Evaluation of incompatible coadministration of continuous intravenous infusions in a pediatric/neonatal intensive care unit

OBJECTIVES: We aimed to evaluate and quantify incompatible coadministrations of continuous intravenous medication in the daily clinical practice of a PICU/NICU. METHODS: We conducted a retrospective, observational study in the setting of an 18-bed PICU/NICU. All concurrently administered continuous infusions, including blood products and parenteral nutrition, were analyzed for 2 months. Raw electronic data were retrieved and subjected to quality controls. Infusion combinations were classified as compatible, incompatible, no data, or variable according to the internal hospital charts, Trissel's database, and the Swiss summary of product characteristics. For situations with incompatible coadministrations, we assessed alternative distributions of infusions among the currently available lumen. RESULTS: Data for 100 patients were analyzed. Patients were exposed to a mean of 6.9 ± 3.6 individual continuous infusions administered through 3.8 ± 1.8 lumina. Among the 1447 coadministered continuous infusions, we detected 146 incompatible combinations (10%), resulting in 105 individually relevant incompatible situations. Furthermore, 185 combinations (13%) were not covered by internal compatibility charts, and for 207 combinations (15%) no data on compatibility were available. We found that 58% of the incompatible situations could have been avoided by a redistribution of the infusions among the available lumina. CONCLUSIONS: Most infusion combinations in the studied PICU/NICU were compatible and covered by the internal compatibility charts. However, we also identified concurrent administrations of incompatible infusions or for which compatibility data are not available. A significant reduction of coadministrations of incompatible infusions could be achieved through optimal use of available lumina

Risk and pharmacoeconomic analyses of the injectable medication process in the paediatric and neonatal intensive care units

Objective To analyse safety risks in injectable medications. To assess the potential impact and pharmacoeconomic aspects of safety tools. Design The injectable drug process was prospectively assessed using a failure modes, effects and criticality analysis. Criticality indexes were estimated based on their likelihood of occurrence, detection probability and potential severity. The impact of 10 safety tools on the criticality index was calculated and extrapolated to all drugs injected daily. Yearly costs for a reduction in criticality by 1 point (=1 quali) per day were estimated. Setting Paediatric and neonatal intensive care units in a University Hospital. Participants Two paediatric nurses, a neonatologist, three hospital pharmacists. Interventions Qualitative and quantitative risk assessment. Main Outcome Measures Failure modes, criticality indexes, cost-efficacy ratios. Results Thirty-one failure modes identified, with the mean of their entire criticality indexes totalling 4540. The most critical failure mode was microbial contamination. The following gains were predicted: 1292 quali (46 500 per day by extrapolation) from ready-to-use syringes, 1201 (72 060) by employing a clinical pharmacist, 996 (59 780) from double check by nurses and 984 (59 040) with computerized physician order entry. The best cost-efficacy ratios were obtained for a clinical pharmacist (1 quali = 0.54 euros), double check (1 quali = 0.71 euros) and ready-to-use syringes (1 quali = 0.72 euros). Computerized physician order entry showed the worst cost-efficacy ratio due to a very high investment costs (1 quali = 22.47 euros). Conclusion Based on our risk and pharmacoeconomic analyses, clinical pharmacy and ready-to-use syringes appear as the most promising safety tool

Pharmacovigilance en milieu hospitalier gériatrique : effets indésirables et variabilité pharmacocinétique du midazolam dans les pratiques endoscopiques

Ce travail aborde selon trois approches complémentaires les principaux problèmes ayant trait aux effets indésirables médicamenteux survenant dans la population gériatrique, caractérisée par une polypathologie et une polymédication importantes. Dans un premier temps, une activité de pharmacovigilance basée sur la notification spontanée d'effets indésirables a mis en évidence la fréquence accrue de réactions hépatotoxiques et d'hyponatrémies dans le collectif étudié. Nous avons ensuite démontré par une étude clinique randomisée contrôlée l'effet bénéfique de l'utilisation du midazolam à faibles doses sur la tolérance à l'examen et sa sécurité d'emploi dans les pratiques endoscopiques. Enfin, diverses approches de pharmacocinétique de population utilisant les logiciels P-PHARM® et NONMEM® ont permis de quantifier l'importante variabilité pharmacocinétique inter- et intraindividuelle de la distribution tissulaire et de l'élimination du midazolam chez le patient âgé, et de démontrer l'absence d'association entre l'apparition d'effets indésirables et la variabilité lors de l'administration de midazolam en bolus intraveineux. Etude menée au sein du Département de gériatrie des HUG

Quality assessment of the visits of pharmaceutical company representatives to hospital pharmacists

OBJECTIVES: To evaluate whether the quality of pharmaceutical company representatives' (PCRs) visits to hospital pharmacists can be improved by written communication of the results of an evaluation of their visits. METHODS: Pilot study with prospective evaluation of overall visit quality and strength of request for adding drugs to the hospital formulary, and of the scientific quality of products presentations using a standardized form. Two one-year study periods (59 vs. 61 visits) separated by the intervention (global results of the first period sent to each drug company). RESULTS: No difference was observed between both periods in overall visit quality (VAS 0 = null, 10 = excellent: mean 4.7 (2.1 SD) vs. 5.2 (2.1) or strength of request for adding drug to hospital formulary (VAS 0 = null, 10 = extreme: 7.0 [2.6] vs. 7.2 [2.7]). Clarity and scientific value of products' presentations and scientific value of responses were better during the second study period, as a sign of quality improvement. CONCLUSIONS: This study suggests that systematic quality evaluation of PCRs visits and communication of results to drug companies may improve the scientific quality of products' presentation

Confusion between Two Amphotericin B Formulations Leading to a Paediatric Rehospitalisation

A heavily immunosuppressed, 43-kg, 9-year-old patient was recovering from a bone marrow transplant. Primary prophylaxis against invasive fungal infections was liposomal amphotericin B (AmBisome(®), 2.3 mg/kg [100 mg] two times per week). Once home, following a first amphotericin B infusion, he presented with strong diarrhoea and vomiting; this was repeated after the second infusion. The clinical situation worsened rapidly and the patient was rehospitalised. On admission, he presented with acute renal failure. During the 2-week hospitalisation, renal function recovered progressively. A few days after returning home, a new administration of amphotericin B was again followed by diarrhoea and vomiting, together with shivering and fever. The child was again rapidly rehospitalised. Investigation revealed that the community pharmacist, relying on drug software, had selected an inappropriate substitute drug: the patient had been administered amphotericin B deoxycholate (Fungizone(®)) and not liposomal amphotericin B. Depending on the indication, intravenous AmBisome(®) is usually administered at a dose between 3 and 5 mg/kg bodyweight; this dose can be increased to up to 10 mg/kg/day. Intravenous Fungizone(®), however, should be administered using an initial dose of 0.25 mg/kg bodyweight, up to a recommended 1-mg/kg/day dose. The child had thus received 100 mg of Fungizone(®), or ten times the recommended dose

Administration de médicaments au nouveau-né par le cathéter ombilical

RésuméObjectif : Revue de la catheterisation vasculaire ombilicale et des donnees disponibles concernant l’administration de medicaments par le catheter ombilical veineux (CVO) et arteriel (CAO) en neonatologie. Source des données : Revue de la litterature medicale sur PubMed (1970 a 2011) et consultations d’ouvrages de references pediatriques. Sélection des études et extraction des données : Donnees extraites d’articles de revues, d’enquetes et de rapports de cas. Analyse des données : Le positionnement des CVO et CAO est determinant dans la survenue de complications lors de l’administration de medicaments. Peu de donnees bien etayees sont disponibles. L’evaluation s’est basee sur 22 publications. L’administration de medicaments par CVO est tres frequente en neonatologie, et cette pratique peut etre consideree comme sure a condition que le CVO soit place en position centrale. L’administration de medicaments par le CAO est peu frequente, car elle est plus risquee. De nombreuses complications (vasospasme, thrombose, necrose) ont ete observees a la suite de l’administration de medicaments par CAO. Une position basse du CAO augmente le risque de complications. Conclusion : L’administration de medicaments par CVO ne semble pas poser de probleme sous reserve que le CVO soit correctement positionne (central). L’administration de medicaments par CAO etant risquee, une liste des medicaments pouvant etre ou non administres par CAO (medicaments vasoconstricteurs, irritants ou hyperosmolaires) a ete etablie afin de securiser la prise en charge des patients en neonatologie. AbstractObjective: To review umbilical vascular catheterization and the data available regarding the administration of medication by umbilical venous and arterial catheters (UVC and UAC respectively) in neonates.Data sources: Medical literature review on Pub- Med for the period 1970–2011 and consultation of pediatric references. Study selection and data extraction: Data extracted from review articles, surveys, and case reports. Data analysis: When administering medications, positioning of the UVC and UAC is a determining factor in the occurrence of complications. Few data to support this are available. The evaluation was based on 22 publications. The administration of medication by UVC is common in neonatology, and this practice can be considered reliable under the condition that the UVC is placed in a central position. The administration of medication by UAC is infrequent because it is riskier. Numerous complications (vasospasm, thrombosis, necrosis) have been observed following the administration of medication by UAC. Having the UAC in the low position increases the risk of complications. Conclusion: The administration of medication by UVC does not seem to cause any problems under the condition that the UVC is properly positioned centrally. Given that the administration of medication by UAC is risky, a list of medications that may or may not be administered by UAC (vasoconstrictive drugs, irritants, hyperosmolar substances) was developed to improve the safe management of neonatal patients