Reimbursement models to tackle market failures for antimicrobials: Approaches taken in France,Germany, Sweden,the United Kingdom,and the United States

IntroductionThe pipeline of new antibacterials remains limited. Reasons include low research investments, limited commercial prospects, and scientific challenges. To complement existing initiatives such as research grants, governments are exploring policy options for providing new market incentives to drug developers.Materials and methodsReimbursement interventions for antibacterials in France, Germany, Sweden, US, and UK were reviewed and analysed by the authors.ResultsIn France, Germany, and the US, implemented interventions centre on providing exceptions in cost-containment mechanisms to allow higher prices for certain antibacterials. In the US, also, certain antibacterials are granted additional years of protection from generic competition (exclusivity) and faster regulatory review. The UK is piloting a model that will negotiate contracts with manufacturers to pay a fixed annual fee for ongoing supply of as many units as needed. Sweden is piloting a model that will offer manufacturers of selected antibacterials contracts that would guarantee a minimum annual revenue. A similar model of guaranteed minimal annual revenues is under consideration in the US (PASTEUR Act).ConclusionsThe UK and Sweden are piloting entirely novel procurement and reimbursement models. Existing interventions in the US, France, and Germany represent important, but relatively minor interventions. More countries should explore the use of novel models and international coordination will be important for ‘pull’ incentives to be effective. If adopted, the PASTEUR legislation in the US would constitute a significant ‘pull’ incentive.     

药源性过敏性休克522例分析

目的 :探讨发生药源性过敏性休克的特点和规律。方法 :检索中文医药卫生期刊1998年～2003年报道的药源性过敏性休克个案 ,并进行统计、分析。结果 :抗微生物药物、中草药、生物制品的过敏性休克发生率及死亡率居前3位 ;静脉用药发生率最高 ,占61 30% ;速发型过敏性休克比例极大 ,占78 73% ;药源性过敏性休克与性别、年龄无关。结论 :用药前询问过敏史 ,严格用药指征 ,观察用药后反应 ,方能确保用药安全。     

Real-time assessment of bacteriophage T3-derived antimicrobial activity against planktonic and biofilm-embedded Escherichia coli by isothermal microcalorimetry

Bacterial biofilms, highly resistant to the conventional antimicrobial therapy, remain an unresolved challenge pressing the medical community to investigate new and alternative strategies to fight chronic implant-associated infections. Recently, strictly lytic bacteriophages have been revalued as powerful agents to kill antibiotic-resistant bacteria even in biofilm. Here, the interaction of T3 bacteriophage and planktonic and biofilm Escherichia coli TG1, respectively, was evaluated using isothermal microcalorimetry. Microcalorimetry is a non-invasive and highly sensitive technique measuring growth-related heat production of microorganisms in real-time. Planktonic and biofilm E. coli TG1 were exposed to different titers of T3 bacteriophage, ranging from 10² to 10⁷ PFU/ml. The incubation of T3 with E. coli TG1 showed a strong inhibition of heat production both in planktonic and biofilm already at lower bacteriophage titers (10³ PFU/ml). This method could be used to screen and evaluate the antimicrobial potential of different bacteriophages, alone and in combination with antibiotics in order to improve the treatment success of biofilm-associated infections.     

Antimicrobial Susceptibility Profiles of Gram-Negative Bacteria Causing Infections Collected Across India during 2014–2016: Study for Monitoring Antimicrobial Resistance Trend Report

Background: The emergence of antibiotic resistance among bacterial pathogens in the hospital and community has increased the concern to the health-care providers due to the limited treatment options. Surveillance of antimicrobial resistance (AMR) in frequently isolated bacterial pathogens causing severe infections is of great importance. The data generated will be useful for the clinicians to decide empiric therapy on the local epidemiological resistance profile of the antimicrobial agents. This study aims to monitor the distribution of bacterial pathogen and their susceptibility pattern to the commonly used antimicrobial agents. Materials and Methods: This study includes Gram-negative bacilli collected from intra-abdominal, urinary tract and respiratory tract infections during 2014–2016. Isolates were collected from seven hospitals across India. All the study isolates were characterised up to species level, and minimum inhibitory concentration was determined for a wide range of antimicrobials included in the study panel. The test results were interpreted as per standard Clinical Laboratory Standards Institute guidelines. Results: A total of 2731 isolates of gram-negative bacteria were tested during study period. The most frequently isolated pathogens were 44% of Escherichia coli (n = 1205) followed by 25% of Klebsiella pneumoniae (n = 676) and 11% of Pseudomonas aeruginosa (n = 308). Among the antimicrobials tested, carbapenems were the most active, followed by amikacin and piperacillin/tazobactam. The rate of extended-spectrum beta-lactamase (ESBL)-positive isolates were ranged from 66%–77% in E. coli to 61%–72% in K. pneumoniae, respectively. Overall, colistin retains its activity in > 90% of the isolates tested and appear promising. Conclusion: Increasing rates of ESBL producers have been noted, which is alarming. Further, carbapenem resistance was also gradually increasing, which needs much attention. Overall, this study data show that carbapenems, amikacin and colistin continue to be the best agents available to treat drug-resistant infections. Thus continuous monitoring of susceptibility profile of the clinically important Gram-negative pathogens is of great importance to guide effective antimicrobial therapy.     

An unusual case of a brain abscess arising from an odontogenic infection

A brain abscess that originates from an odontogenic infection, although rare, can at times be difficult to diagnose, especially in the context of pain and trismus. We report a rare case of odontogenic infection as a result of an infected maxillary third molar, causing an infratemporal and temporalis collection, resulting in a brain abscess with concurrent cerebritis. This is a clinical case review documenting an uncommon but potentially fatal complication.     

Fixed-dose combinations of antimicrobials: A need for special attention

Objective: To highlight the issue of freely available fixed-dose combinations (FDCs) of antimicrobials. Methods: A critique of two such antimicrobial FDCs was undertaken wherein the following aspects were assessed - rational and regulatory issues and justification for clinical use. Available in vitro, in vivo (animals and humans) evidence from published literature was analysed. Conclusions: There are several inadequately addressed aspects of the considered FDCs which are available in Indian market. In view of the growing problem of antimicrobial resistance, this issue must get the required attention.     

慢性胆囊炎单病种临床路径使用抗菌药物的疗效与药物经济学评价

目的:探讨慢性胆囊炎单病种临床路径预防性使用不同抗菌药物以及不预防性使用抗菌药物在预防感染方面的疗效与药物经济学评价。方法:对预防性使用频率较高的3种抗菌药物(头孢呋辛、头孢替安、头孢西丁)以及不预防性使用抗菌药物的380例诊断为慢性胆囊炎或合并胆囊结石行腹腔镜胆囊切除术并实行慢性胆囊炎临床路径的患者病历进行回顾性分析,比较其疗效,并运用成本-效果分析进行药物经济学评价。结果:4种方案取得的疗效相同,未用抗菌药物组、头孢呋辛组患者的成本-效果比低于头孢替安组、头孢西丁组。结论:慢性胆囊炎单病种临床路径不预防性使用抗菌药物或预防性使用头孢呋辛是较佳方案。