[Evaluation of the relevance of the pharmaceutical educational interview on the knowledge and satisfaction of patients who received a vagus nerve neurostimulator implantation]. / Évaluation de la pertinence de l'entretien pharmaceutique éducatif sur les connaissances et la satisfaction de patients ayant bénéficié d'une implantation d'un neurostimulateur du nerf vague.

INTRODUCTION: Vagal neurostimulation (VNS) medical devices (MDs) are used to treat drug-resistant epilepsy. Using a magnet, the patient can activate on the stimulations in order to stop a seizure or interrupt the adverse effects (AEs) of the device. The objective is to evaluate the improvement of the patients' knowledge about the VNS following a pharmaceutical educational interview (PEI) as well as their satisfaction. MATERIALS AND METHODS: The pharmaceutical educational interview regarding drugs and DMs was performed by the clinical pharmacist at the patient's bed after VNS implantation. A questionnaire about VNS devices (operation, adverse effects, recommendations) and assessing knowledge was submitted to patients before and after the PEI. Satisfaction was assessed by the Likert scale. RESULTS: From March 2020 to August 2021, 18 implanted patients were included in the study. In 78% of cases (14/18), the total number of good responses after PEI increased. The mean good response was significantly increased from 16.11/25 (64%) before PEI to 22.33/25 (89%) after PEI (P-value<0.01). The maximum satisfaction score (4/4) was given in 71% of the items. DISCUSSION-CONCLUSION: The results support the relevance of PEI. Patients feel a need for information and consider the interview useful. An improvement in knowledge was observed, which allows us to hope for an optimization of the effectiveness of the device, in particular, a reduction in seizures and AE. This study shows the feasibility and the interest of the development of clinical pharmacy applied to medical devices in complementarity with the expertise on drugs.

From hospitalisation to primary care: integrative model of clinical pharmacy with patients implanted with a PICC line-research protocol for a prospective before-after study.

INTRODUCTION: Clinical pharmacy improves patient safety and secures drug management using information, education and good clinical practices. However, medical device management is still unexplored, and proof of effectiveness is needed. A PICC line (peripherally inserted central catheter) is a medical device for infusion. It accesses the central venous system after being implanted in a peripheral vein. However, complications after implantation often interfere with smooth execution of the treatment. We hypothesise that clinical pharmacy for medical devices could be as effective as clinical pharmacy for medications. The main objective is to assess the effectiveness of clinical pharmacy activities on the complication rate after PICC line implantation. METHODS AND ANALYSIS: This is a before-after prospective study. The study will begin with an observational period without clinical pharmacy activities, followed by an interventional period where pharmacists will intervene on drug and medical device management and provide personalised follow-up and advice. Sixty-nine adult patients will be recruited in each 6-month period from all traditional care units. The main inclusion criteria will be the implantation of a PICC line. The primary outcome is the decrease in the number of complications per patient and per month. Secondary outcomes are the consultation and hospital readmission rates, the acceptance rate of pharmaceutical interventions, the patients' quality of life, the direct hospital induced or avoided costs and the participants' satisfaction. Data will be collected using case report forms during hospitalisation and telephone follow-up after discharge. The analysis will compare these criteria during the two periods. ETHICS AND DISSEMINATION: The study has received the approval of our Ethics Committee (Clermont-Ferrand Southeast VI, France, number AU1586). Results will be made available to the patients or their caregivers, the sponsor and other researchers when asked, as described in the consent form. TRIAL REGISTRATION NUMBER: NCT04359056.

Population analysis of erlotinib in adults and children reveals pharmacokinetic characteristics as the main factor explaining tolerance particularities in children.

PURPOSE: The aim of this pharmacokinetic-pharmacodynamic (PK-PD) analysis was to evaluate the pharmacologic characteristics of erlotinib and its main metabolite (OSI-420) in pediatric patients compared with those in adult patients. EXPERIMENTAL DESIGN: Plasma concentrations of erlotinib and OSI-420 of 46 children with malignant brain tumors included in a phase I study and 42 adults with head and neck carcinoma were analyzed by a population-pharmacokinetic method (NONMEM). The effect of several covariates and single nucleotide polymorphisms (SNP) in ABCB1, ABCG2, and CYP3A5 on pharmacokinetic parameters was evaluated. PK/PD relationships between plasma drug exposure Area Under the Curve (AUC) at day 1 and skin toxicity were studied in children and compared with the relationship observed in adults. RESULTS: A significant difference in erlotinib clearance (P = 0.0001), when expressed in L·h(-1)·kg(-1), was observed between children and adults with mean values of 0.146 and 0.095, respectively (mean difference = 0.051 L·h(-1)·kg(-1), SD = 0.0594). However, a common covariate model was obtained describing erlotinib clearance according to body weight, alanine aminotransferase, ABCB1, and CYP3A5 polymorphisms (2677G > T/A and 6986G > A) for both children and adult patients. The PK-PD relationship was very consistent between the children and adult groups with risk of skin toxicity rising with increasing erlotinib AUC. CONCLUSIONS: The nonlinear population approach applied to pharmacokinetic data combined with a pharmacokinetic-pharmacodynamic analysis revealed that the higher recommended dose in children (125 mg/m(2)/day) compared with adults (90 mg/m(2)/day) is mainly due to pharmacokinetic rather than pharmacodynamic particularities.