The advances in dealing with the safety of medicated drugs in pregnancy

Abstract

The Japan Drug Information Institute in Pregnancy (JDIIP) was established with the aims of providing information on drug safety to women who are worried about drug use during pregnancy and creating evidence through epidemiological studies based on counseling cases. Since being established, JDIIP has made many contributions to the wellness of mothers and children by promoting the proper use of drugs during pregnancy. A network consisting of Core hospitals in 47 prefectures plays an important role in providing information for women living anywhere in Japan. Because cases of exposure to drugs whose safety we want to analyze are usually rare, networks of domestic and foreign teratology information services are necessary in order to produce high-quality evidence. JDIIP has been contributing to the education of pharmacists and doctors and to the creation of clinical practice guidelines in various medical societies by using keywords such as "pregnancy" and "medication". Future issues include creating an environment that is easily accessible for those seeking consultation, building a mechanism that makes it easy to create a basis for safety, and aiming for the continuing development of the organization.

Risk of major birth defects after first‐trimester exposure to carbocisteine and ambroxol: A multicenter prospective cohort study using counseling data for drug safety during pregnancy

“…In fact, the Japan Drug Information Institute in Pregnancy (JDIIP) reported that among 4821 patients for the counseling regarding drug safety during pregnancy between 2005 and 2016, carbocisteine was the most frequently consulted drug (605 patients). 6,7 Similarly, the JDIIP also reported that among 13 000 patients for counseling from 2005 to 2018 in Japan, counseling about general cold medicine accounted for the second largest part of the counseling all over Japan, in which many of those drugs included carbocisteine and ambroxol. 8 However, no epidemiological study to date has investigated whether oral administration of carbocisteine and ambroxol during pregnancy is associated with an elevated risk of major birth defects in infants.…”

“…These drugs prescribed for cold relief, rhinitis, and nasal sinuses inflammation are also frequently taken by reproductive‐aged women during their implantation period or early pregnancy, and when they notice the pregnancy, they become highly anxious about the effect of these drugs on fetal organogenesis. In fact, the Japan Drug Information Institute in Pregnancy (JDIIP) reported that among 4821 patients for the counseling regarding drug safety during pregnancy between 2005 and 2016, carbocisteine was the most frequently consulted drug (605 patients) 6,7 . Similarly, the JDIIP also reported that among 13 000 patients for counseling from 2005 to 2018 in Japan, counseling about general cold medicine accounted for the second largest part of the counseling all over Japan, in which many of those drugs included carbocisteine and ambroxol 8…”

Investigation on the accumulation of background and pregnancy outcome information on cases consulted by the Japan Drug Information Institute in Pregnancy

“…In response, the Japan Drug Information Institute in Pregnancy (JDIIP) 5,6 was established in October 2005 within the National Center for Child Health and Development as a Ministry of Health, Labour, and Welfare project. As of April 2023, 57 facilities in 47 prefectures (including the National Center for Child Health and Development) are using this network to establish a foundation for prompt consultation.…”