4．Evaluation of the Risk Minimization Plan of the Drugs such as Thalidomide / 薬剤疫学

If mother use drugs during pregnancy, the risk to the fetus is concerned. So the management of the drug is important. Previously, we have experienced The Thalidomide Disaster, the drug has not been used for many years since then. However, since thalidomide is found to have an effect on multiple myeloma, its management method is problematic. In the patients who use thalidomide, there are few women with the possibility of pregnancy. And by strict management, it has been concerned about the problem of the things that is difficult to use in patients not related to pregnancy. Isotretinoin is currently being used in the United States as the drug for acne therapy. Although there is no adaptation in Japan, the physician personally import the drug and administer to the patients. Because a lot of childbearing women are included in the patient who use the drug, strict management is necessary. Because the drug is not marketed in Japan, the offer of the information is not enough. Valproic acid has both adaptation the prevention of the migraine headache other than epilepsy. The control of epilepsy is very important, there are patients that use the drug after consideration of risk benefit balance. On the other hand, benefit was relatively small when use it for the prevention of the migraine headache. FDA prohibited the use during pregnancy for this purpose. In Japan, it is the same regulation regardless of adaptation, and balance of the risk benefit is not clear. It was thought that different attention awakening should be carried out by adaptation in future.

<b>4．Evaluation of the Risk Minimization Plan of the Drugs such as Thalidomide </b> / 薬剤疫学

<p>If mother use drugs during pregnancy, the risk to the fetus is concerned. So the management of the drug is important. Previously, we have experienced The Thalidomide Disaster, the drug has not been used for many years since then. However, since thalidomide is found to have an effect on multiple myeloma, its management method is problematic. In the patients who use thalidomide, there are few women with the possibility of pregnancy. And by strict management, it has been concerned about the problem of the things that is difficult to use in patients not related to pregnancy. Isotretinoin is currently being used in the United States as the drug for acne therapy. Although there is no adaptation in Japan, the physician personally import the drug and administer to the patients. Because a lot of childbearing women are included in the patient who use the drug, strict management is necessary. Because the drug is not marketed in Japan, the offer of the information is not enough. Valproic acid has both adaptation the prevention of the migraine headache other than epilepsy. The control of epilepsy is very important, there are patients that use the drug after consideration of risk benefit balance. On the other hand, benefit was relatively small when use it for the prevention of the migraine headache. FDA prohibited the use during pregnancy for this purpose. In Japan, it is the same regulation regardless of adaptation, and balance of the risk benefit is not clear. It was thought that different attention awakening should be carried out by adaptation in future.</p><p></p>

<b>Checklist and Guidance of Scientific Approach to Developing Pharmacovigilance Plan (PVP) in Japan: A Report from a Task Force of JSPE</b> / 薬剤疫学

A Task Force team consisting of members from pharmaceutical companies --a central player to develop and implement RMP (Risk Management Plan)-- as well as health care professionals and members from academia was established in JSPE. The Task Force developed guidance for scientific approach to practical and ICH-E2E-compliant Pharmacovigilance Plan (PVP) stated in Japanese Risk Management Plan issued in April 2012 by the Ministry of Health, Labour and Welfare. The guidance contains the following topics.<br>1．Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities<br>2．How to select Safety Specification (SS) and describe its characteristics<br>・Selection of SS<br>・Characterization of SS<br>・Association with Research Questions (RQ)<br>3．How to define and describe RQ<br>・What is RQ ?<br>・RQ interpretation in other relevant guidelines<br>・Methodology to develop RQ for PVP with examples<br>・Best approach to integrating PVP for whole aspects of safety concern<br>4．How to optimize PVP for specific RQ<br>・Routine PVP or additional PVP ?<br>・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)<br>・Checklist to help develop PVP<br>5．Epilogue:<br>・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.<br>・Significance of background incidence rate and needs for comparator group<br>・Infrastructure for the future PVP activities<br>6．Appendix: Checklist to help develop PVP activities in RMP<br>The task force team is hoping that this guidance help develop and conduct SS and PVP in accordance with ICH E2E, as stated in Japanese Risk Management Plan Guideline.

Intake rate of folic acid among pregnant women consulting the Japan Drug Information Institute in Pregnancy / 医薬品情報学

<b>Objective: </b>In 2000, the Ministry of Health and Welfare issued an advisory that recommended intake of 0.4mg of folic acid in dietary supplements to reduce the risk of development of neural tube defects.  Since subsequent reports of questionnaire surveys by various investigators showed a low in the intake rate, we surveyed and evaluated the folic acid intake rate among the pregnant women consulting the Japan Drug Information Institute in Pregnancy.<br><b>Methods: </b>We evaluated differences in folic acid intake rate according to the consulting women’s background factors. i.e., age, pregnancy planning, pregnancy history, and taking of anticonvulsant drugs in the 1053 women capable of participating in the survey among the 1061 pregnant women who requested a consultation with the Japan Drug Information Institute in Pregnancy between April 2006 and August 2008.<br><b>Results: </b>According to the result of our survey, the intake rate of folic acid was 29% of the 1053 pregnant women.  The only 3 women of the 42 pregnant women taking anticonvulsant drugs took folic acid before they got pregnant.<br><b>Conclusion: </b>Even now, 8 years after the Ministry of Health and Welfare advisory, the folic acid intake rate is low.  Drawing upon successful measures promoting intake in the U.S. and Canada,we play a vital role in delivering this critical health information to pregnant women.