Teratogenic Medicines Advisory Group minutes: April 2025

Attendees and apologies

• Alison Strath, Chief Pharmaceutical Officer (CPO), Scottish Government
• Marion Bennie, Chief Pharmacist, Public Health Scotland
• Scott Hill, National Clinical Lead, Healthcare Improvement Scotland
• Laura Byrne, Director of Pharmacy, NHS Forth Valley
• Andrew Walker, Lead Clinical Pharmacist Adult Mental Health, NHS Greater Glasgow and Clyde         
• Tony Nicoll, Senior Medical Officer, Scottish Government
• Claire Lawrie, Information Consultant, Public Health Scotland
• Racheal Wood, Consultant in Public Health Medicine, Public Health Scotland
• Rachael Merrick, Principal Epidemiologist, Public Health Scotland
• Craig Heath, Consultant Neurologist and Honorary Senior Clinical Lecturer, NHS Greater Glasgow and Clyde
• Richard Brewster, Senior Policy Manager, Neurological Conditions, Scottish Government
• Alpana Mair, Head of Effective Prescribing and Therapeutics team, Scottish Government
• Iain Wilson, Clinical Lead (GP), Effective Prescribing and Therapeutics, Scottish Government
• Stuart Law, Effective Prescribing and Therapeutics, Scottish Government
• Alistair Cook, Principal Medical Officer, Scottish Government
• Frauke Hunter, Medicines Policy Team leader, Scottish Government
• Gemma McCormack, Senior Policy Manager, Scottish Government
• Annie Gonelli, Medicine and Pharmacy Policy Manager Scottish Government – Secretariat

Items and actions

Welcome and introduction

The Chair welcomed everyone to the Scottish Government (SG) Teratogenic Medicines Advisory Group (TMAG) meeting and invited two new members Richard Brewster Senior Policy Manager, Neurological Conditions and Antony Nicoll, Senior Medical Officer, both from the Scottish Government to introduce themselves. The Chair noted apologies. 

Minutes and actions from meeting of 8 October 2024

The minutes of the last TMAG meeting were agreed as accurate.

Actions are either completed or covered on the agenda, and the following updates were provided:

SG medicines policy team met with Digital colleagues in November to discuss capturing medicines indication data to improve patient safety. Digital colleagues advised they are unable to undertake a business analysis due to resourcing at the moment. 

SG medicines policy team liaised with colleagues in the SG Maternal Health team to discuss the possibility of linking male patient data and the acknowledged the challenges, for example, that permission would need to be sought from the biological father to transfer the medical information into the child’s record. 

SG Medicines team worked with Healthcare Improvement Scotland (HIS) to have the valproate easy read tools published on the Right Decision Service.

Public Health Scottland (PHS) update

It was noted that on 1 April, PHS published data on the use of anti-seizure medicines (ASMs) in Scotland in females and males aged 0-54 years, from April 2018 – September 2024.  
PHS presented a high-level overview of the findings from the outcomes analysis.
PHS noted the findings from its outcome analysis will be ready for publication by the end of the month (April), prior to peer review. PHS added that there is potential to have pre-agreed surveillance of other teratogenic medicines included in future. This will be discussed in separate meetings with SG and the Medicines and Healthcare products Regulatory Agency (MHRA). 

• action: SG, MHRA and PHS to discuss the other teratogenic medicines that would benefit from surveillance.

PHS also noted that depending on how rare an adverse event is, this would affect the number of exposures required to undertake such analysis – for example, where there is a 50% likelihood of an adverse event, this would need hundreds of cases – however if it was rare, this would need thousands of cases.

• action: it was noted that local pregnancy registers could provide more granular data and PHS agreed to discuss the potential opportunity to improve linkage with local pregnancy registers.

PHS noted they do not have the infrastructure at present to look at linking paternal data to pregnancy outcomes, adding that there are legal restrictions on the amount of data collected on a mother and father. To explore whether it would be possible to find a way round it would be very labour intensive.

• action: PHS agreed to look at the proportion of data missed for males over 55 years of age, however, it was noted it will not be possible to know what percentage of them have fathered a child.
• action: The Chair noted notwithstanding difficulty accessing male data, we should not lose sight of the potential; and that the medicine policy team will continue to liaise with the digital health team regarding indication data.

The Effective Prescribing Team (EPT) noted they will take forward work on National Therapeutic Indicators (NTIs) for gabapentinoids and will produce guidance in relation to chronic pain in Summer 2025. 

• action: It was agreed the EPT would set up a meeting separately with PHS to discuss this work.

Update on medicines policy work

A summary of SG medicines work since the last meeting was provided and a presentation on the position statement.

• action: medicine policy team to update position statement using a broader definition ‘valproate spectrum disorder’ to include those harmed who are no longer children.

English Patient Safety Commissioners Hughes Report

Policy officials continue to liaise with their counterparts at the UK Government to understand their proposed direction of travel on redress. The Public Health and Women’s Health Minister met with families harmed by valproate on 6 February. Following the meeting and the one year anniversary, the Minister wrote to Baroness Merron in February to request a meeting to discuss the options that the UKG are considering.

Social Security Awareness session

The valproate awareness ‘in conversation session’ for social security decision makers is scheduled to take place on 29 April.

Valproate easy read tools

It was noted the tools were finalised, awaiting pre-publication quality assurance checklist then will be published on the Right Decision Service.

TMAG work plan updates

Circulated prior to the meeting – members were asked to confirm they are content with the workplan by email before publishing on the TMAG web page.

Effective Prescribing Team update

EPT team talked members through the SBAR which was circulated prior to the meeting, noting the EPT are looking at what can be done at practice level by linking Scottish Therapeutics Utility (STU) searches to Pregnancy Prevention Plan coding.
There were no objections from members for the EPT to create a National Therapeutic Indicator (NTI) for gabapentin and pregabalin.

• action: It was agreed to remind Directors of Pharmacy (DoPs) of the ask in terms of setting up a governance/assurance group locally for assurance that boards are implementing the National Patient Safety Alert (NatPSA) actions relating to valproate and topiramate at the DoPs business meeting the following week.

Scottish Epilepsy Register (SER) update

 An overview of epilepsy and the rationale of the SER was provided, noting the SER is to use data driven alerts to improve access to care and improve outcomes in people with epilepsy.
It was noted an electronic form has been developed which allows data extraction.
It was noted that they have built infrastructure for the West of Scotland and are engaging with NHS Lanarkshire and NHS Ayrshire and Arran to incorporate the SER in their Health Boards, adding that by 2026 all health boards will have the SER available to them.
It was noted the SER team is aware one health board does not use Badgernet and they are unsure how to extract data from that health board.
It was noted an aim for SER going forward will be to look at maternal and child outcomes. CH noted the SER needs visibility and support at health board level to encourage usage of the SER across Scotland.

Update from the Sodium Valproate Learning Network (SVLN)

It was noted the SVLN held their fifth meeting in February, where health boards were invited to update on their progress of implementing the MHRA actions from the regulatory changes for prescribing valproate. It was noted at the SVLN meeting, there were resource challenges raised.

The SVLN has taken forward a piece of work to gather views of those with lived experience, this is ongoing until June 2025. It was noted a subset of questions were advised by the SVLN to understand views and they will produce a report on the findings by the end of 2025.

• action: It was agreed to share summary of the findings at the next TMAG meeting.

Next steps

• action: the medicines policy team will circulate an email to members asking for their views on what group of medicines the TMAG should consider going forward.
• action: Medicines policy team to arrange the next meeting.