Objective: The purpose of this study was to clarify the importance of therapeutic drug monitoring (TDM) at acute care hospitals using Diagnosis Procedure Combination (DPC) data.
Methods: We used DPC data from about 3,500,000 inpatients at about 950 acute care hospitals.  The investigation period was from July 2010 to December 2010.  Patients were divided into 2 groups: TDM intervention (n=22,012); and non-TDM intervention (n=26,400).  We compared the clinical indicators (length of hospital stay, payment based on performance and drug costs) and use of antimicrobials.
Results: TDM intervention was carried out in 45.5% patients for whom an anti-MRSA agent was prescribed.  The duration of anti-MRSA agent administration was significantly longer in the TDM intervention group than in the non-TDM intervention group.  The total daily cost of anti-MRSA agents was significantly lower in the TDM intervention group than in the non-TDM intervention group.
Conclusion: Our results suggest that TDM intervention is often performed for seriously ill patients who require continuous treatment.  TDM intervention may prevent adverse reactions as a result of adjusting the dosage of the anti-MRSA agent.

Idiopathic normal pressure hydrocephalus (iNPH) is a disorder observed in elderly patients causing gait disturbance, urinary incontinence and cognitive impairment. Due to the rapidly aging society, the number of patients with iNPH continues to increase yearly. However, iNPH is often overlooked because of its insidious and variable presentation. In the primary care setting, iNPH can be coincidentally discovered by neuroimaging findings, including disproportionately enlarged subarachnoid space hydrocephalus (DESH). We report two cases of iNPH in the elderly living alone that had different outcomes depending upon the availability of neurosurgery specialists. It is essential for primary care physicians to consult neurosurgeons without delay because prompt diagnosis and treatment can improve the patient's quality of life and prolong their duration of living at home.

Objective : Serum albumin is important marker in all aspects of stroke care including rehabilitation. We examined the serum albumin level of stroke patients, and investigated the relation between their serum albumin level and their prognosis. Methods : The serum albumin levels of 295 patients enrolled from 2008 to 2014 were sequentially checked in our hospital and in subsequent rehabilitation hospitals. Functional outcome was measured by functional independence measure (FIM) at the time of discharge from the rehabilitation hospital. Results : In all types (cerebral infarction, cerebral hemorrhage and subarachnoid hemorrhage (SAH)) of apoplexy, serum albumin levels were the highest at the time of admission, temporarily declined after admission, and almost recovered at the time of discharge. In SAH, the serum albumin levels deteriorated at a greater rate than in other types of stroke. In cerebral infarction and cerebral hemorrhage, the lowest serum albumin level was positively correlated with FIM at the time of discharge from the rehabilitation hospital (p<0.001). But, in SAH, there was no significant correlation between the lowest serum albumin level and FIM at the time of discharge (p=0.844). Conclusion : Our data suggest that serum albumin level is associated with the outcome of stroke patients, except for SAH patients. Serum albumin level should be one of the prognostic factors used in stroke patients, but we should consider that SAH patients are exceptional because of other neurological complications.

In Japan, drug therapy for schizophrenia is characterized by high-dose antipsychotic polypharmacy, which is an uncommon approach internationally. In this study, we reduced the number of antipsychotic agents in 5 patients using the Safety Correction of High-dose Antipsychotic Polypharmacy (SCAP) method and conducted a survey regarding treatment satisfaction. The switch from polypharmacy to monotherapy was achieved in all patients. There was no deterioration in psychiatric symptoms, and adverse reactions were reduced. Three of the subjects were satisfied with the decrease in the number of antipsychotic agents and dose-reduction. These results suggest that the SCAP method is a safe and useful method that can be applied in a clinical setting.

Objective: This pharmacovigilance study evaluated the profile of clozapine-related adverse events by region using the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: We categorized each case into five regions (America, Europe/West Asia, Oceania, Asia, and Africa) based on the reporting country information in the FAERS database. The number of clozapine-related adverse events reported in each region was aggregated according to the preferred term (PT) and the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ). Results: A total of 101,872 clozapine-related adverse events were registered in the FAERS database. In America and Europe, leukocyte or neutrophil count abnormalities accounted for half of the top 10 PTs by relative reporting rate.However, Asia had higher relative reporting rates of pyrexia and salivary hypersecretion (13.91% and 10.85%, respectively). Regarding the SMQ, the relative reporting rates of infective pneumonia, convulsions, extrapyramidal syndrome, gastrointestinal obstruction, and hyperglycaemiaew onset diabetes mellitus were higher in Asia than in other regions (5.26%, 9.72%, 12.65%, 5.13%, and 8.26%, respectively), with significant differences even after adjusting for confounding factors using multivariate logistic regression analysis. Conclusion Spontaneous reports of adverse events associated with clozapine show regional disparities, particularly in Asia, where concentration-dependent adverse events are more frequently reported. However, the spontaneous reporting system has several limitations, requiring further research for validation.

Objective: This pharmacovigilance study evaluated the profile of clozapine-related adverse events by region using the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: We categorized each case into five regions (America, Europe/West Asia, Oceania, Asia, and Africa) based on the reporting country information in the FAERS database. The number of clozapine-related adverse events reported in each region was aggregated according to the preferred term (PT) and the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ). Results: A total of 101,872 clozapine-related adverse events were registered in the FAERS database. In America and Europe, leukocyte or neutrophil count abnormalities accounted for half of the top 10 PTs by relative reporting rate.However, Asia had higher relative reporting rates of pyrexia and salivary hypersecretion (13.91% and 10.85%, respectively). Regarding the SMQ, the relative reporting rates of infective pneumonia, convulsions, extrapyramidal syndrome, gastrointestinal obstruction, and hyperglycaemiaew onset diabetes mellitus were higher in Asia than in other regions (5.26%, 9.72%, 12.65%, 5.13%, and 8.26%, respectively), with significant differences even after adjusting for confounding factors using multivariate logistic regression analysis. Conclusion Spontaneous reports of adverse events associated with clozapine show regional disparities, particularly in Asia, where concentration-dependent adverse events are more frequently reported. However, the spontaneous reporting system has several limitations, requiring further research for validation.

Objective: This pharmacovigilance study evaluated the profile of clozapine-related adverse events by region using the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: We categorized each case into five regions (America, Europe/West Asia, Oceania, Asia, and Africa) based on the reporting country information in the FAERS database. The number of clozapine-related adverse events reported in each region was aggregated according to the preferred term (PT) and the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ). Results: A total of 101,872 clozapine-related adverse events were registered in the FAERS database. In America and Europe, leukocyte or neutrophil count abnormalities accounted for half of the top 10 PTs by relative reporting rate.However, Asia had higher relative reporting rates of pyrexia and salivary hypersecretion (13.91% and 10.85%, respectively). Regarding the SMQ, the relative reporting rates of infective pneumonia, convulsions, extrapyramidal syndrome, gastrointestinal obstruction, and hyperglycaemiaew onset diabetes mellitus were higher in Asia than in other regions (5.26%, 9.72%, 12.65%, 5.13%, and 8.26%, respectively), with significant differences even after adjusting for confounding factors using multivariate logistic regression analysis. Conclusion Spontaneous reports of adverse events associated with clozapine show regional disparities, particularly in Asia, where concentration-dependent adverse events are more frequently reported. However, the spontaneous reporting system has several limitations, requiring further research for validation.

Objective: This pharmacovigilance study evaluated the profile of clozapine-related adverse events by region using the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: We categorized each case into five regions (America, Europe/West Asia, Oceania, Asia, and Africa) based on the reporting country information in the FAERS database. The number of clozapine-related adverse events reported in each region was aggregated according to the preferred term (PT) and the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ). Results: A total of 101,872 clozapine-related adverse events were registered in the FAERS database. In America and Europe, leukocyte or neutrophil count abnormalities accounted for half of the top 10 PTs by relative reporting rate.However, Asia had higher relative reporting rates of pyrexia and salivary hypersecretion (13.91% and 10.85%, respectively). Regarding the SMQ, the relative reporting rates of infective pneumonia, convulsions, extrapyramidal syndrome, gastrointestinal obstruction, and hyperglycaemiaew onset diabetes mellitus were higher in Asia than in other regions (5.26%, 9.72%, 12.65%, 5.13%, and 8.26%, respectively), with significant differences even after adjusting for confounding factors using multivariate logistic regression analysis. Conclusion Spontaneous reports of adverse events associated with clozapine show regional disparities, particularly in Asia, where concentration-dependent adverse events are more frequently reported. However, the spontaneous reporting system has several limitations, requiring further research for validation.

OBJECTIVE: Suvorexant is a novel hypnotic drug that does not interact with the conventional γ-aminobutyric acid (GABA)-A receptor. We investigated the method by which suvorexant was introduced in insomnia patients who were taking benzodiazepine receptor agonists (BzRA). METHODS: This was a retrospective study. We extracted clinical data for patients who were prescribed suvorexant and were already using BzRA. The patients were assigned to two groups, the switching and add-on groups. We assessed the suvorexant discontinuation rate at one month after the prescription of the drug. RESULTS: One hundred and nineteen patients were assigned to the switching group, and 109 were assigned to the add-on group. The add-on group exhibited a significantly higher all-cause discontinuation rate than the switching group (odds ratio, 2.7; 95% confidence interval, 1.5 to 5.0; adjusted p < 0.001). Intolerability was a significantly stronger risk factor for suvorexant discontinuation in the add-on group (22.0% vs. 7.6%, p < 0.002), and the most common adverse effect was oversedation. CONCLUSION: Our results show that the add-on of suvorexant increases the frequency of oversedation compared with switching in insomnia patients that are taking BzRA. However, this was only a preliminary retrospective study, and further studies will be required to confirm our findings.
Benzodiazepines* ; Humans ; Methods ; Orexin Receptor Antagonists ; Prescriptions ; Receptors, GABA-A* ; Retrospective Studies* ; Risk Factors ; Sleep Initiation and Maintenance Disorders*

OBJECTIVE: The adverse effects of antipsychotic agents can have a marked influence on medication adherence. In this study, we investigated the adverse events of antipsychotics that are less likely to be reported by patients and the reasons why such symptoms remain latent. METHODS: Data were collected by interviewing patients using a subjective questionnaire, and the associations between unreported symptoms and background factors were investigated. RESULTS: A total of 306 patients with schizophrenia or schizoaffective disorder were examined. Their major symptoms were daytime sleepiness (50.0%), weight gain (42.2%), and sexual dysfunction (38.9%). Sexual dysfunction was nominal significantly more common among the patients that had been treated with antipsychotic agent polypharmacy (odds ratio [OR], 2.14; 95% confidence interval [CI], 1.07 to 4.30), and was nominal significantly more common among outpatients (OR, 1.78; 95% CI, 1.02 to 3.13). Only approximately 30% of the patients had reported their symptoms to their physicians. CONCLUSION: Patients receiving antipsychotic treatment tolerate some symptoms and do not feel able to report them to their physicians. The most common reason for this is an insufficient patient-physician relationship. Sexual dysfunction is especially hard to identify because it is a delicate problem, and our findings demonstrate that subjective questionnaires are helpful for detecting such symptoms.
Antipsychotic Agents ; Asian Continental Ancestry Group* ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Medication Adherence ; Outpatients ; Polypharmacy ; Psychotic Disorders ; Schizophrenia* ; Surveys and Questionnaires ; Weight Gain