Objective: The success rate of third-line treatment for Helicobacter pylori (H. pylori) infection has been reported to depend on the use of antibacterial agents, potassium-competitive acid blockers, and proton pump inhibitors. However, there is insufficient information on the success rate of H. pylori treatment due to the differences in the clinically used drugs. Here, the factors influencing the success rate of third-line treatment for H. pylori infection was investigated.

Methods: Patients aged 20 years or older, who had received third-line treatment for H. pylori infection from January 2013 to December 2021 at the Kameda Medical Center were included. The exclusion criteria were as follows: patients with unknown treatment results and discontinuation of treatment. The primary endpoint was treatment success rate, based on the differences in the treatment regimen and drug choice, which was retroactively investigated from medical records. Confounding factors were adjusted by multivariate logistic regression analysis.

Results: Treatment regimens containing sitafloxacin resulted in higher treatment success rates (p<0.05). Multivariate logistic regression analysis showed that the administration of sitafloxacin was the only statistically significant factor influencing treatment success. However, vonoprazan also tended to influence treatment success.

Conclusion: Treatment with sitafloxacin and vonoprazan increases the success rate of third-line treatment against H. pylori infection.

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Objective: We conducted a survey on drug information accumulated by pharmaceutical companies about the adequacy of administration of crushed or simply suspended internal medicines through enteral feeding tube, examination methods to confirm adequacy and inquiries from medical institutions to pharmaceutical companies about the adequacy of these methods.

Methods: We sent a questionnaire to 162 pharmaceutical companies that sell internal medicines to collect information. The survey was conducted from May 1, 2016 to March 31, 2017.

Results: The questionnaire response rate was 61% (99 companies responded). Eighty and 90 percent of the companies possessed information about the drug crushing methods and simple suspension methods used for administration of internal medicines,respectively. The type of information and examination methods used varied among the companies, was very limited, and was often limited to new drugs. The information acquisition rate about crushing methods was 69.3% in original examination methods of pharmaceutical companies. On the other hand, 90.3% of the information about simple suspension methods was obtained by the unified method of Hand Book of Simple Suspension Method.

Conclusions: In the future, medical practice and patients will benefit if examination methods to confirm the adequacy of crushing and administration through feeding tubes are commonly and consistently obtained by pharmaceutical companies. Furthermore, it would be very useful for information of crushing methods and simple suspension methods to be included in package inserts and interview forms.

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Objective: The importance of self-supervised health care is growing.  In this field, we thought that pharmacists working in the community pharmacy or drugstore could play important roles in the health supervision of local residents, since they are familiar with community.  Here, we examined the effectiveness of “healthcare workshop” or “information service” by drugstore pharmacists on the consciousness of local residents regarding their health or the role of drugstore pharmacists as supporter of their medical health care.
Design and Methods: In the three branches of Yutaka pharmacy Ltd., we performed the “healthcare workshop” (4 times/ 6 months), “information service in regard to health or medical care” (about 10 times/day) and “distribution of medicine notebook” over 6 months.  To evaluate the effectiveness of these activities, the questionnaire was answered by the consumer in drugstores of the Yutaka pharmacy Ltd. before and after the “healthcare workshop” or “information service”.
Results: The recognition of pharmacist in the drugstore was significantly improved (before: 23.4%, after 39.1%).   In addition, the need of information service by drugstore pharmacists also increased from 62.5% to 76.1%.  Furthermore, the bringing ratio of medicine notebook and the percentage of submission of medicine notebook to doctors were increased from 52.1% to 61.5% and from 40.0% to 55.6%, respectively, while the possessive ratio of medicine notebook was not changed.
Conclusions: In the present study indicate that activities such as “healthcare workshop” and “information service” performed by pharmacists in drugstore are effective to provide many medical information extensively and to increase the need of information service by drugstore pharmacists in the local community.  In conclusion, continuance of these activities may important for drugstore pharmacists to be recognized as medical staff who support the health supervision of local residents in the future.

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Objective: Caffeine may cause dependence and sleep disturbance, and interact with psychotropic drugs.　Therefore, the caffeine intake of patients with mental disorders should be monitored.　However, in Japan, there is no report on the effects of caffeine in mental disease patients or on their caffeine intake.　Therefore, we conducted a questionnaire survey to clarify the perception of caffeine for psychiatric outpatients.

Methods: We conducted an anonymous survey on caffeine recognition for outpatients at 8 medical institutions that advocate psychiatry.

Results: We collected questionnaires from 180 people.　The knowledge of foods containing caffeine tended to be high in those who had a positive attitude toward caffeine.　More than 90% of those surveyed knew that coffee contains caffeine, but cocoa and jasmine tea were recognized by less than 25%.　Of those surveyed, 39.4% consumed caffeine‐containing beverages at night.　In addition, the rate of consumption of caffeine‐containing beverages tended to be higher at night because they had a positive attitude toward caffeine.

Conclusion: The knowledge and intake situation of caffeine by patients with mental disorders differed depending on their interests and way of thinking about caffeine.　As caffeine intake may influence psychiatric treatment, correct knowledge regarding caffeine is important.

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Objective: Celecoxib has been reported to enhance the action of warfarin by inhibiting CYP2C9, its major hepatic drug-metabolizing enzyme, but sufficient information about the mechanism has not been obtained, especially in Japan.
Methods: A study was conducted to investigate the prothrombin time international normalized ratio (PT-INR) and the warfarin sensitivity index (WSI) before and after concurrent administration of celecoxib, as well as the Drug Interaction Probability Scale (DIPS) scores to determine causality with drug interactions, in patients commencing concurrent therapy with celecoxib and warfarin at Kanagawa Prefectural Keiyukai Keiyu Hospital during the 4-year period from October 2011 to September 2015.
Results: Analysis of 18 patients showed that the PT-INR increased significantly from 1.53±0.43 before concurrent therapy to 2.18±1.01 after concurrent therapy (p=0.0101).  The WSI also increased significantly from 0.76±0.50 before concurrent therapy to 1.01±0.65 after concurrent therapy (p=0.0044).  According to the DIPS scores, the causal relation was not rated as “Highly Probable” in any of the patients, while it was considered to be “Probable” in 3 patients, “Possible” in 10 patients, and “Doubtful” in 5 patients.
Conclusion: The findings of this study suggested that when celecoxib treatment is initiated in patients who are already taking warfarin, attention must be paid to changes of coagulation profile, especially in elderly patients.

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Objective: To reveal the current use of medication notebooks in clinical practice and the differences in submission rates of medication notebooks among patients with different sociodemographic and medical characteristics.
Methods: We conducted a survey of the submission rates by studying the medication history, from June 19, 2014, to July 3, 2014.
Results: The overall submission rate of returning patients was 57.1% and the submission rate of patients who visit a single medical institution was significantly lower than patients who visit more than two (55.4% vs. 67.7%, p<0.001).  Multivariate logistic regression also indicated significant differences between the single and multiple medical institution visit group (adjusted OR=2.74 [95% CI: 1.93-3.89], p<0.001).  Submission rates for patients in their 20, 30, and 50 s who visit a single medical institution were lower than 40%.
Conclusions: To improve the usefulness of the community pharmacy and increase the submission rate, we need to increase awareness of the importance of medication notebooks among patients who visit a single medical institution.  Additionally, future studies need to focus on factors such as age-related issues that might affect submission rates.

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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.

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Objective: The maintenance and improvement of medication adherence are important in psychiatry.  In the case of patients using home healthcare services, it is necessary to improve their medication adherence through multi-professional collaboration.  However, appropriate methods or measures to provide them with information regarding psychotropics and resolve their problems during home visits have yet to be clarified.  We aimed to promote the appropriate provision of such information in home healthcare services for patients with mental disorders by clarifying the current status and details of information needed during home visits.
Methods: A questionnaire survey was conducted in April 2016, involving healthcare professionals who worked in 9 facilities providing home-visit services for patients with mental disorders.
Results: A total of 116 (86 females and 30 males) responded, among whom nurses accounted for the majority, at 81.9%, followed by psychiatric social workers, at 10.3%, and occupational therapists, at 7.8%.  More than 97% of all respondents assessed medication adherence.  Medication guidance tended to be provided within 15 minutes (81.9%) during each home visit, and the most frequent duration of such guidance was 6 to 10 minutes (37.9%).  Patients most frequently asked about adverse drug effects (57.8%), and the health professionals most frequently faced difficulty answering such questions among all the questions asked (46.6%).  Materials needed during home visits included: <brochures explaining the therapeutic and adverse effects of drugs>, <photographs of drugs>, and <a list of generic drugs>.  Some respondents also noted the necessity of materials that are easy to carry.
Conclusion: The results clarified the details of information to be provided on administering home healthcare services for patients with mental disorders.  As various professionals are engaged in such services, and they are expected to have a certain level of ability to provide information, systems to effectively support information provision by them may be needed.

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Objective: A medication notebook is developed in order to unitedly manage medication information of patients and is used by writing medication information such as history of ethical drugs, over-the-counter drugs and health foods, anamnesis, history of adverse events and allergy.  Adverse events, interaction and duplication of drugs can be prevented by showing a medication notebook to doctors and pharmacists.
Data Sources·Study Selection·Data Extraction: In this article, we reviewed literatures regarding preceding studies on the utilization of medication notebooks comprehensively.
Results·Conclusion: In our review, we could comprehend literature on medication notebooks systematically and could summarize a lot of evidences that confirm the usefulness of medication notebooks.  We need to produce further evidences on medication notebooks to spread medication notebooks.

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慢性疾患や急性疾患により、治療薬を服用しながら自動車運転をしている患者は多いが、服薬による交通事故の実態は不明である。今回、副作用データベース（JADER）を用いてによる交通事故の実態について調査した。2004年4月〜2016年3月において、JADERの総登録件数は390,669件で、有害事象としての交通事故は342件であった。被疑薬176薬品のROR（Reporting Odds Ratio）および95％信頼区間（CI）下限値を算出した結果、82薬品においてCIの下限値が1を超えており因果関係が示唆された。被疑薬としては、プラミペキソール塩酸塩水和物が47件と最も多く、そのうち36件が突発的睡眠が併発有害事象であった。次いでゾルピデム酒石酸塩46件、プレガバリン35件、バレニクリン酒石酸塩19件、スルピリド13件等であり、添付文書に自動車運転等に関する警告や禁止が記載されているが主であった。高齢化が進み、自動車運転に対する療養指導、服用すべきに関する適切な服薬指導は益々重要となる。自動車運転をする患者に対しては、医師や薬剤師が適切にアドバイスする必要があり、その際に、本調査結果は有用な資料の一つとなると考える。

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ガスクロマトグラフィー (GC) による練り歯磨き中のジエチレングリコール (DEG) の迅速かつ簡易な分析法を開発した。練り歯磨き中のDEGは, 1, 4-ブタンジオールを内標準物質として含有するメタノール溶液で超音波処理により抽出した。メタノール抽出液を遠心, ろ過した後, InertCap 624キャピラリーカラムを用いたGCにより分析した。練り歯磨きにDEGを0.1-1.0%添加した場合の回収率は99.4-103.6%であった。練り歯磨き中のDEGの定量限界は0.05%であった。この方法は他の市販化粧品にも適用することができた。この分析法を用いて, 旅館やホテルで使用される練り歯磨き10検体について分析し, 2検体からDEGを検出した。本分析法が化粧品製造販売業者および輸入販売業者における品質管理に役立つことを期待する。

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特集：元素多様化による新たな創薬戦略
特集にあたって：近年，革新的技術の登場により創薬方法論が著しく多様化しているが，低分子が持つコストや品質管理における強みを考慮すると，低分子化合物は今後も創薬の王道として君臨するだろう．その低分子の開発でも，最近，多様性が意識され始め，これまでとして利用されていなかったホウ素，ケイ素，重水素などの元素を利用した創薬研究が最近盛んに進められている．また，ハロゲン結合などの新たな相互作用が提唱されたことにより，創薬におけるハロゲン原子の価値が拡大しつつある．本特集号を通じて，を構成する元素１つ１つに目が向けられ，成熟した低分子創薬が再び飛躍する契機になることを期待したい．
表紙の説明：化学の基本は周期表である．学生の頃はそれを一生懸命覚えたものだが，創薬をしながら周期表を見ることはどのくらいあっただろうか．改めて周期表を見直してみると，きっと元素の特徴を生かした新たな創薬戦略が浮かぶことだろう．周期表から飛び出た元素は，汎用元素という先入観や固定概念を捨てて創薬に挑戦し続けた先生方への敬意と，これら元素を含む創出への期待である．

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「ICH E8臨床試験の一般指針」は，

の承認に必要となる臨床試験や臨床開発の進め方について総論的に述べたICHガイドラインである．ICH E8ガイドラインは，1997年に策定されて以来，改定は行われてこなかったが，近年，臨床試験ではより多様なデザインやデータソースが用いられるようになった．また，ICH E8ガイドラインでは取り扱われていない「臨床試験の質」についても，事後的に実施される文書やデータのレビューやモニタリングによってではなく，試験の計画や手順の中に前向きに作り込むことにより向上させることが重要という考えも提唱されつつある．以上を背景とし，今般，ICH E8（R1）“General Considerations for Clinical Trails” としてガイドラインの改定が行われたことから，本稿では，当該ガイドラインの改定の概要およびその作成経緯について，ガイドライン改定にかかわった規制当局の立場から記載する．

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