Journal of Pharmaceutical Health Care and Sciences最新文献

{"title":"Factors associated with assertiveness among Japanese community pharmacists: a cross-sectional study.","authors":"Mitsuaki Ishii, Sachiko Ozone, Shoichi Masumoto, Tetsuhiro Maeno","doi":"10.1186/s40780-025-00410-z","DOIUrl":"10.1186/s40780-025-00410-z","url":null,"abstract":"<p><strong>Background: </strong>Community pharmacists play a crucial role in promoting medication safety within the community healthcare team. Effective communication by community pharmacists with other health professionals is essential to facilitate the sharing of patient healthcare information. In the context of information sharing between physicians and community pharmacists, assertive self-expression (defined as 'a style of openly expressing one's needs and feelings while respecting others') is beneficial. The aim of this study is to identify factors associated with assertive self-expression among community pharmacists.</p><p><strong>Methods: </strong>A cross-sectional study was conducted by surveying 3,446 Japanese community pharmacists working at pharmacies across 10 prefectures. Participants were invited to complete a survey form by email and assessed for assertive self-expression using the Interprofessional Assertiveness Scale. Characteristics of participants and pharmacies were compared using univariate analysis. A generalized linear model was used to explore the factors associated with assertive self-expression.</p><p><strong>Results: </strong>A total of 961 responses by community pharmacists were included in the analysis. Univariate analysis identified significant differences in assertive self-expression scores based on age, employment status, education, years of working experience as a pharmacist, pharmacist home visit service, and participation in joint regional workshops or conferences. After adjustment, participation in joint regional workshops or conferences was significantly associated with assertive self-expression (odds ratio, 1.037; 95% confidence interval, 1.005-1.070; p = 0.023).</p><p><strong>Conclusions: </strong>This study showed that assertive self-expression among community pharmacists was associated with participation in joint regional workshops and conferences. Further research is needed to examine whether enhancing assertive self-expression facilitates pharmacists' interprofessional communication skills and improves medication safety.</p>","PeriodicalId":16730,"journal":{"name":"Journal of Pharmaceutical Health Care and Sciences","volume":"11 1","pages":"4"},"PeriodicalIF":1.2,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11755941/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143028911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-drug interaction between ensitrelvir and tacrolimus in a patient undergoing treatment for COVID-19: a case report.","authors":"Yuki Miyata, Ryo Yamaguchi, Takehito Yamamoto, Toshiyuki Kishida, Kazuhiko Ikeuchi, Hiroaki Harada, Takeya Tsutsumi, Keishi Fujio, Tappei Takada","doi":"10.1186/s40780-025-00411-y","DOIUrl":"10.1186/s40780-025-00411-y","url":null,"abstract":"<p><strong>Background: </strong>Ensitrelvir is a novel SARS-CoV-2 3-chymotrypsin-like protease inhibitor, similar to nirmatrelvir/ritonavir. Several case reports have demonstrated the efficacy of 3-chymotrypsin-like protease inhibitors in treating prolonged coronavirus disease 2019 (COVID-19) in immunocompromised patients. Tacrolimus (TAC) is a widely used immunosuppressive agent whose blood level can increase significantly due to the inhibition of cytochrome P450 3A (CYP3A) and P-glycoprotein by nirmatrelvir/ritonavir. Since ensitrelvir also inhibits CYP3A and P-gp, similar elevations in TAC levels are expected. A prior case report observed an increase in TAC trough levels with concurrent administration of ensitrelvir. However, no studies have quantitatively described the changes in TAC blood levels and clearances before and after ensitrelvir administration when TAC administration was discontinued to mitigate the drug-drug interaction (DDI) risk; data on safe dosing protocols to avoid the DDI during co-administration of ensitrelvir and TAC remain lacking. Here, we report a case in which TAC levels were successfully managed in a patient with rheumatoid arthritis (RA) who received ensitrelvir for persistent COVID-19 by preemptive discontinuation of TAC and close monitoring of TAC blood levels following ensitrelvir administration.</p><p><strong>Case presentation: </strong>An 81-year-old Japanese woman who had been administered TAC (1.5 mg once daily) for RA received two courses of remdesivir for moderate COVID-19. However, her viral load remained high and her respiratory status deteriorated. Considering persistent COVID-19, we initiated combination therapy with remdesivir and ensitrelvir (day 0). TAC was discontinued, and the TAC blood levels decreased from 3.6 ng/mL to 1.1 ng/mL over five days. Subsequently, we re-administered TAC (0.2 mg), observing a level of 1.0 ng/mL by day 7. The TAC dose was adjusted to 1.0 mg daily, and TAC levels on day 12 and 14 were 6.5 and 3.7 ng/mL, respectively. TAC (1.5 mg daily) was resumed on day 15. The calculated t_1/2 of TAC were 33.7, 71.9, and 114.6 h from day -1 to 0, day 0 to 2, and day 2 to 5, respectively. The t_1/2 of TAC was extended to 3.4-fold its original duration under ensitrelvir treatment.</p><p><strong>Conclusions: </strong>This DDI extended the half-life of TAC by approximately 3.4-fold, an effect that gradually diminished over 7 to 10 days. When patients receiving TAC treatment start ensitrelvir therapy, a dose reduction of TAC by approximately one-third to one-fourth is considered appropriate.</p>","PeriodicalId":16730,"journal":{"name":"Journal of Pharmaceutical Health Care and Sciences","volume":"11 1","pages":"3"},"PeriodicalIF":1.2,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11756168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Availability, pricing, and affordability of antithrombotic medicines in Addis Ababa, Ethiopia: implications for health policy.","authors":"Selam Birhanu, Melaku Tileku Tamiru, Hanan Muzeyin Kedir, Tamrat Assefa Tadesse","doi":"10.1186/s40780-025-00408-7","DOIUrl":"10.1186/s40780-025-00408-7","url":null,"abstract":"<p><strong>Background: </strong>Antithrombotic medications are essential for the management of abnormal clot formation. However, their availability, pricing, and affordability in Ethiopia, particularly in Addis Ababa, have not been comprehensively studied.</p><p><strong>Methods: </strong>A cross-sectional study was conducted in Addis Ababa, Ethiopia to assess the availability, pricing, and affordability of essential antithrombotic medicines. This study utilized the World Health Organization (WHO) and International Health Action Organization methodology. Five public hospital outpatient pharmacies, four private hospitals, ten private pharmacies, four Kenema pharmacies, and two Red Cross pharmacies in Addis Ababa, Ethiopia, were included in the study. All essential antithrombotic medicines in the 6^th edition of Ethiopia's Essential Medicines List were included in this study. Data were collected for originator brands and the lowest-priced generic medicines available at each medicine outlet.</p><p><strong>Results: </strong>The availability of low-priced generic (LPG) antithrombotic medicines was 31%, with private hospitals having the highest availability (52%). Original-brand antithrombotic medicines were rarely available, averaging only 3%, with private pharmacies showing a slightly higher availability (10%). The median price of LPG antithrombotic medicines is higher in private settings. Original-brand (OB) antithrombotic medicines in private hospitals and pharmacies were unaffordable, costing between 256.14 and 3,418 days of wages.</p><p><strong>Conclusion: </strong>The availability of most antithrombotic medicines was low across all sectors compared with the WHO target. Private hospitals showed relatively higher availability of LPG medicines than other pharmacy outlets included in the study. There is a significant disparity between the availability and affordability of LPG and OB medicines. To address these issues, the national drug procurement and distribution systems must be strengthened. Exploring local production and financial assistance programs, implementing effective stock management, regulating medicine prices, promoting high-quality generic medicines, and conducting further research to understand the national landscape are all essential.</p>","PeriodicalId":16730,"journal":{"name":"Journal of Pharmaceutical Health Care and Sciences","volume":"11 1","pages":"2"},"PeriodicalIF":1.2,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11715389/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142950442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Comparison of facilities with and without additional medical fees for nutrition support team activity during the COVID-19 pandemic.","authors":"Akihiko Futamura, Takenao Koseki, Junichi Iida, Akito Suzuki, Nobuyuki Muroi, Michiaki Myotoku, Hiroki Maki, Kazuhisa Mizutani, Hikaru Ogino, Yasuki Taniguchi, Keiichiro Higashi, Masanobu Usui","doi":"10.1186/s40780-024-00407-0","DOIUrl":"10.1186/s40780-024-00407-0","url":null,"abstract":"","PeriodicalId":16730,"journal":{"name":"Journal of Pharmaceutical Health Care and Sciences","volume":"11 1","pages":"1"},"PeriodicalIF":1.2,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11715608/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142950363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of continuous subcutaneous hydromorphone hydrochloride and morphine hydrochloride injection on skin disorders incidence: a retrospective study.","authors":"Rei Tanaka, Takahiro Hashizume, Tadashi Hisanaga, Shinya Masuda, Junya Sato, Hiroshi Ishikawa, Hironori Tanaka, Akiyoshi Saitoh, Tetsumi Sato, Takeshi Kamoshida, Tetsu Sato, Michihiro Shino","doi":"10.1186/s40780-024-00401-6","DOIUrl":"10.1186/s40780-024-00401-6","url":null,"abstract":"<p><strong>Background: </strong>Continuous subcutaneous administration of injectable opioids is simple and effective; however, skin disorders may occur when high opioid dosages are used. Therefore, we investigated opioid injection drugs with a low risk of skin disorders.</p><p><strong>Methods: </strong>A retrospective study was conducted using the electronic medical records of patients prescribed 1% hydromorphone hydrochloride or 4% morphine hydrochloride with instructions for continuous subcutaneous administration at Shizuoka Cancer Center from January 2017 to December 2021. The primary endpoint was skin disorders incidence, and the two groups were compared using Cox proportional hazards model analyses and Fisher's exact test at 5% significance level. Patient background factors expected to influence skin disorders were also investigated, and multivariate logistic analysis of skin disorders incidence was performed.</p><p><strong>Results: </strong>The incidence of skin disorders in the hydromorphone hydrochloride and morphine hydrochloride groups were 3.7% (1/27 patients) and 28.1% (9/32 patients), respectively, showing a significant difference in two statistical analyses between the two groups (Cox proportional hazards model analyses HR: 0.09, 95% CI: 0.01-0.70, P = 0.022. Fisher's exact test OR: 0.10, 95% CI: 0.01-0.84, P = 0.016). In the multivariate analysis, the administration of hydromorphone hydrochloride (OR: 0.04, 95% CI: 0.003-0.48, P = 0.012) was also found to have a significant negative correlation with the occurrence of skin disorders. On the contrary, administration period ≥ 28 days (OR: 18.16, 95% CI: 2.22-148.60, P = 0.007) was a factor with a significant positive correlation.</p><p><strong>Conclusions: </strong>Subcutaneous 1% hydromorphone hydrochloride administration had a lower risk of skin disorders than 4% morphine hydrochloride injection. Moreover, prolonging the administration period increased the risk of developing skin disorders. This suggests that a 1% hydromorphone hydrochloride Injection is a good clinical decision for patients who are likely to have a longer administration period and require a higher dosage of injectable opioids.</p><p><strong>Trial registration: </strong>Retrospectively registered.</p>","PeriodicalId":16730,"journal":{"name":"Journal of Pharmaceutical Health Care and Sciences","volume":"10 1","pages":"82"},"PeriodicalIF":1.2,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11660583/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142864623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical characteristics of patients requiring emergency hospitalization due to immune-related adverse events: a retrospective study.","authors":"Tatsuki Ikeda, Satoru Nihei, Kazuki Saito, Junichi Asaka, Kenzo Kudo","doi":"10.1186/s40780-024-00400-7","DOIUrl":"10.1186/s40780-024-00400-7","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, offering hope for various malignancies by enhancing the immune response against tumors. However, ICIs are associated with unique immune-related adverse events (irAEs), which differ significantly from conventional chemotherapy-induced toxicities. These irAEs, which affect more than 70% of patients and often escalate to severe grades, present substantial clinical management challenges and frequently necessitate emergency hospitalization. Therefore, this study aimed to investigate the clinical characteristics of patients requiring emergency hospitalization due to irAEs during ICI therapy to enhance understanding and improve management strategies.</p><p><strong>Methods: </strong>This retrospective study evaluated patients who received ICIs at Iwate Medical University Hospital between August 1, 2016, and December 31, 2022, and required emergency hospitalization due to irAEs. Clinical data were extracted from the medical records, including patient demographics, presenting complaints, time from ICI initiation to hospitalization, irAE diagnoses, and treatment outcomes. The Spearman rank correlation coefficient was used to analyze the associations between the chief complaints and irAE diagnoses.</p><p><strong>Results: </strong>Of 1009 ICI-treated patients, 96 required emergency hospitalization for irAEs. The cohort's mean age was 73 years, with 75.0% of patients being male. Among patients who required emergency hospitalization, a high proportion were undergoing treatment for lung cancer (41.7%). The median hospitalization duration was 87 days. The chief complaints included dyspnea (34.4%) and fatigue (34.4%), with gastrointestinal and respiratory disorders being the most frequent irAEs (35.4%). Significant correlations were observed between dyspnea and respiratory diseases (Rs = 0.66), skin diseases and disorders (Rs = 0.81), pain and musculoskeletal disorders (Rs = 0.59), and diarrhea and gastrointestinal disorders (Rs = 0.49). Corticosteroids were administered to 64.6% of the patients. Despite emergency interventions, 8.3% of patients succumbed to irAEs, while 33.3% resumed ICI therapy after hospitalization.</p><p><strong>Conclusions: </strong>Emergency hospitalization due to irAEs is a considerable concern in ICI therapy, occurring in 9.5% of treated patients. The high incidence of severe irAEs within the first 3 months of treatment underscores the need for early and vigilant monitoring. This study highlights the importance of recognizing and promptly managing irAEs to improve patient outcomes. Future strategies should focus on developing comprehensive management frameworks and enhancing patient and caregiver education to recognize symptoms that warrant immediate medical attention.</p>","PeriodicalId":16730,"journal":{"name":"Journal of Pharmaceutical Health Care and Sciences","volume":"10 1","pages":"78"},"PeriodicalIF":1.2,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11653787/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142852983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of changes in skin properties due to diabetes mellitus on the titration period of transdermal fentanyl: single-center retrospective study and diabetic animal model study.","authors":"Satoshi Mizuno, Makiko Takabayashi, Hiroko Makihara, Kazuhiro Ogai, Kei Tsukui, Yuriko Ito, Takahiro Kawakami, Yusuke Hara, Arimi Fujita, Yoshihiro Tokudome, Tomoko Akase, Yukio Kato, Tsutomu Shimada, Yoshimichi Sai","doi":"10.1186/s40780-024-00402-5","DOIUrl":"10.1186/s40780-024-00402-5","url":null,"abstract":"<p><strong>Background: </strong>In the dose titration of transdermal fentanyl to prevent unrelieved pain, it is important to consider not only dose adjustment, but also the titration period, which is influenced by the time required to reach the steady state. Many patients with cancer pain experience comorbidities that might affect the skin properties and influence transdermal absorption. We hypothesized that skin changes due to diabetes mellitus (DM) would affect the titration period of transdermal fentanyl. We conducted a retrospective study and diabetic animal model study to test this hypothesis.</p><p><strong>Methods: </strong>In the retrospective study, the titration period was defined in terms of \"dose change\" and \"number of rescue opioids\" in patients initiated on transdermal fentanyl. Multiple logistic regression analysis was performed to analyze the relation between the titration period and comorbidities, including DM. In the diabetic animal model study, intercellular lipids of stratum corneum (SC) were analyzed in Goto-Kakizaki (GK) rats, a model of DM, and the pharmacokinetics of intravenously or transdermally administered fentanyl was examined.</p><p><strong>Results: </strong>In the retrospective study, the titration period ranged from 5 to 39 days (n = 387), and the patients taking a longer period (6 days or more) was significantly related to in patients with unspecified DM: AOR (95% confidence interval), 0.438 (0.217-0.884). In the diabetic animal model study, the ceramides (CERs) content in the SC was decreased by approximately 30% in GK rats compared to Wistar rats. The absorption rate constant (k_a) of fentanyl administered transdermally was increased approximately 1.4-fold in GK rats, though there was no difference in transdermal bioavailability (F) or systemic clearance (CL_tot).</p><p><strong>Conclusion: </strong>Our results suggest that the steady state of transdermally administered fentanyl is reached sooner in cancer patients with DM as a comorbidity. Earlier pain assessment and dose adjustment may be possible in these patients.</p>","PeriodicalId":16730,"journal":{"name":"Journal of Pharmaceutical Health Care and Sciences","volume":"10 1","pages":"80"},"PeriodicalIF":1.2,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11653581/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacist intervention and identification of adverse events related to treatment efficacy in cancer chemotherapy to improve clinical outcomes.","authors":"Hironori Fujii","doi":"10.1186/s40780-024-00403-4","DOIUrl":"10.1186/s40780-024-00403-4","url":null,"abstract":"<p><p>Adverse events (AEs) induced by cancer chemotherapy reduce not only patient quality of life (QOL) but also the efficacy of treatment. Management of AEs can therefore improve both the efficacy and safety of cancer chemotherapy. This review describes the contribution of pharmacists to the management of adverse events aimed at improving the treatment efficacy of cancer chemotherapy. Efforts to improve the evidence-practice gap are a useful approach to countermeasures against AEs. Pharmacists can intervene in these efforts in the course of their daily practice. Here, we made undertook to improve the evidence-practice gap in prophylaxis pharmacotherapy for chemotherapy-induced nausea and vomiting (CINV) and anti-EGFR antibody-induced acneiform rash. After intervention by pharmacists, the rate of adherence to prophylaxis pharmacotherapy for these AEs was significantly improved, and the incidence of CINV and acneiform rash was significantly decreased. Notably, time to treatment failure (TTF) with anti-EGFR antibody therapy tended to be increased, and may have contributed to an improvement in therapeutic effect. Next, we examined adverse events associated with anti-cancer drugs related to the therapeutic effect of cancer chemotherapy. Incidence of hypomagnesemia in patients receiving anti-EGFR antibodies and neutropenia in patients receiving TAS-102 was significantly associated with the therapeutic effect of cancer chemotherapy. Moreover, we examined the impact of cancer cachexia, a cancer-associated AE, on the therapeutic effect of immune checkpoint inhibitors. In patients receiving nivolumab, the presence of cancer cachexia prior to treatment initiation was associated with shorter OS and TTF. In summary, pharmacist management of AEs was shown to improve treatment response. Further, AEs which are predictive of treatment response in cancer chemotherapy were identified. Management of these AEs is an important role for pharmacists aiming to improve patient QOL and treatment efficacy.</p>","PeriodicalId":16730,"journal":{"name":"Journal of Pharmaceutical Health Care and Sciences","volume":"10 1","pages":"81"},"PeriodicalIF":1.2,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11658043/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of talimogene laherparepvec: a real-world retrospective pharmacovigilance study based on FDA Adverse Event Reporting System (FAERS).","authors":"Yifan Hong, Kebin Cheng, Han Qu, Yuting Wang, Yuanyuan Wang, Guorong Fan, Zhenghua Wu","doi":"10.1186/s40780-024-00388-0","DOIUrl":"10.1186/s40780-024-00388-0","url":null,"abstract":"<p><strong>Background: </strong>Oncolytic virus therapy is a rapidly evolving emerging approach for the medical management of cancer. Talimogene laherparepvec (T-VEC) is the first and only Food and Drug Administration (FDA)-approved oncolytic virus therapy. Considering that exactly how T-VEC works is not known, there is a strong need for a comprehensive pharmacovigilance study to identify safety signals of potential risks with T-VEC.</p><p><strong>Objective: </strong>The objective of this study was to assess the risk of adverse events (AEs) related to T-VEC.</p><p><strong>Methods: </strong>We implemented a pharmacovigilance study utilizing individual case safety reports (ICSRs) reported to the FDA Adverse Event Reporting System (FAERS) database dated from 2004 quarter 1 to 2023 quarter 3. In this study, we used two algorithms, reporting odds ratio (ROR) and information component (IC), to assess the risk of AEs related to T-VEC.</p><p><strong>Results: </strong>A total of 1138 ICSRs of patients who received the T-VEC and reported to the FDA dated from 2004 quarter 1 to 2023 quarter 3 were available. A total of seven system organ classes (SOCs) demonstrated statistically significant signals, i.e. General disorders and administration site conditions, Injury, poisoning and procedural complication, Infections and infestations, Neoplasms benign, malignant and unspecified, Skin and subcutaneous tissue disorders, Hepatobiliary disorders, and Endocrine disorders. From the preferred term level perspective, the most reported AEs in T-VEC-treated patients were pyrexia, illness, influenza, influenza-like illness, and chills. Unexpected significant AEs were detected, such as sepsis, encephalitis, syncope, and lymphadenopathy.</p><p><strong>Conclusions: </strong>Most AEs in T-VEC-treated patients have been previously mentioned in the prescriptive information or documented in other clinical trials. But safety signals were also be detected in 4 unexpected AEs (sepsis, encephalitis, syncope, and lymphadenopathy). Further clinical trials need to be undertaken to facilitate a more comprehensive comprehension of the safety profile of T-VEC.</p>","PeriodicalId":16730,"journal":{"name":"Journal of Pharmaceutical Health Care and Sciences","volume":"10 1","pages":"79"},"PeriodicalIF":1.2,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11654148/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142854057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of pharmacist-led aminoglycoside stewardship: a 10-year observational study.","authors":"Yasutaka Shinoda, Kengo Ohashi, Tomoko Matsuoka, Kaori Arai, Nao Hotta, Eiseki Usami","doi":"10.1186/s40780-024-00399-x","DOIUrl":"10.1186/s40780-024-00399-x","url":null,"abstract":"<p><strong>Background: </strong>Aminoglycosides are crucial for treating multidrug-resistant gram-negative infections and endocarditis. However, aminoglycosides are associated with significant risks of nephrotoxicity, necessitating careful dose selection and therapeutic drug monitoring. Therapeutic drug monitoring is essential for minimizing risk; however, few institutions routinely perform it. This study aimed to assess the impact of a pharmacist-driven therapeutic drug monitoring intervention on aminoglycoside usage trends and clinical outcomes.</p><p><strong>Methods: </strong>This retrospective cohort study included 263 patients treated with aminoglycosides between 2014 and 2023. A pharmacist-led therapeutic drug monitoring intervention began in 2017, focusing on monitoring renal function, documenting patient weight, and closely managing aminoglycoside concentrations. Trends in aminoglycoside use and renal outcomes were analyzed.</p><p><strong>Results: </strong>Over the study period, appropriate use of aminoglycosides at the time of initial prescription increased from 49 to 82% (P < 0.01). Pharmacist dosing design at initial prescription increased significantly from 21% pre-intervention to 60% post-intervention (P < 0.01). The proportion of pharmacist intervention in initial dosing design increased over time. The proportion of patients with measured aminoglycoside blood concentrations significantly increased from 53% pre-intervention to 72% post-intervention (P < 0.01). The proportion of patients who were able to manage target blood concentrations from the initial aminoglycoside dose without dose adjustments increased from 31% pre-intervention to 42% post-intervention, although the results were not significantly different (P = 0.07). The incidence rate of renal impairment remained similar (11% vs. 12%; P = 0.85), although the annual average number of cases decreased from 4.3 before the intervention to 2.5 after. Similarly, there were no significant differences in clinical efficacy before and after the intervention (65% vs. 71%; P = 0.35). Furthermore, aminoglycoside stewardship led to a 56% cost saving.</p><p><strong>Conclusions: </strong>Pharmacist-led aminoglycoside stewardship significantly improved the appropriate use of aminoglycosides and decreased the associated costs. Thus, pharmacist involvement is essential for the proper use of aminoglycosides. However, many patients required aminoglycoside dose reductions despite the pharmacist's guideline-based dosing design. Therefore, further accumulation of information on the management of aminoglycoside blood concentration may be necessary for the revision of these guidelines.</p>","PeriodicalId":16730,"journal":{"name":"Journal of Pharmaceutical Health Care and Sciences","volume":"10 1","pages":"77"},"PeriodicalIF":1.2,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11605850/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}