의약품의 위험관리 - 이소프로필안티피린 함유 의약품과 관련하여 -

Recently, there have been discussions about the safety of an analgesic drug containing an active pharmaceutical ingredient called isopropylantipyrine (“IPA”) and a study is currently being conducted with respect to this ingredient. The reason we are evaluating as to reasonableness and appropriateness of the government's measures with respect to the drug's safety is because, going forward, such measures could provide grounds to determine whether or not the government should be held liable for the damages for bodily injury resulting from the use of the drug in question. A government's action should be based on objective and reasonable processes from the perspective of risk management, and the detailed process of such risk management can be divided into the following: ① Initiation and Identification, ② Estimation, ③ Evaluation, ④ Risk Reduction and Control, ⑤ Risk Communication One of the most important matters during the risk management process is for the government to understand the particular tendencies/characteristics of both the expert groups such as drug manufacturers and non-expert groups such as patients, and to take measures that could satisfy both groups. During this process, the objective/subjective reasonableness has to be ensured with respect to the collection of information, risk assessment, policy decision and communication with the relevant groups. With regard to the process regarding the IPA containing analgesic drug, based on the details of the risk management process, the government's measure appears to have been carried out appropriately. Although there are some weaknesses in terms of communication, this does not appear to be a fundamental issue. In any event, based on the results of the current study, the risk management process and the relevant procedures may have to be adjusted.