Leveraging FAERS and Big Data Analytics with Machine Learning for Advanced Healthcare Solutions

This research study explores the potential of leveraging the FDA Adverse Event Reporting System (FAERS), combined with big data analytics and machine learning techniques, to enhance healthcare solutions. FAERS serves as a comprehensive database maintained by the U.S. Food and Drug Administration (FDA), encompassing reports of adverse events, medication errors, and product quality issues associated with diverse drugs and therapeutic interventions.By harnessing the power of big data analytics applied to the vast information within FAERS, healthcare professionals and researchers gain valuable insights into drug safety, discover potential adverse reactions, and uncover patterns that may not have been discernible through traditional methods. Particularly, machine learning plays a pivotal role in processing and analyzing this extensive dataset, enabling the extraction of meaningful patterns and prediction of adverse events.The findings of this study demonstrate various ways in which FAERS, big data analytics, and machine learning can be leveraged to provide advanced healthcare solutions. Machine learning algorithms trained on FAERS data can effectively identify early signals of adverse events associated with specific drugs or treatments, allowing for prompt detection and appropriate actions.Big data analytics applied to FAERS data facilitate pharmacovigilance and drug safety monitoring. Machine learning models automatically classify and analyze adverse event reports, efficiently flagging potential safety concerns and identifying emerging trends.The integration of FAERS data with big data analytics and machine learning enables signal detection and causality assessment. This approach aids in the identification of signals that suggest a causal relationship between drugs and adverse events, thereby enhancing the assessment of drug safety.By analyzing FAERS data in conjunction with patient-specific information, machine learning models can assist in identifying patient subgroups that are more susceptible to adverse events. This information is instrumental in personalizing treatment plans and optimizing medication choices, ultimately leading to improved patient outcomes.The combination of FAERS data with other biomedical information offers insights into potential new uses or indications for existing drugs. Machine learning algorithms analyze the integrated data, identifying patterns and making predictions about the efficacy and safety of repurposing existing drugs for new applications.The implementation of FAERS, big data analytics, and machine learning in advanced healthcare solutions necessitates meticulous consideration of data privacy, security, and ethical implications. Safeguarding patient privacy and ensuring responsible data use through anonymization techniques and appropriate data governance are paramount.The integration of FAERS, big data analytics, and machine learning holds immense potential in advancing healthcare solutions, enhancing patient safety, and optimizing medical interventions. The findings of this study demonstrate the multifaceted benefits that can be derived from leveraging these technologies, paving the way for a more efficient and effective healthcare ecosystem

BIG DATA ANALYTICS IN PHARMACOVIGILANCE - A GLOBAL TREND

Big data analysis has enhanced its demand nowadays in various sectors of health-care including pharmacovigilance. The exact definition of big data is not known to many people though it is routinely used by them. Big data refer to immense and voluminous computerized medical information which are obtained from electronic health records, administrative data, registries related to disease, drug monitoring, etc. This data are usually collected from doctors and pharmacists in a health-care facility. Analysis of big data in pharmacovigilance is useful for early raising of safety alerts, line listing them for signal detection of drugs and vaccines, and also for their validation. The present paper is intended to discuss big data analytics in pharmacovigilance focusing on global prospect and domestic country-India

Challenges and opportunities for mining adverse drug reactions: perspectives from pharma, regulatory agencies, healthcare providers and consumers

Monitoring drug safety is a central concern throughout the drug life cycle. Information about toxicity and adverse events is generated at every stage of this life cycle, and stakeholders have a strong interest in applying text mining and artificial intelligence (AI) methods to manage the ever-increasing volume of this information. Recognizing the importance of these applications and the role of challenge evaluations to drive progress in text mining, the organizers of BioCreative VII (Critical Assessment of Information Extraction in Biology) convened a panel of experts to explore ‘Challenges in Mining Drug Adverse Reactions’. This article is an outgrowth of the panel; each panelist has highlighted specific text mining application(s), based on their research and their experiences in organizing text mining challenge evaluations. While these highlighted applications only sample the complexity of this problem space, they reveal both opportunities and challenges for text mining to aid in the complex process of drug discovery, testing, marketing and post-market surveillance. Stakeholders are eager to embrace natural language processing and AI tools to help in this process, provided that these tools can be demonstrated to add value to stakeholder workflows. This creates an opportunity for the BioCreative community to work in partnership with regulatory agencies, pharma and the text mining community to identify next steps for future challenge evaluations.M.K.: This work was supported in part through the collaboration between the Spanish Plan for the Advancement of Language Technology (Plan TL) and the Barcelona Supercomputing Center; we also acknowledge the 2020 Proyectos de I+D+i - RTI Tipo A (PID2020-119266RA-I00) for support. Ö.U.: This study was supported in part by the National Library of Medicine under Award Number R15LM013209 and R13LM013127.Peer ReviewedPostprint (published version

Using the Literature to Identify Confounders

Prior work in causal modeling has focused primarily on learning graph structures and parameters to model data generating processes from observational or experimental data, while the focus of the literature-based discovery paradigm was to identify novel therapeutic hypotheses in publicly available knowledge. The critical contribution of this dissertation is to refashion the literature-based discovery paradigm as a means to populate causal models with relevant covariates to abet causal inference. In particular, this dissertation describes a generalizable framework for mapping from causal propositions in the literature to subgraphs populated by instantiated variables that reflect observational data. The observational data are those derived from electronic health records. The purpose of causal inference is to detect adverse drug event signals. The Principle of the Common Cause is exploited as a heuristic for a defeasible practical logic. The fundamental intuition is that improbable co-occurrences can be “explained away” with reference to a common cause, or confounder. Semantic constraints in literature-based discovery can be leveraged to identify such covariates. Further, the asymmetric semantic constraints of causal propositions map directly to the topology of causal graphs as directed edges. The hypothesis is that causal models conditioned on sets of such covariates will improve upon the performance of purely statistical techniques for detecting adverse drug event signals. By improving upon previous work in purely EHR-based pharmacovigilance, these results establish the utility of this scalable approach to automated causal inference

European Union pharmacovigilance capabilities : potential for the new legislation

European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed.peer-reviewe

Conceptual graph-based knowledge representation for supporting reasoning in African traditional medicine

Although African patients use both conventional or modern and traditional healthcare simultaneously, it has been proven that 80% of people rely on African traditional medicine (ATM). ATM includes medical activities stemming from practices, customs and traditions which were integral to the distinctive African cultures. It is based mainly on the oral transfer of knowledge, with the risk of losing critical knowledge. Moreover, practices differ according to the regions and the availability of medicinal plants. Therefore, it is necessary to compile tacit, disseminated and complex knowledge from various Tradi-Practitioners (TP) in order to determine interesting patterns for treating a given disease. Knowledge engineering methods for traditional medicine are useful to model suitably complex information needs, formalize knowledge of domain experts and highlight the effective practices for their integration to conventional medicine. The work described in this paper presents an approach which addresses two issues. First it aims at proposing a formal representation model of ATM knowledge and practices to facilitate their sharing and reusing. Then, it aims at providing a visual reasoning mechanism for selecting best available procedures and medicinal plants to treat diseases. The approach is based on the use of the Delphi method for capturing knowledge from various experts which necessitate reaching a consensus. Conceptual graph formalism is used to model ATM knowledge with visual reasoning capabilities and processes. The nested conceptual graphs are used to visually express the semantic meaning of Computational Tree Logic (CTL) constructs that are useful for formal specification of temporal properties of ATM domain knowledge. Our approach presents the advantage of mitigating knowledge loss with conceptual development assistance to improve the quality of ATM care (medical diagnosis and therapeutics), but also patient safety (drug monitoring)