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The quality approach has become essential in geriatric hospital services, but also in the medico-social sector. This process is continuous and shared by all those in charge of the care units, to facilitate unit management and support caregivers in this approach. The weekly structured quality staff meeting is a relevant tool to facilitate the understanding and appropriation of this approach by the medical and nursing managers of the care units., (Copyright © 2024 Elsevier Masson SAS. All rights reserved.)

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Reporting and learning are key components of quality and safety in radiotherapy. Each event must be reported to national authorities if considered significant according to national criteria. Lessons learnt from analysis of causal factors are primordial to decrease the risk of reoccurrence or the severity of further events. Thanks to national or international, mandatory or voluntary incidents reporting systems, and experience feedbacks, various sources of learning are available to improve risk management. This article aims to compare the regulations about mandatory declarations of significant events and describe national or international incident reporting and learning systems available., (Copyright © 2023 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.)

Purpose: In order to study the role perception and the effective involvement of Radiation TherapisTs (RTTs) in risk management in radiotherapy, a survey was developed and distributed in five countries (France, Switzerland, Belgium, Ireland, the Netherlands)., Materials and Methods: The article presents the results of this survey and the comparison between the different countries., Results: Overall, the results of the survey show a good involvement and perception of the RTTs around the risk management approach, although training in this area has yet to be systematized., Conclusion: Although with differences in the results between the participating countries, the survey seems to highlight the deployment of preventive actions that are evaluated as not very effective by the respondents and by the international scientific literature., (Copyright © 2022 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.)

Abstract: Introduction: Information technologies appear to be interesting tools to assess and improve professional practices. In that setting, the management of surgical antibiotic prophylaxis represents an appropriate clinical area for using and evaluating such a tool. Despite the existence of guidelines in one hand and the demonstrated interest for a strict application of recommendations in the other hand, some irregularities in the management of surgical antibiotic prophylaxis remain in France in 2010. Objectives: Since we have had computer systems in our department for several years, we performed an evaluation of practice to assess the impact of both the computer-based help and the updating of knowledge in physicians as tools to improve the application of guidelines for surgical antibiotic prophylaxis. Study design: Clinical audits. Methods: Three clinical audits have therefore been performed before an implementation of computer-based help for clinical decisions and a clinical update for physicians, immediately after, and two years after this combined procedure (2322, 2678 and 2863 patients, respectively). Results: There was an enhancement of clinical practices and compliance to guidelines secondary to the beginning of computer-based prescription (55 to 81%, P <0.05). However, a weaning effect was observed with longer intervals between clinical update and surgical procedure, in association with increased omissions of antibiotic prophylaxis. Conclusion: Computer-based help for clinical decision and prescription seems to be a useful tool for surgical antibiotic prophylaxis but it should be accompanied by direct regular educational measures to update protocols and databases. [Copyright &y& Elsevier]

Abstract: Objective: Burnout is one of the main chronic health problems with negative consequences on health care givers but also on quality of care. The main goal of Physician Health Survey was to study the frequency of burnout among salaried physicians and pharmacists and to compare anesthesiologists and intensivists (AI) with other practitioners (OP). The secondary end points were to analyze risk factors of burnout in each group. Material and methods: An anonymous, self-administered questionnaire was diffused via a specific website. Burnout was measured using the Copenhagen Burnout Inventory (CBI). Several different factors were examined: work/family conflict, salary satisfaction, quality of teamwork, interpersonal relationships, workplace influence, workload and perceived health. The role of each factor was calculated by multivariate logistic regression and comparisons were made between AI and OP. Results: Among the 3196 responses, CBI revealed an elevated score of burnout in 38.4% in AI and in 42.4% in OP. In each group, a great gap was displayed between the CBI results and the self-assessment of burnout (15%). Among AI, risk factors of burnout were high quantitative demand (ORadj=3.40; CI95 1,34–8,63), Work/family conflict (ORadj=; 3.12 CI95 1.60–6.08), low quality of teamwork (ORadj=1.99; CI951.14–3.47) and tense Relation within team (ORadj=1.92; CI95 1.25–2.95). All these factors are observed also among OP. Female gender, young age and dissatisfaction with pay have significant influence but different in the two groups. Claims of recurrent harassment by superiors is a risk factor for burnout only for the AP (adj.OR=1.83; CI95 1.04–3.22). Discussion: Burnout affected near one about two salaried physicians and pharmacists in France. AI were not more concerned by burnout than OP but all of whom have difficulty identifying their own levels of psychological stress and burnout. Decreasing the level of different risk factors i.e. by improving the quality of teamwork should lead to reduce burnout frequency. [Copyright &y& Elsevier]

Since early 2020, the onset of the COVID-19 pandemic, physicians have continued to report adverse events associated with care. Patients also continued to participate in the hospital satisfaction surveys. To date, no study in France has measured the impact of the pandemic on adverse events and patient satisfaction. We looked at the characteristics of these adverse events in relation to the pandemic and put patients' feelings into perspective. A qualitative and observational retrospective study of the REX and MCO48 databases was carried out. The quantitative study of the REX database was supplemented by a qualitative analysis of the declarations. The adverse events more often affects middle-aged men aged 60 years, while deaths occur in older patients with more complex pathologies and more urgent management. The nature of these events is different depending on the reporting period: Those reported in the first wave are more urgent, occur less frequently in the operating room than in the emergency room, and are considered less preventable than those reported in the second wave. The latter are more similar to the events that usually occur. The implementation of effective barriers, particularly within the teams, has made it possible to reduce the impact of the second wave on the occurrence of these events, the role of communication seems essential. The overall patient satisfaction score as well as those for medical and paramedical care has increased, which may reflect patient solidarity with caregivers. The attitude of active resilience on the part of all actors has been a major element in risk management during this crisis and it is essential to capitalize on these collaborative processes for the future.

The French Higher Health Authority's (Haute Autorité de santé [HAS]) certification process is an important issue for a health care facility and in particular for a radiotherapy department. It is based on a quality-risk management methodology driven by the commitment and involvement of professionals. The radiotherapy department of the university hospital in Brest (France) has been engaged for many years in a demanding quality-risk management policy implementation, subjected to regular inspections by the French Nuclear Safety Authority (Autorité de sûreté nucléaire [ASN]). This implementation is driven by a strong commitment from department managers, who are determined to maintaining an efficient level for care quality and safety., (Copyright © 2020 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.)

Medication errors (ME) are frequently encountered and present at every step of the therapeutic process. This study's aims were to take stock of the ME reported to the region's pharmacovigilance (CRPV) and poison control centers (CAPTV) and to identify potential regional actions. A 2-months (January and February 2017) prospective gathering of the calls to the CAPTV regarding the ME and of the ME declarations to the region's CRPV (Clermont-Ferrand, Grenoble, Lyon, Saint-Etienne) has been carried out. The place of occurrence, the event's description and its consequences and data regarding the patient were collected. In addition to that, the regional drug observatory OMEDIT analysis has allowed to determine the ME's types (REMED characterization, never event?) and to look for the results of a potential thorough analysis. The study reported 580 calls for 590 ME and 583 patients. ME mostly affected the ambulatory/domicile sector (76%), the medico-social sector (14%) and the healthcare facilities sector (7%). It usually was about dose errors, medication errors and patient errors with a different profile in each sector. The majority of errors (85%) occurred at the administration step. Almost all the observed ME were confirmed errors having reached the patient (99.5%) but only a few had serious consequences. One out of 5 ME was eligible for a thorough analysis but even less were subjected to that kind of analysis. The main never event concerned the unidose in the ambulatory sector. The health products involved were mostly a single medication (75%) and then the patient's full treatment (12%). The CRPV/CAPTV/OMEDIT's skills are complementary for the gathering, the analysis and the management of the ME. Training campaigns and support are to be considered for the professionals and especially within the medico-social facilities., (Copyright © 2019 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Objective: Transfusion safety is based on the availability of safe and compatible blood products at the right time and to the right patient, and requires close monitoring in order to detect possible incidents. The decree of June 20th 2018, which establishes the national blood transfusion's guiding plan, states that the organization that prevails throughout the national territory is built around an inseparable link between the implementation of erythrocyte immunohematology and the labile blood products delivery by authorised structures., Method: The article describes the two types of the link's organization, structural or functional, used to develop the comparative risk-benefit analysis., Results: The structural link, which has fewer interfaces, reduces risk situations that lead to delays in release by default of a compatible product. The cases in which a functional link may have a greater benefit than the risks generated are those related to a geographical distance between the delivery site and the patient's place of care. In these cases, a functional link is possible provided that certain organizational points are mastered., Conclusion: The comparative analysis shows that the structural link is to be favoured since that the coherence of the patient's care and his care path is ensured. In certain situations, mainly geographical, the functional link can have a benefit that offsets the risks generated by the new interfaces; provided that the system is secured by a real tripartite collaboration between health care institution, biology laboratory and delivery site., (Copyright © 2019 Société française de transfusion sanguine (SFTS). Published by Elsevier Masson SAS. All rights reserved.)

A mortality and morbidity (M&M) review consists in analysing, collectively and retrospectively, the cases of patients whose evolution has been marked by a complication or death. This analysis must question whether such an outcome could have been avoided, making it possible to identify the causes and correct the factors having contributed to its occurrence. After a presentation of the methodological and organisational principles, as well as the M&M reviews carried out in France, attention is turned to those performed in psychiatry and identifying the main perspectives for the discipline., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Hospital at home structures are healthcare institutions in their own right, with the same obligations in terms of governance with regard to quality of care and risk management. However, hospital at home services are characterised by the remote management of the activity and the nursing staff, with specific constraints., (Copyright © 2016. Published by Elsevier Masson SAS.)

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.)

A new approach based on the control of the quality of pharmacological management in hospitals has been undertaken by the public authorities in order to fight against pharmacological iatrogenesis. The requirements imposed by regulations are completed by numerous support measures and operational tools with a view to making the drug distribution circuit in hospitals safe. This programme will be developed across the whole of the patient's care pathway.

Preliminary evaluation of quantitative clinical laboratory measurements is a prerequisite for the accreditation of clinical laboratories, according to the French Committee of Accreditation guidelines following the European reference Standard EN ISO 15189. Numerous papers have been published regarding biochemistry and immunology. However, data are lacking for automated complete blood count accreditation. We report here our experience at Hôpital européen Georges Pompidou hematology laboratory and present the performance characteristics of two mirrored LH750 Beckman-Coulter analysers, including precision, accuracy and uncertainty of measurement.

The management of a healthcare institution generates risks through the very hazards of the management process. The management of these risks is integrated into the global safety management process and into the strategic thinking of geriatric hospitals.

Unlabelled: Further to the occurrence of three cases of suicide attempts or suicides within a few months, a psychiatric team introduced a method of evaluation of the professional practices on this subject., Objective: The objective aimed by the team was to collectively identify the risk factors of the acting out and the strategies to prevent it., Methods: The analysis and the treatment of unwanted events require an approach per problem. Because of the obligation for the doctors to perform an evaluation of their professional practices, a proposition to use a method presented by the High Authority of Health was looked for. Considering the necessity of favoring the exchanges between team members, the articulation of two methods was proposed: a morbidity mortality review (MMR) and an analysis of the detailed causes. The objective of the MMR is to analyze the deaths of certain predetermined morbid accidents within a service. The aim of the MMR is to highlight actions for improvement. The analysis of the causes allows the professionals to list all the causes of the problem identified, without limiting themselves to the immediate causes. In this case, a simple method was chosen: the Ishikawa diagram (or fishbone diagram, or also cause-and-effect diagram)., Results: A specific Ishikawa diagram for suicide was created by the coordinating physician and was proposed to the team. In the term of the first MMR, the tool was improved by the collective clinical experience and served as support of analysis for the studied events. Three cases related to the evaluation were prepared beforehand by the referent doctor and later presented by him in MMR sessions. For each case, approximately a dozen of professionals were invited to fill in the biography of the patient. A discussion was then engaged by the external doctor on the circumstances of self injuries or suicide attempts. The three detailed analyses of cases were transcribed into a virgin Ishikawa diagram. Furthermore, several points were discussed on the safety aspects (diversion of the possessions with suicidal aim, and importance of the "almost incident") and on the interest in exchanging on the current and\or local professional practices (exchange on tools possibly used in the other psychiatric health establishments; favor the training). The actions of improvement put in perspective mainly concerned the professional practices. In this particular case, the awareness of professional knowledge was the most sought by the ancillary medical members of the team., Discussion: We observed an important investment of the team, as far as the MMR bases are concerned, on a shared clinical method. The participants easily got to grips with the tool. The initiation with the MMR tool was time consuming, in particular for the doctor coordinating the project and the referent doctor of the department (30 hours). The exchanges also permitted the assessment of the competence of each professional present, and the common priorities were fast identified and focused on sharing the professional practices. The intervention of an external speaker (doctor, qualitician or other) seems important since it favors the emergence of questionings in the team., Conclusion: When faced with unwanted events such as suicides or suicide attempts, the MMR method allows the care teams to have time to ponder, listen and argument. What is learnt from dealing with unexpected events should enable the collective development of the capacity to react with the right reflexes when a surprising situation occurs. The RMM should find a place in the systems of clinical risk management, as a supplement to the declaration of the incidence. The results make it possible to anticipate on the use of the MMR in other thematic studies or issues of risk management., (Copyright (c) 2009 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.)

Background: Few studies have been devoted to in-patients' suicides. This covers all suicides that occurred during hospitalisation, whatever the place (inside or outside the institution) and often, for psychiatric in-patients, suicides carried out within 24 hours after leaving the institution., Literature Findings: However, the incidence of suicide in hospital is high, higher than that observed in the general population. It is 250 per 100,000 admissions in psychiatric hospitals and 1.8 per 100,000 admissions in general hospitals, which is four to five times more than in general population. Five to 6.5% of suicides are committed in the hospital: 3 to 5.5% occur in psychiatric hospitals and about 2% in general hospitals. Many risk factors for suicide were identified in this context. The accessibility to one or more means of suicide (water, rail, high floor [third floor or beyond], knives, possibility of hanging...) is a recognized factor in psychiatric institutions. In the psychiatric environment, hospitalisation period also determines the risk of suicide: it is highest during the 1st week of hospitalisation and within 2 weeks after leaving. The same is true for the conditions of care: inadequate supervision, the underestimation of the risk of suicide by teams, poor communication within the teams and the lack of intensive care unit promote suicide risk. The controlled studies conducted in a psychiatric environment distinguish two periods for identifying risk factors. The first period is the time of hospitalisation. Are recognized as risk factors: the existence of suicidal personal history (but also family) and attempted suicide shortly before admission, the diagnosis of schizophrenia or mood disorder (non-controlled studies also emphasize the importance of alcoholic comorbidity), being hospitalised without consent, living alone, absence from the service without permission. The second period covers the time-period immediately following the hospitalisation. For this period, risk factors are: the existence of personal history of suicide and suicidal ideation or attempt of suicide shortly before admission (but also attempt of suicide during hospitalisation), the existence of relational difficulties, the existence of stress or loss of employment, living alone, a decision on leaving the hospital unplanned and lack of contact with nursing in the immediate postdischarge period. In general hospitals, the chronicity and severity of the somatic disease, the personality of the patient and the existence of a psychiatric comorbidity are the suicidal factors most often quoted. Furthermore, we also found only a low rate of psychiatric consultation during the hospitalisation of patient who will commit suicide. Among the countries which have a national program of suicide prevention, only England registered the question of the in-patients suicide among its priorities. The elements of a prevention policy appear however in certain scientific publications and some programs of local or regional initiative. These elements can be grouped under five items: securing the hospital environment, optimisation of the care of the patients at suicidal risk, training of the medical teams in the detection of the risk and in the care of the suicidal subjects, involvement of the families in the care and implementation of post-event procedures following a completed suicide or an attempt., (Copyright © 2009 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.)

Purpose: To deploy an inductive process for radiotherapy risk management in a regional cancer centre and to infer the actions required to solve the situations of criticality., Methods: Close collaboration between the department of radiation oncology-biophysics and the department of quality and risk management in the same institution allowed to create a multiprofessional and multidisciplinary task force and to make the experience feedback easier. A preliminary risk analysis method was used to identify the generic dangers, the mapping of risks and the specification of the scales of criticality. This method helped to evaluate and to rate each apprehended event. Four scales have been defined: seriousness scale in five levels, likelihood scale in five classes, endeavour scale in four levels and criticality scale in three categories: acceptable (criticality 1) tolerable under control (criticality 2) and unacceptable (criticality 3)., Results: Fifty-seven level 1 dangerous situations linked to 78 scenarios of criticality acceptable, tolerable and unacceptable in 24, 44 and 10 cases respectively have been identified in the department of radiotherapy leading to carry out 28 risk reduction actions., Conclusions: The performed risk analysis offered an original frame for a collective thinking among the care providers and contributed to modify their mode of conceiving both security and radioprotection. The study allowed us to give a relevant answer to the High Authority of Health and the Authority of Nuclear Security demands either in terms of efficient management of the risks in radiotherapy or regarding the daily concerns of the caregivers., (2009 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.)

In February 2007, the radiation therapy department of the Jean Monnet Hospital in Epinal (France) has stopped the radiotherapy treatments after the discovery of a radiotherapy accident and bad practices leading to overexposure of patients between 1987 and 2006. The Regional Cancer Center "Centre Alexis Vautrin" in Nancy (France) was given the task of the new start of treatment activity. From February 2007 to January 2008, actions of training, updates of equipments and practices have been performed in the Epinal Hospital, guided by the quality approach, allowing the treatment of new patients in February 2008, with the radiation oncologists and the medical physicists of the Centre Alexis Vautrin, with the highest conditions of security and confidence.

Background: Failures may occur in each part of the medication use process. This study aimed to evaluate the barriers existing in hospital pharmacies in order to prevent medication errors and to help institutions to make improvement actions., Methods: Within the framework of the SECURIMED project, risk assessment visit (interviews, observations, analysis of adverse event scenario by professionals...) were conducted in volunteer hospital pharmacies. A restitution meeting, after visit in each pharmacy permitted exchanges between visitors and professionals on barriers and weaknesses and then on solutions to reduce identified risks., Results: Twenty-one hospital pharmacies participated. Despite presence of safeguards in some pharmacies, many weaknesses were retrieved (multiplicity of process, lack of resources...) and clinical pharmacy was not enough developed., Conclusion: This project has led to an overview of the situation in Aquitaine, and created a regional dynamic to improve the medication system safety.

In medicine, as in oncological radiotherapy, as elsewhere, the precept of quality has no meaning if it is not defined. In France as everywhere radiotherapy has its forces and its weaknesses. As in every country, its future seems assured by its character cost effective as by its capacity to make progress in the triple point of view of its equipment, its professions and its organization. However, the French radiotherapy is in crisis. The professionals saw clearly. For more than 10 years they had recalled the medical authorities to their responsibilities concerning the demographic trends for the radiotherapists and the physicists, the renovation of the equipment, the modernization of the organizations, the promotion of the evaluation of procedures and outcomes and the development of a greater fairness in the financings. But the delay taken, the setting under pressure of the professionals by the State, its services, its agencies and the media following the recent accidents cause numerous perverse effects and worried the staff. The accident of Epinal was the starting fact of an effort of professionalisation of the risk management, but also of a disturbed period favourable with a certain confusion of minds, discouragement and protective behaviors. The risks felt by the professionals then seem especially to come from the authorities and the media. It appears that the topic of quality is at the center of all these speeches. Under this vocable, it is in fact the respect of the procedures related to the requirement of security which is privileged by the State and its representatives. The apparent security seems to override the real quality of the practices. Thus, time came for a clarification of the quality and security concepts, of organizations which contribute to it and for the development of a clear strategy bringing together the interprofessionnal actors. In this context, the implication of the College and especially of the Société française de radiothérapie oncologique is a requirement.

Background: In France, antimicrobial resistance monitoring is based on the contribution of many microbiological partners and networks, especially hospital laboratories. In order to complete this surveillance, the InVS implemented a network based on private-sector laboratories (PSL): the Labville network., Method: Stratified by French region, 69 PSL were randomly selected. The microbiological analysis results, including anonymized individual patient data, are translated into an appropriate data format within an automated reading process. This data is then sent to InVS through a secure Internet connection., Results: The specifications of the automated system were defined according to a feasibility study conducted in 2003. The first stage of the project consisted in defining a global strategy for the reading of printed microbiological results. Then, the parameters were adapted for each PSL using a set of specific analysis over two to three weeks. After validation by InVS, the reading strategy was applied on to routinely printed results. The strategy was definitely validated after four month of a daily data transmission. The general approach needs to be adapted to each PSL and undergoes several adjustments. This long step of the project still requires microbiological expertise., Conclusion: The automated data extraction process used for Labville project is innovating. It is not affected by the compatibility and diversity of computing systems and reduces the biologist's workload. The Labville network is a challenging project motivating future development of other electronic surveillance networks.

The study carried out at Percy hospital (Clamart, France) gives a description of nurses' practices for each stage of the drug use process. Their knowledge about drugs risk was also evaluated. Results of this background give an assessment of practices before hospital accreditation and will be used to define the priority actions of improvement. Recent implementation of unit dose drug dispensing system and simplification of adverse drug event report illustrate these actions to enhance safety and to decrease iatrogenic risk. In addition, pharmacists proposed a training for nurses about drug iatrogenic disease.

The code de santé publique imposes to all health professionals an obligation to declare serious and undesirable events following cares applied during treatment investigations or prevention actions. An experimentation has been installed under the responsibility of the Institut de Veille sanitaire further to the 9 August 2004 bill. It aims to define how to declare undesirable adverse events to test its feasibility, its efficiency and to identify the necessary conditions to widespread its modalities. The field of these experimentations concerns all health professionals, working in public hospital or in private practice. The definition of undesirable adverse events should be clarified. Different ways to declare these events will be discussed with SFRO (Société française de radiothérapie oncologique) to improve the current management of incidents and adverse events.

Large modifications are on going in our medical practice in oncology (cancer incidence, ageing, rules, authorizations, billings...). To obtain the best results as possible implies a quality control of the equipments (drugs, machines...), of the professionals (certification) and of the organisations (accreditations). Radiation oncology plays a key role in the multidisciplinary treatment of cancer ant is very sensitive to quality assurances due to its specificities: different tumours, various patients, multiple sequences of treatment with high tech machines and information systems. From 2003, a progress policy has been developed with the MeaH (Mission d'évaluation et d'audit hospitalier). Rapidly, the transfer of security policies from industry to medicine has been considered. This paper will present the first results and their potential implications in the field of oncology.

The environment of drug safety is changing. In addition to the current system of pharmacovigilance based on spontaneous report of adverse events, clinical data observed in a given patient with a given symptom is taken into consideration and compared with information coming from pharmacovigilance data bases, which is then analyzed for causality by the experts of both the promotor and the public network. Such information is integrated into a risk management strategy, defined together by the French drug agency (Afssaps) and the marketing authorization holder. This strategy includes a pharmacovigilance plan and, if possible, a risk minimisation plan.

The recent increase in the incidence of severe anaphylaxis calls for continual assessment of risk factor and dangers associated with food allergy, keeping abreast of changes in the food industry. Allergologists, regulatory bodies and the food industry are all responsible for food safety. The Allergy Vigilance Network, founded by a university research team and comprising 398 French and Belgian allergologists, has developed a three-point strategy. First, reporting cases of severe anaphylaxis of document allergic origin makes it possible to monitor the prevalence of food allergens and to evaluate the quality of management of allergy-related emergencies, thus providing data suitable for estimating the economic burden of anaphylaxis. The second objective of the network is to set up multicenter trials to determine the prevalence of sensitization to risk allergens, such as peanut, lupin and plant pollen, of which transgenic varieties will soon emerge. The third objective is screening and long-term monitoring of dangers related to new foods, ingredients and adjuvant sensitizing factors. Post-marketing monitoring of potential allergic risks arising from genetically modified food is another aim of the network, together with the establishment of a serum bank, following WHO/FAO recommendations. The Allergy Vigilance Network, together with the French National Institute for Food Safety (AFSSA), the Ministry of Consumer Affairs (DGCCRF) and various patient associations, is striving to analyse and deal with dangers related to the allergenicity of natural and modified food proteins.

In 1999, The Regional Center of Pharmacogilance and the Department of Infectious Disease of the Toulouse University Hospital set up a system to improve the data collection about antiretroviral-induced adverse reactionss (ADRs). From November 1999 to April 2003, a resident of pharmacovigilance collected ADRs reported with antiretroviral drugs during 2 weekly medical consultations. A total of 613 ADRs corresponding to 428 patients were reported, classified as "non serious" in 88.6% of cases and required the withdrawal of suspected drugs in 57% of cases. Our data show an improvement of antiretroviral drug-induced ADRs reporting.

Surveillance activities first target health problems for which treatment, effective prevention or control measures are available. The data produced by surveillance systems allow prioritising public health actions and defining the objectives of infectious diseases control or prevention. The surveillance of infectious diseases relies on a large number of partners grouped in a public health network in which clinicians have a prominent role. In France, the surveillance of infectious diseases is based on mandatory notification of some diseases, national reference centers, networks of voluntary health professionals and repeated surveys, alerting health authorities in case of threats and identifying the determinants of changes in the population health's status. At hospital, the infectious risk is significant and the risk of epidemic outbreaks very high. A solid system for surveillance is mandatory. An educational program is needed to define the prevention program based on the use of hand disinfection and other standard precautions, antiviral and pneumococcal vaccination. A strong cooperation between general practitioners, healthcare team and relatives is necessary.

Throughout medical training, medical risk management is a subject that has been insufficiently addressed and treated without a global vision. Yet the different dangers often make the front page of a media that addresses the question of health security when there is a failure of the system or new legal developments. Added to this disequilibrium of communication and training is the great complexity of risk management. Not only is the nature of the potentially dangerous agents extraordinarily varied but also the entity that detects the risk is sometimes a stranger to the causes of its appearance. The surrounding regulations are themselves complex and dense. Using the examples that have arisen over the last 2 or 3 years, this article describes the current French protocols in risk management, that rely upon the agencies delivering their expertise, certain of which are endowed with the power of policing these regulations. In practice, the doctor should understand the role of these agencies, know how to find the validated information that they can provide, and understand his role in this picture. A role that is perceived as far away as long as the risk has not emerged, but is in the forefront once the event arises.

The precautionary principle has boomed in the French public health sector through blood transfusion. There has been, however, no perambulatory reflection on the definition, objectives, methods of application or consequences of this principle. The question of the pertinence of its application remains unanswered. This study, based on interviews with blood transfusion practitioners, aims to establish their perceptions of the precautionary principle's application in this specific field and of its consequences in terms of risk management and patients' rights. The pros and cons of this application are analysed based on these perceptions. According to our analysis, the precautionary principle seems to be born of confusion. It is seen more as a way to protect decision makers than patients and, if taken to extremes, could prejudice medical logic. Nevertheless, it also brings measures which renew and encourage evolution in transfusion risk management.

Introduction: The misuse of drugs, common practice for some, is a source of iatrogenic diseases and considerable supplementary costs in hospital budgets. The aim of this study was to quantify the number of adverse events (AE) related to the misuse of drugs., Methods: This was a study conducted on 200 new validated AE case reports. In each report, we searched for the drug(s) responsible and checked whether the prescription respected the SPC (summary of product characteristics) and current guidelines or not., Results: Among the 200 reports, 49 (24.5%) cases of AE were related to the misuse of a drug in 46 patients, with a mean age of 65.8 years [24 to 97]. Among these cases, 33 (67.3%) were at the origin of hospitalisation or prolongation of the latter. In 17 cases (34.7%), there was no therapeutic alternative to the drug used in the framework of misuse., Discussion: The notion of good or bad use of a drug progresses with the life of the drug. We therefore selected as criterion of misuse the non-respect of the SCP but also other guidelines. Regarding the cases that could have been avoided, these concerned an AE related to poor surveillance and assessment of the benefit/risk ratio of treatments prescribed to elderly patients and also the commonplace use of non-steroidal anti-inflammatories, at the origin of digestive haemorrhages., Conclusion: The prevention of misuse implies all the actors of the health system. A reassessment of the prescription of certain therapeutic classes of drugs would avoid a great number of iatrogenic accidents and would lead to considerable economy in the field of health.

After several decades of gradual improvement in its system for managing health risks, France was confronted in 1996 with the bovine spongiform encephalopathy crisis. This triggered a collective questioning, which highlighted the need to reform a system that had shown its limitations. Risk analysis, established as a key principle by the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) of the World Trade Organization (WTO), was cast as the necessary basis of the reform, objectives of which were to better identify priority risks in order to ensure the protection of human and animal health, and to improve the quality of measures implemented by the public authorities. The Act of 1 July 1998 founded several independent risk assessment agencies, including the French Agency for Food Safety (AFSSA), with the specific mandate of food safety at every stage of the food chain. Other organisational reforms enhanced the new system, notably the separation between the functions of risk management and economic support for food industries, initially at central level, then in 2002 at the level of field services in the 100 French départements. Lastly, new procedures were introduced. These were designed, in accordance with the principles of risk assessment, to better identify and to individualise the different decision-making sequences. The decision-making process was extended to include submission to the agency in charge of evaluating health risks and examination by the agency of the resulting draft decision.

The PRISMAL (Perception, representation and health risk management in rural settings) network comprises three academic research teams, two health insurance agencies, and two health care networks in the Franche-Comté region that share their expertise to study the relationship between health and the rural environment. Three main objectives guide the network's activities and are linked to the following questions: 1) What are the epidemiological changes linked to the rural setting; what are their causes and effects? 2) What are the relationships between the rural environment, health risks, behaviours in seeking health care, access to health care services and quality of life? 3) What are the perceptions and representations of the affected populations on health risks specific to the rural setting? Research activities utilise specific diseases as examples of the result from interaction with the rural environment, such as "farmer's lung", alveolar echinococcosis, occupational risks for farmers, lung cancer, suicide attempts, premature birth, and vascular stroke. The partnership's framework extends well beyond the medical world and includes ecologists, geographers, sociologists, administrators and environmental technicians.

The creation of the Etablissement Français du Sang (EFS) was mentioned in the Law of July 1, 1998, pertaining to sanitary safety. The EFS is the sole operator of blood transfusion. With a unique legal status, supervised by the Ministry in charge of Health, the EFS organizes the activities involved in the transfusion chain over the whole territory, it promotes research activities and take part in international scientific cooperation. Its activities include medical biology as well as cell and gene therapy. As part of the new 2000-2004 territorial transfusion scheme, the EFS network comprises 18 centers (versus 43 in the previous plan), 14 of which are located in the French territory and the other 4 overseas. The network includes 18 technical platforms for the biological qualification of blood products, while 27 are dedicated to their preparation, transformation and storage. The activities of collection and distribution, which comply with the principle of proximity to both donors and patients, are ensured by 220 sites spread over the whole territory. For the future, the EFS wants to focus its efforts on reducing residual infectious risks (using molecular biology tools), preventing immunological risks, drawing up an education program aiming at teaching transfusion medicine differently. Despite the advances achieved in biotechnologies, the development of substitution products to replace blood transfusion will still require a lot of time. The EFS wishes to focus its action following three different axes: transfusion medicine, medical biology and cell engineering. With its 18 centers and its 8,200 persons, the EFS must face the challengers of the 2000s, relying on the advances in biotechnologies.

International marketing of animals, animal products and food stuffs and the emergence or re-emergence of food poisoning has raised the risk of international transmission of certain infectious agents. Risk analysis, with its three components, assessment, management, and information, constitutes a new approach to state health policies. To guarantee health safety of the human, animal and plant populations, states can prohibit importation or marketing of food products if their decisions are based on open scientific evidence. Risk assessment is a structured open process evaluating available data designed to modelize transmission of the infectious agent integrating the different elements of the food chain from production to consumption. The assessment process involves four phases, The results of risk assessment depend on the pertinence and the quality of the data used for each of these four phases. Data required to implement risk assessment are unfortunately widely dispersed. The food and agriculture industry, official regulatory agencies, consumer watch organizations, and the scientific community all have useful information for risk assessment. The lack of standard methods to collect, process and diffuse data further complicates the problem.

Genetic transformation constitutes a new tool for improvement of microorganisms, animals and plants used in food. Foreseeable risks are evoked, as well as management measures to avoid GMO unsuspected risks. Few risks are specific to GMOs. Present elements of french and european regulations concerning placing on the market and follow up GMOs and other novel foods are described.