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PloS One 2017The first aim of this research was to assess the effectiveness, in terms of emotional and behavioral reactions, of moderately vs. highly TVWs (Threatening Visual...
The influence of threatening visual warnings on tobacco packaging: Measuring the impact of threat level, image size, and type of pack through psychophysiological and self-report methods.
The first aim of this research was to assess the effectiveness, in terms of emotional and behavioral reactions, of moderately vs. highly TVWs (Threatening Visual Warnings) displayed on tobacco packs. Given the key role that emotional reactions play in explaining the effect of TVWs on behaviors, psychophysiological and self-report methods were used-for the first time in this context-to measure the emotions provoked by TVWs. The second aim of this research was to determine whether increasing the size of warnings, and their display on plain packaging (compared with branded packaging) would improve their effectiveness. A within-subjects experiment was conducted. Three variables were manipulated: health warning threat level (high vs. moderate), image size (40% vs. 75%) and pack type (plain vs. branded). A convenience sample of 48 French daily smokers participated. They were exposed to eight different packs of cigarettes in a research lab at the University of Rennes. Smokers' emotions and behavioral intentions were recorded through self-reports. Emotions were also evaluated using psychophysiological measurements: electrodermal activity and facial electromyography. The results revealed that TVWs with a high threat level are the most effective in increasing negative emotions (fear, disgust, valence, arousal) and behavioral intentions conducive to public health (desire to quit, etc.). They also highlight the appeal of increasing the size of the warnings and displaying them on plain packs, because this influences emotions, which is the first step toward behavioral change. Increasing the threat level of TVWs from moderate to high seems beneficial for public health. Our results also confirm the relevance of recent governmental decisions to adopt plain packaging and larger TVWs (in the UK, France, Ireland, Canada, New Zealand, Hungary, etc.).
Topics: Adult; Attention; Attitude to Health; Drug Packaging; Emotions; Female; France; Humans; Male; Middle Aged; Product Labeling; Product Packaging; Self Report; Smoking; Smoking Prevention; Nicotiana; Young Adult
PubMed: 28910317
DOI: 10.1371/journal.pone.0184415 -
PloS One 2022High-dimensional LASSO (Hi-LASSO) is a powerful feature selection tool for high-dimensional data. Our previous study showed that Hi-LASSO outperformed the other...
High-dimensional LASSO (Hi-LASSO) is a powerful feature selection tool for high-dimensional data. Our previous study showed that Hi-LASSO outperformed the other state-of-the-art LASSO methods. However, the substantial cost of bootstrapping and the lack of experiments for a parametric statistical test for feature selection have impeded to apply Hi-LASSO for practical applications. In this paper, the Python package and its Spark library are efficiently designed in a parallel manner for practice with real-world problems, as well as providing the capability of the parametric statistical tests for feature selection on high-dimensional data. We demonstrate Hi-LASSO's outperformance with various intensive experiments in a practical manner. Hi-LASSO will be efficiently and easily performed by using the packages for feature selection. Hi-LASSO packages are publicly available at https://github.com/datax-lab/Hi-LASSO under the MIT license. The packages can be easily installed by Python PIP, and additional documentation is available at https://pypi.org/project/hi-lasso and https://pypi.org/project/Hi-LASSO-spark.
Topics: APACHE; Drug Packaging; Gene Library; Libraries
PubMed: 36455001
DOI: 10.1371/journal.pone.0278570 -
Indian Journal of Ophthalmology Apr 2022Patient safety errors can arise due to similarity in packaging of medications. We aimed to describe the clinical features of patients presenting with accidental...
PURPOSE
Patient safety errors can arise due to similarity in packaging of medications. We aimed to describe the clinical features of patients presenting with accidental application of joint pain liniments and gum lotion in the eye due to confusion arising from similarity in packaging.
METHODS
This was a retrospective case series with eight consecutive patients presenting from December 2020 to August 2021 with history of accidental application of joint pain liniments or gum lotion in the eye instead of eye drops. All patients underwent visual acuity assessment and slit-lamp examination with fluorescein staining of the cornea to look for corneal involvement and was reassessed till complete resolution.
RESULTS
Of the eight patients, three were males and five were females. Seven had accidentally applied joint pain liniment, while one had applied gum lotion into the eye. Five of them had corneal involvement ranging from punctate erosions to near-total epithelial defects. Two patients needed referral to a tertiary center and hospital admission. Treatment duration ranged from 2 days to 1 month. Two patients were lost to follow-up.
CONCLUSION
This study highlights patient safety errors arising from confusion of medication due to similar labeling and packaging of different drugs. While there was no permanent morbidity, such confusions lead to needless discomfort and waste of time, money, and effort for the patient as well as the health-care system.
Topics: Arthralgia; Drug Packaging; Female; Humans; Liniments; Male; Medication Errors; Retrospective Studies
PubMed: 35326006
DOI: 10.4103/ijo.IJO_2328_21 -
Drug Safety Oct 2018This article provides an overview of the current situation regarding the traceability of medicinal products, with a focus on drug safety and biologics. Limited...
This article provides an overview of the current situation regarding the traceability of medicinal products, with a focus on drug safety and biologics. Limited traceability of biologics, in particular with regard to the batch number, is associated with incomplete recording of exposure information in clinical practice. The current pharmaceutical barcode standards in the EU do not support the automatic recording of dynamic product information, such as batch numbers and expiry dates, by means of electronic barcode scanning in clinical practice. New barcode requirements, such as the 2D DataMatrix with encoded batch numbers and expiry dates, provided on both the primary and the secondary package, can facilitate routine barcode scanning at all points in the supply chain in different healthcare settings. To build a full track-and-trace system for medicines with electronic capture of relevant exposure information, alignment with other topics, such as the Falsified Medicines Directive and initiatives to reduce medication errors, is needed to increase the buy-in from all stakeholders and to solve multiple issues with a joint effort.
Topics: Biological Products; Counterfeit Drugs; Drug Labeling; Drug Packaging; Electronic Data Processing; Humans; Medication Errors
PubMed: 29721822
DOI: 10.1007/s40264-018-0678-7 -
Analytical Chemistry Aug 2018Single-use technologies (SUTs) are widely used during biopharmaceutical manufacture as disposable bioreactors or media and buffer storage bags. Despite their advantages,...
Single-use technologies (SUTs) are widely used during biopharmaceutical manufacture as disposable bioreactors or media and buffer storage bags. Despite their advantages, the risk of release of extractable and leachable (E&Ls) substances is considered an important drawback in adopting disposables in the biomanufacturing process. E&Ls may detrimentally affect cell viability or productivity or may persist during purification and present a risk to the patient if remaining in the final drug product. In this study, 34 plastic films from single-use bags (SUBs) for cell cultivation were extracted with selected solvents that represent reasonable worst-case conditions for most typical biomanufacturing applications. SUBs were incubated at small-scale under accelerated-aging conditions that represented standard operational conditions of use. Leachables analysis was performed following dispersive liquid-liquid microextraction (DLLME) for analyte preconcentration and removal of matrix interference. Resulting extracts were characterized by GC-headspace for volatiles, high resolution GC-Orbitrap-MS/MS for semivolatiles, high resolution LC-Orbitrap-MS/MS for nonvolatiles, and ICP-MS for trace elemental analysis. Multivariate statistical analysis of the analytical data revealed significant correlations between the type and concentration of compounds and bags features including brand, manufacturing date and polymer type. The analytical data demonstrates that, over recent years, the nature of E&Ls has been altered due to the implementation of manufacturing changes and new types of polymers and may change further with the future advent of regulations that will limit or ban the use of certain raw materials and additives. The broad E&L database generated herein facilitates toxicological assessments from a biomanufacturing standpoint and provides practical guidelines for confident determination of E&Ls to enable screening and elimination of nonsatisfactory films for single use bioprocessing.
Topics: Biological Products; Chromatography, Liquid; Drug Contamination; Drug Packaging; Equipment Design; Gas Chromatography-Mass Spectrometry; Humans; Liquid Phase Microextraction; Mass Spectrometry; Plastics; Solvents; Tandem Mass Spectrometry; Volatile Organic Compounds
PubMed: 29943976
DOI: 10.1021/acs.analchem.8b01208 -
Diving and Hyperbaric Medicine Jun 2018It has been our institution's policy to not place glass medication ampoules inside our hyperbaric chamber for fear of rupture. There is only a small and conflicting...
INTRODUCTION
It has been our institution's policy to not place glass medication ampoules inside our hyperbaric chamber for fear of rupture. There is only a small and conflicting amount of data as to whether glass ampoules are safe for use under hyperbaric conditions.
OBJECTIVES
The primary objective of this study was to test the safety and usability of glass medication ampoules inside a hyperbaric chamber.
METHODS
Repetitive, rapidly staged compressions and decompressions were performed on multiple different glass medications ampoules inside the medical lock of a medical hyperbaric chamber. Medication ampoules of varying sizes (1 ml to 10 ml) of medication that may be required in a hyperbaric emergency were assessed. The ampoules were rapidly compressed 100 times to pressures of 142 kPa, 183 kPa, 300 kPa, 405 kPa and 507 kPa. They were then dropped from a height of 30 cm while compressed at 507 kPa and then half the ampoules were opened while pressurized at 507 kPa.
RESULTS
No ampoules were broken during compression or decompression. No ampoules broke when dropped from 30 cm onto the chamber floor. All ampoules opened at a pressure of 507 kPa functioned normally. No lids/ampoules shattered upon opening.
CONCLUSION
This study suggests that glass medication ampoules appear to be safe for use inside a medical hyperbaric chamber at routine treatment pressures.
Topics: Drug Packaging; Emergencies; Glass; Humans; Hyperbaric Oxygenation; Pressure
PubMed: 29888383
DOI: 10.28920/dhm48.2.107-109 -
PloS One 2022With the growing concerns about research reproducibility and replicability, the assessment of scientific results' fragility (or robustness) has been of increasing...
With the growing concerns about research reproducibility and replicability, the assessment of scientific results' fragility (or robustness) has been of increasing interest. The fragility index was proposed to quantify the robustness of statistical significance of clinical studies with binary outcomes. It is defined as the minimal event status modifications that can alter statistical significance. It helps clinicians evaluate the reliability of the conclusions. Many factors may affect the fragility index, including the treatment groups in which event status is modified, the statistical methods used for testing for the association between treatments and outcomes, and the pre-specified significance level. In addition to assessing the fragility of individual studies, the fragility index was recently extended to both conventional pairwise meta-analyses and network meta-analyses of multiple treatment comparisons. It is not straightforward for clinicians to calculate these measures and visualize the results. We have developed an R package called "fragility" to offer user-friendly functions for such purposes. This article provides an overview of methods for assessing and visualizing the fragility of individual studies as well as pairwise and network meta-analyses, introduces the usage of the "fragility" package, and illustrates the implementations with several worked examples.
Topics: Drug Packaging; Network Meta-Analysis; Reproducibility of Results
PubMed: 35648746
DOI: 10.1371/journal.pone.0268754 -
Yakugaku Zasshi : Journal of the... 2015Recently, there has been a transition from glass to plastic injection containers in Japan. In our previous study, we suggested that plastic containers had less impurity... (Review)
Review
Recently, there has been a transition from glass to plastic injection containers in Japan. In our previous study, we suggested that plastic containers had less impurity contamination than glass containers. However, the use of some plasticizers has been limited because of their endocrine disrupting effects. Therefore, contamination has been a concern due to chemicals in injection solution packed with plastic containers. Indeed, in our recent study, photoinitiators were detected in an injection solution coming from plastic containers. Photoinitiators mainly exist in ink. We therefore speculated that ink originating from a photoinitiator directly printing on plastic containers had migrated into the injection solutions. In a clinical setting, plastic containers are very tractable because they are lightweight and less breakable. On the other hand, from a safety view point, these containers may be hazardous because of permeation by steam, ambient air or photoinitiators. In the present symposium, we will discuss the risk of photoinitiators leaking into injection solution packed with plastic containers, and countermeasures to avoid this risk.
Topics: Cell Survival; Drug Contamination; Drug Packaging; Endocrine Disruptors; Humans; Pharmaceutical Solutions; Photochemical Processes; Plastics
PubMed: 25747222
DOI: 10.1248/yakushi.14-00228-6 -
Human Factors Dec 2016Our aim was to test if highlighting and placement of substance name on medication package have the potential to reduce patient errors.
OBJECTIVE
Our aim was to test if highlighting and placement of substance name on medication package have the potential to reduce patient errors.
BACKGROUND
An unintentional overdose of medication is a large health issue that might be linked to medication package design. In two experiments, placement, background color, and the active ingredient of generic medication packages were manipulated according to best human factors guidelines to reduce causes of labeling-related patient errors.
METHOD
In two experiments, we compared the original packaging with packages where we varied placement of the name, dose, and background of the active ingredient. Age-relevant differences and the effect of color on medication recognition error were tested. In Experiment 1, 59 volunteers (30 elderly and 29 young students), participated. In Experiment 2, 25 volunteers participated.
RESULTS
The most common error was the inability to identify that two different packages contained the same active ingredient (young, 41%, and elderly, 68%). This kind of error decreased with the redesigned packages (young, 8%, and elderly, 16%). Confusion errors related to color design were reduced by two thirds in the redesigned packages compared with original generic medications.
CONCLUSION
Prominent placement of substance name and dose with a band of high-contrast color support recognition of the active substance in medications.
APPLICATION
A simple modification including highlighting and placing the name of the active ingredient in the upper right-hand corner of the package helps users realize that two different packages can contain the same active substance, thus reducing the risk of inadvertent medication overdose.
Topics: Adult; Age Factors; Aged; Color Perception; Drug Labeling; Drug Packaging; Humans; Pattern Recognition, Visual; Recognition, Psychology; Young Adult
PubMed: 27591209
DOI: 10.1177/0018720816664824 -
Clinical Medicine (London, England) 2002Patient safety has been an under-recognised and under-researched concept until recently. It is now high on the healthcare quality agenda in many countries of the world...
Patient safety has been an under-recognised and under-researched concept until recently. It is now high on the healthcare quality agenda in many countries of the world including the UK. The recognition that human error is inevitable in a highly complex and technical field like medicine is a first step in promoting greater awareness of the importance of systems failure in the causation of accidents. Plane crashes are not usually caused by pilot error per se but by an amalgam of technical, environmental, organisational, social and communication factors which predispose to human error or worsen its consequences. In healthcare, the systematic investigation of error in the administration of medication will often reveal similarly complex causation. Experience and research from other sectors, in particular the airline industry, show that the impact of human error can be reduced if the necessary work is put in to detect and then remove weaknesses and vulnerabilties in the system. The NHS is putting in place a comprehensive programme to learn more effectively from adverse events and near misses. This aims to reduce the burden of the estimated 850,000 adverse events which occur in hospitals each year as well as targeting high risk areas such as medication error.
Topics: Awareness; Drug Labeling; Drug Packaging; Humans; Medical Errors; Risk Management; Safety Management; United Kingdom
PubMed: 12448595
DOI: 10.7861/clinmedicine.2-5-452