Journal of Pharmaceutical Health Care and Sciences最新文献

Background: People living with human immunodeficiency virus (PLWH) require high rates of medication adherence to antiretroviral therapy (ART) for a successful treatment outcome. Understanding the factors associated with incomplete adherence among those receiving integrase strand transfer inhibitor-containing single-tablet regimens (INSTI-STRs) is crucial for improving treatment outcomes. This study aimed to identify the factors contributing to incomplete ART adherence among Japanese PLWH receiving INSTI-STRs.

Methods: This multicenter cross-sectional study was conducted at 11 Japanese institutions as an anonymous survey. ART adherence was assessed using a self-reported questionnaire. We defined incomplete ART adherence as missing ≥ 1 dose of antiretroviral drugs (ARVs) over the past month. The factors associated with incomplete ART adherence were assessed using logistic regression analysis. Additionally, we investigated the associations between patients' satisfaction score with and need for ARVs and their adherence to ART.

Results: The final analysis included data of 387 patients who were treated with INSTI-STRs. Multivariate logistic regression demonstrated significant association of younger age (adjusted odds ratio [aOR], 0.79; 95%confidence interval [CI]: 0.64-0.99 for each 10-year increment) with incomplete ART adherence. Additionally, female sex (aOR, 3.98; 95%CI: 1.36-11.60); depressive symptoms (mild depression: aOR, 1.68; 95%CI: 1.001-2.82, moderate depression: aOR, 2.98; 95%CI: 1.35-6.53, and severe depression: aOR, 8.73; 95%CI: 1.38-55.00 vs. minimal depression); were also significantly associated with incomplete ART adherence when compared with the reference categories. Concomitant medication usage was significantly associated with a lower rate of incomplete ART adherence (1-4 medications: aOR, 0.53; 95%CI: 0.31-0.89 and ≥ 5 medications: aOR, 0.30; 95%CI: 0.13-0.70 vs. no concomitant medication usage). In the incomplete ART adherence group, satisfaction scores for various aspects were significantly lower. Furthermore, a lower proportion of patients in the incomplete ART adherence group preferred the option of "taking tablets daily and visiting the hospital every 3 months," compared to those in the complete ART adherence group (p = 0.008).

Conclusions: This study demonstrated that factors associated with incomplete ART adherence include younger age, female sex, no concomitant medication, and depressive symptoms. Despite ART simplification, incomplete adherence among PLWH receiving INSTI-STRs, remains a challenge, requiring additional actions.

Background: Ipilimumab (Ipi) plus nivolumab (Nivo) is the recommended first-line treatment for renal cell carcinoma (RCC). This report describes a case where pancreatic metastases disappeared after only two courses of Ipi + Nivo therapy. The primary tumor was cured by surgery, and a pathological Complete Response (pCR) was observed despite multiple serious immune-related Adverse Events (irAEs).

Case presentation: A 54-year-old woman with RCC and pancreatic metastasis at stage IV, diagnosed with intermediate risk according to the International Metastatic RCC Database Consortium classification, underwent initiation of Ipi + Nivo therapy. On day 26, she developed hyperthyroidism accompanied by tachycardia, leading to the commencement of metoprolol tartrate treatment. Following the resolution of tachycardia, a second course of Ipi + Nivo therapy was administered on day 50. By day 70, the patient exhibited Grade 3 hepatic dysfunction, followed by the onset of hypothyroidism on day 75, necessitating treatment with steroids and levothyroxine. After positive treatment, a Grade 3 skin disorder emerged on day 87 while tapering steroids, prompting treatment with methylprednisolone (mPSL) pulse therapy. The skin disorder responded to steroids, allowing for tapering. However, on day 113, a recurrence of Grade 3 skin disorder occurred, necessitating another mPSL pulse. The patient responded well to treatment, exhibiting improvement in her condition. On day 131, she presented at the hospital with complaints of respiratory distress, prompting a Computed Tomography (CT) scan that revealed interstitial pneumonia. By day 272, subsequent CT imaging showed the disappearance of pancreatic metastasis and shrinkage of the primary tumor. On day 294, she underwent a laparoscopic left nephrectomy. Pathological analysis confirmed a pCR in the primary tumor, indicating successful eradication of RCC through surgical intervention.

Conclusions: This case report presents a scenario where multiple severe irAEs appeared in a patient, yet metastases disappeared after only two courses of Ipi + Nivo therapy. The patient was ultimately cured by surgery and achieved a pCR. This case highlights that despite the occurrence of severe irAEs during RCC treatment with Ipi + Nivo therapy, they can be managed appropriately to maximize the therapeutic effects of checkpoint inhibitors.

Background: COMISA is a common disorder that results in nighttime awakenings ,daytime sleepiness and PAP intolerance. Cognitive behavioral therapy for insomnia is used to improve PAP adherence and no medication has been evaluated in such population yet. Melatonin with its chronobiotic and antioxidant effects may have potential benefits on COMISA consequences at the appropriate dose and time. This study aimed to evaluate the effect of melatonin on sleep quality, daytime sleepiness and PAP Compliance in patients with COMISA.

Methods: This double-blind placebo trial randomly assigned eligible OSA patients who suffered from insomnia despite using PAP for over a month to receive either melatonin 10 mg or placebo. The primary outcomes were measured by changes in the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire (FOSQ-10) over one month. Adherence to PAP was measured by the results of the PAP device reports on the average length of time and number of nights that the device was used.

Results: Thirty patients were enrolled in the study after randomization. The melatonin arm showed significant improvement in all four primary outcomes compared to the placebo arm. The PSQI score was 3.836±1.839 in the melatonin arm versus 10.522±3.626 in the placebo arm (Pvalue<0.001). The ISI score was 8.476±3.568 in the melatonin arm versus 14.47±4.50 in the placebo arm (Pvalue<0.001). The ESS score was 6.854±4.334 in the melatonin arm versus 13.298±5.119 in the placebo arm (Pvalue<0.001). The FOSQ-10 score was 24.93±5.02 in the melatonin arm versus 19.87±4.24 in the placebo arm (Pvalue= 0.006). Additionally, nighttime consequences such as sleep latency and awakenings showed significant improvement in the melatonin arm. PAP devices results revealed improvement in duration of PAP use overnight.  CONCLUSIONS: Administering melatonin has been shown to improve self-reported sleep quality and PAP adherence in patients with COMISA.

Trial registration: Registration number IRCT20220105053635N1 was issued by the Iranian Registry of Clinical Trials (IRCT).

Background: Pimobendan reportedly improves the subjective symptoms of heart failure. However, evidence of improved prognosis is lacking. This study aimed to determine whether reinforcing guideline-directed medical therapy (GDMT) improved rehospitalization rates for worsening heart failure in patients administered pimobendan.

Methods: A total of 175 patients with heart failure who were urgently admitted to our hospital for worsening heart failure and who received pimobendan between January 2015 and February 2022 were included. Of the 175 patients, 44 were excluded because of in-hospital death at the time of pimobendan induction. The remaining 131 patients were divided into two groups, the reduced ejection fraction (rEF) (n = 93) and non-rEF (n = 38) groups, and further divided into the GDMT-reinforced and non-reinforced groups.

Results: In patients with rEF, the rate of rehospitalization for heart failure was significantly lower in the GDMT-reinforced group than in the non-reinforced group (log-rank test, P = .04). However, the same trend was not observed in the non-rEF group.

Conclusions: Reinforcing GDMT may reduce the heart failure rehospitalization rate in patients with pimobendan administration and rEF. However, multicenter collaborative research is needed.

Trial registration: IRB Approval by the Nippon Medical School Hospital Ethics Committee B-2021-433 (April 10, 2023).

Coronary heart disease, also known as ischemic heart disease, is induced by atherosclerosis, which is initiated by subendothelial retention of lipoproteins. Plasma lipoproteins, including high density lipoprotein, low density lipoprotein (LDL), very low density lipoprotein, and chylomicron, are composed of a surface monolayer containing phospholipids and cholesterol and a hydrophobic core containing triglycerides and cholesteryl esters. Phospholipids play a crucial role in the binding of apolipoproteins and enzymes to lipoprotein surfaces, thereby regulating lipoprotein metabolism. High LDL-cholesterol is a well-known risk factor for coronary heart disease, and statins reduce the risk of coronary heart disease by lowering LDL-cholesterol levels. In contrast, the relationships of phospholipids in plasma lipoproteins with coronary heart disease have not yet been established. To further clarify the physiological and pathological roles of phospholipids, we have developed the simple high-throughput assays for quantifying all major phospholipid classes, namely phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, phosphatidic acid, phosphatidylinositol, phosphatidylglycerol + cardiolipin, and sphingomyelin, using combinations of specific enzymes and a fluorogenic probe. These enzymatic fluorometric assays will be helpful in elucidating the associations between phospholipid classes in plasma lipoproteins and coronary heart disease and in identifying phospholipid biomarkers. This review describes recent progress in the identification of phospholipid biomarkers of coronary heart disease.

Background: Fruits and vegetables are abundant in alkali precursors and effectively reduce the Potential Renal Acid Load (PRAL) from diet. Oral alkali supplements are supposed to exert comparable alkalizing effects on the human body, and have been shown to beneficially affect bone and kidney health. A comparative analysis of the available dietary alkali supplements in Germany was performed, contrasting their potential PRAL-lowering potential.

Methods: We reviewed the currently available dietary citrate-based alkali supplements sold in Germany with a special focus on their mineral content, their PRAL-lowering potential and other characteristics inherent to each product. Supplements containing either potassium-, calcium- or magnesium citrate or any combination of these organic salts were reviewed. The total alkali load (TAL) was calculated based on the recommended daily dosage (RDD).

Results: Sixteen supplements with a mean alkali powder content of 220.69 ± 111.02 g were identified. The mean magnesium content per RDD was 239.93 ± 109.16 mg. The mean potassium and median calcium content were 550 ± 325.58 mg and 280 (240) mg, respectively. Median TAL was 1220 (328.75) mg. The PRAL-lowering potential from a single RDD ranged from - 51.65 mEq to -8.32 mEq. Substantial price differences were found, and the mean price of the examined supplements was 16.67 ± 5.77 Euros. The median price for a 1 mEq PRAL-reduction was 3.01 (3.14) cents, and ranged from 0.77 cents to 10.82 cents.

Conclusions: Noticeable differences between the identified alkali supplements were encountered, warranting an individual and context-specific approach in daily clinical practice.

Background: Pharmacists should be aware of their thought processes in dispensing work, including differences in the dispensing complexities owing to different drug positions in the left, center, and right areas. Dispensing errors associated with "same-name drugs (a pair of drugs with the same name but a different ingredient quantity)" are prevalent and often negatively affect patients. In this study, using five pairs of comparative models, the gaze movements of pharmacists in dispensing work were analyzed using an eye-tracking method to elucidate their thought processes.

Methods: We prepared verification slides and displayed them on a prescription monitor and three drug rack monitors. The dispensing information (drug name, drug usage, location display, and total amount) was displayed on a prescription monitor. A total of 180 drugs including five target drugs were displayed on the three drug rack monitors. Total gaze points in the prescription area, those in the drug rack area, total vertical movements between the two areas, and time required to dispense drugs were measured as the four classifications Gaze 1, Gaze 2, Passage, and Time, respectively. First, we defined the two types of location displays as "numeral combination" and "color/symbol combination." Next, we defined two pairs of models A₁-A₂ (numerals) and B₁-B₂ (color/symbol) to compare differences between the left and right areas. Moreover, three pairs of models C₁-C₂ (left), D₁-D₂ (center), and E₁-E₂ (right) were established to compare differences between "numeral combination" and "color/symbol combination."

Results: Significant differences in the complexities of dispensing work were observed in Gaze 2, Passage, and Time between the models A₁-A₂ (A₁2), in Gaze 2 between the models B₁-B₂ (B₁>B₂), and in Gaze 2 and Time between the models C₁-C₂, D₁-D₂, and E₁-E₂ (C₁>C₂, D₁>D₂, and E₁>E₂, respectively).

Conclusions: Using the current dispensing rules, pharmacists are not good at dispensing drugs located in the right area. An effective measure for reducing the dispensing complexity is to introduce visual information in the prescription content; the utilization of the right brain facilitates reducing the complexity in the right dispensing area.

Background: The relationship between plasma tenofovir (TFV) concentration at the beginning of tenofovir disoproxil fumarate (TDF) administration and the development of renal dysfunction during long-term administration of TDF has not been demonstrated yet. The objective of the present study was to determine whether plasma TFV trough concentrations during early TDF administration could serve as an indicator of renal dysfunction when TDF is administered for long periods.

Methods: We included 149 HIV-1 infected Japanese patients who were prescribed TDF. We investigated the relationship between plasma TFV trough concentrations and the rate of discontinuation due to the development of renal dysfunction for up to five years after the start of TDF administration. We also examined how the decrease in renal function over time due to TDF administration was related to factors associated with high TFV levels and plasma TFV trough concentrations.

Results: The median TFV trough concentration in the TDF discontinuation group was 88 ng/mL, which was significantly higher (p = 0.0041), than that in the continuation group (72 ng/mL). Further, using an ROC curve, the cut-off value for TFV trough concentration at which TDF discontinuation was significantly high was found to be 98 ng/mL. Logistic multivariate analysis of factors associated with discontinuation of TDF due to renal function-related adverse events showed that being ≥ 50 years old (OR = 2.96; 95% CI, 1.01-8.64), having eGFR < 80 mL/min/1.73m² at the start of TDF administration (OR = 5.51; 95% CI, 1.83-17.5), and TFV trough concentration ≥ 98 ng/mL (OR = 2.96; 95% CI, 1.16-7.60) were independent factors.

Conclusions: The results suggested that the importance of measuring TFV concentrations to evaluate the risk of developing renal function-related adverse events during long-term TDF administration.

Background: Medication errors related to the pre-admission medication history obtained on admission are a major cause of medication error during hospitalization. Medication reconciliation (MR) improves patient safety through the detection of inadvertent medication discrepancies at transitions of care. The aim of this study was to evaluate the effect of MR by pharmacists for patients prior to hospital admission on the incidence of medication errors in the early post-admission period.

Patients and methods: Patients admitted to the orthopedic ward for surgery between April 2012 and March 2020 were included. Pharmacist-led MR for pre-admission patients was started on April 1, 2017. The incidence of medication errors related to pre-admission medications that occurred during hospitalization were compared between the pre- and post-initiation of pharmacist-led MR (pre-initiation: April 1, 2012 to March 31, 2015, post-initiation: April 1, 2017 to March 31, 2020).

Result: In the post-initiation group, 94.2% (1245/1321) of patients who were taking medications on admission had a pharmacist-led MR before admission. The proportion of patients whose physicians ordered the prescription of their pre-admission medications at the time before hospitalization to continue from admission was significantly higher in the post-initiation group than in the pre-initiation group (47.4% vs. 1.0%, p < 0.001). The incidence of medication errors related to pre-admission medications during hospitalization was significantly lower in the post-initiation group than in the pre-initiation group (1.83% vs. 0.85%, p = 0.025). Pharmacist-led MR prior to admission was a significant protective factor against incidents related to pre-admission medication (odds ratio (OR), 0.3810; 95% confidence interval (CI); 0.156-0.9320, p = 0.035).

Conclusion: Pharmacist-led MR for patients prior to hospital admission led to a reduction in medication errors related to pre-admission medications during hospitalization. Patient safety during hospitalization can be improved by accurate medication histories provided early by pharmacists.

Background: Human resource management may become complex for community pharmacists owing to recent changes in work volume and content. Few studies have examined job satisfaction, well-being, and quality of work life (QWL) among community pharmacists in Japan. This study focused on QWL, a more comprehensive concept than job satisfaction, and aimed to develop the QWL questionnaire for Japanese community pharmacists (the QWLQ for JCP) and assess its reliability and validity.

Methods: A questionnaire survey was conducted among 2027 pharmacists who worked in pharmacies with the cooperation of 20 corporations running pharmacies. Collected data were subjected to principal component factor analysis with Promax rotation via SPSS Windows version 28.

Results: The factor analysis used data from 1966 pharmacists. In total, five significant components, which formed the basis of the QWLQ for JCP, were identified. These included "Influence of work on mind and body," "Relationships with colleagues," "Relationship with the boss," "Meaning of existence in the workplace," and "Pride in work." Cronbach's alpha, which expressed reliability, ranged from 0.585 to 0.854 for all the subscales.

Conclusion: The QWLQ for the JCP significantly explained the concept of QWL, which indicated that its validity was sufficient.