Denis Lebel

Use of alternative and complementary therapies in children with cancer

The use of complementary and alternative medicines (CAM) is becoming increasingly popular. Although considered beneficial by users, the potential for interaction or substitution with conventional treatment should not be overlooked by health care professionals. It is therefore important to gain insight into the prevalence and the factors related to the use of CAM. To establish the prevalence of use of CAM among children with cancer treated in a large pediatric hospital, describe the profile of use and factors related with use. As a secondary objective we aimed at measuring quality of life of the children aged 5 or more and compare the scores between users and non‐users.

A Population Pharmacokinetic Model for Vancomycin in Pediatric Patients and Its Predictive Value in a Naive Population

ABSTRACT The objectives of this study were to (i) construct a population pharmacokinetic (PK) model able to describe vancomycin (VAN) concentrations in serum in pediatric patients, (ii) determine VAN PK parameters in this population, and (iii) validate the predictive ability of this model in a naive pediatric population. Data used in this study were obtained from 78 pediatric patients (under 18 years old). PK analyses were performed using compartmental methods. The most appropriate model was chosen based on the evaluation of pertinent graphics and calculation of the Akaike information criterion test. The population PK analysis was performed using an iterative two-stage method. A two-compartment PK model using age, sex, weight, and serum creatinine as covariates was determined to be the most appropriate one to describe serum VAN concentrations. The quality of fit was very good, and the distribution of weighted residuals was found to be homoscedastic (Wilcoxon signed rank test). Fitted population PK parameters (mean ± standard deviation) were as follows: central clearance (0.1 ± 0.05 liter/h/kg), central volume of distribution (0.27 ± 0.07 liter/kg), peripheral volume of distribution (0.16 ± 0.07 liter/kg), and distributional clearance (0.16 ± 0.07 liter/kg). The predictive ability of the developed model (including the above-mentioned covariates) was evaluated in a naive population of 19 pediatric patients. The predictability was very good. Precision (±95% confidence interval [CI]) (peak, 4.1 [±1.4], and trough, 2.2 [±0.7]) and bias (±95% CI) (peak, −0.58 [±2.2], and trough, 0.63 [±1.1] mg/liter) were significantly (P < 0.05) superior to those obtained using a conventional method (precision [±95% CI]: peak, 8.03 [±2.46], and trough, 2.7 [±0.74]; bias: peak, −7.1 [±2.9], and trough, −1.35 [±1.2] mg/liter). We propose the use of this population PK model to optimize VAN clinical therapies in our institution and others with similar patient population characteristics.

Risk perception and reasons for noncompliance in pharmacovigilance: a qualitative study conducted in Canada.

Background: The postmarketing safety evaluation of drugs relies on the spontaneous reporting of adverse reactions to authorities. Under-reporting is a known issue, with only 3% of all adverse reactions that occur actually being reported. Therefore, the postmarketing safety evaluation of medications is compromised.Objective: This investigation aimed to identify determining factors that influence reporting as well as corrective actions. We specifically wanted to define the perceptions physicians and pharmacists have of pharmacovigilance, of the local and national reporting systems, of their role and that of other players in reporting adverse reactions, and of its consequences in their clinical practice.Methods: Three focus groups with pharmacists and 16 semi-structured interviews with physicians from four different clinical services were conducted.Results: Four major obstacles to reporting adverse reactions were identified: (i) pharmacovigilance is seen as an unrealistic ideal; (ii) the reporting authority is perceived as a virtual and remote entity; (iii) healthcare professionals do not feel concerned by the risks associated with the medications used in their practice; and (iv) healthcare professionals are uncertain about the scope of their role in reporting adverse effects.Conclusion: In order to promote reporting and a greater awareness of the system, a redefinition of its expectations and targeted feedback seem to be essential. Increased reporting can also be achieved by the presence of an onsite professional dedicated to reporting and educating others. Several definite measures are proposed in order to achieve this goal.

Impact and appreciation of two methods aiming at reducing hazardous drug environmental contamination: The centralization of the priming of IV tubing in the pharmacy and use of a closed-system transfer device

Objectives The main objective was to evaluate the impact of two methods aiming at reducing hazardous drug environmental contamination: the centralization of the priming of IV tubing in the pharmacy and the use of a closed-system transfer device. The secondary objective was to evaluate the satisfaction of pharmacy technicians using a survey. Methods Sites in the hematology-oncology satellite pharmacy and care unit were analyzed for the presence of cyclophosphamide, ifosfamide and methotrexate before and after the centralization of the priming of IV tubing in the pharmacy and before and after using a closed-system transfer device. The limits of detection for cyclophosphamide, ifosfamide and methotrexate were, respectively, of 0.0015 ng/cm2, 0.0012 ng/cm2 and 0.0060 ng/cm2. The pharmacy technician satisfaction was evaluated using a questionnaire. Results A total of 225 samples was quantified. After the centralization of priming in the pharmacy, no significant difference was found in the proportion of positive samples for cyclophosphamide, ifosfamide and methotrexate. Traces of cyclophosphamide found on the floor in patient care areas was significantly reduced (median[min-max] 0.08[0.06−0.09]ng/cm2 vs. 0.03[0.02−0.05], p < 0.0001). After using a closed-system transfer device, a significant difference was found for the proportion of cyclophosphamide positive samples (15/45(33%) vs. 0/45(0%), p < 0.0001), but no significant difference was found for ifosfamide (12/45(27%) vs. 5/45(11%), p = 0.059) and methotrexate (1/45(2%) vs. 2/45(4%), p = 0.557). Pharmacy technicians raised issues following the centralization of priming (e.g. workload) and the use of closed-system transfer devices (e.g. spills, particles, workload and handling difficulties). Conclusion The centralization of the priming of IV tubing in the pharmacy reduced floor contamination in patient care areas without increasing surface contamination in the pharmacy. Closed-system transfer devices reduced contamination in pharmacy, but handling issues were raised by pharmacy technicians.

Unlicensed and Off-Label Drug Use in Children Before and After Pediatric Governmental Initiatives.

OBJECTIVES Governmental agencies (US Food and Drug Administration and European Medicines Agency) implemented initiatives to improve pediatric clinical research, starting in 1997 and 2007, respectively. The aim of this review was to quantify the unlicensed and off-label drug uses in children before and after these implementations. METHODS Literature review of unlicensed and off-label drug uses was performed on PubMed and Google-Scholar from 1985 to 2014. Relevant titles/abstracts were reviewed, and articles were included if evaluating unlicensed/off-label drug uses, with a clear description of health care setting and studied population. Included articles were divided into 3 groups: studies conducted in United States (before/after 2007), in Europe (before/after 2007), and in other countries. RESULTS Of the 48 articles reviewed, 27 were included. Before implementation of pediatric initiatives, global unlicensed drug use rate in Europe was found to be 0.2% to 36% for inpatients and 0.3% to 16.6% for outpatients. After implementation, it marginally decreased to 11.4% and 1.26% to 6.7%, respectively. Concerning off-label drug use rates, it was found to be 18% to 66% for inpatients and 10.5% to 37.5% for outpatients before the implementation. After implementation, it decreased marginally to 33.2% to 46.5% and to 3.3% to 13.5%, respectively. In other countries, unlicensed and off-label drug use rates were found to be, respectively, 8% to 27.3% and 11% to 47%. CONCLUSIONS Governmental initiatives to improve clinical research conducted in children seem to have had a marginal effect to decrease the unlicensed and off-label drug uses prevalence in Europe.

The AMÉLIE project: failure mode, effects and criticality analysis: a model to evaluate the nurse medication administration process on the floor

OBJECTIVE The objective of this article was to critically evaluate the causes of adverse drug events during the nurse medication administration process in paediatric care units in order to identify and prioritize interventions that need to be implemented. METHODOLOGY This is a failure mode, effects and criticality analysis (FMECA) study. A multidisciplinary committee composed of nurses, pharmacists, physicians and risk managers evaluated through consensus the process of administering medications at the Centre hospitalier universitaire de Sainte-Justine. By mapping the process, all the failure modes were identified and associated with at least one cause each. Using a summary grid, each failure mode was evaluated by rating frequency (from 1 to 9), likelihood of failure detection (from 0 to 100%) and severity (from 1 to 9) using adapted versions of already published scales. RESULTS A 10-member committee was set up, and it met eight times between January and April 2010. In the two specialized paediatric units selected (n = 38 beds), an average number of approximately 20 000 drug doses was administered monthly from about 400 non-proprietary names. Through consensus, the committee identified 16 processes and 53 failure modes. While frequency and severity were based on perceptions that could be objectivized with local data and scientific documentation, the likelihood of detection was mainly based on individual perception. CONCLUSION FMECA is a useful approach to improve the medication process.

A medication reconciliation form and its impact on the medical record in a paediatric hospital.

OBJECTIVES The objective of this study was to evaluate the quality of medication information available in medical charts before and after the implementation of a medication reconciliation form. PATIENTS AND METHODS This study is a retrospective chart review of patients under 18 years who were taking two medications or more at home and were admitted to a paediatric hospital for more than 24 hours and discharged from a general paediatrics, infectious disease, gastroenterology or pneumology ward over two 20-week periods (pre- and post-implementation). Each week, 10 medical records were randomly chosen and reviewed. The quality of the medication information was measured on admission (dose, route of administration and frequency) and on discharge (dose, route of administration, frequency and duration of treatment). The proportion of medications that fully met these criteria was compared between the groups using the chi-squared test. RESULTS Information was analysed for a total of 3275 medications in the pre-implementation group, vs. 3240 medications in the post-implementation group. Baseline characteristics were similar in both groups. On admission, the quality of medication information was comparable between the pre- and post-implementation groups (29.1 vs. 29.3%, respectively; P = 0.86). However, on discharge, an improvement in the quality of information was observed in the post-implementation group (51.7 vs. 65.2%; P < 0.001). CONCLUSION Our study demonstrated that the forms used in the reconciliation process, in particular the discharge prescription, could increase the quality of the information related to drug use in medical charts. We believe that medication reconciliation forms should be widely used by all the health care professional teams involved in the drug history or prescription process.

Comparative efficacy of two doses of nebulized colistimethate for the eradication of Pseudomonas aeruginosa in children with cystic fibrosis

BACKGROUND Cystic fibrosis (CF) affects the respiratory and digestive systems. It evolves toward deterioration of pulmonary function through colonization with Pseudomonas aeruginosa. There is no consensus with respect to its eradication. Nebulized colistimethate is used for eradication treatment, but the optimal dose and duration is yet to be determined. OBJECTIVES To compare the efficacy of two doses of nebulized colistimethate (30 mg versus 75 mg twice daily) for the eradication of P aeruginosa in children with CF and intermittent colonization. METHODS A cohort study with both historical (30 mg) and prospective (75 mg) arms was conducted from 1999 to 2003. Medical records were used to collect data. RESULTS Eighty-one patients were recruited in the retrospective group, for a total of 111 treatment courses. Twenty patients were recruited in the prospective group, for a total of 20 events. There was no statistically significant difference in the rate of eradication of P aeruginosa at days 28 and 90, neither when comparing the doses of colistimethate nor duration of treatment. There was a statistically significant difference (P=0.004) between days 1 and 90 in all analyzed subgroups (regardless of dose or duration of treatment) for forced vital capacity only. In the group of patients in whom eradication was achieved at day 28 (after receiving a three-week treatment course of colistimethate), 50% of patients developed a new infection 5.75 months later, on average, regardless of the dose administered. In the group of patients who achieved eradication at day 90 (after receiving a 15-week treatment course of colistimethate), 50% of the 14 patients developed a new infection after an average period of 7.3 months (P=0.28). CONCLUSIONS There is no difference in the efficacy between a 30 mg dose and a 75 mg dose of colistimethate for P aeruginosa eradication in children with CF and intermittent colonization.

Identifying and reducing distractions and interruptions in a pharmacy department

Interruptions are an acknowledged problem in health care systems.[1][1] Health care workers are exposed to various types of stimuli that may cause distractions or interruptions. Interruptions are a major concern in the hospital pharmacy setting, given the nature and the requirements of the work.

Ondansetron for the prevention and treatment of nausea and vomiting following pediatric strabismus surgery

BACKGROUND Neither droperidol nor ondansetron has been proven completely effective, and there are conflicting data comparing the efficacy of the two agents. The purpose of this study was to compare the efficacy, safety and cost of a combination of ondansetron administered intravenously in the operating room followed by oral ondansetron treatment at home with the more commonly used treatment of intravenous droperidol therapy and oral dimenhydrinate therapy, for the prevention and treatment of postoperative nausea and vomiting in children undergoing strabismus surgery. METHODS Double-blind randomized clinical trial with parallel comparison groups. All patients aged 6 months to 18 years who underwent strabismus surgery at a pediatric hospital in Montreal between Nov. 13, 2000, and June 12, 2001, were included. The exclusion criteria were nausea or vomiting, or use of antiemetics or narcotics in the 24 hours preceding surgery, and past history of hepatic, gastric or renal disease. The outcome measures were frequency of nausea and vomiting, severity of nausea and adverse effects in hospital, during transportation home and during the first 24 hours at home. Data were obtained through nursing notes and through a telephone interview conducted 24 to 48 hours after discharge. RESULTS Of the 208 eligible patients, 172 were randomly assigned to the study groups (88 to the ondansetron group and 84 to the droperidol/dimenhydrinate group). We found no statistically significant difference in the incidence of nausea and vomiting in hospital or at home between the two groups (25.3% vs. 31.6%, p = 0.371). There was a significant difference between the two groups in the rate of vomiting during transportation home (3.6% vs. 12.6%, p = 0.044). The incidence of severe nausea was 14.4% with ondansetron and 15.4% with droperidol, a nonsignificant difference (p = 1.00). No significant difference was observed between the two groups in the incidence of any nausea (p = 0.434) or adverse effects (p = 0.220). We calculated that the combination of droperidol and dimenhydrinate was seven times less costly than the ondansetron regimen. INTERPRETATION In this study, the efficacy and safety of intravenous administration of droperidol followed by oral use of dimenhydrinate did not differ from that of intravenous followed by oral use of ondansetron in children undergoing strabismus surgery. Since treatment with ondansetron is much more costly than the combination of droperidol and dimenhydrinate, at this time the use of ondansetron in the prevention and treatment of vomiting and nausea in this population may not be beneficial on a cost basis if all other variables are considered.