1.Analysis of Adverse Reaction in Kampo-Medicines Using JADER Database of PMDA
Hideo Shimodaira ; Mayu Nozaki ; Yeondae Kwon ; Naoki Kamimura ; Fusao Kaiho
Japanese Journal of Drug Informatics 2014;16(1):16-22
Objective: Recently, since usage of the kampo-medicines has changed from conventional usage, it is possible that the tendency of adverse reaction also changes. Pharmaceuticals and Medical Devices Agency (PMDA) discloses information reported by Pharmaceuticals and Medical Devices Safety Information Reporting System. In this study, we analyzed adverse drug events of kampo-medicines using Japanese Adverse Drug Event Report (JADER) database of PMDA. We also investigated what adverse drug events are likely to be occurred by kampo-medicines and what kampo-medicine is likely to cause a particular adverse drug event.
Methods: We focused on reports referring to suspected drugs for kampo-medicines from JADER database of PMDA for about nine years from April 2004 to February 2013. We analyzed kampo-medicines, organs, and adverse drug events based on the number of reports.
Results and Conclusion: We found 1,958 reports on adverse drug events for kampo-medicines. The largest number of reports for kampo-medicines was on Shakuyakukanzoto, followed in order by Bofutsushosan, Saireito and Yokukansan. The breakdown of each organ of adverse drug events reported was 34% for hepatobiliary system disorders, followed in order by 26% for respiratory, thoracic and mediastinal disorders, and 9% for metabolism and nutrition disorders. A total of the above adverse drug events accounts for 70% of all adverse drug events. The largest number of adverse drug events reported was 406 cases for interstitial lung disease, followed in order by 294 cases for liver disorder, 260 cases for hepatic dysfunction, 165 cases for hypokalemia, and 102 cases for pseudoaldosteronism. There are many reports about pseudoaldosteronism of Yokukansan regardless of containing only 1.5 g ricorice per day. As for cardiac disorders of Yokukansan, we need to pay attention to information in the future.
2.Effective Use of Over-The-Counter (OTC) Drugs during a Disaster:
Yoshiaki Shikamura ; Aika Tanaka ; Kenichi Negishi ; Hideo Shimodaira ; Susumu Wakabayashi ; Toshio Tsukahara ; Kaori Nomura ; Keiji Izushi ; Choichiro Miyazaki ; Mayumi Mochizuki ; Naoki Kamimura
Japanese Journal of Drug Informatics 2017;18(4):242-250
Objective: For effective use of over-the-counter (OTC) drugs that are provided as relief supplies during a disaster, we aimed to develop a list of OTC drugs that can be used during a disaster.
Methods: We obtained information about OTC drugs useful during a disaster by examining results of previous studies and lists of drugs used during a disaster. We analyzed this information with the expert pharmacist of disaster support and established a rationale for our list and developed “the List of Useful OTC Drugs During a Disaster” and “the Information Card on Useful OTC Drugs During a Disaster.”
Results: We developed our list of OTC drugs based on the following parameters: (1) while people with severe disorders (e.g. renal failure) are treated by medical teams, those with minor physical conditions are treated using OTC drugs and (2) those OTC drugs that can be used as substitutes for prescription drugs were preferably selected. The List of Useful OTC Drugs ()—During a Disaster (containing 56 items) was developed for use mainly by medical professionals. Further, pharmacists from disaster-relief medical teams may not always be available in disaster-stricken areas; therefore, the Information Card on Useful OTC Drugs During a Disaster was developed to enable disaster victims to independently make a certain level of decision. The information card contained pictograms to call the attention of the disaster victims.
Conclusion: Our results can provide a common tool for drug suppliers, medical professionals engaging in relief works in disaster-stricken areas, and disaster victims.