Teratogenic Medicines Advisory Group minutes: November 2023

Attendees and apologies

• Alison Strath (Chair), Chief Pharmaceutical Officer, Scottish Government 
• Richard Davenport, Consultant Neurologist, NHS Lothian
• Marion Bennie, Chief Pharmacist, Public Health Scotland
• Stuart McTaggart, Principal Pharm Tech specialist, Public Health Scotland
• Fiona Black, Information Consultant, Strategic development, Public Health Scotland
• Lynne Jarvis, Principal Information Analyst, Prescribing, Public Health Scotland
• Emily Moore, Senior Information Analyst, Consulting services, Public Health Scotland
• Laura Byrne, Director of Pharmacy, NHS Forth Valley
• Roch Cantwell, Consultant Perinatal Psychiatrist, Perinatal Mental Health Network Scotland
• Craig Heath, Consultant Neurologist and Honorary Senior Clinical Lecturer, NHS Greater Glasgow and Clyde
• Scott Hill, National Clinical Lead, Healthcare Improvement Scotland
• Alpana Mair, Head of Effective Prescribing and Therapeutics, Scottish Government
• Iain Wilson, Clinical Lead (GP), Effective Prescribing and Therapeutics, Scottish Government
• Alexandra Foster, on behalf of Justine Craig, Scottish Government
• Naya Koulocheri, on behalf of Irene Oldfather, Health & Social Care Alliance Scotland
• Frauke Hunter, Policy Team Leader, Scottish Government
• Gemma McCormack, Senior Policy Manager, Scottish Government (secretariat)

Apologies

• Andrew Walker, Lead Clinical Pharmacist Adult Mental Health, NHS Greater Glasgow and Clyde
• Alastair Cook, Principal Medical Officer, Scottish Government
• Juliet Brock, Medical Officer, Mental Welfare Commission
• Corinne Love, Senior Medical Officer, Maternity and Women’s Health, Scottish Government
• Laura McIver, Chief Pharmacist, Healthcare Improvement Scotland
• Daniel Smith, Professor of Psychiatry, University of Glasgow
• Dionne Mackison, Head of Medicines Policy, Scottish Government
• Irene Oldfather, Director Strategic Partnerships and Engagement, the Alliance
• Justine Craig, Chief Midwifery Officer, Scottish Government

Items and actions

Welcome and introduction

The Chair welcomed everyone to the Scottish Government Teratogenic Medicines Advisory Group (TMAG) meeting and invited members to introduce themselves.

A welcome was extended to additional colleagues from Public Health Scotland (PHS) attending to provide an update on their agenda item. 

Minutes and actions from meeting of 30 November 2022

The minutes of the last TMAG meeting were agreed with an amendment to the wording under agenda item 5. It was noted that all actions were in hand or have been completed.

• action 1: The SG Effective Prescribing and Therapeutics team noted their animation is now online and agreed to share with the medicine policy team
• action 2: The SG Effective Prescribing and Therapeutics team agreed to come back to the next meeting with timelines for the therapeutic indicators, noting the need to ensure the work is joined up

Update from Scottish Government including Gap analysis of neurodevelopmental services in NHS Scotland

The medicine policy team provided background on approaching the NHS Directors of Planning to take forward the work in relation to specialist services, a recommendation from the Independent Medicines and Medical Devices Safety Review (IMMDSR), and noted that the Head of Planning and Information at NHS Ayrshire and Arran, took forward the gap analysis work for specialist services. A draft gap analysis paper was circulated prior to the meeting for discussion. The analysis was received in October and the medicine policy team are now considering next steps. 

Members discussed the findings and noted the need to consider how the gap analysis is presented and communicated.

It was noted the gap analysis is not a national picture as there was a low response rate from Boards and only territorial Boards were included.

• action 3: The medicine policy team to discuss next steps with the Head of Planning and Information at NHS Ayrshire and Arran

It was noted the medicine policy team has been liaising with NHS England and are aware the DHSC have asked NHS England to take forward work to improve care pathways for children and families adversely affected by medicines in pregnancy, in response to the Cumberlege recommendation about specialist services.

It was noted the medicine policy team continues to work with the MHRA around the updated MHRA regulatory measures for sodium valproate.

Update from the Anti–Seizure Medicines Task and Finish Group 

It was noted the group has drafted a Terms of Reference (ToR) and had its first meeting on 4 September 2023, where members considered the group’s aims, and what had gone well and not so well previously in relation to the Sodium Valproate Pregnancy Prevention Plan (PPP) implementation. Members recognised the approach to anti–seizure medicines would cover all teratogenic medicines but it was agreed at the first meeting that the focus would be sodium valproate as a starting point. It was noted the group agreed to develop a consensus statement to support Health Boards. It was noted the Chair of the task and finish group met with Scottish Government Learning Disability colleagues to understand the challenges faced by patients with learning disabilities when communicating with healthcare professionals. It was noted the NHS England Decision Support Tool was shared with Learning Disability colleagues along with comments from members of the task and finish group with a view to develop communications for patients. It was noted 1 in 4 people of the learning disability population have epilepsy, however some members of the group queried if this figure was accurate.

• action 4 : SG medicine policy team to clarify the source of the ‘1 in 4’ figure
• action 5: SG medicine policy team to share ToR for the task and finish group with TMAG members

Update from Public Health Scotland (PHS) on the Medicines in Pregnancy surveillance asset

PHS sent an SBAR to members of this group which provided an overview of the medicines in pregnancy surveillance capability commissioned by Scottish Government. They invited feedback on this, including  potential outputs and who should be involved as a sounding board.

Its first report will mirror the England-only Medicines and Pregnancy Registry report, with some enhancements (some secondary care data). It should be available as a draft at the end of January, with a view to publish at the end of March 2024.

Members suggested including all the anti-seizure medicines (there are less than 20) to the medicine list for the outputs - a list of these were shared with PHS during the meeting.

Members asked how PHS defined ‘exposure’ and ‘conception’.

PHS noted ‘exposure’ was the event between date of conception and date for end of the pregnancy, based on dispense date, with prescribing behaviour data (prescription not administered) available: There was the option for sensitivity analysis starting within 28 or 56 days of estimated date of conception, looking at either prescribed date and the decision to prescribe; dispensed date and patient in possession.

‘Conception’ was based on antenatal and pregnancy records including birth registry data, with outcomes for around 90% of pregnancies. Where gestation data unavailable, PHS used ’10 weeks’ estimates.

Members asked if PHS had looked at the electronic medical record BadgerNet (online maternity data). It was noted BadgerNet is commissioned by Boards, not all used it, it was not at national level, and PHS did not have access to it.

PHS asked for clinical and patient representatives to join a new Task and Finish group to comment guide on what outputs and draft outputs, prior to being fed back to TMAG members. 

• action 6: PHS agreed to pick up discussions regarding BadgerNet with colleagues in PHS who lead on work around maternity and neonatal data hub
• action 7: SG medicine policy team agreed to send a list of contacts to PHS for volunteers to assist with outputs

Update on the Scottish Epilepsy Register (SER)

The consultant neurologist at NHS Greater Glasgow and Clyde who is leading on this work gave an update on progress. It was noted a project manager has been employed 2 days per week to facilitate the roll out of the SER across Boards. It was advised that at the beginning of 2024 the SER will be live in the whole of the West of Scotland. In the following year adoption is anticipated in Forth Valley and Tayside. It was noted work was underway locally to look at adapting the SER to be able to collect routine data manually. It was noted the SER now incorporated an electronic version of the MHRA PPP for sodium valproate.

It was suggested to amend the MHRA PPP form to capture indication data, this could be captured when women were seen.

In relation to the discussion on age groups to be included in registries, it was noted that as part of its review of births to women with epilepsy in Greater Glasgow and Clyde, there had been no births to women over 50 since 2015.

Any other business   

The Chair thanked everyone for their contributions to the meeting. 

The medicine policy team will arrange the next meeting of the TMAG for end of February/beginning of March 2024. 

• action 8: medicine policy team to arrange the next TMAG meeting