Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz最新文献_第2页

[Piloting an electronic death certificate (eTB app)-physicians' user experiences]. [试行电子死亡证明（eTB应用程序）-医生的用户体验]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-02 DOI: 10.1007/s00103-025-04082-w

Sebastian Brunner, Michaela Hesse, Diana Borucki, Ulrich Vogel, Martin Mücke, Gülay Ateş

{"title":"[Piloting an electronic death certificate (eTB app)-physicians' user experiences].","authors":"Sebastian Brunner, Michaela Hesse, Diana Borucki, Ulrich Vogel, Martin Mücke, Gülay Ateş","doi":"10.1007/s00103-025-04082-w","DOIUrl":"https://doi.org/10.1007/s00103-025-04082-w","url":null,"abstract":"Background: Funded by the Federal Ministry of Health, the Federal Institute for Drugs and Medical Devices, in cooperation with the Federal Statistical Office, developed an electronic death certificate app and tested it in two federal states to assess its user-friendliness and acceptance. Death certificates are filled out by hand and pass through various offices for transcription and coding before cause of death statistics are published. The certificates are often incorrect and difficult to read. In Germany, there are 16 different forms depending on the federal state, and none of them meet World Health Organization (WHO) requirements for international comparability.Methods: A mixed-methods approach was used with validated questionnaires and semi-structured guided interviews (February to September 2023). The quantitative data were analysed descriptively with SPSS and the qualitative data were analysed using content analysis with MAXQDA.Results: In two federal states, a total of 89 out of 201 physicians completed the surveys and a further 11 were interviewed. Almost all respondents (n = 70) have a positive attitude towards digitalisation in healthcare (94%), see a benefit in processes and organisation (93%) and have no concerns about data security (73%). The majority confirmed the user-friendliness of the eTB app. The qualitative data highlighted that plausibility checking, error prevention and improved readability were convincing arguments in favour of the eTB app.Conclusion: The eTB app is easy to use and useful. In particular, the fast data transfer makes the eTB app an important milestone in digitalization. Improvements are required for use in practice.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144207754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Phage therapeutics and pharmaceutical legislation: classification, manufacture, placing on the market, and application]. [噬菌体疗法和药物立法：分类、生产、上市和应用]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-05-09 DOI: 10.1007/s00103-025-04054-0

Timo Faltus

{"title":"[Phage therapeutics and pharmaceutical legislation: classification, manufacture, placing on the market, and application].","authors":"Timo Faltus","doi":"10.1007/s00103-025-04054-0","DOIUrl":"10.1007/s00103-025-04054-0","url":null,"abstract":"Currently, most phage therapeutics are individualized, that is, prepared specifically for a single patient. In this case, the preparation is usually decentralized and takes place in the respective hospital pharmacies as extemporaneous preparations. The technical supply of phage medicinal products thus differs from the guiding principle of pharmaceutical law. The assurance of quality, efficacy, and safety of medicinal products is typically adapted to the supply of medicinal products that are centrally manufactured independently of the patient in advance and administered decentrally. Only in legally defined exceptional cases may medicinal products be prepared decentrally by pharmacies or physicians without the need for a manufacturing authorization or a marketing authorization prior to application.The article shows why, from a legal perspective, phage medicinal products based on wild-type phages are simple, non-specifically classified medicinal product by virtue of function. Based on this, the article describes the legal requirements under which individualized and non-individualized phage medicinal products can be manufactured, placed on the market and administered. The article also addresses legal issues relating to phage lysins. Furthermore, the article shows the impact of the legal handling of phage pharmaceuticals on the requirements for the reimbursement of phage pharmaceuticals by health insurance providers. In view of the technical requirements of phage therapy, the article discusses the extent to which the current legal framework enables the translation of phage medicinal products into standard medical care. Finally, the article provides an overview of currently planned legislative changes and their likely impact on the legal handling of phage medicinal products.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"638-644"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130056/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Phage therapy-fighting bacteria with viruses]. [噬菌体治疗与病毒对抗的细菌]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-06-02 DOI: 10.1007/s00103-025-04064-y

Timo Faltus, Christian Willy

引用次数: 0

[Health economic significance of antimicrobial resistance]. [抗菌素耐药性的卫生经济意义]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-05-08 DOI: 10.1007/s00103-025-04061-1

Christian Willy, Felix Bröcker

{"title":"[Health economic significance of antimicrobial resistance].","authors":"Christian Willy, Felix Bröcker","doi":"10.1007/s00103-025-04061-1","DOIUrl":"10.1007/s00103-025-04061-1","url":null,"abstract":"The global dissemination of multi-resistant pathogens represents a significant challenge for public health and the economy, given the considerable difficulties it presents in terms of disease control and economic stability. It is projected that the number of deaths associated with multi-drug-resistant organisms (MDROs) could increase significantly worldwide by 2050. MDROs are responsible for approximately 6% of healthcare-associated infections, which equates to 24,000 to 36,000 MDRO infections per year in Germany. In total, this equates to approximately 54,500 infections per year, including those acquired by outpatients. In Germany, the number of deaths directly attributable to MDROs is estimated to be 9700 per year. It is anticipated that there will be a notable rise in the number of carbapenem-resistant isolates of Klebsiella pneumoniae and Acinetobacter baumannii in the future, particularly within the context of inpatient care. A rough estimate of the total additional economic costs of a MRE infection for inpatient treatment in Germany is approximately € 27,000 per case. When economic consequences are considered, the total cost to Germany is estimated to be approximately € 4 billion. It should be noted that the data presented in the studies are usually based on estimates. There is a considerable need for research in order to adequately account for cost areas such as expenses for rehabilitation and the consequences of the large-scale use of antibiotics in animal husbandry. However, more valid data are essential in order to adequately evaluate the effectiveness of future measures to prevent and contain multi-resistance.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"584-592"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143955015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Potential of bacteriophage therapy in Germany: evidence and clinical relevance]. [噬菌体治疗在德国的潜力：证据和临床相关性]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-04-28 DOI: 10.1007/s00103-025-04048-y

Felix Bröcker, Christian Willy

{"title":"[Potential of bacteriophage therapy in Germany: evidence and clinical relevance].","authors":"Felix Bröcker, Christian Willy","doi":"10.1007/s00103-025-04048-y","DOIUrl":"10.1007/s00103-025-04048-y","url":null,"abstract":"Bacteriophage therapy (phage therapy) holds great potential in addressing the growing threat of infections caused by multidrug-resistant bacteria. Registry studies and systematic reviews indicate that phage treatments are effective in approximately 80-90% of antibiotic-resistant infections across various indications. In principle, the approximately 62,000 annual cases of infections caused by resistant or difficult-to-treat pathogens in Germany could be treated with phage therapy. Currently, several clinical trials are underway to assess the safety and efficacy of phage therapy for specific indications; however, no product has yet undergone a formal approval process. Furthermore, the timely applicability of phage therapy for individual cases is constrained by high production costs, limited capacities, and regulatory hurdles. The first market approvals in the USA and Europe are expected within the next three to five years, which could significantly strengthen the outlook for phage therapy. Concrete steps to accelerate the implementation of phage therapy in Germany to relieve the healthcare system include establishing a dedicated phage manufacturing facility, reducing regulatory barriers for compassionate use, promoting innovative technologies for production and diagnostics, and supporting clinical approval studies.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"608-616"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130139/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Cost aspects and reimbursement requirements of phage therapy]. [噬菌体治疗的费用方面和报销要求]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-05-13 DOI: 10.1007/s00103-025-04065-x

Dennis Häckl, Jutta Dillschneider, Christian Elsner

{"title":"[Cost aspects and reimbursement requirements of phage therapy].","authors":"Dennis Häckl, Jutta Dillschneider, Christian Elsner","doi":"10.1007/s00103-025-04065-x","DOIUrl":"10.1007/s00103-025-04065-x","url":null,"abstract":"Phage therapy is considered a promising approach for the targeted treatment of bacterial infections. It has not yet been approved as a regular form of medical therapy in Germany. This article examines the economic and reimbursement challenges of phage therapy as a targeted treatment option for bacterial infections. Two production approaches are distinguished. On the one hand, patient-independent, industrial production of standardized phage therapies could potentially lower costs through economies of scale, yet is associated with uncertainties due to fixed costs, requirements for Good Manufacturing Practice (GMP), and host-specific activity. On the other hand, individual production in (hospital) pharmacies enables patient-specific phage mixtures via magistral compounding but requires production, logistical efforts, and quality management. A significant cost factor is also the diagnostics needed for the identification of bacterial pathogens, which requires additional investments.The current situation in Germany shows that phage therapeutics are so far prescribed and reimbursed only as part of individual treatment attempts; they are neither established as regular medicinal products nor as first-line therapy. Exceptions such as the \"Potential Method\" (§ 137c SGB V) and emergency supply (§ 2 Abs. 1a SGB V) allow for reimbursement under certain conditions, but require justifications and generate transaction costs.This article provides recommendations for promoting phage therapy, including drawing parallels to the reimbursement of CAR-T cell therapy with additional fees for patient-specific therapeutics; for ready-to-use products, outcome-based reimbursement models and evidence-based assessments are discussed. To create economic incentives, state funding instruments are needed.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"653-659"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130093/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Format für die Berichterstattung der zuständigen obersten Landesbehörden an das Bundesministerium für Gesundheit/Umweltbundesamt über die Qualität von Wasser für den menschlichen Gebrauch. 负责向联邦卫生部/联邦环境署报告供人类使用的水质量的最高州当局的格式。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 DOI: 10.1007/s00103-025-04053-1

引用次数: 0

[Basic knowledge of phages and their therapeutic application]. [噬菌体的基本知识及其治疗应用]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-05-02 DOI: 10.1007/s00103-025-04051-3

Christine Rohde

{"title":"[Basic knowledge of phages and their therapeutic application].","authors":"Christine Rohde","doi":"10.1007/s00103-025-04051-3","DOIUrl":"10.1007/s00103-025-04051-3","url":null,"abstract":"Phages (bacteriophages) are viruses that specifically infect and kill bacteria. They are very abundant in nature, playing a highly relevant role in microbial ecosystems. In medicine, they are investigated as a potential alternative or supplement to antibiotics and can be used to treat wound, urinary tract and lung infections, for example. Single phages or so-called \"phage cocktails\" are applied.This overview article on basic knowledge of phages sheds light on well-known keywords from classical knowledge of phage biology and on state-of-the-art research focuses. Mechanisms of phage activity are presented as a basis for therapeutic application. Particularly, the phage-host interaction, lysis mechanisms, phage morphologies and specific methods for visualisation are discussed. Being part of the human microbiome, phages contribute to immune defence, especially in the mucosa. Temperate phages that are able to reside in bacterial genomes as prophages and therefore not suitable for therapy use as well as the CrAss phages (Crassvirales) and Lak megaphages discovered in recent years are also introduced. Further topics are bacterial phage defence, phage resistance and phage-antibiotic synergies. An outlook on future research is given, emphasising the importance of a coordinated collection of scientific results.Phages should not replace antibiotics, but they can even improve their efficiency. Currently, the licensing processes for phage therapy are still challenging. However, trust in phage preparations must be based on quality, which has to be guaranteed by harmonised standards.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"600-607"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12129868/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143966594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Medical ethical challenges of phage therapy-informed consent, study design and therapeutic trial]. [噬菌体治疗的医学伦理挑战——知情同意、研究设计和治疗试验]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-05-06 DOI: 10.1007/s00103-025-04056-y

Hans Zillmann

{"title":"[Medical ethical challenges of phage therapy-informed consent, study design and therapeutic trial].","authors":"Hans Zillmann","doi":"10.1007/s00103-025-04056-y","DOIUrl":"10.1007/s00103-025-04056-y","url":null,"abstract":"The antibiotics crisis is increasing interest in bacteriophages and related therapeutic approaches. The translation of phage therapy into clinical application faces various ethical challenges. These include the patient's informed consent based on patient information as well as open questions regarding an ethically sound study design. In addition, further ethical problems arise from the current situation of phage therapy in Germany with regard to equity of access. This article reflects on the three aspects of phage therapy mentioned above. The results show that phage therapy does not pose any requirements for patient information that could not be solved by adapting the information provided. Questions regarding an adapted study design arise against the background of the placebo dilemma, possible resistance to antibiotics and the expected small number of study participants. An attempt can be made to respond to these challenges by adapting the study design. As a result, the studies deviate from the gold standard, which is randomized, controlled and double-blind studies. A balance must be struck here between evidence requirements and the protection of study participants. From an ethical point of view, the protection of participants must be given greater weight. The current situation of phage therapy in Germany poses an ethical problem, as both the individualised therapeutic trial and the resulting medical tourism that can be observed stand in the way of the demand for fair access and distribution. In order to overcome this status, the magistral prescription represents a possible interim step until clarity has been gained about an appropriate study design.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"631-637"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12129839/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Regulation of phage therapy medicinal products: developments, challenges and opportunities]. [噬菌体治疗药品监管：发展、挑战和机遇]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-05-05 DOI: 10.1007/s00103-025-04060-2

Miriam Fürst-Wilmes, Vanessa Respondek, Nils Lilienthal, Katrin Buss, Anja Düchting

{"title":"[Regulation of phage therapy medicinal products: developments, challenges and opportunities].","authors":"Miriam Fürst-Wilmes, Vanessa Respondek, Nils Lilienthal, Katrin Buss, Anja Düchting","doi":"10.1007/s00103-025-04060-2","DOIUrl":"10.1007/s00103-025-04060-2","url":null,"abstract":"Due to their biological properties, bacteriophages represent a regulatory peculiarity and a challenge for drug approval. Adopted European guidelines on pharmaceutical quality, preclinical, and clinical development are only partially applicable to phage products. The increasing threat of infections with multi-resistant pathogens has not only given a major boost to the development of bacteriophages for the treatment of bacterial infections in recent years but has also led to major progress in the adaptation of regulatory requirements. This review article presents these recent developments and the current status of regulatory requirements for phage therapeutics.In 2024, harmonised quality criteria for phage products and active pharmaceutical ingredients have been implemented in the European Pharmacopoeia for the first time. Both the EU pharmaceutical reform and the national Medical Research Act should enable exemptional regulations taking into account the special features of phage therapeutics and allow novel regulatory pathways. Although increasing clinical data on the use of phage therapeutics have been published, the desired breakthrough in the form of proof of efficacy in randomised controlled clinical trials has not yet been achieved. However, the growing knowledge on phage preparations could be used to adjust the regulatory requirements. The next and decisive step on the path to approval of a defined phage product is the evidence-based proof of efficacy and safety in a randomised controlled clinical trial.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"645-652"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12129831/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0