Objective: In many medical institutions in Japan, 10% lidocaine gel is prepared as an in-hospital formulation to treat intractable neuropathic pain. Clinical studies have reported the short-term efficacy of topical lidocaine therapy for neuropathic pain, while there are few reports in real-world practice. To clarify the clinical usage and its usefulness, in this study, we investigated the duration of use, amount, effectiveness, and safety of 10% lidocaine gel.

Design: We conducted a retrospective study investigating the actual usage of 10% lidocaine gel using electronic medical records.

Methods: This study included 74 patients treated with 10% lidocaine gel in Kyoto University Hospital between July 2019 and January 2022. Information about disease (purpose of use), concomitant medications and other background information of the patients were collected. In addition, the duration of use, amount, adverse events, and discontinuation of 10% lidocaine gel were investigated. Effectiveness was determined by physician interviews and the pain visual analogue scale (VAS).

Results: Ten percent lidocaine gel was used primarily to treat postherpetic neuralgia and, in some cases, other types of chronic pain for a median duration of use of 3.2 months (0.03-118.5). Pain relief was achieved in 73.3% of patients according to physician interviews, with a significant decrease in the VAS score. Although adverse events were observed in 12 patients (16.2%), including skin problems (12.2%), paralysis (4.1%), and somnolence (1.4%), eight patients continued to use 10% lidocaine gel after their occurrence. Three patients discontinued it due to adverse events, and their symptoms subsequently improved thereafter.

Conclusion: The present results suggest that 10% lidocaine gel is effective and safe even when used for a long-time. Although this is a single-center study, it is the first systematic investigation of real-world usage of an in-hospital formulation of 10% lidocaine gel and is expected to assist clinical practice and drug development.

Objective: We examined the descriptions of reference information regarding the dispensing process in the interview form (IF). If there was no description, we determined the test data’s availability from the pharmaceutical company.

Methods: The survey targeted 78 drugs that complied with the new description IF guidelines, for regular tablets and capsules launched from April 2018 to December 2021. The survey was conducted between March 13th and June 14th, 2022. We investigated the reference information regarding the stability of the medications during the crushing and simple suspension method during dispensing.

Results: Regarding the data related to the stability of medications during the crushing process, ten drugs were described as having “data available,” 18 drugs were to be “inquired individually,” 31 drugs had “no applicable data,” and 14 drugs had “no items.” Regarding the status of descriptions on the simple suspension method, ten drugs were described as having “data available,” 18 drugs had data that was to be “inquired individually,” 32 drugs had “no applicable data,” and 14 drugs had “no items.” Regarding the 35 drugs for which both the stability during crushing and the simple suspension method were listed as either “no applicable data” or “no items,” we contacted the pharmaceutical companies to inquire about the test data for the stability during the crushing and simple suspension method. We found that four drugs had “data available” on the stability of medications during the crushing process, while six drugs had “data available” on the simple suspension method.

Conclusion: Many IFs that complied with the new description guidelines had items for reference information regarding dispensing. However, the test data’s description was not sufficient. Furthermore, even if there is no description of reference information regarding dispensing in the IF, we confirmed that the pharmaceutical company owns the test data.

Objective: Chemotherapy-induced nausea and vomiting (CINV) can affect a patient’s quality of life and make them resistant to the treatment. We created an electronic patient reported outcome ePRO-linked pharmaceutical management system (PMS) for CINV (CINVePRO) for storing information, such as nausea and vomiting status, food intake, etc., and suggesting the type of anti-nausea medication and dosage changes to the physicians for controlling CINV.

Design: At the Gifu University Hospital, the collaborative research institute, inpatients and pharmacists in charge used CINVePRO-PMS, and a questionnaire survey was done to assess the system’s reliability.

Methods: The daily entry of data into CINVePRO shows the number and duration of vomiting, degree of nausea, and amount of food consumed and displays a list and graph of these data over time. The PMS enables pharmacists to list the presence or absence of nausea and the number of vomiting for all patients in their charge and record the intervention and display its list.

Results: The questionnaire was distributed to 17 inpatients. All patients and pharmacists answered the questionnaire. According to the results of the questionnaire survey of patients, each screen of CINVePRO received a good evaluation that mentioned it was “easy to understand,” “easy to use,” and “especially useful for communicating one’s symptoms.” In addition, the results of a questionnaire survey of the pharmacists revealed that the system was rated as easy to check the patients’ symptoms and practical to use.

Conclusion: CINVePRO-PMS was evaluated as a convenient and applicative system. However, linking CINVePRO to the electronic medical record of each hospital is necessary for sharing it among multiple professions.

Objective: Continuous medication management is demanded from community pharmacists, including mandatory follow-ups (FUs) during the medication period. To improve their efficiency and quality, a software application (app) is being introduced. We investigated the use of the app for FUs by comparing it to the use of phone calls.

Design: This was a retrospective studythat collected FU records from participating pharmacies.

Methods: FU records of an automated question-and-answer post-dispensing app and phone calls made at 10 pharmacies in June-July 2021 were collected. Differences in the work time and contents of each FU tool were evaluated.

Results: Of the 138 eligible cases, 69 (50.0%) used the app and 62 (44.93%) used phones. There was 1 case of FU interruption using the app and 12 for those using phone calls. Preparation time to initiate FU was shorter using the app than phone calls (0.28 ± 0.96 min vs. 5.06 ± 5.44 min). Moreover, there were more cases of pharmaceutical problems identified using the app than phone calls (69.57% vs. 35.48%).

Conclusion: The FU app maybe a more efficient tool for identifying problems than phone calls. Further studies are needed to optimize the tool according to patient characteristics.

Objective: Crimes related to falsified medicines for medical use are of international concern and becoming increasingly sophisticated. Therefore, in this study, we investigated information on education and training/enlightenment activities on falsified medicines worldwide that are open to the public on the Internet to contribute to medical/pharmaceutical professionals’ and consumers’ education regarding falsified medicines in Japan.

Methods: In April 2023, we searched the information written in English and Japanese on education and training/enlightenment activities on falsified medicines using the Internet.

Results: We surveyed several countries and obtained important findings. In particular, the World Medical Association (WMA), the International Pharmaceutical Federation (FIP), and the World Health Professions Alliance (WHPA) released programs for healthcare professionals. The US news programs, the US Department of Justice, and the Council of Europe released consumer warning videos. Japan issued the “Guidelines for Good Distribution Practice (GDP)” to the pharmaceutical distribution industry in 2018. Additionally, US and UK medicine regulators and the International Criminal Police Organization (ICPO) offered programs for professionals such as police and customs officers, and public prosecutors.

Conclusion: These programs contain useful information not only for medical/pharmaceutical professionals in Japan but also for consumers. However, many are provided by foreign governments or international organizations, while few are from Japan. Therefore, to prevent the distribution of falsified medicine in Japan, educational institutions must further strengthen education and training/enlightenment activities and develop and publish educational tools for falsified medicines.

Objective: The wrong dose of high-risk drugs such as oral steroids is a serious issue that needs to be addressed. This study aims to determine the appropriate upper tolerable dose threshold and to develop a multi-variable logistic regression model to detect dose-errors in oral prednisolone tablets.

Methods: Data on Prednisolone prescriptions were obtained from a single center. Out of the data collected, positive cases consisted of cases where dose-related modifications were made. A univariate logistic regression model was developed with the current daily dose. In the model, the Youden Index was used to determine the upper tolerable dose threshold. The investigation was done to determine whether the performance of the multivariate model was improved by adding clinical department and previous prescription information as variables.

Results: Univariate models (AUC: 0.645) with only current daily doses and estimated optimal thresholds of 6 mg/day or 11 mg/day, respectively were determined to be appropriate. Including variables improved the performance of the predictive model; the best performing model (AUC: 0.840) was derived when the following variables were entered: “current daily dose,” “current prescription days,” “clinical department,” “daily dose of the previous prescription,” and “prescription days of the previous prescription”.

Conclusion: A single upper tolerance limit is insufficient to determine dose adequacy for prednisolone tablets owing to their broad clinical dose range. Itmay be possible to develop a high-performance dose audit support model by adding information.