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Aim: The aim of the study was to identify and to characterize patients with Alzheimer's disease or related dementia describing antipsychotics and other psychotropic expositions., Methods: The study was performed, in 2010, based on Provence-Alpes-Côte d'Azur region (PACA)-Corse Alz cohort included patients with dementia, with chronic condition 'Alzheimer disease or related disease' and/or had at least one delivery of Alzheimer's specific treatment, registered in the General Health Care System. Psychotropic drugs were extracted according anatomical, therapeutical and chemical code. Chronic exposure defined as more than 3 consecutive deliveries., Results: Among 34 696 included patients, 26.9% were men and 68.8% were 80 years old and more. Among them, 26% received at least one antipsychotic medication, with a chronic exposition estimated around 61.3%. Antidepressant and anxiolytic were consumed respectively by 47% and 45.3% of patients. Risperidone was the most used antipsychotic (11.2%). The Health care use (hospitalizations, nurses and physicians visits) was significantly higher among patients with antipsychotics., Conclusion: Antipsychotics use in patients with dementia remains high. The follow up of this regional cohort would be helpful to identify the impact of guidelines on the prescription and the care of patients with dementia., (© 2014 Société Française de Pharmacologie et de Thérapeutique.)

Objective: To assess the national market penetration rate (PR) of generic high-dosage buprenorphine (HDB) in 2008 and its evolution since their marketing (2006), and making a point for each dosage and at regional level., Methods: Retrospective study over data using national and regional health reimbursement database over three years (2006-2008)., Results: In 2008, the generic HDB's national MPR was 31%. The PR for each dosage were 45% for 0.4 mg, 36% for 2 mg and 19% for 8 mg. The (PR) based on Defined Daily Dose (DDD) was 23% in 2008, 15% in 2007 and 4% in 2006. In 2008, at the regional level, disparities were observed in the adjusted penetration rate from 15% in Île de France to 39% in Champagne Ardennes Lorraine., Conclusion: The national PR of generic HDB has increased. There are differences in MPR in terms of dosage and area. However, this PR is still low (in 2008, 82% of the delivered drugs are generics)., (© 2012 Société Française de Pharmacologie et de Thérapeutique.)

Purpose: Today, haematopoietic stem cell graft from placental blood concerns more than 15 % of allogeneic grafts. An inter-laboratory study of the quality control of defrosted cord blood units has been coordinated by the French society for cell and tissue bioengineering (SFBCT), with the cord blood bank of Bourgogne Franche-Comté and controlled by the French health products safety agency (Afssaps). The aim of this study is to ensure the inter-laboratory reproducibility of the quality controls practised by the banks during defrosting. The cellular outputs were analyzed according to the defrosting techniques, according to the method used in flow cytometry: single-platform (SP) versus double-platform (DP), or the product nature, i.e. in total blood or miniaturized., Methods: Forty-two units of placental blood (USP), which were out of range were provided for defrosting to 14 participating sites. USP were defrosted and controlled according to the procedures of each bank. Once the USP is defrosted, a part of the product was controlled by the site and the other part by Afssaps. Following controls were carried out: numeration of the total nucleated cells (TNC) and of CD34+ cells (made by a SP method in Afssaps) and functional assay., Results: Concerning TNC, the defrosting sites obtained a cellular output of 94 %+/-28 in day 0 compared with an output of 72 %+/-24 in Afssaps showing a rather good stability of the USP transmitted with an average deviation of 23 %+/-22. The freezing process with or without reduction of volume does not affect this variation. Concerning the numeration of CD34+ cells, the average deviation between the participating sites and Afssaps was 29 %+/-23 compared with 21 %+/-16 for the sites using a SP method against 47 %+/-25 for those using a DP method. The CD34+ outputs are equal to 82 % +/- 60 in day 0 for the participating sites against 52 %+/-20 for Afssaps. For the sites using a DP method, it is stressed that this output is particularly high with a rate of 126 %+/-90 (n=15) whereas it is 62 %+/-20 (n=32) for the sites using a SP method., Conclusion: These results underline a good stability of viable CD34+ cells and a greater reliability of the SP methods for the CD34+ cell numeration for these defrosted USP. Lastly, the results of the functional assay regarding the average clonogenicities (equal to 15 %) reinforce the conclusions on the quality of the defrosted products., (Copyright 2010 Elsevier Masson SAS. All rights reserved.)

Background: Dry eye syndrome with tear deficiency can be improved with artificial tears, which can be associated with topical anti-inflammatory agents. Autologous serum can provide the ocular surface with beneficial growth factors and vitamins., Patients and Methods: Twenty-one patients suffering from severe dry eye due to Sjögren's syndrome were treated with 20% autologous serum for 2 Months. The Schirmer I test, break-up time, and fluorescein and lissamine green stainings were performed before and after treatment. Subjective complaints such as burning, foreign body sensation, dryness and photophobia were assessed by a questionnaire as well as a face score reflecting the current condition of patients' eyes., Results: Lissamine green and fluorescein scores improved significantly as well as subjective symptoms of burning, foreign body sensation and dryness (p<0.05). The face score was significantly improved. Bacterial culture of serum delivered to the patients all remained negative., Discussion: Autologous serum provides growth factors and vitamins that are useful for an altered ocular surface due to Sjögren's disease. However, some problems still remain: risk of contamination, arbitrary dilution of autologous serum, and a current lack of regulations for use of autologous serum. A close collaboration between ophthalmologists and the Etablissement Français du Sang (French Blood Bank) is mandatory because autologous serum should be considered as a useful tool to treat severe ocular surface disorders., Conclusion: The use of autologous serum improved symptoms and objective signs caused by severe Sjögren's syndrome. Currently, a lack of clear regulations prevents its widespread use in severe ocular surface disorders.

Objectives: Intraoperative blood cells salvage using a Cell Saver technique is controversial in oncologic surgery because tumor cells could be aspirated and reinfused to the patient. The goal of this review was to discuss the risk associated with this technique, and the way to minimize it., Data Sources: A review of the literature has been made by questioning PubMed site (http://nbci.nlm.nih.gov) on the period of 1968 to 2000. The key words were: intraoperative blood salvage, blood transfusion, autologous, cancer. Cases reports have been excluded., Study Selection: Tumor cells aspirated and reinfused have been numbered in both experimental and clinical studies. In clinical studies, the outcome after intraoperative cells salvage/reinfusion has been compared to published data or historical groups of allogeneic transfusion, all in non randomized studies., Data Synthesis: Both experimental and clinical studies confirmed the presence of cancer cells in the blood either aspirated or reinfused. However, six clinical studies with limited number of patients did not show metastatic spread associated with Cell Saver. The addition of leukocyte filters reduces greatly this quantity of cancer cells. Irradiation of the pack did not destroy tumor cells but blocked their proliferative capacity. In the other hand, some infiltrative tumors were shown to have permanent cancer cells seeding, quantitatively superior to the seeding observed when a Cell Saver is used., Conclusion: It seems reasonable to use the Cell Saver in oncologic surgery, if possible with a leukocyte filter, not only in case of unexpected major bleeding (consensus), but also in programmed cases with high risk of huge hemorrhage.

The transfusion unit of the Institut Gustave Roussy has tested seven pre-transfusion ABO control devices registered at the Agence française de sécurité sanitaire et des produits de santé. Determination of the optimal plan to replace the existing plan in our institution was the primary objective of this study. A significant heterogeneity was observed among tested devices. None of the tested plans fulfilled all the desired quality criteria.

Transfusion safety rests on measures ensuring that patients are transfused in accordance with the requirements of state-of-the-art scientific knowledge. This strict attitude is part of a quality approach which now applies to all fields of health. Transfusion is historically characterized by its ambivalence: it was the first medical discipline which integrated Quality Assurance concepts, it was also the first which proved unable to respond adequately in the face of uncontrolled risks. Today transfusion must create a system to rapidly: identify any risk, whether emergent or hypothetical; decide which action should be taken; monitor and assess corrective action; study the medico-economic impact of the whole approach. Quality assurance applies to every stage of the transfusion process, from blood donor to labile blood component recipient. This includes blood donor selection and biological control, labile blood component processing, qualification, transport and conditioning, prescription and distribution of blood components and transfused patient follow-up of. Quality controls, "safety locks", must be implemented at every stage to allow early problem detection, thus avoiding potentially dangerous attitudes and guaranteeing transfusion quality all along the process. Medical prescriptions must follow similar rules and meet Good Practice requirements defined by members of the medical and scientific community. A transfusion should not be prescribed unless it is absolutely necessary. In addition to sanitary surveillance, scientific surveillance must also be implemented to help transferring the findings of fundamental research to transfusion activities and continuously improve transfusion safety. INSERM is initiating sociological studies to identify and better understand donors' attitudes leading to risks. More sensitive tests based on nucleic acid amplification should reduce the incidence of residual viral risks. Various viral cell derivative inactivation techniques are being evaluated: the idea is to remove antigens to suppress the risk of post-transfusion alloimmunization. Numerous R&D; programs address substitution products. Transfusion safety requires all actors in the field of health being equally involved. Putting together experiences and know-how will continuously strengthen the quality approach adopted in transfusion.

FUNDAMENTAL PRINCIPLES: Rigorous prescription of labile blood products is a fundamental step in assuring safe transfusion. The clinician must avoid all unnecessary transfusions and choose the most adapted blood product to meet the patient's clinical requirements. TRANSFUSION THERAPY: The patient's immunological situation, past history, prognosis, and potential need for future transfusions must be taken into account in a global approach aimed at determining which transfusion product is most adapted for each individual patient. PACKED RED CELLS: Packed red cells should be prescribed after evaluating the risk of tissue hypoxia in light of the patient's clinical situation. Restrictions on transfusion should be particularly drastic if the anemic state could respond to specific treatment (vitamin B12, iron, folic acid, erythropoietin). PLATELETS: There has been considerable development in platelet transfusion over the last few years, particularly in onco-hematology. Nevertheless, very few clinical studies are available for determining which cases require curative transfusion (solely in case of blood loss) and which situations require preventive transfusion (standard versus apheresis products). The platelet threshold indicating transfusion remains a subject of wide debate. FROZEN FRESH PLASMA: In France, regulatory indications for frozen fresh plasma were established by a ministerial decree and concern situations where a plasma fraction substitution product (medically derived blood product) cannot be prescribed. WHITE BLOOD CELL: The transfusion of this type of product should be reserved for clinical situations determined on a consensus basis between clinicians and hemobiologists.

LABILE BLOOD PRODUCTS: Labile blood products are therapeutic products produced from blood which do not have the characteristics of drugs. This category of products include packed red cells, platelets as well as white cell concentrates and frozen fresh plasma. PACKED RED CELLS AND PLATELET CONCENTRATES: These products used to be prepared from total blood. Specific components can be selected using a cell separator (apheresis). This process has made available platelet apheresis products, white cell concentrates and fresh plasma for therapeutic indications. The major impact of apheresis on blood donation has been to reduce the number of donors required for platelet transfusion. PLASMA: In France, plasma is produced from total blood by fractionation in order to assure the production of blood-derived drugs (albumin, coagulation factors, immunoglobulins, biological glue...). Viral inactivation concerns only detergent solvant viro-inactivated plasma. No therapeutic process has been fully validated for other labile blood products. TRANSFORMATION AND CHARACTERISTICS: Labile blood products may undergo several types of transformation: deplasmatization, plasma volume reduction, cyropreservation, irradiation. Since April 1, 1998, all labile cellular blood products produced in France must be leukocyte-depleted. Additional donor-related characterization (phenotype, CMV negative) may also be determined.

VIRUS RISKS: Since 1991, the medical community has focused what can be termed transfusion phobia on transmissible viral diseases. Such diseases do not however reflect the overall risk of transfusion. The residual virus risk is the risk of not detecting a viral disease in the donor population which is transmissible by blood or blood products. This risk depends on the prevalence of the disease in the donor population, the duration of serological silence period and the sensitivity of the screening tests. Hepatitis B virus is the number one transfusionally transmissible virus (1/30,000 to 1/250,000 blood transfusion units), but the main risk of post-transfusion viral disease is caused by the hepatitic C virus. The residual risk of HIV contamination is in the range of 1/200,000 to 1/2,000,000 transfusion units. There is a possible risk of transmitting non-conventional agents (Creutzfeldt-Jakob) but no estimation can be established to date. OTHER RISKS: Potentially severe post-transfusion complications are not limited to transmissible viral diseases. All transfusions carry the risk of bacterial contamination, endotoxinic shock, circulary overload, and anti-leukocyte alloimmunization. Currently, the most frequent and most severe transfusion risks concern acute intravascular hemolysis subsequent to an ABO error or incompatibility with another antigen system and presence of alloantibodies.

ENHANCED SURVEILLANCE: Safety in transfusion medicine involves all the different procedures designed to guarantee safe transfusion in accordance with standards established on the current scientific knowledge. It is thus crucial to continuously monitor scientific advances in order to transfer progress in fundamental research as rapidly as possible to transfusion applications and thus maintain the highest level of safety. RISK REDUCTION: The risk of residual viral contamination might be additionally reduced by the introduction of genomic screening. Several virus inactivation processes are currently under evaluation for products derived from blood cells. The risk of post-transfusion alloimmunization might be reduced by eliminating or masking antigens (immunogens). SUBSTITUTION PRODUCTS: There are several ongoing research and development programs concerning substitution products. Products under study include perfluocarbon emulsions, hemoglobin solutions, membrane fragments, and platelet substitutes.

Allogeneic peripheral blood hematopoietic stem cell transplantation is being evaluated in a randomized French study comparing the use of peripheral blood stem cells vs. bone marrow graft stem cells. In order to standardize immunohematological (IH) assessment and transfusion practices within our protocol, we made suggestions to 25 allo-transplantation French centers on the following elements: pre-inclusion IH assessment, IH exclusion criteria, transfusion rules, post-transplantation IH surveillance and treatment of hemolysis. The analysis of their responses to our suggestions led us to elaborate recommendations which were approved and implemented by the French Bone Marrow Transplantation Society (SFGM). These recommendations concern the transfusion practice in the general framework of allogeneic hematopoietic stem cell transplantation and can therefore be considered as referential.

In this review, we develop four topics on the relationship between blood transfusion and cancer. First, the rationale for not allowing blood donations from patients with infiltrating tumors is presented. Second, the different possibilities for autotransfusions in cancer patients are discussed. Predeposited autotransfusions are rarely possible in these patients, in addition to the high cost. The usefulness of another method, intraoperative autologous transfusion with blood saved from the surgical field, is not well established. Our third topic concerns the effect of transfusion on cancer induction. In some cases, the risk of cancer is higher after allogenic transfusion resulting from a mechanism involving alterations of the immune function. Finally, the relationship between transfusion and cancer recurrence is controversial. In spite of numerous studies attempting to elucidate this relationship, no final conclusion can be drawn at the present time. What is sure, is that patients requiring blood transfusion have a higher risk of recurrence than patients who do not need transfusion.