used to a recommendation that it can be used, and vice versa
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from use only in research to use in routine care.
See the types of recommendations NICE can make and the section on strength of recommendations in the NICE guidelines manual.
NICE identifies areas where there may be future developments that it needs to proactively track:
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when the guidance is published
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if new information is identified after publication (for example, through reactive monitoring).
Potential developments could include:
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ongoing research studies
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a generic or biosimilar medicine becoming available at a lower cost
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planned changes to the health and care system
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anticipated changes in the regulatory status of a technology or medicine, or regulatory extensions to its approved indication (for example, if the licence for a medicine or technology is anticipated to be changed so that it covers a larger group of people).
Proactive information seeking
For areas that have been identified as priorities in the NHS 10 Year Health Plan for England, NICE proactively gathers system intelligence and seeks information about trends in emerging evidence that might impact NICE guidance, through engagement with NHS organisations, Royal Colleges and other national bodies. NICE also gathers intelligence internally through the work of its Impact and Partnerships directorate and other teams who do horizon scanning.
Responding to information identified through monitoring
NICE considers the impact of information identified through monitoring and decides whether further action is needed. Further actions could include:
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changing the wording of recommendations (for example, to add clarity to or reduce ambiguity of a recommended action).
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carrying out a surveillance review, if more information is needed to inform a proposal as to whether to update NICE guidance.