Knowledge exchange between patient and pharmacist: A mixed methods study to explore the role of pharmacists in patient education and counseling in asthma and pulmonary arterial hypertension.

OBJECTIVES: To better understand the role of pharmacists in patient education and counselling: describe the perception of knowledge exchange (KE) between asthma/pulmonary arterial hypertension patients and pharmacists (hospital/community) according to four dimensions (4C-typology): cure (C1), care (C2); coordination/supply chain (C3), characteristics of the pathophysiology/disease mechanisms (C4); factors correlated with KE. METHODS: A mixed methods approach was used. Part A: data from semi-structured patient interviews were processed (thematic analysis), and a questionnaire developed. Part B: completed patient questionnaires were processed by correspondence factor analysis. RESULTS: KE (4C-typology) was correlated with pathology, disease severity, disease duration, age, hospital/community pharmacist. Patients expected pharmacists to provide C2/C3 services. KE with pharmacists covered C1/C2/C3, and with physicians, C1/C2/C4. While patients perceived KE as a means of self-learning to improve self-care skills, the two-way nature meant it provided specific experiential information feedback to pharmacists. CONCLUSIONS: This 4C-typology provides a holistic framework for optimising the pharmacists' role in education and counselling of patients with chronic diseases.

[Pharmaceutical cares as means of prevention against drug iatrogenic: Case of oral anticoagulant]. / Les soins pharmaceutiques comme moyen de prévention contre les risques iatrogènes des médicaments : cas des anticoagulants oraux.

Oral anticoagulant can have a significant risk of adverse events, particularly when it is initiated, modified or interrupted. Pharmaceutical care through medication reconciliation could improve the benefit-to-risk ratio of these drugs. A prospective and interventional single center study was conducted from March through August 2018 in medicine and surgical units. Patients with an oral anticoagulant prescribed and coming from outpatient sector were included. These patients received a medication reconciliation at admission and discharge. Frequency and type of discrepancies were studied. Their gravity rating was assessed using the Cornish et al. scale. This study included 162 patients. The medication reconciliation at the admission allowed the detection of 133 unintentional discrepancies which 16 of them represented a high risk for the patient included nine errors about oral anticoagulant prescribing. Concerning the reconciliation at discharge, 51 unintentional discrepancies had been detected: 12 of them represented a high risk for the patient included eight errors about oral anticoagulant prescription. The acceptance rate of the discrepancies was 86% and reflected discrepancies severity. This result reached 96.4% if we took into account discrepancies with a severe clinical impact. This study highlighted oral anticoagulant represented relevant prioritization criteria to the long-lasting implementation of pharmaceutical care. This secures the management of the patient since the admission until the hospital discharge. The last step of our approach would be to study the needs about data transmission to the community caregivers.

[Design and assessment of a outpatient living with PICC-line support program: A pilot study]. / Étude pilote d'évaluation d'un programme d'accompagnement pour les patients quittant l'hôpital avec un PICC-line.

The peripheral insertion central catheter (PICC-Line) is indicated for long term intravenous medication administration. Some adverse events (AE) might occur, especially for patients after hospital discharge. Therefore, patient empowerment about the side effects and precaution for use is essential to prevent potential patient harm. A multidisciplinary working group met and designed support program for outpatient living with PICC-line. Pharmacy consultations (PC) were proposed to patient before and after PICC-line insertion. A strip cartoon and card game were created to facilitate patient education. The aim of the study was to assess the comprehension of patient then secondarily to follow up AE awareness. During 10 months, 30 patients of mean age 65.9±14 years were included. Thirty-sixPICC-Line were installed and followed on 1659days of catheterization. 4, 9 and 13patients received respectively no, at least one and two PCs before discharge from the hospital. Although the differences were not statistically significant, comprehension tends to improve when patients benefit from both PCs especially when it concerns complications. Twenty-fiveambulatory AEs were recorded including 9infections or suspicion of infection, 2 thrombosis and 2 displacements of PICC-line. Among the patients who had no PC, four experienced delayed care. In comparison, it occurred in only one patient in the group who received at least one PC after PICC-line insertion. Further studies are warranted to confirm this trend.

[Improvement approaches in the hospital setting: From total quality management to Lean]. / Démarches d'amélioration en milieu hospitalier : du management de la qualité totale au Lean.

Hospitals have to deal strong with economic constraints and increasing requirements in terms of quality and safety of care. To address these constraints, one solution could be the adoption of approaches from the industry sector. Following the decree of April 6, 2011 on the quality management of the medication use process, some of these approaches, such as risk management, are now part of the everyday work of healthcare professionals. However, other approaches, such as business process improvement, are still poorly developed in the hospital setting. In this general review, we discuss the main approaches of business process improvements that have been used in hospitals by focusing specifically on one of the newest and most currently used: Lean.

Evaluation of a program of pharmaceutical counseling for French patients on oral anticoagulant therapy.

Background Oral anticoagulants are widely used for treatment and prevention of thromboembolic diseases. We set up a pharmaceutical counseling program for both direct oral anticoagulant and vitamin K antagonist drugs in our hospital in 2015. Objective Evaluate patient satisfaction and the evolution of their knowledge throughout the pharmaceutical counseling program on anticoagulants and identify knowledge variability factors. Setting Cardiology Inpatient Unit from the University Antoine Béclère Hospital, France. Methods Evaluation was based on data collection of patients surveyed between 2015 and 2018. Inpatients in the cardiology department on oral anticoagulants were eligible. The learning process was designed to enhance patient knowledge and understanding based on 10 cognitive or self-management skills, relating to the optimization of oral anticoagulant therapy management. It consisted in 2 face-to-face interviews during hospitalization and 2 additional phone interviews one and six months after discharge. The median patient score was evaluated at each step of the process as well as the mean score for each item from the global population. A sub-analysis was run on the less well-acquired skills in order to identify risk factors for limited knowledge. The association between those factors and the level of knowledge (score ≥ 7 or < 7) was assessed using Chi square test followed by multivariate analysis. Main outcome measure Patient knowledge of anticoagulation therapy depending on specific factors. Results Of the 880 patients eligible for pharmaceutical counseling, 319 entered the process and 102 completed it. Median knowledge scores were 8/10 and 9/10 after the first and the final interviews respectively with a significant improvement (p = 0.0003). The least well-acquired items at each step were surveillance and under-dosing management. The sub-analysis showed the use of vitamin K antagonist to be linked to an enhanced understanding related to treatment surveillance (p = 0.029). Patients suffering from atrial fibrillation were found to have a worse understanding of under-dosing management (p = 0.013). Finally, patients evaluated the process as helpful and suitable for their conditions. Conclusion Pharmaceutical counseling is appropriate for patients, improving and maintaining knowledge of oral anticoagulants. Our evaluation highlights the need to focus on patient-specific profiles to reach a satisfactory level of knowledge.

[Rectal pentobarbital sedation for children undergoing auditory brainstem response testing]. / Sédation au pentobarbital par voie rectale pour enregistrement des PEA chez l'enfant.

OBJECTIVES: The aim of our study was to determine if rectal sedation with pentobarbital sodium provides safe and effective sedation for children undergoing auditory brainstem response (ABR) testing. MATERIAL AND METHODS: A prospective study was conducted in the ENT pediatric department of Robert Debre's hospital (APHP, Paris). 68 children under 8 years of age were given rectal pentobarbital for ABR testing at a dosage of about 5 mg/kg. RESULTS: 61 children of 68 (89.7%) were adequately sedated with rectal pentobarbital. The mean elapsed time from drug administration to full sedation was 36,1 minutes. No adverse event was reported in 84.1% of children. CONCLUSION: Pentobarbital provides safe and effective sedation. Rectal administration is easy, painless and with brief duration of action. It's a good alternative to general anesthesia for young children undergoing ABR testing.

Near infrared spectroscopy and process analytical technology to master the process of busulfan paediatric capsules in a university hospital.

The prescription of unlicensed oral medicines in paediatrics leads the hospital pharmacists to compound hard capsules, such as busulfan, an alkylating agent prescribed in preparative regimens for bone marrow transplantation. In this study, we have investigated how the general principle of process analytical technology (PAT) can be implemented at the small size of our hospital pharmacy manufacturing unit. Near infrared spectroscopy (NIRS) was calibrated for raw material identification, blend uniformity analysis and final content uniformity of busulfan hard capsules of 11 different strengths. Measurements were performed on capsules from 2 to 40 mg (n=440). After optimisation, accuracy and linearity of the NIRS quantitative method was demonstrated after comparison with a previously validated quantitative high performance thin layer chromatography (HPTLC) method. Such a comparison led to attractive NIRS precision: +/-0.7 to +/-1.0 mg for capsules from 2 to 40 mg, respectively. As NIRS is a rapid and non-destructive technique, the individual control of a whole batch of busulfan paediatric capsules intended to be administrated is possible. Actually, mastering the process of busulfan paediatric capsules with the NIRS integrated into the notion of PAT is a powerful analytical tool to assess the process quality and to perform content uniformity of at least 5mg busulfan-containing capsules.

[Treatment of severe perianal cutaneous lesions in hospitalized neonates: Orabase ointment interest]. / Traitement des lésions cutanées sévères du siège chez le nouveau-né hospitalisé: intérêt de la pâte Orabase.

Cholestyramine ointment is an hospital preparation used as a second-intention treatment for severe perianal skin lesions. These preparations have to be declared to AFSSAPS. The aim of this study was to assess the equivalence of Orabase, a marketed paste, with intention of substitution. A clinical trial was performed to evaluate the effectiveness of cholestyramine ointment versus Orabase paste. This study was conducted in the neonatalogy unit. The principal evaluation criterion was the time to clinical recovery. Nurses also gave their subjective evaluation of each product. Although 34 children were included in the study, the time to clinical recovery delay was evaluated in 28. Time to clinical recovery was 90.5 hours for the cholestyramine ointment and 81 hours for Orabase paste. Concerning the subjective assessment, Orabase paste achieved a higher score than cholestyramine ointment (p<0.01). Orabase paste was considered to be equivalent to cholestyramine ointment.

Stability and sterility of meglumine gadoterate injection repackaged in plastic syringes.

The analytical and microbiological stability of meglumine gadoterate (Dotarem) repackaged in polypropylene syringe for 3 months at either +4 degrees C or room temperature was studied. For analytical study: six polypropylene syringes (20 ml) were filled with 15 ml of meglumine gadoterate. Three syringes were stored at 4+/-2 degrees C and three at 25+/-2 degrees C, all syringes were kept upright and protected from daylight. Samples were taken on days 0, 6, 14, 30, 45, 60, 75 and 90. Meglumine gadoterate and its degradation product (free Gd3+) concentrations were obtained using a specific HPLC assay. Osmolality and pH determination were made on days 0, 14, 45 and 90. For microbiological study: 28 plastic syringes (5 ml) were filled with 2.5 ml of meglumine gadoterate. Syringes were stored at 25+/-2 degrees C and protected from daylight. At each day of analysis (0, 15, 35, 45, 60, 75 and 90), four syringes were tested as described in European Pharmacopoeia. After 90 days the concentration of gadoterate remained unchanged and no free Gd3+ were detected. The injectable solution of this gadolinium contrast agent was sterile according to European Pharmacopoeia guidelines. The meglumine gadoterate repackaged in polypropylene syringe was stable for 3 months at all the temperatures studied.

Stability and compatibility of an aerosol mixture including N-acetylcysteine, netilmicin and betamethasone.

The physicochemical stability and the compatibility between N-acetylcysteine (1 g/5 ml), betamethasone (4 mg/1 ml) and netilmicin (100 mg/1 ml) were studied at room temperature (25+/-2 degrees C) over 1 h. During this study, drug concentrations were measured using three separate HPLC methods with UV detection at t=0, 5, 10, 20, 30, and 60 min. The pH of the mixture was determined. Degradation products of the drugs were assayed using HPLC. This study demonstrates the stability and compatibility of the mixture over 1 h at room temperature. The pinkish non-remnant coloration observed when pouring N-acetylcysteine into a recipient has no effect on the stability of the drug.

Dual-mode gradient HPLC procedure for the simultaneous determination of chloroquine and proguanil.

In order to assay the antipaludic capsule of the Service de Santé des Armées (SSA), that contains two antimalarial drugs, i.e. chloroquine sulfate (CQS, cp1) and proguanil hydrochloride (PGH, cp5), a HPLC procedure was developed. A reversed-phase ion-pair high-performance liquid chromatography (HPLC) method with an ultraviolet detection at 254 nm was set up and validated. Elution system includes programming of both organic concentration and flow-rate known as 'dual-mode gradient'. This method allows the simultaneous determination of both active compounds and separation of four process related substances. The method is simple, rapid, selective and accurate, and the precision is good with an inter- and intra-assay of <2%. The sensitivity is particularly suitable for pharmaceutical quality control.

Quantitative determination of fat emulsion using 1,6-diphenyl-1,3,5-hexatriene as fluorescence probe: application to the compounding of all-in-one parenteral nutrition admixtures.

The potential contamination of binary bags by traces of fat emulsion stemmed from ternary bags prepared just before, led us to determine traces of lipids into the line set of the automated compounder MM23. Diphenylhexatriene (DPH) was chosen as fluorescence probe due to its strong fluorescence enhancement in a lipid environment. Optimization of experimental conditions (i.e. DPH amounts, pH of fat emulsion samples, ultrasounds use, light, temperature and contact duration) for fluorescence measurement and validation of analytical method were performed. This method was linear over 0.5-8.0 mg l(-1) (r=0.999) of fat emulsion. The intra-day and inter-day precisions were inferior to 2% for the 2.0 and 8.0 mg l(-1) standards. Under optimized conditions, the detection limit and quantitation limit were 0.10 and 0.29 mg l(-1) of lipids respectively. Compared to the colorimetric method using sodium dichromate, it is at least 100 times more sensitive. The proposed method permitted to rapidly measure fat emulsion traces in automated compounder line set for parenteral nutrition solutions and thus, to assess the risk of contamination of binary bags by lipids. At last, this method was shown to be conveniently applied to the analysis of fat emulsion in the final total parenteral nutrition bag.

[Absence of chemical interaction between short catheters (ETFE) and three major antibiotics. Study model]. / Absence d'interaction chimique entre des cathéters courts (ETFE) et trois antibiotiques majeurs. Modèle d'étude.

Recourse to sounding with vein catheters is more and more frequent in hospital environments. At the same time, a perceptible increase in incidents and accidents linked to this constantly growing practice is noted. The multiplication of new biomaterials used in the composition of catheters leads to taking into account the criteria of innocuousness and physiochemical inertia as discriminant elements in the choice of biomaterials. A study in vitro has been undertaken of the interaction between short catheters made of ethylenetetrafluoroethylen (ETFE) and antibiotic solutions widely used in hospital environments. The confrontation concerned solutions of vancomycine (Vancocin), ciprofloxacine (Ciflox) and the amoxicillin-clavulanic acid (Augmentin) association. A device has been fitted up and operative conditions have been set in order that the flushing out of the catheters by the solutions be in quality and quantity, as near as possible to actual conditions of use. The interaction marked chosen being a possible release of fluorides ions by the polymer, the determination of this anion has been made by liquid-gas chromatography paired with a flame ionization detection. We show the inertia of ETFE catheters with respect to the solutions examined. Taking into account the initially defined objectives, the conclusion of the work is important and constitutes a considerable factor of security for the catheters user whether he be buyer or practitioner. The model of study making up this approach could very be applied to other categories of materials and therapeutics.

Medication use in pregnancy: a cross-sectional, multinational web-based study.

OBJECTIVES: Intercountry comparability between studies on medication use in pregnancy is difficult due to dissimilarities in study design and methodology. This study aimed to examine patterns and factors associated with medications use in pregnancy from a multinational perspective, with emphasis on type of medication utilised and indication for use. DESIGN: Cross-sectional, web-based study performed within the period from 1 October 2011 to 29 February 2012. Uniform collection of drug utilisation data was performed via an anonymous online questionnaire. SETTING: Multinational study in Europe (Western, Northern and Eastern), North and South America and Australia. PARTICIPANTS: Pregnant women and new mothers with children less than 1 year of age. PRIMARY AND SECONDARY OUTCOME MEASURES: Prevalence of and factors associated with medication use for acute/short-term illnesses, chronic/long-term disorders and over-the-counter (OTC) medication use. RESULTS: The study population included 9459 women, of which 81.2% reported use of at least one medication (prescribed or OTC) during pregnancy. Overall, OTC medication use occurred in 66.9% of the pregnancies, whereas 68.4% and 17% of women reported use of at least one medication for treatment of acute/short-term illnesses and chronic/long-term disorders, respectively. The extent of self-reported medicated illnesses and types of medication used by indication varied across regions, especially in relation to urinary tract infections, depression or OTC nasal sprays. Women with higher age or lower educational level, housewives or women with an unplanned pregnancy were those most often reporting use of medication for chronic/long-term disorders. Immigrant women in Western (adjusted OR (aOR): 0.55, 95% CI 0.34 to 0.87) and Northern Europe (aOR: 0.50, 95% CI 0.31 to 0.83) were less likely to report use of medication for chronic/long-term disorders during pregnancy than non-immigrants. CONCLUSIONS: In this study, the majority of women in Europe, North America, South America and Australia used at least one medication during pregnancy. There was a substantial inter-region variability in the types of medication used.

Risk assessment of neonatal excipient exposure: lessons from food safety and other areas.

Newborn babies can require significant amounts of medication containing excipients intended to improve the drug formulation. Most medicines given to neonates have been developed for adults or older children and contain excipients thought to be safe in these age groups. Many excipients have been used widely in neonates without obvious adverse effects. Some excipients may be toxic in high amounts in which case they need careful risk assessment. Alternatively, it is conceivable that ill-founded fears about excipients mean that potentially useful medicines are not made available to newborn babies. Choices about excipient exposure can occur at several stages throughout the lifecycle of a medicine, from product development through to clinical use. Making these choices requires a scalable approach to analysing the overall risk. In this contribution we examine these issues.

[Therapeutic patient education in heart failure: a program's assessment]. / Éducation thérapeutique du patient dans l'insuffisance cardiaque : évaluation d'un programme.

UNLABELLED: Heart failure is a chronic, common and severe disease. It leads to frequent hospitalizations and decrease of patient's quality of life. A therapeutic patient education program, named "school of heart failure" was implemented at Antoine-Béclère hospital. AIM OF THE STUDY: To assess the effectiveness of this program. PATIENTS AND METHODS: This therapeutic patient education program included patients with heart failure, hospitalized in a cardiology unit. Four types of evaluation were carried out: evaluation of patients' skills before they leave the hospital, patient's knowledge (associated with the degree of certainty), satisfaction regarding the program and self-assessment of changes in their lifestyle 3 months after discharge. RESULTS: Twenty-four patients were included in 9 months. The program's evaluation showed promising results with respect to the acquisition of skills (94%), the improvement of patients' knowledge associated with self-confidence increase, their satisfaction towards the program (80%) and their ability to change their habits (75%). Self-assessment has demonstrated changes in their lifestyle. CONCLUSION: These preliminary results are promising according to the program's effectiveness and its ability to meet patients' educational needs. The program was certified by French authorities in 2011. Knowledge and skills acquisition will have to be confirmed on long term.

Simultaneous quantitation of tobramycin and colistin sulphate by HPLC with evaporative light scattering detection.

A rapid and simple method for the simultaneous determination of tobramycin and colistin sulphate in a pharmaceutical formulation by reversed phase HPLC and evaporative light scattering detection is described. Chromatographic separation was carried out in gradient mode using a Zorbax SB C18 column (150mmx4mm, 3.5microm) with mobile phases of acetonitrile and water containing trifluoroacetic at 1ml/min. The method was validated using methodology described by the International Conference of Harmonization. The method was shown to be specific, precise, accurate and linear. Real samples were analyzed to demonstrate the applicability of the chromatographic method in a routine use.

Near InfraRed Spectroscopy homogeneity evaluation of complex powder blends in a small-scale pharmaceutical preformulation process, a real-life application.

Near InfraRed Spectroscopy (NIRS) is a potentially powerful tool for assessing the homogeneity of industrial powder blends. In the particular context of hospital manufacturing, we considered the introduction of the technique at a small pharmaceutical process scale, with the objective of following blend homogeneity in mixtures of seven components. This article investigates the performance of various NIRS-based methodologies to assess powder blending. The formulation studied is prescribed in haematology unit, as part of the treatment for digestive decontamination in children receiving stem-cell transplantation. It is composed of the active pharmaceutical ingredients (APIs) colimycin and tobramycin and five excipients. We evaluated 39 different blends composing 14 different formulations, with uncorrelated proportions of constituents between these 14 formulations. The reference methods used to establish the NIRS models were gravimetry and a High Performance Liquid Chromatography method coupled to an Evaporative Light Scattering Detection. Unsupervised and supervised qualitative and quantitative chemometric methods were performed to assess powder blend homogeneity using a bench top instrument equipped with an optical fibre. For qualitative evaluations, unsupervised Moving Block Standard Deviation, autocorrelation functions and Partial Least Square Discriminant Analysis (PLS-DA) were used. For quantitative evaluations, Partial Least Square Cross-Validated models were chosen. Results are expressed as API, and major excipient percentages of theoretical values as a function of blending time. The 14 different formulations were only satisfactorily discriminated by supervised algorithms, such as an optimised PLS-DA model. The homogeneity state was demonstrated after 16 min of blending, quantifying three components with a precision between 1.2% and 1.4% w/w. This study demonstrates, for the first time, the effective implementation of NIRS for blend homogeneity evaluation, as early as the preformulation step in a small hospital manufacturing unit. It shows how NIRS involving sampling with an optic fibre can be useful to characterise, optimise and control a small-scale mixing processes on the basis of the distribution of APIs and excipients during blending.