Concerning one case of rupture of a flow regulator: How patient safety procedures contribute to the correct use of medical devices.

Flow regulators are widely used in hospitals to assist with intravenous (IV) infusion of medication. The rupture of a flow regulator at the base of the clamp was observed during parenteral nutrition. This rupture resulted in fluid leakage and an inlet of air, responsible for an air embolism in a fragile patient who had undergone a bilateral lung transplant. The patient's clinical condition required him to be transferred to a continuous monitoring unit. A serious Adverse Event in Healthcare (AEH) was reported, as well as a medical device vigilance report. A Feedback Committee (FC) was set up and it recommended an audit within the health care departments to study the conditions for use of flow regulators and to propose corrective actions. Despite the technical data sheet of the device not recommending the administration of lipid emulsions and glucose solutions above 10%, the manufacturer's expert report concluded that the mechanical failure could not be linked to the type of solution. However, the audit did reveal a lack of knowledge of certain rules for using this device. The analysis of this AEH is part of the establishment's patient safety procedure. The AEH highlighted a deviation in care concerning the conditions for use of flow regulators, thus resulting in misuse. The collaboration between the various actors involved in the analysis of this AEH led to the implementation of improvement actions on the root causes, related to the lack of information and of training for professionals on correct use of the medical device.

[Occurrence of delayed symptoms after a challenge test with methacholine]. / Survenue de symptômes tardifs après un test de provocation par la méthacholine.

There are few prospective studies available on the development of delayed symptoms following challenge tests with methacholine (MCT) at the currently recommended doses. The objective of this study was to describe the nature and frequency of respiratory symptoms suggestive of bronchospasm developing within 24hours after a MCT. The study was offered to adult patients who underwent MCT seen consecutively between June and October 2015. Following the test, a questionnaire adapted from the GINA asthma control questionnaire bearing on diurnal and nocturnal symptoms (cough, dyspnoea, wheeze and tightness), was delivered to the patient and the replies collected by telephone 24hours later. Of the 101 patients included (initial FEV1 2.82±0.79L), 46 (46 %) were MCT+ and 55 (54 %) MCT-. Among the MCT-, 4 (7 %) presented with immediate symptoms (S+) and 4 (7 %) with delayed symptoms. Among the MCT+ patients, 36 (78 %) presented with immediate symptoms (P<0.001 compared with the MCT- patients), and 39 (85 %) with delayed symptoms (P<0.001 compared with the MCT- patients). Delayed symptoms developed with a mean of 5h30 after the provocation test. Immediate and delayed symptoms were more frequent in subjects having significant non-specific bronchial hyper-reactivity. Informing patients of the risk of developing delayed symptoms seems useful and allows optimization of their management after a MCT.

[Imprecision of vancomycin prepared for intravenous administration at the bedside in a neonatal intensive care unit]. / Étude de la variabilité dans les reconstitutions de vancomycine intraveineuse en réanimation pédiatrique.

In pediatric units, most of the intravenous medications are prepared by the attending nurse at the bedside that can be affected by an error margin, so can be imprecise. Despite the possible consequences of imprecise medications administration, published studies on the topic are scarce. The main objective of this study was to measure the difference between the prescribed vancomycine concentration and the actual concentration measured in the medication administered to the patient. The secondary objective was to determine which step in the preparation was linked to the difference in concentrations. It was a prospective study, setting in a pediatric and neonatal university hospital intensive care unit. Over a 3-month period, an aliquot from every preparation for continuous infusion of vancomycin, made at the bedside by a nurse, was collected and the modalities of the preparation noted. Vancomycin concentration was measured by high performance liquid chromatography. Sixty-four preparations, accounting for 24 patients (gestationnal age: 67 ± 75 weeks, weigh: 4.8 ± 6.5 kg) were included. Vancomycin concentrations ranged from 3.33 to 60.0mg/mL. Measured concentration were in mean 7% smaller than prescribed concentration (P<10(-3)), with a large confidence interval (75.8%-120.4% of the prescribed concentration). Imprecision the preparations was much higher than this admitted for manufactured preparation. We could not highlight any factor related to the difference in concentrations, but one third of the preparation did not respect all the ISO 7886 standards for syringes use. Bedside vancomycin preparations, like preparations for other molecules, are far more imprecise than industrial intravenous medications. Our results urge that all pediatric intravenous medications should be made only by manufacturers or pharmacists. However, it also urged clinical studies, in parallel to pharmacodynamic and pharmacokinetic studies, to make intravenous treatments as accurate as they should be.

Stability of amphotericin B in 5% dextrose ophthalmic solution.

The stability of amphotericin B 5 mg/mL in 5% dextrose ophthalmic solution prepared by the Hospital Pharmacy Service was studied in different conditions of storage and use. Admixtures of amphotericin B were aseptically prepared in low-density polyethylene dropper bottles. The stability of amphotericin B was evaluated in ophthalmic dropper bottles stored in a refrigerator, at room temperature, protected from, or exposed to, light. To simulate the effect of exposure to air, some ophthalmic dropper bottles were opened twice daily and two drops were removed. Immediately after preparation, samples were collected to determine the initial drug concentration by high-performance liquid chromatography and to assess pH, osmolality and sterility. The same tests were conducted after four, eight and 15 days of storage in ophthalmic containers opened daily and unopened after eight, 15, 30, 60, 75 and 120 days of storage. Samples were visually inspected daily for signs of physical incompatibility. An additional study was conducted in four ophthalmic containers collected in the ophthalmology unit after eight or 15 days of current patient use testing the same parameters. Ophthamlic containers stored in the refrigerator (the closed and the opened daily set) showed no loss or deterioration of amphotericin B during the corresponding period of storage (120 and 15 days, respectively). We observed precipitation and degradation after 13 days of storage in ophthalmic containers exposed to normal lighting conditions at room temperature, and after 16 days in ophthalmic containers protected from light. There was no appreciable change in pH or osmolality in any of the samples. Microbiological invesigation disclosed negative culture results for all samples. This study shows that aseptically prepared amphotericin B ophthalmic solution packaged in low-density polyethylene bottles can be stored safely for up to 120 days when unopened and stored at 4 deg C and protected from light, for 16 days when stored at 22 deg C and protected from light and for 13 days when stored at 22 deg C and exposed to light.

[Utilization of transcutaneous anesthetics during heart catheterization]. / Utilisation des anesthésiques transcutanés au cours des cathétérismes cardiaques.

OBJECTIVES: Assess the efficacy of an anesthetic cream for cardiac catheterization. PATIENTS AND METHODS: Percutaneous anesthesia was studied in a series of 100 consecutive patients undergoing cardiac catheterization. The anesthesia was composed with an eutetic mixture of local anesthetics and applied precisely over the puncture area in a randomized controlled study. After admission, patients were randomized into two groups: 50 patients received lidocaine infiltration and 50 patients received associated cream and infiltration. Percutaneous anesthesia was to be applied 2 hours before entering the operating room. RESULTS: No complication developed with this cream combined with lidocaine infiltration. Serum concentration indicated very low levels which were very well tolerated. Patient comfort improved with the anesthetic cream-lidocaine infiltration association. CONCLUSION: The use of an anesthetic cream is safe and effective, especially combined with lidocaine infiltration during cardiac catheterization. Cost is high and the association might be reserved for special indications (obesity, children).

Evaluation of drug use and cost of hospital care for AIDS patients between 1990 and 1994.

This study was designed to evaluate drug use and drug costs of treatment of 1112 AIDS patients at the Infectious Diseases Unit at F. Houphouët Boigny Hospital in Marseilles, France, between January 1, 1990 and December 31, 1994. All drug expenditures directly or indirectly related to AIDS treatment were recorded for both inpatients and outpatients. There were 1952 hospital stays. For each stay baseline characteristics including age, sex risk factors, costs, and duration of hospitalization were noted. Patients were mainly young male drug addicts around thirty years of age. Reason for admission was also noted. The overall number of admissions per year has decreased since 1991 probably due to development of outpatient care. The number of stays per patient per year has decreased since 1993 because of the use of more appropriate therapeutic and prophylactic protocols. The number of drugs used was high increasing from 750 in 1990 to 868 in 1994. Cost of treatment doubled between 1990 and 1994 due to the introduction of many expensive new drugs. Closer analysis showed that the greatest increase in expenditure involved 'antibiotic/antiviral', 'psychiatry/neurology' and 'specialized therapy'. Although not frequently prescribed, costly drugs such as immunoglobulins, hematopoietic growth factors, and parenteral nutrition solutions accounted for a high proportion of total costs. Since AZT, ddI and ddC were used mainly for outpatient treatment, their cost was low in inpatients. Cytomegalovirus-related retinitis, tuberculosis, and multiple infections were cost-intensive complications. The increasing number of cytomegalovirus infections underlines the need for cost evaluation and surveillance of this complication. This study demonstrates that cost of treating AIDS patients is rising due to the use of more and costlier drugs. This finding underlines the need to evaluate and compare new therapeutic modalities in terms of cost effectiveness.

Preparation and use of morphine capsules in paediatric patients with burns.

Morphine is an analgesic agent used for the symptomatic relief of moderate to severe pain. The lack of oral paediatric form of morphine hydrochloride has led the pharmacy unit to develop capsules containing 1 mg of morphine. These capsules are prepared in conformity with G.M.P. and controlled by H.P.L.C. 73 burn children were treated in this study with pain suppression without adverse effects. This galenic form may be an adequate candidate for the management of paediatric patients because of its analgesic qualities and of numerous advantages.

Selective decontamination of the digestive tract in multiple trauma patients. A prospective double-blind, randomized, placebo-controlled study.

STUDY OBJECTIVE: The aims of the study were to evaluate the technique of selective digestion decontamination (SDD) in preventing the development of nosocomial infections in a selected population and to assess the effects on colonization of the oropharynx, nares, and bronchi. A financial assessment was also performed. DESIGN: Prospective, double-blind, randomized placebo-controlled trial using amphotericin B, colistin sulfate (polymixin E), and gentamicin applied to the nares, the oropharynx, and enterally; no parenteral antibiotics were given during the study period. The SDD was applied every 6 h during the study period. SETTING: Multidisciplinary ICU in a university hospital. PATIENTS: A total of 148 trauma patients admitted emergently and intubated within less than 24 h were enrolled. Seventy-two patients who received placebo and 76 treated patients were analyzed on an "intention-to-treat" basis. INTERVENTIONS: Microbiologic surveillance samples of oropharyngeal and bronchial secretions, urine, and any other potentially infected sites were taken at the time of ICU admission and twice weekly thereafter until discharge from the unit. MEASUREMENTS AND RESULTS: With the use of SDD, colonization was significantly reduced in the oropharynx and nares (<0.05) but not in bronchi. However, episodes of bronchopneumonia were significantly reduced (19 in the active group vs 37 in the placebo group; p,0.01). Staphylococcus aureus remained the main potential pathogen causing bronchial colonization and subsequent bronchopneumonia. There was no reduction in the incidence of other infections. Days in the ICU, duration of mechanical ventilation, and mortality rate were unchanged. After the use of SDD, Gram-positive colonization tended to increase and this was mainly due to methicillin-resistant coagulase-negative staphylococci. The total cost of antibiotic therapy ($62,117 [US] in the placebo group and $36,008 in the SDD group) was decreased by 42% with the use of SDD. Clinically important complications of SDD were not encountered. CONCLUSIONS: The use of SDD in this population of trauma patients reduced the incidence of bronchopneumonia and the total charge for antibiotics. Stay in the ICU, mechanical ventilation, and mortality rate were unchanged. Methicillin-resistant coagulase-negative staphylococci were selected by SDD in some patients and the clinical relevance of this colonization needs further evaluation.

[Hypnotics and anxiolytics: nominal daily delivery and development of their consumption at North University Hospital Center of Marseille (1991-1994)]. / Hypnotiques et anxiolytiques: Mise en place de la D.N.J et évolution de leur consommation au sein de C.H.U Nord de Marseille (1991-1994).

For public health concerns, a nominal daily delivery of anxiolytic and hypnotic drugs has progressively been set up since March 1992 for the whole of the North University-Hospital Center (U.H.C) of Marseille. The purpose of this monitored prescription process is to limit their use, which seemed undue. After the first six month of implementation, drug use decreased significantly(-50%) and has since stabilized. This reduction is particularly pronounced for benzodiazepines and especially anxiolytic drugs. The decree of August 9, 1991 has enabled us to optimize the delivery of these drugs and thus improve prescription for more rational indications.

Selective digestive decontamination in multiple trauma patients: cost and efficacy.

A double-blind randomized placebo-controlled study was carried out to evaluate the efficacy and the cost of selective digestive decontamination (SDD) to prevent nosocomial pneumonia in multiple-trauma patients. Nosocomial infections, particularly pneumonia, were more frequent in the placebo group. The most common infectious agent was Staphylococcus: Staphylococcus aureus in the placebo group and Staphylococcus epidermidis in the SDD group. Methicillin-resistant Staphylococcus epidermidis was detected more often in the SDD group. No methicillin-resistant Staphylococcus aureus was observed in this study. Fewer patients in the SDD group required antibiotherapy. SDD resulted in a saving of about 41% in drug expenditure.

[Evaluation of medication costs in hospitalization of AIDS patients]. / Evaluation du coût médicamenteux des séjours d'hospitalisation chez des malades atteints de sida.

The aim of this study was to examine the global pharmaceutical cost of AIDS patients hospitalized in a ward of infectious diseases in Marseille. They were 209 patients at various clinical stages of HIV infection receiving or not AZT or another specific drugs. All of the 319 hospitalization stays entailed a pharmaceutical cost of 1,065,593 FF for year 1990. A detailed analysis of the therapies, excepted for AZT, determined very large expenses of anti-infectious, hypnotics and other patent drugs of gastroenterology, pneumology, stomatology and toxicology. The study showed that the total drug cost increased with the hospitalization duration.

[Spatial and temporal variations of the quantities of pollen from Cupressaceae-Taxaceae collected in Marseilles]. / Variations spatiales et temporelles des quantités de pollen de Cupressacées-Taxacées recueillies à Marseille.

Marseille has two sites (Centre and North) where airborne pollens are collected and counted. The most numerous pollens are from Cupressaceae Taxaceae. We compared the quantities collected with both pollen traps during February, March and April 1988 and 1989. Most of pollinization takes place in March. In Marseille's Centre, there were three times more trapped pollen during 1989 than in 1988. In 1989, there was 40% more pollen on northern site as compared with the other one. As indicated in 1989 with both sites, it suggests a circadian periodicity of Cupressaceae Taxaceae pollen: their highest count is usually between 9 and 11 hours a.m.

Continuous infusion of high-dose cisplatin in children: pharmacokinetics of free and total platinum.

A pharmacokinetic study was carried out in two infants and two (older) children with high-dose cisplatin (CP) (40 mg/m2/day) by 5-day continuous infusion. Following interruption of the infusion, the decrease in total plasma platinum was biphasic, with a terminal half-life of 155.5-418 h. During administration the urinary concentrations were between 7.66 and 15.2 mg/l. Thirty to thirty five per cent of the administered dose was eliminated within 48 h of discontinuing infusion. Free platinum (FP) levels declined in a biphasic manner, with a mean (+/- S.E.) elimination half-life of 81.25 (+/- 34.9) h. FP was still detectable in the plasma 10 days after the end of infusion with levels above 0.010 micrograms/ml. FP availability, measured as the area under the curves (AUC) of the FP concentration--up to 2 h after ending the infusion--were 768 (+/- 326) micrograms.min/ml. Inter- or intra-individual differences in AUC values were not observed.

Pharmacokinetic study of Cis-dichlorodiammine platinum II, in children after rapid infusion.

This study involves 3 children ranging from 10 to 13 years and an eight-month-old infant who received Cis-DDP (30-100 mg/m2) every fourth week by means of a short-term infusion (20-35 minutes). Platinum levels in plasma and urine were determined by flameless atomic absorption spectrophotometry. The decrease in total plasma platinum is triphasic, consistent with the distribution expected for a 3 compartment model. In the elimination phase, the half-life values are high and vary between 149 and 541 hours. The total plasma clearances are extremely low and range from 0.027 to 0.187 litre/hour. The urinary excretion of platinum during the first 5 and 7 days respectively, in two children following administration of Cis-DDP results in large platinum concentrations (40-71 mg/litre) in the first urine excreted from each child. The cumulative urinary platinum excretion in the first twelve hours is high i. e. 27.2 to 32.5% of the administered dose but them it does not exceed 50% even after 5 days. These results confirm that after a short-term infusion of Cis-DDP in a single dose, the kidneys are suddenly subjected to platinum in high concentrations. In order to minimize the nephrotoxicity of this platinum complex, while maintaining sufficient plasma levels to ensure its anti-neoplastic activity, we recommend a schedule consisting of fractionated doses.