Abstract
The efficacy and safety of pharmacotherapeutic agents are critical as they can spell the difference between wellness, debility, and even death. Some of the essential points to consider include how much and how often a drug is prescribed, what consequences there will be if over or under prescribed, and how it will impact on the underlying medical condition. These issues pertain not only to adult medicine, but also to pediatric medicine. At present, pediatric practice guidelines and approved pediatric product labels often vary widely, especially in Japan, in terms of dosage and administrations, and in some cases, indications. The standard drugs used worldwide for pulmonary tuberculosis in children include isoniazid, rifampicin, pyrazinamide streptomycin, and ethambutol. However, package inserts for rifampicin, pyrazinamide, and ethambutol do not provide the appropriate information for Japanese pediatric dosages. Globally and domestically, while essential drugs such as these have been used off-label successfully, it is critical to ensure they are safe and beneficial when used in children. Hence, there is a need to accommodate both the need for extemporaneous drug information and to overcome the lack of data and clinical experiences with them. In this study, we demonstrated evidence of such discrepancies and highlighted the importance of having identical information on dosing, administration, and drug indication in both products labels and practice guidelines, especially those that comply with the regulations of the Pharmaceutical Affairs Law.
