Thalidomide and the derivatives, lenalidomide and pomalidomide, are the most potent teratogenic medicines. Thalidomide Education and Risk Management System （TERMS^®）and RevMate^® for lenalidomide and pomalidomide have been operated with a goal of no exposed embryo to the drugs. The TERMS^®and the RevMate^®, a centralized management system, were revised in 2016 according to a request by a patient group. After the revision, the patient self-check sheet on adherence to conception prevention is primarily confirmed by his/her doctor, and the content of the completed sheet is sent to the management center in the pharmaceutical company after dispensing of the drug. The points for evaluation of the revised system will be as follows. (1) Has an appropriate procedure in accordance with the revised system been established in respective hospitals? (2) The rate of non-compliance with the procedure by the doctors or pharmacists, (3) Effect on awareness and behavior of the patients. Questionnaire studies of the patients, doctors, and pharmacists have been performed by the third-party committees.

Recently, medical real world data involving claims data, drug data, and electrical medical record database have been developed worldwide and can be utilized for the phrmacoepidemiology research.The results of the pharmacoepidemiology research with these database contribute not only to post-marketing safety research but also to the outcomes research and pharmacoeconomic evaluation. On the other hand, collaborating with a number of local governments, we have developed maternal and child health check-up and school health check-up database in Japan. The development of healthcare lifecourse data like this will contribute to the preventive medicine, the understanding of the rare diseases, and drug development.

Various measures have been taken to minimize risk for individual drug products in the past. It is noteworthy that these measures are now documented and made public as a　“risk minimization plan” with the implementation of the scheme of Risk Management Plan （RMP). Risk minimization activities are conducted with the aim of securing and enhancing patients' safety, and at the same time, it places additional burdens on patients, healthcare practitioners and manufacturers/distributors. In this context, it should be assessed whether the original purpose is achieved. It is the key　for RMP to revise the plan effectively based on the assessment result. Measures to evaluate the effectiveness of risk minimization activities include analysis using medical information databases, questionnaire survey/interview to healthcare practitioner and patients. We may need to conduct prospective/retrospective surveys for some cases. There is no single method to be universally applied to different situations and we have no other way than putting our heads together and moving into action.

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.

Objective: The government has been promoting further contribution to home care by pharmacists since almost all homebound patients are prescribed more than one medicine. However, little information is available on the adverse drug reactions (ADRs) in home care setting. This study was conducted to describe the ADRs reported by pharmacists in home care and examine factors related to their reports.

Design: Questionnaire survey

Methods: We requested patient-visiting pharmacists at community pharmacies throughout Japan to answer questions about their patients. Main questions included patient characteristics, number of drugs taken, presence of ADRs and details, and pharmacists' workload related to home-visiting.

Results: Data on 5,447 patients were collected from 1,890 pharmacies. The percentage of patients in whom the visiting pharmacists found ADRs was 14.4%. ADRs reported in 10 or more cases covered 12 categories, accounting for 85.2% of all ADRs. The top five categories were: dizziness, grogginess, or lightheadedness; gastrointestinal disturbances; clinical test value abnormality; altered mentation; and cutaneous symptoms. In seven of the 12 ADR categories, central nervous system drugs such as sleeping pills, antianxiety drugs, and psychoneurosis drugs were in the top three suspected drugs. Additionally, patients' gender, residential situation, and the number of drugs taken were implied as factors related to ADRs.

Conclusion：Our study indicated that, while the percentage of ADR occurrences in home-visiting service in Japan was at the same level as outpatients in other countries, drugs for the central nervous system accounted for a higher percentage of suspected drugs. Further, occurrence of ADRs was associated with the use of more than 6 concomitant drugs. These results suggest that physicians and pharmacists need to collaborate in decreasing the number and dose of central nervous system drugs.

Objective: Monitoring the incidence of atypical femoral fractures (AFFs) using medical claim databases is useful to assess the safety of long-term bisphosphonate exposure. Therefore, we aimed to validate the relationship between clinically-defined suspected AFFs and the candidate patients obtained from claims data at three hospitals in Japan.

Design: A cross-sectional study involving three hospitals that perform bone fracture surgery and from which electronic medical record databases of diagnoses and procedures are available.

Methods: Candidate patients were at the medical databases using two International Classification of Diseases, 10th Edition (ICD-10) codes (subtrochanteric fracture and fracture of shaft of femur) in the claims databases. These potential cases by claim-based definition were validated using clinically-confirmed information such as, the patient operation records, the discharge records, or radiographic imaging findings as suspected AFFs.

Results: Among fracture cases in the hospitals, and 9 cases with subtrochanteric fracture and 23 cases with femoral shaft fracture were identified based on the ICD-10 codes in the claims databases. Clinically confirmed subtrochanteric fracture had a sensitivity of 81.8% (95% CI: 48.2-97.7%), and a specificity of 100.0% (95% CI: 99.9-100.0%). For femoral shaft fracture, the sensitivity was 82.1% (95% CI: 63.1-93.9%), and the specificity was 100.0% (95% CI: 99.9-100.0%). In subgroup analyses, the sensitivities in patients over the age of 50 years with a single fracture site and with osteoporosis were relatively higher than in other subgroups.

Conclusion: The claims-based definitions of suspected AFFs are accurate, indicating the value of pharmacoepidemiological studies using the National Receipt Database.

In recent years, medical database has been utilized in many studies and researches. There is a higher demand of high quality management of these data upon utilization. Within this manuscript, it will include how the data is accumulated to data providing, and management of data quality.