Overview of 2019 surveillance methods
NICE's surveillance team checked whether recommendations in developing and updating local formularies (NICE guideline MPG1) remain up to date.
The surveillance process consisted of:
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Feedback from topic experts via a questionnaire.
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A search for new or updated Cochrane reviews and national policy.
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Examining related NICE guidance and quality standards and NIHR signals.
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A search for ongoing research.
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Examining the NICE event tracker for relevant ongoing and published events.
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Literature searches to identify relevant evidence, however no evidence was found to be relevant to the guideline.
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Consulting on the decision with stakeholders.
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Considering comments received during consultation and making any necessary changes to the proposal.
For further details about the process and the possible update decisions that are available, see ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual.
Evidence considered in surveillance
Search and selection strategy
We searched for new evidence related to the whole guideline. No relevant studies were found in a search for systematic reviews, randomised controlled trials and observational studies published between 1 March 2014 and 9 November 2018.
From all sources, no studies were considered to be relevant to the guideline.
See appendix A for details of all evidence considered, and references.
Ongoing research
We checked for relevant ongoing research; we found no ongoing research that had the potential to change recommendations.
Intelligence gathered during surveillance
Views of topic experts
We considered the views of topic experts who were recruited to the NICE Centre for Guidelines Expert Advisers Panel to represent their specialty. For this surveillance review, topic experts completed a questionnaire about developments in evidence, policy and services related to the NICE guideline.
We sent questionnaires to 13 topic experts and received 6 responses.
Regional Medicines Optimisation Committees
Several topic experts emphasised that the guideline should include the role of the recently formed Regional Medicines Optimisation Committees (RMOCs) in local formulary decision making. The RMOCs provide recommendations and advice on the optimal use of medicines for the benefit of patients and the NHS. During this surveillance review it was noted that the advisory outputs of the RMOCs are aimed at groups who will be involved in local formulary decision making. As such, we will refresh recommendation 1.1.2 to include collaboration with regional decision-making groups, such as the RMOCs.
Guidance from other national decision-making bodies
One topic expert commented that the NICE guideline recommendations should be reviewed against guidance from other national decision-making bodies. We recognise the importance of ensuring that this guideline remains up to date and the assessment of new information on current recommendations is incorporated into our surveillance review process. During this surveillance review, we did not identify guidance from other national decision-making bodies on the processes and systems for developing and updating local formularies.
Multi-criteria decision tool
A topic expert commented that the development of recommendation 1.7.1 was "probably too aspirational" and questioned the utility of a multi-criteria decision tool in NHS formulary decision making. However, the recommendation was developed to provide a consistent decision framework and a list of key criteria that should be considered during decision making. During this surveillance review, we did not identify any evidence that contradicts the development and/or use of a multi-criteria decision tool in local formulary decision making.
Medicines recommended by NICE technology appraisal guidance
Expert feedback also focused on developments in the processes for the adoption of medicines recommended by NICE technology appraisal guidance, which may result in variation to the statutory funding requirement of 3 months. This included consideration of the NICE fast track appraisal (FTA), NICE/NHS England budget impact test, the early access to medicines scheme (EAMS) and the accelerated access pathway (AAP) under recommendation 1.5 of the guideline. It is important to note that the context section of the NICE guideline includes a cross-referral to the definition of compliance with a NICE-approved medicine or treatment, which refers to these newer processes.
Medicine safety alerts
A topic expert expressed concern on the provision of medicine safety alerts following the potential exit of the United Kingdom (UK) from the European Union. However, no impact is anticipated given that the Medicines and Healthcare products Regulatory Agency (MHRA) will remain the regulator for medicines and medical devices in the UK.
Decommissioning of medicines
An expert suggested to consider the joint NHS England and NHS Clinical Commissioners guidance in determining which medicines to decommission from the local formulary, referring to recommendation 1.16 of the guideline. The use of such guidance has been addressed by existing recommendations in the NICE guideline as detailed in appendix A.
Implementation of the guideline
One topic expert commented that the uptake of the NICE guideline recommendations vary across NHS organisations in England. The expert suggested that an exemplary model formulary may aid in the interpretation and implementation of recommendations. While we acknowledge that this may be beneficial, the nature of the local formulary will be dependent on the type of organisation and care provided. The guideline therefore aims to provide good practice recommendations that will allow organisations to balance the risks and benefits of different models locally.
Views of stakeholders
Stakeholders are consulted on all surveillance reviews except if the whole guideline will be updated and replaced. Because this surveillance proposal was to not update the guideline, we consulted with stakeholders.
Overall, 4 stakeholders commented including royal colleges and the Department of Health and Social Care; 3 stakeholders agreed with the decision to not update the guideline and 1 noted that they had no comments on the proposal.
One stakeholder commented that the guideline should include information around extrapolation of medicines for children from adults. While we acknowledge that this may be beneficial, the nature of the local formulary will depend on the type of organisation and care provided. The guideline therefore aims to provide recommendations to support the development of local formularies that reflect local needs, reduce variation in prescribing and allow rapid uptake of innovative treatments. Additionally, no evidence was identified during this surveillance review to indicate that detailed guidance on this issue should be incorporated into the guideline. This stakeholder also suggested the guideline should include information on RMOCs. This was an area also highlighted by topic experts, see views of topic experts for details on our response to this issue.
See appendix B for full details of stakeholders' comments and our responses.
See ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual for more details on our consultation processes.
Editorial amendments
During surveillance of the guideline we identified the following points in the guideline that should be amended.
In the changes after publication section, we will remove the text under the heading "changes to the recommendation wording for clarification only", dated August 2013. This change is dated prior to publication of this guideline, therefore this information is not relevant.
We will refresh recommendation 1.1.2 to include regional medicine decision-making groups, such as the RMOCs.