[Impact of the new European regulation 2017/745 on medical devices on hospital pharmacies activity: Example on pharmaceutical supply function within a French university hospital center]. / Impact du nouveau règlement européen 2017/745 relatif aux dispositifs médicaux sur l'activité des pharmacies hospitalières : exemple de la fonction d'approvisionnement pharmaceutique au sein d'un centre hospitalo-universitaire français.

OBJECTIVE: The new European regulation (MDR) on medical devices (MD) is expected to have major impacts on the industrial sector, but also consequences on healthcare professionals. Our objective was to evaluate the impact of the MDR on the supply of MDs in hospital pharmacies at the level of a French university hospital. MATERIAL AND METHODS: We conducted a prospective follow-up of marketing cessations and supply disruptions directly related to the MDR between November 2019 and September 2020. The data were analyzed accounting for the nature of the suppliers (status/size), the nature of the MDs (route/class), and the proposed alternatives. The economic impact on hospital pharmacies was also estimated. RESULTS: Over this period, 96 MD product designations were declared out of stock or in cessation (total of 402 references), of which half corresponded to class IIa MDs, mainly used for surgical procedures. Of the 14 companies concerned (36% French), the majority were manufacturers, of small/medium-size or intermediate size. Substitutions were proposed for only 15 products (15.6%). The cost of pharmaceutical management of these disruptions/marketing cessations was estimated at 3052€. CONCLUSION: Even before the official date of its application, the impacts of the MDR on the supply function of hospital pharmacies are already visible. In the short, medium and long term, prospective monitoring of the impacts, positive or negative, would seem to be justified at the level of manufacturers, healthcare professionals and end users of MDs.

Drug-related problems among older patients: Analysis of 8 years of pharmacist's interventions.

OBJECTIVES: To analyse the most frequent DRP over time and pharmacists' interventions made among older patients aged over 75 years old. DRP between older patients and younger patients aged 18 to 74 years and between older patients treated in geriatric wards or not were also compared. METHODS: A cross-sectional observational study conducted on DRP detected by pharmacists at the university hospital centre of Lyon and prospectively recorded in the Act-IP© database from January 2008 to December 2015. RESULTS: A total of 56,223 DRP were investigated - 19,056 in older patients and 37,167 in younger patients. A supratherapeutic dosage was mainly reported (22.4% in older patients vs. 19.0% in younger patient) and pharmacists made interventions mostly to adjust dosage (27.3% vs. 24.2%). Physicians' acceptance was significantly lower in older patients (57.1% vs. 64.3%). DRP associated to a drug included a supratherapeutic use of acetaminophen (5.2% vs. 3.8%) and hypnotics (4.0% vs. 1.4%), medication in cardiology used without indication (1.4% vs. 0.2%) and underuse of vitamin D (1.2% vs. 0.1%). Supratherapeutic dosages were more significantly detected with a lower overall physicians' acceptance in older patients treated in general wards. CONCLUSIONS: This study highlights the specificity of DRP among older patients and encourages health care professionals to remain especially alert regarding older patients treated in general wards. These findings can contribute to define or adjust training needs and quality indicators to improve the daily practices of health care professionals.

[Ensuring safety of patients under antipsychotic drugs: Impact of medical and pharmaceutical collaboration at prison]. / Sécurisation de la prise en charge médicamenteuse des patients sous antipsychotiques : impact de la collaboration médico-pharmaceutique à la Maison d'Arrêt de Lyon-Corbas.

OBJECTIVE: Antipsychotics are the standard treatment for psychosis. However, when combined with other lifestyle factors they are partially responsible for an excessive mortality rate. A clinical and paraclinical monitoring of patients is therefore necessary. In 2011, this element led doctors and pharmacists to improve monitoring and formalize a follow-up adapted to inmate patients. The aim of this study was to assess the impact of medical-pharmaceutical collaboration on monitoring quality of patients treated by antipsychotics. METHODS: This is a retrospective study including all patients treated by antipsychotics for at least 6 months in 2011 and again in 2015. Data were collected from medical files. The indicator assessing the monitoring quality was the compliance percentage, of registred parameters for each patient on the basis of specific guidelines. RESULTS: In 2015 compared to 2011, the monitoring quality increased for 9 out of 10 parameters. This improvement was statisticaly significant for 7 of them : Body Mass Index, lipid test, complete blood count, transaminase, ionogram, glycemia, glomerular filtration rate. CONCLUSION: The actions of improvement collectivelly implemented in 2011 had a concrete impact on patients in the follow-up in 2015.

Benzodiazepine dose reduction in prisoner patients: 15 years' teamwork between psychiatrists and pharmacists.

WHAT IS KNOWN AND OBJECTIVE: Benzodiazepines are widely consumed in prisons, despite the iatrogenic risks associated with this therapeutic class. A multidisciplinary pharmacotherapy programme was therefore initiated by pharmacists in 2001. The aim of this study was to demonstrate the efficacy of teamwork between psychiatrists and pharmacists in benzodiazepine dose adjustment, with 15 years of hindsight. METHOD: In this retrospective study, daily prescribed benzodiazepine doses were compared between a reference group of patients in prisons in Lyon, France, in 2000, and four groups after psychiatrist-pharmacist teamwork in 2004, 2008, 2012 and 2016. RESULTS AND DISCUSSION: A number of 1249 patients were included. Prescribed doses of benzodiazepine decreased in the intervention groups, to a mean of 29-35 mg diazepam equivalent per day, compared to the control group (42 mg/day) (P < .001). The first 4-year period (2000-2004) demonstrated that monthly meetings and systematic pharmaceutical medication review had an impact on prescribed benzodiazepines, limiting consumed doses. The others (2004-2008, 2008-2012 and 2012-2016) confirmed that physicians' adherence to prescription guidelines and the efficacy of pharmacotherapy programme was maintained, particularly in those inmates taking high doses. WHAT IS NEW AND CONCLUSION: A continuous quality programme conducted by psychiatrists and pharmacists showed positive impact in reducing doses of benzodiazepine prescribed to prisoner patients and contributing to reduce risk of benzodiazepine-related problems.

[Drug management of prisoners: Role of the pharmaceutical staff to ensure patient safety]. / Prise en charge médicamenteuse en milieu carcéral : contribution de l'équipe pharmaceutique à la sécurité des patients.

OBJECTIVES: In the prisons of Lyon, drug management of inmates implies cooperation between general practitioners, psychiatrists and pharmacists. All the medical prescriptions are reviewed by the pharmacists of the medical unit. The aim of this work was to synthesize the pharmaceutical interventions performed and show the implication of the pharmaceutical staff in detecting and handling prescribing errors. METHODS: Pharmaceutical interventions performed between the 1st of June 2012 and the 31st December 2014 and entered in the Act-IP(®) database (SFPC) were retrospectively analyzed. RESULTS: Among the 18,205 prescriptions reviewed, 4064 (22.3%) had a prescription error. The main problems encountered were by decreasing order of frequency: missing monitoring (15% of the interventions), lack of compliance (13%), over dosage (10%), lack of conformity with recommendations or consensus (8%). Interventions were accepted in 78% cases. Most prescribing errors implied medications of the central nervous system. Among the interventions, 8% were initiated by pharmacy technicians, mainly lack of compliance. CONCLUSIONS: The pharmaceutical interventions reported reflected actions of securisation initiated by the pharmacists in cooperation with physicians: monitoring of patients taking antipsychotic medications or benzodiazepines maximal dosages. Besides, in this population with a high prevalence of psychiatric comorbidities and important suicide rate, detection of patients with default of compliance is one of the keys for drug optimization among these patients as it is an explanation for therapeutic failure.

[Technical criteria of central venous catheters: Anaesthesiologist/intensivist and pharmacist opinions]. / Critères de choix d'un cathéter veineux central : points de vue de l'anesthésiste-réanimateur et du pharmacien.

INTRODUCTION: The lack of technical information from suppliers and from the literature, a wide variety of features and the absence of medical device reference document explain the difficulty for medical and pharmaceutical staffs to choose a central venous catheter (CVC). The aim of this study was to establish the specifications to choose a CVC according to the clinician needs. METHODS: An analysis of suppliers' technical documentation and a literature review was performed to identify criteria and to collect them in a questionnaire to conduct semi-structured interviews between 1 pharmacist and 5 anaesthesiologists/intensivists. With these interviews, the technical criteria were classified according to their importance in 3 levels. RESULTS: Thirteen technical criteria were identified after reading the technical documents and the literature. Among them, 8 were classified as "essential criteria" (level I) by the physicians: J-shaped guide, one clamp on each way, identified lumen, radiopacity, graduation every centimeter by 5 to 20 cm from the distal extremity, a length of 15 to 25 cm, a single-lumen catheter with a 14 to 16G way and a three-lumen catheter with 14 to 18G way. Finally, three criteria were classified as "intermediate criteria" (level II) and two as "optional criteria" (level III). CONCLUSIONS: This collaborative approach allowed to reference new medical devices according to the clinicians needs. These CVC are a mean to respect guidelines for physicians and nurses and to secure the patient's care.

[Massive transfusion: analysis of practices according to available medical devices]. / Transfusion massive : analyse des pratiques en fonction des dispositifs médicaux disponibles.

INTRODUCTION: An assessment of practices and available medical devices during the treatment of a massive haemorrhage has been realised in the shock unit of our hospital. MATERIAL AND METHODS: Parameters influencing transfusion flow rate have been identified. Medical devices and equipment to accelerate the flow rate were analyzed on the basis of manufacturers' data and users opinion in relation with their practices. RESULTS: The system, from blood bags to venous access, influences flow rate: red blood cell viscosity, catheter and pressure gradient. Three types of acceleration systems are available: accelerated transfusion set, pressure cuff with a gravity blood IV set and fast-flow fluid warmers. Their benefits and disadvantages are presented and discussed. DISCUSSION: Maximum flow rates noted by manufacturers are not the real values because some parameters such as venous catheter diameter (limitative factor) and the red blood cell viscosity (diluted or not) are not considered. The choice of an infusion system is mainly based on the technical capacities (flow rate fluctuations, pressure gradient on blood bags, warming, air purging), practical modalities of use (medical devices and assembly) and cost. The pressure cuff with transfusion gravity set should be limited to non-critical situations or during the assembly of the fast flow fluid warmers (but no warming fluids, no air embolism prevention). The accelerated transfusion set is not the best option for a shock unit because it needs an operator permanently. The fast-flow fluid warmers are recommended for all types of massive haemorrhages, they are more secure but they require a long time to be assembled.

[Most frequent drug-related events detected by pharmacists during prescription analysis in a university hospital]. / Problèmes médicamenteux les plus fréquemment détectés par l'analyse pharmacothérapeutique des prescriptions dans un centre hospitalier universitaire.

PURPOSE: In France, the analysis of the prescriptions by a pharmacist in hospital is mandatory since 1991. However, for various reasons, this activity remained poorly developed and little research has been performed. Consequently, this activity suffers of a lack of visibility to hospital decision-makers and others health care professionals. The aim of this paper is to describe drugs related problems identified by pharmacist prescriptions analysis on a large number of orders in a large teaching hospital. This was done in order to highlight recurrent and preventable problems. METHODS: During 1 year period, drug related problems detected by pharmacists when performing prescription analysis were registered prospectively. RESULTS: Among 70,849 orders, 7073 drug related problems were registered. Most frequently detected drug related problems were: over dosages, especially with three drugs (zopiclone, zolpidem and acetaminophen) representing more than 10% of the pharmacist's interventions; optimization of drug administration especially with tablets that should not be crushed and intravenous to oral step-down therapy (7.5%); lack of conformity with consensus recommendations and contra-indications (12.8%); drug-drug interactions (11.6%) with a high proportion of absorption inhibition of one drug by another along the digestive tract; problems related to computerized physicians order entry (5.1%) appeared as an emerging phenomenon. CONCLUSION: These results should be used to reexamine hospital drug prescription policy. They prompt health care professionals to be aware about new medications errors potentially related to computerized prescription order entry. Finally, they invite to modify initial and continuous education programs of health care professionals.

[Can we use a Bayesian method to build a pharmacokinetic population in two steps?]. / Peut-on utiliser une méthode bayésienne pour constituer une population pharmacocinétique en deux étapes?

The aim of this study is to evaluate the use of a pharmacokinetic population model built by the two-stage method and individual parameters determined by a Bayesian estimation instead of nonlinear regression. We performed a retrospective analysis on 32 patient files (mean age: 82 years). First, we analysed prediction of amikacin serum levels for the Bayesian method (MAP) and nonlinear regression (MLS). Second, we compared pharmacokinetic parameter values for each patient with MAP and MLS methods for a one- or two-compartment model. For the one-compartment model, no difference in prediction performance was found (correlation coefficient: rMLS = 0.911, rMAP = 0.903, p > 0.05; precision: pMLS = 134.3, pMAP = 147, p > 0.05). A significant difference was observed only for systematic error (eMLS = -4.47, eMAP = -3.34, p < 0.05). For a two-compartment model, the Bayesian method was better for long-term prediction: 4-8 days (rMLS = 0.877, rMAP = 0.886, p > 0.05; eMLS = 5.26, eMAP = 0.04, p < 0.01; pMLS = 441.7, pMAP = 149, p < 0.05). The comparison of MAP and MLS estimated pharmacokinetic parameter values for a one-compartment model showed that the Bayesian method used to built a pharmacokinetic population in two stages does not influence pharmacokinetic parameter estimation (p > 0.05 for Vd, Kslope, Kel and t1/2). We conclude that we can use a Bayesian method to build a pharmacokinetic population in two steps in order to perform adaptative control of a drug-dosage regimen.