Teratogenic Medicines Advisory Group minutes: February 2024

Attendees and apologies

 

• Alison Strath, Chief Pharmaceutical Officer (CPO), Scottish Government (Chair)
• Marion Bennie, Chief Pharmacist, Public Health Scotland (until item 3)
• Lynne Jarvis, Senior Information Analyst, Public Health Scotland (until item 3)
• Laura Byrne, Director of Pharmacy, NHS Forth Valley
• Roch Cantwell, Professional Advisor, Perinatal and Early Years Mental Health, Scottish Government
• Alexa Foster, Professional Advisor, Midwifery and Perinatal Care (covering for Justine Craig, Chief Midwifery Officer, Scottish Government)
• Scott Hill, National Clinical Lead, Healthcare Improvement Scotland
• Alistair Cook, Principal Medical Officer, Scottish Government
• Irene Oldfather, Health & Social Care Alliance Scotland
• Daniel Morales, GP, University of Dundee
• Alpana Mair, Head of Effective Prescribing and Therapeutics, Scottish Government
• Stuart Law, Effective Prescribing and Therapeutics, Scottish Government (covering for Iain Wilson)
• Dionne Mackison, Head of Medicines Policy, Scottish Government
• Frauke Hunter, Medicines Policy Team leader, Scottish Government (covering for Gemma McCormack) Secretariat

Apologies  

• Craig Heath, Consultant Neurologist and Honorary Senior Clinical Lecturer, NHS Greater Glasgow and Clyde
• Daniel Smith, Professor of Psychiatry, University of Glasgow
• Richard Davenport, Consultant Neurologist, NHS Lothian
• Laura McIver, Chief Pharmacist, Healthcare Improvement Scotland
• Justine Craig, Chief Midwifery Officer, Scottish Government (Alexa Foster covering)
• Iain Wilson, Clinical Lead (GP), Effective Prescribing and Therapeutics, Scottish Government (Stuart Law covering)

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. The Chair noted apologies, as above.

The Chair also noted the summary on the Scottish Epilepsy Register to TMAG which was circulated prior to today’s meeting.

Minutes and actions from meeting of 06/11/2023

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

In terms of outstanding actions:

The Chair clarified the “1 in 4” reference relating to learning disabilities and epilepsy, noting the NICE website (2023) which cited that “people with learning disabilities have higher rates of epilepsy than the general population, making up about 25% of the total of people with epilepsy.”

This action linked to conversation about communication resources and why these were needed, but having spoken to colleagues it was agreed that having a succinct guide for everyone would be helpful.

The Scottish Government (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, and would be able to provide an update at the next meeting.

• action 1: SG effective prescribing team will report back at next TMAG meeting

Public Health Scotland (PHS) and the Effective Prescribing and Therapeutics team were to consider medicines safety guidance for the next meeting: they advised this needed to be considered alongside priorities for 2024/25.

• action 2: SG effective prescribing team will report back at future TMAG meetings

PHS agreed to pick up discussions regarding BadgerNet with colleagues in PHS who lead on work around maternity and neonatal data hub: they confirmed dialogue was ongoing.

• action 3: PHS will report back at future TMAG meetings

All other actions were complete.

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

The Chair invited PHS to provide an update. The first meeting of the data subgroup had taken place and was constructive. PHS presented a timeline for the forthcoming ‘Anti-seizure medicines in pregnancy’ report, which would be published by PHS on 2 April. The purpose was to provide data on prescribing of anti-seizure medicines in women and in pregnancy, including trends, starting and stopping medicines.

Future reports would be roughly every 6 months, on a rolling timeline aligned with NHS England’s, with the next report out in October 2024, which would include data up to June 2024.

The report would feature valproate and topiramate and be supported by more detailed data in Excel tables for other anti-seizure medicines.

The next subgroup meeting on 12 March would be about future outputs. PHS summarised feedback from recent subgroup on future developments including child outcomes and Sudden Unexpected Death in Epilepsy (SUDEPs), the possibility of looking at HB level (more likely to be management information), and the development of a dashboard.

The Chair noted the CPOs’ interest around SUDEPs in terms of impacts of regulatory changes; and for indications, in the context of 2018 digital work, SG medicines policy would ask SG Health Digital colleagues to capture this.

• action 4: medicine policy team to contact digital colleagues about indication data

It was noted that indications were tricky to capture, but important, and interest in paternal valproate data. PHS confirmed this had been raised by the subgroup and that they were considering what can and cannot be done.

PHS confirmed the Brittish National Formulary section was included, as it gave early indication of prescribing patterns.

Strengthened regulatory measures for valproate 

The Chair noted in relation to the National Patient Safety Alert (NatPSA) issued on 28 November 2023, that SG was asked by the Medicines and Healthcare products Regulatroy Agency (MHRA) to follow up with Health Boards in Scotland to confirm that the Action and Improvement Plans were now in place and had been communicated with all relevant parties.

The Chair added that on 24 January, the medicines policy team issued a checklist to support Health Boards in Scotland with internal assurance processes.

The Chair noted that the learning network group was doing work around the checklist which would be covered under the next agenda item.

Update on medicines policy work

The following updates were provided:

English Patient Safety Commissioner’s Report
SG received some inquiries following the publication of the English Patient Safety Commissioner’s redress report which was published on 7 February. They noted that the report’s recommendations were made in relation to England, and it would be for the UK Government to respond to the Commissioner. SG was reviewing the report to see what the implications were for Scotland.

Gap analysis 
SG looked at the gap analysis and as the analysis was based on questionnaire responses from 5 health boards, they were conscious that it did not provide a comprehensive and therefore accurate picture on the services and support available in Scotland. Therefore, medicines policy would draw on the analysis, supplemented by stakeholder inputs, and produce a SG response to the specialist centres recommendation from the Baroness Cumberlege report.

• action 5: medicine policy team to draft a SG position on specialist services and invite feedback from TMAG members and Valproate Scotland

Update from the valproate learning network

It was noted there had been three network meetings to date and an overview of discussions was provided, i.e.  the meetings had good representation from the MHRA to update and answer questions, and that the purpose of meetings was to share information and learning. Alerts and regulatory changes covered patient engagement and health inequalities, therefore the network discussed how to take that forward on a national basis.

It was noted that the strategic group mental health pharmacists had similar discussions and wondered whether they were involved in the network, which was confirmed.

The Alliance asked about national versus local engagement and agreed it was good to have national focus, but noted that the earlier they had sight of outputs the better, so they could link up and connect. It was agreed to keep the Alliance linked in.

Update from the Anti–Seizure Medicines (ASM) Task and Finish Group

It was noted an assurance check list was needed to support Health Boards in Scotland. The group continued to work with SG learning disabilities colleagues on a tool for parents and carers ‘why valproate? what does it mean for me?’ to be used for all consultations. The next subgroup meeting would consider topiramate, in advance of any new regulatory measures.

The Chair expressed her thanks to the group for the checklist work.

The importance of how we communicate and a good communication plan was noted.

It was noted that the ASM and risks were the focus, given the regulatory requirements, but stated that while they would not want to confuse these issues, they could remind clinicians that discussions around other medicines might be needed and signposted, and could be added to the tool.  It was agreed to raise this with ASM group.

• action 6 – ASM group to consider adding other medicines to the tools under development

The Chair noted links with polypharmacy work and it was noted it would depended on how the tool was used and implemented.

The Chair wondered about who was using the tools and service capacity concerns. These concerns were acknowledged, noting who the tool was aimed at and why, in the main, it was part of manual risk acknowledgements by epilepsy colleagues, to help with conversation of risks of valproate. 

Wider action plans and potential next steps

The Chair introduced this item, which was about the TMAG work plan, and asked the group what they thought should be future priorities, and whether the group wanted to review what would be best next steps. It was agreed that this would be an agenda item for next TMAG meeting.

• action 7: medicine policy team to add to next agenda and circulate work plan prior to that meeting

It was noted other work focussed on: ‘medication without harm’, and that the term ‘teratogenic medicines’ may lack general awareness, also the importance about knowing how to get robust information, and that it was worth considering getting feedback from public and clinicians.

Any other business

The Chair thanked everyone for their contributions to the meeting. There was no other business.

The medicines policy team will arrange the next meeting of the TMAG for June 2024. 

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