Objective: The risk management plan (RMP) is a useful information source for healthcare professionals, including pharmacists, to ensure drug safety. The “risk minimization activities” (RMA) of the RMP are especially important elements for healthcare professionals. It is known that “Medication Guides for Patients” (MGP) and “Early post-marketing phase vigilance” (EPPV) are items listed as part of the RMA. However, the creation of MGPs and the implementation of EPPVs are not performed for all medicines. In a previous study, it was difficult to evaluate this sufficiently with the safety specifications. The aim of this investigation was to evaluate RMAs, especially MGPs and EPPVs, not in terms of the safety specifications of RMP.Methods: The previously published RMPs of 177 drugs were obtained on February 22,2016, and used in the analysis. The relationship between the creation of the MGP and the description in the RMA and the relationship between the conduct described in the EPPV and the description in RMA was investigated for each medicine.Results: An MGP was created in 151 of the analyzed drugs. Of these, it was not listed in the RMA of 40 drugs. In contrast, EPPV was not listed in RMA in 2 out of 33 drugs when underway. EPPV was described in the RMA of 33 of the EPPV finished drugs. The time lag from the end of EPPV until the revision of the RMP was 4.5 month son average.Conclusion: MGPs and EPPVs are created especially for drugs requiring patient education, information provision, or safety monitoring. Therefore, for drugs for which MGPs or EPPVs are required, they should be listed in the RMA. In this study, the time lag of RMP revision was also highlighted as a problem. In order to promote the utilization of RMP by pharmacists, these issues should be resolved.

Objective：This study aimed to clarify the objective criteria for assessing walking independence using cane in patients with stroke in the convalescent rehabilitation ward.Methods：Participants were in-patients with hemiparetic stroke who could walk with a cane, and they were categorized into the independent (ID) and supervised (SV) walking groups. Stroke impairment assessment set-motor for lower extremity (SIAS-LE), trunk control test (TCT), Berg balance scale (BBS), 10-m walking speed (m/s), and functional independence measure-cognitive (FIM-C) were assessed. ID and SV used the scores at the time of independent walking and at the discharge time, respectively. Additionally, falls after independence were investigated. Statistical analysis was performed using univariate analysis and decision tree analysis.Results：In total, 148 patients (ID：n=101, 68±13 years, SV：n=47, 79±12) were included. Significant differences were observed in walking speed, TCT score, BBS score, and FIM-C score between the groups. Moreover, walking speed, FIM-C score, and BBS score were selected in the decision tree analysis in this order and divided into five groups namely：1) walking speed ≥ 0.42 and FIM-C ≥ 22 (percentage of independent patients 97％/percentage of fallers 5％), 2.) walking speed ≥ 0.42, FIM-C＜22, and BBS ≥ 50 (100％/0％), 3.) walking speed ≥ 0.42, FIM-C＜22, and BBS＜50 (52％/8％), 4.) walking speed＜0.42, and BBS ≥ 28 (49％/28％), and 5) walking speed＜0.42 and BBS＜28 (0％/0％). The overall percentage of fallers was 8.9％, with group 4 having the highest number of fallers.Conclusion：Walking speed, FIM-C, and BBS, in decreasing order, were involved in walking independence. Patients with low walking speed were more likely to fall. Therefore, careful assessment of walking independence is particularly required.

Objective：This study aimed to clarify the objective criteria for assessing walking independence using cane in patients with stroke in the convalescent rehabilitation ward.Methods：Participants were in-patients with hemiparetic stroke who could walk with a cane, and they were categorized into the independent (ID) and supervised (SV) walking groups. Stroke impairment assessment set-motor for lower extremity (SIAS-LE), trunk control test (TCT), Berg balance scale (BBS), 10-m walking speed (m/s), and functional independence measure-cognitive (FIM-C) were assessed. ID and SV used the scores at the time of independent walking and at the discharge time, respectively. Additionally, falls after independence were investigated. Statistical analysis was performed using univariate analysis and decision tree analysis.Results：In total, 148 patients (ID：n=101, 68±13 years, SV：n=47, 79±12) were included. Significant differences were observed in walking speed, TCT score, BBS score, and FIM-C score between the groups. Moreover, walking speed, FIM-C score, and BBS score were selected in the decision tree analysis in this order and divided into five groups namely：1) walking speed ≥ 0.42 and FIM-C ≥ 22 (percentage of independent patients 97％/percentage of fallers 5％), 2.) walking speed ≥ 0.42, FIM-C＜22, and BBS ≥ 50 (100％/0％), 3.) walking speed ≥ 0.42, FIM-C＜22, and BBS＜50 (52％/8％), 4.) walking speed＜0.42, and BBS ≥ 28 (49％/28％), and 5) walking speed＜0.42 and BBS＜28 (0％/0％). The overall percentage of fallers was 8.9％, with group 4 having the highest number of fallers.Conclusion：Walking speed, FIM-C, and BBS, in decreasing order, were involved in walking independence. Patients with low walking speed were more likely to fall. Therefore, careful assessment of walking independence is particularly required.