In the realm of cancer treatment, summarizing adverse drug events (ADEs) reported by patients using prescribed drugs is crucial for enhancing pharmacovigilance practices and improving drug-related decision-making. While the volume and complexity of pharmacovigilance data have increased, existing research in this field has predominantly focused on general diseases rather than specifically addressing cancer. This work introduces the task of grouped summarization of adverse drug events reported by multiple patients using the same drug for cancer treatment. To address the challenge of limited resources in cancer pharmacovigilance, we present the MultiLabeled Cancer Adverse Drug Reaction and Summarization (MCADRS) dataset. This dataset includes pharmacovigilance posts detailing patient concerns regarding drug efficacy and adverse effects, along with extracted labels for drug names, adverse drug events, severity, and adversity of reactions, as well as summaries of ADEs for each drug. Additionally, we propose the Grouping and Abstractive Summarization of Cancer Adverse Drug events (GASCADE) framework, a novel pipeline that combines the information extraction capabilities of Large Language Models (LLMs) with the summarization power of the encoder-decoder T5 model. Our work is the first to apply alignment techniques, including advanced algorithms like Direct Preference Optimization, to encoder-decoder models using synthetic datasets for summarization tasks. Through extensive experiments, we demonstrate the superior performance of GASCADE across various metrics, validated through both automated assessments and human evaluations. This multitasking approach enhances drug-related decision-making and fosters a deeper understanding of patient concerns, paving the way for advancements in personalized and responsive cancer care. The code and dataset used in this work are publicly available.

In the era of Large Language Models (LLMs), given their remarkable text understanding and generation abilities, there is an unprecedented opportunity to develop new, LLM-based methods for trustworthy medical knowledge synthesis, extraction and summarization. This paper focuses on the problem of Pharmacovigilance (PhV), where the significance and challenges lie in identifying Adverse Drug Events (ADEs) from diverse text sources, such as medical literature, clinical notes, and drug labels. Unfortunately, this task is hindered by factors including variations in the terminologies of drugs and outcomes, and ADE descriptions often being buried in large amounts of narrative text. We present MALADE, the first effective collaborative multi-agent system powered by LLM with Retrieval Augmented Generation for ADE extraction from drug label data. This technique involves augmenting a query to an LLM with relevant information extracted from text resources, and instructing the LLM to compose a response consistent with the augmented data. MALADE is a general LLM-agnostic architecture, and its unique capabilities are: (1) leveraging a variety of external sources, such as medical literature, drug labels, and FDA tools (e.g., OpenFDA drug information API), (2) extracting drug-outcome association in a structured format along with the strength of the association, and (3) providing explanations for established associations. Instantiated with GPT-4 Turbo or GPT-4o, and FDA drug label data, MALADE demonstrates its efficacy with an Area Under ROC Curve of 0.90 against the OMOP Ground Truth table of ADEs. Our implementation leverages the Langroid multi-agent LLM framework and can be found at https://github.com/jihyechoi77/malade.

The mining of adverse drug events (ADEs) is pivotal in pharmacovigilance, enhancing patient safety by identifying potential risks associated with medications, facilitating early detection of adverse events, and guiding regulatory decision-making. Traditional ADE detection methods are reliable but slow, not easily adaptable to large-scale operations, and offer limited information. With the exponential increase in data sources like social media content, biomedical literature, and Electronic Medical Records (EMR), extracting relevant ADE-related information from these unstructured texts is imperative. Previous ADE mining studies have focused on text-based methodologies, overlooking visual cues, limiting contextual comprehension, and hindering accurate interpretation. To address this gap, we present a MultiModal Adverse Drug Event (MMADE) detection dataset, merging ADE-related textual information with visual aids. Additionally, we introduce a framework that leverages the capabilities of LLMs and VLMs for ADE detection by generating detailed descriptions of medical images depicting ADEs, aiding healthcare professionals in visually identifying adverse events. Using our MMADE dataset, we showcase the significance of integrating visual cues from images to enhance overall performance. This approach holds promise for patient safety, ADE awareness, and healthcare accessibility, paving the way for further exploration in personalized healthcare.

Large Language Models (LLMs) are widely used in critical fields such as healthcare, education, and finance due to their remarkable proficiency in various language-related tasks. However, LLMs are prone to generating factually incorrect responses or "hallucinations," which can lead to a loss of credibility and trust among users. To address this issue, we propose a multi-stage framework that generates the rationale first, verifies and refines incorrect ones, and uses them as supporting references to generate the answer. The generated rationale enhances the transparency of the answer and our framework provides insights into how the model arrived at this answer, by using this rationale and the references to the context. In this paper, we demonstrate its effectiveness in improving the quality of responses to drug-related inquiries in the life sciences industry. Our framework improves traditional Retrieval Augmented Generation (RAG) by enabling OpenAI GPT-3.5-turbo to be 14-25% more faithful and 16-22% more accurate on two datasets. Furthermore, fine-tuning samples based on our framework improves the accuracy of smaller open-access LLMs by 33-42% and competes with RAG on commercial models.

Also known as drug safety, it relates to the'collection, detection, assessment, monitoring, and prevention' of adverse effects of pharmaceutical products. For obvious reasons it's important for clinicians to know how the drugs they prescribe to patients will interact with other medications they're already on. The wrong combination could reduce the effectiveness of the medication or increase the risk of side effects. It's the reason why the process is heavily vetted and certified. I've been a doctor since 1999 and a GP since 2008.

Don't miss our upcoming virtual workshop with John Snow Labs, Improve Drug Safety with NLP, to learn more about our joint NLP solution accelerator for adverse drug event detection. The World Health Organization defines pharmacovigilance as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine-related problem." While all medicines and vaccines undergo rigorous testing for safety and efficacy in clinical trials, certain side effects may only emerge once these products are used by a larger and more diverse patient population, including people with other concurrent diseases. To support ongoing drug safety, biopharmaceutical manufacturers must report adverse drug events (ADEs) to regulatory agencies, such as the US Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in the EU. Adverse drug reactions or events are medical problems that occur during treatment with a drug or therapy.

Explainable Artificial Intelligence (XAI) has been identified as a viable method for determining the importance of features when making predictions using Machine Learning (ML) models. In this study, we created models that take an individual's health information (e.g. their drug history and comorbidities) as inputs, and predict the probability that the individual will have an Acute Coronary Syndrome (ACS) adverse outcome. Using XAI, we quantified the contribution that specific drugs had on these ACS predictions, thus creating an XAI-based technique for pharmacovigilance monitoring, using ACS as an example of the adverse outcome to detect. Individuals aged over 65 who were supplied Musculo-skeletal system (anatomical therapeutic chemical (ATC) class M) or Cardiovascular system (ATC class C) drugs between 1993 and 2009 were identified, and their drug histories, comorbidities, and other key features were extracted from linked Western Australian datasets. Multiple ML models were trained to predict if these individuals would have an ACS related adverse outcome (i.e., death or hospitalisation with a discharge diagnosis of ACS), and a variety of ML and XAI techniques were used to calculate which features -- specifically which drugs -- led to these predictions. The drug dispensing features for rofecoxib and celecoxib were found to have a greater than zero contribution to ACS related adverse outcome predictions (on average), and it was found that ACS related adverse outcomes can be predicted with 72% accuracy. Furthermore, the XAI libraries LIME and SHAP were found to successfully identify both important and unimportant features, with SHAP slightly outperforming LIME. ML models trained on linked administrative health datasets in tandem with XAI algorithms can successfully quantify feature importance, and with further development, could potentially be used as pharmacovigilance monitoring techniques.

Cognitive computing can transform the practice of pharmacovigilance, from a tedious, resource-intensive process to a dynamic and efficient method focusing on risk management. FREMONT, CA: As pharmacovigilance deals with the activities relating to the detection, understanding, assessment, and prevention of adverse effects of pharmaceutical products, it has to navigate through a large volume of complex data. It cannot be avoided for its complex nature because pharmacovigilance audit accesses the compliance of pharma companies with worldwide laws, regulations, and FDA guidance. There arises a demand for handling enormous data by remaining compliant with the changing regulations globally while maintaining and improving the information contained in the individual case safety reports. The cost of handling pharmacovigilance is increasing with the exponential growth of cases received by pharmaceutical companies. The technical advancement like cloud-based solutions, mobile health devices, artificial intelligence, blockchain, and machine learning can improve the effectiveness of PV and the efficacy of drugs.

Adverse drug reactions or adverse drug events refer to unwanted or harmful reactions experienced following the administration of a medicine or combination of medicines under normal conditions of use. A clinician or patient then suspects the reaction, such as rash or a headache, to be linked to the drug. The event is reported back to the manufacturer of the medicine for investigation and be subject to scrutiny by a regulatory agency, such as the U.S. Food and Drug Administration (FDA). The practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions is referred to as pharmacovigilance, and monitoring is an activity incumbent upon drug manufacturers. The process is also designed to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

Objective Social media is becoming increasingly popular as a platform for sharing personal health-related information. This information can be utilized for public health monitoring tasks, particularly for pharmacovigilance, via the use of natural language processing (NLP) techniques. However, the language in social media is highly informal, and user-expressed medical concepts are often nontechnical, descriptive, and challenging to extract. There has been limited progress in addressing these challenges, and thus far, advanced machine learning-based NLP techniques have been underutilized. Our objective is to design a machine learning-based approach to extract mentions of adverse drug reactions (ADRs) from highly informal text in social media. Methods We introduce ADRMine, a machine learning-based concept extraction system that uses conditional random fields (CRFs).