Legal duty of care and the community nurse.

In this month's Policy column, the author explores the concepts of duty of care, forseeability and proximity, and how the community nurse can be better prepared when caring for the patient.

Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening.

BACKGROUND: Seven national medicines regulatory authorities in the East African Community (EAC) have embraced regulatory reliance, harmonization and work sharing through the EAC Medicines Regulatory Harmonization programme. Measuring the performance of regulatory systems provides key baseline information to build on regulatory system-strengthening strategies. Therefore, the aim of the study was to evaluate the regulatory performance of the EAC joint scientific assessment of applications approved between 2018 and 2021. METHODS: Utilising a data metrics tool, information was collected reflecting timelines for various milestones including submission to screening, scientific assessment and communication of regional recommendations for biologicals and pharmaceuticals that received a positive regional recommendation for product registration from 2018 to 2021. RESULTS: Several challenges as well as possible solutions were identified, including median overall approval times exceeding the EAC 465-day target and median times to issue marketing authorisation following EAC joint assessment recommendation that far exceeded the 116-day target. Recommendations included establishment of an integrated information management system and automation of the capture of regulatory timelines through the EAC metric tool. CONCLUSIONS: Despite initiative progress, work is required to improve the EAC joint regulatory procedure to achieve regulatory systems-strengthening and ensure patients' timely access to safe, efficacious and quality medicines.

Considering claims against the NHS.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses the NHS Resolution annual report and accounts for 2020/21 and recent advice from the Medical Defence Union.

Malpractice litigation and spinal surgery in the National Health Service: a single tertiary-level centre perspective over 12 years.

INTRODUCTION: Medical malpractice litigation is a major concern for all spine surgeons. Our aim was to evaluate the incidence and burden of successful litigation relating to the management of spinal disorders over 12 years within a UK NHS tertiary-level spinal unit and compare these litigation costs with those of other specialties. METHODS: We obtained all data held by our claims department from its inception in January 2008 to December 2019. We also obtained costs for the total financial burden incurred by our Trust during this period. RESULTS: In total, there were 83 closed claims involving spinal pathologies. Over 80% of these comprised negligent surgery (n = 28, 34%), delay to diagnose/treat (n = 25, 30%) and negligent care (n = 18, 22%). The vast majority of claims were withdrawn without incurring any cost to the hospital (n = 59, 71%) and only 24 (29%) resulted in successful litigation for the claimant. The total cost of damages for these 24 successful claims was just over £8 million, including legal costs of £2.5 million, out of total litigation costs of £381 million over this period. DISCUSSION: Fewer than 30% of initial claims against a tertiary spinal surgical referral unit resulted in a successful financial outcome for the claimant. The total costs incurred were just over £8 million, with one-third apportioned to high legal costs, reflecting the complexity of resolving spinal litigation. Our entire legal expenses accounted for only 2% of the total legal bill paid by our hospital over a 12-year period.

Medical negligence in urology: an untapped database.

INTRODUCTION: The aim of this study was to identify the causes of urological litigation in the NHS and to make recommendations how to reduce the burden of litigation to both injured patients and urologists. METHODS: Under the Freedom of Information Act, the National Health Service Resolution (NHSR) was asked to provide the figures for the number of cases of litigation in urology reported between 2010 and 2020. RESULTS: The number of urological claims more than doubled between 2011 and 2020. Many of the claims that are made result from avoidable errors. CONCLUSION: More education is needed, of both urologists in training and consultant urologists, on the causes of errors that lead to litigation and how many of them can be avoided.