Search

Objectives: Carry out a national inventory of the current situation regarding the quality management of the investigational health products circuit, to develop adapted standardised tools., Methods: A survey of 76 questions, developed by a regional working group, was conducted among clinical research pharmacists in French facilities. Tools were developed to meet the identified needs and validated by participating pharmacists, using the Delphi method. The consensus was defined by achieving a score above 80% on relevance, clarity and evaluability., Results: Among 94 pharmacists participating in the survey, 88 were interested in standardised tools. The score for the implementation of a quality approach depended on the type of health facility (P<0.0005) and increased with the number of active trials (P<0.0005). All nine proposed tools were useful for over two thirds of pharmacists, but the self-assessment and audit grids have been prioritised. Indeed, only 26% of pharmacies carried out a prior risk assessment and 14% carried out internal audits. The review of both grids led to a consensus on 89% and 97% of the criteria respectively. The validated grids include 62 and 72 criteria respectively., Discussion: The quality approach of the investigational health products circuit is heterogeneous in the participating centres, with a strong need for standardised tools. The two grids are relevant tools developed by and for professionals., Conclusion: The tools developed will enable to optimise the quality approach by identifying the non-conformities of the investigational health products circuit., (Copyright © 2021 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

The investigational drugs circuit has specific risks, and medication errors may occur in clinical trials, possibly associated with adverse reactions. These risks must therefore be managed. In fact, there are few reports of medication errors during clinical trials. In a context of regulatory interpretation difficulties on this subject, we conducted a national survey that highlighted the heterogeneity of the methods used by academic sponsors to collect, code and report medication errors and the need to develop a culture of reporting these errors in clinical trials. This is why the REVISE group (safety officers of French institutional sponsors) has issued recommendations to clarify the sponsor and investigator responsibilities and guide them in the management of medication errors. These new guidelines recommend that any serious or potentially serious medication error or other "special situation" (e.g. overdose, misuse, quality defect) should be notified immediately to the sponsor by the investigator. The clinical research pharmacist place is strategic to detect medication errors and other special situations. The integration of the pharmacist into the reporting system, in collaboration with the investigator, could be discussed with clinical research professionals and health authorities., (Copyright © 2021 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Objective: To objectively assess the quality of "crisis communication" media, during the COVID-19 pandemic, in the three Greater Maghreb countries (Tunisia, Algeria, Morocco)., Methods: A compliance audit for press releases and epidemiological bulletins was analyzed against a quality benchmark, which had been specifically designed by the authors. This framework, made up of five dimensions and 50 items, graded (0/1), was applied by two researchers in preventive medicine. Multiplying the scores by a coefficient of two resulted in a partial score of 20 points for each dimension and a total score of 100 points for the checklist taken as a whole. The quality of the communication media was considered to be good when exceeding the thresholds of 15/20 for the different dimensions and 75/100 for the entire grid., Results: A total of 141 information media were included in this audit (Tunisia: 60; Algeria: 60; Morocco: 21). The overall median quality score for these media was only 56/100 (IIQ: [46-58]), without major variability between countries. The most appreciated dimension was "maintaining the confidence of the population", with an overall median score of 14/20 (12/20 for epidemiological bulletins and 16/20 for press releases). The most poorly rated dimension was "strengthening community participation", with a median score of only 4/20 (6/20 for epidemiological bulletins and 4/20 for press releases)., Conclusion: The quality of the Maghreb crisis communication media during COVID-19 was insufficient in most of its dimensions and items, particularly from a psychosocial standpoint. Reinforcement of the capacities of communication officers to develop information material and supports during health crises is indispensable and should be considered as an urgent matter., (Copyright © 2021. Published by Elsevier Masson SAS.)

Objective: Describe the process for designing and creating SimUPAC 360°, a virtual reality training in anti-cancer drug production units., Methods: A multi-centre (a University Hospital, a General Hospital and a Cancer Control Centre), inter-professional (pharmacists, hospital pharmacy technicians and health executives) working group has been set up. It was based on videoconferencing and online document sharing. The work was divided into six phases: choice of target audience and training objectives, definition of the business model, development of the scenario, shooting and editing, creation of the training tool and finally tests, adjustments and validation of the tool., Results: After brainstorming, 77 errors were proposed. Three areas have been defined: covering area, storage and production area, and isolator. They contained 15 errors among the 77 proposed and 20 points of interest. The shooting was carried out over 2 days, in 2 hospitals. Assembly was carried out by a service provider specialist in real virtuality. Before to go online, the tool was tested and validated by experts., Discussion: The establishment of a multi-centric and interdisciplinary working group, the choice of target audience, pedagogical objectives and business model ensure the economic viability and scientific and technical robustness of the tool. The scenario development requires to define: activity areas and then, number, difficulty and typology of errors., Conclusion: Creation of a virtual reality training requires a consistent and structured methodology. This methodology will make it possible to develop other training scenarios., (Copyright © 2020 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Chile faced a severe aquatic animal health crisis in 2007 that affected the production of Atlantic salmon (Salmo salar) after an outbreak of infectious salmon anaemia (ISA). The outbreak had a considerable national economic impact. The response was led by the Competent Authority, the National Fisheries and Aquaculture Service (Sernapesca), which immediately implemented surveillance and control actions to mitigate the crisis. At the end of the initial response, the Competent Authority, together with the industry, set out a roadmap to return to sustainable salmon production. The success of the response was due to early detection and the implementation of biosecurity and control measures at all stages of production and control. These measures underpin the sanitary management model for aquaculture. The Chilean Veterinary Service has analysed critical health measures for salmon production and concluded that there has been an improvement in fish health, as evidenced by decreased mortalities, reduced use of antimicrobials, and improved management and control of prevalent diseases, such as salmon rickettsial syndrome (piscirickettsiosis), caligidosis and ISA. Improvements in health have contributed to increased harvests over time, with the largest monthly harvest for Atlantic salmon being achieved in January-February 2018, with 120,000 tonnes. The ISA crisis provided salutary lessons for the continued recovery and sustainability of Chile's salmon sector. The crisis highlighted the importance of strengthened Veterinary Services and public-private links, as well as a collaborative relationship with research entities and training centres. It was also important to enact new regulations to ensure recovery and sustainability. Fundamentally, the response to this crisis was based upon having good baseline surveillance already in place, supported by a Veterinary Service trained to manage emergency disease outbreaks.

Aquatic animal disease outbreaks affect both the public (represented by the government) and the private sector (represented by the aquaculture and fisheries industry). However, all too often, the responsibilities and costs of responding to an outbreak may not be shared. Without a mechanism for public and private sectors to work together, the outcomes of an emergency response may not be ideal, or of common benefit to all potentially affected parties. In Australia, a mechanism is being developed for public and private sectors to share the responsibilities and costs of responding to aquatic animal disease outbreaks, through an industry- government aquatic emergency animal disease response agreement. The agreement provides an approach for both public and private sectors to share the responsibilities and costs of responding to a disease outbreak and to coordinate disease prevention activities to reduce their shared risk. The key elements of the agreement include provisions to incentivise faster notification of disease outbreaks, facilitate a faster response, share decision-making and costs (including compensation for affected businesses), clarify the responsibilities of all parties and, most importantly, strengthen risk mitigation activities. This paper describes how the draft agreement has been developed among 18 industry and government parties, how key elements of the agreement may contribute to improved aquatic animal health outcomes, and the principles which could be applied by other OIE Member Countries.

With recent outbreaks of Middle East respiratory syndrome coronavirus (MERS-CoV), anthrax, Nipah and the highly pathogenic avian influenza virus, much emphasis has been placed on the rapid identification of infectious agents globally. As a result, laboratories are building capacity, conducting more advanced and sophisticated research, increasing their staff, and establishing reference collections of dangerous pathogens in an attempt to reduce the impact of infectious disease outbreaks and to characterise disease-causing agents. With this expansion, the global laboratory community has started to focus on laboratory biosafety and biosecurity in order to prevent the accidental and/or intentional release of these agents. Laboratory biosafety and biosecurity systems are used around the world to help to mitigate the risks posed by dangerous pathogens in the laboratory. Veterinary laboratories carry unique responsibilities with regard to workers and communities to handle disease-causing microorganisms safely and securely. Many microorganisms studied in veterinary laboratories not only infect animals, but also have the potential to infect humans. This paper will discuss the fundamentals of laboratory biosafety and biosecurity.

Emerging infectious animal and zoonotic diseases can inflict significant losses on animal production and public health, and threaten the safety and security of the food system. Threat analysis (forecasting), which monitors the measurable risk indicators of disease emergence, should be in place before the emergence of any threat. Animal and public health authorities develop and regularly re-evaluate disease preparedness, response and recovery plans, based on the 'One Health' principle. These plans should include surveillance, biosecurity measures, communication channels and training for personnel. Scenarios for outbreaks of natural emerging infectious disease or bioterrorist events should be prepared and practised. National and international legislation should be regularly updated to provide a robust legal basis to manage outbreaks. Reference laboratories should have reliable and validated diagnostic tools for rapid, high-throughput testing. Strict biosafety, biocontainment and biosecurity control measures must be implemented in laboratories in order to prevent the accidental or malicious release of pathogens. The pharmaceutical industry should be incentivised to develop vaccines and/or antiviral drugs against disease outbreaks. Conventions between public authorities and the pharmaceutical industry should guarantee adequate stockpiling of the pharmaceuticals needed to control large-scale outbreaks. In the early phase of disease emergence (early warning), veterinarians and stakeholders play an important role in early detection at the farm level. Upon notification, veterinary authorities must take rapid response measures to limit disease spread. National and international short- and medium-term strategic research agendas should be developed, based on a comprehensive gap analysis and horizon scan. This planning will help to guide funding agencies and non-governmental organisations in their quest to support relevant research.

Arboviruses - viruses transmitted by haematophagous arthropods - are responsible for febrile syndromes, which sometimes include haemorrhagic or neurological symptoms. Human activities have facilitated the emergence of these originally zoonotic viruses and the domestication and spread throughout the world of their major vectors. The last decade has seen significant changes in the epidemiology of arboviruses transmitted by mosquitoes of the genus Aedes, particularly in relation to the intercontinental spread of Aedes albopictus. Here, we address the epidemiological consequences of the invasion by this species into Central Africa and Europe in a context of viral globalization. The risk of transmission in these areas is influenced by virus-vector adaptation phenomena as well as environmental phenomena including climate. Faced with these new risks, it is essential to develop competences in entomological and virological surveillance, risk assessment and forecasting of epidemic risk in order to develop strategies for the prevention and control of epidemics., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

Background: Medication care of patients in nursing homes involves a complex circuit whose related risks need to be identified. The aim of this study was first to map risks related to medication care in a representative panel of nursing homes under contract with community pharmacies in Alsace, then to propose improvement action plans to remedy the weaknesses identified., Methods: This study was conducted on a representative sample of 23 nursing homes in Alsace in 2014. A self-assessment questionnaire (Interdiag EHPAD), divided into 7 fields and made up of 198 questions, was completed by each of the 23 nursing homes during multidisciplinary meetings that were organized by the OMEDIT (observatoire du médicament, des dispositifs médicaux et de l'innovation thérapeutique of Alsace). The percentages of controlled risks were calculated for each of the 7 fields of the medication circuit, both at nursing home and regional levels. Similarly, the percentages of non-controlled risks were calculated for each of the 198 items., Results: Considering the 7 fields, regional percentages of controlled risks varied from 63% to 85%. The field relative to drug supply was the best controlled, while that relative to prevention was the least controlled. Considering the 198 items, 30 important vulnerability points were identified, among which stand out: failure to report and to analyze adverse drug events, lack of involvement of general practitioner in nursing homes through collaborative approaches and transcription by nurse staff of oral or handwritten prescriptions in medical software. The analysis of those items led to the proposal of 13 improvement actions., Conclusion: The study pointed out mainly difficulties linked to the absence of suitable risk management policies and the lack of adjustment between nursing home staffs and general practitioners. In contrast, it revealed that the collaboration between nursing homes and community pharmacies was successful overall. Finally, we hope that this multi-center study, that led to identify concrete proposals, will help nursing homes to improve the quality of medication care for their residents., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

Background: In the healthcare domain, different analytic tools focused on accidents appeared to be poorly adapted to sub-accidental issues. Improving local management and intra-institutional communication with simpler methods, allowing rapid and uncomplicated meta-reporting, could be an attractive alternative., Methods: A process-centered structure derived from the industrial domain - DEPOSE(E) - was selected and modified for its use in the healthcare domain. The seven exclusive meta-categories defined - Patient, Equipment, Process, Actor, Supplies, work Room and Organization- constitute 7CARECAT™. A collection of 536 "improvement" reports from a tertiary hospital Post anesthesia care unit (PACU) was used and four meta-categorization rules edited prior to the analysis. Both the relevance of the metacategories and of the rules were tested to build a meta-reporting methodology. The distribution of these categories was analyzed with a χ 2 test., Results: Five hundred and ninety independent facts were collected out of the 536 reports. The frequencies of the categories are: Organization 44%, Actor 37%, Patient 11%, Process 3%, work Room 3%, Equipment 1% and Supplies 1%, with a p-value <0.005 (χ 2). During the analysis, three more rules were edited. The reproducibility, tested randomly on 200 reports, showed a <2% error rate., Conclusion: This meta-reporting methodology, developed with the 7CARECAT™ structure and using a reduced number of operational rules, has successfully produced a stable and consistent classification of sub-accidental events voluntarily reported. This model represents a relevant tool to exchange meta-informations important for local and transversal communication in healthcare institutions. It could be used as a promising tool to improve quality and risk management., (Copyright © 2013. Published by Elsevier SAS.)

By the time vCJD was first described in 1996, it was already far too late to offset further disaster from transmission of the disease by blood transfusion: almost all the humans who would be infected and infectious were already diseased. Nothing done by the blood transfusion services around that time, with the exception of excluding transfusion recipients as blood donors, would have made any useful contribution to containing the extent of the epidemic. The ability to spread emerging diseases before the problem is manifest or understood is a fixed and unavoidable feature of blood transfusion as it is practiced today. A second fixed property of blood transfusion is that the root cause of disaster is not within the control of the blood transfusion universe. Strategies that have emerged to cope with similar threat in other enterprises that also contain these properties comprise the components of robust design: surveillance, preparedness for action, engagement, herding together, evasion or avoidance, early adoption of potentially useful measures, engineered resilience, defence in depth, damage limitation including modularity and removal of feedback loops, and contingency, redundancy and failure management, and ultimately, individual escape. Early adoption of leucodepletion based on the possibility that it might work rather than any hard evidence was a good example of threat management. Exclusion of previously transfused donors is a robust mechanism for containing any future infection; optimal blood use structures that provide a national transfusion rate as low as possible also constitute an effective threat management strategy., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)