1.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.
2.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.