Faster, more accurate, more confident? An exploratory experiment on soccer referees' yellow card decision-making.

This study aimed to examine how soccer referees make decisions about issuing yellow cards for fouls. The research involved 60 male participants, divided into expert (n=30) and novice (n=30) groups based on their experience and qualifications as referees. They took part in a 2×2×2 mixed-design experiment. The study looked at Decision-Making Style (DMS: Analytical Decision-Making [ADM] vs. Intuitive Decision-Making [IDM]), Video Type (yellow card foul vs. non-yellow card foul), and Referee Level (expert vs. novice) as independent variables. The dependent variables were accuracy rate (ACC), discrimination index (D), self-confidence index (C), and overconfidence index (OC). The findings showed that Analytical Decision-Making (ADM) led to higher accuracy compared to Intuitive Decision-Making (IDM). Expert referees demonstrated better accuracy than novice referees. There was also an interaction between Decision-Making Style and Referee Level, showing differences in the effectiveness of ADM and IDM between expert and novice referees. Additionally, the study revealed that both expert and novice referees showed overconfidence, with experts demonstrating significantly higher overconfidence, particularly during IDM. In conclusion, the research highlighted the complexity of referees' decision-making in high-pressure situations and emphasized the potential benefits of employing Analytical Decision-Making strategies. The study contributed to understanding cognitive biases in sports officiating and suggested the need for targeted training programs to help referees improve their performance and reduce overconfidence in challenging situations.

Temporal features of goals, substitutions, and fouls in football games in the five major European league from 2018 to 2021.

The "Big Five" European football leagues, comprising England's Premier League, Germany's Bundesliga, Spain's La Liga, Italy's Serie A, and France's Ligue 1, command significant attention. While the occurrence of goals, substitutions, and fouls in football games is often considered random, of the presence of an inherent inevitability is unclear. To investigate, we analyzed a public dataset detailing timing of goals, substitutions, and yellow cards in regular time from WhoScored across three seasons (2018-2019, 2019-2020, 2020-2021) in the top five European football leagues. We employed various mathematical descriptive models (including linear, sigmoid, and gaussian functions) to measure the temporal tendency of goals, substitutions, and yellow cards. Our results indicate that, whether in the first or second half of the match, the temporal distribution of these elements exhibits evenness a (indicative of randomness). However, specific characteristics were discerned through distinct model parameters, capturing novel phenomena that were intuitively illustrated. Furthermore, we explored the interaction of the timing of goals, substitutions, and yellow cards. In this analysis we found that scoring in the second half leads to more substitutions and yellow cards. Changing players in the second half corresponded with more goals, while the impact of yellow card fouls showed no differences in goals in the first and second halves. Our research is the first to systematically study the laws of modern football matches, providing valuable guidance and reference for many football coaches.

899 serious adverse events including 13 deaths, 7 strokes, 211 thromboembolic events, and 482 immune reactions: The untold story of cyanoacrylate adhesive closure.

OBJECTIVE: The aim was to retrieve and analyse the serious adverse events of venous occlusion systems used in cyanoacrylate adhesive closure (CAC) submitted to regulatory agencies. METHODS: The Total Product Life Cycle (TPLC) database of the US Food and Drug Administration (FDA), the Database of Adverse Event Notifications (DAEN) of the Australian Therapeutic Goods Administration (TGA), and the Yellow Card database of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were reviewed. Three Freedom of Information (FOI) requests had to be submitted to the MHRA to obtain data. RESULTS: The TPLC contained 899 reports which included 13 cases of death, 7 strokes, 211 thromboembolic events, and 482 immune reactions. The DAEN recorded three reportable adverse events, and the MHRA recorded seven adverse incidents including one death. CONCLUSION: CAC is associated with serious adverse events including death. These events are under-reported in the medical literature and only sub-optimally reported to the regulatory agencies.

Assessing and further developing age-appropriate information for young people about reporting suspected adverse drug reactions.

AIMS: The Medicines and Healthcare products Regulatory Agency Yellow Card scheme (YCS) is the UK's system that collects spontaneous reports about suspected adverse drug reactions (ADRs). Reporting of suspected ADRs by young people (age <19 years) in the UK is extremely uncommon, driving efforts to improve awareness and reporting. METHODS: Quality improvement project, using an anonymous online survey about updated information for young people, distributed through school pupils (age 13-18 years) across the UK through the Alder Hey Research Ambassador programme. RESULTS: Research Ambassadors were recruited in 21 schools and colleges, generating 2933 responses (15 November 2022-08 April 2023); 6.3% of respondents had heard of the YCS, and 0.8% had previously reported a Yellow Card. There were 307 suspected drug-event combinations reported, 36 of which required attendance at hospital. The updated YCS reporting guide was understood by 92.8% of young people, and 90.8% reported knowing more about ADRs after reading the guide. The percentage of young people 'Not comfortable' reporting a suspected ADR decreased from 13.3% (before reading) to 4.1% after reading (P < .000001), and 84.5% of young people reported willingness to report a side effect in the future. The most common comments regarding further improvement of the information were content, or length of the text could be altered in some way (n = 543, 26.1%) and graphic design could be improved (n = 357, 17.2%). CONCLUSIONS: The age-appropriate information provided met many of their needs, increasing willingness to report. Integration into existing education curricula in the UK would facilitate knowledge transfer and improve reporting.

Angiotensin II receptor blockers (ARBs) and manufacturing contamination: A retrospective National Register Study into suspected associated adverse drug reactions.

AIMS: The aim of this study was to determine if any suspected adverse drug reactions (ADRs) observed with the use of angiotensin II receptor blockers (ARBs) could be linked to either (a) their unique respective physicochemical and pharmacological profiles and (b) the recently disclosed suspected carcinogenic manufacturing contaminants found in certain sartan drug class batches. METHODS: The pharmacology profiles of ARBs were data-mined from the Chemical Database of bioactive molecules with drug-like properties, European Molecular Biology Laboratory (ChEMBL). Suspected ADR data (from 01/2016-10/2022, inclusive) and prescribing rates of ARBs over a 5-year prescribing window (from 09/2016 to 08/2021, inclusive) were obtained via analysis of the United Kingdom Medicines and Healthcare products Regulatory Authority (MHRA) Yellow Card drug analysis profile and Open prescribing databases, respectively. RESULTS: The overall suspected ADRs and fatalities per 100 000 prescriptions identified across the ARBs studied were found to be different between the sartan drug class members (chi-squared test, P < .05). There is a greater relative rate of reports for valsartan across all investigated organ classes of ADRs, than other ARBs, despite valsartan's more limited pharmacological profile and similar physicochemical properties to other sartans. The disparity in ADR reporting rates with valsartan vs other ARBs could be due to the dissimilarity in formulation excipients, patient factors and publicity surrounding batch contaminations, amongst others. Cancer-related ADRs and fatalities per 100 000 prescriptions identified across the ARBs studied are not statistically significant (chi-squared test, P > .05) based on the datasets used over the 5-year period. CONCLUSION: No connection between ARB pharmacology and their suspected ADRs could be found. No conclusion between sartan batch contaminations and increased suspected cancer-related ADRs was found.

A Comparative Safety Analysis of Medicines Based on the UK Pharmacovigilance and General Practice Prescribing Data in England.

BACKGROUND/AIM: Adverse drug reactions (ADRs) represent a major concern leading to significant increases in both morbidity and mortality globally. Providing healthcare professionals (HCPs) and patients with real-world data on drug safety is imperative to facilitate informed decision-making. The study aimed to determine the feasibility of creating comparative safety charts for medicines by mapping ADR reporting onto prescribing data. MATERIALS AND METHODS: Data on serious and fatal ADR reports from the Yellow Card database was mapped onto general practice prescription data in England. The rate of serious and fatal ADR reports per million items prescribed was calculated for commonly-prescribed medicines. RESULTS: Quantitative comparative analyses for 137 medicines belonging to 26 therapeutic classes were conducted. Significant differences were observed within most therapeutic classes for the rate of serious and fatal ADR reports per prescribing unit. CONCLUSION: Despite the limitations of ADR reporting and prescribing databases, the study provides a proof-of-concept for the feasibility of mapping ADR reporting onto prescribing data to create comparative safety charts that could support evidence-based decision-making around formulary choices.

Identifying and managing adverse drug reactions: Qualitative analysis of patient reports to the UK yellow card scheme.

INTRODUCTION: Adverse drug reactions (ADRs) can have significant negative impact on peoples' daily lives, with physical, economic, social and/or psychological effects. Patient reporting of ADRs has been facilitated by pharmacovigilance systems across Europe. However, capturing data on patients' experiences of ADRs has proved challenging. Existing patient reports to the UK Yellow Card Scheme contain free-text comments which could be useful sources of information. OBJECTIVES: To investigate patients' experiences of ADRs and their impact on patients as described in free-text data within patient Yellow Card (YC) reports submitted to the Medicines and Healthcare products Regulatory Agency. METHODS: A qualitative review of narrative texts was conducted on free-text data from 2255 patient YC reports from July to December 2015. RESULTS: Three key narrative themes emerged from analysis of the free-text data in 2255 reports: (1) identification of ADRs, (2) severity and impact of ADRs, and (3) management of ADRs. Temporal associations were the most common method of identification followed by differential diagnoses and confirmation with information sources such as healthcare professionals (HCPs). A combination of explicit and implicit impacts were described: physical, psychological, economic and social effects often persisted and caused serious disruption to many patients' lives. A range of strategies were used to manage ADRs, including consultation with HCPs, stopping/reducing the medicine or taking medicines to alleviate symptoms. CONCLUSION: Free-text data from YC reports has been an underutilised resource to date, but this research has confirmed its potential value to pharmacovigilance and medication safety research.

Public awareness in Wales of the UK Yellow Card scheme for reporting suspected adverse drug reactions.

We used the HealthWise Wales (HWW) platform to explore public knowledge about the UK Yellow Card scheme (YCS), the spontaneous reporting scheme for suspected adverse drug reactions (ADRs) and whether a short information video could improve awareness. Members of the public in Wales (n = 1606) completed a questionnaire about the YCS, watched the information video and then completed a follow-up questionnaire. Almost half (46.5%) of respondents said they had previously experienced an ADR (>90% of the ADRs involving prescribed medicines). Before the video, 18% of respondents knew how to report an ADR via the YCS and of these, 34% were from allied-health professions. Immediately after watching it, 71% participants reported knowing how to report and 82% reported being confident to report. If this awareness were maintained, such an approach could contribute to improved reporting of suspected ADRs by the public.

Corrigendum: Close to a Decade of Decrease in Antimicrobial Usage in Danish Pig Production-Evaluating the Effect of the Yellow Card Scheme.

[This corrects the article DOI: 10.3389/fvets.2020.00109.].

Relevance of physicochemical properties and functional pharmacology data to predict the clinical safety profile of direct oral anticoagulants.

Direct oral anticoagulants (DOACs) have rapidly become the drug class of choice for anticoagulation therapy in secondary care. It is known that gastrointestinal hemorrhage are potential side effects of the DOAC drug class. In this study we have investigated the relevance of molecular structure and on/off-target pharmacology as a predictor of adverse drug reactions (ADRs) for the DOAC drug class. Use of the Reaxys MedChem module allowed for data mining of all possible reported off-target effects of the DOAC class members. For the first time, the MHRA Yellow card database in combination with prescribing rates in the United Kingdom (data for n = 30 566 936 DOAC Rx (up to 2017) and ADR data n = 22 275 (up to 2018)) were used for our data comparison of DOACs. From the underlying reported data, we were able to rank the DOACs in terms of the likely adverse events we would expect to observe. We identified potential risks of ADRs based on the DOACs pharmacology including the expected GI hemorrhage, but also the unexpected risk of stroke, pulmonary embolism and kidney injury. Statistically significant (P < .001) differences were found between all DOACs and their total number of ADRs. Although the risks are small, strong statistical correlation between observed pharmacology and national ADR data is observed in three out of the five areas of concern.

Close to a Decade of Decrease in Antimicrobial Usage in Danish Pig Production-Evaluating the Effect of the Yellow Card Scheme.

The emergence and dissemination of antimicrobial resistant pathogens have led to rising concern about the widespread and excessive use of antimicrobials in veterinary medicine. Denmark has implemented several initiatives to reduce antimicrobial use in animals since the 90s, with the Yellow Card scheme implemented in 2010. The aim of the present study is to investigate the effects on antimicrobial use in Danish pig farms of changes in the legislation regarding the Yellow Card, based on analysis of temporal trends in monthly antimicrobial consumption calculated at herd-level from 2010 to 2017. A dynamic linear model with a linear growth component was used to model the data. The percentage of herds with a negative growth component and a significant decline below zero (based on 95% credible intervals) was assessed for the entire study period. The analysis was run separately for the different age groups within each farm: weaners (up to 30 kg), sows and finishers herds, and categorized according to antimicrobial use before the Yellow Card initiative (2008-2009), as groups of herds with "low," "moderate," or "high" consumption. The results evidence a decline of the antimicrobial consumption in Danish pig herds, more pronounced during two periods: with the introduction of the Yellow Card and in relation to the announcements and changes in the legislation in 2014. Weaner herds in the high consumption category had the highest percentage of herds with a negative growth component, reaching 82% of herds in January 2011, followed by weaner herds with moderate antimicrobial consumption reaching 71% of herds in October 2012. For finisher herds in the moderate consumption category, the proportion with a negative growth increased from 38% in January 2010 to 71% in July 2011. A decline in antimicrobial consumption was also evident after announcements and changes in the legislation in 2014, particularly for sows and finishers. Our findings suggest that changes in the Yellow Card scheme promoted a continuous reduction in antimicrobial use in Danish pig herds, particularly in herds with high antimicrobial consumption.

Making medicines safer: analysis of patient reports to the UK's Yellow Card Scheme.

Objectives: No studies describing UK patient Yellow Card reports have been published since the evaluation of the first two years of direct patient reporting (2005-7), when 5,180 reports were analyzed.Methods: Patient Yellow Card reports submitted July-December 2015 for vaccines and other drugs were analyzed. Comparisons to the initial evaluation were made of: reporting method, number of suspect drugs, proportion classed as serious. Factors affecting seriousness of reports were examined.Results: There were 3,060 patient Yellow Card reports analyzed. Vaccine reports have increased from very few in 2005-7 to 25% of reports. The proportion of reports citing one drug (94.3%) and the proportion considered serious (70.3%) increased from the 84% and 58% respectively found in 2005-7. The main method of reporting had changed from paper (61%) to internet (88.5%). Serious reports were more common in females, for vaccines in young persons, but in adults for other drugs, and included more reaction terms than non-serious reports.Conclusion: Patient reporting, in particular to vaccines, has increased dramatically since 2005-7. Increases in the proportion of reports concerning one drug and the proportion considered serious could indicate that the usability of patient reports may have improved in comparison to early reporting.

Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada.

Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product. However, such prescriptions are carried out in a controlled manner. Prior to being approved, the medicinal product will have been evaluated in a population pool containing fewer than 5,000 patients and in a predesigned environment where several factors may be lacking, such as the absence of women of childbearing potential, geriatric patients and paediatric patients. Therefore, it is not surprising that several major adverse drug reactions are detected only when the product has been prescribed to the general population. National and international regulatory bodies have devised systems for monitoring medicinal products after marketing, commonly known as postmarketing surveillance systems. Postmarketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. The primary purpose for conducting postmarketing surveillance is to identify previously unrecognized adverse effects as well as positive effects. The Yellow Card scheme, practiced in the United Kingdom and the Canada Vigilance Program adopted in the Canadian jurisdiction, are two of the most successful postmarketing surveillance systems implemented across the world. Therefore, this article intends to discuss postmarketing surveillance and its role in the context of the United Kingdom and Canadian jurisdictions with a view on presenting key aspects and measures that are employed for operating an efficient postmarketing surveillance system in regulated markets.

Adverse drug reaction reporting by community pharmacists-The barriers and facilitators.

PURPOSE: The United Kingdom's "Yellow Card Scheme" for reporting of adverse drug reactions (ADRs) has been operating for 50 years, but reporting rates by community pharmacists remain low. The aim of the study was therefore to investigate the views and experiences of ADR reporting by community pharmacists in Wales, with a particular focus on the potential barriers and facilitators to reporting. METHODS: Following ethics approval and piloting, a self-complete questionnaire was mailed to all registered community pharmacies in Wales, UK (n = 713). A follow-up mailing was sent to nonresponders after 2 weeks. RESULTS: A response rate of 52% (n = 372) was achieved, of whom 57% had never submitted a yellow card. Key barriers to reporting were not seeing ADRs, difficulty identifying the causative drug, not being sure which ADRs to report, and lack of time. Key facilitators were being able to report through dispensary software and having clearer guidelines about what to report. Differences between those who had previously reported ADRs and those who had not suggested lack of confidence and uncertainty about what to report were more of a barrier for nonreporters. Conversely, reporters wanted feedback on reports, ability to keep reports on their dispensary records, and remuneration to aid them with reporting. CONCLUSIONS: While the respondents generally expressed positive attitudes towards ADR reporting, a number of barriers and potential facilitators were nevertheless identified. Clearer support and guidance for reporting, such as through a "champions" scheme similar to that run in Welsh hospitals, may help current nonreporters to engage.

Is There a Potential of Misuse for Venlafaxine and Bupropion?

Objective: Traditionally, studies on the non-medical use of pharmaceutical products have focused on controlled substances; e.g., opiates/opioids; and benzodiazepines. Although both bupropion and venlafaxine have been reported as being misused, only anecdotal reports have been made available so far. Hence, the European Monitoring Agency (EMA) Adverse Drug Reactions (ADRs), misuse/abuse/dependence and withdrawal, venlafaxine- and bupropion-related, database was here analyzed. Methods: All EMA spontaneous reports relating to venlafaxine (2005-2016) and bupropion (2003-2016) notifications were here analyzed, to provide a descriptive analysis by source, gender, age, and type of report. The UK-based, 2000-2016, Yellow Card Scheme pharmacovigilance database, bupropion and venlafaxine withdrawal reports were compared as well with those pertaining to fluoxetine and paroxetine. Results: Out of 20,720 (bupropion) and 47,516 (venlafaxine) total number of ADRs, some 2,232 (10.8%), and 4,071 (8.5%) misuse/abuse/dependence ADRs were respectively associated with bupropion and venlafaxine. Conversely, bupropion withdrawal-related ADRs were here reported in 299/20,720 (1.44%) cases and in 914/47,516 (1.92%) cases for venlafaxine. Overall, all bupropion and venlafaxine misuse-/abuse-/dependence- and withdrawal-ADRs were related to a respective number of 264 and 447 patients. According to the Proportional Reporting Ratio (PRR) computation, in comparison with venlafaxine bupropion resulted to be more frequently misused/abused (PRR: 1.50), but less frequently associated with both dependence (PRR: 0.92) and withdrawal (PRR: 0.77) issues. Yellow Card Scheme data suggested that paroxetine and venlafaxine, in comparison with fluoxetine and bupropion, were associated with higher number of withdrawal-related reports. Conclusions: The dopaminergic, stimulant-like, bupropion activities may be associated with its possible recreational value. Present data may confirm that the occurrence of a withdrawal syndrome may be a significant issue for venlafaxine-treated patients.

Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms.

AIM: Different forms and online tools are available in different countries for spontaneous reporting, one of the most widely used methods of pharmacovigilance. Capturing sufficient information and adequate compatibility of online systems with respective reporting form is highly desirable for appropriate reporting of adverse drug reactions (ADRs). This study was aimed to compare three major online reporting systems (US, UK, and WHO) of the world and also to check their compatibility with the respective ADR reporting form. MATERIALS AND METHODS: A total of 89 data elements to provide relevant information were found out from above three online reporting systems. All three online systems were compared regarding magnitude of information captured by each of them and scoring was done by providing a score of "1" to each element. Compatibility of ADR reporting forms of India (Red form), US (Form 3500), and UK (Yellow card form) was assessed by comparing the information gathered by them with that can be entered into their respective online reporting systems, namely, "VigiFlow," "US online reporting," and "Yellow card online reporting." Each unmatching item was given a score of "-1". RESULTS: VigiFlow scored "74" points, whereas online reporting systems of the US and UK scored "56" and "49," respectively, regarding magnitude of the information gathered by them. Compatibility score was found to be "0," "-9," and "-26" in case of ADR reporting systems of US, UK, and India, respectively. CONCLUSION: Our study reveals that "VigiFlow" is capable of capturing the maximum amount of information but "Form 3500" and "Online reporting system of US" are maximally compatible to each other among ADR reporting systems of all three countries.

Adverse drug reactions: classification, susceptibility and reporting.

Adverse drug reactions (ADRs) are increasingly common and are a significant cause of morbidity and mortality. Historically, ADRs have been classified as type A or type B. Type A reactions are predictable from the known pharmacology of a drug and are associated with high morbidity and low mortality. Type B reactions are idiosyncratic, bizarre or novel responses that cannot be predicted from the known pharmacology of a drug and are associated with low morbidity and high mortality. Not all ADRs fit into type A and type B categories; therefore, additional categories have been developed. These include type C (continuing), type D (delayed use), and type E (end of use) reactions. Susceptibility to ADRs is influenced by age, gender, disease states, pregnancy, ethnicity and polypharmacy. Drug safety is reliant on nurses and other healthcare professionals being alert to the possibility of ADRs, working with patients to optimise medicine use and exercising vigilance in the reporting of ADRs through the Yellow Card Scheme.

An observational study to compare the contents and quality of information furnished in CDSCO ADR reporting form, yellow card, medwatch and blue form by the healthcare professionals.

BACKGROUND: Spontaneous adverse drug reaction (ADR) reporting form is a vital tool for collecting information about ADRs, which helps in establishing the causal assessment and generating a signal. This is feasible if quality information is translated into the reporting form by health care professional (HCPs). Hence, present study was carried out to compare efficiency of HCPs in translating suspected ADR information in the spontaneous reporting forms and to compare the ADR reporting forms of different countries and their duration of training in pharmacovigilance. METHODS: In a cross-sectional study, 50 doctors, 50 Nurses and 50 Pharmacists were asked to fill different reporting forms (CDSCO form, Medwatch, Yellow card and the Blue form) using different simulated ADR case reports. Filled forms were analysed for their contents, information captured and time taken to fill these forms. They were also asked about their training and exposure to pharmacovigilance related activities. RESULTS: All the spontaneous ADR reporting forms had 24-26 data elements to furnish information. Information regarding dechallenge was lacking in the Yellow card and Blue form. Blue form also lacked the information on rechallenge. Overall nurses took longer time to fill all the ADR reporting forms as compared to the doctors and pharmacists. Majority of HCPs missed to fill reporter's information in all the forms. CONCLUSION: Study suggested that the quality of information translated by the HCPs needs improvement for which they should be sensitized periodically on the basic elements of pharmacovigilance.

Views of British community pharmacists on direct patient reporting of adverse drug reactions (ADRs).

PURPOSE: To survey British community pharmacists' views and practices concerning direct patient reporting of ADRs. METHODS: Cross-sectional postal survey of community pharmacists in Britain RESULTS: Of 1096 questionnaires distributed, 297 usable responses were obtained, (27.1%). Respondents' estimates of the frequency of patients reporting a suspected ADR to them had a median of 1.0 per month. Almost a fifth of respondents (19.6%) do not specifically ask patients about ADRs, and 38.7% do not encourage patients to report. Only 18.5% displayed a poster promoting the YC Scheme in their pharmacy, but 57.9% claimed to have patient YCs available. A quarter (24.9%) of respondents considered that ADR reporting should be restricted to health professionals and 14.4% considered that patients were not at all capable of identifying ADRs. CONCLUSIONS: The low response rate and overall results suggest that British community pharmacists may lack interest in and do not promote direct patient reporting. Increased awareness of the benefits and mechanisms of patient reporting may be required to ensure that pharmacists can provide the necessary support to facilitate patient reporting.