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Fatal accidents caused by electric shock have been occurring since electricity was first introduced. Overall, the number of fatal accidents is decreasing. However, the decrease in the number of fatalities has slowed in recent years. A statistical study is needed to reconsider the preventive measures against these accidents. In this paper, the trend of fatalities by accident type and industry in Japan is studied statistically. These results show that the electric fatality rates differ by industry. The fatalities in the construction and the electrical-construction industries make up approximately 60% of the total fatalities. In addition, the accident type is most frequently contact with electrical lines by either the human body or a tool. In these industries, the elimination of fatal accidents from shocks is an important subject. These results will be helpful in preventing fatal accidents by electric shock. [ABSTRACT FROM PUBLISHER]

Pharmacovigilance science has traditionally been a discipline focussed on the postmarketing or post-authorisation period, with due attention directed towards pre-clinical safety data, clinical trials and adverse events. As the biological sciences have evolved, pharmacovigilance has slowly shifted toward earlier, proactive consideration of risks and potential benefits of drugs in the pre- and peri-approval stages of drug development, leading to a maturing of drug safety risk management. Further advances in biology, pharmacology and improvements in computational applications to medicine have led to the development of more complex medicines previously unobtainable and have also permitted a more thorough assessment of risks and potential benefits even earlier in the development process. Elevated public concern with the safety of more sophisticated medicines, combined with new science, have led pharmaceutical innovators, regulators and healthcare professionals to collaborate to develop guidelines, which drive enhanced pharmacovigilance and safety risk management earlier in drug development.In this paper, we review international guidelines on pharmacovigilance planning applicable to the pre-approval phases of medicines development and provide author opinion on these guidelines’ potential drug safety implications. We discuss the possible evolution of a pharmaceutical industry model to respond to these guidelines; a view on multidisciplinary safety management teams is provided to encourage refinement of safety-signal identification and risk assessment early in drug development and to communicate important safety concerns to internal research efforts, patients, investigators and regulators. We further describe these functions in the context of the complexities of vulnerable populations, including the example of medicines research for paediatric populations. We also discuss the special role of epidemiology in pre-approval drug development and the impact on epidemiological science of changes to the pharmacovigilance paradigm. [ABSTRACT FROM AUTHOR]