Overview
The Commission has published an independent review of the systems thinking analysis undertaken to support prevention of Foetal Anticonvulsant Syndrome (FACS) in New Zealand. The review identifies opportunities to improve safety when medicines with potentially teratogenic effects are used.
FACS is associated with exposure in pregnancy to medicines with teratogenic effects, including some anti-seizure medicines. These medicines can significantly increase the risk of congenital malformations and developmental delay.
The Commission acknowledges that harm has occurred to children, individuals and whānau as a result of the use of these medicines in pregnancy. Preventing further harm remains a shared priority across the health system.
Reports
This page brings together information from the following reports:
- Independent review of the Systems Thinking Analysis Report on Foetal Anticonvulsant Report 17 December 2025
- Systems Thinking Analysis to Prevent Foetal Anticonvulsant Syndrome (FACS) 31 May 2023
- Systems Thinking Analysis to Prevent Foetal Anticonvulsant Syndrome (FACS) 27 January 2022
These reports reflect the original systems thinking analysis prior to the health reform and afterwards.
Context
In 2021, following a cross-agency stakeholder hui, we commissioned an independent human factors expert to undertake a systems thinking analysis of FACS prevention which was further extended to include all teratogenic medicines.
The analysis used a Systems Theoretic Process Analysis (STPA) methodology to examine how the health system manages medicines with teratogenic risk. It helps identify:
- where communication or processes can break down
- how risks can build across different parts of the system
- what needs to be in place to keep people safe.
By mapping interactions between clinicians, consumers, organisations and systems, STPA highlights that preventing FACS depends on how well the system supports informed decision-making and safe prescribing over time, not any single point of failure.
Work on the reports occurred during a period of significant disruption and change, including the COVID‑19 response and the health system reform. As a result:
- system structures and accountabilities changed during development
- some initial proposed responsibilities are no longer feasible or aligned with current mandates
- implementation context has evolved since publication of the 2023 report.
Following completion of the systems thinking analysis, an Action Plan based on the report’s recommendations was developed and endorsed in 2024 by the National Medicines Steering Group (NMSG) convened by the Ministry of Health to guide ongoing work to reduce medicine-related harm in pregnancy.
Different perspectives
Stakeholders, including the Ministry of Health and FACS New Zealand (FACSNZ), have held differing views on aspects of the systems thinking reports (January 2022 or May 2023), including the interpretation of findings, allocation of responsibilities across agencies and how recommendations should be translated into action
We recognise these differences and have included links to both reports, shared for transparency and to support understanding. Importantly however, both versions of the systems thinking analysis highlight consistent themes including:
- gaps in informed consent and consumer understanding of teratogenic risk
- variability in clinician awareness of teratogenic medicines
- fragmented data systems and reporting
- limited system-wide coordination and governance
- challenges maintaining continuity of care across services.
The analysis highlighted that these issues arise from system complexity rather than isolated individual failures.
In 2025, the Ministry of Health requested a further independent review to reassess the previous report to reflect changes in the health system, consider what initiatives had occurred and any new activities required to reduce medicine-related harm in pregnancy
The independent review (Allen + Clarke) found:
- there is broad consensus that preventing medicine-related harm in pregnancy is critical and requires a systems approach
- many responsibilities in earlier reports were not feasible or were misaligned with agency mandates and suggestions on where these should be allocated have been made
- effective action requires cross-agency accountability rather than single-agency ownership
- improvements are needed in data, reporting and information sharing to support safer prescribing.
The review recommends updating the existing Action Plan (endorsed in 2024) to ensure actions are achievable, clearly allocated, and aligned with current system structures.
Action and next steps
An Action Plan to address FACS prevention was endorsed in May 2024 and is overseen by the National Medicines Steering Group (NMSG). Consistent with the independent review, the Action Plan overseen by the NMSG and involving FACSNZ will be:
- reviewed and updated to reflect current health system arrangements
- refined to ensure realistic and accountable actions
- progressed through a cross-agency approach.
Acknowledgement
The Commission acknowledges the experiences of those affected by FACS and the ongoing advocacy of individuals and whānau. Their contribution has been essential in advancing understanding and improvement across the health system.
Attachments
