Trace level quantification of N-nitrosorasagiline in rasagiline tablets by LC-TQ-MS/MS.

Parkinson's disease is a chronic, progressive neurological disease that currently affects about more than 10 million population worldwide. Rasagiline is a selective, irreversible monoamine oxidase type B inhibitor used as monotherapy in early Parkinson's disease. Rasagiline tablets have been recalled from market due to the presence of unacceptable levels of nitrosamine impurity. European Medical Agency has set up very stringent limit 100ng/day of N-nitrosorasagiline (NSRG) in drug product based on its mutagenicity. The analytical methods need to be sufficiently sensitive in order to adequately detect and quantify trace levels of NSRG. A highly sensitive LC-MS/MS method for determination of NSRG in rasagiline tablet formulation was developed by effectively separating on zorbax eclipse XDB C18 column using 0.1% formic acid in mixture of water and acetonitrile (35:65 v/v) in an isocratic mode at 0.5mL/min flow rate. The measurement of NSRG was performed using triple quadrupole mass detection accompanied by electrospray ionization in the multiple reaction monitoring mode. The validation of the method was comprehensive, demonstrating strong linearity across the concentration spectrum of 2 to 200ng/mL for NSRG. The obtained correlation coefficient exceeded 0.998, signifying a robust relationship. Recoveries spanning from 80.0% to 120.0% for NSRG were deemed satisfactory. The developed method was able to detect and quantitate NSRG at a concentration level of 1 to 2ng/mL respectively (1 to 2ppm with respect to 1mg/mL of rasagiline tablet sample concentration). The developed and validated method can be employed for routine quality control testing of rasagiline tablets.

[Reform of early access program in France: Impact on workload in a pharmacy and risk identification]. / Réforme de l'accès dérogatoire : impact sur la gestion dans une PUI et identification des risques.

The reform of derogatory access authorisations (DAs) on 1st July 2021 has distorted the routine of the hospital pharmacists dealing with innovative medicines that are waiting for marketing authorization or approval. There are two distinct categories of DAs: Compassionate Access Authorisations (CAAs) are granted by the French National Agency for the Safety of Medicines (ANSM) while Early Access Authorisations (EAPs) are granted at the request of pharmaceutical companies by the French National Authority for Health (HAS). All AAPs and a majority of the AACs are supported by a Protocol for Therapeutic Use and Data Collection (PTU-DC). The aim of this study is to assess the impact of the reform on pharmacy process one year following its implementation, and to identify the risks related to the new circuits. The working group, composed of three pharmacists carried out an initial assessment of the effects first measured the impact of the reform on medicine processes in DAs. They performed a comparison of the changes in their management methods: 3 months prior to the reform (M0), and 3 (M3) and 12 months (M12) post-reform. Risks analysis was conducted using the Failure Modes, Effects and Criticality Analysis (FMEA) method. The analysis was limited to the process steps specific related to DAs drugs were analyzed. The critical severity of the risk situations identified was rated. A critical hierarchy matrix was used to establish priority actions. The priority actions to be taken were determined using the critical hierarchy matrix. Over the span of one year, the number of DAs in our establishment showed a 31.7% increase, from 41 at M0 to 54 at M12. At M0, the proportion of drugs needed inclusion via a drug-specific digital platform, specific to each drug, stood at 27% (11/41) of drugs at M0 while at M12, it rose to 52% (28/54). The percentage of PTU-DCs therefore increased by a factor of 1.7, rising from 29% (12/41) at M0 to 47% (21/45) at M3 and 60% (32/54) at M12. For orders, which are always nominative, approval depends on both the presence of the PTU-DC tracking sheet being present in 12% of PAAs, and the inclusion number in 26% of PAAs. The risk analysis shows 49 failure modes leading to risk situations. Among the failure modes, 36 have a consequence of acceptable or tolerable criticality under control, whilst 13 are deemed of unacceptable criticality. A suitable control method exists has been identifies for 5 of them. Finally, the ranking evaluation of criticalities has highlighted 4 situations which require immediate action as a priority: delivery times, obtaining completed tracking sheets and ordering procedures. The aim of the DAs reform is to simplify access to innovative medicines. However, the reform has significant and damaging repercussions on pharmaceutical activities. Corrective measures need to be taken in conjunction with all parties involved in the circuits including laboratories and service providers (CROs), authorities and healthcare professionals.

[Optimizing the use-by date of reusable medical devices. Experience in a healthcare establishment]. / Optimisation de la date limite d'utilisation des dispositifs médicaux réutilisables. Expérience dans un établissement de santé.

OBJECTIVES: Sterilized reusable medical devices have a use-by date, after which sterility is no longer guaranteed. There is currently no consensus on how this should be determined. The aim is to re-evaluate the expiry date of reusable medical devices, by means of a risk analysis and an assessment of the maintenance of the sterile state of reusable medical devices over time. METHODS: The risk analysis focused on the stages whose malfunction could compromise the sterility of reusable medical devices over time: packaging, transport and storage. Risk mapping was carried out in accordance with the methodology recommended by the French Health Authority. Based on standard NF EN ISO 11737, the assessment of the maintenance of the sterile state was checked on reusable medical devices after two, four and six months storage and on reusable medical devices that had expired more than a year previously. RESULTS: The risk analysis identified four failures and sixty-eight potential causes. The most sensitive stage was storage, which accounted for most of the critical and major causes. Improvement actions were proposed, such as the definition of a container maintenance plan. At the same time, 256 reusable medical devices were tested. The cultures remained sterile for all the containers, for folded products tested at 6 months and more and for the sachets tested at 2 and 4 months and at more than one year of storage. CONCLUSIONS: The DLU has been extended to 4 months for sachets, 6 months for folded products and maintained at six months for containers.

[Staff hebdomadaire qualité et gestion des risques en gériatrie: un outil d'appropriation de la démarche qualité pour le management des unités]. / Staff hebdomadaire qualité et gestion des risques en gériatrie : un outil d'appropriation de la démarche qualité pour le management des unités.

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.

[Setting up a training program in a geriatric short-stay department]. / Mise en place d'un programme de formations au sein d'un service de court séjour gériatrique.

As the department's team had been renewed in less than two years, it was necessary to invent a method to improve cohesion and communication, and to enhance the skills of professionals. This led to the creation of a training program using a variety of methods (theoretical training, care approaches and quality coffees).

[Drug Consumption Rooms : Opinion and willingness among people who inject drugs in Marseille, France]. / Salles de consommation à moindre risque : opinion et volonté d'utilisation des personnes injectrices de substances psychoactives à Marseille, France.

BACKGROUND: In France, people who inject drugs (PWID) are still one of the most at risk population for contracting hepatitis C virus (HCV). Drug consumption rooms (DCR) have shown their effectiveness on HCV risk behaviors abroad and in France, where they have been recently evaluated with the COSINUS study. In France, two DCRs opened in 2016, one in Paris and another in Strasbourg. The objective of this sub-analysis was to explore the willingness to use a DCR in PWID living in Marseille, where no DCR is opened. METHODS: The COSINUS study is a prospective multicenter cohort that included 665 PWID recruited in Bordeaux, Marseille, Paris and Strasbourg between 2016 and 2019. Investigators administered questionnaires face-to-face at regular intervals at baseline, 3 months, 6 months and 12 months. In Marseille, 199 PWID were recruited. A multivariable logistic regression model was performed to assess factors associated with willingness to use DCR among this population. RESULTS: Among 545 observations corresponding to 195 distinct participants selected for analyses, 57% declared they were willing to attend a DCR. The main reason given was "to consume more cleanly". Receiving allowances (OR = 2.38; 95% confidence interval (CI) (95% CI) = 1.17-4.81), not having health insurance (OR = 3.61; 95% CI = 1.49-8.75), injecting daily (OR = 1.97; 95% CI = 1.05-3.70) and in a public space (OR = 2.66; 95% CI = 1.29-5.47) were all positively associated with willingness to use a DCR. CONCLUSIONS: DCR are devices that target PWID exposed to high sanitary or social risks, i.e. people living in precarious conditions, who have to inject in public spaces, in deleterious sanitary environments and with rapid gestures in order not to be seen. These analyzes highlight that the people who most want to attend a DCR are aware of the harms associated with their practices and show a desire to seek protection from street-based drug scenes.

[Drug abuse of pregabalin - state of the situation, risks and means of control]. / Détournement de la prégabaline à des fins toxicomaniaques - état de la situation, risques et moyens de lutte.

Pregabalin is an anticonvulsant widely used for the treatment of epilepsy and neuropathic pain. However, there is a growing concern about its misuse, particularly among drug users and patients with substance use disorders (SUD). It is often used in combination with other psychoactive molecules and at levels well above the recommended doses. Increasing cases of overdose and death associated with the misuse of pregabalin have been reported worldwide. Therefore, raising prescribers' awareness of this scourge is mandatory and the role of the pharmacist is crucial in reducing this phenomenon.

[Evaluation of practices through simulation: Implementation of Horror Week in a cytotoxic preparation unit]. / Évaluation des pratiques par simulation : mise en place de la semaine de l'horreur dans une unité de préparation de cytotoxiques.

OBJECTIVES: The objective of this work is to describe the interest of developing a simulation for the evaluation and improvement of practices through the realization of a horror week in a cytotoxic preparation unit. METHODS: The simulation was divided into five days, each corresponding to a step in the cytotoxic circuit. Five errors per day were produced and presented to the team in a dedicated room. An observation form was used to collect the errors identified by each person. A satisfaction questionnaire was distributed and a collective debriefing took place remotely. RESULTS: The average number of errors identified per day was 3.8. The least common errors were reversal of patient height and weight, overloading of the sterilization basket, failure to follow dressing rules in the controlled area, absence of the temperature-monitoring disk, and absence of an opaque bag for photosensitive chemotherapy. The perceived level of difficulty was 3.33/5 and the organization was satisfactory to all participants. CONCLUSIONS: Horror Week achieved its objectives by raising awareness among professionals of the risks of the chemotherapy circuit. The errors that were found to be the least significant allowed us to develop priority areas for ongoing training for our unit.

Profiles and health risks (STIs, HCV, HIV) of injecting drug users.

OBJECTIVE: The aim of this article is twofold: to present the sociodemographic profiles of people who inject drugs (PWID) in Togo and to assess the prevalence of health risks (sexually transmitted infections [STIs], the hepatitis C virus, and HIV), the problems linked to drug injection, and the factors characterizing PWIDs. PARTICIPANTS AND METHODS: Using a questionnaire, this cross-sectional descriptive study was conducted on 384 PWIDs in Togo. The questionnaire focused on sociodemographic characteristics, consumption history, and known health problems and risks. Snowball sampling allowed for data collection in all regions of the country. RESULTS: In the sampling, the results revealed prevalence of 17% for STIs and 53% for the hepatitis C virus. The onset of medical problems and STI signs was significantly triggered when the person was female, over 25 years of age, polygamous, not attending school, unemployed, and had been using drugs for more than five years. Moreover, reused injection equipment was shown to be associated with the high STI prevalence. CONCLUSION: Drug injection is dangerous and results in numerous health problems. This study shows that PWID vulnerability of stems from specific characteristics, such as being uneducated, single, unemployed, bereft of parents, and having a low monthly income. Additional research is required to further investigate the health risks associated with drug injection in view of providing PWIDs with comprehensive care.

[Perinatal maternal suicide: How to prevent?] / Suicide maternel périnatal : comment prévenir ?

The sixth report of the National Confidential Survey on Maternal Deaths provides insights into the frequency, risk factors, causes, adequacy of care, and preventability of maternal deaths occurring in 2013-2015 in France. The method developed ensures an exhaustive identification and a confidential analysis of maternal deaths. It was organized in three steps. 1) All deaths occurring during pregnancy or up to 1 year after its end, whatever the cause or mode of termination, being considered 2) A pair of volunteer assessors (midwives, gyneco-obstetricians, anesthesiologists, psychiatrists) was in charge of collecting the information (history of the woman, course of her pregnancy, circumstances of the event that led to the death and management); 3) Review and classification of deaths by the National Committee of Experts on Maternal Mortality which made a collective judgment on the cause of death, on the adequacy of the care provided, and on what could been done to avoid the death depending on the existence of circumstances that could have prevented the fatal outcome. The operation of the committee has been enriched by new resources to further explore these cases. Specifically, a module of the survey questionnaire, the recruitment of psychiatrists whose contribution allows relevant documentation of the suicides, and the participation of a psychiatrist as an associate expert for the analysis of the appropriateness of the management and the variable determining factors of these cases. Suicide becomes one of the two main causes of maternal mortality, (the other cause being cardiovascular pathologies), with 35 suicides on the triennium among the 262 maternal deaths, that is to say 13.4 % of maternal deaths, about 1 per month. In this population, the average age of women who died by suicide was 31.4years. The majority of the women were born in France, 68 % were prima parous, and in 9 % of cases suicide followed a twin pregnancy. Psychiatric history was known in 33.3 % of the suicidal mothers, and 30.3 % had a history of psychiatric care that was unknown to the maternity team.43 % of the women had psychosocial vulnerability factors, a history of violence, and eviction from the home and/or financial difficulties. In 23 % of the cases, the time of occurrence of these suicides was within the first 42days postpartum, and in 77 % between 43 days and one year after birth with a median delay of 126days. Only one suicide occurred during pregnancy. Maternal suicides were mostly violent deaths. Suboptimal care was present in 72 % of cases, where 91 % of potentially preventable deaths related to a lack of multidisciplinary management and/or inadequate interaction between the patient and the health care system. Among these potentially avoidable deaths, we were able to distinguish: women whose psychiatric pathology was known and for whom multidisciplinary management was not optimal, and women whose psychiatric pathology was not known or was not present - for whom it was rather a matter of a failure to detect and identify the signs, particularly by obstetric care providers or general emergency services. Based on the analysis of the cases, strong messages were identified, with the aim of optimizing management: - The screening by structured questioning of psychiatric history from the moment of registration in the maternity ward, repeated at each consultation throughout the pregnancy. - The reassessment of the psychological and somatic state through an early postnatal interview at one month; - The identification of warning symptoms, with screening tools for depression. If necessary, a further recourse to the psychologist and/or psychiatrist of the maternity hospital, organisation of a home hospitalization, and a private midwife to provide a link in the pre- and postpartum period. This, in addition to the earliest possible care in the PMI (Maternal and Infantile Protection, of the French social care system), appointments with mental health professionals,and the link with the attending physician; - The implementation of a coordinated care pathway in case of a known psychiatric pathology with pre conception counselling. This includes a multidisciplinary collaboration, an adaptation of psychotropic treatment, management of comorbidities referral to specialized perinatal psychopathology teams, prenatal meeting with the pediatrician of the maternity hospital, anticipation of the birth, postpartum and discharge options, liaison sheet established for the organization of the delivery and postpartum, and a regular written transmissions between the intervening parties throughout the care; - The generalization of medico-psycho-social staffs, in maternity wards, for all situations identified as at risk. In addition to the need for training and increased awareness on psychological issues during the perinatal period and on the different pathologies encountered by adult mental health professionals and front-line workers, it is necessary to encourage the development of resources in the country. Particularly, joint child psychiatrist-adult psychiatrist consultations at the territorial level, responsible for being resource contacts for maternity wards and local care professionals, as well as the promotion of case pathway referrals.

[Early intervention in bipolar affective disorders: Why, when and how]. / Intervenir précocement dans les stades débutants du trouble bipolaire : pourquoi, quand et comment.

OBJECTIVES: Bipolar disorder (BD) is a chronic and severe psychiatric disease. There are often significant delays prior to diagnosis, and only 30 to 40 % of patients will experience complete remission. Since BD occurs most often at a young age, the disorder can seriously obstruct future socio-professional development and integration. Vulnerability-stress model of BD is considered to be the result of an interaction between vulnerability genes and environmental risk factors, which leads to the onset of the disorder most often in late adolescence or early adulthood. The clinical "staging" model of BD situates the subject in a clinical continuum of varying degrees of severity (at-risk status, first episode, full-blown BD). Given the demonstrated effectiveness of early intervention in the early stages of psychotic disorder, we posit that early intervention for early stages of BD (i.e. at-risk status and first episode mania or hypomania) would reduce the duration of untreated illness and optimize the chances of therapeutic response and recovery. METHODS: We conducted a narrative review of the literature to gather updated data on: (1) features of early stages: risk factors, at-risk symptoms, clinical specificities of the first manic episode; (2) early screening: targeted populations and psychometric tools; (3) early treatment: settings and therapeutic approaches for the early stages of BD. RESULTS: (1) Features of early stages: among genetic risk factors, we highlighted the diagnosis of BD in relatives and affective temperament including as cyclothymic, depressive, anxious and dysphoric. Regarding prenatal environmental risk, we identified peripartum factors such as maternal stress, smoking and viral infections, prematurity and cesarean delivery. Later in the neurodevelopmental course, stressful events and child psychiatric disorders are recognized as increasing the risk of developing BD in adolescence. At-risk symptoms could be classified as "distal" with early but aspecific expressions including anxiety, depression, sleep disturbance, decreased cognitive performance, and more specific "proximal" symptoms which correspond to subsyndromic hypomanic symptoms that increase in intensity as the first episode of BD approaches. Specific clinical expressions have been described to assess the risk of BD in individuals with depression. Irritability, mixed and psychotic features are often observed in the first manic episode. (2) Early screening: some individuals with higher risk need special attention for screening, such as children of people with BD. Indeed, it is shown that children with at least one parent with BD have around 50 % risk of developing BD during adolescence or early adulthood. Groups of individuals presenting other risk factors, experiencing an early stage of psychosis or depressive disorders should also be considered as targeted populations for BD screening. Three questionnaires have been validated to screen for the presence of at-risk symptoms of BD: the Hypomanic Personality Scale, the Child Behavior Checklist-Paediatric Bipolar Disorder, and the General Behavior Inventory. In parallel, ultra-high risk criteria for bipolar affective disorder ("bipolar at-risk") distinguishing three categories of at-risk states for BD have been developed. (3) Early treatment: clinical overlap between first psychotic and manic episode and the various trajectories of the at-risk status have led early intervention services (EIS) for psychosis to reach out for people with an early stage of BD. EIS offers complete biopsychosocial evaluations involving a psychiatric examination, semi-structured interviews, neuropsychological assessments and complementary biological and neuroimaging investigations. Key components of EIS are a youth-friendly approach, specialized and intensive care and client-centered case management model. Pharmaceutical treatments for at-risk individuals are essentially symptomatic, while guidelines recommend the use of a non-antipsychotic mood stabilizer as first-line monotherapy for the first manic or hypomanic episode. Non-pharmacological approaches including psychoeducation, psychotherapy and rehabilitation have proven efficacy and should be considered for both at-risk and first episode of BD. CONCLUSIONS: EIS for psychosis might consider developing and implementing screening and treatment approaches for individuals experiencing an early stage of BD. Several opportunities for progress on early intervention in the early stages of BD can be drawn. Training first-line practitioners to identify at-risk subjects would be relevant to optimize screening of this population. Biomarkers including functional and structural imaging measures of specific cortical regions and inflammation proteins including IL-6 rates constitute promising leads for predicting the risk of transition to full-blown BD. From a therapeutic perspective, the use of neuroprotective agents such as folic acid has shown particularly encouraging results in delaying the emergence of BD. Large-scale studies and long-term follow-up are still needed to achieve consensus in the use of screening and treatment tools. The development of specific recommendations for the early stages of BD is warranted.

[Literature review on pharmacovigilance of medicines derived from traditional pharmacopoeias. Part II: Risks assessment and prevention]. / Revue de la littérature sur la pharmacovigilance des médicaments issus des pharmacopées traditionnelles. Partie II : évaluation et prévention des risques.

After the initial stage of the pharmacovigilance process for medicines from traditional pharmacopoeias - which concerns the identification of the risks associated with their use - the risk assessment should now be approached. The latter makes it possible to detect potential signals early and to take preventive measures. We sought to understand, from a review of the literature, the steps and methods of risk assessment relating to traditional medicines, as well as the prevention strategies applied to them. All of the work carried out on the subject has shown that the steps and methods for assessing and preventing drug risks are the same for both conventional and traditional medicines. Risk assessment includes analysis of the quality of individual notifications, assessment of causality, detection and evaluation of signals. The World Health Organization method is the most widely used for causality assessment internationally, while disproportionality measures are the most applied for signal detection. Regarding prevention, risk communication is the main strategy for the risks associated with traditional medicines. This review suggests the involvement of traditional medicine practitioners both in the notification system and in the communication strategy on the risks associated with their products.

[Literature review on pharmacovigilance of medicines derived from traditional pharmacopoeias. Part I: Risks identification]. / Revue de la littérature sur la pharmacovigilance des médicaments issus des pharmacopées traditionnelles. Partie I : identification des risques.

Globally, the use of drugs from traditional pharmacopoeias is a major subject. The confidence of the populations in these drugs is linked to their presumption of safety and also to the fact that geographically and financially they are more accessible than synthetic drugs. In view of the high exposure of the world population to traditional medicines, they are subject to pharmacovigilance guaranteeing their safety in use. Thus, this review aims to take stock of the risks identified by the national pharmacovigilance systems. It is based on research referenced in PubMed, Embase, ScienceDirect and GoogleScholar. These studies indicate that the use of traditional drugs can involve risks including adverse effects, interactions with synthetic drugs, adulteration and contamination. The spontaneous notification system was the basis for their identification. Strengthening this system and making populations aware of these risks constitute the key levers for traditional medicines pharmacovigilance progress.

[Risk mapping associated with organization of a COVID-19 immunization campaign]. / Cartographie des risques liés à l'organisation de la campagne de vaccination contre la COVID-19.

OBJECTIVES: COVID-19 caused more than 260,000 hospitalizations and nearly 64,000 deaths in France in 2020. Vaccination has become the best hope for gaining control of the pandemic. Our objective is to map the major risks associated with organization of the start of a COVID-19 immunization campaign in the Provence-Alpes-Côte d'Azur region, from December 2020 to April 2021 (inclusive). MATERIALS AND METHODS: The process associated with organization of a COVID-19 immunization campaign was described. Risks, causes, consequences and control elements were identified by 14 semi-structured interviews, involving 19 professionals involved in the important stages in the process. The analysis was performed using the process approach and by a Failure Mode, Effects and Criticality Analysis (FMECA). RESULTS: The process is divided into two approaches, one collective and one individual. Forty-seven risks have been identified and 15 actions proposed. Regional supply logistics chain, vaccination sites, appointment management and the Vaccine-COVID information system are the critical points. Overwork is the most common risk, which has been experienced by the study participants (n=18). It favours the disaffection of the health professionals, which is the major threat of this organization. Eligibility, medical consultation, and the post-vaccination period are under control. CONCLUSIONS: Principal risks associated with organization of a COVID-19 immunization campaign have been identified and action plans have been proposed to optimize current and future practices. It gives a regional vision, to be compared with other regional, national, and international data.

[Patient safety culture in neonatal intensive care units as seen by nurses]. / La culture de sécurité des patients dans les unités de soins intensifsnéonatals vue par les équipes.

Neonatal intensive care units (NICUs) are critical environments in terms of safety of care, with a high risk of adverse events. Measuring the patient safety culture of the professionals working there should help to improve the care offered. A descriptive cross-sectional study, conducted among 141 nurses and childcare workers in 2020 in 5 Tunisian hospitals, examined this question.

Thermal inactivation and kinetic parameters for Campylobacter jejuni on chicken skin.

New Zealand has a higher reported incidence rate of campylobacteriosis than other developed countries. It has been suggested that this may be due to the emergence of heat-resistant strains that can survive normal cooking. To test this, typed Campylobacter strains ST474 and ST48 were inoculated onto slices of chicken skin <18 mm in diameter and 4 mm thick using a pipette, and placed in a special aluminium cell, which was heated to a predetermined temperature (in the range of 56.5 to 65 °C) using a temperature-controlled water bath. Survivor curves were plotted, and GlnaFit software was chosen to fit the experimental data; inactivation parameters were estimated using 1-step and 2-step regression. The D values and z values were in the range of 3-6 s and 8-11 °C, respectively. The D values at 60 and 56 °C were in the range of 12-41 s. These D values are in general agreement with previously published reports. Thus, New Zealand's higher reported rate of campylobacteriosis is possibly due to factors other than the emergence of heat-resistant strains.

[Factors influencing drainage productivity in breast reduction: A retrospective study of 222 breasts]. / Facteurs influençant la productivité du drainage dans la réduction mammaire : étude rétrospective sur 222 seins.

INTRODUCTION: The objective of this study is to highlight the factors that influence drain productivity in reduction mastoplasty. MATERIALS AND METHODS: We have retrospectively referenced from November 2015 to November 2017 all breast reduction performed in the plastic surgery, reconstructive and esthetic surgery department of the University Hospital of Nancy. A total of 222 breasts were analyzed by listing age, weight, height, Body Mass Index (BMI), smoking status, surgeon, technical used, hospitalization stay, breast volume removed, type and size of drain and their productivity. Multivariate analysis were realised. RESULTS: 118 patients were included with an average age of 42.2 years. The average productivity of drains was 50 millilitres (ml). There was a significant difference in productivity of drainage according to the operator with a median ranging from 10ml to 60ml (P<0.0001). The median was 20ml for 10 Redon-Jost drains versus 50ml for the 16 Redon-Jost drains (P<0.0001). Multivariate analysis of the various factors influencing the total productivity of postoperative drainage showed a relative risk of 1.16 for smokers, 0.24 for one surgeon, 1.68 for the Skoog technique, and 1.000 for breast volume removed. CONCLUSION: The drain productivity is not predictable before a breast reduction. Indeed, none of the characteristics studied have sufficient influence on the productivity of the drains.

Risk evaluation of the use of complementary and alternative medicines in cancer.

INTRODUCTION: Cancer patients use complementary and alternative medicines (CAM) to improve their well-being. Little is known about real risks. OBJECTIVE: To highlight 3 different types of axes: 1/cancer patients' perceptions concerning CAM; 2/misinformation/miscommunication about CAM; 3/CAM toxicity (direct toxicity, CAM-anticancer drugs, CAM-cancer interactions). METHOD: A questionnaire was proposed to cancer patients for 2 months. The CAM toxicity was analyzed if patients documented their drugs and CAM. RESULTS: Eighty-five patients responded: 72/85 were taking≥1CAM. In total, 95% patients were satisfied. There was an increasing CAM intake after cancer diagnosis. One hundred and seventeen different CAM were identified (63 herbs, 24 essential oils, 28 food supplements, 2 homeopathic specialities). Only 30/85 were aware CAM could interact with anticancer drugs. No other type of risk was perceived. INFORMATION SOURCES: 43/85 Internet, 38/85 general practitioner, 38/85 community pharmacist, 32/85 entourage, 25/85 other patients, 22/85 oncologist. In total, 81.3% questioned healthcare professionals (HCP) about CAM. Twelve patients noticed HCP lacked knowledge regarding CAM. The toxicity analysis was carried out for 24 patients who consumed 1 to 24CAM. In total, 133CAM were reported, including 87 different CAM. For only 43CAM/87, studies were found. All patients presented≥1risk: 14 at risk of CAM-cancer interactions, 15 of CAM-anticancer drug interactions, 21 of CAM direct toxicities. CONCLUSION: Many CAM are used by patients. The diagnosis of cancer favors their use. The risks are manifold: low perception of risk that can be induced by CAM, diverse and insecure sources of information and many potential toxicities that are not scientifically documented.

[Hybrid medicines in France. Hybrid medicines: Overviews in France and in Paris Public Hospitals]. / Les médicaments hybrides en France. État des lieux des médicaments hybrides en France et à l'Assistance Publique­Hôpitaux de Paris.

OBJECTIVES: The aim of this study is to give an overview of hybrid medicines, term introduced in France by the Social Security Financing Act for 2019, with special attention to those available in Paris Public Hospitals (AP-HP), and to analyze their therapeutic values and economic issues. METHODS: Research by keywords on European and French health authorities' websites was done to provide a list of hybrid medicines. Then, an analysis of their profile and of their differences from reference medicinal products was done. A reflection on hybrid medicines likeness to "new medicines" or to "generic medicines" was carried out. Lastly, their therapeutic interests, their risks and their costs were assessed. RESULTS: In France 85 hybrid medicines were identified, including 41 commercialized, and 21 available in AP-HP. Six different types of differences from the reference medicinal product were found out. Over 90% of hybrid medicines show at least one interest compared to the reference medicines, even if it is not a major innovation. However, more than a third of hybrid medicines are associated to a risk in case of drug substitution with the reference medicinal product. Hybrid medicines costs appear to be lower than reference medicines, but with smaller discounts than what is usually observed with generic medicines. CONCLUSION: Hybrid medicines constitute a very heterogeneous population, whether in terms of differences from reference medicines, of interests or risks. Common rules development for all hybrid medicines may be complex and would require taking every couple hybrid/reference medicines specificities into account.

[Quality guidelines for radiopharmacy: Development of a risk-assessment tool]. / Référentiel qualité en radiopharmacie : création d'un outil d'analyse des risques.

OBJECTIVES: The medical management of patients, which involves securing the drug circuit, is a major public health objective. As part of quality management, a number of risk assessment and risk management tools in care units are validated and available. However, medication management in radiopharmacy departments represents a complex and specific process. The aim of the "Quality guidelines for radiopharmacy" working group of the French society of radiopharmacy (SoFRa) was to develop a risk-assessment tool that is a priori adapted to radiopharmacy activity. METHODS: A qualitative risk matrix was developed, based on available analysis tools and current regulations concerning radiopharmacy practice. The tool was then programmed to obtain a summary and scoring for each risk category, as well as a quantitative analysis of the risks identified in radiopharmacy. RESULTS: Our tool contains 262 issues. The qualitative study integrates the risks related to the circuit of radiopharmaceuticals, but also risks related to personnel. The quantitative study makes it possible to carry out an automated analysis of the actions to carry out in priority to improve the practices. CONCLUSIONS: This work led to the development of a self-assessment tool for the a priori analysis of risks that are adapted to the practice of radiopharmacy. It allows easy analysis of the entire circuit of radiopharmaceuticals from a single tool and meet the expectations of health authorities. This common and validated tool is available to the pharmaceutical community.