ObjectiveParallel to an ever stronger advocacy for the use of generics, various sources of information report concerns regarding substitution. The literature indicates that information regarding substitution is not univocal. The aim of this qualitative study was to explore patients’ representations regarding generics in patients suffering from non-specific disabling chronic musculoskeletal pain, as these patients are confronted with the issue of the prescription and/or substitution of original formulations with generics.MethodsQualitative methods were selected because the aim was to access the range of patients' representations and to consider their conceptions. Standardized face-to-face semi-structured interviews were used, and transcripts were submitted to content analysis.ResultsPatients’ representations suggest that they might be confident in taking a generic medication: when he/she has an understanding of generics as resulting from a development process that has become part of the public domain; the generic medication is prescribed by the physician; each prescription is discussed, i.e., the patient is prescribed the generic version of a given medication and not a generic medication.DiscussionEconomic arguments are not sufficient to justify substitution, and may even raise issues calling upon cognitive dissonance. Even in non-life-threatening diseases, negative cues require attention and need be de-emphasized - in particular lower price as an indication of lower quality, and generic status as contradictory with advocating individualization of medication.

A large clonal outbreak caused by vancomycin-resistant Enterococcus faecium (VRE) affected the Bern University Hospital group from the end of December 2017 until July 2020. We describe the characteristics of the outbreak and the bundle of infection prevention and control (IPC) measures implemented. The outbreak was first recognised when two concomitant cases of VRE bloodstream infection were identified on the oncology ward. During 32 months, 518 patients in the 1,300-bed hospital group were identified as vanB VRE carriers. Eighteen (3.5%) patients developed an invasive infection, of whom seven had bacteraemia. In 2018, a subset of 328 isolates were analysed by whole genome sequencing, 312 of which were identified as sequence type (ST) 796. The initial IPC measures were implemented with a focus on the affected wards. However, in June 2018, ST796 caused another increase in cases, and the management strategy was intensified and escalated to a hospital-wide level. The clinical impact of this large nosocomial VRE outbreak with the emergent clone ST796 was modest. A hospital-wide approach with a multimodal IPC bundle was successful against this highly transmissible strain.

Most Mycobacterium fortuitum infections described involve direct inoculation through skin lesions. We describe the case of a patient without risk factors who presented with an intracranial mass and a pulmonary infection with M. fortuitum. As M. fortuitum are rarely pathogens, there is little knowledge about the optimal treatment and outcome of such infections: what is the best mode of administration, what is the best therapy duration and is surgery always required are some of the unanswered questions. In our patient, surgical removal of the mass associated with a 1-year antimycobacterial therapy led to a full recovery. Even though M. fortuitum was rapidly identified in sputum, it was initially considered non-pathogenic and the definitive diagnosis required almost 6 weeks of investigations. New molecular techniques will probably lead to more identifications of M. fortuitum in the next few years and a better knowledge of their possible pathogenicity and optimal treatment.

Introduction: Several orphan drugs have been approved by the European Medicines Agency (EMA) over the past 2 decades. However, the prices of the drugs are expensive, and in some instances, the evidence for effectiveness is not convincing at the time of regulatory approval. Our objective was to evaluate the clinical effectiveness of orphan drugs which have been granted marketing licenses in Europe, determine the annual costs of each drug, compare the costs of branded orphan drugs against their generic equivalents, and explore any relationships between orphan disease prevalence and annual costs. Methods: We searched the EMA database to identify orphan drugs granted marketing authorization up till April, 2014. Electronic searches were also conducted in PubMed, Embase, and Google Scholar to assess data on effectiveness, safety, and annual costs. Two reviewers independently evaluated the levels and quality of evidence and extracted data. Results: We identified 74 orphan drugs, with 54 (73%) demonstrating moderate quality of evidence. Eighty-five percent showed significant clinical effects, but serious adverse events were reported in 86.5%. Their annual costs were between £726 and £378,000. There was a significant relationship between disease prevalence and annual costs (P = 0.01); this was largely due to the influence of the ultra-orphan diseases. We could not determine whether the balance between effectiveness and safety influenced annual costs. For 10 drugs where generic alternatives were available, the branded drugs were 1.4 to 82,000 times more expensive. Conclusion: The available evidence suggests that there is inconsistency in the quality of evidence of approved orphan drugs, and there is no clear mechanism for determining their prices. In some cases far cheaper generic agents appear to be available. A more robust, transparent, and standard mechanism for determining annual costs is imperative.

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