Safety and efficacy of prophylactic levetiracetam for prevention of epileptic seizures in the acute phase of intracerebral haemorrhage (PEACH): a randomised, double-blind, placebo-controlled, phase 3 trial.

Background: The incidence of early seizures (occurring within 7 days of stroke onset) after intracerebral haemorrhage reaches 30% when subclinical seizures are diagnosed by continuous EEG. Early seizures might be associated with haematoma expansion and worse neurological outcomes. Current guidelines do not recommend prophylactic antiseizure treatment in this setting.

Implementation assessment of a patient personalized clinical pharmacy programme (5P project) into orthogeriatric care pathway.

What Is Known And Objective: The orthogeriatric path (hip-fractured elderly patients) is composed of several transition points (emergency surgery, orthopaedic, geriatric and rehabilitation units). The intervention of clinical pharmacists can ensure the continuity of patients' drug management during their hospital stay. The aim of the study was to assess the implementation of clinical pharmacy activities in an orthogeriatric pathway, regarding its impact on medication error prevention, the healthcare professionals' and patients' satisfaction, and the estimated associated pharmaceutical workload.

How a Patient Personalised Clinical Pharmacy Programme Can Secure Therapeutic Care in an Orthogeriatric Care Pathway (5P Project)?

Background: A new model was developed for integrating a personalised clinical pharmacy programme (5P project) into the orthogeriatric care pathway.

Objective: To secure the therapeutic care of orthogeriatric patients.

Design And Setting: Prospective descriptive study in a multisite teaching hospital from June 2019 to January 2020.

Development of clinical pharmacy programs integrated into patient care pathways using adverse event risks.

Background: In the strained actual economic context, all clinical pharmacy activities cannot be achieved for all patients of all care pathways. So finding a way to prioritize moments and patients needing those activities is essential. This is the challenge of the "5P project" (Patient personalized clinical pharmacy program integrated into care pathway).

[Prospective risk analysis in a retrocession unit: Focus on drug dispensation process].

Objectives: Failure mode effect analysis (FMEA) improves safety in the drug life cycle. As the drug dispensation by hospital's pharmacy can be at risk, the FMEA tool has been used to evaluate and enhance the process.

Methods: After detailing the process, a first FMEA has been run in 2015.

Minoxidil versus placebo in the treatment of arterial wall hypertrophy in children with Williams Beuren Syndrome: a randomized controlled trial.

Background: Insufficient elastin synthesis leads to vascular complications and arterial hypertension in children with Williams-Beuren syndrome. Restoring sufficient quantity of elastin should then result in prevention or inhibition of vascular malformations and improvement in arterial blood pressure.

Methods: The aim of this study was to assess the efficacy and safety of minoxidil on Intima Media Thickness (IMT) on the right common carotid artery after twelve-month treatment in patient with Williams-Beuren syndrome.

Production and stability study of a hospital parenteral nutrition solution for neonates.

Standard parenteral nutrition solutions are mixtures comprising interacting components that may degrade themselves over time. The objective of this study was to investigate the physicochemical and microbiological stability of a hospital preparation for parenteral nutrition in neonatology. The analyses were performed throughout the storage of the preparations at 2-8 °C (up to 4 months).

Long-term stability of gentamicin sulfate-ethylenediaminetetraacetic acid disodium salt (EDTA-Na) solution for catheter locks.

A lock solution composed of gentamicin sulfate (5 mg/mL) and ethylenediaminetetraacetic acid disodium salt (EDTA-Na, 30 mg/mL) could fully eradicate in vivo bacterial biofilms in totally implantable venous access ports (TIVAP). In this study, fabrication, conditioning and sterilization processes of antimicrobial lock solution (ALS) were detailed and completed by a stability study. Stability of ALS was conducted for 12 months in vial (25 °C ± 2 °C, 60% ± 5% relative humidity (RH), and at 40 °C ± 2 °C, RH 75% ± 5%) and for 24 h and 72 h in TIVAP (40 °C ± 2 °C, RH 75% ± 5%).

[Pharmaceutical interviews for rheumatoid arthritis patients: Perceptions and expectations of community pharmacists].

Introduction: Rheumatoid arthritis has a low level of medication adherence. Abroad, the community pharmacist has a positive impact on the patients' adherence in several chronic diseases. In France, community pharmacists' missions are developing with the implementation of pharmaceutical interviews.

Dual 0.02% chlorhexidine digluconate - 0.1% disodium EDTA loaded thermosensitive ocular gel for Acanthamoeba keratitis treatment.

Poor bioavailability and low residence time limit the efficiency of conventional biguanide-based eye drops against Acanthamoeba keratitis. The aim of this work was to formulate an original anti-amoebic thermoreversible ocular gel combining biguanide and metalloproteases inhibitor - chelating agent. Chlorhexidine digluconate (CHX)-ethylenediaminetetraacetic acid disodium salt (NaEDTA) were compounded in poloxamer 407 saline solution.

Assessment of the clinical relevance of pharmacists' interventions performed during medication review in a rheumatology ward.

Background: Pharmacists contribute to reduce the number of medication errors during medication review. Nevertheless, few French studies report the potential clinical impact of pharmacists' interventions performed after detecting drug-related problems. The objective was to evaluate the clinical relevance of pharmacists' interventions in a rheumatology ward from medical and pharmaceutical perspectives.

Formulation, stability testing, and analytical characterization of melatonin-based preparation for clinical trial.

A new institutional clinical trial assessed the improvement of sleep disorders in 40 children with autism treated by immediate-release melatonin formulation in different regimens (0.5 mg, 2 mg, and 6 mg daily) for one month. The objectives of present study were to (i) prepare low-dose melatonin hard capsules for pediatric use controlled by two complementary methods and (ii) carry out a stability study in order to determine a use-by-date.

[Management of outpatient medications in care units: An audit of clinical practices].

Objectives: To assess the outpatient medication management in care units two years after the release of an institutional procedure. To assess the patients' satisfaction with their treatment and with the information transmitted by healthcare professionals.

Methods: An audit of clinical practices was conducted in 23 units of our universitary hospital - general, surgery, emergency departments.

Nilotinib and peginterferon alfa-2a for newly diagnosed chronic-phase chronic myeloid leukaemia (NiloPeg): a multicentre, non-randomised, open-label phase 2 study.

Background: Nilotinib is now recommended for patients with newly diagnosed chronic myeloid leukaemia in chronic phase and leads to important rates of molecular response 4·5 log (MR(4·5)), allowing the prospect of therapy cessation. However, most patients do not reach this criterion and nilotinib is taken for lengthy periods, resulting in chronic or late-onset adverse events. Nilotinib combined with interferon might further increase rates of MR(4·5), avoid late side-effects, and allow therapy cessation.

Infraorbital and infratrochlear nerve blocks combined with general anaesthesia for outpatient rhinoseptoplasty: A prospective randomised, double-blind, placebo-controlled study.

Introduction: We conducted a study to determine the efficacy of bilateral extraoral infraorbital and infratrochlear nerve blocks during outpatient rhinoseptoplasty under general anaesthesia.

Patients And Methods: In this prospective, double-blind, randomised, controlled trial, 40 adult patients undergoing outpatient rhinoseptoplasty under general anaesthesia were assigned to receive bilateral infraorbital and infratrochlear nerve blocks with either 10mL of 0.25% levobupivacaine (Group LB) or isotonic saline (control group).

Evaluation of Safe Infusion Devices for Antineoplastic Administration.

Nurses endure daily low-level exposure to cytotoxic drugs, which can lead to significant absorption with potential harmful consequences. New sterile medical devices called cytotoxic safe infusion systems (CSISs), intended by their manufacturers to improve safety and quality of cytotoxic drug infusions, have been made commercially available. CSISs from 3 manufacturers were tested in 2 cancer units and compared with standard infusion sets.

New easy handling and sampling device for bioavailability screening of topical formulations.

Biopharmaceutical assessment of topical drug formulations is widely carried out by using vertical diffusion cells (Franz type cell). Although Franz diffusion cell model is well designed for percutaneous absorption studies, the extent of drug penetration within the skin requires more adapted device. Recently, we have developed a new patented versatile, easy-to-use, and disposable diffusion cell called VitroPharma.

[Long-term benzodiazepine use among dialysis patient: A descriptive study].

Background: 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.

[Injectable hospital preparation of valine labeled with the carbon 13 and nitrogen 15 (5 mg/mL) for a clinical trial on the brain tumor metabolism: Pharmaceutical control of active pharmaceutical ingredient and stability study of the finished product].

Introduction: The L-Valine labeled (L-[U-(13)C,(15)N] Val) is a stable isotopic tracer administered by parenteral route within the framework of a new clinical research program concerning the brain tumor metabolism. To meet regulatory requirements and have ready to use solution with an expiration date, a pharmaceutical control of active pharmaceutical ingredient followed by stability study of hospital preparation were realised.

Materials And Methods: After the pharmaceutical control of the L-[U-(13)C,(15)N] Val, the hospital preparation was prepared according to the good manufacturing preparation.

[Advantages and special features of hospital preparations of parenteral nutrition in neonatalogy].

Introduction: The care of premature infants requires specific, suitable parenteral nutrition, in which the dosage must be frequently adjusted.

Method: A comparative analysis of four industrial standard parenteral nutrition formulations NP 100®, Pediaven AP-HP Nouveau-né 1®, Pediaven AP-HP Nouveau-né 2® and Numetah G13% E® and of two hospital preparations made specifically in hospital pharmacies produced by two separate university hospitals (Nutrine® HCL and Formule standardisée début de nutrition) was conducted. The comparison between the formulations focused on electrolytic compositions and protein/energy ratio.

[Aseptic process validation and stability study of an injectable preparation of fructose (5%)-glycerol (10%) as part of a hospital clinical research program on endoscopic curative treatment for early epithelial neoplastic lesions of the gastrointestinal tract].

Introduction: As part of a hospital clinical research program on endoscopic curative treatment for early epithelial neoplastic lesions of the gastrointestinal tract, a new hospital sterile and non-pyrogenic preparation of fructose (5%)-glycerol (10%) was realized. Under pharmaceutical legislation, the provision of this hospital preparation involves of aseptic process validation and achieve a stability study.

Materials And Methods: After the aseptic process validation with Mediafill Test, the preparation was made under aseptic conditions associated with a sterilizing filtration according to the good practices preparation.

[Injectable preparation of labeled leucine with the carbon 13 for a clinical research program on the Alzheimer disease: pharmaceutical control of raw materials and the finished product and stability study].

Introduction: The L-leucine labeled (L-[U-(13)C] Leu) is a stable isotopic tracer administered by parenteral route within the framework of a new clinical research program concerning the diagnosis of the Alzheimer's disease. To meet regulatory requirements and have ready to use solution with an expiration date, a pharmaceutical control of raw materials and the finished product followed by a stability study were realised.

Materials And Method: After the pharmaceutical control of raw materials, the solution of L-[U-(13)C] Leu was prepared according to the good practices preparation.

[Pharmacist's interventions on outpatient prescriptions in a university hospital drugs sales service].

Unlabelled: For public health reasons, some drugs are only available in hospital drugs sales service. This activity takes place in a specific risk context of organization, patients and/or drugs. A systematic prescription analysis by pharmacist contributes to securise treatment dispensed.