1.Appearance of Side Effects Related to Non-ionic Iodine Contrast Medium
Hiroaki Watanabe ; Hiroshi Azuma ; Hironao Tanaka ; Syunya Takeno ; Yasutaka Inoue ; Takahiro Inagaki ; Kunihiro Tobisawa ; Takahito Imai
Japanese Journal of Drug Informatics 2012;14(3):94-100
Objective: We investigated the incidence of side effects related to contrast medium employed in our hospital based on monitoring materials to improve the safety of contrast-enhanced examinations. Furthermore, we compared the incidence of side effects between the original product and generic drugs to confirm the safety of each preparation.
Methods: The survey period was from April 2007 until March 2011. Based on the number of patients who underwent contrast-enhanced examinations and that of patients with side effects, we calculated the incidence of side effects in our hospital, and confirmed its annual changes. Subsequently, we again collected the incidence of side effects per each manufacturer’s preparation employed, and confirmed the state of side effects of individual preparations. Furthermore, we evaluated the symptoms as side effects, interval until appearance, and treatment for side effects during the data collection period, as well as the subsequent state, symptoms as side effects, and interval until appearance. The chi square independence test was employed to compare the results among groups. p<0.05 was regarded as significant (paired test).
Results: There were no changes in the annual incidence of side effects. There were also no significant differences in the annual incidence of side effects among the preparations. Furthermore, there were no marked differences in the symptoms, interval until appearance, treatment for side effects, or subsequent state among the preparations.
Conclusion: We investigated the appearance of side effects regarding contrast-enhanced examinations for 4 years. We confirmed that there were no differences in the incidence of side effects among the preparations.
2.Study of TTR in Patients Receiving Warfarin Therapy
Hironao TANAKA ; Shunya TAKENO ; Chiho KURUMAZUKA ; Yasutaka INOUE ; Kunihiro TOBISAWA ; Takahito IMAI ; Hiroaki WATANABE
Journal of the Japanese Association of Rural Medicine 2016;64(5):827-832
We worked out TTR values in patients receiving warfarin treatment in Abashiri-Kosei General Hospital. The patients were divided into two groups - those with satisfactory TTR values and those with poor TTR values - and associations between patient factors and average dosing interval were examined in the two groups. A total of 178 patients joined this study. The average TTR value worked out at 65.1±24.8%. It was found that the average TTR value for those patients aged at 70 and above came to 72.7±21.4%, which was significantly high as compared with 51.06plusmn;24.6% for those under 70 years of age. When the average TTR value was calculated after the optimal PT-range for the group of those below the age of 70 was changed from 2.0~3.0 to 1.6~2.6, it rose from 51.0% to 74.9%. These findings made it clear that PT-INR, regardless of age, was under control within the range from 1.6 to 2.6 in this hospital in accordance with the results of the J-RHYTHM Registry analysis.
3.Assessments of Therapeutic Equivalence and Pharmacoeconomics of Original-Brand and Generic Drug of Glimepiride (Amaryl® vs. Glimepiride [Tanabe])
Nami Azuchi ; Kazuya Hiura ; Chinami Suzuki ; Daichi Kan ; Takumi Yukita ; Shunsuke Fuchigami ; Akina Suyama ; Takahiro Inagaki ; Takahito Imai ; Akio Shibanami ; Hiroaki Watanabe ; Yuji Kohara
Japanese Journal of Drug Informatics 2016;17(4):199-204
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.
4.Effects of Intervention in Patients Using Long-Term Intravenous Antibiotics
Kozue KATO ; Shohei HASUI ; Shohei KAWAGUCHI ; Nami AZUCHI ; Takahito IMAI ; Ryu KOBAYASHI
Journal of the Japanese Association of Rural Medicine 2019;68(4):496-504
In recent years, the problem of antimicrobial resistance (AMR) from inappropriate use of antimicrobial drugs has emerged, and a plan to counter AMR has been formulated. From October 2017, our hospital started interventions to guide prescribing physicians in the proper use of intravenous antibiotics for patients requiring said treatment for more than 15 days. In the present study, we investigated the status of treatment with intravenous antibiotics and considered the effects of intervention. This study targeted a total of 2627 patients, 1971 of whom were hospitalized, who started using intravenous antibiotics from June 2017 to January 2018. We assigned those who started between June and September 2017 to the pre-intervention group and those who started between October 2017 and January 2018 to the post-intervention group. The number of patients using long-term intravenous antibiotics, total number of days of treatment, antimicrobial use density (AUD), day of therapy (DOT), and rate of use by lineage of antibiotics were compared. The number of patients using long-term intravenous antibiotics decreased to 40 in the pre-intervention group and 31 in the post-intervention group. There was no significant difference in the total number of treatment days, which was 5.1 ± 5.5 days before and 4.8 ± 4 9 days after, in the intervention group. The AUD of penicillin antibiotics increased and that of aminoglycosides decreased. Furthermore, the DOT of third-generation cephems and lincomycin decreased. Penicillin had an increased lineage use ratio, while that for thirdgeneration cephems, carbapenems, and lincomycin decreased. The number of patients using long-term intravenous antibiotics as well third-generation cephem and carbapenem antibiotics, which are broad spectrum antibiotics, decreased; the overall use of penicillin, a narrow-spectrum antimicrobial, increased. This suggested that the intervention resulted in the promotion of proper use of antimicrobial drugs.