Tayside Breast Cancer Independent Advisory Group: final report

Background

1. An individual in NHS Tayside contacted the Chief Medical Officer for Scotland (CMO), the Chief Pharmaceutical Officer for Scotland (CPO) and the former Cabinet Secretary for Health & Sport to raise concerns relating to a failure in medicines governance in the context of breast cancer treatment in NHS Tayside. The specific allegations related to 'under-dosing' of two oncology medicines included in a type of chemotherapy treatment known as the FEC-T regime at NHS Tayside. The individual further alleged that appropriate patient consent had not been obtained in relation to this variation in practice.

2. These concerns led to the CMO and the CPO commissioning Healthcare Improvement Scotland (HIS) to undertake a fact finding exercise around the lack of consensus on the clinical management of breast cancer in what was then called the North of Scotland Cancer Network (NoSCAN), specifically current practice for the use of systemic anticancer therapy in early breast cancer, and the use of Oncotype DX testing. The HIS visiting panel determined that NHS Tayside practices were at variance with other NHS Boards in Scotland and that improvements in medicines governance arrangements were required. On 1 April 2019, HIS published its report, 'Clinical management of breast cancer in NHS Tayside'. That report made 5 recommendations.

3. Following the publication of the HIS report, an Immediate Review Group (IRG) was commissioned by the CMO and CPO to deliver a clinical risk assessment relating to this variation in clinical practice in NHS Tayside, and its potential impact on patient safety. This risk assessment was focused solely on the content of the HIS Report. The IRG report was subsequently published on 16 April 2019.

4. In April, the CMO also commissioned an Independent Advisory Group to consider both the HIS and IRG reports. This Group was convened to advise the CMO on how recommendations in both the HIS and IRG reports could be implemented to ensure safe and effective delivery of cancer medicines in the recently renamed North Cancer Alliance (NCA – previously known as NoSCAN).

5. The full remit, terms of reference and purpose of this Group can be found at Annex A with membership at Annex B.

6. Links to key reference documents considered by the Group can be found at Annex C.

7. From the outset, the Group was clear that its role and remit was forward looking.

8. The Group did not have access to individual patient records and it was not within the Group's remit to express an opinion on the original clinical decision making processes of the NHS Tayside consultant oncologists, or to undertake any literature review on the evidence underpinning those decisions. In meeting the terms of reference of the Group, it quickly became apparent that looking at one NHS Board (NHS Tayside) or one network (the NCA) in isolation would not prevent a similar occurrence outwith those geographical boundaries. The national solutions offered in this report, if adopted, will mean that a similar occurrence cannot happen anywhere else in Scotland in the future.

9. The ordering of recommendations does not reflect any prioritisation by the Group, but suggested timescales for implementation and lead responsible body(ies) have been indicated