Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku
Online ISSN : 1882-790X
Print ISSN : 1342-0445
ISSN-L : 1342-0445
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Showing 1-12 articles out of 12 articles from the selected issue
Joint statement to consolidate the pharmacovigilance systems for securing safety of the COVID-19 vaccine products
Original Article
  • Daisuke ABE, Mari SAITO OBA, Yoshitaka MURAKAMI, Shinji HISATAKE, Tak ...
    Type: research-article
    2021 Volume 26 Issue 1 Pages 5-13
    Published: June 20, 2021
    Released: July 26, 2021
    [Advance publication] Released: December 15, 2020
    JOURNALS FREE ACCESS

    Objective:The number of heart failure (HF) patients is increasing in Japan as its population continues to age, but little is known about current medication strategies. We investigated the relationship between medication changes during hospitalization and the readmission rate among older Japanese patients with new-onset HF.

    Design:Retrospective cohort study.

    Methods:We analyzed medical record data from Toho University Medical Center Omori Hospital between March 2004 and April 2018. Initial admissions for new-onset HF in patients aged≥75 years were examined (n=329). The class Ⅰ recommended medications stipulated in the JCS 2017/JHFS 2017 guidelines were used as the target medications for this study. Patients with dose titrations or additions of the target medications during hospitalization (dose titrations or additions group) were compared with patients without these changes (the other group). The primary outcome was readmission due to HF within one year of discharge. A hazard ratio, adjusted for potential confounders, was estimated using a Cox proportional hazards model.

    Results:There were 231 patients in dose titrations or additions group and 98 patients in the other group.

    The one-year readmission rate was 26.5% in dose titrations or additions group and 31.8% in the other group. The adjusted hazard ratio of medication changes for readmission was 0.82 (95% confidence interval, 0.51-1.33, P=0.415), but was not statistically significant.

    Conclusion:The older HF patients in dose titrations or additions group showed a reduced risk of readmission, but lacked significance due to low statistical power.

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  • Hideyuki MIYAUCHI, Takuji KOMEDA, Masakazu FUJIWARA Ph.D., Takamichi B ...
    Type: research-article
    2021 Volume 26 Issue 1 Pages 15-26
    Published: June 20, 2021
    Released: July 26, 2021
    [Advance publication] Released: February 03, 2021
    JOURNALS FREE ACCESS

    Aim/Objective:Baloxavir marboxil (baloxavir) is an anti-influenza drug with a novel mechanism of action. The objective of this study is to compare the frequency of hospitalization and death in outpatients treated by baloxavir with other anti-influenza drugs, neuraminidase inhibitors.

    Study design:Cohort study

    Method:Using a Japanese acute hospital-based claims database, we identified outpatients with age≥1 years old who had the starting date of influenza medical care (Day 1) during the 2018-2019 influenza season. According to the anti-influenza drug prescribed on Day 1, the patients were divided into baloxavir group and three controls; oseltamivir group, zanamivir group, and laninamivir group. We calculated the proportion of hospitalization which occurred during Day 2 to Day 14 and estimated odds ratio (OR) and 95% confidence intervals (CIs) by adjusting imbalanced age among drugs. In addition, we calculated the proportion of in-hospital death.

    Results:The proportion of hospitalization in patients with baloxavir (1.37% (223/16,309)) was comparable with that in oseltamivir (1.37% (655/47,843)), and slightly greater than that in zanamivir (0.77% (19/2,474)) and laninamivir (0.91% (234/25,831)). Age-adjusted OR (vs baloxavir, as denominator) and 95% CIs was 1.125[0.961-1.317], 1.173[0.726-1.897]and 0.944[0.783-1.140]for oseltamivir, zanamivir and laninamivir, respectively. In addition, the proportion of death in patients with baloxavir (0.03%, n=5) was comparable with that in oseltamivir (0.03%, n=16), laninamivir (0.01%, n=3), while there were no deaths in zanamivir due to the small number of patients.

    Conclusion:In an observational study of Japanese acute hospital-based claims database, the frequency of severe events in influenza outpatients was comparable with that in other treatment groups, supporting that baloxavir may help prevent severe influenza as a new treatment option.

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  • Takuma KOINUMA, Manabu AKAZAWA
    Type: research-article
    2021 Volume 26 Issue 1 Pages 27-40
    Published: June 20, 2021
    Released: July 26, 2021
    [Advance publication] Released: February 03, 2021
    JOURNALS FREE ACCESS

    Objective:In epidemiological studies, changes in patient conditions caused by treatment would be chronologically repeated. Thus, the manner of representing this change can create time-dependent bias which researchers should address. In this study, we aimed to validate the estimators obtained using various epidemiological methods based on the infection risk between the administration of methotrexate (MTX) alone and MTX combined biologicals.

    Design:Cohort study

    Methods:We extracted data regarding 3769 rheumatoid arthritis (RA) patients, consisting of 2805 patients with MTX alone and 964 patients with MTX combined biologicals from the claims data from JMDC Inc.. We represented each time course using the time axis of the elapsed time, the prescription number, and the administration time to make the corresponding data set. Subsequently, we performed time-conditional propensity score (PS) matching for matched points in each time axis. We also performed Inverse Probability Weighting Estimator (IPW) and Augmented Inverse Probability Weighting Estimator (AIPW) analyses.

    Results:The Odds Ratios (OR) estimated by each method using the time axis of the elapsed time, the prescription number, and the administration time were 1.48 (95%CI 0.71-3.11), 1.60 (95%CI 0.72-3.55), and 1.04 (95%CI 0.58-1.86), respectively. We performed PS weighting, of each Average Treatment Effect obtained from IPW, and the AIPW were estimated to be 0.31% (95%CI −0.91-1.53) and 0.29% (95%CI −0.91-1.49), respectively, and the average treatment effect on the treated was estimated to be 0.10% (95%CI −1.11-1.32). We support the findings of a previous study which showed that the combination of biologicals was not statistically associated with increased infection risk.

    Conclusion:This study suggests that estimators from different perspectives might be obtained by using some epidemiological methods. Therefore, our results could contribute to the establishment of an improved methodology.

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Review Article
  • Shinichi MATSUDA, Nobuyuki FUKADA, Masahito OISHI, Hiroaki OKA, Ryou ...
    Type: review-article
    2021 Volume 26 Issue 1 Pages 41-54
    Published: June 20, 2021
    Released: July 26, 2021
    [Advance publication] Released: March 18, 2021
    JOURNALS FREE ACCESS

    Real-world data (RWD), such as a health insurance claim database and electronic medical record database, which records daily medical care information, is one of the most important data sources in pharmacoepidemiological studies. In Japan, a post-marketing database study has been added as a new category of post-marketing surveillance since April 2018. It is expected that the post-marketing database studies will be conducted in the actual risk management plan; however, at this point, few have reached the stage of publishing study results. On the other hand, overseas, many database research results using RWD have already been reported. Although it is necessary to keep in mind that there are differences in the characteristics of the databases (e.g., data contents, structures) and the differences in the medical environment between overseas and Japan, we think that critically reviewing these reports has a reference value for the planning, execution, and interpretation of the results in performing post-marketing database studies in Japan. The purpose of this report is to examine the characteristics and cautions of the database studies through a critical review of published articles of overseas RWD studies and to make recommendations that are useful for conducting post-marketing database studies in Japan. We hope this article will become a help in the planning and implementation of future post-marketing database studies.

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Special Issue on “COVID-19 from the View of the Experts in Different Fields”
  • Kyoko MURAKAMI
    Type: other
    2021 Volume 26 Issue 1 Pages 55
    Published: June 20, 2021
    Released: July 26, 2021
    JOURNALS FREE ACCESS
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  • Ataru IGARASHI
    Type: editorial
    2021 Volume 26 Issue 1 Pages 56-62
    Published: June 20, 2021
    Released: July 26, 2021
    JOURNALS FREE ACCESS

    “Appropriate/Rational allocation for limited healthcare resources”, which was the fundamental concept of the health economics, had not been widely accepted/disseminated for the general public in Japan. Although vast majority agreed with the existence of healthcare budget constraint, it had not been widely recognized that “physical” healthcare resources, such as healthcare professional and/or healthcare facilities, were also limited and restricted, until current COVID-19 ERA.

    The HTA (Health Technology Assessment) concept could be used for COVID-19 related resource allocation issues, such as prioritization of the vaccination. Kohli et al. conducted cost-utility analysis of various treatment strategy for the hypothetical vaccine in the US setting. They proved that vaccination for elderly and stuffs for health care/long term care facilities were cost-effective (dominant and USD 20,000/QALY, respectively), while we need to take into account relatively low incidence rate of COVID-19 in Japan.

    However, current framework of the HTA with narrower perspective, could not capture entire value of the preventive intervention against COVID-19. Appleby et al. argued that broader perspective, under which external impacts, outside of healthcare area, would be incorporated, would be needed for appropriate decision making.

    Faced with COVID-19 pandemic, importance of re-defining (or expanding) the value of intervention would be widely recognized and further conceptual research should be warranted.

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  • Ichiro WADA
    Type: editorial
    2021 Volume 26 Issue 1 Pages 63-70
    Published: June 20, 2021
    Released: July 26, 2021
    JOURNALS FREE ACCESS

    Novel coronavirus infection(COVID-19)is having a significant impact on diverse areas of society. We investigated the features of Japan's policies from the perspective of analogies used in social welfare policy and policy science. The results revealed that Japan's statistics do not represent reality; the government is unable to respond with world-class policies; the system is maintained through excessive workloads in the workplace; local governments adopt different directions to national policy; non-experts are confusing society; and other areas are affected due to the inability to implement concentrated investment and support. If we apply these findings to the current COVID-19 response, there are problems including statistical issues, an inability to respond with world-class policies, confusion of policy objectives and means of implementation, increased public opinion guidance that disregards human life, and the inability to adopt optimal measures due to a lack of resources, which worsened the situation and affected other areas. Therefore, it is presumed that insufficient care and compensation to individuals adversely affected by the social effects of COVID-19 would delay economic and social recovery. Accordingly, as a future response, we will present policies including establishment of a crisis management organization, accumulation of experience, and implementation of suitable statistical information to deal with infectious diseases that exceed a certain disaster level. We also recommend that preparations be implemented during normal times, rather than waiting until a crisis has occurred, and a system for finding and supporting people who have suffered due to these events should also be considered. All these issues can be resolved by politics. In other words, all of Japan's problems can be said to converge on the political arena; hence, it is predicted that the current society that excessively burdens its citizens will persist for a long time unless suitable policies are implemented through the political process.

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  • Yasuko AITOKU
    Type: editorial
    2021 Volume 26 Issue 1 Pages 71-78
    Published: June 20, 2021
    Released: July 26, 2021
    JOURNALS FREE ACCESS

    The COVID-19 pandemic has had a major impact on all citizens, industries, governments, and academia, and has provided an opportunity to consider the intrinsic value of various resources and activities. The pharmaceutical industries are making a concerted effort to prevent and treat against COVID-19 with rapid research and development to address the emerging need for vaccines and therapeutic drugs for infectious diseases. In terms of HTA, previous guidelines for evaluating the value of vaccines and therapeutics have focused on cost-effectiveness, but the experience of the pandemic has led to the need to consider factors other than cost and utility, which are quantitative evaluations. With the pandemic experience, values that should be considered in addition to the quantitative evaluation of cost and utility were discussed in terms of previously published papers and industry perspectives.

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  • Masayuki IMAGAWA
    Type: editorial
    2021 Volume 26 Issue 1 Pages 79-89
    Published: June 20, 2021
    Released: July 26, 2021
    JOURNALS FREE ACCESS

    Cases of Pneumonia of unknown etiology detected in Wuhan City, China, at the end of 2019, was diagnosed as pneumonia caused by a new-type coronavirus (SARS-CoV-2) in a subsequent study and was named COVID-19. The infection epidemic expanded to the whole world in a moment, and the number of infected cases exceeded 90 million, and the number of deaths exceeded 2 million as of January, 2021. While Humans are in an unprecedented crisis since plague and the Spanish cold, and are trying to end COVID-19 pandemic by accelerating the development of vaccines and therapeutics at an unprecedented speed, there has been a movement toward reluctance to get vaccinated called Vaccine Hesitancy, and the hurdle to acquire herd immunity may be heightened by delayed vaccine rollout. For the future, it is also an important issue to establish a system that allows the vaccine industries to develop and produce vaccines in Japan without relying solely on imported vaccines when emerging or re-emerging infectious diseases spread in Japan. This article provides recommendations for solutions against these issues from the perspective of the vaccine industry and the private sector.

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  • Wataru SUGIURA
    Type: editorial
    2021 Volume 26 Issue 1 Pages 91-97
    Published: June 20, 2021
    Released: July 26, 2021
    JOURNALS FREE ACCESS

    The development of therapeutic agents is important for controlling emerging infectious diseases. However, looking back into our experiences for the last three decades, there were no effective treatments at the beginning of the pandemics.

    Generally, the first step to develop therapeutic agents for emerging infectious diseases is to search for already existing agents that might have therapeutic effects, and so did with COVID-19. Many candidates have been examined with hopes of success for the past year. Up to now, only two agents, remdesivir and dexamethasone, which were anti-viral and anti-inflammatory agents, respectively, were approved as therapeutic agents.

    The two drugs are approved based on the results of clinical trials performed overseas and not in Japan. Though many other candidate drugs have been proposed and clinical trials have been carried out in Japan, few studies have reached clear conclusions. The reasons for these ineffective study-progress are not clear, but it appears that high hurdles may exist for doctors to participate in RCTs, probably due to the lack of human resources that can be invested in implementing RCTs. Based on the lessons learned from this pandemic, to proceed RTCs effectively, a new organization with the role of a command tower to manage and support RCTs is eagerly awaited.

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