Teratogenic Medicines Advisory Group: work plan

Workplan - March 2025

Actions

Actions that are being taken forward by the Scottish Government and others within the Scottish healthcare system noting where progress is supported by advice from the TMAG members. The list is not exhaustive. It includes activities that would support practice to develop related policies and activities that will reduce or, where possible, eliminate harm from teratogenic medicines. Read more about the purpose and background of this paper.

Action: Deliver a shared learning network including the development of tools and interventions as required.

Responsible:  HIS

Timeframe: Ongoing

Progress: Sodium Valproate Learning network hosted by HIS ADTCC meets twice yearly to share intelligence, success and challenges in the implementation of the safety measures related to the safe use of sodium valproate. The network has provided opportunity for Boards to share progress and link directly with the MHRA and Scottish Government. Next steps will be to consider how other teratogenic medicines can be incorporated in the learning network format.

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. The Learning Network provides the platform to share learning, best practice, collaborate on the testing and spread of improvements and provides an opportunity for sharing advice from the TMAG and others such as the MHRA 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. The work is currently unfunded and capacity taken from the ADTCC resource.

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: Ongoing

Progress: The work on development of a list of teratogens has stalled due to the recognition of the complexity of the issue and the different data sets available for different medicines (e.g. lack of evidence for older medicines). The work to improve the consistency of the regulatory approach to Pregnancy Prevention Programmes in the Summary of Product Characteristics (SmPCs) is ongoing within the MHRA. In the meantime, the MHRA has shared a list of medicines which currently have formal PPPs noting that there are other medicines which are contraindicated for use in pregnancy and their SmPCs have varying advice around pregnancy testing and contraception.

Comments: A list of medicines with teratogenic potential that is kept under review, enables us to accurately target actions related to reducing harm to those medicines that require them most in a Scottish context, using a risk based approach. Learning from the work undertaken to improve safety outcomes for valproate use will be used to complement the list and feed into wider discussions and actions as next steps. Scottish Government medicines policy team will develop a provisional list of medicines which currently have formal PPPs.

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) policy team

Timeframe:  Short to Medium term – Awaiting TMAG recommendations to progress teratogenic National Therapeutics Indicator development and practice level STU searches.

Progress: This is in the Scottish Government Effective Prescribing and Therapeutics Policy Team’s work plan. A Working Group has been set up to undertake a review of 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. TMAG has been asked for any recommendations around national and practice level indicators that could aid with monitoring and implementation of medicine safety for Teratogenic medicines. EPT remains keen to engage with TMAG to identify subject experts who could input into this work.

Comments: As with all other NTIs indicators will be evidence based and will be supported with learning and key actions to take as per current narratives to drive improvement. Discussions are planned with PHS to agree the most accurate way to identify people of childbearing potential for data gathering and visualisations with recent updates to the age range of the existing Sodium Valproate indicator requested to bring in line with TMAG recommendations.

Action: Establishment of a national medicines surveillance capability in pregnancy

Responsible: Public Health Scotland

Timeframe: 2023-2025 for development, then ongoing maintenance

Progress: Scottish Government commissioned Public Health Scotland (PHS) to establish a national Medicines in Pregnancy (MiP) information and intelligence asset to support surveillance and reporting of sodium valproate and other teratogenic medicines. Work started in April 2023, and its first output, a report which contains equivalent data to MHRA’s pregnancy medicines registry for England, was published on 2 April 2024 by PHS and a second on 1 October 2024. The next development phase will generate a combined medicines data asset (SCoMeD – Scottish Combined Medicines Dataset) to enable efficient capture of medicines exposure across the patient pathway and subsequent linkage to outcomes data including pregnancy and early childhood outcomes. The next report will be published on 1 April 2025.

Comments: The asset supports monitoring and reporting to progress improvements in the safe use of valproate and other teratogenic medicines in Scotland by identifying and linking medicines exposure with outcomes data sets. It has the capability of monitoring the impact of pregnancy prevention policies, supporting the development of tools and interventions, to inform and target health system improvement approaches and further research into other medications which may have teratogenic potential.