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Occurrence and Risk Factors of Volume Depletion Requiring Treatment Following SGLT2 Inhibitor Therapy

Kentaro OTOMO ; Ikkou HIRATA ; Yuta SAKAGUCHI ; Ryohkan FUNAKOSHI

Japanese Journal of Drug Informatics.2024;26(1):1-7. doi:10.11256/jjdi.26.1

Objective: Sodium glucose cotransporter 2 inhibitors (SGLT2i) are widely used for diabetes, chronic heart failure, and chronic kidney disease. However, the incidence of volume depletion in patients when pharmacists implement risk-minimization strategies is unknown. Risk factors for volume depletion requiring further treatment have not been investigated in detail. Therefore, we retrospectively investigated the occurrence and risk factors of volume depletion in patients taking SGLT2i. Methods: This study included patients 18 years or older using SGLT2i between November 2014 and December 2021. Patients prescribed an SGLT2i at another hospital who were referred to our clinic where their initial SGLT2i prescription was a continuation prescription, patients who were referred to another medical institution during their 52-week follow-up, patients who discontinued their visits to our clinic or unknown reasons were excluded. The pharmacist provided patients with risk management plan literature at their first provision of an SGLT2 inhibitor. The endpoints were the rate of patients on SGLT2i who experienced volume depletion, rate of hospitalization to treat volume depletion, discontinuation rate, and risk factors. Results: SGLT2i caused volume depletion in 12 patients (0.5 %) and hospitalization in 1 patient (0.04 %), 83.3% of them occurred within 3 months after starting treatment. Risk factors for volume depletion were identified as age ≧ 75 years, renal dysfunction with eGFR less than 60 mL/min/1.73 m2, history of chronic heart failure, and chronic kidney disease. Conclusion: This study revealed risk factors associated with SGLT2i-induced volume depletion, but further investigation is required with an increased number of cases.

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Current Status and Issues of Countermeasures against Immediate Allergy Caused by Contrast Media in Hospitals:

Shinya SUZUKI ; Hayato KIZAKI ; Tadamasa KAMIMURA ; Akinori OMATA ; Shungo IMAI ; Satoko HORI

Japanese Journal of Drug Informatics.2024;26(1):19-27. doi:10.11256/jjdi.26.19

Objective: Contrast media side effects range from minor ones such as itching and vomiting to life-threatening ones such as hypotension and loss of consciousness. The purpose of this study was to determine how contrast media side effects are actually managed in hospitals nationwide, as well as to identify opportunities for the pharmacy department to be involved in contrast media administration, and pharmacists’ awareness of the risk of contrast media side effects. Methods: A self-administered, unmarked questionnaire survey was conducted in the pharmacy departments of 2,000 hospitals nationwide. The survey asked about the existence of internal rules and manuals regarding contrast media at each facility, how to deal with patients at risk for side effects, opportunities for intervention with patients by the pharmacy department, and opportunities for discussion among pharmacists and other professionals regarding the administration of contrast media. Results: Of the 2,000 facilities, 96 responded to the questionnaire, among which 69 had internal regulations or manuals. In those with manuals, the manuals stipulated measures such as not administering contrast media or administering premedication in the case of patients with a history of contrast media side effects. In facilities where the manual recommended premedication, it was found that premedication was administered in both inpatient and outpatient settings. Regarding the role of the pharmacy department, it was found that intervention in all items related to risk factors for adverse drug reactions was achieved for only about 10% of the outpatients. Conclusion: This study revealed that many facilities are involved in the management of contrast media side effects. The results indicate that there is scope for pharmacy departments to intervene more proactively in outpatient settings to ensure appropriate contrast media use in the future.

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Surveys on Suspected Adverse Effects Related to Coronavirus Disease 2019 Vaccination and the Impact of Early Publication of Results

Go MORIKAWA ; Ken KUBOTA ; Katsuko OKAZAWA ; Takemasa MARUYAMA ; Tomoshige CHIAKI

Japanese Journal of Drug Informatics.2024;26(1):28-35. doi:10.11256/jjdi.26.28

Objective: The coronavirus disease 2019 (COVID-19) vaccine was a specially approved pharmaceutical in Japan in February 2021. However, several people were concerned about its safety. Therefore, we conducted a survey on our hospital staff with suspected adverse effects related to COVID-19 vaccines and promptly published the results on our website. Methods: The current study included hospital staff who received the COVID-19 vaccine. A questionnaire survey on suspected adverse effects was conducted after each vaccination from the first to the fifth dose. Data on the survey results were promptly posted on the hospital’s website. The number of hits and time spent on the site were also evaluated. Then, we examined. the media (newspapers and television) that reported our findings and the content of their coverage. Results: There were no new findings regarding suspected adverse effects of the COVID-19 vaccines. An article published on our website on June 18, 2021, received more than 9,000 page views with an average time spent of > 3 min. Four media outlets reported on our hospital’s articles from June to July 2021, when public interest in the first and second doses of the vaccine was high. Conclusion: The early release of the survey results has provided a source of information for people who want to obtain safety information regarding the adverse effects of the COVID-19 vaccine.

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A Pharmaceutics Evaluation for the Taking Medicine Support to the New Introduction Patient of PF Eye Drops and Use-Related Comparison

Harunori TAKESHITA ; Saki ADACHI ; Miki SHIMIZU ; Aya INO ; Takashi HATAE ; Misa TAJIMA ; Tsuneo HAMAGUCHI ; Chikako NUMATA

Japanese Journal of Drug Informatics.2024;26(1):36-44. doi:10.11256/jjdi.26.36

Objective: Eye drops may contain certain preservatives, and there is concern in patients who use them on a daily basis for the treatment of diseases, including corneal epithelial disorder and glaucoma. PF eye drops (Rohto Nitten Co., Ltd.) are used widely; however, their usability may be difficult in patients prescribed these medications for the first time. Therefore, fact-finding was performed on the usability of PF eye drops, particularly the difficulty in squeezing out these eye drops. Methods: The squeezing forces for various eye drops in 11 different shapes were determined. A sensuality evaluation examination on “the easiness of pushing out the eye drops” was performed in addition to a questionnaire survey targeting patients who used eye drops at a community pharmacy. Results: The squeezing forces ranged from 2.0 to 17.1 N. This study showed that the squeezing force tended to increase as the drop got closer to the opening of the container. Significant differences in the sensuality examination scores were found: 3.09 points for Santen Pharmaceutical Co., Ltd.; 3.07 points for Senju Pharmaceutical Co., Ltd.; 2.47 points for Sawai Pharmaceutical Co., Ltd.; and 1.37 points for PF eye drops for any place other than Santen and Senju (p<0.001). Conclusion: When eye drops were prescribed for an elderly individual, the pharmacist considered it necessary to suggest an alternative agent to the doctor depending on body function. In addition, it is important to explain to the patient that an additional squeezing force is required to push out the drop as it gets closer to the opening of the container.

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A Study on Continuous Risk Management Plan Utilization after Drug Approval:

Yuki KOBAYASHI ; Rieko SAITO ; Seiko MIYAZAKI

Japanese Journal of Drug Informatics.2024;26(1):45-50. doi:10.11256/jjdi.26.45

Objective: In Japan, pharmaceutical manufacturers have been required to develop a Risk Management Plan (RMP) since April 2013. Publication of the RMP is expected to enable the wide content-sharing of post-marketing risk management and its utilization among medical professionals to further enhance and strengthen post-marketing safety measures. In this study, we examined what points should be focused on for continuous utilization of RMPs after drug approvals by investigating the numbers of safety concerns addition of antineoplastic and immunomodulating agents, and where safety concerns added after approval are listed in package inserts. Furthermore, we investigated the reasons why these safety concerns were considered as such. Methods: Antineoplastics and immunomodulating agents, which account for more than half of all drugs containing new active ingredients approved in recent years, among drugs containing new active ingredients approved from fiscal year (FY) 2013 to FY 2019 were included in the study. The safety concerns (excluding important missing information) in RMPs as of April 1, 2021 for the subject drugs were compared with those at the time of approval. Safety concerns added after approval were investigated where they were listed in package inserts as of April 1, 2021. Furthermore, risks that were added as important potential risks were investigated as to why they were considered as such. Results: There were 117 risks added after approval. Those added to the important identified risks were listed in one of the sections of the package insert, whereas 11 risks were added to the important potential risks that could not be confirmed in the package inserts. Some important potential risks added after approval are suspected to have a causal relationship with the drug, but were not listed in the package inserts. Conclusion: It is important to utilize RMPs continuously to further understand risks of taking the drug.

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Questionnaire Survey on Human Resources and Operational Conditions Associated with Drug Information (DI) Services in Medical Institutions

Takeshi UCHIKURA ; Takamasa SAKAI ; Noriko SAKAKIBARA ; Atsushi DAIKOH ; Masahiro OHBA ; Eriko SUGAYA ; Sumire SUZUKI ; Miho OHTAKE ; Susumu WAKABAYASHI

Japanese Journal of Drug Informatics.2024;26(1):8-18. doi:10.11256/jjdi.26.8

Objective: The purpose of this survey is to identify the individuals responsible for providing drug information (DI) services in medical institutions across the nation and understand their work conditions. Method: This survey was conducted across medical institutions nationwide, each with at least 200 general hospital beds. The survey focused on personnel in charge of DI services at medical institutions. Results: Responses were collected from 181 facilities, representing a response rate of 13.7%. The median number of full-time equivalent DI personnel at each facility was 1.2 (ranging from 0.2 to 7 (n = 180)). Among the respondents, 90 (49.7%) individuals learned their DI responsibilities from their predecessors, 81 (44.8%) individuals learned through participation in academic societies (excluding the Japanese Society for Drug Information), and 61 (33.7%) individuals gained their knowledge from academic journals, with these methods listed in their order of prevalence. The most sought-after knowledge and skills for DI personnel included the knowledge of adverse drug reaction reporting system (134 (74.0%)), basic PC skills (130 (71.8%)), knowledge of medical fees (128 (70.7%)), and expertise in disease treatment methods (125 (69.1%)). Results and Conclusion: The findings of the survey revealed that several medical institutions with 200 or more beds have only one or two individuals in charge of DI duties. Apart from their core role in drug information, the DI staff members are expected to possess extensive knowledge concerning medical fees and related matters. However, they predominantly rely on their skills for DI operations. The tasks identified in the survey are tasks that are presently being performed by DI personnel at medical institutions. This underscores the pressing need for immediate attention to be given to acquiring the essential knowledge and education required for these tasks.

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Trends and issues of intellectual property for digital medicine

Hiroshi KATO

Japanese Journal of Drug Informatics.2024;26(1):N1_1-N5. doi:10.11256/jjdi.26.N1_1

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A Questionnaire Survey on the Effects of the Shift from Paper-Based to Electronic Package Inserts for Prescription Drugs

Omata AKINORI ; Shinya SUZUKI ; Takuro OKADA ; Emiko IGUCHI ; Ryohkan FUNAKOSHI

Japanese Journal of Drug Informatics.2024;25(4):171-181. doi:10.11256/jjdi.25.171

Objective: We surveyed community pharmacists and hospital pharmacists on the usefulness of electronic package inserts since they replaced paper-based package insert information for prescription drugs.Methods: We conducted a questionnaire survey with 1,258 community pharmacists and 126 hospital pharmacists on how they search for package insert information, handle data revisions, use paper or electronic media, and their opinions on work efficiency.Results: Questionnaire responses were obtained from 178 community pharmacists (response rate: 14.1%) and 82 hospital pharmacists (response rate: 65.1%). Among respondents, 98.9% and 98.8% of community and hospital pharmacists used personal computers connected to the internet, and 30.9% and 56.1% of community and hospital pharmacists used personal digital assistants. As for package insert medium, 79.2% and 61.8% of community pharmacists used paper and electronic media for package inserts while 50.0% and 98.8% of hospital pharmacists used paper and electronic media. To nine of ten questions about work efficiency, more than half of the hospital pharmacists reported that efficiency increased with electronic package inserts. More than half of community and hospital pharmacists reported that revision made to electronic data were more quickly reflected in practice.Conclusion: The survey revealed that community pharmacists prefer paper-based package inserts, while hospital pharmacists prefer electronic package inserts to check package insert information. The results also showed that using electronic package inserts was perceived to improve work efficiency. Furthermore, personal digital assistants will become important in promoting electronic package inserts.

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Selection and Evaluation of Core Journals Based on Bradford’s Law

Hisashi IIJIMA ; Yumeka WASHIO

Japanese Journal of Drug Informatics.2024;25(4):182-188. doi:10.11256/jjdi.25.182

Objective: Exhaustive search is the basis for meta-analysis and evidence based medicine (EBM). The validity of searches can be confirmed by evaluating the core journals included in the search results. Core journals also exert significant influence because they serve as the hub of each discipline. However, the qualitative relationship between core journals and published articles has not been fully evaluated; therefore, core journals were selected for clinical articles on respiratory infectious diseases and were evaluated for their quality.Methods: We searched PubMed for clinical articles in three areas: drugs for respiratory infections, drug resistance, and vaccines. The core journals were selected based on Bradford’s Law. The quality of the selected articles was further assessed using the double-blind and randomized controlled trial (RCT) methods.Results: The Bradford curve that was created displayed a high R2 accuracy of 0.9971, 0.9981, and 0.9953 at the linear portion. Evaluation of the research quality of selected core journals revealed a statistically high quality in the field of respiratory infections and vaccines; however, no statistically significant difference was observed in the field of resistant bacteria.Conclusion: With exceptions in some areas, the quality of publications tended to be higher when core journals were selected based on Bradford’s Law. Different evaluation methods are required for fields unsuitable for randomization or blinding. In the future, it will be vital to consider evaluation methods for core journals according to the characteristics of the studies.

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Survey on the Actual Work of Registered Sales Clerks of Pharmaceuticals and Their Awareness of Changes in the Pharmaceutical Sales System

Koji NARUI ; Yuta OKI ; Yuji GOTO ; Shintaro BESSHOH ; Eric M. SKIER

Japanese Journal of Drug Informatics.2024;25(4):189-194. doi:10.11256/jjdi.25.189

Objective: The “One-half Rule” for OTC drug sales has been eliminated, and furthermore, “Remote-controlled sales” of OTC medicines by qualified sellers is under discussion. The number of registered sales clerks is greater than the number of pharmacists selling OTC drugs. Although this is a result of the different employment status of pharmacists and registered sales clerks due to their salary structure and role in the store, it can be said that registered sales clerks are the main people to deal with the general public when they purchase OTC drugs. Therefore, we conducted a survey of registered sales clerks in order to understand their actual work and their awareness of the revision of the system, and to estimate the impact on customers and patients.Methods: The questionnaire was administered at an external training session held by the Tokyo Metropolitan Druggist Association from April 16 to 18, 2022.Results: Valid responses were obtained from 319 participants. Responses were obtained for the ratio of work as a registered sales clerk before becoming a qualified, after qualification (present), and what they think would be an ideal work ratio. The percentage of “pharmaceutical consultation and sales” increased from 7.7 to 15.9, and finally 26.4% before, at present, and ideally, respectively. It was clear that the acquisition of the certification increased the percentage of specialized tasks and that the respondents would like to further increase this percentage. Awareness of the “One-half Rule” and “Remote-controlled sales” was 43.6 and 23.8%, respectively.Conclusion: It was inferred that the introduction of “Remote-controlled sales” would improve convenience but dilute interpersonal work, which would hinder the operation, maintenance, and management of the store, including courteous customer service that cannot be handled through a screen. Therefore, from this study, we believe that registered sales clerks express doubt about the introduction of “Remote-controlled sales”.

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