Multi-Institutional Joint Study on Adverse Events of Original and Generic Gemcitabine Drugs (Gemzar® vs. Gemcitabine Sandoz) Using Propensity Score Matching / 医薬品情報学

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.

Questionnaire Survey on Career Formation, Qualifications Acquisition, and Research Activities of Hospital Pharmacists at Sapporo-Kosei General Hospital / 日本農村医学会雑誌

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.

Assessments of Therapeutic Equivalence and Pharmacoeconomics of Original-Brand and Generic Drug of Glimepiride (Amaryl® vs. Glimepiride [Tanabe]) / 医薬品情報学

<b>Objective: </b>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]).<br><b>Methods: </b>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.<br><b>Results: </b>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.<br><b>Conclusion: </b>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.