A Proposal of New Prescription Drug Labeling

Abstract

Prescription drug labeling currently used in clinical practice is legally required drug information, and is regulated by the MHLW notification entitled “Guidance to describe prescription drug labeling” issued in 1997. Previous research has revealed that the majority of physicians and pharmacists, who are real users of the drug labeling, acknowledged the importance of drug labeling and recognized that the order of description in the labeling is appropriate. However, over a half of them did not recognize that “conditions for approval” are described in the labeling. The aim of the present study was to develop new format and contents of prescription drug labeling and to verify the new labeling by a large-scale questionnaire survey on physicians and pharmacists who work in clinical practice. New format and contents of prescription drug labeling were created to solve the problems indicated by previous studies. The questionnaire was distributed by post to 2,004 physicians and pharmacists to verify the new format and contents of prescription drug labeling, and 1,100 questionnaires were returned (response rate: 54.9%). Over 85% of respondents agreed to number all the items in drug labeling. Over 84% of them agreed to group the information of patients included in “administration with caution”, “pediatrics”, “pregnant and lactating women” and “elderly” into a single item of “information on special populations”. Regarding the newly created item “information on medical insurance coverage”, the majority of the respondents (over 96%) agreed. The proposed new format and contents of prescription drug labeling were verified and supported by physicians and pharmacists. Further activities are needed to distribute the proposed new format and contents of prescription drug labeling to a wide range of medical professionals to collect more opinions.