Objective: The aim of this study was to review cautionary statements regarding hypersensitivity to drugs with a moiety similar to sulfonamide on Japanese package inserts.
Methods: From approved drugs listed as of March 2015, we selected those with a moiety similar to sulfonamide and examined their therapeutic categories, together with the presence or absence, location, and wording of cautionary statements regarding usage, and matters pertaining to a history of drug hypersensitivity that was not limited to sulfonamide, on the package inserts.
Results: We extracted 73 drugs (65 components) that included a moiety similar to sulfonamide.  Their therapeutic categories were diverse, and 39 (53.4%) had cautionary statements about hypersensitivity caused by a moiety similar to sulfonamide.  Among these 39 drugs, the cautionary statements were located in different sections (Contraindication 31, Careful Administration 4, and Important Precautions 4).  The cautionary statements showed differences in wording according to the individual drugs or positions.  For 10 of the drugs, information pertaining to a history of drug hypersensitivity not limited to sulfonamide was provided.
Conclusion: Medical staff should recognize that package inserts are not standardized with regard to cautionary statements about hypersensitivity caused by moieties similar to sulfonamide, and that it is necessary to predict or judge the likelihood of cross-hypersensitivity reaction to such moieties on the basis of their chemical structure.  In addition, it is necessary to carefully observe the clinical condition of individual patients who are receiving drugs that have a moiety similar to sulfonamide.

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Background: Because generic medicines reduce the financial burden on patients and medical insurance providers, they become more popular year after year.  However, there are still few reports that analyze the efficacy and safety of generic medicines, especially in terms of their characteristics and side effects.
Methods: Paclitaxel is an antineoplastic frequently used with good results in the treatment of breast cancer, ovarian cancer, gastric cancer, and angiosarcoma, but fat solubility is high and various kinds of adverse events, such as myelosuppression and arthralgia, peripheral neuropathy, and alcohol hypersensitivity are known to develop.  We investigated the efficacy, characteristics, and the incidence of adverse events for the generic product of paclitaxel.
Results: Differences were found for the generic version in terms of the characteristics and preparation time.
Conclusion: The incidence of adverse events was not significant, suggesting that the generic version could be a reasonable substitute.

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Objective: We have used therapeutic drug monitoring (TDM) analysis software to set the initial dose of vancomycin in our hospital.  In contrast, the TDM guideline, in which the initial dose of vancomycin per body weight was set, was published in 2012.  We looked forward with utilizing the TDM guideline in the clinical setting, after which we conducted multiple surveys to determine the important points of the TDM guideline.
Methods: We surveyed patients treated with vancomycin, in whom the initial dose was set using the TDM analysis software and the concordance rate between the vancomycin dose set with the software and that set with the TDM guideline.
Results: The concordance rate of vancomycin dose was 42.1%.  The mean age of the high-dose group (vancomycin dose higher than that recommended by the TDM guideline), was younger than that of the recommended-dose group.  Additionally, the mean body weight of the high-dose group was significantly lower than that of the recommended-dose group.  The corrected creatinine clearance of the low-dose group was significantly lower than that of the recommended-dose group.
Conclusion: Our results suggest that when the initial dose is set after referring the TDM guideline in patients who are not very high age, and having low body weight and decreased renal function, the dose may differ from the dose set by using TDM analysis software.  In addition, since the recommended dose per body weight is a range and not a single value, setting the dose appropriate to target trough concentration is necessary.

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Objective: Clinical articles are important for individualization of drug therapy.  Especially, meta-analysis is positioned at the highest evidence level.  Therefore, we assessed the Quality Score of Meta-Analysis (QSMA) which provides simple assessments of both the quality and the format of meta-analyses, by applying them to incretin-related drugs as a model.  Furthermore, we attempted to extract clinical data from the literature employing a certain minimum standard.
Method: We searched for meta-analyses of incretin-related drugs for diabetes in PubMed and the Cochrane Library, scoring the extracted articles for format using PRISMA statements, and for quality using QSMA.  Additionally, we classified these articles into two groups with a QSMA score of 70% as the basis, and verified the analysis sets (ITT, FAS, PP or APT) and sensitivity analysis.  Furthermore, we looked into those articles that scored 70% or higher to extract data that were deemed to have significant statistical differences.
Results: Scoring of the 66 articles studied yielded 69.9±19.4% (mean ± SD) for format and 62.1±17.8% for quality.  These two variables produced a regression line of y=0.777x+7.834.  Comparison of the two groups classified on the basis of a 70% score on QSMA yielded a significant difference in sensitivity analysis only (p<0.05).  Seven effects and five side effects were extracted from articles with a QSMA score of 70% or higher.
Conclusion: Although QSMA can provide simple assessment of quality and structure using eight items, analysis sets needs to be verified individually.  As the articles assessed provided statistically endorsed data, the clinical application of QSMA will be an issue in the future.

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Objective: Pharmacist interventions are effective for appropriate medical management.  The Japanese Society of Hospital Pharmacists has recommended the “pre-avoid report” to foster appropriate pharmacotherapy since 1999.  The “pre-avoid report” format consists of two forms : “serious report” and “preventive report.”  The number of “preventive reports” has comprised about 90% of “pre-avoid reports.”  However, this format of the “preventive report” since 1999 has shown inadequacy due to changes in pharmacists’ ability.  In the present study, we conducted a re-modification of the “preventive report” format using an assay to create the present “preventive report” format.
Methods: We retrospectively reviewed the pharmacists’ “preventive report” of the “pre-avoid report” from January 2014 to December 2014 in the Department of Pharmacy, Okayama University Hospital.
Results: The present format included 101 cases of “others” in the “preventive report” format.  This “others” section consisted of “non-intervention of pharmacotherapy” (51%), “forget to stop pre-operation drugs” (14.7%), and “inadequate treatment (wrong administration day, unnecessary treatment).  These factors were not identified with the present format of the “preventive report.”
Conclusion: In the present study, we suggested that it is necessary to revise the format of the “preventive report” to reflect.

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There have been concerns that neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) cause neuropsychiatric adverse events (NPAEs).  We evaluated the number of relevant reports, reporting ratio, and reporting odds ratio (ROR) by using spontaneous reporting database, such as the Japanese Adverse Drug Event Report (JADER) (April 2004 to July 2014).  The RORs of oseltamivir, zanamivir, laninamivir, and peramivir were 11.8 (95% confidence interval (CI), 10.8-13.0), 47.0 (95% CI, 40.0-55.3), 9.5 (95% CI, 6.8-13.2), and 3.3 (95% CI, 2.1-5.1), respectively.  The lower limit of the ROR 95% CI of NPAEs of all neuraminidase inhibitors was ≥1.  We analyzed the association of age and gender with NPAEs in patients treated with oseltamivir using a logistic regression model.  The adjusted ROR of NPAEs was 66.9 (95% CI, 50.3-88.9) in male patients treated with osletamivir aged 10-19 years.  The adjusted RORs of NPAEs were increased in male and female patients under the age of 20 years.  Neuraminidase inhibitors including oseltamivir treatment could be associated with NPAEs.  Therefore, these drugs should be used carefully in clinical practice.

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Objective: From September 2009, the Department of Pharmacy of Kitasato University Kitasato Institute Hospital started operation room services, and the pharmacist in charge also responds to the inquiries from the operation room staff (doctors and nurses) concerning pharmaceutical compounds.  In the present study, we collected the inquiries and analyzed their contents in order to understand the information of pharmaceutical compounds required by the operation room staff.
Methods: The inquiries from operation room staff received between October 2009 and March 2012 were collected and the contents were analyzed.
Results: A total of 625 inquiries (mean, 20.8 inquiries per month) were received.  Regarding the contents of inquiry, the most frequent inquiry was on “the presence or absence of the stock” (70.7%), followed by “drug information” (17.0%), “handling of controlled substances” (5.9%), and “handling of non-controlled substances” (4.2%).  For “the presence or absence of the stock,” the most common pharmaceutical compounds inquired were antibacterial agents, anesthetics, and infusion fluids.  For “drug information,” the contents were diverse, ranging from drug efficacy to operation method, whether compounds are included in hospital drug list, in-hospital preparations, and drug selection.  For “handling of non-controlled substances,” the most frequent inquiries were associated with the expiration date after unsealing.
Conclusion: The most frequent inquiry from the operation room staff was on “the presence or absence of the stock,” and the common subject of inquiry was presumably pharmaceutical compounds frequently used at the time of surgery.  The analysis showed that the operation room requires a wide range of information.

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Objective: We conducted a survey on the anti-doping consultation data among domestic athletes, including the number of monthly consultations, the fields targeted for consultation, and proportion (%) of consultations for medications that should be avoided or prohibited, in order to address relevant issues.
Methods: Data collected from the domestic athletes' anti-doping consultations with the pharmaceutical consultation committee of the Shiga Pharmaceutical Association in 2012 were analyzed.
Results: Most consultations occurred in March.　Most (80%) of the consultations conducted within a year were sought by teams from schools, clubs, and competition associations, whereas 16% were sought by individual athletes.　The remaining 4% were sought by medical institutions.　The percentage of consulted ethical medications was unexpectedly high at 69%, while that of over-the-counter (OTC) drugs was 26% and that of "others," which comprised dietary and health supplements, was 5%.　Among the medications consulted for, 25% were classified as "should avoid" and "prohibited" because of violations of the anti-doping code.　Among the ingredients of the substances consulted for, most (75%) were classified as "others," followed by OTC drugs (38%) and ethical medicines (15%).
Conclusions: As the training environment greatly differs between domestic and international athletes, so should be the anti-doping activities.　Thus, anti-doping activities suitable for domestic athletic meets should be promoted.

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