Survey of workflow and cost implications of decommissioning regarding the Falsified Medicines Directive in Hungarian hospital pharmacies

Objectives, setting and participantsIn July 2011, the EU adopted the Falsified Medicines Directive (FMD) primarily aiming to prevent the infiltration of falsified medicines into the legitimate supply chain. Our aim was to measure the cost elements of FMD implementation and operation using an internationally adaptable tool among Hungarian hospital pharmacies.DesignA 41-item questionnaire was developed to evaluate the implementation process and associated cost consequences leading up to February 2019, and the stabilisation period.ResultsOur representative data are supported by the high response rate, as 44.8% of the Hungarian hospital pharmacies have completed the survey. Human resource requirements related to decommissioning activities were measured as working hours and were expressed in full time equivalent (FTE). We have found an increased workload with extra 0.25 pharmacist and 0.75 technician FTE/institution at the end of the stabilisation period. The entire infrastructural and IT implementation costs were determined as €2173, on average (SD: €3366) and the median was €1506 (range: €0–€20 723). The total IT investment cost per institution was valued at €1410 (SD: €335). We identified a positive correlation (R=0.663) in consideration of the costs, the number of beds and the number of hospital locations with a multivariate linear regression model. At the time of our survey, 76.7% of the respondents experienced drug shortages, 58.1% reported suspected increase in drug costs regarding serialised medications, and 53.5% noticed an increase in packaging size.ConclusionsNotably, our research is the first complex study depicting FMD cost implications in the hospital pharmacy sector in Central Europe, indicating decommissioning significantly impacted workflow referencing human resources and IT.

Perinatal stabilisation of infants born with congenital diaphragmatic hernia: a review of current concepts

Congenital diaphragmatic hernia (CDH) is associated with high mortality rates and significant pulmonary morbidity, mainly due to disrupted lung development related to herniation of abdominal organs into the chest. Pulmonary hypertension is a major contributor to both mortality and morbidity, however, treatment modalities are limited. Novel prenatal and postnatal interventions, such as fetal surgery and medical treatments, are currently under investigation. Until now, the perinatal stabilisation period immediately after birth has been relatively overlooked, although optimising support in these early stages may be vital in improving outcomes. Moreover, physiological parameters obtained from the perinatal stabilisation period could serve as early predictors of adverse outcomes, thereby facilitating both prevention and early treatment of these conditions. In this review, we focus on the perinatal stabilisation period by discussing the current delivery room guidelines in infants born with CDH, the physiological changes occurring during the fetal-to-neonatal transition in CDH, novel delivery room strategies and early predictors of adverse outcomes. The combination of improvements in the perinatal stabilisation period and early prediction of adverse outcomes may mitigate the need for specific postnatal management strategies.

Esophageal Atresia with Tracheo-Esophageal Fistula Presenting Beyond 7 Days

Aim: To describe our experience of neonates with esophageal atresia with tracheo-esophageal fistula (EA with TEF) who presented after a week.Design: Retrospective study of the patients of EA with TEF who presented after a week.Study Setting: Department of Pediatric Surgery, Government Medical College Nagpur.Study Duration: Eight years.Materials and Methods: Demographic information, hematological, biochemical and radiological data were obtained from the patients' medical records. The gap between two ends of the esophagus, nature of upper pouch and lower esophagus were noted intra-operatively. Outcome in terms of mortality and surgical complications were noted. In operated group, babies who survived were compared with non-survivors with respect to various preoperative variables.Results: Of 52 patients, 27 babies expired during initial stabilisation period before surgery. The causes of mortality were severe pneumonitis and septicemia. One baby had associated cyanotic heart disease. Twenty-five patients with mean age of 8.28±1.21 days underwent surgery. Nearly two-third of them were male. All of them were born at full-term with mean birth weight of 2.47±0. 12 kg. More than 80% were previously hospitalised and nearly 70% babies were given feeds before present hospitalization. Mean Downe’s score for respiratory distress was 5.8±1.49. All patients were positive for septic profile. Associated congenital anomalies were present in ten patients. Intra-operatively, two ends of esophagus were either approximating or have short gap in 24 patients. All patients had well developed, thick and muscular upper oesophageal pouch. Lower esophagus at fistula was thin but dilated in 18 patients while thin and narrowed in 7 patients. However, esophageal anastomosis was possible with ease without any tension in all except one patient. There were 15 deaths in our study (13 due to pneumonitis and 2 during follow up due to aspiration). Three survivors required anti-reflux surgery. Comparison of preoperative variables of survivors and non-survivors showed a significant difference with respect to the variables like feedings, abdominal girth, immature band cells to neutrophil ratio and nature of pharyngeal or endotracheal aspirate.Conclusions: Late presentations in EA with TEF are associated with high mortality but less anastomotic complications after surgery. Preoperative factors like feedings, abdominal distension, immature band cells to neutrophil ratio and bilious pharyngeal or endotracheal aspirate are associated with high mortality.

Preliminary stabilisation of stormwater biofilters and loss of filter material

Stabilisation affects performance of stormwater biofilters operating under intermittent wetting and drying, mainly due to wash-off of filter material. Understanding the dynamics of solids wash-off is crucial in designing stormwater biofilters. The current study analysed the dynamics of solids wash-off in stormwater biofilters and quantified the loss of solids from the filter. Four Perspex™ bioretention columns (94 mm internal diameter) were fabricated with a filter layer that contained 8% organic material and were fed with tap water with different numbers of antecedent dry days (0–40 day) at 100 mL/min. Samples were collected from the outflow and tested for particle size distribution and total solids and turbidity. Solids of particle size less than 50 microns were washed off from the filter during the stabilisation period, indicating that no sand particles were washed off. The very first event after commissioning the filter resulted in the highest wash-off of solids (approximately 75 g of fines) while a significant drop in wash-off followed from the second event. An empirical model fitted to the data showed that preliminary stabilisation of a filter occurs in the first three events, during which almost 25% of fines are lost from the filter.

A Combination of an Anaerobic Baffled Reactor with Membrane Filtration for Decentralised Wastewater Treatment

This paper presents the performance of a laboratory-scale anaerobic baffled reactor (ABR) with a combined membrane filtration polishing step. The plant treated a synthetic blackwater comprised of a faecal and urine slurry obtained from ventilated improved pit latrine (VIP) toilets. Feed to the system was kept constant at 2 000 mg COD/L with COD, TS and VS removal efficiencies of 81, 24 and 20% obtained through the ABR. Two effluent polishing systems were investigated: a hollow-fibre system that housed Polymem modules and a flat-sheet system that housed Kubota and locally-produced fabric modules. Membranes were operated in the dead-end mode under ultra-low pressures using a hydrostatic pressure head (less than a metre). Fouling behaviour differed with the type of filtration process despite the same feed characteristics. Effluent filtration with the Polymem module showed that the flux did not reach a stabilisation period with severe fouling occurring after 8 d. Membrane fouling was largely reversible with the fouling layer easily removed by a simple tap water wash. In contrast, effluent filtration with Kubota and fabric membranes resulted in a period of low stabilised flux (˜0.5 L/m2.h) at ultra-low pressures with flux independent on the TMP used. Kubota modules exhibited a similar performance to fabric ones but were able to produce slighter higher fluxes after prolonged filtration. Membrane fouling in both flat-sheet module types was irreversible with a gel-like layer forming during filtration. The difference in hollow-fibre and flat-sheet modules may be due to a number of factors, such as pore size and the manufacturing process used to prepare membranes. Through deductive investigations, it was concluded that the fouling constituents in the effluent may be colloidal and/or soluble in nature.

Set up of a newin vitromodel to study dietary fructans fermentation in formula-fed babies

A newin vitrofermentation model with immobilised infant faecal microbiota simulating the proximal colon of a formula-fed baby was developed and used to test the effects of known prebiotic fructans. Intestinal fermentation, based on a previously developed colonic fermentation model, using a new feeding medium simulating a formula-fed infant ileal chyme, was carried out for seventy-one consecutive days divided into four stabilisation periods intercalated with four prebiotic treatment periods. At the end of the first stabilisation period, total bacterial concentration in colonised beads and in faecal sample was similar, metabolite concentrations returned to stabilisation values after each treatment period. As expected, the four prebiotic treatments significantly increased the bifidobacterial populations, whereas they decreased bacteroides and clostridia. No difference was observed in the prebiotic effect of these substrates selected. The treatments significantly increased total production of SCFA and decreased ammonia compared to stabilisation periods. Long-term stability of the system together with the reproducibility of the known prebiotic effects highlights the potential of the present model to quantify and compare the effects of different substrates in a formula-fed infant microbiota within the same fermentation experiment.

Primary hyperaldosteronism in the cat: A series of 13 cases

Thirteen cases of feline primary hyperaldosteronism were diagnosed based on clinical signs, serum biochemistry, plasma aldosterone concentration, adrenal imaging and histopathology of adrenal tissue. Two cases presented with blindness caused by systemic hypertension, whilst the remaining 11 cases showed weakness resulting from hypokalaemic polymyopathy. Elevated concentrations of plasma aldosterone and adrenocortical neoplasia were documented in all cases. Seven cases had adrenal adenomas (unilateral in five and bilateral in two) and six had unilateral adrenal carcinomas. Three cases underwent medical treatment only with amlodipine, spironolactone and potassium gluconate; two cases survived for 304 and 984 days until they were euthanased because of chronic renal failure, whilst the third case was euthanased at 50 days following failure of the owner to medicate the cat. Ten cases underwent surgical adrenalectomy following a successful stabilisation period on medical management. Five cases remain alive at the time of writing with follow-up periods of between 240 and 1803 days. Three cases were euthanased during or immediately following surgery because of surgical-induced haemorrhage. One cat was euthanased 14 days after surgery because of generalised sepsis, whilst the remaining cat was euthanased 1045 days after surgery because of anorexia and the development of a cranial abdominal mass. It is recommended that primary hyperaldosteronism should be considered as a differential diagnosis in middle-aged and older cats with hypokalaemic polymyopathy and/or systemic hypertension and should no longer be considered a rare condition.

Über die circadiane Variation der Stoffwechselgröße des isolierten Gewebes / Circadian Rhythm of Metabolie Rate in Isolated Tissue

The circadian variation of oxygen uptake of isolated mouse diaphragm has been measured by means of the direct Warburg-technique in two series with sets of each 8 successive experiments. Under our experimental conditions oxygen uptake in the isolated diaphragm remains constant for 5 hours at least. The 24-hour period could therefore be completed with 8 single measurements of each 10 - 20 isolated diaphragms started at 3 h intervals with a overlap in experimental time of 2 h hours between each single experiment. Similar to the results concerning the spontaneous locomotive activity of the mouse (ASCHOFF 1955) we found maximum values of metabolic rate during the night, minimum values during day time and a interpolated relative maximum of oxygen uptake between 600 -800 h. Oxygen uptake after the stabilisation period of approximately 1 h seems to be determined by the time of the death of the animal.