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3.  Before-and-After Study of Interruptions in a Pharmacy Department 
Few data exist on interruptions in the drug-use process in hospital pharmacies and their effects on patient care.
The primary objective was to compare the hourly number of stimuli received and emitted (i.e., generated) by pharmacists and pharmacy technicians before and after implementation of measures intended to reduce interruptions. The secondary objective was to evaluate the impact of the corrective measures on 4 specific stimuli.
This before-and-after cross-sectional observational study was conducted in the main dispensing area of the pharmacy department of a Canadian university hospital centre. Stimuli received and emitted by pharmacists and pharmacy technicians were counted before (2010) and after (2012) implementation of corrective measures designed to limit interruptions. The effect of corrective measures on targeted stimuli was measured with a t test.
Data were collected during a total of 93 randomly scheduled 30-min observation periods: 62 periods in 2010 (n = 2663 stimuli) and 31 periods in 2012 (n = 1217 stimuli). The average hourly stimulus rate (± standard deviation) was unchanged after implementation of corrective measures: 85.9 ± 22.2 in 2010 and 78.5 ± 20.1 in 2012 (p = 0.06). However, a significant decline was observed for many individual stimuli, including the number of face-to-face nonprofessional conversations among pharmacists (4.4 ± 4.2 in 2010 versus 1.2 ± 1.8 in 2012, p = 0.003).
Despite the implementation of corrective measures, there was no statistically significant change in the hourly stimulus rates from 2010 to 2012. Other studies are needed to better characterize the nature and repercussions of stimuli, distractions, and interruptions.
PMCID: PMC3583790  PMID: 23467669
hospital pharmacy practice; drug-use process; interruptions; distractions; stimuli; pratique de la pharmacie hospitalière; processus de distribution des médicaments; interruptions; distractions; stimuli
10.  Automated Compounding of Parenteral Nutrition for Pediatric Patients: Characterization of Workload and Costs 
Parenteral nutrition (PN) compounding in large hospital centers is now largely automated using volumetric pump systems. No study has examined the pharmacy workload and costs associated with this process. This study was designed to characterize these elements at our center and to identify areas for potential improvement.
We retrospectively analyzed all PN orders compounded from May 19, 2007, to June 25, 2010. Patients were divided into groups according to the ward where PN was initiated.
The age and weight of patients at initiation of PN were similar throughout the study, except in neonatology, where initiation now occurs earlier in life (age 1.3 ± 2.7 days in 2010 vs. 3.4 ± 9.4 in 2007; p=0.003). An average of 894 orders per month were compounded. A total of 59% of orders were for neonatal patients. The average cost of source solutions per PN order increased from Can$23.27 in 2007 to Can$37.78 in 2010. Partially used source solutions discarded at the end of the day represented between 7.7% and 9.2% of total source solution cost. Amino acids in 3-L bags were responsible for the largest waste, with Can$953 to Can$1048 wasted monthly.
PN compounding at our center represents an important workload and increasing costs. A reduction in source solution waste, for example, by reducing the use of large source solution containers, would be beneficial.
PMCID: PMC3567892  PMID: 23411509
drug compounding; neonatology; parenteral nutrition; pediatrics; pharmacy
13.  Perspective sur les ruptures d’approvisionnement de médicaments en établissement de santé de 2006 à 2010 
Si les ruptures d’approvisionnement de médicaments font partie de la réalité de la pratique pharmaceutique depuis plusieurs décennies, elles deviennent une préoccupation quotidienne pour les pharmaciens dans les années 2000 et dépassent les frontières de la littérature pharmaceutique.
L’objectif principal de cette étude était de quantifier le nombre de médicaments en rupture de stock par année et la durée de ces interruptions. L’objectif secondaire visait à décrire le nombre de médicaments en rupture de stock par fabricant et par classe thérapeutique.
Cette étude descriptive et rétrospective des ruptures d’approvisionnement en médicaments a porté sur l’ensemble des médicaments à contrat pour les hôpitaux des régions administratives de Montréal, de Laval et de l’Estrie, au Québec. Le nombre de ruptures de stocks, le nombre de jours de rupture de stock et leur durée moyenne par année ont été calculés par fabricant et par classe thérapeutique. De plus, la proportion de produits en rupture de stock et la proportion de jours de rupture de stocks ont été déterminées par classe thérapeutique. Les données ont été analysées à l’aide de statistiques descriptives (c.-à-d. somme, moyenne, écart-type, médiane, intervalle).
Entre le 1er janvier 2006 et le 31 août 2010 (une période de 56 mois), 2400 ruptures de stocks ont été dénombrées pour un total de 258 105 jours de rupture de stocks (durée moyenne de 108 jours, écart-type de 130 jours et intervalle de 5 à 1623 jours). Un total de 70 fabricants étaient impliqués dans la survenue de toutes les ruptures d’approvisionnement de médicaments relevées durant cette période. Cinquante pour cent (50 %) des ruptures de stocks et des jours de rupture de stocks provenaient de quatre fabricants. Les interruptions étudiées touchaient la majorité des classes thérapeutiques de médicaments disponibles sur le marché. Toutefois, 50 % des ruptures de stocks provenaient de trois classes thérapeutiques (médicaments du système nerveux central, agents anti-infectieux et médicaments cardiovasculaires).
Il s’agit des premières données canadiennes publiées sur l’étendue des ruptures d’approvisionnement sur le marché hospitalier. L’étude a démontré que les ruptures de stocks touchent la plupart des fabricants et la majorité des classes thérapeutiques. D’autres études sont nécessaires afin d’explorer les causes et les conséquences des ruptures d’approvisionnement en établissements de santé.
PMCID: PMC3242576  PMID: 22479098
ruptures d’approvisionnement en médicaments; rupture de stock; fabricant; établissement de santé; drug shortages; inventory shortage; manufacturer; hospital
14.  A Pilot Study of Bar Codes in a Canadian Hospital 
In 2004, the US Food and Drug Administration issued a new rule requiring most prescription and some over-the-counter pharmaceutical products to carry bar codes down to the level of individual doses, with the intent of reducing the number of medication errors. Despite these regulatory changes in the United States, Health Canada has not yet adopted any mandatory bar-coding of drugs.
To evaluate the feasibility of using commercial bar codes for receipt and preparation of drug products and to evaluate the readability of the bar codes printed on various levels of drug packaging.
This cross-sectional observational pilot study was conducted in the Pharmacy Department of a Canadian mother–child university hospital centre in July 2010. For the purposes of the study, research drugs and cytotoxic drugs in various storage areas, as well as locally compounded medications with bar codes generated in house, were excluded. For all other drug products, the presence or absence of bar codes was documented for each level of packaging, along with the trade and generic names, content (i.e., drug product), quantity of doses or level of packaging, therapeutic class (if applicable), type of bar code (1- or 2-dimensional symbology), alphanumeric value contained in the bar code, standard of reference used to generate the alphanumeric value (Universal Product Code [UPC], Global Trade Item Number [GTIN], or unknown), and readability of the bar codes by 2 scanners.
Only 33 (1.9%) of the 1734 products evaluated had no bar codes on any level of packaging. Of the 2875 levels of packaging evaluated, 2021 (70.3%) had at least one bar code. Of the 2384 bar codes evaluated, 2353 (98.7%) were linear (1-dimensional) and 31 (1.3%) were 2-dimensional. Well over three-quarters (2112 or 88.6%) of the evaluated bar codes were readable by at least 1 of the 2 scanners used in the study.
On the basis of these results, bar-coding could be used for receipt of 80.9% of the drug products at this Canadian hospital and for the preparation and dispensing of 70.1% of the products.
PMCID: PMC3161800  PMID: 22479068
bar-coding; pharmaceutical products; packaging; code-barres; produits pharmaceutiques; conditionnement
15.  Utilisation de lignes directrices dans le cadre de l’implantation de cabinets automatisés décentralisés en établissement de santé 
Contexte :
Il existe peu de données sur les conséquences de l’utilisation des cabinets automatisés décentralisés (CAD) en établissements de santé.
Méthode :
Il s’agit d’une étude descriptive de la conformité des pratiques par rapport à des lignes directrices publiées dans le cadre de l’implantation de CAD. L’objectif principal de l’étude est d’évaluer la conformité globale et celle de chaque processus du circuit du médicament. L’étude se déroule au sein du Centre hospitalier universitaire (CHU) Sainte-Justine, un établissement mère–enfant de 500 lits. À partir des lignes directrices portant sur l’utilisation sécuritaire des CAD de l’Institute for Safe Medication Practice (aux États-Unis) (2008) et de son outil d’autoévaluation (2009), nous avons évalué la conformité de la pratique à 30 jours et à 120 jours après l’implantation.
Résultats :
Nous avons procédé de novembre 2009 à avril 2010 à l’implantation de sept stations de CAD au sein du CHU Sainte-Justine. Le profil de conformité est passé de 66 % à 74 % de janvier à avril 2010. Pour chaque processus relatif à l’utilisation sécuritaire des CAD, nous présentons une brève description des critères ainsi que les éléments de non-conformité liés à la technologie ou aux aspects organisationnels. Pour chaque élément de non-conformité, nous avons déterminé les actions requises auprès du fabricant afin de modifier l’équipement (c. à .d. aspects technologiques) et auprès de l’établissement afin de modifier les modalités d’utilisation (aspects organisationnels) en précisant le ou les processus impliqués.
Conclusion :
Cette étude décrit la conformité des pratiques au CHU Sainte-Justine par rapport à des lignes directrices publiées par l’Institute for Safe Medication Practices. L’utilisation de lignes directrices dans le cadre de l’implantation de cabinets automatisés décentralisés en établissement peut aider à guider les actions tant sur le plan technologique qu’organisationnel.
PMCID: PMC3093417  PMID: 22479039
automatisation; gestion des risques; gestion de la qualité; automation; risk management; quality management
16.  A Pilot Comparative Study of the Clarity and Assessability of the Drug Management Standards of Accreditation Canada and the US Joint Commission 
There are few data comparing the drug management standards of the US and Canadian agencies that accredit health care institutions.
To evaluate the clarity and assessability of criteria in the drug management standards adopted by Accreditation Canada and the Joint Commission (United States).
A pilot study was conducted to compare the clarity and assessability of the criteria listed in the 2 standards. Criteria that were common to the 2008 versions of the Canadian and US drug management standards were identified. A panel of 12 health care professionals was assembled to independently rate the clarity (i.e., clear or unclear) and the assessability (i.e., assessable or not assessable) of each statement, using a validated comparative grid.
In total, there were 143 Canadian standards and 103 US standards. Sixty-two (43%) of the 143 Canadian criteria could be directly paired with a US criterion, whereas 70 (68%) of the 103 US criteria could be paired with one or more Canadian criteria. Six of the US criteria were paired with more than one Canadian criterion, and 12 of the Canadian criteria could be paired with more than one US criterion. Four of the 22 themes in the Canadian standards had no equivalent criteria in the US standards. Panel members from the pharmaceutical practice group evaluated the clarity and assessability of the Canadian criteria more severely than panel members from the nursing practice group: 86% versus 95% of individual ratings were deemed “clear” by these two groups, respectively (p < 0.001) and 64% versus 88% of individual ratings were deemed “assessable” (p < 0.001). There were no criteria that were considered unclear or unassessable by all of the panel members.
Few data are available on drug management standards and their impact on health care. A better understanding of these standards, as well as comparisons of Canadian standards with those of other countries, might help in determining their clarity and assessability. A larger-scale study is required to validate the observations reported here.
PMCID: PMC3093418  PMID: 22479040
accreditation; standards; drug management; pharmacy practice; agrément; normes; gestion des médicaments; pratique de la pharmacie
19.  Predictors of Publication Productivity Among Hospital Pharmacists in France and Quebec 
To describe publications by hospital pharmacists in France and Quebec and evaluate factors predictive of publication productivity.
Variables related to scientific publication productivity were identified through a search of the literature and organized into 4 themes (ie, personal and professional characteristics, hospital activities, research and publishing activities, publication-related motivations and perceptions). A questionnaire was developed that included short-answer items and 58 multiple-choice questions to determine respondents' level of agreement with statements about their motivations and perceptions surrounding publishing.
Four hundred twenty-two hospital pharmacists (218 respondents from France and 204 from Quebec) were recruited. Respondents from France were more prolific than those from Quebec, even when considering factors such as time worked and gender. Furthermore, the percentage of respondents working in a university health center was lower in France than Quebec (46% vs. 70%, p = 0.001), as was the percentage of respondents indicating a mastery of English (43% vs. 88%, p = 0.001).
Seven factors were predictive of the number of publications per respondent in France and Quebec: practicing hospital pharmacy in France, being male, having academic duties or a PhD, having participated in a clinical trial, having secured funding in one's own name for a research project, and allocating a greater number of hours per week to research.
PMCID: PMC3049658  PMID: 21451771
publication; pharmacists; hospital; France; Canada; scholarship; research
23.  Comparative efficacy of two doses of nebulized colistimethate for the eradication of Pseudomonas aeruginosa in children with cystic fibrosis 
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.
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.
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.
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).
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.
PMCID: PMC2677772  PMID: 18060092
Colistimethate; Cystic fibrosis; Pseudomonas aeruginosa; Pulmonary function tests
24.  Evaluation of Conformity of a First Prescription of Lipid-Based Formulation of Amphotericin B in a University-Teaching Pediatric Hospital 
Invasive fungal infections are an important cause of morbidity and mortality in immunodeficient children. Amphotericin B is an important therapeutic agent for the treatment of invasive fungal infections but is associated with significant toxicities and high acquisition costs. The purpose of this study was to evaluate physician adherence to a local guideline for the use of lipid-based amphotericin B.
The study was approved through Pharmacology & Therapeutics (P&T) committee activities. A retrospective drug utilization review (DUR) was conducted. All orders written between January 1, 2003, and December 31, 2004, were reviewed. Demographic and descriptive clinical data were collected as well as variables related to the drug order process. Conformity rates were calculated for the primary objective criteria (authorized prescribers – infectious disease members; recommended drug of choice—Abelcet; accepted indications; and presence of underlying conditions).
A total of 109 orders for 70 patients were reviewed by a single research assistant for a 2-year period. Global conformity rate for all four criteria was calculated at 7.3%. Non-conformity was mostly associated with the absence of underlying conditions (e.g., prerenal insufficiency or presence of nephrotoxicity due to amphotericin B desoxycholate) in 84.5% of the cases. Infusionrelated adverse drug reactions partly explained a switch to a non-formulary lipid-based amphotericin B product. External factors (newly published results since the adoption of the guideline and continuous marketing practices) and internal factors (availability of non-formulary process, inefficient DUR process) could have contributed to non-adherence to a local guideline.
This study shows low adherence to P&T committee drug guidelines on lipid-based amphotericin B. Continuous and efficient DUR processes should be in place to monitor drug guideline adherence.
PMCID: PMC3468071  PMID: 23118649
abelcet; ambisome; amphotericin B; drug utilization review; pediatrics
25.  A Population Pharmacokinetic Model for Vancomycin in Pediatric Patients and Its Predictive Value in a Naive Population 
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.
PMCID: PMC89671  PMID: 10639350

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