Japan Society of Chemotherapy Unapproved Drug Issues Review Committee Advisory committee on high dose meropenem

In Japan, the approved daily dose of meropenem (MEPM) was "up to 2 g" for all indications, despite approval for 3 g in Europe and the United States for some severe/refractory infectious diseases. Using a questionnaire, we investigated "Utilization of MEPM in the Japanese clinical setting", "Needs of a higher daily dose of MEPM than the approved dose" and "Change of frequency of prescription of MEPM at a high dose if high dose usage were to be approved". This questionnaire was sent to 2,653 institutions in which members of the Japan Society of Chemotherapy and certified Infection Control Doctors (ICD) were employed. As a result, valid responses were obtained from 450 institutions (response rate: 17.0%). A high dosage (above 2 g/day) of MEPM was primarily prescribed for brain abscesses and bacterial meningitis, and in some cases, for infectious endocarditis, febrile neutropenia, and myelitis. Among the valid respondents, 27.8% have prescribed MEPM at a high dose. There was greater willingness to prescribe a high dosage among respondents working in institutions with above 200 beds or by certified ICDs. In total, 51.2% of respondents agreed with the high dose usage of MEPM. Furthermore, this result showed the possibility that MEPM would be prescribed in high dose at higher frequency, if high dose usage were to be approved. Based on the Pharmacokinetics/Pharmacodynamics (PK-PD) theory, the increase in the maximum daily dose would improve efficacy for severe infection. To meet the needs of current clinical practice, usage of MEPM up to 3 g/day was approved for severe/refractory infectious diseases on March 2011 in Japan. Based on this Guidance, we should further clarify the types of infection to be treated with 3 g/day of MEPM. Also, we look forward to early approval usage of 6 g/day of MEPM for bacterial meningitis, etc.