Errors associated with the preparation of aseptic products in UK hospital pharmacies: lessons from the national aseptic error reporting scheme

Background Pharmacy aseptic units prepare and supply injectables to minimise risks. The UK National Aseptic Error Reporting Scheme has been collecting data on pharmacy compounding errors, including near-misses, since 2003. Objectives The cumulative reports from January 2004 to December 2007, inclusive, were analysed. Methods The different variables of product types, error types, staff making and detecting errors, stage errors detected, perceived contributory factors, and potential or actual outcomes were presented by cross-tabulation of data. Results A total of 4691 reports were submitted against an estimated 958 532 items made, returning 0.49% as the overall error rate. Most of the errors were detected before reaching patients, with only 24 detected during or after administration. The highest number of reports related to adult cytotoxic preparations (40%) and the most frequently recorded error was a labelling error (34.2%). Errors were mostly detected at first check in assembly area (46.6%). Individual staff error contributed most (78.1%) to overall errors, while errors with paediatric parenteral nutrition appeared to be blamed on low staff levels more than other products were. The majority of errors (68.6%) had no potential patient outcomes attached, while it appeared that paediatric cytotoxic products and paediatric parenteral nutrition were associated with greater levels of perceived patient harm. Conclusions The majority of reports were related to near-misses, and this study highlights scope for examining current arrangements for checking and releasing products, certainly for paediatric cytotoxic and paediatric parenteral nutrition preparations within aseptic units, but in the context of resource and capacity constraints.

A novel method for measuring lag times in division of individual bacterial cells using image analysis

A method is presented for determining the time to first division of individual bacterial cells growing on agar media. Bacteria were inoculated onto agar-coated slides and viewed by phase-contrast microscopy. Digital images of the growing bacteria were captured at intervals and the time to first division estimated by calculating the "box area ratio". This is the area of the smallest rectangle that can be drawn around an object, divided by the area of the object itself. The box area ratios of cells were found to increase suddenly during growth at a time that correlated with cell division as estimated by visual inspection of the digital images. This was caused by a change in the orientation of the two daughter cells that occurred when sufficient flexibility arose at their point of attachment. This method was used successfully to generate lag time distributions for populations of Escherichia coli, Listeria monocytogenes and Pseudomonas aeruginosa, but did not work with the coccoid organism Staphylococcus aureus. This method provides an objective measure of the time to first cell division, whilst automation of the data processing allows a large number of cells to be examined per experiment. (c) 2005 Elsevier B.V. All rights reserved.

Modeling the variability of single-cell lag times for Listeria innocua populations after sublethal and lethal heat treatments

Optical density measurements were used to estimate the effect of heat treatments on the single-cell lag times of Listeria innocua fitted to a shifted gamma distribution. The single-cell lag time was subdivided into repair time ( the shift of the distribution assumed to be uniform for all cells) and adjustment time (varying randomly from cell to cell). After heat treatments in which all of the cells recovered (sublethal), the repair time and the mean and the variance of the single-cell adjustment time increased with the severity of the treatment. When the heat treatments resulted in a loss of viability (lethal), the repair time of the survivors increased with the decimal reduction of the cell numbers independently of the temperature, while the mean and variance of the single-cell adjustment times remained the same irrespective of the heat treatment. Based on these observations and modeling of the effect of time and temperature of the heat treatment, we propose that the severity of a heat treatment can be characterized by the repair time of the cells whether the heat treatment is lethal or not, an extension of the F value concept for sublethal heat treatments. In addition, the repair time could be interpreted as the extent or degree of injury with a multiple-hit lethality model. Another implication of these results is that the distribution of the time for cells to reach unacceptable numbers in food is not affected by the time-temperature combination resulting in a given decimal reduction.

Lag-1 sparing in the attentional blink: benefits and costs of integrating two events into a single episode

When people monitor a visual stream of rapidly presented stimuli for two targets (T1 and T2), they often miss T2 if it falls into a time window of about half a second after T1 onset-the attentional blink. However, if T2 immediately follows T1, performance is often reported being as good as that at long lags-the so-called Lag-1 sparing effect. Two experiments investigated the mechanisms underlying this effect. Experiment 1 showed that, at Lag 1, requiring subjects to correctly report both identity and temporal order of targets produces relatively good performance on T2 but relatively bad performance on T1. Experiment 2 confirmed that subjects often confuse target order at short lags, especially if the two targets are equally easy to discriminate. Results suggest that, if two targets appear in close succession, they compete for attentional resources. If the two competitors are of unequal strength the stronger one is more likely to win and be reported at the expense of the other. If the two are equally strong, however, they will often be integrated into the same attentional episode and thus get both access to attentional resources. But this comes with a cost, as it eliminates information about the targets' temporal order.

Video activity extraction and reporting with incremental unsupervised learning

The present work presents a new method for activity extraction and reporting from video based on the aggregation of fuzzy relations. Trajectory clustering is first employed mainly to discover the points of entry and exit of mobiles appearing in the scene. In a second step, proximity relations between resulting clusters of detected mobiles and contextual elements from the scene are modeled employing fuzzy relations. These can then be aggregated employing typical soft-computing algebra. A clustering algorithm based on the transitive closure calculation of the fuzzy relations allows building the structure of the scene and characterises the ongoing different activities of the scene. Discovered activity zones can be reported as activity maps with different granularities thanks to the analysis of the transitive closure matrix. Taking advantage of the soft relation properties, activity zones and related activities can be labeled in a more human-like language. We present results obtained on real videos corresponding to apron monitoring in the Toulouse airport in France.

A potential lag between the open solar magnetic source flux and solar EUV and X-ray emissions as measured by the Earth's ionosphere during total solar eclipses

Measurements of the ionospheric E-region during total solar eclipses have been used to provide information about the evolution of the solar magnetic field and EUV and X-ray emissions from the solar corona and chromosphere. By measuring levels of ionisation during an eclipse and comparing these measurements with an estimate of the unperturbed ionisation levels (such as those made during a control day, where available) it is possible to estimate the percentage of ionising radiation being emitted by the solar corona and chromosphere. Previously unpublished data from the two eclipses presented here are particularly valuable as they provide information that supplements the data published to date. The eclipse of 23 October 1976 over Australia provides information in a data gap that would otherwise have spanned the years 1966 to 1991. The eclipse of 4 December 2002 over Southern Africa is important as it extends the published sequence of measurements. Comparing measurements from eclipses between 1932 and 2002 with the solar magnetic source flux reveals that changes in the solar EUV and X-ray flux lag the open source flux measurements by approximately 1.5 years. We suggest that this unexpected result comes about from changes to the relative size of the limb corona between eclipses, with the lag representing the time taken to populate the coronal field with plasma hot enough to emit the EUV and X-rays ionising our atmosphere.

Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials

In this paper we set out what we consider to be a set of best practices for statisticians in the reporting of pharmaceutical industry-sponsored clinical trials. We make eight recommendations covering: author responsibilities and recognition; publication timing; conflicts of interest; freedom to act; full author access to data; trial registration and independent review. These recommendations are made in the context of the prominent role played by statisticians in the design, conduct, analysis and reporting of pharmaceutical sponsored trials and the perception of the reporting of these trials in the wider community.

The potential for bias in reporting of industry-sponsored clinical trials

Concerns about potentially misleading reporting of pharmaceutical industry research have surfaced many times. The potential for duality (and thereby conflict) of interest is only too clear when you consider the sums of money required for the discovery, development and commercialization of new medicines. As the ability of major, mid-size and small pharmaceutical companies to innovate has waned, as evidenced by the seemingly relentless decline in the numbers of new medicines approved by Food and Drug Administration and European Medicines Agency year-on-year, not only has the cost per new approved medicine risen: so too has the public and media concern about the extent to which the pharmaceutical industry is open and honest about the efficacy, safety and quality of the drugs we manufacture and sell. In 2005 an Editorial in Journal of the American Medical Association made clear that, so great was their concern about misleading reporting of industry-sponsored studies, henceforth no article would be published that was not also guaranteed by independent statistical analysis. We examine the precursors to this Editorial, as well as its immediate and lasting effects for statisticians, for the manner in which statistical analysis is carried out, and for the industry more generally.

Equalisation with adaptive time lag

In an adaptive equaliser, the time lag is an important parameter that significantly influences the performance. Only with the optimum time lag that corresponds to the best minimum-mean-square-error (MMSE) performance, can there be best use of the available resources. Many designs, however, choose the time lag either based on preassumption of the channel or simply based on average experience. The relation between the MMSE performance and the time lag is investigated using a new interpretation of the MMSE equaliser, and then a novel adaptive time lag algorithm is proposed based on gradient search. The proposed algorithm can converge to the optimum time lag in the mean and is verified by the numerical simulations provided.

Flexible MMSE DFE using length and LAG adaptation

This paper investigates how to choose the optimum tap-length and decision delay for the decision feedback equalizer (DFE). Although the feedback filter length can be set as the channel memory, there is no closed-form expression for the feedforward filter length and decision delay. In this paper, first we analytically show that the two dimensional search for the optimum feedforward filter length and decision delay can be simplified to a one dimensional search, and then describe a new adaptive DFE where the optimum structural parameters can be self-adapted.

Lag-time effects on a naturally ventilated large thermometer screen

Systematic natural ventilation effects on measured temperatures within a standard large wooden thermometer screen are investigated under summer conditions, using well-calibrated platinum resistance thermometers. Under low ventilation (2mwind speed u2 < 1.1 m s−1), the screen slightly underestimates daytime air temperature but overestimates air temperature nocturnally by 0.2◦C. The screen’s lag time L lengthens with decreasing wind speed, following an inverse power law relationship between L and u2. For u2 > 2 m s−1, L ∼ 2.5 min, increasing, when calm, to at least 15 min. Spectral response properties of the screen to air temperature fluctuations vary with wind speed because of the lag changes. Ventilation effects are particularly apparent at the higher (>25◦C) temperatures, both through the lag effect and from solar heating. For sites where wind speed decreases with increasing daytime temperature, thermometer screen temperatures may consequently show larger uncertainties at the higher temperatures. Under strong direct beam solar radiation (>850W m−2) the radiation effect is likely to be <0.4◦C. Copyright c 2011 RoyalMeteorological Society