Learning from the report of the independent medicines and medical devices safety review: “first do no harm”

This is a review of the learning points from the Independent Medicines and Medical Devices Safety Review, 1 chaired by Baroness Julia Cumberlege CBE DL. This system-wide review was initiated by the then Secretary of State for Health and Social Care, following patient-led campaigns. It looked at how the “healthcare system reacted as a whole, and how that response can be made more robust, speedy and appropriate”. We aim to highlight the learning points for doctors in Obstetrics and Gynaecology as these are relevant to our current practice and future changes in our healthcare system. These are: Aims of the review: why it was initiated and how it was conducted Overarching themes and missed opportunities to prevent avoidable harm Three clinical scenarios: their histories, issues and adverse events associated with their use and the current response in Scotland The hormone pregnancy test - Primodos The anti-epileptic drug - sodium valproate Surgical mesh for prolapse & incontinence The recommendations made by the review and implementation guidance Responses to the review, such as apologies issued by BSUG 2 /BAUS 3 /RCOG, 4 and compensations schemes such as the Scottish scheme as recommended by the review

Manifestations of intraocular inflammation over time in patients on brolucizumab for neovascular AMD

Purpose To describe the adverse events associated with brolucizumab, in particular the sequence of intraocular inflammation (IOI), retinal vasculitis (RV), and/or retinal vascular occlusion (RO). Methods This was an unmasked post hoc analysis of the randomized HAWK/HARRIER clinical trials. Patients with neovascular AMD in the brolucizumab arms of the trials were included. IOI-related adverse events reported by study investigators were analyzed to determine early signs and the time course of IOI-related adverse events, using a subgroup of patients with definite/probable IOI cases identified in an independent unmasked post hoc review by an external safety review committee. A limited literature review on IOI following anti-VEGF therapy was also conducted. Results Among 50 patients with definite/probable IOI cases identified by the safety review committee, 12 had RV or RO adverse events reported by the investigators. For 6 of 12, IOI (other than RV) was reported before RV or RO. The duration from the first IOI adverse event to the first RV or RO adverse event ranged from 16 to 171 days for 5 patients and was 553 days for 1 patient. Four of the 6 patients received ≥ 1 brolucizumab injection on or after the date of the first IOI adverse event and before the first RV or RO adverse event. Conclusions IOI may precede RV or RO in some patients treated with brolucizumab.

Review planned for Fukushima waste-water release

The International Atomic Energy Agency (IAEA) is to conduct a safety review of the planned discharge of millions of tonnes of treated waste water from the Fukushima nuclear reactor into the ocean.

India and Pakistan: United by Covid-19

Madam, the number of new Covid-19 cases in India peaked at 362,902 on the 27th of April, 2021.1 This is the highest single day total for the world. India sold double the oxygen in 2020-21 than the previous year, now it faces a shortage of medical oxygen as it struggles with rising cases.2 Additionally, it struggles with the vaccine drive. In an article, Kamala Thiagarajan states that the initial block was mistrust of local vaccines, even among frontline healthcare workers. Other conspiracies followed, including fear of price hikes and reports about adverse effects, as approval for its own vaccines was rushed without proper evaluation to ensure safety.3 When adverse effects were observed in AstraZeneca and Johnson & Johnson trials, they were paused to conduct a safety review. However, no such thing occurred during the Covaxin trial.4 Continuous...

Risk assessment of collisions of an autonomous passenger ferry

Autonomous transportation is an increasingly popular concept and is gradually becoming a reality. This transformation also changes the way people travel. For example, the autonomous ferry is an emerging alternative for residents living in coastal areas. To evaluate the safety of an autonomous ferry, a thorough safety review is necessary. This paper makes an initial attempt by developing a model for performing a risk assessment of collisions between an autonomous ship with manned vessels and applying this to a specific ferry operating in a canal. The safety barriers to prevent a collision are identified, as well as the respective failure modes. A Bayesian belief network is employed to model the collision and to quantitively assess the collision risk of the autonomous ferry. Relevant data are collected to perform a quantitative risk analysis. By running the model, the likelihood of a collision is calculated. A sensitivity analysis is also performed to identify the most contributing causes.

MAP OF RADIOISOTOPE PRODUCTION AND BATAN RESEARCH REACTOR UTILIZATION

Currently, Indonesia through BATAN is operating three research reactors, namely the RSG-GAS reactor with the power of 30 MWt at Puspiptek south Tangerang (the first criticality in 1987), the TRIGA 2000 reactor with the power of 2 MW in Bandung which the first criticality in 1965 with the power of 250 kW, was increased to 1 MW in 1971, and further upgraded to 2 MW in 2000. Beside that, there is Kartini reactor with a power of 100 kW located in Yogyakarta (first criticality in 1979). These reactors are quite old, and in accordance with Bapeten regulations, have carried out the first periodic safety review, to obtain a reactor license for the next 10 years of operation. In line with this, one of BATAN's current national research programs is to increase the production of radioisotopes and radiopharmaceuticals, where reactors play a very important role in the production of certain isotopes. In tracing the data obtained from operational reports related to irradiation requests from reactor users, namely PTRR, PSTNT, and PT INUKI for radioisotope production, which has been carried out in the last 5 years, May 2015 until 25 August 2020, show that the irradiation request at RSG-GAS is still not optimal. In term of the utilization of RSG-GAS, it can still be optimized, which in this case needs to be balanced with post-irradiation processing capabilities. Meanwhile, from the results of tracing and data collection, it can be shown that at this time the reactors are still operating. The utilization activities of the reactors complement each other according to their age and facilities.

Radial artery access for neuroendovascular procedures: safety review and complications

Although enthusiasm for transradial access for neurointerventional procedures has grown, a unique set of considerations bear emphasis to preserve safety and minimize complications. In the first part of this review series, we reviewed anatomical considerations for safe and easy neuroendovascular procedures from a transradial approach. In this second part of the review series, we aim to (1) summarize evidence for safety of the transradial approach, and (2) explain complications and their management.

Postscript

This chapter reveals some of the major changes in the European and UK regulatory framework following the UK leaving the EU (Brexit), public health consequences of the supply of infected blood products, and the Covid-19 pandemic. It covers issues that occurred after Brexit, the independent medicines and medical devices safety review, and the UK blood enquiry. It also mentions the Medicines and Healthcare products Regulatory Agency (MHRA) that became the UK’s standalone regulator of medicines and medical devices since 1 January 2021, acting independently in joint work with other international regulators. The chapter elaborates on the UK’s intention to develop a new regulatory framework for medical devices that reflect the Independent Medicines and Medical Devices Safety Review published in July 2020. It highlights the European Medicines Agency’s (EMA) cooperation with the World Health Organization (WHO) on developing potential Covid-19 treatments by facilitating large-scale clinical trials.