Purpose and method: The aim of this study was to explore the child-care and housework difficulties experienced by fathers during their wife’s cancer treatment. 7 men who had 0 to 15-year-old children when their wife was diagnosed with cancer were interviewed using a semi-structured interview format. Main results: Subjects’ report of their difficulties was assessed using the following 3 categories: 1) burden of housework 2) stress from life together with the in-laws 3) contact with schools and nurseries. The influence of background factors was considered: a) experience of housework in the family prior to his wife’s illness; b) experience of living with in-laws; c) degree of cooperation with their parents; d) degree of trust in their relationship with their in-laws; e) child’s/children’s age; f) availability of childcare resources; and g) assistance prepared by their wife. Providing information on child care and housework support or opportunities for exchanging information with other husbands in similar situations can be considered valid forms of assistance for fathers whose background factors may predispose them to a greater degree of hardship in child care and housework during their wife’s illness.

In repeated-dose 28-day oral toxicity study design, the low dose is fixed as the no observed effect level (NOEL). But, in practice the low dose usually shows significant difference in few measurable items in most of the studies. We investigated 109 of repeated-dose 28-day oral toxicity studies in rats conducted according to the Chemical Substance Control Law, Japan and examined the measurable items (functional observational battery, urinalysis, hematology, blood chemistry and absolute and relative organ weights) of the low dose group which showed a statistical significant difference (P<0.05) compared to the respective control groups. The investigation revealed that, 205/12,167 (1.6%) measurable items showed a significant difference in the low dose groups. The significant difference shown by urinalysis was high (3.3%), followed by clinical chemistry parameters, hematology, relative organ weights and absolute organ weights (1.8-1.1%). We conclude from the investigation that the low dose may be considered as NOEL, if the significant difference of measurable items of it is about 2% (maximum <5%), compared to the control. However, due consideration may be given to the clinical relevance of the items that showed a significant difference.
Animals ; Chemistry, Clinical ; Hematology ; Japan ; Jurisprudence ; No-Observed-Adverse-Effect Level ; Organ Size ; Rats ; Urinalysis

In repeated-dose 28-day oral toxicity study design, the low dose is fixed as the no observed effect level (NOEL). But, in practice the low dose usually shows significant difference in few measurable items in most of the studies. We investigated 109 of repeated-dose 28-day oral toxicity studies in rats conducted according to the Chemical Substance Control Law, Japan and examined the measurable items (functional observational battery, urinalysis, hematology, blood chemistry and absolute and relative organ weights) of the low dose group which showed a statistical significant difference (P<0.05) compared to the respective control groups. The investigation revealed that, 205/12,167 (1.6%) measurable items showed a significant difference in the low dose groups. The significant difference shown by urinalysis was high (3.3%), followed by clinical chemistry parameters, hematology, relative organ weights and absolute organ weights (1.8-1.1%). We conclude from the investigation that the low dose may be considered as NOEL, if the significant difference of measurable items of it is about 2% (maximum <5%), compared to the control. However, due consideration may be given to the clinical relevance of the items that showed a significant difference.
Animals ; Chemistry, Clinical ; Hematology ; Japan ; Jurisprudence ; No-Observed-Adverse-Effect Level ; Organ Size ; Rats ; Urinalysis

In order to promote regional cooperation in palliative care, we developed a regional cooperation clinical pathway for home palliative care that offers simple support and is easy to use. We then administered a questionnaire survey to 14 healthcare professionals with various specialties who were involved in the introduction of the pathway, and we revised the pathway on the basis of the survey results. The revised pathway was then tested in 13 patients who were discharged from 3 designated cancer care hospitals in Toyama City to home care, and another questionnaire survey was conducted afterwards in the same manner. The mean overall score on the questionnaire was 2 in seven, 3 in seven (on a scale of 0 to 3) at the time of introduction, whereas the score after trial use was 1 in one, 2 in four, 3 in five. We believe that more innovative approaches to the implementation of such pathways are required.

Purpose and Methods: Aiming at the relief of suffering by the palliative care team and prompt information sharing between healthcare professionals with various specialties, We introduced new IT cloud system, carried out questionnaire survey and examined the usefulness to 11 persons of healthcare professionals. Five cases where the palliative care team was concerned during the hospitalize became a home palliative care to the tried half a year. Results: All the members were using the personal computer as an input device. Four persons were using the iPhone. Two persons had the experience inputted on the spot. Nine persons of the input time were 5 or less minutes. All the members were perusing at various places by various device. Urgently and vital mail was useful: 3 in six, 2 in three, 1 in one, 0 in one. Information content were suitable: 3 in nine, 2 in two. Cooperation were completed in the smooth: 3 in nine, 2 in two. Have you utilized EIR for the home palliative care?: 3 in nine, 2 in two. Conclution: To the support of information sharing and palliative care team by IT cloud system transduction, the useful probability was suggested in the home palliative care.

Background/Aims: Adalimumab has been shown to induce and maintain clinical remission in patients with moderate to severe ulcerative colitis (UC). However, no large-scale population-based studies have been performed in Japan. This study was conducted to evaluate the safety and effectiveness of adalimumab in clinical practice in Japanese patients with UC. Methods: In this 52-week, prospective, multicenter, single-cohort, noninterventional, observational, postmarketing surveillance study, patients with moderate to severe UC received an initial subcutaneous injection of adalimumab 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. Safety assessments were the incidence of adverse drug reactions (ADRs) and serious ADRs. Effectiveness assessments were clinical remission, corticosteroid-free remission, mucosal healing, and change in C-reactive protein (CRP) levels from baseline. Results: Of 1,593 registered patients, 1,523 (male, 57.6%; mean age, 41.8 years) and 1,241 patients were included in the safety and effectiveness populations, respectively. ADRs were reported in 18.1% and serious ADRs in 4.9% of patients. Clinical remission was achieved in 49.7% of patients at week 4, increasing to 74.4% at week 52. Corticosteroid-free remission rates increased over time, from 10.4% at week 4 to 53.1% at week 52. More than 60% of patients demonstrated mucosal healing at weeks 24 and 52. Mean CRP levels (mg/dL) decreased from 1.2 at baseline to 0.6 at week 4 and 0.3 at week 52. Conclusions This large real-world study confirmed the safety and effectiveness of adalimumab in patients with UC in Japan. No new safety concerns were identified.

Objective: Doping is strongly prohibited in sports.  Sports pharmacist was born in 2010 in Japan, and the anti-doping activity is expected.  On the other hand, doping by arising from a lack of knowledge about prohibited substances in athletes, so-called “unwilling doping” is developing into a social issue.  In this study, we investigated the percentage of prohibited substances in all drugs and prescriptions in a general hospital, to collect information to prevent an unwilling doping.
Methods: We constructed system to extract the drugs corresponding to prohibited substances in the prescription order entry system in Otaru Municipal Hospital, and we analyzed 3,306 prescriptions of 10 to 59 years old patients, from July to September 2010.
Results: Thirteen point five percent of our hospital drugs met definition of the prohibited substance.  The number of prescriptions including prohibited substance(s) was 350 (10.6%), and its category was different from each age-group and clinical department.
Consideration: Because prohibited substances are included in approximately 10% of prescriptions, athletes are exposed to danger of becoming an unwilling doping.  Pharmacist should be well informed about prohibited substances to prevent athletes from unwilling doping.  And they should provide information promptly and adequately for athletes.

Background/Aims: Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings. Methods: This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI). Results: The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks. Conclusions Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting.

Background/Aims: The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. Methods: This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. Results: Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P< 0.0001), patients taking concomitant oral corticosteroids (P< 0.0001), and those not self-administering adalimumab (P= 0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37). Conclusions This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)

Background/Aims: The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. Methods: This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. Results: Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P< 0.0001), patients taking concomitant oral corticosteroids (P< 0.0001), and those not self-administering adalimumab (P= 0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37). Conclusions This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)