Contributors to Fatigue of MineWorkers in the South African Gold and Platinum Sector

BACKGROUND: Mine workers in South Africa face challenges relating to poor health and safety, including fatigue risks, and poor socioeconomic and living conditions. Fatigue results in impaired mental and physical performance. The aim of this study was to assess contributors to fatigue of mine workers in South Africa. METHODS: Data collection took place at four gold mines and one platinum mine in South Africa. A total of 21 focus groups were held with individuals in management, union representatives, and mine workers, and 564 questionnaires were completed by mine workers to gather information about fatigue and potential contributors to fatigue at these mines. RESULTS: Qualitatively (through focus groups), fatigue was attributed to extended working hours, harsh working conditions, high workloads, production pressure, and resource constraints, along with aspects relating to demographic and socioeconomic factors, living conditions, lifestyle, health, and wellness. Greater fatigue was significantly associated with younger age, indebtedness, a lack of exercise, poor nutrition, less sleep, increased alcohol use, poor self-reported health, more sick leave, higher stress, and lower job satisfaction. CONCLUSION: The aim of the study was achieved; numerous work-, sociodemographic-, lifestyle-, and wellness-related factors were linked to fatigue in the participating mine workers. Contributors to fatigue should be addressed to improve health, safety, and sustainability in the industry.

Risk evaluation and mitigation strategy in oncology products / 中国药学杂志

OBJECTIVE: To review and analyze the specificity and dynamic changes in developing the Risk Evaluation and Mitigation Strategy (REMS) in oncology products. METHODS: Based on FDA's requirement for REMS for some high-risk drugs and biologics, the REMS literatures of oncology products were tracked and accessed. The approved and released REMS programs of anti-cancer drugs were summarized and analyzed. RESULTS: REMS is a key tool for FDA to help manage and ensure the safe use of the medications. Though a disproportionate number of drugs with complex REMS are required in patients with cancer, the percentage of the oncology drugs with REMS requirement is not much higher than non-oncology products. This mainly resulted from the specificity of cancer and chemotherapy, in which much collaborative interaction among health care practitioners as well as the emerging target therapy with highly specificity and selectivity may contribute to minimize risk from medications.CONCLUSION: The necessity of developing REMS for an oncology product depends on its properties and the new circumstances in oncology practice.

Risk management and principal features of REMS

A safe drug is defined as one for which the benefit of the medication is greater than the expected risk, taking all factors into account. To enhance the safety of drugs, the risk of the drugs should be minimized. These risk management (RM) actions are assessment, confrontation, intervention, communication of risk, and evaluation of each process, in that order. To maximize the effect of RM, it should take place as early as possible in the drug life cycle, such as from the drug development period before marketing, and also after marketing. In areas of advanced drug development and a large drug market share, these activities have been legislated as Risk Evaluation and Mitigation Strategies (REMS, 2007) in the United States and the Risk Management Plan (2006) in the EU. REMS is briefly summarized in this paper. In Korea, these policies were accepted and carried out beginning in 2011 as the first stage of legal support and modification of drug safety plans. Also, proactively, the Korea Institute of Drug Safety was launched to manage information about drug safety and develop a scientific method for enhancing RM. RM should be approached in a global scope in order to foster many experts in diverse fields and to keep openness and transparency for close and effective collaboration, which is essential for successful RM and health outcomes.