論文

第31回日本医療薬学会年会において開催された「薬剤師のキャリアパスに関するシンポジウム」を視聴した薬剤師65名を対象とし、職場環境やキャリアパスへの満足度に関する質問紙調査を行った。結果、職場におけるロールモデルの存在に関する満足度は全体的に低かった一方で、家族によるキャリアパス支援に関する満足度は比較的高い傾向が認められた。顧客満足度(CS)分析の手法を用い、キャリアパスに関して優先的に解決すべき課題について薬剤師はどのように考えているのか分析した結果、優先順位が最も高かったのは「教育研修体制」であり、次いで「ワーク・ライフバランス」、「研究活動」の順であった。シンポジウムの感想を自由記述してもらい、対応分析を行った結果、キャリア満足度が低い群に特徴的な語として[必要][視聴][大変][参考]などがあり、キャリア満足度が高い群に特徴的な語として[経験][研究][振り返る][現状][想像][上司][目標][違い][勉強]などがあった。

抗癌薬による皮膚障害のうち、主に固形癌の治療において汎用されるタキサン系抗癌薬による爪障害、フッ化ピリミジン系薬による手足症候群、抗EGFR抗体薬による皮膚障害について、その概論および予防・治療方法を解説した。次いで、宮城県立がんセンターにおける皮膚障害対策として、皮膚症状ケアハンドブックの作成、薬剤師外来での取り組みを紹介した。

日本の添付文書で妊婦禁忌と記載された医薬品を特定し、海外における妊娠期の医薬品安全性分類と比較、評価した。2022年4月時点で薬価収載されている医療用医薬品19022医薬品のうち、妊娠禁忌の医薬品は4111医薬品(21.6%)であり、妊娠時期を限定せずに禁忌となっているものが9割以上を占めていた。薬効分類別では循環器用薬に次いでその他の代謝性医薬品が多く、the Australian categories for prescribing medicines in pregnancy(TGA分類)で禁忌に相当するXに分類された成分は16成分(4.3%)のみであった。医療関係者は添付文書における妊婦禁忌の留意点を適切に認識し、妊婦における医薬品の安全性情報を十分に評価した上で、使用可否について慎重に判断するべきであることが示唆された。

ドセタキセル(以下DTX)による皮膚障害は、患者のQOLの低下をもたらす。今回、DTX投与患者の手に発現した皮膚障害について、外的環境との関連を後方視的に調査した。当院にて、2013/1-2015/4の期間にDTXを含む周術期化学療法(DTX 75mg/m2、3週毎、4コース)を開始した女性の乳癌患者を調査対象とし、手における皮膚障害発現群と非発現群で、化学療法施行期間中の平均気温および平均水蒸気圧を比較した。対象患者63名中、手に皮膚障害が発現したのは9名(14.3%)であった。多変量解析の結果、化学療法施行期間中の平均気温≦13.4℃であることが、手における皮膚障害の発現と独立して有意に関連していた(オッズ比:10.6, 95% 信頼区間:1.2-92.5)。DTXを投与中の乳癌患者において、化学療法施行期間中の平均気温と手における皮膚障害の発現との関連が示唆された。(著者抄録)

2019年から2020年にかけて著者らが開催した国内外の医療従事者および医療系学生を対象としたジャーナルクラブのアウトカムについて検証した。医療従事者および医療系学生延べ142名を対象とした。質問紙調査の回答は53名中33名から得られ、薬剤師18名(54.6%)、医療系学生4名(12.1%)、医師4名(12.1%)の順に多く、居住国は日本が25名(75.8%)、日本以外のアジア諸国(タイ、韓国、台湾)が7名(21.2%)、米国が1名(3.0%)であった。ジャーナルクラブ参加前後での論文の批判的吟味に関する能力の自己評価、英語で議論する能力に関する自己評価、エビデンスに基づき実臨床を行う能力に関する自己評価および議論中の発言のしやすさはいずれも参加後において有意にスコアが改善していた。本ジャーナルクラブは、国際化が進む医療現場でがんの多職種チーム医療を円滑に遂行するために有用であると考えられた。

ABSTRACT Purpose Pharmacotherapy during pregnancy should be approached with caution due to the potential risk of adverse effects, including birth defects, in the fetus. Appropriate post‐marketing surveillance and perinatal pharmacoepidemiology are essential to ensure the safety of pharmacotherapy during pregnancy. However, due to limited research infrastructure in pharmacoepidemiology, collecting reliable data on drug safety in pregnant women and infants remains a challenge in Japan. Thus, we examined the suitability (fitness for purpose) of Japanese medical databases for perinatal studies to establish infrastructure in this field. Methods We assessed seven available databases in Japan: the DeSC database, EBM provider, Japanese Adverse Drug Event Report database, JMDC claims database, MDV analyzer, the National Database of Health Insurance Claims, and Tohoku Medical Megabank Project Birth and Three‐Generation Cohort Study (TMM BirThree Cohort Study). To assess the quality of databases for maternal studies, we evaluated the content of each mother‐infant linkable database based on the core data elements recommended for perinatal pharmacoepidemiology. Results Three of the databases were found to be mother‐infant linkable: the DeSC database, JMDC claims database, and the TMM BirThree Cohort Study. The coverage of core data elements in perinatal pharmacoepidemiology was 73.5% in the DeSC and JMDC claims databases and 92.9% in the TMM BirThree Cohort Study. Conclusion Some representative medical databases in Japan are well suited for use in perinatal pharmacoepidemiologic research on infant outcomes.

Maintaining medication adherence remains a major clinical challenge, as higher daily dosing frequencies are often associated with decreased adherence. Although once-daily regimens are generally preferred, specific patient preferences regarding dosing frequency are unclear, despite implications for improving patient satisfaction and optimizing pharmacotherapy. Here, we evaluated the frequency at which patients begin to perceive dosing as excessive. A web-based questionnaire survey using the personal health record infrastructure of electronic medication notebooks was administered between July 20 and 26, 2023. Eligible participants were aged ≥20 years and had received oral tablets or capsules within 90 d of the survey. The questionnaire consisted of 6 items, including whether participants felt that the daily medication frequency was excessive. A multivariate logistic regression analysis was performed to identify the frequency beyond which patients perceive dosing as excessive, adjusting for confounders, such as medication formulation, number of medications, and patient characteristics. Of 1478 respondents, 1236 were included in the analysis. In total, 28.9% of participants reported that their medication frequency felt excessive. In the multivariate logistic regression analysis, twice-daily or more frequent dosing was significantly associated with the perception of excessiveness, using once-daily dosing as the reference. Twice-daily dosing is the frequency beyond which patients are significantly more likely to perceive medication as excessive. Our findings emphasize the importance of simplifying dosing regimens.

ABSTRACT Purpose To evaluate the accuracy of diagnostic coding for acute kidney injury (AKI) in Japan. Methods The data analyzed were obtained from the JMDC hospital‐based administrative claims database from cases registered between April 2014 and August 2022. Only patients who underwent serum creatinine measurements two or more times with intervals of 7 days or less were eligible for inclusion. AKIs were identified by International Classification of Diseases 10th Revision (ICD‐10) codes N14 and N17. These were assessed according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Results A total of 467 019 patients (median age, 74 [range, 20–99] years; male, 50.9%) were eligible for inclusion. Among these patients, 1849 (0.4%) were assigned ICD‐10 codes for AKI. Among these 1849 patients, the code was assigned within 7 days of the occurrence of AKI (as defined by the KDIGO criteria) in 212 patients, within 14 days in 294 patients, and within 30 days in 386 patients. The positive predictive values and 95% confidence intervals of the ICD‐10 code for AKI at these timepoints were as follows: within 7 days, 11.5% (10.1%–13.0%); within 14 days, 15.9% (14.3%–17.6%); and within 30 days, 20.9% (19.1%–22.8%). Conclusions The ICD‐10 codes for AKI showed poor positive predictive values for AKI as defined by the KDIGO criteria, suggesting that it may be difficult to identify AKI using ICD‐10 codes alone in the Japanese context.

OBJECTIVES: This study aimed to identify the impact of the coronavirus disease 2019 (COVID-19) pandemic on changes in the trend and quality of adverse drug reaction (ADR) reports in the Japanese Adverse Drug Events Report (JADER) database using the vigiGrade completeness score as an indicator. METHODS: A JADER dataset consisting of ADR reports from April 2004 to March 2025 was used. VigiGrade completeness scores were determined for ADR reports, and the quality of the reports was assessed as 'well documented' or not, depending on the score obtained. KEY FINDINGS: Of 969 520 ADR reports, 393 168 submitted between the fourth quarter of 2018 and the fourth quarter of 2024 were included. The number of ADR reports declined in the first quarter of 2020 but peaked in the second quarter of 2021. The proportion of 'well-documented' reports remained between ~20% and 30% during most quarters, but increased to ~40% in the first and second quarters of 2021, during which COVID-19 vaccine-related reports accounted for 29.0% and 39.2% of all reports, respectively. This surge in vaccine-related submissions coincided with a temporary improvement in documentation quality. CONCLUSIONS: The COVID-19 pandemic and the increase in ADR reports related to COVID-19 vaccines have affected the trends and quality of reporting in the JADER database. Notably, a substantial increase in vaccine-related ADRs during mass immunization corresponded with a temporary rise in reporting quality. These findings highlight the importance of maintaining robust pharmacovigilance systems that can adapt to large-scale public health interventions and sustain data quality during future emergencies.

PURPOSE: Although the efficacy of trifluridine/tipiracil hydrochloride (TAS-102) in treating metastatic colorectal cancer (mCRC) is well established, its non-hematologic toxicities in relation to renal function remain unclear. This study aimed to assess the impact of creatinine clearance (Ccr) on non-hematologic toxicities, including nausea and vomiting, in patients with mCRC treated with TAS-102. METHODS: This study was conducted as a post-hoc analysis of the JASCC-CINV2001 study, a multicenter observational study of mCRC patients. Using a Cox proportional hazards model, we assessed the relationship between Ccr and nausea or vomiting, and used a generalized estimating equations (GEE) logistic regression model to analyze the association between Ccr and additional toxicities, including fatigue, constipation, diarrhea, insomnia, and dysgeusia. Toxicities were evaluated at weekly intervals over four weeks. RESULTS: Among 100 patients, median Ccr was 80.5 ml/min. The primary analysis showed no significant association between Ccr and nausea or vomiting. However, the secondary analysis revealed a significant link between lower Ccr and the incidence of diarrhea (P = 0.02). CONCLUSION: These results suggest that although TAS-102-induced nausea and vomiting are not strongly influenced by renal function, decreased renal function increases the risk of diarrhea. Enhanced antiemetic measures may not be necessary for TAS-102 patients with impaired renal function, but monitoring for diarrhea is recommended.

Abstract Purpose We conducted a comprehensive analysis of esketamine-related adverse events (AE) on the FDA Adverse Event Reporting System (FAERS) database, taking into account for the first time drug-drug interaction signals. Methods We conducted a retrospective case/non-case study of esketamine-related AEs reported in the FAERS database up to the last quarter (Q4) of 2024. Potential signals were detected using the reporting odds ratio (ROR) and confidence intervals (CI), while drug-drug interactions were studied using different metrics such as lift, conviction and the combination risk ratio detection algorithm. An analysis of sex differences was also performed using the relative ROR and CI. Results The analysis of 7,790 reports in which esketamine was a primary or secondary suspect identified potential safety signals for 173 AEs. Novel signals include homicidal ideation (ROR = 5.30, 95% CI: 2.38-11.82) and substance use disorder (ROR = 6.12, 95% CI: 2.54-14.73). Women showed a longer time to onset than men (p = 0.003). In addition, we detected sex differences in 23 AEs, seven of which were more likely to be reported in women, while 16 in men. Among these, four were significant exclusively in women (oxygen saturation decreased, abnormal behaviour, unresponsive to stimuli and aggression) and two in men (vision blurred and bradycardia). Potential signals of additive and multiplicative drug-drug interactions were detected for antidepressants (venlafaxine for“dizziness” and bupropion for “agitation”) and antipsychotics (risperidone for “vertigo”). Conclusions Our results increase knowledge on potential risks related to esketamine AEs and potential drug-drug interaction signals in a real-world setting.

Abstract Background The clinical implementation of prediction models can face important barriers, particularly regarding user-friendliness and interpretability for healthcare professionals. We recently developed and externally validated a risk prediction model for denosumab-induced hypocalcemia. The present study aimed to evaluate the model’s utility and identify challenges for its clinical implementation through pilot testing conducted by hospital pharmacists. Methods A paper-format prediction model was distributed to pharmacists at Kameda General Hospital, Miyagi Cancer Center, and Gunma Prefectural Cancer Center. Participants trialed the model outside their routine workflow by applying it to data from patients scheduled to receive their first dose of denosumab. A subsequent questionnaire survey, available in paper and electronic formats, was conducted to gather feedback on the model’s utility and limitations. Results A total of 49 responses were obtained, predominantly from pharmacists in their 20 s and 30 s with diverse professional responsibilities. The model was positively evaluated in terms of its clear target population, predicted outcome (47/49, 95.9%), and simple, straightforward nature (47/49, 95.9%). However, some participants provided neutral feedback on its ease of use (10/49, 20.4%). While its potential as an auxiliary tool for risk prediction was acknowledged, there were also some neutral views on its practical utility. One concern was the inconvenience of implementing a paper-format tool in clinical environments that primarily operate on electronic health records. Conclusions The paper-format prediction model was positively evaluated by frontline pharmacists, especially for its clear and straightforward nature. As anticipated, however, limitations such as manual data input and paper-based format were identified by some participants. Integration into electronic health records and broader clinical validation will be necessary to advance the clinical application of this prediction model and ensure real-world applicability.

Aims Spontaneous reporting of adverse drug reactions (ADR) after a product has reached the market is essential for drug safety. This study analysed patient ADR reports and compared them with reports from the Japanese Adverse Drug Event Report (JADER) database to identify differences and trends. Methods ADR reports from the Pharmaceuticals and Medical Devices Agency website, including patient reports from March 2019 to March 2024, and JADER reports from January 2019 to March 2024, were utilized. Information on demographics, drugs, ADR types and outcomes was analysed. Frequencies and comparisons between the two reporting groups were performed. Results A total of 2913 patient reports and 343 894 JADER reports were analysed. Patients were often younger (30–50 years) and mostly female, whereas JADER reports included older patients (60–80 years) and mostly male. Patients reported subjective symptoms, such as fatigue and headache, often associated with drugs targeting the central nervous system. In contrast, JADER reports focused on serious conditions, such as interstitial lung disease and pneumonia, which are commonly associated with anticancer drugs. Patient and professional ADR reports differed in focus. Patients highlighted quality‐of‐life‐related symptoms, whereas professionals reported more serious medical conditions. Differences in demographics and reporting methods indicate that these systems are complementary. Offering more reporting options, such as telephone‐based submissions, can make the system more inclusive. Conclusions The study highlights how patient ADR reports provide valuable insights into drug safety. Although differences exist, patient and professional reports improve monitoring after drug approval.