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AbstractObjective:The days of therapy (DOT) metric, used to estimate antimicrobial consumption, has some limitations. Days of antibiotic spectrum coverage (DASC), a novel metric, overcomes these limitations. We examined the difference between these 2 metrics of inpatient intravenous antimicrobial consumption in assessing antimicrobial stewardship efficacy and antimicrobial resistance using vector autoregressive (VAR) models with time-series analysis.Methods:Differences between DOT and DASC were investigated at a tertiary-care center over 8 years using VAR models with 3 variables in the following order: (1) the monthly proportion of prospective audit and feedback (PAF) acceptance as an index of antimicrobial stewardship efficacy; (2) monthly DOT and DASC adjusted by 1,000 days present as indices of antimicrobial consumption; and (3) the monthly incidence of 5 organisms as an index of antimicrobial resistance.Results:The Granger causality test, which evaluates whether incorporating lagged variables can help predict other variables, showed that PAF activity contributed to DOT and DASC, which, in turn, contributed to the incidence of drug-resistant P. aeruginosa. Notably, only DASC helped predict the incidence of drug-resistant Enterobacterales. Another VAR analysis demonstrated that a high proportion of PAF acceptance was accompanied by decreased DASC in a given month, whereas increased DASC was accompanied by an increased incidence of drug-resistant Enterobacterales, unlike with DOT.Conclusions:The VAR models of PAF activity, antimicrobial consumption, and antimicrobial resistance suggested that DASC may more accurately reflect the impact of PAF on antimicrobial consumption and be superior to DOT for predicting the incidence of drug-resistant Enterobacterales.

AbstractAimsTo estimate the cost of antiviral medication guidance and/or support from the perspective of healthcare professionals by administration route (oral or inhalant).MethodsAn online survey (December 2020) was conducted among physicians, pharmacists, and certified care workers. Those aged 20–64 years working in workplaces with experience of prescribing (physicians) or dispensing (pharmacists) antivirals for influenza, or having care service recipients who took antivirals (certified care workers) since October 2018, were selected through screening questions. The time required for guidance and/or support for drug administration was asked, and its monetary value was calculated by applying the Japanese average wage. Respondents who had a fear of infection while providing guidance and/or support were asked about the monetary value of this fear; the cost of fear was estimated from their responses and the percentage who reported such a fear.ResultsResponses were collected from 1,000 physicians, 1,000 pharmacists, and 642 certified care workers. The cost of the time for guidance and/or support in the entire workplace was estimated as JPY 244 (USD 2.14, as of October 2021) for oral antivirals and JPY 289 for inhalants among physicians, JPY 260 and JPY 428 among pharmacists, and JPY 555 and JPY 557 among certified care workers. The cost of fear was estimated to be JPY 965 for oral and JPY 1,361 for inhalants among physicians, JPY 756 and JPY 2,711 among pharmacists, and JPY 2,419 and JPY 2,837 among certified care workers.LimitationsRespondents might not be representative of Japanese society. The reliability of the results depends on whether the respondents accurately understood the questions and their truthfulness.ConclusionsHigher costs for guidance and/or support were suggested for inhalant antivirals in physicians and pharmacists compared to oral antivirals. For certified care workers, almost no difference in costs was suggested between administration routes.

Objective. To assess costs, effectiveness, and cost-effectiveness of inhaled corticosteroids (ICS) augmenting bronchodilator treatment for chronic obstructive pulmonary disease (COPD). Data Sources. Claims between 1997 and 2005 from a large managed care database. Study Design. Individual-level, fixed-effects regression models estimated the effects of initiating ICS on medical expenses and likelihood of severe exacerbation. Bootstrapping provided estimates of the incremental cost per severe exacerbation avoided. Data Extraction Methods. COPD patients aged 40 or older with [greater than or equal to] 15 months of continuous eligibility were identified. Monthly observations for 1 year before and up to 2 years following initiation of bronchodilators were constructed. Principal Findings. ICS treatment reduced monthly risk of severe exacerbation by 25 percent. Total costs with ICS increased for 16 months, but declined thereafter. ICS use was cost saving 46 percent of the time, with an incremental cost-effectiveness ratio of $2,973 per exacerbation avoided; for patients [greater than or equal to] 50 years old, ICS was cost saving 57 percent of time. Conclusions. ICS treatment reduces exacerbations, with an increase in total costs initially for the flail sample. Compared with younger patients with COPD, patients aged 50 or older have reduced costs and improved outcomes. The estimated cost per severe exacerbation avoided, however, may be high for either group because of uncertainty as reflected by the large standard errors of the parameter estimates. Key Words. Chronic obstructive pulmonary disease, managed care, administrative data, cost-effectiveness analysis, Chronic obstructive pulmonary disease (COPD) is characterized by progressive airflow limitation and airway inflammation leading to a gradual loss in lung function (Global Initiative for Chronic Obstructive Lung Disease [GOLD] [...]

ABSTRACTA national routine pneumococcal pneumonia immunization program started in Japan in 2014. It targeted the population aged ≥65 years and used a 23-valent pneumococcal polysaccharide vaccine; PPSV23. However, its effectiveness was not well defined because of the lack of a comprehensive database on the PPSV23 vaccination status of each subject. We used interrupted time-series analyses to assess the changes in the incidence and prognosis of elderly patients hospitalized for pneumonia before and after initiation of the program. First, we estimated the PPSV23 coverage rates in subjects aged ≥65 years based on the number of shipped PPSV23 syringes and the estimated population in each prefecture. The estimated coverage rates reached around 40% in 2014 for the 3 Tohoku prefectures, while those in the other prefectures remained below 20%. After the national routine immunization program started, the estimated coverage rate increased significantly in every prefecture and exceeded 40% in 2017. Next, we aggregated the data extracted from the Japanese Diagnosis Procedure Combination database from April 2011 through February 2017 for hospitalized pneumonia patients aged ≥65 years. The data included data from 655,746 patients, excluding those in the 3 Tohoku prefectures. Interrupted time-series analyses found no change in the incidence of hospitalized pneumonia patients and in-hospital mortality after the vaccination program, but there was a decrease in the in-hospital mortality of pneumonia patients with severe comorbidities defined by the modified Charlson comorbidity index. These results suggest an association between the vaccination program and an improved outcome in hospitalized elderly pneumonia patients with severe comorbidities in Japan.

A new rechargeable dual‐channel deep brain stimulation (DBS) system has been introduced for the treatment of Parkinson's disease and other movement disorders. However, the clinical value of the device, which has a high cost, remains unclear. We conducted a cost‐minimization analysis using a national database of health insurance claims in Japan. DBS‐related costs were compared between rechargeable and non‐rechargeable devices and estimated across a 20‐year period. Although the price of rechargeable DBS was higher than that of non‐rechargeable DBS, we observed total cost‐savings of 8.4 million yen across 20 years by considering costs related to implantation surgery, frequency of replacement, and risk of complications. In this study, real‐world evidence indicated that rechargeable dual‐channel DBS is a reasonable choice for saving total medical costs. Price revisions should consider cost‐effectiveness findings for medical devices.

Pneumococcal pneumonia is the most frequent form of pneumonia. We herein assessed the effectiveness of the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in the prevention of pneumonia overall in rheumatoid arthritis (RA) patients at risk for infections. We hypothesized that PPSV23 vaccination is superior in preventing pneumococcal pneumonia compared with placebo in RA patients. A prospective, multicenter, double-blinded, randomized, placebo-controlled (1:1) trial was conducted across departments of rheumatology in Japanese National Hospital Organization hospitals. RA patients (n= 900) who had been treated with biological or immunosuppressive agents were randomly assigned PPSV23 or placebo (sodium chloride). The primary endpoints were the incidences of all-cause pneumonia and pneumococcal pneumonia. The secondary endpoint was death from pneumococcal pneumonia, all-cause pneumonia, or other causes. Cox regression models were used to estimate the risk of pneumonia overall for the placebo group compared with the vaccine group. Seventeen (3.7%) of 464 patients in the vaccine group and 15 (3.4%) of 436 patients in the placebo group developed pneumonia. There was no difference in the rates of pneumonia between the two study groups. The overall rate of pneumonia was 21.8 per 1000 person-years for patients with RA. The presence of interstitial pneumonia (hazard ratio: 3.601, 95% confidence interval: 1.547–8.380) was associated with an increased risk of pneumonia in RA patients. PPSV23 does not prevent against pneumonia overall in RA patients at relative risk for infections. Our results also confirm that the presence of interstitial lung disease is associated with pneumonia in Japanese patients with RA. UMIN-CTR UMIN000009566. Registered 17 December 2012.

In rheumatoid arthritis (RA) patients receiving immunosuppressive treatments, vaccination against Streptococcus pneumoniaeis recommended. The objective of the study was to evaluate the effects of tacrolimus (TAC) on immune response following administration of a 23-valent pneumococcal polysaccharide vaccine (PPSV23) in patients with established RA. Patients with RA (n= 133) were vaccinated with PPSV23. Patients were classified into TAC (n= 29), methotrexate (MTX) (n= 55), control (n= 35), and TAC/MTX (n= 14) treatment groups. We measured the concentrations of pneumococcal serotypes 6B and 23F by using an enzyme-linked immunosorbent assay and determined antibody functionality by using a multiplexed opsonophagocytic killing assay, reported as the opsonization index (OI), before and 4 to 6 weeks after vaccination. A positive antibody response was defined as at least a twofold increase in the IgG concentration or as at least a 10-fold increase in the OI. IgG concentrations and OIs were significantly increased in all treatment groups after PPSV23 vaccination. The TAC treatment group appears to respond in a manner similar to that of the RA control group in terms of 6B and 23F serotype concentration and function. In contrast, the MTX group had the lowest immune response. Patients who received a combination of TAC and MTX (TAC/MTX) also had a diminished immune response compared with those who received TAC alone. TAC monotherapy does not appear to impair PPSV23 immunogenicity in patients with RA, whereas antibody production and function may be reduced when TAC is used with MTX. Thus, PPSV23 administration during ongoing TAC treatment should be encouraged for infection-prone TAC-treated patients with rheumatic diseases. University Hospital Medical Information Network Clinical Trials Registry: UMIN000009566. Registered 12 December 2012.

Patients with rheumatoid arthritis (RA) treated with abatacept (ABT) are at increased risk for vaccine-preventable infections. The aim of the present study is to evaluate the humoral response to 23-valent pneumococcal polysaccharide (PPSV23) vaccination in RA patients receiving ABT. The immunogenicity study was nested within a randomized, double-blind placebo-controlled study, designed to evaluate the efficacy of the PPSV23. PPSV23 was given to 111 RA patients, who were classified into three groups: RA control (n = 35), methotrexate (MTX) alone (n = 55), and ABT (n = 21). Before and 4–6 weeks after vaccination, we measured the patients’ concentrations of antibodies against pneumococcal serotypes 6B and 23F using an enzyme-linked immunosorbent assay and determined their antibody functionality using a multiplexed opsonophagocytic killing assay, reported as the opsonization index (OI). The pneumococcal serotype-specific IgG concentrations and OIs were both significantly increased in all treatment groups in response to PPSV23 vaccination. In the ABT group, the IgG responses for the 6B serotype were lower compared with those in the MTX alone or control groups, whereas the OI responses were similar to those in the other two groups. In a subgroup analysis, the pneumococcal serotype-specific IgG responses were significantly lower in both serotypes (6B and 23F) in the ABT/MTX group; however, the OI responses in the ABT group were not different from the control group. There was no association between the pneumococcal serotype-specific IgG and OI responses for the 6B serotype in patients receiving ABT in contrast to the control or MTX alone patients. No severe adverse effects were observed in any of the treatment groups. OI responses indicate antibody functionality rather than simply their amount, so the similarity of these measurements between all three groups suggests that RA patients receiving ABT still benefit from receiving the PPSV23 vaccination, even though they produce less IgG in response to it. The results suggest an influence of ABT on the humoral response to PPSV23 vaccination under MTX treatment; however, preserved opsonin responses are expected in RA patients treated with ABT plus MTX. University Hospital Medical Information Network Clinical Trials Registry: UMIN000009566. Registered 12 December 2012.

Pharmacy-based drug utilization reviews were conducted through the Brown Bag program to understand drug-use patterns, identify potential safety concerns, and provide appropriate consultation for elderly individuals.

The effect of SiOxmonolayer coverage on the rate of TiO2photocatalytic oxidation of cetylpyridinium bromide (CPB) in aqueous solutions has been studied. The rate of CPB removal from the solution (5