Background : As the consequence of the decision at the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) progress, drug safety information reporting system in Japan is being revised. This has led to inevitable increases in the number of safety reports submitted to the industries and in turn, the Ministry of Health and Welfare (MHW). In 1997, the MHW announced they would publicize this acquired information starting in 1999. In the USA, Food and Drug Administration (FDA) has released safety related information to the public, acquired over the years since 1969, though such means in the Web page of MEDWatch using the internet.
Purpose : (1) To review accessibility of individual adverse experience (AE) reports in MEDWatch through internet, (2) to give advise to other possible Japanese users on the use of it and, (3) to give recommendation to the new system being developed in Japan by the MHW and/or other regulatory agency.
Method : Case study started by using personal computer.
Results : (1) The information cannot be accessible only using personal computers. Computer expert assistance and big computer are needed to access the information. (2) Information from more than a million AE cases is accessible. (3) Searches for information can be organized by pharmaceutical name, event term, patient demographics, and others. (4) The detailed information such as the course of the individual case from which drug causality could be assessed is not accessible. (5) The improvement of system should be needed for easy access such as “quick search”. (6) More “user friendly” system is desired to be developed by the MHW and/or other regulatory agency in Japan which enable easy and full access of the information.

Objective : To get first-hand information on and understand MEDWatch, a newly created program of the US FDA, on safety information reporting and management.
Design and Method : Through a visit to the FDA office by Japanese members of the ICH M1 (Medical Terminology) Expert Working Group (EWG) and other concerned experts, and discussion with relevant FDA staffs.
Results and Conclusion : (1) The MEDWatch program was introduced in June 1993, to accelerate the spontaneous reporting of adverse events (AE) to FDA by developing a single Adverse Event Reporting Form, i.e., FDA 3500, for (1) drugs, (2) biologics (except vaccine), (3) medical devices, (4) food, and (5) veterinary medicines; (2) Five responsible sectors in FDA have been working together to develop a smooth flow of information from health care professionals and industries; (3) The remarkable result from the development of this new program is the increased reporting of serious AE; (4) Much efforts have been exerted by FDA on the education of health professionals through various health societies and through publications; (5) Some of the issues which remain unresolved include database integration of NDA and PMS information; (6) Advocacy of the AE concept and importance of reporting thereof by health care professionals and the use of simple, easy-to-fill-out form is recommended in Japan.

Background : Since 2002, Keio University Hospital's Kampo Clinic has promoted itself actively through the media, public presentations, faculty outreach and an internet home page. However, the relative value of these promotions is unknown. Additionally, the range and prevalence of presenting concerns, and the ages and the gender ratio of the patients served at Keio is unknown.Objective and Methods : To better understand and better serve the patients, the medical charts of every new patient who presented to Keio University Hospital's Kampo Clinic from November 2004 to November 2005 (n=791) were retrospectively analyzed for 1) referral source, 2) age, 3) gender, and, 4) disease category.Results : The internet webpage was by far the best source of new patient referrals. The out-of-hospital referral rate to the clinic was remarkably low. Women exceeded men by a 3 : 1 ratio. Most women were in their thirties but male patients were fairly evenly distributed across the age spectrum. Patients under 16 and over 70 were gender-balanced. The vast majority of patients presented with general medicine/pediatric, dermatological or gynecological problems.Conclusion : A patient-oriented internet home page provides a good source of new patient referrals. Given the low rate of referrals from outside hospitals and physicians, additional outreach directed at internal medicine, dermatology or obstetrics/gynecology physicians appears warranted.
Clinic ; Hospitals ; Medicine, Kampo ; seconds ; Universities

A 47-year-old woman visited our clinic, and thereafter she had taken various Kampo medicines until she turned 58 years old. She took each medicine, containing 1-3.5 g/day of glycyrrhiza, for one or two months. Hypertension or edema was not observed in those days. From the age of 60, she took 7.5 g of tokishigyakukagoshuyushokyoto, containing 2 g of glycyrrhiza, day after day. Hypertension or edema was not observed for 35 months. However, when she was 63 years old, pseudoaldosteronism with headache, hypertension, edema,and hypopotassemia was observed for the first time. This case suggests that administration period or patient's age influences the development of pseudoaldosteronism.

Kampo medicines have been used for treatment by an increasing number of doctors in recent years, and are becoming more frequently prescribed in combination with Western drugs. In the present study, we conducted a questionnaire of outpatients at the Kampo Clinic of Keio University Hospital in order to determine their perceptions and compliance regarding Kampo medicines.Ninety eight percent of patients used Kampo medicines in granular form, and approximately 30% of these patients reported difficulty in taking medicine due to reasons such as “bad taste”. Sixty percent of patients used Kampo medicines three times daily. Patients most often forgot to take afternoon doses, and so desired doses once daily. Furthermore, the same number of patients preferred Kampo medicines in tablet form as those who preferred Kampo medicines in granular form.The present findings clarified patients' perceptions toward Kampo medicines. Doctors and pharmacists must provide suitable treatment for patients by recognizing their perceptions of Kampo medicines.
Medicine, Kampo ; Clinic ; Use of ; percent ; therapeutic aspects