High-purified cannabidiol efficacy and safety in a cohort of adult patients with various types of drug-resistant epilepsies.

About 30% of patients with epilepsy are drug resistant. Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) and tuberous sclerosis complex (TSC) are diseases for which high-purified-cannabidiol (CBD) known as Epidiolex® (GW pharma) can be prescribed in add-on of other medications in case of drug-resistance. Currently, there are only a few recent data in the literature about the efficacy and safety of CBD in other forms of refractory epilepsies especially focal epilepsies in adults. We report retrospectively the experience of high-purified-CBD use in two French reference medical centers for epilepsy in various forms of drug-resistant epilepsy. We distinguished two groups of patients: group A with epileptic encephalopathies and group B with focal or multifocal epilepsy. Safety and efficacy (% of responder patients) were evaluated. Finally, 73 patients (51 in group A and 22 in group B) used high-purified CBD as an add-on treatment for their drug-resistant epilepsy. Patients in group A were significantly younger (P=0.0155), with a longer exposition of treatment (P=0.0497) than group B and with higher doses (P=0.0300). Respectively, 15 patients (29.4%) and five patients (22.7%) were responders during the follow-up period (P=0.552). The association with clobazam was more frequent in responders than in non-responder patients (16 patients [80%] versus four [20%]). The most frequent side effect was somnolence. At the end of follow-up, 15 patients in group A (29.4%) and nine patients in group B (40.1%) had stopped the high-purified-CBD treatment due to aggravation of seizure, absence of positive effects, or adverse events. This study showed no significant difference regarding the type of drug-resistant epilepsy and suggests that this treatment may be of interest for all types of drug-resistant epilepsy.

ANTIFON-CLIC®, a new clinical decision support system for the treatment of invasive aspergillosis: is it clinically relevant?

BACKGROUND: Invasive aspergillosis (IA) is increasing especially in new groups of patients. Despite advances in management, morbidity and mortality related to IA remain high. Thus, Clinical Decision Support System (CDSS) dedicated to IA are needed to promote the optimal antifungal for each group of patients. PATIENTS AND METHODS: This was a retrospective multicenter cohort study involving intensive care units and medical units. Adult patients who received caspofungin, isavuconazole, itraconazole, liposomal amphotericin B, posaconazole, or voriconazole, for the treatment of IA were eligible for enrollment. The primary objective was the concordance between the clinician's prescription and the prescription recommended by the CDSS. The secondary objective was the concordance according to different hospitals, departments, and indications. RESULTS: Eighty-eight patients (n=88) from three medical hospitals were included. The overall concordance was 97% (85/88) including 100% (41/41) for center A, 92% (23/25) for center B, and 95% (21/22) for center C. There was no significant difference in concordance among the hospitals (P=0.973), the departments (P=1.000), and the indications (P=0.799). The concordance was 70% (7/10) for isavuconazole due to its use as an empirical treatment and 100% (78/78) for the other antifungals. DISCUSSION: The concordance rate was high whatever the hospital, the department, and the indication. The only discrepancy was attributed to the use of isavuconazole as an empirical treatment which is a therapeutic option not included in the CDSS. CONCLUSIONS: This new CDSS dedicated to IA is meeting the clinical practice. Its implementation in routine will help to support antifungal stewardship.

[EASYSCAN: French pilot study for securing drug administration by barcode reading]. / EASYSCAN : étude pilote française pour la sécurisation de l'administration des médicaments par lecture code-barres.

OBJECTIVES: Medication errors are common at the time of administration. To prevent them, technologies allowing consistency check by bar code technology at bedside have been developed. Our study focuses on the evaluation of a BarCode Medication Administration (BCMA) called EASYSCAN with Electronic Medication Administration Record (e-MAR) to verify both patient's identity and medication to be administrated. METHODS: A prospective observational study was conducted during seven weeks in a French medicine ward. The performance of the system was evaluated by the success rate of BCMA and by the average time for administration with and without EASYSCAN. A satisfaction questionnaire about BCMA was proposed to nurses. RESULTS: We observed 182 administrations including 87 (48%) with EASYSCAN. The verification of the patient's identity was successful in 77% of administrations and 65% of the drugs were scanned successfully. The main causes of check failures were the lack of datamatrix on the drug (81%), error messages (14%) and the lack of system functionality (5%). The average time for administration per patient was significantly increased: 4.68min/patient with versus 2.87min/patient without EASYSCAN. CONCLUSIONS: The study shows the EASYSCAN's performance in its first version. Material and software evolutions and an increase of nurses'pratices will be necessary to continue the experimentation of this system still unpublished in France.

[Factors influencing the acceptability of pediatric galenic formulations]. / Facteurs influençant l'acceptabilité des formulations galéniques en pédiatrie ­ revue de la littérature.

BACKGROUND AND GOAL OF THIS STUDY: Few available galenic formulations of drugs have pediatric doses, so that many of them are used off label in children. The influence of such pharmaceutical formulation on therapeutic adherence was evaluated in a systematic review of the literature. MATERIALS AND METHODS: This search was performed in 4 data bases: Medline, the Cochrane Library, Web of Science and Science Direct. Included articles were in French or English and focused on therapeutic adherence and route of administration. RESULTS: Overall, 51 articles were included in the study: 46 from Medline (27 selected), 1 from The Cochrane Library (1 duplicate), 61 from Web of Science (13 selected) and 23 articles from Science Direct (11 selected). The two main pharmaceutical formulations studied were liquid dosage form 51% (n=28) and solid oral form 35% (n=19). DISCUSSION: Easy use of liquid forms (n=18) (easy dose adjustment and administration) was associated with good adherence. Optimization of organoleptic properties was found to improve adherence (n=20). The main limitations to the use of solid oral formulations are the risk of choking in a child under 6 and difficulty adapting doses for pediatric use. Commercialization of minitablets should help solve these problems (n=3) and therapeutic education sessions could make it possible to prescribe selected pills to children aged 4 or older (n=2). A risk of misuse because of incorrect administration seems to be the reason that aerosols are underused. CONCLUSION: Drug formulation influences therapeutic adherence in children, which is a cornerstone for successful pharmacotherapeutic management.

[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.

[Best practice agreement: implementation of best practice guidelines in HCL hospitals in Lyon, France]. / Contrat de bon usage : mise en oeuvre opérationnelle des référentiels de bon usage aux hospices civils de Lyon.

Since 2004, the Hospices Civils de Lyon (HCL) hospitals are committed to comply with best practice guidelines for healthcare products that are reimbursed in addition to diagnosis related groups' (DRGs) tariffs in France, and that, even before the publication of the law concerning best practice agreement. It has been necessary to adapt national drugs best practice guidelines to every-day practice. A working group, COPIL RBU, has been created in HCL hospitals to manage the best practice guidelines locally. This group has two main activities: it conducts a scientific and regulatory information watch and follows up emerging indications at HCL. The group's best practice guidelines contain a classification of indications into three categories: approved indications (market authorization and temporary protocol of treatment), currently-assessed indications and contra-indications. Our best practice guidelines are more than a rewriting of national guidelines since they include emerging indications validated by prescribing physicians at HCL hospitals. A scientific argumentation is made for each emerging indication that is classified in our guidelines, based on the level of scientific evidence available. The practical use of our best practice guidelines is made through a best practice prescription that enables the traceability of drugs from the prescription to the administration to the patient. These prescriptions are accompanied with best practice guidelines made by medical and pharmaceutical professional groups. Audits will then be conducted to assess the indications' conformity to our guidelines and to have a better knowledge of current medical practice.

Oral dosage form administration practice in children under 6 years of age: A survey study of paediatric nurses.

The purpose of this study was to interview paediatric nurses on administration issues using extemporaneous capsules and marketed capsules and tablets in children younger than 6 years old, based on most frequently administered drugs in six participating wards. The 59 responding nurses estimated respectively at 7.7±1.7 and 7.3±1.8years the age from which children would properly swallow extemporaneous capsules and marketed solids, with 33% and 37% of nurses considering that children under 6 would not get their prescribed treatment using these dosage forms. Refusal of the child to take the solid was the first reason to explain administration failure (85% of nurses for extemporaneous capsules, 89% for marketed solids). Although type of formulation and requirement of chewing were factors influencing the age at which children would take solid from nurses' experience, size of conventional tablets was not among these factors. All respondents use to crush tablets in children unable to swallow whole solids; 37% of nurses systematically split the tablets to ease the swallowing in children able to swallow. Only 11 nurses had an information tool at their disposal to guide manipulation of solids, with 7 of them using it in their daily practice. Providing specific-ward questionnaires, this study gives factual information on administration practices, perceptions and issues faced by paediatric nurses.

Evaluation of the microbicidal efficacy of Steris System I for digestive endoscopes using GERMANDE and ASTM validation protocols.

In the light of more and more invasive procedures being carried out in digestive endoscopy using sterile devices, it appears necessary to put in place a process of endoscope reprocessing capable of ensuring the complete elimination of micro-organisms contaminating the device. We undertook a study of the microbial efficacy of STERIS SYSTEM 1 (SS1) which purports to achieve this objective. The channels of a gastroscope and a colonoscope were contaminated with suspensions of Pseudomonas aeruginosa, Aspergillus niger and Bacillus subtilis spores. Two procedures were then followed: (1) manual washing only, and (2) treatment in SS1 without prewashing. Recoveries of organisms were made from each channel according to a standard methodology to discover any survivors. Contamination controls we re assessed to measure the logarithmic reduction between the initial contamination and that recovered from the channels. Six cycles per micro-organisms, per type of endoscope, and per type of procedure were carried out. From an initial contamination leve l of 10(6) micro-organisms per endoscope, no micro-organisms were recovered in 35 of the 36 cycles with the SS1. In one cycle with the colonoscope, three B. subtilis organisms were recovered from the channels. Washing only gave microbial reductions which varied according to the micro-organism tested. The maximum reduction with washing alone was by a factor of 10(3 +/- 0.1)for B. subtilis and the minimum reduction factor was 10(3 +/- 0.3)for P. aeruginosa. Considering the results obtained with SS1 without prewashing and the efficacy obtained from washing only, the washing step offers an additional antimicrobial assurance reduction factor of between 10 and 103.1. This study shows that SS1, integrated into an overall reprocessing procedure for digestive endoscopes, is capable of delivering the complete elimination of contaminating micro-organisms in a reduced time and eliminates the toxic risk of reprocessing associated with aldehyde based disinfectants.