Masami Tsuchiya1,2, Taku Obara3,4, Takamasa Sakai5, Kaori Nomura6, Chizuko Takamura1, Nariyasu Mano2,3. 1. Department of Pharmacy, Miyagi Cancer Center, Natori, Japan. 2. Laboratory of Clinical Pharmacy, Tohoku University Graduate School of Pharmaceutical Sciences, Sendai, Japan. 3. Department of Pharmaceutical Sciences, Tohoku University Hospital, Sendai, Japan. 4. Division of Preventive Medicine and Epidemiology, Tohoku Medical Megabank Organization, Tohoku University, Sendai, Japan. 5. Drug Informatics, Faculty of Pharmacy, Meijo University, Nagoya, Japan. 6. Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.
Abstract
INTRODUCTION: The spontaneous adverse drug reaction (ADR) reporting system plays an important role in pharmacovigilance by providing information from clinical settings in the postmarketing environment. The Japanese Adverse Drug Event Report (JADER) database contains a portion of Japanese ADR reports, and no previous study has described the quality or characteristics of ADR reports in the JADER. OBJECTIVE: The aim of this study was to identify the characteristics of the JADER database and to evaluate the quality of ADR reports contained in the JADER using the documentation-grading scheme developed by the World Health Organization. METHODS: Of 478 508 ADR reports in the JADER, the analysis set consisted of 395 091 reports meeting inclusion criteria. An analysis was carried out to evaluate the quality of the reports according to the type of report, the type of sender, and the qualification of the reporter. Annual changes in the number of reports from medical institutions submitted by pharmacists were compared with changes in the number submitted by physicians. RESULTS: The distribution of documentation grade differed according to the type of report, the type of sender, and the qualification of the reporter. Regarding "medical institution reports", the quality of reports was similar among qualification types, while the quality of reports submitted by physicians was higher for "company reports" and "study reports" (P < .0001, respectively). CONCLUSION: Our study showed that the quality of the ADR reports in the JADER differed among the type of report, the sender of the report, and the qualification of the reporter.
INTRODUCTION: The spontaneous adverse drug reaction (ADR) reporting system plays an important role in pharmacovigilance by providing information from clinical settings in the postmarketing environment. The Japanese Adverse Drug Event Report (JADER) database contains a portion of Japanese ADR reports, and no previous study has described the quality or characteristics of ADR reports in the JADER. OBJECTIVE: The aim of this study was to identify the characteristics of the JADER database and to evaluate the quality of ADR reports contained in the JADER using the documentation-grading scheme developed by the World Health Organization. METHODS: Of 478 508 ADR reports in the JADER, the analysis set consisted of 395 091 reports meeting inclusion criteria. An analysis was carried out to evaluate the quality of the reports according to the type of report, the type of sender, and the qualification of the reporter. Annual changes in the number of reports from medical institutions submitted by pharmacists were compared with changes in the number submitted by physicians. RESULTS: The distribution of documentation grade differed according to the type of report, the type of sender, and the qualification of the reporter. Regarding "medical institution reports", the quality of reports was similar among qualification types, while the quality of reports submitted by physicians was higher for "company reports" and "study reports" (P < .0001, respectively). CONCLUSION: Our study showed that the quality of the ADR reports in the JADER differed among the type of report, the sender of the report, and the qualification of the reporter.