The notice issued by the Ministry of Health, Labour and Welfare on April 28, 2023 on the newly approved oral abortion drug, Mefeego Pack
Important Points to Keep in Mind When Using Mifepristone and Misoprostol Products (Request)
To the Director-General of the Health Management Department (Bureau) of each prefecture, city with public health centers, and special ward
From the Director, Drug Evaluation and Control Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare and the Director, Maternal and Child Health Division, Child Health and Welfare Bureau, Child and Family Affairs Agency
We would like to thank you for your understanding and cooperation in the Ministry of the Health, Labour and Welfare and the Administration for Children and Families.
We would like to inform you of the following matters concerning the use of Mifepristone and Misoprostol (trade name: Mefeego Pack) (hereinafter referred to as "the Drugs"). Mifepristone and Misoprostol (trade name: MephigoPac) were approved today for the indication of “abortion for confirmed intrauterine pregnancy of 63 days (9 weeks and 0 days) or less of gestation”. In Japan, only designated doctors under the Maternal Body Protection Law (Act No. 156 of 1948) are allowed to perform abortions, and the use of this product is treated in the same way. We would therefore like to ask you to take the following points into consideration when using the drug. We would like to add that we have separately requested the same information to the President of the Japan Medical Association.
The details of the request are as follows:
1. The administration of the drug (oral administration of Mifepristone and buccal administration of Misoprostol) must be performed under the confirmation of a designated doctor under the Maternal Body Protection Law.
2. The package insert states that the designated doctor under the Maternal Body Protection Law should administer the drug under a system that can take appropriate actions in an emergency (a system for receiving constant contact from the person who received the drug in case of any abnormality and an emergency system that includes cooperation with other medical institutions).
However, until an appropriate system for the drug use is established, the drug should be used in a hospital or clinic where patients can be admitted for the time being. After the administration of Misoprostol, patients must be hospitalized or remain in the medical institution until the fetal sac is discharged. In this case, "for the time being, until an appropriate system for use is established" will be reviewed and judged based on the results of a sufficient amount of research to be conducted after approval, in which an appropriate medical coordination system will be evaluated.3. The approval of this product is subject to the condition that "necessary measures shall be taken to ensure that this product is used only by designated doctors under the Maternal Body Protection Law, including the implementation of distribution management in cooperation with related organizations, etc." In the Distribution Management Procedures, etc., each prefectural medical association is required to receive monthly reports from drug manufacturers, distributors, and medical institutions on sales volume, usage volume, and other necessary matters, respectively. Each prefectural medical association shall provide necessary supervision and guidance to designated doctors under the Maternal Body Protection Law by checking the consistency of these reports as appropriate. In doing so, it is acceptable to tailor the operation to the actual conditions of each region.
4. Although dead fetuses under 4 months of pregnancy are not subject to the Graveyards and Burials Act (1948 Law No. 48), we request that they be handled appropriately at each medical institution, while giving consideration to the feelings of women who have experienced an abortion.
5. If a designated doctor under the Maternal Body Protection Law uses this drug in a medically appropriate manner, a series of abortions with this drug falls under the definition of "abortion" in Article 2.2 of the Maternal Body Protection Law, and if the discharge of the gestational sac is observed before the administration of Misoprostol and the designated doctor under the Maternal Body Protection Law determines not to administer the Misoprostol, it can be interpreted that an abortion is being performed under the Maternal Body Protection Law.
