Objective: The use of generic drugs is promoted for the purpose of reductions of medical costs and patient’s copayment.  In general, it is thought that clinical effects of the original brand and the generic drugs are equal if they are bioequivalent.  However, it is necessary to inspect their therapeutic equivalence to use the generic drugs securely.  We, therefore, assessed the therapeutic equivalence and pharmacoeconomics by substitution of an original drug (Amaryl®) with a generic drug (Glimepiride [Tanabe]).
Methods: Therapeutic Equivalence: The total variation was calculated by using the HbA1c levels before it switched from Amaryl® to Glimepiride [Tanabe].  The tolerance limits were set as 1/4 of the total variation.  Pharmacoeconomics: The difference of drug prices and the difference of patient’s copayment were calculated.
Results: As the variation of HbA1c levels was within tolerance limits before and after switching from Amaryl® to Glimepiride [Tanabe], we evaluated that their therapeutic effect was equivalent.  The difference of drug prices after switching from the original to the generic one was 4,582.6 yen/year on average (minimum: 949.0 yen, maximum: 12,045.0 yen); the difference of patient’s copayment was 872.5 yen/year on average (minimum: 0 yen, maximum: 3,613.5 yen).  These data show that the use of the generic drugs is effective to reduce medical costs.
Conclusion: For further promoting the use of the generic drugs, we consider it essential to compare the therapeutic equivalence and the safety of the original and the generic drugs in clinical practice.

There have been few reports on suvorexant (SUV), a benzodiazepine-agonist hypnotic, used concomitantly with benzodiazepines (BZDs) or non-benzodiazepines (non-BZDs). Therefore, we investigated the use of SUV in patients taking BZDs and non-BZDs. Subjects were 73 individuals who were prescribed SUV while taking either BZDs or non-BZDs for 4 weeks or more from November 2015 to the end of March 2017. Subjects were divided into three groups as follows: those with no weight change compared to baseline (the non-weight loss group (n = 32)), those with some weight loss (the weight loss group n = 23)), and those who discontinued the drugs (the withdrawal group (n = 18)). Age, sex, presence or absence of antipsychotic medication, continuation rate of SUV in each week after 4 weeks, and diazepam equivalent value before and after SUV administration were compared in each group. In addition, we investigated the occurrence of side effects after SUV initiation. When comparing the SUV continuation rate at 24 weeks in each group, no significant difference was found between the 3 groups, but at 8 weeks, the weight loss group showed significantly decreased rates compared to the non-weight-loss group. When diazepam conversion values were compared before and after BZD and non-BZD administration, significant differences were found in the non-weight-loss group, weight-loss group, and withdrawal group before administration. Side effects were 18.8％ in the non-weightloss group, 13.0％ in the weight loss group, and 16.7％ in the withdrawal group; 6.3％, 8.6％, and 16.7％ were in the central nervous system. It was thought that continuation rate might fall by concomitant use of SUV with BZDs or non-BZDs. For patients using SUV when taking BZDs or non-BZDs, it is desirable not only to reduce or stop the BZDs or non-BZDs, but also to be aware of withdrawal symptoms. This is because side effects may increase following discontinuation. Despite causing weight reduction, it is also important to consider improved safety.

Sodium glucose co-transporter 2 (SGLT2) inhibitors typically have various secondary effects in addition to the hypoglycemic effect. Therefore, we examined their effectiveness and other secondary effects. We targeted 86 patients with type 2 diabetes treated with SGLT2 inhibitors for the first time from June 2014 to the end of March 2017 at our hospital. Mean body mass index (BMI) was 28.69±4.91kg/m2. Body weight, BMI, and levels of hemoglobin A1c (HbA1c), aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transpeptidase (γ-GTP), estimated glomerular filtration rate (eGFR), triglyceride (TG) and uric acid (UA) were significantly lower,while hematocrit (HCT), blood urea nitrogen (BUN), creatinine (Cre), and high-density lipoprotein cholesterol were significantly higher 2 months after than before administration of SGLT2 inhibitors. A significant negative correlation was observed between HbA1c, body weight, AST, ALT, γ-GTP, BUN, low-density lipoprotein cholesterol (LDL-C), and change in UA before and 2 months after administration of SGLT2 inhibitors. HbA1c was lower in patients with high HbA1c before treatment, and weight loss was noted in patients with increased body weight before treatment. These results suggest that SGLT2 inhibitors may be highly effective in patients with type 2 diabetes with uncontrolled obesity. In addition, potential risk factors for cardiovascular events and deranged liver function test values were identified, and there was a possibility that long-term SGLT2 inhibitor use could induce cardiovascular events, but with possible improvement of fatty liver. However, because it was observed that HCT was elevated and renal function was impaired, it may be necessary to administer rehydration therapy in the initial stages of treatment and to continuously monitor renal function.

Objective: Management of low-density lipoprotein cholesterol (LDL-C) and triglyceride (TG) is important for patients with type 2 diabetes merger hyperlipidemia. Pemafibrate (PF) has different characteristics from conventional fibrates. In this study, we retrospectively compared the efficacy and safety of PF and bezafibrate (BF) in patients with type 2 diabetes merger hypertriglyceridemia.Methods: Patients who were administered PF (0.2 mg/day) or BF (400 mg/day) for 24 weeks or longer were included. Twenty patients in each group were extracted using propensity score matching (PS). PS was calculated using the patient background (before the start of administration) of PF or BF. We investigated lipid-related parameters (TG, high density lipoprotein cholesterol [HDL-C], and LDL-C) and other laboratory test parameters pre administration and 24 weeks post administration.Results: TG decreased significantly in both groups (p<0.05). However, there were no significant differences between the two groups in the TG treatment target (<150 mg/dL) achievement rate (p =1.00), TG change rate (p=0.84), and TG change amount (p=0.77). In addition, there were no significant changes in HDL-C and LDL-C in both groups. In the PF group, alanine transaminase (ALT) (p< 0.05), alkaline phosphatase (p<0.05) decreased. In the BF group, ALT (p<0.05) and γ-GTP (p<0.05) decreased. Both groups showed improvement in liver function after 24 weeks. eGFR (p<0.05) significantly decreased only BF group. There were no significant changes in renal function, creatine kinase (CK), or hemoglobin A1c (HbA1c) in either group.Conclusion: Our study suggests that there is no difference in the TG lowering effect and safety of PF and BF in type 2 diabetic patients.

Pharmacists are required to work as specialists, but few studies have investigated the career paths available to certified/specialist pharmacists. Therefore, we surveyed hospital pharmacists on career formation, qualifications acquisition, and research activities. We administered an anonymous questionnaire using Google Forms to all 37 pharmacists at Sapporo-Kosei General Hospital and all responded. Responses to career path questions were compared between the current job and a job in the future. For the current job, there were more responses for acquiring a wide range of experience, knowledge, and skills and fewer responses for acquiring experience, knowledge, and skills in a specialized field and for acquiring certified/specialist pharmacist qualifications. This suggests that pharmacists intend to improve their expertise after acquiring a wide range of experience, knowledge, and skills. A high percentage of respondents cited interest in specialized fields as a reason to become qualified as a certified/specialist pharmacist. This suggests that interest in specialized fields is the greatest incentive to acquire further qualifications. In regard to research activity, items on daily workload, making time for research, and cooperation with research team members were often selected as problems. This suggests that time management and scheduling are important issues.

Engaru-Kosei General Hospital expanded its pharmacist duties in hospital wards in April 2018 following the nationwide switch to out-of-hospital prescriptions. The purpose of this study was to examine the effect of pharmacists’ ward duties on nursing duties. Pharmacists expanded their duties to cover drug distribution management, infusions of total parenteral nutrition (TPN) mixed with drugs, and aseptic preparation of 24-h infusions (including peripheral parenteral nutrition). The effects were compared between April 2018 before the expansion of duties and May-September 2018 after the expansion, and we compared the number of meetings set up to discuss nurses’ overtime hours and patient problems. In addition, interviews were conducted about the changes experienced on site. Drug distribution management averaged 3,150 cases/month. The number of TPN mixed infusions was 25 cases/month before expansion and this increased to 88 cases/month after expansion. The number of mixed injections of 24-h infusions was 296/month. Nurses' overtime hours did not decrease significantly, but the number of meetings increased from 47/month to 79.4/month. In the interviews, positive responses were obtained about, for example, the increased number of meetings held and more time for patient care. The pharmacist and the nurse collaborated to improve work by using their expertise, we think that the results obtained from work improvement contributed to the improvement of medical quality and medical safety.

Objective: The use of generic drugs is promoted to reduce medical costs and copayments. However, tumor agents are expensive and generic drugs are not widelyused. Thus, it is necessaryto evaluate the safetyof generic drugs in more detail. We compared the incidence of adverse events between the original drug (Gemzar®: GEM) and generic drug (Gemcitabine [Sandoz]: GE-GEM) using propensityscore (PS) matching.Methods: We investigated adverse events in patients who received one course of GEM or GE-GEM. The patient background (age,sex, BSA, cancer type, stage, metastasis, surgical history, and radiotherapy) and administration status (administration route and RDI) were used to calculate the PS.Results: Among all patients (GEM: 51, GE-GEM: 54), a significantlygreater number in the GE-GEM group had cancer metastasis. On comparison of adverse events, there were significantlymore cases of vascular pain (p＜0.05) in the GEM group, and manycases of nausea (p＝0.08) and rash (p＝0.08). Fortypatients in each group were extracted byPS matching. There were no significant differences in the patient background between the groups, and on comparison of adverse events, the two groups did not significantly differ.Conclusion: Our studysuggested that there is no difference in side effects between Gemzar® and gemcitabine [Sandoz]. To compare the incidence of adverse events, it is useful to use PS matching in clinical practice.