'Safety in the Grey Zone': Evaluation of a training program to improve the safety of incident responders on high-speed roads.

INTRODUCTION: Workers operating on high-speed roads (i.e., incident responders and emergency service workers) are at significant risk of being fatally injured while working. An identified gap in current prevention strategies is training focused on developing the skills of workers to effectively communicate and coordinate safety responses when operating on roads. METHODS: This study discusses the development of a program designed to optimize communication and coordination of safety practices at the scene of an incident on a high-speed road. The program is referred to as 'Safety in the Grey Zone.' The goal of the study is to present the results from an evaluation on its implementation across 23 sessions involving 158 participants from 7 incident response agencies in 1 state in Australia. RESULTS: The results of this study provide support for effectiveness in implementing the program as planned. The results also provide preliminary support for effectiveness of the program in achieving its learning outcomes as demonstrated by feedback received from participants following completion of the program. CONCLUSIONS: The findings of this study provide recommendations to consider in the program's future roll-out, as well as suggestions for future evaluations to assess the program's effectiveness in improving the safety of incident responders operating on high-speed roads.

Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes.

ICH Q12 asserts that science- and risk-based approaches are applicable to stability studies supporting Chemistry, Manufacturing and Controls (CMC) post-approval changes (PAC) to enable more timely implementation; however, no guidance or specific examples are provided to demonstrate how prior knowledge of the product can inform the risk assessment for the proposed change(s). Ten diverse case studies are presented in this manuscript to demonstrate how science- and risk-based stability strategies were used to support drug substance and product CMC PAC and lifecycle management activities. The accumulated stability knowledge held by original manufacturers of marketed products is substantial, and different elements of this knowledge base were used to assess the risks and impact of the proposed changes for confident change management. This paper provides ways to leverage science- and risk-based stability strategies as part of the post-approval change-management risk-mitigation strategy, which may enable a reduced stability data commitment and/or a reduced reporting category for change implementation.

Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies.

In consideration of the recent ICH Quality Discussion Group (QDG) recommended revision to the ICH series of stability guidelines, the IQ Consortium (International Consortium for Innovation and Quality in Pharmaceutical Development) Science- and Risk-based Stability Working Group conducted a comprehensive review of ICH Q1A, Q1B, Q1C, Q1D, Q1E, and Q5C to identify areas where the guidelines could be clarified, updated, and amended to reflect the potential knowledge gained from current risk-based predictive stability tools and to consider other science- and risk-based stability strategies in accordance with ICH Q8-12. The recommendations propose a holistic approach to stability understanding, utilizing historical data, prior knowledge, modeling, and a risk assessment process to expand the concept of what could be included (or would be acceptable) in the core stability data package, including type and amount of stability evidence, assignment of retest period and shelf-life for a new product, and assessment of the impact of post-approval changes.

Safety outcomes for incident responders operating on high speed roads: An analysis of the relationship with behaviour, motivation and role clarity.

High-speed roads present a considerable level of risk for frontline workers operating in these environments. To optimise safety, prevention activities need to target the key skills required to mitigate risk. The aim of this research was to explore the behavioural (compliance, participation, voice), motivational (safety motivation) and work demand (role clarity) factors that influence safety outcomes for incident responders working on high-speed roads. Safety outcomes included secondary incidents and near misses with passing vehicles. A total of 295 complete survey responses were received from six emergency service and incident response agencies in one Australian state. Data were analysed using structural equation modelling. The results showed that higher levels of safety voice, safety motivation and, role clarity were significantly associated with safer self-reported safety outcomes after controlling for the number of incidents attended. The findings from this study will be used to guide the development of a training program to improve the cognitive, behavioural and perceptual skills of incident responders operating on high-speed roads. Some insight into the structure and format of this program is provided.

Intracavernous epinephrine: a minimally invasive treatment for priapism in the emergency department.

Priapism is the prolonged erection of the penis in the absence of sexual arousal. A 45-year-old man, an admitted frequent cocaine user, presented to the Emergency Department (ED) on two separate occasions with a history of priapism after cocaine use. The management options in the ED, as exemplified by four individual case reports, in particular the use of a minimally invasive method of intracorporal epinephrine instillation, are discussed.