Journal of Pharmaceutical Health Care and Sciences最新文献

Background: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) represent life-threatening mucocutaneous reactions, predominantly triggered by medications. This case report presents a rare instance of SJS-TEN overlap in a young Indian female precipitated by the combined use of fluoroquinolone (ofloxacin), cephalosporin (cefixime), and paracetamol-an uncommon drug triad not widely reported in existing literature. The case highlights the importance of early diagnosis, thorough drug history evaluation, and the challenges of managing polypharmacy-induced severe cutaneous adverse reactions (SCARs).

Case presentation: A 29-year-old Indian female developed widespread dusky purpuric plaques, mucosal erosions (oral, genital, conjunctival, nasal), and bullae six days after local consultation with ofloxacin, cefixime, paracetamol, and other symptomatic agents. She presented to the emergency department with painful vesiculobullous eruptions involving > 10% body surface area, mucosal ulcerations, eye involvement with crusting, and systemic symptoms including fever, vomiting, and urinary discomfort. Laboratory investigations revealed anemia, elevated RDW, and positive ketones in urine. Diagnosis of SJS-TEN overlap was made clinically. The patient was managed with a multi-disciplinary approach involving systemic corticosteroids (IV dexamethasone), hydration, antibiotics (azithromycin), antihistamines, electrolyte balance, topical agents, ophthalmic care, and pain management. The extensive yet individualized treatment regimen reflected a robust pharmacovigilance response to avoid further drug-induced complications. Improvement was noted with complete re-epithelialization and symptomatic resolution over two weeks.

Conclusion: This case highlights the necessity for clinicians to maintain high suspicion for SCARs in patients presenting with mucocutaneous symptoms and recent drug exposure-even with commonly used medications not frequently associated with SJS-TEN. The unique presentation involving synchronous ocular, nasal, oral, and genital erosions alongside use of a rare drug combination strengthens the need for early recognition, comprehensive clinical assessment, and cautious prescription practices. Individualized treatment and close monitoring are crucial in preventing mortality and minimizing complications. This case underscores the importance of pharmacovigilance and personalized care in managing drug-induced hypersensitivity reactions, especially in resource-limited or polypharmacy scenarios.

Background: Falls are a serious concern for hospitalized patients, as they can lead to a decline in quality of life (QOL) and increased nursing care needs. Chemotherapy-induced peripheral neuropathy (CIPN) increases the risk of falls; however, only a few reports have investigated CIPN in conjunction with other factors. This study aimed to identify risk factors for falls in hospitalized patients undergoing chemotherapy.

Methods: We retrospectively analyzed 21,717 hospitalized patients, including 443 who received chemotherapy, at Matsuyama Shimin Hospital between April 2016 and March 2023. Multivariate logistic regression analysis was performed to assess the fall risk in hospitalized patients who received chemotherapy.

Results: Among 21,717 hospitalized patients, 930 (4.3%) experienced at least one fall. Multivariate logistic regression identified 13 factors, including age, sex, BMI, and mobility assistance. Notably, chemotherapy showed the highest odds ratio among these factors (OR 3.40, 95% CI 2.49-4.65). In the chemotherapy subgroup (n = 443), multivariate analysis identified five factors (body mass index (BMI); decline in judgment, comprehension, and memory; treatment with hypoglycemic drugs; treatment with high-risk CIPN drugs; and lung cancer). The fall rate was significantly higher in patients who received both hypoglycemic drugs and high-risk CIPN drugs (37.5%, 6/16) than in those who received either factor alone (14.1%, 27/192; p < 0.05).

Conclusions: Chemotherapy was identified as an independent risk factor for falls. Among patients receiving chemotherapy, both hypoglycemic drugs and high-risk CIPN drugs were associated with an increased risk of falls, and the fall rate was significantly higher in those treated with both drugs. Therefore, these patients should be carefully monitored for fall risk.

Background: The clinical implementation of prediction models can face important barriers, particularly regarding user-friendliness and interpretability for healthcare professionals. We recently developed and externally validated a risk prediction model for denosumab-induced hypocalcemia. The present study aimed to evaluate the model's utility and identify challenges for its clinical implementation through pilot testing conducted by hospital pharmacists.

Methods: A paper-format prediction model was distributed to pharmacists at Kameda General Hospital, Miyagi Cancer Center, and Gunma Prefectural Cancer Center. Participants trialed the model outside their routine workflow by applying it to data from patients scheduled to receive their first dose of denosumab. A subsequent questionnaire survey, available in paper and electronic formats, was conducted to gather feedback on the model's utility and limitations.

Results: A total of 49 responses were obtained, predominantly from pharmacists in their 20 s and 30 s with diverse professional responsibilities. The model was positively evaluated in terms of its clear target population, predicted outcome (47/49, 95.9%), and simple, straightforward nature (47/49, 95.9%). However, some participants provided neutral feedback on its ease of use (10/49, 20.4%). While its potential as an auxiliary tool for risk prediction was acknowledged, there were also some neutral views on its practical utility. One concern was the inconvenience of implementing a paper-format tool in clinical environments that primarily operate on electronic health records.

Conclusions: The paper-format prediction model was positively evaluated by frontline pharmacists, especially for its clear and straightforward nature. As anticipated, however, limitations such as manual data input and paper-based format were identified by some participants. Integration into electronic health records and broader clinical validation will be necessary to advance the clinical application of this prediction model and ensure real-world applicability.

Background: Patients with lung cancer are at increased risk for methicillin-resistant Staphylococcus aureus (MRSA) infection, which prolongs treatment and worsens prognosis. Therefore, preventing MRSA infection is critically important in this population. We aimed to investigate whether the incidence rate of MRSA among patients with lung cancer declined after the coronavirus disease (COVID-19) pandemic, owing to the widespread reinforcement of hand-rub use.

Methods: We conducted a nationwide, retrospective, interrupted time-series analysis using a claims database in Japan Medical Data Vision. Hospitalized patients diagnosed with lung cancer between December 2016 and August 2022 were followed for 6 months. MRSA was identified using International Classification of Diseases, 10th Revision, codes in combination with a same-month prescription for an anti-MRSA agent. The incidence rate of MRSA among patients with lung cancer was compared between the pre-COVID (December 2016-April 2020) and post-COVID (April 2020-August 2022) periods using segmented Poisson regression with Newey-West errors and seasonal adjustment.

Results: Among 93,508 eligible patients, 364 developed MRSA. The pre-COVID slope for the incidence rate of MRSA among patients with lung cancer was flat (0.20 per 1,000 person-years/year), whereas the post-COVID slope declined to -8.97 per 1,000 person-years/year. The slope difference (-9.17 per 1,000 person-years/year) indicates a sustained decline in the incidence rate of MRSA among this population after April 2020.

Conclusions: The incidence rate of MRSA among hospitalized patients with lung cancer decreased steadily after the COVID-19 pandemic. These findings suggest that routine hospital-wide infection control measures implemented during the pandemic may yield lasting benefits even in the absence of targeted interventions.

Background: The neutralizing monoclonal antibody combination of casirivimab and imdevimab (CAS + IMD) is the only therapy approved for preventing coronavirus disease 2019 (COVID-19) following exposure to severe acute respiratory syndrome coronavirus 2. However, the efficacy of CAS + IMD against Omicron variants remains uncertain, with in vitro studies indicating reduced neutralizing activity. This study aimed to evaluate the clinical efficacy of CAS + IMD in preventing COVID-19 among uninfected hospitalized contacts of patients with COVID-19.

Methods: A retrospective chart review was conducted on 154 inpatients exposed to patients with COVID-19 between October and December 2022. Fifty-two uninfected participants who were unvaccinated or immunosuppressed and had risk factors for severe COVID-19 were included. The primary endpoint was the COVID-19 incidence rate. Statistical analyses included the chi-square test, Fisher's exact test, and Mann-Whitney U test, as appropriate. Factors associated with COVID-19 incidence (p < 0.05) in univariate analysis were included in the multivariate logistic regression. Statistical significance was set at p < 0.05.

Results: Among the 52 participants, 14 and 38 were included in the CAS + IMD and non-CAS + IMD groups, respectively. The COVID-19 incidence rate was significantly lower in the CAS + IMD group than in the non-CAS + IMD group (14.3% vs. 52.6%, p = 0.013). Multivariate analysis identified CAS + IMD administration as significantly associated with reduced COVID-19 incidence (adjusted odds ratio [OR], 0.121; 95% confidence interval [CI], 0.020-0.710; p = 0.019), whereas long-term use of immunosuppressive therapy was associated with increased incidence (adjusted OR, 4.320; 95% CI, 1.090-17.126; p = 0.037).

Conclusions: CAS + IMD may be effective for post-exposure prophylaxis of COVID-19 during the Omicron BA.5 subvariant epidemic. However, prudent clinical use should consider the circulating variant profile. Further research is warranted to validate CAS + IMD's role in COVID-19 post-exposure prophylaxis.

Background: Resilience has recently attracted attention as a means of coping with challenging situations. Although there have been several studies on resilience among healthcare professionals, there are limited reports on resilience among pharmacists. In this study, we conducted a survey of resilience among clinical pharmacists and examined factors related to self-efficacy, burnout, and work.

Methods: Clinical pharmacists at 38 medical institutions were surveyed regarding basic attributes, work status, resilience, self-efficacy, and burnout using a web-based questionnaire. Descriptive statistics for each survey item were calculated, and exploratory factor analysis was conducted. The relationships between resilience scores and each factor were examined using Spearman's rank correlation coefficient (ρ), the Mann-Whitney U test, and the Kruskal-Wallis test. A multiple regression analysis was conducted using resilience scores as the objective variable and other factors as explanatory variables. The "Bidimensional Resilience Scale" was used to measure resilience.

Results: Responses were obtained from 285 participants, which confirmed the reliability of the psychological scale. Factor analysis extracted five new factor structures but confirmed that the two-dimensional structure was maintained. The correlations were significant for self-efficacy, burnout, and the percentages of research, teaching, and other work (RTOW). Multiple regression analysis suggested that "self-efficacy" was the factor most strongly associated with resilience (overall), innate resilience, and acquired resilience.

Conclusions: This study revealed the relationship between resilience, self-efficacy, and RTOW among clinical pharmacists in Japan. Criterion-related validity was also evidenced by high self-efficacy. RTOW being newly identified as an associated factor in this context provides insights for further development of the scale.

Background: Multiple myeloma is an incurable hematologic malignancy. Although novel treatments have improved outcomes, many patients continue to relapse and eventually develop treatment resistance. Elranatamab, a bispecific antibody, has demonstrated promising efficacy in patients with relapsed/refractory multiple myeloma. However, clinical experience with elranatamab remains limited, and its immunomodulatory effects may increase the risk of opportunistic infections and viral reactivation. Here, we describe hepatitis B virus (HBV) reactivation in a patient with resolved HBV infection who was treated with elranatamab.

Case presentation: A 76-year-old man with resolved HBV infection and treatment-resistant multiple myeloma received elranatamab. HBV DNA was not detected prior to treatment. On day 17 after initiation, an outpatient specimen returned as detectable but below the assay's lower limit of quantification (< 1.0 log10 IU/mL). Elranatamab was discontinued due to hypotension, and the patient was subsequently hospitalized one week later with pneumonia. On day 78 after initiation, HBV DNA increased to 3.6 log10 IU/mL with transaminase elevation; tenofovir alafenamide 25 mg once daily was started the same day, after which HBV DNA declined to below the lower limit of quantification.

Conclusions: Although elranatamab-specific information on HBV reactivation is limited, this case highlights a clinically relevant risk. Clinicians should remain vigilant for reactivation in patients receiving elranatamab, particularly those with resolved infection. Regular HBV DNA monitoring and prompt initiation of nucleos(t)ide analog therapy are essential to prevent severe complications, including fulminant hepatitis. Additionally, in the context of profound hypogammaglobulinemia during or after elranatamab, intravenous immunoglobulin may be considered to mitigate infection risk.

Background: Congenital cytomegalovirus (CMV) infection is a major cause of neonatal morbidity. However, optimizing ganciclovir (GCV) dosing in preterm infants is complicated by immature renal function and developmental pharmacokinetics. Population pharmacokinetic (PPK) parameters for GCV and valganciclovir (VGCV) have been reported, but data remain limited for extremely low birth weight infants. We aimed to characterize longitudinal changes in GCV clearance in a preterm infant with congenital CMV infection using Bayesian modeling.

Methods: GCV/VGCV were administered over a 15-week period, with concurrent therapeutic drug monitoring. Individual parameters were estimated using a previously published PPK model and a postnatal age-based maturation function in NONMEM. Scr clearance was measured at two time points using the 24-h urine collection method.

Results: GCV clearance increased from 0.048 to 0.273 L/hr/kg from postnatal day 30 to day 93, whereas VGCV bioavailability remained stable (~ 52-55%). Scr clearance values matched estimated GCV clearance, supporting the validity of the model. The maturation function indicated that tubular secretion likely contributes to accelerated drug elimination. Late-phase GCV clearance exceeded typical glomerular filtration rate, indicating possible catch-up in renal function.

Conclusion: Renal maturation should be considered in addition to body weight when adjusting GCV dosing in preterm infants. This case highlights the importance of aligning individualized dosing strategies with the developmental physiology of preterm neonates.