Abstract
Objective: Medicines that are approved by Ministry of Health, Labour and Welfare are obliged to include a risk management plan (RMP) since April 2013. Pharmacists utilize the information from RMPs to ensure medicine safety for patients. Accordingly, a system was developed through which ward pharmacists could detect the risk of medicines.
Methods: The ward pharmacists utilized the RMP with the summary, and detected the safety specifications (identified risk, potential risk, and missing information) using a risk checklist. Additionally, we confirmed adverse drug reaction (ADR) signals using an ADR signal checklist.
Results and Conclusion: The RMPs of the medicines of 249 items as 223 constituents were posted on the PMDA website by December 2016. Of these, 10 medicines had prepared the risk sheets. The ward pharmacists detected 84 safety specifications and 6,983 ADR signals until December 2016. Before the ADR signal detection system was in operation, there were no reports in terms of an ADR signal, but 84 safety specifications and 6,983 ADR signals were extracted post-operation. Because these were early symptoms of ADR, these data could contribute to its early detection. The detection of ADR signals is possible by systematically focusing on the risk checklist and the ADR checklist.
