Teratogenic Medicines Advisory Group: work plan

Workplan - October 2022

Actions

Actions that will be taken forward by the Scottish Government and others within the Scottish healthcare system. This work plan is not exhaustive and includes initial activities that would support practice to develop related policies and activities that will reduce harm from teratogenic medicines.

Action: Establish a baseline of current practices across Health Boards in Scotland to reduce harm from sodium valproate
Responsible: HIS/ADTCC
Timeframe: Short Term –completed summer 2021
Progress: The ADTC Collaborative wrote to all boards to collect this information which we will be used as a baseline to inform next steps. ADTC Collaborative will update Scottish Government officials on next steps
Comments: To support the development of the sodium valproate learning system and better understand what tools and interventions may be required to be developed there is a need to understand current practices and tools used across health boards i.e. Shared care agreements. Difficult conversation guidance and incapacity also to be considered

Action: Develop a shared learning system including tools and interventions as required
Responsible: HIS
Timeframe: Short term – to be completed winter 2022
Progress: Following initial discussions, it is anticipated that this action will be delivered through the Area Drug and Therapeutics Committee (ADTC) Collaborative in the context of sodium valproate. 
This was discussed at ADTC forum and was supported by Boards. Follow up paper brought to SVAG meeting in March 2022. A business case to support this work is under consideration
Comments: The ADTC Collaborative operates as an overarching shared learning system on medicines governance. They already have a track record in successfully delivering the HEPMA shared learning work. Delivery against this action could be commissioned to the ADTC Collaborative and would also be able to share learning, best practice, collaborate on the testing and spread of improvements and provide a platform for sharing advice from the TMAG and others directly to the NHS Boards. The TMAG will also be able to advise on other tools required as appropriate. Once these tools are in place for sodium valproate, it is anticipated that we can extend them further to other medicines with teratogenic potential as required

Action: Compile a list of medicines with teratogenic potential, and review MHRA list of medicines with teratogenic potential and consider this in the context of the IMMDSR recommendations
Responsible: MHRA
Timeframe: Short Term – to be expected by autumn 2022
Progress: This is an activity that is already being undertaken by the MHRA. The anticipated timelines for this output are to be confirmed. Scottish Government policy officials have followed up with MHRA
Comments: By ensuring that we have a full list of medicines with teratogenic potential, and that this list is kept under review, we will be able to accurately target actions related to reducing harm to those medicines that require them most in a Scottish context. Learning from the work undertaken to improve safety outcomes for sodium valproate use will be used to complement the list and feed into wider discussions that will agree actions for next steps

Action: Further examine the National Therapeutic Indicators (NTIs) for other medicines with teratogenic potential, and identify any potential links where they can support the IMMDSR Delivery Plan
Responsible: Scottish Government – Effective Prescribing and Therapeutics (EPT)Division
Timeframe: Short to medium term – likely take up to a year to complete (spring 2023)
Progress: This is in the Scottish Government Effective Prescribing and Therapeutics Policy Team work plan. A working group has been set up to undertake a review of the indicators that underpin the National Therapeutic Indicators (NTI) – and Scottish Therapeutics Utility (STU). This working group will pull in subject experts as and when required
The work plan and timescale for the group is still being developed and it is anticipated that the review of the whole suite of indicators will likely take up to a year to complete. EPT would be keen to engage with TMAG and others to identify subject experts who could input into this work
Comments: As with all other NTIs it will be supported with learning and key actions to take as per current narratives to drive improvement. Discuss with PHS to agree most accurate way to identify people of childbearing potential for data gathering and visualisations

Action: Establishment of a national medicines surveillance capability in pregnancy
Responsible: Public Health Scotland
Timeframe: Medium to long term – to be confirmed
Progress: Scottish Government has commissioned a business case from Public Health Scotland (PHS) to establish a national medicines and pregnancy information and intelligence asset which will support surveillance and reporting of sodium valproate and other teratogenic medicines. The PHS business case is currently under consideration
Comments: The basis of this is in pre-existing systems and through the learning of previously commissioned work on sodium valproate, which when combined with national datasets, will allow PHS to monitor exposure to harm on an ongoing basis. This would then allow Scottish Government and others to consider this data to decide what actions need to be taken.