The Royal College of Physicians Invited Review: Report of the clinical record review of Tayside breast oncology
7 November 2022
The Royal College of Physicians Invited Review:
Report of the clinical record review of Tayside breast oncology
The Royal College of Physicians (RCP) has delivered the findings of its independent, external report of the clinical record review of NHS Tayside breast oncology.
The review was commissioned by NHS Tayside following previous concerns raised by a whistle-blower which were related to under-prescribing of breast cancer chemotherapy drugs in Tayside between 2016 and 2019. As stated in the review, this is the first report written by the RCP looking at these concerns. The RCP presented its findings and recommendations to the Board of NHS Tayside at its public meeting on 27 October.
The RCP team was made up of independent specialist clinical reviewers, including three consultant medical oncologists, a consultant clinical oncologist and a specialist clinical pharmacist with an expertise in chemotherapy prescribing.
Examining the clinical case notes of a number of patients chosen by the RCP at random, the team reviewed the prescribing of chemotherapy (and specifically a type of chemotherapy regime called FEC-T) which was taking place before the April 2019 publication of the Healthcare Improvement Scotland (HIS) report into the clinical management of breast cancer in Tayside. They also looked at the clinical practice and prescribing immediately after the publication of the report and up to February 2020.
The reviewers found that before the HIS report was published, cancer treatment in a number of cases was outside of recommended guidelines. The report states that the dosing was considered lower than standard practice as recommended by the National Institute for Health and Care Excellence NICE (NG101).
The review team also reached a number of key conclusions relating to clinical assessment and prescribing, including:
• there were lower than standard doses of chemotherapy prescribed to patients without a clear rationale documented
• decision making for the lower than standard doses of FEC-T was based on a conservative approach to prescribing, and potentially more focused on toxicity avoidance rather than using contemporary evidence-based drug dose regimens
• the clinical decision making for adjuvant chemotherapy dosing was not supported by evidenced-based prescribing
These findings are in line with the HIS report which found that NHS Tayside’s practice for prescribing FEC-T was at variance with all other NHS boards in Scotland. Two further external reports undertaken in 2019 also concluded that NHS Tayside was an outlier for chemotherapy prescribing for breast patients.
NHS Tayside accepted all the recommendations in the previous three reviews back in 2019 and made the necessary changes to how breast cancer chemotherapy was offered to patients, ensuring it was in line with practice across the rest of Scotland. The Board also made changes to improve the patient consenting process.
The RCP review team acknowledged that the clinicians who treated those patients with lower doses of FEC-T no longer work at NHS Tayside.
The RCP reported the following improvements made by NHS Tayside after the publication of the HIS report in 2019:
• The review team was reassured by the clinical record review which showed there has been a positive change towards standard chemotherapy prescribing practice in the current clinical team and following the release of the HIS report.
• There has been a shift in the prescribing of chemotherapy towards standard dosage following the release of the HIS report.
• The review team welcomed the development of a standard operating procedure for consent and noted that the oncology department had changed its consenting practices to using national consent forms.
• Whilst the review team were of the opinion that further refinements are needed to auditing tools, they recognised positive progress had been made to ensure that the patients are in receipt of a standardised approach to their treatment plans.
The RCP team has also made a number of recommendations to strengthen governance, review policies and procedures and improve multi-disciplinary working.
NHS Tayside has accepted the RCP’s report’s recommendations in full and clinical teams are developing an Action Plan in response.
The current Tayside oncology team has delivered significant improvements since the RCP’s reporting period, which runs up to February 2020, including changes to leadership, consenting processes and clinical governance.
The team are very keen to reassure patients that breast oncology services continue to be delivered here in Tayside, except for radiotherapy sessions for around six to seven patients per week.
The new Action Plan in response to the RCP report will run alongside the current Tayside oncology team’s own improvement plans as they seek to deliver their ambition to rebuild Tayside cancer services. The multi-disciplinary group of staff is committed to working together to deliver the best services they can for patients.
Background information:
• An individual in NHS Tayside contacted the Chief Medical Officer for Scotland (CMO) to raise concerns relating to the breast cancer clinical management guidelines and alleged ‘under-dosing’ of oncology medicines and lack of informed consent.
• The concerns that were raised led to the CMO and the Chief Pharmaceutical Officer (CPO) commissioning Healthcare Improvement Scotland (HIS) to undertake an investigation into the clinical management of breast cancer in NHS Tayside. The HIS report was published on April 1, 2019.
• The report found there was variation in prescribing and patients who required a type of chemotherapy for breast cancer in Tayside were being treated differently from patients in the rest of NHS Scotland.
• NHS Tayside took immediate action to change the prescribing practice in line with the recommended guidelines.
• An Immediate Review Group (IRG) was commissioned by the CMO and CPO to deliver a risk assessment relating to this variation in clinical practice in NHS Tayside.
• This group’s conclusions, published on April 16 2019, were in line with the HIS findings in that they advised that the reduced dose regimens being used by NHS Tayside were at variance with those in the other NHS Scotland centres.
• They went on to state that, whilst the decision to reduce doses in 2016 was taken in the best interests of patients, and based on an audit of toxicity, this decision lacked robust challenge or consultation.
• Another independent group – the Independent Advisory Group - was set up by the CMO in response to the HIS and IRG reports to advise the CMO on how recommendations in both reports could be implemented to ensure safe delivery of cancer medicines in the North Cancer Alliance.
• NHS Tayside accepted all the recommendations in all of the external reviews in 2019 and made the necessary changes to prescribing practice in 2019.
ENDS
