Details of a Researcher - Kizaki, Hayato

Papers - Kizaki, Hayato

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Analyzing the Impact of Drug Name Similarity on Dispensing Errors: An Examination Using a Drug Name Similarity Index

Sagawa H;Kizaki H;Yoshikawa K;Kamimura T;Suzuki S;Hayashi S;Tamaki H;Satoh H;Sawada Y;Hori S

Biol. Pharm. Bull. (accepted for publication) 47 ( 8 ) 1460 - 1466 2024.07

Research paper (scientific journal), Joint Work, Accepted, ISSN 09186158

Dispensing errors pose a significant health risk, with drug name similarity being a potential contributory factor. To determine the impact of drug name similarity on dispensing errors within clinical settings, we analyzed 563 dispensing errors at an acute hospital in Japan from April 2015 to June 2018. Drug name similarity between two drugs was classified into Name-Similar and Name-Dissimilar groups using the m2-vwhtfrag index, the value of the drug name similarity. Drug efficacy similarity was categorized into Efficacy-Same, Efficacy-Close, and Efficacy-Far. The drug name similarity and drug efficacy similarity of all possible pair combinations were obtained and similarly classified. The proportion of the number of pairs with dispensing errors per the total number of drug pairs in the hospital’s drug formulary in each category was calculated. The highest proportion of the number of pairs with dispensing errors was 36% for the Efficacy-Same and Name-Similar group, and the lowest proportion was 0.022% for the Efficacy-Far and Name-Dissimilar group. The proportion of the number of pairs with dispensing errors was significantly higher in the Name-Similar category than in the Name-Dissimilar category for all drug efficacy categories. Our results indicate that drug name similarity increases the risk of dispensing errors, and that m2-vwhtfrag is a useful indicator to assess dispensing errors in clinical practice. Such drug name and efficacy similarity evaluations can help identify factors causing dispensing errors, and predict the risk of dispensing errors for newly adopted drugs, considering the relationship with the whole drug formulary in the hospital dispensary.

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Exploring a method for extracting concerns of multiple breast cancer patients in the domain of patient narratives using BERT and its optimization by domain adaptation using masked language modeling

Watabe S;Watanabe T;Yada S;Aramaki E;Yajima H;Kizaki H;Hori S

PLOS ONE 19 ( 9 ) e0305496 2024.07

Research paper (scientific journal), Joint Work, Accepted

Narratives posted on the internet by patients contain a vast amount of information about various concerns. This study aimed to extract multiple concerns from interviews with breast cancer patients using the natural language processing (NLP) model bidirectional encoder representations from transformers (BERT). A total of 508 interview transcriptions of breast cancer patients written in Japanese were labeled with five types of concern labels: "treatment," "physical," "psychological," "work/financial," and "family/friends." The labeled texts were used to create a multi-label classifier by fine-tuning a pre-trained BERT model. Prior to fine-tuning, we also created several classifiers with domain adaptation using (1) breast cancer patients’ blog articles and (2) breast cancer patients’ interview transcriptions. The performance of the classifiers was evaluated in terms of precision through 5-fold cross-validation. The multi-label classifiers with only fine-tuning had precision values of over 0.80 for "physical" and "work/financial" out of the five concerns. On the other hand, precision for "treatment" was low at approximately 0.25. However, for the classifiers using domain adaptation, the precision of this label took a range of 0.40–0.51, with some cases improving by more than 0.2. This study showed combining domain adaptation with a multi-label classifier on target data made it possible to efficiently extract multiple concerns from interviews.

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Evaluation of Patient Outcomes after Pharmacological Intervention in Home Health Care Utilizing Pharmaceutical Care Records

柳澤友希, 横川祐希, 木﨑速人, 佐山杏子, 横山さくら, 佐々木剛, 染谷光洋, 谷口亮央, 今井俊吾, 堀里子

Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan ((公社)日本薬学会) 144 ( 8 ) 839 - 845 2024.07

Research paper (scientific journal), Joint Work, Accepted, ISSN 0031-6903

薬剤服用歴(薬歴)には患者の主訴が記載されるだけでなく、薬剤師によるアセスメントが経時的に記載されることから、薬剤師の介入による患者の転帰が追跡できる可能性がある。今回、在宅患者に対し薬剤師が医師と連携して服用薬の減薬や医薬品の適正使用推進に取り組んだ事例を対象とし、経時的に記録された薬歴をもとに、薬剤師介入後のフォローアップ実施状況や患者アウトカムの変化について調査した。対象は、株式会社ナカジマ薬局において在宅医療対応件数の多い7店舗で2020年4月～2021年12月に薬歴が記録された当該患者366例とした。調査の結果、薬剤師の介入内容として最も多かったのは「症状の発生に対する介入で」あり、介入後の転帰は半数以上で症状の改善が認められていた。薬剤師の介入によって症状は安定しているが、投与継続されていた薬剤の中止や減量がなされた事例も多くあり、介入後の転帰は9割以上が症状に変化なく経過していたことから、患者の症状コントロールを保ちながら多剤併用解消の一助になっていたと考えられた。

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Concomitant use of lansoprazole and ceftriaxone is associated with an increased risk of ventricular arrhythmias and cardiac arrest in a large Japanese hospital database.

Mitsuboshi S, Imai S, Kizaki H, Hori S

The Journal of infection (Journal of Infection) 89 ( 2 ) 106202 2024.06

Research paper (scientific journal), Accepted, ISSN 0163-4453

Objectives: To determine whether concomitant use of ceftriaxone and oral or intravenous lansoprazole increases the risk of ventricular arrhythmia and cardiac arrest in the real-world setting in Japan. Methods: The data analyzed were obtained from the JMDC hospital-based administrative claims database for the period April 2014 to August 2022. Patients who received a proton pump inhibitor (PPI) while receiving ceftriaxone or sulbactam/ampicillin were identified. The frequency of ventricular arrhythmia and cardiac arrest was analyzed according to whether oral or intravenous PPI was concomitant with ceftriaxone or sulbactam/ampicillin. Estimates of the incidence of ventricular arrhythmia and cardiac arrest were then compared among the groups, using the Fine–Gray competing risk regression model. Results: The results showed that the risk of ventricular arrhythmia and cardiac arrest was significantly higher with concomitant ceftriaxone and oral lansoprazole (hazard ratio 4.57, 95% confidence interval 1.99–4.29, P < 0.01) or intravenous lansoprazole (hazard ratio 4.57, 95% confidence interval 1.24–16.80, P = 0.02) than with concomitant sulbactam/ampicillin and oral or intravenous lansoprazole. Conclusions: Oral and intravenous lansoprazole may increase the risk of ventricular arrhythmia and cardiac arrest in patients who are receiving ceftriaxone.

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病院における造影剤による即時型アレルギー対策の現状と課題　病院薬剤部門を対象とした質問紙調査

鈴木信也, 木崎速人, 上村忠聖, 男全昭紀, 今井俊吾, 堀里子

医薬品情報学 ((一社)日本医薬品情報学会) 26 ( 1 ) 19 - 27 2024.05

Research paper (scientific journal), Accepted, ISSN 1345-1464

造影剤副作用マネジメントの実態や薬剤部門が造影剤投与に関わる機会ならびに造影剤の副作用リスクに対する薬剤師の意識を調査した。医療機関マスタを用いて無作為に抽出した2000施設の病院の薬剤部門を対象にアンケートを依頼し、96施設から回答を得た。造影剤の副作用発症リスクの高い患者への対応などについて、院内で統一された内規やマニュアルがあるのは41施設(42.7%)であり、造影剤による副作用の既往を持つ患者については67施設(69.8%)が施設でとるべき対応を定めていた。薬剤部門として所属病院内で造影剤投与による副作用のリスク管理やその方法に関する議論を行っていたのは39施設(40.6%)であり、外来患者における造影剤投与時に薬剤部の介入が必要と考えるかについては45施設(46.9%)が「とてもそう思う」「ややそう思う」と回答した。「どちらともいえない」が42施設(43.8%)と同程度であり、「あまりそう思わない」「まったくそう思わない」と回答した施設もあった。

Medication incidents associated with the provision of medication assistance by non-medical care staff in residential care facilities.

Kizaki H, Yamamoto D, Maki H, Masuko K, Konishi Y, Satoh H, Hori S, Sawada Y

Drug discoveries & therapeutics 18 ( 1 ) 54 - 59 2024.03

Research paper (scientific journal), Accepted, ISSN 1881-7831

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Detection of Adverse Event Signals with Severity Grade Classification from Cancer Patient Narrative.

Nishioka S, Asano M, Yada S, Aramaki E, Yajima H, Kizaki H, Hori S

Studies in health technology and informatics 310 554 - 558 2024.01

Research paper (international conference proceedings), Accepted, ISSN 0926-9630

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Factor Analysis of Patients Who Find Tablets or Capsules Difficult to Swallow Due to Their Large Size: Using the Personal Health Record Infrastructure of Electronic Medication Notebooks

Asano M., Imai S., Shimizu Y., Kizaki H., Ito Y., Tsuchiya M., Kuriyama R., Yoshida N., Shimada M., Sando T., Ishijima T., Hori S.

Journal of Medical Internet Research (Journal of Medical Internet Research) 26 ( 1 ) e54645 2024.01

Research paper (scientific journal), Accepted, ISSN 1439-4456

Background: Understanding patient preference regarding taking tablet or capsule formulations plays a pivotal role in treatment efficacy and adherence. Therefore, these preferences should be taken into account when designing formulations and prescriptions. Objective: This study investigates the factors affecting patient preference in patients who have difficulties swallowing large tablets or capsules and aims to identify appropriate sizes for tablets and capsules. Methods: A robust data set was developed based on a questionnaire survey conducted from December 1, 2022, to December 7, 2022, using the harmo smartphone app operated by harmo Co, Ltd. The data set included patient input regarding their tablet and capsule preferences, personal health records (including dispensing history), and drug formulation information (available from package inserts). Based on the medication formulation information, 6 indices were set for each of the tablets or capsules that were considered difficult to swallow owing to their large size and concomitant tablets or capsules (used as controls). Receiver operating characteristic (ROC) analysis was used to evaluate the performance of each index. The index demonstrating the highest area under the curve of the ROC was selected as the best index to determine the tablet or capsule size that leads to swallowing difficulties. From the generated ROCs, the point with the highest discriminative performance that maximized the Youden index was identified, and the optimal threshold for each index was calculated. Multivariate logistic regression analysis was performed to identify the risk factors contributing to difficulty in swallowing oversized tablets or capsules. Additionally, decision tree analysis was performed to estimate the combined risk from several factors, using risk factors that were significant in the multivariate logistic regression analysis. Results: This study analyzed 147 large tablets or capsules and 624 control tablets or capsules. The “long diameter + short diameter + thickness” index (with a 21.5 mm threshold) was identified as the best indicator for causing swallowing difficulties in patients. The multivariate logistic regression analysis (including 132 patients with swallowing difficulties and 1283 patients without) results identified the following contributory risk factors: aged <50 years (odds ratio [OR] 1.59, 95% CI 1.03-2.44), female (OR 2.54, 95% CI 1.70-3.78), dysphagia (OR 3.54, 95% CI 2.22-5.65), and taking large tablets or capsules (OR 9.74, 95% CI 5.19-18.29). The decision tree analysis results suggested an elevated risk of swallowing difficulties for patients with taking large tablets or capsules. Conclusions: This study identified the most appropriate index and threshold for indicating that a given tablet or capsule size will cause swallowing difficulties, as well as the contributory risk factors. Although some sampling biases (eg, only including smartphone users) may exist, our results can guide the design of patient-friendly formulations and prescriptions, promoting better medication adherence.

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Exploring the factors associated with difficulties in extracting tablets or capsules from press-through-package sheets

Tsuchiya M., Imai S., Asano M., Shimizu Y., Kizaki H., Ito Y., Tsuchiya M., Kuriyama R., Yoshida N., Shimada M., Sando T., Ishijima T., Hori S.

British Journal of Clinical Pharmacology 91 ( 2 ) 479 - 484 2024

Research paper (scientific journal), Accepted, ISSN 03065251

Exploring factors related to difficulties in extracting tablets or capsules from press-through-packages is essential for optimizing the dosage form. To achieve this, the involvement of patient insight is important. In the present study, the preferences of patients regarding drugs that are difficult to extract from their packaging were collected using an electronic medication notebook (‘harmo®’) based on dispensing data. We found that approximately 30% of respondents had difficulty removing tablets or capsules from their packaging, with 125 specific drugs identified as ‘hard to push out’. Independent factors related to ‘hard-to-push-out’ drugs were female sex and feeling of weakness in the hands or fingers. Furthermore, several ‘hard-to-push-out’ drugs had characteristics such as a spherical shape or small major axis or small major axis drug-to-pocket size ratio. The findings of this study may help improve the quality of drug packaging, thus enhancing the patients' medication experience.

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Adverse Event Signal Detection Using Patients’ Concerns in Pharmaceutical Care Records: Evaluation of Deep Learning Models

Nishioka S., Satoshi W., Yanagisawa Y., Sayama K., Kizaki H., Imai S., Someya M., Taniguchi R., Yada S., Aramaki E., Hori S.

Journal of Medical Internet Research (Journal of Medical Internet Research) 26 ( 1 ) e55794 2024

Research paper (scientific journal), Accepted, ISSN 1439-4456

Background: Early detection of adverse events and their management are crucial to improving anticancer treatment outcomes, and listening to patients’ subjective opinions (patients’ voices) can make a major contribution to improving safety management. Recent progress in deep learning technologies has enabled various new approaches for the evaluation of safety-related events based on patient-generated text data, but few studies have focused on the improvement of real-time safety monitoring for individual patients. In addition, no study has yet been performed to validate deep learning models for screening patients’ narratives for clinically important adverse event signals that require medical intervention. In our previous work, novel deep learning models have been developed to detect adverse event signals for hand-foot syndrome or adverse events limiting patients’ daily lives from the authored narratives of patients with cancer, aiming ultimately to use them as safety monitoring support tools for individual patients. Objective: This study was designed to evaluate whether our deep learning models can screen clinically important adverse event signals that require intervention by health care professionals. The applicability of our deep learning models to data on patients’ concerns at pharmacies was also assessed. Methods: Pharmaceutical care records at community pharmacies were used for the evaluation of our deep learning models. The records followed the SOAP format, consisting of subjective (S), objective (O), assessment (A), and plan (P) columns. Because of the unique combination of patients’ concerns in the S column and the professional records of the pharmacists, this was considered a suitable data for the present purpose. Our deep learning models were applied to the S records of patients with cancer, and the extracted adverse event signals were assessed in relation to medical actions and prescribed drugs. Results: From 30,784 S records of 2479 patients with at least 1 prescription of anticancer drugs, our deep learning models extracted true adverse event signals with more than 80% accuracy for both hand-foot syndrome (n=152, 91%) and adverse events limiting patients’ daily lives (n=157, 80.1%). The deep learning models were also able to screen adverse event signals that require medical intervention by health care providers. The extracted adverse event signals could reflect the side effects of anticancer drugs used by the patients based on analysis of prescribed anticancer drugs. “Pain or numbness” (n=57, 36.3%), “fever” (n=46, 29.3%), and “nausea” (n=40, 25.5%) were common symptoms out of the true adverse event signals identified by the model for adverse events limiting patients’ daily lives. Conclusions: Our deep learning models were able to screen clinically important adverse event signals that require intervention for symptoms. It was also confirmed that these deep learning models could be applied to patients’ subjective information recorded in pharmaceutical care records accumulated during pharmacists’ daily work.

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Medication Management Initiatives Using Wearable Devices: Scoping Review

Iino H., Kizaki H., Imai S., Hori S.

JMIR Human Factors 11 e57652 2024

Research paper (scientific journal), Accepted

Background: Wearable devices (WDs) have evolved beyond simple fitness trackers to sophisticated health monitors capable of measuring vital signs, such as heart rate and blood oxygen levels. Their application in health care, particularly medication management, is an emerging field poised to significantly enhance patient adherence to treatment regimens. Despite their widespread use and increasing incorporation into clinical trials, a comprehensive review of WDs in terms of medication adherence has not been conducted. Objective: This study aimed to conduct a comprehensive scoping review to evaluate the impact of WDs on medication adherence across a variety of diseases, summarizing key research findings, outcomes, and challenges encountered. Methods: Adhering to PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, a structured search was conducted across MEDLINE, Web of Science, and Embase databases, covering the literature from January 1, 2010, to September 30, 2022. The search strategy was based on terms related to WDs and medication adherence, specifically focusing on empirical studies to ensure the inclusion of original research findings. Studies were selected based on their relevance to medication adherence, usage of WDs in detecting medication-taking actions, and their role in integrated medication management systems. Results: We screened 657 articles and identified 18 articles. The identified studies demonstrated the diverse applications of WDs in enhancing medication adherence across diseases such as Parkinson disease, diabetes, and cardiovascular conditions. The geographical distribution and publication years of these studies indicate a growing interest in this research area. The studies were divided into three types: (1) studies reporting a correlation between data from WDs or their usage and medication adherence or drug usage as outcomes, (2) studies using WDs to detect the act of medication-taking itself, and (3) studies proposing an integrated medication management system that uses WDs in managing medication. Conclusions: WDs are increasingly being recognized for their potential to enhance medication management and adherence. This review underscores the need for further empirical research to validate the effectiveness of WDs in real-life settings and explore their use in predicting adherence based on activity rhythms and activities. Despite technological advancements, challenges remain regarding the integration of WDs into routine clinical practice. Future research should focus on leveraging the comprehensive data provided by WDs to develop personalized medication management strategies that can improve patient outcomes.

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Adverse event signal extraction from cancer patients’ narratives focusing on impact on their daily-life activities

Nishioka S., Asano M., Yada S., Aramaki E., Yajima H., Yanagisawa Y., Sayama K., Kizaki H., Hori S.

Scientific Reports (Scientific Reports) 13 ( 1 ) 15516 2023.12

Research paper (scientific journal), Accepted

Adverse event (AE) management is important to improve anti-cancer treatment outcomes, but it is known that some AE signals can be missed during clinical visits. In particular, AEs that affect patients’ activities of daily living (ADL) need careful monitoring as they may require immediate medical intervention. This study aimed to build deep-learning (DL) models for extracting signals of AEs limiting ADL from patients’ narratives. The data source was blog posts written in Japanese by breast cancer patients. After pre-processing and annotation for AE signals, three DL models (BERT, ELECTRA, and T5) were trained and tested in three different approaches for AE signal identification. The performances of the trained models were evaluated in terms of precision, recall, and F1 scores. From 2,272 blog posts, 191 and 702 articles were identified as describing AEs limiting ADL or not limiting ADL, respectively. Among tested DL modes and approaches, T5 showed the best F1 scores to identify articles with AE limiting ADL or all AE: 0.557 and 0.811, respectively. The most frequent AE signals were “pain or numbness”, “fatigue” and “nausea”. Our results suggest that this AE monitoring scheme focusing on patients’ ADL has potential to reinforce current AE management provided by medical staff.

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Influence of Participation in a Medical-Themed Science Café on Patient Activation

Okazawa Y., Kizaki H., Suzuki N., Osaka W., Hori S.

Patient Preference and Adherence (Patient Preference and Adherence) 17 3093 - 3106 2023.11

Research paper (scientific journal), Joint Work, Accepted, ISSN 1177-889X

Purpose: This study aims to investigate the impact of a Science Café (SC) dealing with medical topics on participants’ patient activation (PA), a concept that refers to patients’ involvement in managing their own health, working with their healthcare providers, and maintaining their health. Material and Methods: Semi-structured interviews were conducted with patients who had participated in a medical SC (n = 10) to identify the medical SC-associated factors that influenced PA. Through a questionnaire of medical SC participants (n = 23), the impact on PA and correlations with relevant psychological measures were quantitatively assessed. Results: The interviews revealed three factors: “Experience & acceptance of chronic conditions”, “Features of medical SC” and “Changes as a result of participation.” The questionnaire results showed a positive correlation between PA and resilience and a negative correlation with decision regret. Conclusions: Participation in a medical SC by people with illnesses can improve PA by improving knowledge and skills for self-management and increasing self-awareness of illness in a supportive environment. The study highlights the potential benefits of using medical SC as a strategy for healthcare providers to improve PA and health outcomes.

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Comparison of different sustained-release opioids and acute respiratory conditions in patients with cancer and chronic kidney disease

Mitsuboshi S., Imai S., Kizaki H., Hori S.

Pharmacotherapy (Pharmacotherapy) 44 ( 2 ) 122 - 130 2023.11

Research paper (scientific journal), Accepted, ISSN 02770008

Study Objective: Few data are available on the association between the use of oxycodone in patients with chronic kidney disease (CKD) and acute respiratory conditions. The aim of this study was to investigate whether oxycodone is associated with an increased risk of acute respiratory conditions in patients with cancer and CKD compared with other opioids. Design and Setting: The data were obtained from a claims database in Japan. Patients with cancer and CKD who had received sustained-release opioids, including oral oxycodone, oral morphine, or transdermal fentanyl, between April 2014 and May 2021 were selected. The primary outcome was defined as an acute respiratory condition. Data for age and sex, morphine equivalent daily dose, concomitant use of specified medications, comorbidities defined based on the modified Charlson comorbidity index, substance use disorder, and lung cancer or metastatic lung cancer were investigated as covariates. Distribution of acute respiratory conditions was compared among the three sustained-release opioid groups using the log-rank test. Estimates of the incidence of acute respiratory conditions were compared among the groups using a Cox proportional hazards model with time-varying variables. Main Results: A significant difference in the distribution of acute respiratory conditions was found among the three groups (p < 0.01). Cox regression analysis showed a significantly higher risk of acute respiratory conditions with morphine (hazard ratio [HR]: 3.04, 95% confidence interval [CI]: 1.07–8.65, p = 0.04) compared with oxycodone but no significant difference in risk with oxycodone (HR 0.67, 95% CI: 0.32–1.38, p = 0.27) compared with fentanyl. Conclusions: The findings suggest that the risk of acute respiratory conditions may be lower in patients with CKD who use oxycodone for cancer pain than in those who use morphine. Additionally, no difference in the risk of acute respiratory conditions was found between oxycodone and fentanyl use.

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Influence of Voiced and Semi-voiced Sounds on the Subjective Similarity of Different Drug Names: A Cognitive Psychological Experiment

Yoshikawa K., Kizaki H., Imai S., Hori S.

Biological and Pharmaceutical Bulletin (Biological and Pharmaceutical Bulletin) 46 ( 11 ) 1630 - 1634 2023.11

Research paper (scientific journal), Accepted, ISSN 09186158

The similarity of drug names is one of the common causes of medication error. In Japan, similarity evaluation is performed prior to approval of new drugs in order to avoid potential confusion. However, existing indices do not take account of the difference between characters that contain voiced or semi-voiced and unvoiced sounds, so it is not clear whether such sounds influence the subjective similarity of drug names. Thus, we performed a cognitive psychological experiment to investigate this issue, using participants who had not received any education in medicine, nursing, or pharmacy. An analogue scale questionnaire was used to evaluate the subjective similarity of the names of drug pairs. Drug pairs for the main analysis were prepared by matching the first 0 to 3 characters, and then varying the difference in the number of voiced and semi-voiced characters from 0 to 3 in these matched characters. By means of this procedure, the drug pairs were classified into a total of 10 groups. Then, a total of 60 drug pairs were created by assigning 6 drugs to each group. The subjective similarity tended to increase with increasing number of common characters among the first three characters. When classified according to the number of these common characters, the subjective similarity was significantly decreased when voiced or semi-voiced sounds were present, as compared with when they were absent. These results indicate that a new drug name similarity index that takes account of voiced and semi-voiced sound differences should be developed to minimize medication errors.

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A Survey of the Status of Methadone Switching in Japan Using a Hospital-Based Administrative Claims Database

Imai S., Aoki N., Ikegami K., Kizaki H., Hori S.

Journal of Clinical Pharmacology (Journal of Clinical Pharmacology) 64 ( 2 ) 189 - 195 2023.09

Research paper (scientific journal), Joint Work, Accepted, ISSN 00912700

Methadone is generally used for the management of cancer pain in patients who cannot obtain adequate analgesia from other strong opioids; however, it has a complicated and inconsistent conversion ratio from pre-switching opioid dosage to methadone. This issue may be pronounced in Japan because only oral tablets are commercially available. We aimed to elucidate the status of methadone switching in Japan, focusing on its dosage. Using a Japanese hospital-based administrative claims database, we included patients who switched to methadone between April 2008 and January 2021. The proportion of methadone switching completion that required more than the defined conversion ratio in the Japanese package insert (called “high-dose methadone switching”) was evaluated as a primary endpoint. Other endpoints included “the duration from initiation to completion of methadone switching” and “factors affecting high-dose methadone switching by using multivariate logistic regression analysis”. Of 1585 patients who received methadone, 370 were enrolled. Among those, 130 (35.1%) received high-dose methadone switching. The median duration of methadone switching completion (12 days) was longer in the high-dose methadone switching group than in other patients. Four variables were identified as factors affecting high-dose methadone switching. Younger age and outpatient status increased the risk of requiring high-dose methadone switching, whereas the concomitant use of nonsteroidal anti-inflammatory drugs and fentanyl as a pre-switching opioid decreased the risk. In conclusion, more than 30% of the patients underwent high-dose methadone switching and required long completion periods, suggesting that methadone switching remains challenging in Japan.

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Exploring Factors Affecting the Occurrence of Hypersensitivity Reactions Induced by Nonionic Iodine Contrast Media

Chatani R., Kondo S., Kamimura T., Suzuki S., Komatsubara E., Hayashi S., Hashiguchi M., Kizaki H., Imai S., Hori S.

Journal of Clinical Pharmacology (Journal of Clinical Pharmacology) 63 ( 9 ) 1002 - 1008 2023.09

Research paper (scientific journal), Accepted, ISSN 00912700

Hypersensitivity reactions induced by nonionic iodine contrast media sometimes occur and can be life threatening. However, independent factors affecting their occurrence remain to be fully established. Therefore, the purpose of this study was to clarify independent factors affecting the occurrence of hypersensitivity reactions induced by nonionic iodine contrast media. Patients who received nonionic iodine contrast media at Keiyu Hospital from April 2014 to December 2019 were included. The adjusted odds ratio (OR) and 95% confidence interval (CI) for factors affecting hypersensitivity reactions induced by contrast media were calculated by logistic regression analysis. The multiple imputation method was used to impute missing data. Hypersensitivity reactions occurred in 0.72% (163 cases) of 22,695 cases enrolled in this study. In univariate analysis, 10 variables met the criteria of P <.05 and proportion of missing data <50%. In multivariate analysis, age (OR, 0.98; 95% CI, 0.97–0.99), outpatient status (OR, 2.08; 95% CI, 1.20–3.60), contrast medium iodine content (OR, 1.02; 95% CI, 1.01–1.04), history of drug allergy (OR, 2.41; 95% CI, 1.50–3.88), and asthma (OR, 17.4; 95% CI, 7.53–40.1) were identified as independent factors affecting contrast media–induced hypersensitivity reactions. Among these factors, history of drug allergy and asthma appear to be clinically relevant and reliable due to their high OR and plausible biological mechanisms, but the other three factors require further validation.

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Detection of Vaccine Adverse Events Before Package Insert Revisions Using a Japanese Spontaneous Reporting System

Suzuki S., Imai S., Mitsuboshi S., Kizaki H., Hashiguchi M., Hori S.

Journal of Clinical Pharmacology (Journal of Clinical Pharmacology) 63 ( 8 ) 903 - 908 2023.08

Research paper (scientific journal), Accepted, ISSN 00912700

The usefulness of disproportionality analysis for the pharmacovigilance of vaccines in the Japanese Adverse Drug Event Report (JADER) database is yet to be proven. This study aimed to verify whether significant disproportionality could be detected before adding new vaccine adverse event information to package inserts. Information on package insert revisions related to vaccine adverse drug events from January 2013 to March 2023 was extracted from the Pharmaceuticals and Medical Devices Agency website. This period was set as the maximum period for which early disproportionalities could be detected by the latest JADER database (April 2004 to December 2022). From JADER data, 15 revision histories (10 types of vaccines) of package inserts were identified, and 823,662 cases were obtained. Of the 15, 12 (80%) adverse events were identified as significant disproportionalities before package insert revisions were made. Nine of the 15 (60%) events were identified as significant disproportionalities earlier than at least 12 months. These findings suggest that the JADER database may detect vaccine adverse events earlier than package insert revisions, indicating its usefulness for the safety surveillance of vaccines.

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Reply to: Comment: Detection of Vaccine Adverse Events Before Package Insert Revisions Using a Japanese Spontaneous Reporting System.

Suzuki S, Imai S, Mitsuboshi S, Kizaki H, Hashiguchi M, Hori S

Journal of clinical pharmacology 63 ( 10 ) 1171 2023.07

Research paper (scientific journal), Accepted, ISSN 0091-2700

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病院における造影剤副作用マネジメントと薬剤部門の関わり方に関する実態調査

近藤咲良, 鈴木信也, 上村忠聖, 木崎速人, 今井俊吾, 堀里子

医薬品情報学 ((一社)日本医薬品情報学会) 25 ( 1 ) 31 - 37 2023.05

Research paper (scientific journal), Accepted, ISSN 1345-1464

首都圏の急性期病院10施設の薬剤部門にアンケートを行い、「造影剤投与に関する内規やマニュアルの有無」「造影剤副作用リスク因子を有する患者への各施設の対応、薬剤部門の介入」などについて調査した。結果、内規やマニュアルの有無については、院内で統一された内規やマニュアルがあると答えたのが5施設、放射線科で統一された内規やマニュアルがあると答えたのが2施設、内規やマニュアルはないと答えたのが3施設であった。造影剤副作用リスク因子として「副作用の既往」「喘息の既往」「造影剤以外によるアナフィラキシーショックの既往」等を有する患者に対しては、半数以上の施設で取るべき対応が定められていた。薬剤部門の介入として、副作用・喘息既往や薬剤アレルギー既往の聴取が7施設で行われており、副作用予防薬の投与が内規やマニュアルで推奨されているのは4施設であった。

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