[The Role of Laboratory Tests in the Safety Management of Pharmaceuticals -Remarks of the Chairperson-].

Masaharu Yamazaki
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Abstract

More than 700,000,000 prescriptions are issued every year for the approximately 18,000 pharmaceutical products in Japan. Consequently, numerous measures have been implemented to ensure the safety and efficacy with which these large quantities of drugs are managed. One of these approaches is the PreAVOID report, which focuses on the prevention and avoidance of adverse reactions and drug interactions by collect- ing and analyzing pharmaceutical care reports compiled by hospital pharmacists. According to the Japanese Society of Hospital Pharmacists, more than 20,000 such reports are issued annually. These reports are screened for abnormal clinical test values to identify which adverse reactions occur at the highest frequencies. While many hospital pharmacists scrutinize these laboratory test sheets, the awareness of clinical laboratory specialists regarding prescribed medicines is not known. We therefore invited specialists who are well versed in matters related to pharmaceutical risk management to this symposium to present the latest topics related to the influence of prescribed medicines on laboratory test values, and to discuss current issues asso- ciated with monitoring adverse events and adverse reactions. In addition, we examined potential strategies for avoiding severe adverse effects by establishing specialist teams and the role of laboratory specialists on such teams. [Review].

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[实验室检测在药品安全管理中的作用-主席讲话-]。
在日本,每年约有1.8万种药品开出超过7亿张处方。因此,已采取了许多措施,以确保管理这些大量药物的安全性和有效性。其中一种方法是PreAVOID报告,该报告通过收集和分析医院药师编写的药学服务报告,重点关注预防和避免不良反应和药物相互作用。据日本医院药剂师协会称,每年发布的此类报告超过2万份。这些报告筛选异常的临床试验值,以确定哪些不良反应发生频率最高。虽然许多医院药剂师仔细检查这些实验室测试单,但临床实验室专家对处方药的认识尚不清楚。因此,我们邀请了精通药物风险管理相关事宜的专家参加本次研讨会,介绍处方药对实验室检测值影响的最新主题,并讨论与监测不良事件和不良反应相关的当前问题。此外,我们研究了通过建立专家团队和实验室专家在这些团队中的作用来避免严重不利影响的潜在策略。(审查)。
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