著者

酒井 隆全

出版者

一般社団法人 日本薬剤疫学会

雑誌

薬剤疫学 (ISSN:13420445)

巻号頁・発行日

vol.25, no.2, pp.64-73, 2020-10-25 (Released:2020-11-30)

参考文献数

25

被引用文献数

1

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自発報告は市販後の医薬品安全性監視において重要な情報源である.日本では 2012 年に Japanese Adverse Drug Event Report database (JADER) が公開されており,以来,データマイニング手法を用いた数多くの学会発表,論文投稿が行われている.自発報告は,一般的に過少報告,分母情報の欠如,報告バイアスの影響など種々の限界点を有しており,これらは JADER にも当てはまる.また,JADER では主に重篤な症例が集積されていることや,依頼に基づく報告も含まれていることなど,自発報告が収集されている制度的背景も影響をもたらす.統計学的に検出されたシグナルは必ずしも医薬品と有害事象に因果関係があることを意味するものではなく,検出されたシグナルには慎重な解釈が必要となる.しかしながら,留意すべき限界点について考えずに用いられているという指摘の声があがっている.企業の医薬品安全性監視活動におけるシグナルの取扱いについては,EU における Guideline on Good Pharmacovigilance Practices (GVP) Module Ⅸ,米国における Guidance for Industry - Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment などが参考となる資料として存在している.一方,研究者が自発報告データベースを利用して得られた科学的知見を報告する際に向けたガイダンスなどはほとんど整備されていない.そこで,我々は主に JADER を用いて研究発表を行う研究者の視点から,一般社団法人 日本医薬品情報学会 平成29年度課題研究班において「JADER を用いたデータマイニング (主に不均衡分析によるシグナル検出) の研究発表の際に留意すべきチェックリスト」を作成した.本稿では,このチェックリストの項目について,チェックリスト作成にあたり参考とした “CIOMS Working Group Ⅷ報告 ファーマコビジランスにおけるシグナル検出の実践” を参照しつつ概説する.

著者

酒井 隆全 和田 侑輝人 古閑 晃 田辺 公一 後藤 伸之 大津 史子

出版者

一般社団法人 日本医薬品情報学会

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.22, no.1, pp.7-16, 2020-05-29 (Released:2020-06-13)

参考文献数

16

被引用文献数

1

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Objective: The purpose of this study was to create a checklist that summarizes checkpoints that should be noted when using the Japanese Adverse Drug Event Report database (JADER). After we created the checklist, we then used it to survey published academic papers that used JADER.Method: First, we created a draft checklist for research that uses JADER by citing the report of CIOMS working group VIII “Practical Aspects of Signal Detection in Pharmacovigilance”. Then, we conducted a pilot test and revised the draft checklist. Finally, the checklist was completed after the review by a pharmacoepidemiology expert. The checklist was applied to published academic papers that used JADER, and the fulfill rate of each checkpoints was calculated.Results: A “checklist of important points to be noted during research that uses the data mining method in JADER (mainly signal detection by disproportionality analysis)” was created. We also revealed problems with published academic papers that used JADER. For example, some researchers were thought to be inappropriately using JADER as a source of their research while others used an inappropriate version of MedDRA.Conclusion: The checklist created in this study summarizes key points that could be noted in research that uses JADER and is thought to contribute to an improvement in quality of research that uses JADER. Additionally, in our investigation of published academic papers that used JADER, we found the possibility that both the role of signal detection and the impact on analysis of JADER using the updated MedDRA version are not well understood.

著者

森 千与 酒井 隆全 矢野 玲子 田辺 公一 後藤 伸之 大津 史子

出版者

一般社団法人日本医薬品情報学会

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.18, no.4, pp.261-269, 2017-02-28 (Released:2017-03-17)

参考文献数

24

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Purpose: The purpose of this study is to elucidate the characteristics of adverse events in pregnant women, the offending drugs, and patient backgrounds from reports of adverse events.  We performed a case series study.Methods: We used CARPIS, a database of adverse events and toxication reported in Japan spanning from 1987 to 2014 and created by the Drug Information Center, Meijo University.  We extracted cases of adverse events in pregnant women, their fetuses, and newborns and investigated the age, primary disease, and history of allergies of the women and the intended use of/offending drugs, therapeutic category, and names for adverse events.Result: We collected 434 cases of adverse events in pregnant women, and 251 pediatric cases with adverse events.  The most frequent offending drug in both groups was ritodrine hydrochloride.  The most frequent adverse event in pregnant women was pulmonary oedema due to the administration of ritodrine hydrochloride.  The most frequently reported adverse events in pediatric cases were transient hypothyroidism and withdrawal symptoms in newborns and birth abnormalities in fetuses and newborns, all of which were caused by drugs given for the underlying diseases of their mothers.Discussion: We elucidated serious adverse events in pregnant women caused by the administration of ritodrine hydrochloride.  Frequent factors for adverse events were the onset of physiological factors in pregnant women and complicated factors of the mechanism of action of ritodrine hydrochloride.  We need to monitor both mothers and fetuses during the drug administration.  It is suggested that adverse events in pediatric cases are associated with drugs given for underlying diseases in mothers.  Thus, it is necessary to give appropriate information and communicate the risks of taking these drugs before pregnancy.  We believe the results could be helpful in the early detection of adverse events in the future.

著者

酒井 隆全 大津 史子 後藤 伸之

出版者

Japanese Society of Drug Informatics

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.13, no.4, pp.183-188, 2012 (Released:2012-03-15)

参考文献数

8

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Objective: The purposes of this study were to verify the actual state and to identify the problems associated with research activities by pharmacists.Methods: The abstracts presented at the 42nd and the 37th Japan Pharmaceutical Association (JPA) Congress of Pharmacy and Pharmaceutical Science were investigated.  They were categorized into six research types: “Outcome research”; “Intervention research”; “Observational study”; “Status report”; “Case report”; and “Other”.  They were then ranked according to evidence level, with “Outcome research” ranked the highest.  In addition, “Outcome research”, “Intervention research” and “Observational studies” were checked for whether they had structured abstracts, and form scores were awarded.Results: We found that only 0.8% of abstracts were “Outcome research”.  but the level was higher at the 42nd Congress than the 37th (p=0.03).  Structured abstracts were also more common at the 42nd Congress than at the 37th (p<0.01).  However, the form scores were not significantly different between the 42nd and 37th Congresses.Conclusions: Our findings suggest that pharmacist research activities are improving, but that there is still room for further development.  The referee system and the guidelines for research design are useful methods to encourage more activity.  The target of this study was community pharmacy, and further studies are necessary for hospital pharmacy.

著者

酒井 隆全

出版者

公益社団法人 日本薬学会

雑誌

YAKUGAKU ZASSHI (ISSN:00316903)

巻号頁・発行日

vol.141, no.2, pp.165-168, 2021-02-01 (Released:2021-02-01)

参考文献数

12

被引用文献数

3

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In recent years, a variety of medical information has been digitized, and hence, various medical big data have become available. Spontaneous reporting databases are a part of the medical big data. In Japan, the Pharmaceuticals and Medical Devices Agency has developed the “Japanese Adverse Drug Event Report (JADER) database” which has been available since 2012. Thus, everyone can publish safety signal information based on the results of disproportionality analysis using the spontaneous reporting database. Since the release of JADER, many researchers and healthcare professionals are interested in it, and many reports have been prepared using JADER. Although we tend to focus on the fact that it is a publicly available database with many cases, it also has various limitations such as lack of the denominator information, under-reporting, and reporting biases. Detected signals do not necessarily imply a causal relationship between the drug and adverse event. In the “Guideline on good pharmacovigilance practices (GVP) Module IX by European Medicines Agency”, signal detection is the first step in the signal management process. Signal detection alone does not complete pharmacovigilance activities. It is important to understand that spontaneous reporting databases are not only for researchers but also for those who are considering to apply them to clinical work by referring to research using these databases. In this symposium review, I will discuss the role and applicability of spontaneous reporting databases in medical big data.

著者

岩出 賢太郎 下路 静佳 正木 秀典 酒井 隆全 田辺 公一 後藤 伸之 大津 史子

出版者

公益社団法人 日本薬学会

雑誌

YAKUGAKU ZASSHI (ISSN:00316903)

巻号頁・発行日

pp.18-00205, (Released:2018-12-05)

参考文献数

19

被引用文献数

1

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We investigated the possibility that having pharmacists give asthma patients informational sheets on climate and environmental changes at insurance pharmacies during patient counseling might prevent the worsening of asthma symptoms. Patients with hyperlipidemia were comparative subjects. We created informational sheets about climate and environmental changes and their influence on asthma. During patient counseling, pharmacists gave them to all asthma patients who visited insurance pharmacies over a period of 2 months, between November and December 2017. Based on previous studies, we called days which showed certain climate or environmental changes as compared to the previous day “change days”. We compared the number of visiting patients on change days after preventative information was provided (between January and March 2018) with the number before information was provided (between January and March 2017). In addition, we compared those numbers with the number of patients who visited the target pharmacies between January and March 2016 in order to examine the influence of yearly climate change. The same procedure was used with hyperlipidemic patients. The number of visiting asthma patients after information was provided significantly decreased (5.1±2.1, p=0.03) compared with the number before information was provided, between January and March 2017 (6.1±2.8). The number of aforementioned visits compared to those between January and March 2016 also significantly decreased (p=0.01). Our results suggest that preventative information about climate and environmental changes provided by pharmacists during patient counseling might influence the number of asthma patient visits and prevent the exacerbation of their symptoms.