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Resume Introduction La place du preparateur en pharmacie hospitaliere (PPH) au sein des unites de soins est peu reconnue en France. Dans notre etablissement, un modele de PPH de proximite a ete propose dans 4 unites de soins. L’objectif du travail etait de decrire ce modele puis d’evaluer le ressenti des equipes soignantes. Materiels et methodes Le modele du PPH de proximite a ete decrit a partir de ses missions et des avantages de sa presence en unite de soins. Un questionnaire de satisfaction a ensuite ete propose aux cadres de sante et infirmiers des unites ou un PPH intervenait. Resultats Le PPH de proximite a un role dans la gestion des medicaments, la preparation des doses a administrer, et la securisation et promotion du bon usage des medicaments. Sa collaboration avec les autres professionnels de sante est essentielle. Au total, 28 professionnels (4 cadres de sante, 24 infirmiers) ont repondu a l’enquete de satisfaction. En moyenne, la satisfaction globale etait de 9,4/10. Discussion et conclusion La satisfaction des equipes soignantes renforce l’interet du modele de PPH de proximite developpe dans notre etablissement. D’autres activites de pharmacie clinique pourraient etre etudiees pour optimiser ce modele.

This study aims at evaluating fluconazole exposure in critically ill patients and identifying variables associated with the latter.This was a 2-year (2018-2019) retrospective multicenter cohort study. Adult patients 18 years-old with at least one fluconazole concentration measurement during their ICU stay were included.Twenty patients were included. Only 11 patients had a fluconazole trough concentration (Cmin) within the target range (≥15 mg/L). According to bivariable analysis, SOFA score, GGT, fluconazole clearance, Ke, and Vd, were independently associated with a decrease in fluconazole Cmin. The median loading dose required to achieve the Cmin target appeared to be greater in patients with higher SOFA or GGT level and in patients undergoing renal replacement therapy.This study supports recommendation for routine fluconazole therapeutic drug monitoring in ICU patients so as to avoid underexposure, especially if SOFA score is ≥ 7 and/or GGT is ≥ 100 U/L.

Resume Contexte Les troubles anxieux et du sommeil sont frequents chez les patients dialyses et justifient l’utilisation de benzodiazepines. Bien que la duree de traitement ne doive pas exceder 3 mois, beaucoup de patients dialyses utilisent ces molecules au long cours. Les risques d’une telle consommation sont bien connus. Les nephrologues doivent frequemment initier ou poursuivre des traitements par benzodiazepines chez les patients dialyses. Cette prescription est complexe et les etudes relatives aux facteurs associes a leur prise chez cette population particuliere sont pauvres. Objectifs Determiner la prevalence et les facteurs associes a une utilisation au long cours des benzodiazepines chez les patients dialyses, ainsi que la prevalence et les motivations des patients desirant entamer une demarche d’arret suite a l’apport d’une information sur les risques d’une telle consommation. Methodes L’etude a inclus 91 patients dialyses chroniques. Les donnees sont recueillies a partir du dossier medical informatise et au moyen d’entretiens avec les patients. Resultats Au total, 50,5 % des patients (âge moyen : 65,8 ans) consomment une benzodiazepine. La prevalence d’utilisation au long cours est de 78,3 %. Les patients utilisateurs chroniques sont (a) plus âges, (b) moins actifs, (c) plus frequemment atteints de diabete, (d) de depression, (e) plus frequemment en incapacite de marche, (f) moins souvent inscrits sur la liste d’attente de greffe renale, et (g) ont moins souvent beneficie d’une greffe renale prealable. Les doses de benzodiazepines des patients consommateurs au long cours etaient plus elevees que celles des consommateurs sur une courte periode. De plus, 60 % des patients consommateurs chroniques ayant beneficie de l’information desirent entreprendre une demarche d’arret. La constatation d’effets indesirables, l’impression d’inefficacite et la peur de la dependance constituent les motivations les plus souvent identifiees pour justifier le desir d’arret. Conclusions La prevalence de la consommation chronique de benzodiazepines chez les patients dialyses est elevee. L’apport d’une information concernant l’utilisation de ces molecules semble avoir un impact positif sur la demarche d’arret.

Resume Objectifs L’efficacite, le profil de tolerance et l’impact economique de la capsaicine en patch (Qutenza®), dans la prise en charge des douleurs neuropathiques peripheriques (DNP), ont ete evalues en conditions de vie reelle. Materiel et methode Une etude de type cout-consequences a ete initiee sur une periode maximale de suivi de 24 semaines. L’evaluation des couts directs a ete faite selon les perspectives de l’hopital et l’Assurance maladie. Resultats Quatre-vingt onze patients avec DNP d’etiologie majoritairement post-chirurgicale (42,9 %) ont ete selectionnes. Une reponse therapeutique a ete observee a 12 et 24 semaines pour 27,9 % et 37,1 % des patients respectivement. Le score mental de qualite de vie SF-36 a ete ameliore. Un surcout hospitalier de 154 euros a ete mesure par administration sans impact sur les depenses medicamenteuses ambulatoires. Conclusion Cette etude confirme l’interet du Qutenza® pour une faible proportion de patients avec DNP severes et refractaires.

BACKGROUND: Despite frequent anemia and multiple transfusions in patients undergoing chemotherapy and allogeneic hematopoietic stem cell transplantation (allo-HSCT) for acute myeloid leukemia , recommendations for use of erythropoiesis-stimulating agents (ESAs) in these populations are still missing. The primary objective was the effect of ESA administration on patient's quality of life (QoL). Secondary objectives were hemoglobin (Hb) recovery, red blood cell (RBC) transfusions, overall survival, and event-free survival. METHODS: Adult patients with Hb ≤ 11 g/dL after consolidation chemotherapy for acute myeloid leukemia (group 1), or after allo-HSCT for any hematological diseases (group 2), were prospectively included. ESA was administered subcutaneously once per week during a maximum period of 6 months and was stopped when Hb level reached 12 g/dL. A paired-matched analysis using a historical control group was performed for secondary endpoints. Fifty-two patients were included in group 1, and 55 patients were in group 2. RESULTS: For the global population, a significant improvement of QoL was noticed with ESA use; 83% (group 1) and 71% (group 2) of patients achieved an Hb level ≥ 12 g/dL without transfusion requirement. The pair-matched analysis showed a reduction of 4 RBC units per patient in group 1 (P = .0002) and 3 RBC units per patient in group 2 (P = .04). No significant difference in terms of thromboembolic events, overall survival, and event-free survival was observed between ESA and control groups. A RBC transfusion median savings of €1712 per patient was estimated in each group. CONCLUSIONS: ESAs have a clinical and economic benefit on Hb recovery, could improve a patient's QoL, and lead to a significant reduction in number of RBC transfusions with no effect on survival. Cancer 2013. © 2012 American Cancer Society.

This phase I/II study was designed to demonstrate the tolerance and the efficacy of a combination of pegylated interferon-α 2a to Imatinib mesylate (IM) 600 mg daily in cytogenetically IM-resistant but in CHR chronic phase CML patients. The combination was generally well tolerated in the 15 evaluable patients. A significant reduction of the Ph1 + BM metaphases was observed in these poor prognosis patients, with 2 long-term CCyR including 2 MMR. After a median follow-up of 43 months, 93% of patients are alive. The addition of PegIFNα2a to IM600 is feasible, and able to overcome resistance within this context.

BACKGROUND: Beyond the usual regimens based on streptozocin and doxorubicin or 5-fluorouracil, no second-line therapy of metastatic neuroendocrine tumor has gained wide acceptance. Gemcitabine and oxaliplatin are generally well tolerated and have shown activity against a wide range of malignancies. The authors assessed the efficacy of gemcitabine-oxaliplatin combination (GEMOX) in the treatment of patients with metastatic neuroendocrine tumors. METHODS: Twenty consecutive patients with progressive disease were treated with GEMOX, in most cases after failure of other chemotherapy regimens (median = 2). Patients were followed for evidence of toxicity, response, and survival. Two patients were chemotherapy-naive at treatment initiation and were excluded from the efficacy analysis. RESULTS: Toxicity was manageable overall; however, 6 (30%) patients had to discontinue treatment because of oxaliplatin-induced neurotoxicity (grade 2). Three (17%) of 18 patients had a partial response, median progression-free survival was 7.0 months, and median overall survival was 23.4 months. CONCLUSIONS: Gemcitabine-oxaliplatin combination shows interesting activity and is well tolerated in pretreated patients with neuroendocrine tumors. Cancer 2009. © 2009 American Cancer Society.

Summary Objectives Alcoholic cirrhosis and viral (especially hepatitis C) cirrhosis account for 50% of liver transplantation indications. The aim of our study was to evaluate the cost of liver transplantation from the hospital's perspective, according to indication. Methods This retrospective study at a university hospital included 60 patients (cause of liver disease: alcoholic or hepatitis C-induced cirrhosis) who underwent liver transplantation between 1996 and 1999. All patients received the liver of brain-dead donors. The outcome measure was the cost of hospitalization from admission for transplantation through two years afterwards. The study does not include the costs of pre-transplantation evaluation or organ procurement. To calculate medical costs, we collected data about pharmaceutical use and laboratory tests for each patient. Logistic costs were calculated from French data for diagnosis-related groups, according to length of stay. Consultations and admissions in the two years after transplantation were collected, and their costs calculated. Results Length of stay for transplantation (mean: 24 days, range 11-66) and costs (average 40k€ per patient, range: 27.8-75.7, i.e., 52k€ after escalation to 2006 levels) were similar. The cost of transplantation was higher (p=0.002) for Child C patients (mean: 46k€ per patient, range: 31,1-72,8). Costs of follow-up after transplant (mean 5.4k€ per patient, range: 0.87-19.7) varied, with consultation costs higher (p=0.002) in the alcoholic cirrhosis group (0.38k€ versus 0.3k€) and hospitalization more expensive (p=0.0496) for the viral cirrhosis group (6k€ versus 4,6k€). Conclusion We found that length of stay was the most important determinant of hospital costs for liver transplantation and that the indication for transplantation has a slight influence on resource utilization during the first two years after surgery.

Dialysis patients frequently have anxiety and sleeping disorders and that explains a benzodiazepine treatment. A significant proportion of dialysis patients are long-term users even though it is not recommended to take benzodiazepine for more than 3 months. Risks of such a use are well identified. Nephrologists frequently have to prescribe benzodiazepines. This prescription is complex and there are few studies regarding the factors of benzodiazepine use among this population.To determine the prevalence and the factors related to a long-term benzodiazepine use by dialysis patients. To determine the prevalence and the motivation of patients to stop taking medication among the long-term users who got information about the risk of such a use.The study includes 91 dialysis chronic patients. Their characteristics were collected from medical records and interviews with the patients.The average age of patients is 65,8 years. In all, 50.5% take benzodiazepines. Among benzodiazepine users, the prevalence of long-term use is 78.3%. Long-term benzodiazepine users (a) are older, (b) less active, (c) frequently diabetic, (d) depressive, (e) unable to walk, (f) less often registered on the kidney transplant waiting list, and (g) had less kidney transplant previously. Benzodiazepine doses of long-term users were higher than the doses of short-term users. Moreover, 60% of patients who are chronic users want to take action and stop the treatment. Observation of side effects, impression of ineffectiveness and fear of addiction are the most identified motivation to stop treatment.The prevalence of benzodiazepine chronic use by dialysis patients is high. Giving information to the patient about the use of these molecules seems to have a positive impact on the decision to stop.

The capsaïcine 8% cutaneous patch (Qutenza®) was recently approved for the management of patients with peripheral neuropathic pain (PNP). Considering its limited clinical efficacy data, its improvement of medical benefit was determined to be 5 which was insufficient to support its reimbursement in addition to diagnosis related groups'tarifs. Nevertheless its commercialization was associated with a marked interest considering the unmet therapeutic needs for patients with PNP.Our objectives were to assess the effectiveness, the safety, and the economic impact of Qutenza® in real-life conditions.An observational cost-consequences study was launched under the aegis of the Drug Committee of our hospital. Medical charts and prescriptions of all patients who received at least one patch application were analyzed. Effectiveness and safety were assessed after 12-week and 24-week of follow-up. The economic impact was measured within the Hospital and Health Insurance perspective and with limitation to direct costs.From March 2012 to October 2013, 91 patients (54.3 ± 14.1 years; 52.7% of male) received at least one application. The average follow- up duration was 188.3 ± 86.4 days. The PNP etiologies were mainly post-surgery (42.9%) and post-traumatology (20.8%). A therapeutic response (decrease of ENS score of least 30%) after 12 weeks and 24 weeks was observed in 27.9% and 37.1% of patients respectively. The SF-36 mental score was significantly improved. The safety profile was good. The application of the patch resulted in incremental costs of 154 euros per hospital stay without impact on outpatient-prescription drug expenditures.This study confirms the interest of Qutenza® for heavily pretreated, refractory patients with PNP. The clinical profile of responders has to be further investigated in large observational studies.

Despite frequent anemia and multiple transfusions in patients undergoing chemotherapy and allogeneic hematopoietic stem cell transplantation (allo-HSCT) for acute myeloid leukemia , recommendations for use of erythropoiesis-stimulating agents (ESAs) in these populations are still missing. The primary objective was the effect of ESA administration on patient's quality of life (QoL). Secondary objectives were hemoglobin (Hb) recovery, red blood cell (RBC) transfusions, overall survival, and event-free survival.Adult patients with Hb ≤ 11 g/dL after consolidation chemotherapy for acute myeloid leukemia (group 1), or after allo-HSCT for any hematological diseases (group 2), were prospectively included. ESA was administered subcutaneously once per week during a maximum period of 6 months and was stopped when Hb level reached 12 g/dL. A paired-matched analysis using a historical control group was performed for secondary endpoints. Fifty-two patients were included in group 1, and 55 patients were in group 2.For the global population, a significant improvement of QoL was noticed with ESA use; 83% (group 1) and 71% (group 2) of patients achieved an Hb level ≥ 12 g/dL without transfusion requirement. The pair-matched analysis showed a reduction of 4 RBC units per patient in group 1 (P = .0002) and 3 RBC units per patient in group 2 (P = .04). No significant difference in terms of thromboembolic events, overall survival, and event-free survival was observed between ESA and control groups. A RBC transfusion median savings of €1712 per patient was estimated in each group.ESAs have a clinical and economic benefit on Hb recovery, could improve a patient's QoL, and lead to a significant reduction in number of RBC transfusions with no effect on survival.

Alcoholic cirrhosis and viral (especially hepatitis C) cirrhosis account for 50% of liver transplantation indications. The aim of our study was to evaluate the cost of liver transplantation from the hospital's perspective, according to indication.This retrospective study at a university hospital included 60 patients (cause of liver disease: alcoholic or hepatitis C-induced cirrhosis) who underwent liver transplantation between 1996 and 1999. All patients received the liver of brain-dead donors. The outcome measure was the cost of hospitalization from admission for transplantation through two years afterwards. The study does not include the costs of pre-transplantation evaluation or organ procurement. To calculate medical costs, we collected data about pharmaceutical use and laboratory tests for each patient. Logistic costs were calculated from French data for diagnosis-related groups, according to length of stay. Consultations and admissions in the two years after transplantation were collected, and their costs calculated.Length of stay for transplantation (mean: 24 days, range 11-66) and costs (average 40 keuro per patient, range: 27.8-75.7, i.e., 52 keuro after escalation to 2006 levels) were similar. The cost of transplantation was higher (p=0.002) for Child C patients (mean: 46 keuro per patient, range: 31,1-72,8). Costs of follow-up after transplant (mean 5.4 keuro per patient, range: 0.87-19.7) varied, with consultation costs higher (p=0.002) in the alcoholic cirrhosis group (0.38 keuro versus 0.3 keuro) and hospitalization more expensive (p=0.0496) for the viral cirrhosis group (6 keuro versus 4,6 keuro).We found that length of stay was the most important determinant of hospital costs for liver transplantation and that the indication for transplantation has a slight influence on resource utilization during the first two years after surgery.

Objective To evaluate the efficacy and safety of oral miglustat treatment in patients with mucopolysaccharidosis type III. The primary outcome was efficacy with improvement or stabilization in at least two domains of Vineland Adaptative Behavior Scales at 6 months. The secondary outcome measured the evolution of other cognitive tests at 12 months. The safety and tolerability were assessed throughout the study. Study design This was a randomized, double-blind, placebo-controlled, monocenter, institutional, phase IIb to III study. In case of efficacy at 6 months, the study would go on for another 6 months on an open design with all patients receiving miglustat. In the absence of efficacy at 6 months, the trial had to be continued for 6 more months with the initial design. Results After 6 months, efficacy was not superior in patients with miglustat. The independent review board confirmed continuing the study until 12 months. Conclusion Miglustat treatment was not associated with any improvement/stabilization in behavior problems in patients with mucopolysaccharidosis type III. Miglustat has an acceptable safety profile. However, the study has confirmed that miglustat is able to pass through the blood-brain barrier without significantly decreasing ganglioside levels.

Abstract 3810 Introduction: Despite frequent anemia and multiple transfusions during AML chemotherapy and allogeneic hematopoietic stem cell transplantation (allo-HSCT), recommendations and marketing authorization for erythropoietin (EPO) use are still missing. In the current prospective study, as primary objective, we evaluated the effect of EPO on patient's quality of life (QOL). Secondary objective was hemoglobin (Hb) recovery. In addition, a paired matched analysis using similar population was conducted to compare platelets (Pt) and red blood cells (RBC) transfusion number. Materials and methods: We included adult patients with Hb level ≤11g/dl induced by 1, 2 or 3 consolidation chemotherapy for AML in complete remission (CR) (group 1); or by allo-HSCT for any hematological disease (group 2). EPO was administered Sc. once per week during a maximum period of 6 months: for group 1, ARANESP® 150μg; for group 2, NEORECORMON® 30000IU; Hb level was monitored every week. Injections were stopped once the Hb level reached 12g/dl without any transfusion. If after 4 injections, no improvement was observed, doses were doubled, and if after 8 injections, no improvement was observed, patient was taken off-study for EPO inefficiency. The QOL was measured at baseline, at 1, 2, 3 and 6 months by the Functional Assessment of Cancer Therapy–Anemia (FACT–An). EPO responders patients were defined as having Hb level ≥12g/dl (EPO CR) or a ≥ 2g/dl increase [EPO partial response (EPO PR)] compared with baseline value without any transfusion requirement. The matching analysis took into account: sex, age, disease status, for the two groups, associated to cytogenetics, type of chemotherapy, sequential chemotherapy number for group 1, and diagnosis, conditioning, HSC source, number of previous transplants and GVHD for group 2. Results: Between April 2006 and December 2009, among 261 screened patients, 55 were included in group1 and 61 in group 2, patient characteristics for each group are summarized in Table1. Main exclusion criteria were EPO contra-indication and patient refusal. The median number of EPO injections/patient was 13 (3 – 24) in group1 and 8 (2 - 28) in group 2. For the global population (111 evaluable patients [52 group1 and 59 in group 2]), we have noticed a significant improvement of QOL during the 6 months follow-up according to FACT-An anemia (p=0.01). Despite a non-significant improvement for FACT-G, we observed a significant improvement in physical well-being (p Conclusion: This prospective study showed a real benefit of EPO administration on QOL, an achievement of a normal Hb level and a significant spare of RBC and Pt transfusions. Young AML patients, male allo-HSCT recipient, ABO compatible pairs seem to be the best candidates to benefit from EPO administration, with low AEs and no impact on OS or EFS. A cost-effectiveness study is ongoing and results will be communicated. Disclosures: No relevant conflicts of interest to declare.

Introduction Les carcinomes endocrines differencies (CED) constituent un groupe heterogene de tumeurs pour lesquelles aucune chimiotherapie de seconde ligne n’est actuellement validee. De nombreuses etudes de phase II n’ont rapporte qu’une efficacite limitee de la plupart des drogues actuellement disponibles en monotherapie, y compris l’oxaliplatine. Peu de donnees sont cependant disponibles sur l’utilisation de ces drogues en association. Nous rapportons ici l’experience de notre centre avec l’association gemcitabine-oxaliplatine. Patients et Methodes Entre Juin 2004 et Avril 2008, 20 patients d’âge median 56 ans (32-72) ont ete traites par gemcitabine 1 000 mg/m2 et oxaliplatine 100 mg/m2 toutes les 2 semaines. Les sites primitifs etaient : intestin grele (5), pancreas (5), poumons/bronche (4), thymus (2), ovaire (1), vesicule biliaire (1), rectum (1), inconnu (1). Tous les patients presentaient une progression documentee lors de l’initiation du traitement par GEMOX. Seuls 2 patients etaient non-pretraites, le nombre median de chimiotherapies prealables etait de 2 (0-4), 15 patients avaient recu un autre type de traitement medical (analogues de la somatstatine n = 12, interferon n = 10, inhibiteur de mTOR n = 1), 6 patients avaient beneficie d’une chimioembolisation et 3 d’un traitement par radionucleides. Deux patients etaient greffes hepatiques. La reponse tumorale etait evaluee tous les 2 mois selon les criteres RECIST et la toxicite cotee selon les criteres NCI-CTC. Resultats Quatre patients (20 %) ont eu une reponse partielle, 12 patients une stabilisation de la maladie et 4 patients ont d’emble progresse. La mediane de survie sans progression a ete de 7,0 mois et la mediane de survie globale de 23,4 mois. Au total 136 cycles de GEMOX ont ete administres, 13 cycles (10 %) ont du etre decales pour thrombopenie (6), asthenie (4), toxicite digestive (2) et infection (1). Aucun patient n’a du etre hospitalise pour neutropenie febrile. Cinq patients lourdement pre-traites ont recu leur chimiotherapie a dose reduite (50 %) et 2 patients supplementaires ont eu une reduction de dose pour thrombopenie recidivante. Le traitement par GEMOX a du etre interrompu chez 10 patients pour toxicite, dont 6 pour neuropathie de grade II, et pour progression chez 6 patients. Conclusion L’association gemcitabine-oxaliplatine montre une activite anti-tumorale interessante dans les CED avec un profil de tolerance acceptable. Les donnees d’efficacite de cette association paraissent comparables a celles obtenues avec les therapeutiques ciblees (medicaments antiangiogeniques et inhibiteurs de mTOR) en seconde ligne.

This analysis studied 197 autologous HSCT performed in 132 patients treated for multiple myeloma (MM) in our center between 2000 and 2007. There were 53 females and 79 males with a median age of 56.8 years (34–72). At diagnosis there were 71 IgG (49κ, 22λ), 26 IgA (15κ,11λ), 2 IgD (1κ, 1λ), 27 light chain (18κ,9λ), 2 plasma cell leukemia, 3 non secretory, 1 non secretory/non excretory. There were 11 stage I (10A and 1B), 12 IIA, 96 III(75A and 21B) and 13 not classified. At diagnosis, 24/98pts had a del(13), and 65/179 had high levels of β2microglobulin. Before 2004, 50% of transplants were done and the median interval between diagnosis and HSCT was 7.8 months (3.5–131). We divided the population into 2 groups (I = 65: double-auto, II = 67 simple auto). The disease status pre-transplant according to the number of apheresis were: 1 apheresis (group I: 3CR, 29PR, 3SD, 1PD; group II: 2CR, 24PR, 3PD), 2 apheresis (group I: 16PR, 1SD, 1PD; group II: 3CR, 9PR, 1PD), 3 apheresis (group I: 1CR, 4PR; group II: 10PR, 1unknown), 4 apheresis (group I: 4PR, 1PD; group II: 1CR, 10PR, 2SD), 6 apheresis (group II: 1PR) and 8 apheresis (group: 1PR). PBSC were mobilized in steady state in 135 cases, 53 after cyclophosphamide alone, 9 cyclophosphamide with other drugs. During mobilization, we used GCSF in 179cases, GM-CSF in 5cases, SCF in 4 cases and associations of GM-CSF+ GCSF in 2(1%) cases and SCF+GCSF in 7(3.5%) cases. The median number of infused cells were: TNC 5×107/kg (1–59), CFU-GM 70.5×104/kg (0–2616) and CD34+cells 3×106/kg (0–27). Of these, 115 (58%) had a number of CD34+cells a conditional logistic-regression model to analyze associations between these variables and length of hospitalization, number of RBC and Pt transfusions; a multivariate analysis using Cox model to analyze the impact of these variables on length of aplasia ( We observed no significant impact of all studied variables on length of hospitalization and RBC transfusions and a significant negative impact of long interval diagnosis-T (p=0.05) and of the period > 2004 on Pt transfusion number (p=0.03). We showed a significant positive impact of CFU-GM number [HR=1 (1000–1.002) (p=0.03)] and growth factor use after transplantation [HR=0.55 (0.36–0.85) (p=0.005)] on days