ABSTRACT
<b>Objective: </b>Currently, the creation of a pharmaceutical risk management plan (RMP) for new drug information is obliged to pharmaceutical companies. The created RMP is published on the Pharmaceuticals and Medical Devices Agency (PMDA) website. RMP is a useful information source to ensure drug safety by healthcare professionals, including pharmacists. “Risk minimization activities” of the RMP are especially important elements for healthcare professionals because they describe measures to minimize risk to patients. We conducted a cross-sectional survey of the description of the contents of “risk minimization activities” in the RMP.<br><b>Methods: </b>The RMP of 177 drugs that had been published in February 22, 2016 were investigated.<br><b>Results: </b>Total risks enumerated for the study drugs were 1,678. “Routine risk minimization activities” constituted 92.0% of total risks. The most listed item on “routine risk minimization activities” was “attention on the product labeling of the drug package insert” (91.3%). Differences in the expression level on “attention on the product labeling” were observed. On the other hand, the most listed item of “additional risk minimization activities” was “the creation of documents for healthcare professionals” (38.3%) and “implementation of Early Post-marketing Phase Vigilance” (27.1%).<br><b>Conclusion: </b>A clear understanding of RMP by healthcare professionals is important. In the RMP, “risk minimization activities” (especially “additional risk minimization activities”) are the most important contents for healthcare professionals, because they include information of documents created by the pharmaceutical company for patient safety. The level of description of the contents of RMP varies between drugs. It is essential that these descriptions be uniform the expression level to be easily and accurately utilized by healthcare professionals.
ABSTRACT
<p>Decreased adherence to medications among the elderly has become a problem in recent years. To overcome this problem, the dispensing of one-dose packages of medicines has been suggested. The purpose of this study was to survey elderly outpatients in a regional hospital at the Tokachi Development and Promotion Bureau and to analyze the factors that influence patients’ preference for a one-dose package medicine. The dispensation of one-dose package medication was observed in 20% of elderly outpatients. A correlation between the percentage of dispensed one-dose package medications and the number of agents was observed. Furthermore, dispensing rates of one-dose package medications increased with aging. Within the various departments analyzed, one-dose packaging rate was high in the Departments of Cardiology and Psychiatry. In this study, the correlation between residential municipalities of outpatients and one-dose package medications was examined. In the municipalities with a high rate of aged individuals and high average of household members, one-dose package medication rate was low. Multivariate logistic regression analysis confirmed these factors as significant. That one-dose packaging rates increased with the number of drugs and aging are consistent with the notion that one-dose package medications are designed to increase drug adherence among the elderly. Interestingly, one-dose package dispensing rate was low in areas with advanced aging. Because aging in Japan is expected to advance in the future, it is important to survey one-dose package dispensations.</p>