1.Examination for Safety of Antiplatelet Therapy in the Elderly Patients Using Data Mining of the Japanese Adverse Drug Event Report (JADER) Database
Yoshihiro Noguchi ; Kosuke Saito ; Hiroki Esaki ; Kazumasa Usui ; Misa Kato ; Tomoya Tachi ; Hitomi Teramachi
Japanese Journal of Drug Informatics 2016;17(4):192-198
Objective: Antiplatelet therapy is useful for infraction prevention. But, in elderly patients, adverse events are easily observed, owing to the decrease in metabolism and excretion of drugs. Furthermore, applying guidelines for medical care of each disease does not necessarily result in good conclusions. Therefore, we used Japanese Adverse Drug Event Report database and assessed safety signals with signal detection about adverse events developed by the antiplatelet therapy in the elderly patients.
Methods: We analyzed all adverse events reported on ticlopidine hydrochloride that should be carefully administered, and clopidogrel, bisulfate and aspirin that are recommended as the alternative drugs. We used the proportional reporting ratio for a safety index of drugs.
Results: While some adverse events were expressed in only ticlopidine hydrochloride, bleeding signal was detected in all the subject agents. In addition, onset risk of ticlopidine hydrochloride was found to be the lowest value. Moreover, adverse events expressed in clopidogrel bisulfate and aspirin were of a wide-variety compared with ticlopidine hydrochloride.
Conclusion: It is necessary to carefully administer not only ticlopidine hydrochloride but also the alternative drugs to the elderly patients as indicated, and there is a need to pay careful attention to administration of the alternative drugs.
2.Questionnaire Survey of Implementation Status of “Education for Medicines” at Junior High School in Gifu
Hitomi Teramachi ; Tomoya Tachi ; Kousuke Saito ; Hiroki Esaki ; Misa Kato ; Kazumasa Usui ; Yoshihiro Noguchi ; Shingo Katsuno
Japanese Journal of Drug Informatics 2016;18(2):106-113
Objective: Medical education was initiated in 2012 as part of health and physical education (HPE) in junior high schools. This new measure was a result of a revision of school curriculum guidelines. In this study, we aimed to clarify the implementation status of medical education in schools.
Methods: A questionnaire survey targeting junior high school teachers in Gifu (from 184 junior high schools) was conducted by mail.
Results: 60.9% of schools responded (112/184). HPE teachers and school pharmacists were found to be in charge of providing medical education in 94.6% and 10.7% of schools, respectively. The average duration of classes was 50 min and the average frequency was 1.2 times a week. On average, 0.9% of schools stated that implementing medical education was “under contemplation,” 2.7% held “occasional” classes, and 2.7% only held “drug abuse-related” classes. It was also found that the most commonly used educational material was the school textbook (91.1% of schools). Additionally, 87.5% of schools responded “yes” to “lectures are delivered by outside lecturers,” and 69.6% responded “yes” to “we hope to introduce workshop participation.”
Conclusion: The results of the survey indicated that many junior high schools have provided medical education classes and that HPE teachers were in charge of teaching these classes. However, some schools have not provided these classes. It is considered necessary to enhance medical education activities in the pharmaceutical field by involving specialists from different areas.
3.Pharmacoepidemiological Examination for the Safety of the Oral laxatives in the Elderly Patients
Yoshihiro Noguchi ; Yuta Hayashi ; Aki Yoshida ; Ikuto Sugita ; Hiroki Esaki ; Kousuke Saito ; Kazumasa Usui ; Misa Kato ; Tomoya Tachi ; Hitomi Teramachi
Japanese Journal of Drug Informatics 2016;18(3):179-185
Objective: Many of the elderly patients are suffering from constipation, are using the oral laxative. However the risk assessment of the oral laxative is not performed. Therefore, we used Japanese Adverse Drug Event Report database (JADER) and examined for the safety of the oral laxative in the elderly patients.
Methods: Since the analysis target medicines; 12 oral laxatives and target ADEs; “digestive disorders” and “electrolyte abnormality,” the JADER database for April 2004 to January 2015 were analyzed in adults of age exceeds 60. We used the reporting odds ratio for a safety index of drugs, using reporting odds ratio, when the Lower bound of the 95% two-sided confidence interval exceeds 1, it is the signal detection of ADE.
Results: The oral laxatives detected the signal of “digestive disorders” were three medicines, and “electrolyte abnormality” were five medicines. Especially, for electrolyte abnormalities not only increases the blood magnesium values as magnesium oxide, that there is also affect other electrolyte revealed.
Conclusion: Some oral laxatives were also intended to signal detections of the adverse events that are not listed in the attached document, it is necessary to pay attention to the use of them for the elderly patients.
4.Search for Oral Medicine That Might Exacerbate the Prognosis of Adverse Drug Events in Elderly Patients
Yoshihiro Noguchi ; Yuta Hayashi ; Aki Yoshida ; Ikuto Sugita ; Hiroki Esaki ; Kousuke Saito ; Kazumasa Usui ; Misa Kato ; Tomoya Tachi ; Hitomi Teramachi
Japanese Journal of Drug Informatics 2017;18(4):277-283
Objective: Elderly patients commonly experience adverse drug events (ADEs) owing to their poor drug metabolizing and excretion ability, and these often cause multiple organ dysfunction syndrome. Therefore, it is important that we identify the adverse drug events early on during prognosis. We searched for oral medicines that might exacerbate the prognosis of ADEs in elderly patients.
Methods: The objects under analysis were oral medicines that were registered in the Japanese Adverse Drug Event Report database (JADER). The associations between the elderly/non-elderly patients and exacerbation risk/non-exacerbation risk were analyzed by risk ratios (RR). The signal detection of exacerbation risk was defined as 95% confidence interval of lower limit of risk ratio>1 and χ2≥4.
Results: The oral medicines that might markedly exacerbate the prognosis of ADEs in the elderly patients in comparison with the ADEs of young patients included 84 items, of which 63 have not been described as potentially inappropriate medicines in all guidelines for medical treatment of the elderly patients.
Conclusion: In this study, while we could not search for oral medicines having a high risk of ADEs, we were able to search for oral medicines that might exacerbate the prognosis of ADEs in elderly patients. This result could contribute to the proper use of medicines in the elderly patients.