Antibiotic therapy for infectious hemodialysed patients in Bamako: Pharmacokinetic analyses and first improvement suggestions.

Infection which occurs in renal kidney failure patient have to be therapeutically managed immediately and the treatment must be aggressive to be quickly efficient. In Bamako (Mali). Posology adaptation cause a problem in nephrology, especially for the most common used antibiotics to care these infections. Drug dosage is not routinely performed in Bamako. The main objective of this work is to compare anthropometric, clinical and pharmacokinetic profiles and the clinical future between infected hemodialysis patients following an antibiotic therapy in Bamako and Lyon (hospital used as a reference). To reach these objectives, a preliminary punctual study of clinical pharmacokinetic of vancomycin were set up at Bamako, following the personalization therapeutics model from Lyon. Bamako patients' samples were imported to France and dosage analysis were performed at Lyon. BestDose software was used to view and compare complete pharmacokinetic profile. It includes for the first time, in routine, the 50 ml/mn of the renal function during dialyses for 58 patients: 31 for Bamako and 21 for Lyon. The residual concentration at the beginning of the dialysis session was compared. In Bamako, patients are younger, the renal failure is more severe and arteriovenous fistula are never set up, treatments are limited in dose and in duration; the residual concentration before the dialyses are too low; as a consequence, infections are rarely quickly reduced and more especially the death linked to these infections are more important (9 in Bamako versus 1 in Lyon). Urgent corrective measures have to be proposed: propose a conciliation between therapeutic requirements formulated within Lyon protocols and the financial ability of the patient, to promote arteriovenous fistula creation as soon as possible, and develop first dose strategy (unfortunately there is often only one dose): a more aggressive dose estimated from simulation profile performed in this study.

Cost-effectiveness of stent-retriever thrombectomy in large vessel occlusion strokes of the anterior circulation: Analysis from the French societal perspective.

OBJECTIVES: To determine the cost-effectiveness of stent retriever thrombectomy (SRT) added to standard of care (SOC) in large vessel occlusion (LVO) strokes, adopting the French societal perspective given the lack of published studies with such perspective. METHODS: We developed an hybrid model (decision tree until one year post-stroke followed by a Markov model from one year onward). The time horizon was 20 years. We calculated transition probabilities across the modified Rankin Scale (mRS) based on a published meta-analysis. The main outcome measure was quality adjusted life-years (QALYs) gained. Resources and input costs were derived from a literature search. We calculated the incremental cost-effectiveness ratio (ICER) expressed as cost/QALY. We used 1-way deterministic and probabilistic sensitivity analysis (PSA) to evaluate the model uncertainty. RESULTS: In the base-case, adding SRT to SOC resulted in increased effectiveness of 0.73 QALY while total costs were reduced by 3,874€ (ICER of -5,400€/QALY). In the scenario analysis adopting the French healthcare system perspective, the ICER was 4,901€/QALY. Parameters the most influential were the relative risks of SRT over SOC for 90-days mortality and for 90-days mRS 0-2, and the time horizon. PSA showed the 95% confidence interval of the ICER was -21,324 to 4,591€/QALY, with SRT having 85.5% chance to be dominant and 100% to be cost-effective at a threshold of 50,000€/QALY. CONCLUSION: SRT was dominant from a French societal perspective, from 9 years post-stroke onwards. Cost-effectiveness of SRT added to SOC becomes undisputable with evidences from payer and societal viewpoints.

Stent retriever thrombectomy for acute ischemic stroke: A systematic review and meta-analysis of randomized controlled trials, including THRACE.

BACKGROUND AND PURPOSE: Endovascular thrombectomy has become the reference therapy for patients with large vessel occlusion (LVO). However, no meta-analysis including the THRACE Trial has yet been reported. Thus, the present review assessed the outcomes of stent retriever thrombectomy added to medical care compared with medical care alone in LVO patients. MATERIALS AND METHODS: A systematic review was conducted of all randomized controlled trials (RCTs) examining stent retrievers added to medical care vs medical care alone in the MEDLINE, Embase and Web of Science databases. Meta-analyses of 90-day functional outcomes and mortality, and the occurrence of symptomatic intracranial hemorrhage (sICH), with thrombectomy plus medical care vs medical care alone were performed. RESULTS: Six multicenter RCTs involving 1673 patients were included. Successful recanalization (modified thrombolysis in cerebral ischemia grades 2b-3) was seen in 71% of patients (95% CI: 62-79%) after thrombectomy. These patients also had significantly higher rates of 90-day functional independence (mRS scores 0-2) compared with those receiving medical care only (OR: 2.14, 95% CI: 1.72-2.67; P<0.00001), as well as excellent outcomes (mRS scores 0-1, OR: 2.05, 95% CI: 1.58-2.67; P<0.00001). Also, the rate of functional independence was higher (OR: 2.39, 95% CI: 1.88-3.04; P<0.00001) in the subgroup analysis without the THRACE Trial. The effect of endovascular therapy on 90-day mortality was inconclusive (OR: 0.82, 95% CI: 0.62-1.07; P=0.15), and there was no increased occurrence of sICH (OR: 1.11, 95% CI: 0.66-1.88; P=0.70). CONCLUSION: Stent retriever thrombectomy added to medical care improved 90-day functional outcomes compared with medical care alone with no impact on mortality and risk of sICH in LVO patients.

[Economic evaluation of medical devices not included in the French list of products and services qualifying for reimbursement: Example of biologic meshes]. / Impact économique à l'hôpital de dispositifs médicaux non remboursés en sus des GHS : exemple des prothèses de renfort biologiques.

OBJECTIVES: To present a method aimed to evaluate the economic impact associated with the use of medical devices (DM) not reimbursed in addition to diagnosis related groups (DRGs) tariffs using the example of biological meshes for parietal reinforcement. METHODS: In this multicenter retrospective cohort study, we included all patients who received a biological mesh between January 2010-April 2014 (University hospitals of Saint-Étienne, France) or between January 2010-March 2015 (Lyon University hospitals, France). Measured costs associated with biologic meshes were compared to those of the "Étude nationale des coûts à méthodologie commune" (2012) to weigh the economic impact of biologic meshes with the French DRGs costs. We also compared these costs to the fares perceived by the hospital from the French sickness fund (GHS). RESULTS: Thirty-six patients received a biological mesh and were treated by a total of 38 biological meshes. Of these, the implant was Protexa®, Permacol® and Strattice® in 66%, 29% and 5% of cases respectively. The hospitals incomes were 10,496±5562€ per stay. Meshes-related expenditures represented in average 28% of DRGs costs and 38% of GHS tariffs. The mean additional cost for biological meshes was 3793±2292 euros compared to the mean cost on implantable medical devices in the French DRGs. CONCLUSION: Given their currently restricted use, the hospital budget impact of biological meshes remains limited although the incremental cost per patient is substantial. Analytic costs data can be useful within the scope of decision-making related to DM not refunded by the French health system.

Current trends in vasopressor use to the operating room: A pharmacoepidemiologic study in French teaching and military hospitals.

OBJECTIVES: Phenylephrine, ephedrine and norepinephrine are the vasopressors most commonly used in the operating room to treat anaesthesia-induced hypotension. Two new diluted forms of phenylephrine were released in 2011 (500µg/10mL and 500µg/5mL). We initiated a study to evaluate trends in the use of vasopressors in the operating room in French hospitals over the period 2011-2014. METHODS: We conducted a longitudinal, retrospective, observational study between 2011 and 2014 in French teaching and military hospitals. A questionnaire was sent in February 2015 to hospital pharmacists of each centre to retrospectively collect the consumption of each type of vasopressor. Yearly numbers of vasopressor ampoules were divided by the yearly numbers of anaesthetics recorded. For each vasopressor, we calculated the number of ampoules per 100 anaesthetics recorded (/100A). RESULTS: Thirty-two hospitals (82%) completed the questionnaire. One hundred per cent of hospitals had registered the diluted form of phenylephrine (61% had chosen the dilution 500µg/10mL), whereas concentrated ampoules were available in 68% of hospitals. Over the period, an exponential increase in the use of diluted phenylephrine was observed (from 1.0 ampoule/100A in 2012 to 31.7 in 2014), the use of ephedrine remained stable (26 ampoules and 17 prefilled syringe/100A), and use of norepinephrine trended upwards (from 6.7 to 8.2 ampoules/100A). CONCLUSIONS: The use of diluted phenylephrine has exponentially increased without reducing consumption of other vasopressors. This trend might be secondary to practice changes in hypotension treatment following the release of French guidelines in 2013 related to fluid management, the restriction of indications of hydroxylethyl-starch solutions in 2013, and a better knowledge of the benefit of blood pressure optimisation to reduce postoperative morbidity.

Prevalence of drug-related problems associated with direct oral anticoagulants in hospitalized patients: a multicenter, cross-sectional study.

WHAT IS KNOWN AND OBJECTIVE: The complex dose regimens of the direct-acting oral anticoagulants (DOAC) make their appropriate prescribing highly challenging. Inappropriate prescribing of the DOAC remains poorly addressed. We studied the patterns of DOAC prescription and estimated the prevalence of drug-related problems (DRPs) associated with their use. METHODS: A cross-sectional study was conducted using data from medical records system of the Lyon teaching hospitals. DRPs, identified among patients who received a DOAC, between 1 January 2010 and 31 July 2013, were categorized according to the Pharmaceutical Care Network Europe Classification System. The prevalence of hospital stays with a DRP was estimated, and a subgroup analysis according to DOAC and their indication for use was provided. Clinical outcomes were not assessed. RESULTS: Of the 4154 hospital stays with at least one DOAC administration [3412 patients; median age (range): 71 years (14-98), 57% female], 70·8% were excluded from the analysis mainly due to missing information for renal function and/or patient weight. Of the 1188 hospital stays that were screened, 100 DRPs were identified (prevalence 8·4%; 95% CI, 6·8-10·0). The highest prevalence was found among patients who received rivaroxaban for atrial fibrillation (14·6%; 95% CI, 10·7-18·5). A too low drug dose was the most frequent DRP (n = 56; 4·7%), followed by a too high drug dose (n = 37; 3·1%), contraindication (n = 5; 0·4%), and pharmacokinetic problem requiring dose adjustment (n = 2; 0·2%). WHAT IS NEW AND CONCLUSION: Drug-related problems associated with the DOACs occur quite commonly among hospitalized patients. Although these DRPs were considered to be of minor severity, prescribing protocols to support better prescribing should be disseminated to reduce the risk to patients. Renal function and body weight data should be mandatory on prescriptions to allow cross-checking.

Xenograft biologic mesh in parietal and general surgery: Technical assessment and review of clinical effectiveness and safety data.

STUDY AIM: To describe the main technical characteristics of biologic prostheses used for parietal reinforcement and to present the state of the art on their risk/benefit ratio. METHODS: We conducted a technical analysis of manufacturer specifications of the biologic prostheses that are currently available in France accompanied by a literature review by selecting meta-analyses and systematic reviews, randomized controlled trials and publications of health technology rating agencies. RESULTS: Biological implants for parietal reinforcement are mainly intended for use in a contaminated environment where the use of synthetic prostheses is contra-indicated. We identified fourteen systematic reviews and meta-analyses and one randomized controlled trial. Six ongoing clinical trials were identified as well as two clinical trials that had been interrupted. In the current state of knowledge, there are no high-level evidence data on the therapeutic contribution of biologic prostheses that allow prioritization of the various biologic prostheses according to their characteristics or their different manufacturing processes. CONCLUSION: Pending the results of current randomized controlled trials to validate the indications and an eventual specific reimbursement, indications for the use of biologic parietal reinforcement prostheses seems to be limited to rare clinical situations and only after collegial discussion.

The cost-effectiveness of tumor-treating fields therapy in patients with newly diagnosed glioblastoma.

BACKGROUND: There is strong concern about the costs associated with adding tumor-treating fields (TTF) therapy to standard first-line treatment for glioblastoma (GBM). Hence, we aimed to determine the cost-effectiveness of TTF therapy for the treatment of newly diagnosed patients with GBM. METHODS: We developed a 3-health-state Markov model. The perspective was that of the French Health Insurance, and the horizon was lifetime. We calculated the transition probabilities from the survival parameters reported in the EF-14 trial. The main outcome measure was incremental effectiveness expressed as life-years gained (LYG). Input costs were derived from the literature. We calculated the incremental cost-effectiveness ratio (ICER) expressed as cost/LYG. We used 1-way deterministic and probabilistic sensitivity analysis to evaluate the model uncertainty. RESULTS: In the base-case analysis, adding TTF therapy to standard of care resulted in increases of life expectancy of 4.08 months (0.34 LYG) and €185 476 per patient. The ICER was €549 909/LYG. The discounted ICER was €596 411/LYG. Parameters with the most influence on ICER were the cost of TTF therapy, followed equally by overall survival and progression-free survival in both arms. The probabilistic sensitivity analysis showed a 95% confidence interval of the ICER of €447 017/LYG to €745 805/LYG with 0% chance to be cost-effective at a threshold of €100 000/LYG. CONCLUSION: The ICER of TTF therapy at first-line treatment is far beyond conventional thresholds due to the prohibitive announced cost of the device. Strong price regulation by health authorities could make this technology more affordable and consequently accessible to patients.

Estimated economic impact of pre-filled ephedrine syringes in the operating room.

BACKGROUND: Syringes of ephedrine are usually prepared ahead of time in order to reduce the time to injection. Commercial pre-filled syringes of ephedrine have been introduced to minimize the amount of waste. Our primary objective was to determine the economic impact of commercial syringes. We hypothesized that costs could be reduced compared to standard syringes. METHODS: Using data extracted from our medical records system, we retrospectively measured the total dose of ephedrine received per patient in 2013 to estimate the number of administered standard syringes. The proportion of administered standard syringes was calculated as the total number of administered standard syringes divided by the number of delivered ampoules in 2013. Thereafter, we calculated the annual cost difference as the difference between the cost for commercial syringes and the cost for standard syringes. Endpoints were calculated overall and for each operating room. RESULTS: At least one dose of ephedrine was given in 19,422 patients (44,943 administrations). The overall proportion of administered standard syringes was estimated to 52.8%. The threshold proportion of administered standard syringes for which commercial syringes would add no extra cost was 20.4%. In 30/32 operating rooms, the proportion of administered standard syringes was higher than 20.4%. The overall cost increase with commercial syringes was estimated to 51,567 €. Among operating rooms, incremental costs varied between -703 and 5086 €. CONCLUSION: Based on our findings, pre-filled ephedrine commercial syringes do not appear to reduce costs.

Current trends in the management of glioblastoma in a French University Hospital and associated direct costs.

WHAT IS NEW AND OBJECTIVES: Trends in the care of glioblastoma in actual practice settings are poorly described. In a previous pharmacoepidemiologic study, we highlighted changes in the management of patients with glioblastoma (GBM) newly diagnosed between 2004 and 2008. Our aim was to complete and to extend the previous report with a study of a cohort of patients diagnosed in 2011 to emphasize the trends in the pharmacotherapy of GBM over the last decade. METHODS: A single-centre study was undertaken of three historic cohorts of GBM patients newly diagnosed during years 2004, 2008 and 2011 (corresponding to groups 1, 2 and 3, respectively) but limited to patients eligible for radiotherapy after initial diagnosis. The type of medical management was described and compared, as well as overall survival and total cost from diagnosis to death or the last follow-up date. Cost analysis was performed from the French sickness fund perspective using tariffs from 2014. RESULTS: Two hundred and seventeen patients (49 in Group 1, 73 in Group 2, 95 in Group 3) were selected with similar baseline characteristics. Fluorescence-guided surgery using 5-ALA was increasingly used over the three periods. There was a strong trend towards broader use of temozolomide radiochemotherapy (39%, 73% and 83% of patients, respectively) as first-line treatment as well as bevacizumab regimen at recurrence (6%, 48% and 58% of patients, respectively). The increase in overall survival between Group 2 and Group 1 was confirmed for patients in Group 3 (17·5 months vs. 10 months in Group 1). The mean total cost per patient was 53368 € in Group 1, 70 201 € in Group 2 and 78355 € in Group 3. Hospital care represented the largest expenditure (75%, 59% and 60% in groups 1, 2 and 3, respectively) followed by chemotherapy drug costs (11%, 30% and 29%, respectively). WHAT IS NEW AND CONCLUSION: This is the first study to report on changes in the management of GBM in real-life practice. The ten-year study indicates an improvement in overall survival but also an increase in total cost of care. The data should be useful for informing the care of GBM patients in settings similar to ours.

Endovascular Treatment of Intracranial Aneurysms with the WEB Device: A Systematic Review of Clinical Outcomes.

BACKGROUND AND PURPOSE: Despite the improvement in technology, endovascular treatment of bifurcation intracranial wide-neck aneurysms remains challenging, mainly due to the difficulty of maintaining coils within the aneurysm sac without compromising the patency of bifurcation arteries. The Woven EndoBridge (WEB) device is a recent intrasaccular braided device specifically dedicated to treating such aneurysms with a wide neck by disrupting the flow in the aneurysmal neck and promoting progressive aneurysmal thrombosis. MATERIALS AND METHODS: Using several health data bases, we conducted a systematic review of all published studies of WEB endovascular treatment in intracranial aneurysms from 2010 onward to evaluate its efficacy and safety profile. RESULTS: The literature search identified 6 relevant studies (7 articles) including wide-neck bifurcation aneurysms in ≥80% of cases. Clinical data supporting the efficacy and safety of the WEB are limited to noncomparative cohort studies with large heterogeneity from a methodologic standpoint. The WEB deployment was feasible with a success rate of 93%-100%. Permanent morbidity (mRS of >1 at last follow-up) and mortality were measured at 2.2%-6.7% and 0%-17%, respectively. The adequate occlusion rate (total occlusion or neck remnant) varied between 65% and 85.4% at midterm follow-up (range, 3.3-27.4 months). CONCLUSIONS: Endovascular treatment of bifurcation wide-neck aneurysms with the WEB device is feasible and allows an acceptably adequate aneurysm occlusion rate; however, the rate of neck remnants is not negligible. The WEB device needs further clinical and anatomic evaluation with long-term prospective studies, especially of the risk of WEB compression. Prospective controlled studies should be encouraged.

Direct costs associated with the management of progressive early onset scoliosis: estimations based on gold standard technique or with magnetically controlled growing rods.

BACKGROUND: The main disadvantage of the surgical management of early onset scoliosis (EOS) using conventional growing rods is the need for iterative surgical procedures during childhood. The emergence of an innovative device using distraction-based magnetically controlled growing rods (MCGR) provides the opportunity to avoid such surgeries and therefore to improve the patient's quality of life. HYPOTHESIS: Despite the high cost of MCGR and considering its potential impact in reducing hospital stays, the use of MCGR could reduce medical resource consumption in a long-term view in comparison to traditional growing rod (TGR). MATERIALS AND METHODS: A cost-simulation model was constructed to assess the incremental cost between the two strategies. The cost for each strategy was estimated based on probability of medical resource consumption determined from literature search as well as data from EOS patients treated in our centre. Some medical expenses were also estimated from expert interviews. The time horizon chosen was 4 years as from first surgical implantation. Costs were calculated in the perspective of the French sickness fund (using rates from year 2013) and were discounted by an annual rate of 4%. Sensitivity analyses were conducted to test model strength to various parameters. RESULTS: With a time horizon of 4 years, the estimated direct costs of TGR and MCGR strategies were 49,067 € and 42,752 €, respectively leading to an incremental costs of 6135 € in favour of MCGR strategy. In the first case, costs were mainly represented by hospital stays expenses (83.9%) whereas in the other the cost of MCGR contributed to 59.5% of the total amount. In the univariate sensitivity analysis, the tariffs of hospital stays, the tariffs of the MCG, and the frequency of distraction surgeries were the parameters with the most important impact on incremental cost. DISCUSSION: MCGR is a recent and promising innovation in the management of severe EOS. Besides improving the quality of life, its use in the treatment of severe EOS is likely to be offset by lower costs of hospital stays. LEVEL OF EVIDENCE (WITH STUDY DESIGN): Level IV, economic and decision analyses, retrospective study.

Management of glioblastoma: comparison of clinical practices and cost-effectiveness in two cohorts of patients (2008 versus 2004) diagnosed in a French university hospital.

WHAT IS KNOWN AND OBJECTIVE: Therapeutic options for the management of glioblastoma (GBM) have greatly evolved over the last decade with the emergence of new regimens combining radiotherapy plus temozolomide and the use of bevacizumab at recurrence. Our aim was to assess the clinical and economic impacts of those novel strategies in our center. METHODS: A single-center retrospective chart review was conducted on patients newly diagnosed with a GBM over two periods (year 2004, group 1 or year 2008, group 2) with limitations to those eligible to radiotherapy after initial diagnosis. The type of medical management was described and compared, as well as overall survival and total costs from diagnosis to death or the last follow-up date. Cost analysis was performed under the French Sickness Fund perspective using tariffs from 2012. RESULTS: One hundred twenty-two patients were selected (49 in group 1 and 73 in group 2) with similar baseline characteristics within the two groups. Patients from group 2 received more frequently temozolomide radiochemotherapy (71% vs. 39%, P < 0·05) as first-line treatment as well as bevacizumab regimen at recurrence (48% vs. 6%, P < 0·05); the median overall survival was increased between the two periods (respectively 17 vs. 10 months, P < 0·05). The mean total cost per patient was 54,388 € in group 1 and 71,148 € in group 2 (P < 0·05). Hospital care represented the largest expenditure (76% and 58% in groups 1 and 2 respectively) followed by chemotherapy drugs costs (11% and 30% respectively). The total cost difference between the two groups was explained by the increasing use of temozolomide and bevacizumab. The incremental cost-effectiveness ratio was estimated at 54,355 € per life-year gained. WHAT IS NEW AND CONCLUSION: As far as we know, this is the first study reporting the total cost of GBM management based on the French perspective, as well as the cost-effectiveness of clinical practices in term of cost per life-year gained. Those novel strategies have contributed to improve overall survival while inducing a substantial, but acceptable, increase of total costs.

[Study of physicochemical and bacteriological impact of a weekly assembly of automated compounding BAXA(®) Exacta-Mix 2400 on parenteral nutrition admixture manufacturing]. / Étude de l'impact physicochimique et bactériologique d'un montage hebdomadaire de l'automate BAXA(®) Exacta-Mix 2400 sur la fabrication des poches de nutrition parentérale.

INTRODUCTION: The parenteral nutrition admixtures are manufactured with an automated compounding BAXA(®) Exacta-Mix 2400. A 48-hour assembly has been validated. To optimize time and cost, a weekly assembly was tested. MATERIALS AND METHODS: Assembly was made on the first day. Ten identical parenteral nutrition admixtures (different volumes and compositions) were produced each day. A macroscopic examination was done at D0, D7 and D14. Physicochemical controls (electrolytes determinations by atomic absorption spectrophotometry, osmolalities measurements) were performed. Microbiological tests included a filtration membrane sterility test (Steritest(®)) and a plate count agar environmental monitoring. RESULTS: All mixtures were considered stable. The 12 Steritest(®) (H24, H48, D7 and D14) did not show any bacterial or fungal contamination. No microorganism has been detected on the plate count agar at D4 and D7. Concerning the physicochemical parameters of each parental nutrition admixture, no significant difference (Wilcoxon test) with the first day was found. DISCUSSION AND CONCLUSIONS: The automated filling system BAXA(®) Exacta-Mix 2400 improves the quality and safety of production. According to these results, the weekly assembly is validated and permit to save time (80hours/year) and cost (40 000 euros on consumable/year).

[Impact of sugammadex on neuromuscular blocking agents use: a multicentric, pharmaco-epidemiologic study in French university hospitals and military hospitals]. / Impact du sugammadex sur les consommations de curares : étude pharmaco-épidémiologique multicentrique dans les centres hospitalo-universitaires et hôpitaux d'instructions des armées français.

INTRODUCTION: Seven Neuromuscular Blocking Agents (NMBA) are commercialized in France. Four of them have an intermediate duration of action. Sugammadex required the use of NMBA slightly employed in clinical practice in France. Its introduction in routine practice could have an impact on NMBA use in clinical practice. This study was then conducted to assess and compare NMBA use before and after the commercialization of sugammadex. MATERIALS AND METHODS: A longitudinal, retrospective, observational study was conducted between 2008 and 2011 in French university hospitals and military hospitals. The consumption data for sugammadex and NMBA were collected using a collection grid which was filled by pharmacists or anesthesiologists. Drug use was measured by the number of vials used divided by the annual number of hospitalizations in surgery and obstetrics (HSO). An overall analysis of the annual frequency of NMBA use was firstly performed, then individual data of each hospital were analyzed. Descriptive statistical analysis including mean, standard deviation, median, minimum and maximum was achieved. RESULTS: Thirty-four out of 39 hospitals participated in the study (87%) and analysis was performed on 26 of them (7%). The data of eight institutions were excluded due to missing values or because of the non-admission of sugammadex in their formulary. The NMBA mostly used were non-steroidal NMBA (75% of market share) with an increased use between 2008 and 2011 concerning atracurium (from 41 to 51 vials of 50mg atracurium used per 100 HSO). The overall analysis revealed an increase of the occurrence of rocuronium (between 2008 and 2011: from 1 to 4.8 vials of 50mg rocuronium used per 100 HSO). Individual analyses on each hospital showed a possible effect of sugammadex introduction on NMBA use in nine hospitals. DISCUSSION AND CONCLUSIONS: The commercialization of sugammadex seems to have induced a discrete increase of steroidal NMBA but non-steroidal NMBA remain the leading agent in France. A long-term follow-up is deserved.

[Stability and sterility of parenteral nutrition admixture for patients home care manufactured by the automated compounding BAXA® EM 2400]. / Étude de stabilité et de stérilité des poches de nutrition parentérale pour patients à domicile fabriquées à l'aide de l'automate BAXA® EM 2400.

INTRODUCTION: Initially, parenteral nutrition admixtures are produced by sterile filtration with a stability of 14 days This study was conducted to check the stability (physicochemical and microbiological) when automated compounding BAXA(®) EM 2400 is used. MATERIALS AND METHODS: Forty pockets corresponding to 10 patients have been manufactured in according to Good Manufacturing Practice. Macroscopic and physicochemical tests (determination of electrolytes by atomic absorption spectroscopy, osmolality and pH measurements) were performed at different times (D0, D7, D14). To complete these checks, the emulsions were analyzed (size, stability, optical microscopy) at D0 and D14. Finally, microbiological research (Bact-Alert(®), filtration membrane sterility tests Steritest(®) and plate count agar) was performed. RESULTS: No lipid cluster was observed with an optical microscope. Comparison of data observed for all controls showed no significant difference in the production of D0 by the Wilcoxon test. Microbiology (Bact-Alert filtration membrane sterility tests Steritest(®) and plate count agar) was negative for all samples. Consequently, all mixtures were considered stable. DISCUSSION AND CONCLUSIONS: The automated compounding BAXA(®) EM 2400 ensures quality and safety of production. The results of this study have shown stability and sterility of parenteral nutrition admixtures for 14 days.

[A programme to support clinical evaluation of medical devices: pilot experiment in the Rhône-Alpes region]. / Structure de soutien à l'évaluation clinique des dispositifs médicaux : expérience pilote en région Rhône-Alpes.

INTRODUCTION: The drug and medical devices Committee of the University Hospital of Lyon faces the weakness of clinical data available to justify medical devices purchase. The Hospital of Lyon has worked with several organisms of the Rhône-Alpes region to set up a pilot programme aimed at encouraging small and medium enterprises (SMEs) to realise clinical studies for the evaluation of their medical device. We report the results of this experiment which took place from 2007 to 2010. METHODS: Eligible projects were selected on the basis of their scientific interest. A specific structure for regulatory and methodological support was set up. RESULTS: Twenty companies applied, seventeen were selected. Eight research protocols were written; four clinical studies were implemented. These studies were performed by micro-companies for medical devices that could be considered as innovative device or substantial novelty. Two draft protocols were started but deferred by choice of the company. For projects that did not lead to a research protocol or study, the main causes were: a longer than expected development phase (n = 3); a problem linked to methodological feasibility (n = 1); the unsuccessful search for a principal investigator (n = 2); or the company's choice (n = 5). DISCUSSION AND CONCLUSION: This pilot experience in France has supported and trained regional SMEs in clinical research. Its continuation could encourage manufacturers to conduct clinical trials of good quality.

[Hospital pharmacist has a rule for best practice use and French hospital activity tariffs. Example of a pharmaceutical quality control for drugs reimbursed in addition of DRGs]. / Le pharmacien hospitalier au cœur des enjeux du bon usage des médicaments et de la tarification à l'activité. Exemple d'une organisation de contrôle qualité pharmaceutique pour le remboursement des médicaments en sus des GHS.

The best practice contract has given a new objective to the hospital pharmacists for the reimbursement in addition to Diagnosis Related Groups' (DRGs) tariffs. We built our pharmaceutical quality control for the administration traceability follow-up regarding the DRGs and the cost of care, for two reasons: the nominal drugs dispensation in link with the prescription made by pharmacist and the important expenditure of these drugs. Our organization depends on the development level of the informatized drugs circuit and minimizes the risk of financial shortfalls or wrong benefits, possible causes of economic penalties for our hospital. On the basis of this follow-up, we highlighted our activity and identified problems of management and drugs circuit organization. The quality of the administration traceability impacts directly on the quality of the medical records and the reimbursements of the expensive drugs. A better knowledge of prescription software is also required for a better quality and security of the medical data used in the medical informatic systems. The drugs management and the personal treatment in and between the care units need to be improved too. We have to continue and improve our organization with the future financial model for ATU drugs and the FIDES project. The health personnel awareness and the development of best informatic tools are also required.