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.
Special Issue on “Database for the Pharmaco-epidemiological Study in Japan; Current Status of the Quality Control”
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.
National Clinical Database (NCD) is a multidisciplinary clinical registry platform collecting patient case information throughout Japan in close linkage with the board certification systems for various Japanese professional medical societies. Since its initiation of data collection in 2011, NCD has grown in its size as more national level professional societies joined its activity. Its current case registration volume is above 150 million cases per year. In this commentary, we will introduce four patterns of utilization examples of NCD: 1) data use for the assessment and improvement of healthcare quality in Japan, 2) data use for conducting observational studies to answer physician generated clinical questions, 3) data use for health services research, and 4) Use of the registry platform for industry-government-academia collaboration. We will also go over some of the data quality management and improvement activities at NCD, which they regard as one of the top priority issues in the operation of the institution. These include: defining and designing of the data elements, administrative support from the office staffs, data error checking using the web based registration system, and data audit and validation.
The utilization of medical information is a pressing issue for pharmaceutical companies, particularly from the perspective of pharmacovigilance applications. There are currently some types of adverse reaction risks that cannot be detected in Japan but can be detected in Europe and the U.S.A. because secondary use of medical information is possible there. To remedy this lag, it is essential that we update the framework of Japan's system. We must create medical information standards that allow public use and we must define a level of quality control.
Proceedings of the 21st Annual Meeting of Japanese Society of Pharmacoepidemiology
We conducted a case-control study nested within a small cohort identified by using a hospital information system in Japan to examine the relationship of the use of calcium channel blockers (CCBs) to myocardial infarction. Although the crude odds ratio of myocardial infarction associated with CCBs was high, the ratio was reduced when adjusted by known confounding factors, suggesting a mechanism of confounding by indication. In addition, the results obtained in this study using records from a single hospital should not be generalized. Quality Indicators (QIs) are a tool for assessing healthcare quality, and QIs monitoring works to improve the quality of medical care. When QIs would be analyzed by using a hospital information, confounding factors should be removed if we measure QIs using the same method in the same hospital in chronological order. QIs analyzed by using a hospital information system are valuable and applicable to patients. It would be a driving force of the medical quality improvement that the number of the pharmaco-epidemiology experts would increase more and more. Because they can make the drug information conformed to Evidence-based Medicine using a medical database. Then, the medical quality improvement will decrease medical cost in Japan.