The extraction of pharmacological knowledge from regulatory documents has become a key focus in biomedical natural language processing, with applications ranging from adverse event monitoring to AI-assisted clinical decision support. However, research in this field has predominantly relied on English-language corpora such as DrugBank, leaving a significant gap in resources tailored to other healthcare systems. To address this limitation, we introduce DART (Drug Annotation from Regulatory Texts), the first structured corpus of Italian Summaries of Product Characteristics derived from the official repository of the Italian Medicines Agency (AIFA). The dataset was built through a reproducible pipeline encompassing web-scale document retrieval, semantic segmentation of regulatory sections, and clinical summarization using a few-shot-tuned large language model with low-temperature decoding. DART provides structured information on key pharmacological domains such as indications, adverse drug reactions, and drug-drug interactions. To validate its utility, we implemented an LLM-based drug interaction checker that leverages the dataset to infer clinically meaningful interactions. Experimental results show that instruction-tuned LLMs can accurately infer potential interactions and their clinical implications when grounded in the structured textual fields of DART. We publicly release our code on GitHub: https://github.com/PRAISELab-PicusLab/DART.

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.

Adverse Drug Reactions (ADRs) from psychiatric medications are the leading cause of hospitalizations among mental health patients. With healthcare systems and online communities facing limitations in resolving ADR-related issues, Large Language Models (LLMs) have the potential to fill this gap. Despite the increasing capabilities of LLMs, past research has not explored their capabilities in detecting ADRs related to psychiatric medications or in providing effective harm reduction strategies. To address this, we introduce the Psych-ADR benchmark and the Adverse Drug Reaction Response Assessment (ADRA) framework to systematically evaluate LLM performance in detecting ADR expressions and delivering expert-aligned mitigation strategies. Our analyses show that LLMs struggle with understanding the nuances of ADRs and differentiating between types of ADRs. While LLMs align with experts in terms of expressed emotions and tone of the text, their responses are more complex, harder to read, and only 70.86% aligned with expert strategies. Furthermore, they provide less actionable advice by a margin of 12.32% on average. Our work provides a comprehensive benchmark and evaluation framework for assessing LLMs in strategy-driven tasks within high-risk domains.

In clinical treatment, identifying potential adverse reactions of drugs can help assist doctors in making medication decisions. In response to the problems in previous studies that features are high-dimensional and sparse, independent prediction models need to be constructed for each adverse reaction of drugs, and the prediction accuracy is low, this paper develops an adverse drug reaction prediction model based on knowledge graph embedding and deep learning, which can predict experimental results. Unified prediction of adverse drug reactions covered. Knowledge graph embedding technology can fuse the associated information between drugs and alleviate the shortcomings of high-dimensional sparsity in feature matrices, and the efficient training capabilities of deep learning can improve the prediction accuracy of the model. This article builds an adverse drug reaction knowledge graph based on drug feature data; by analyzing the embedding effect of the knowledge graph under different embedding strategies, the best embedding strategy is selected to obtain sample vectors; and then a convolutional neural network model is constructed to predict adverse reactions. The results show that under the DistMult embedding model and 400-dimensional embedding strategy, the convolutional neural network model has the best prediction effect; the average accuracy, F_1 score, recall rate and area under the curve of repeated experiments are better than the methods reported in the literature. The obtained prediction model has good prediction accuracy and stability, and can provide an effective reference for later safe medication guidance.

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.

User-generated data sources have gained significance in uncovering Adverse Drug Reactions (ADRs), with an increasing number of discussions occurring in the digital world. However, the existing clinical corpora predominantly revolve around scientific articles in English. This work presents a multilingual corpus of texts concerning ADRs gathered from diverse sources, including patient fora, social media, and clinical reports in German, French, and Japanese. Our corpus contains annotations covering 12 entity types, four attribute types, and 13 relation types. It contributes to the development of real-world multilingual language models for healthcare. We provide statistics to highlight certain challenges associated with the corpus and conduct preliminary experiments resulting in strong baselines for extracting entities and relations between these entities, both within and across languages.

We present a novel data augmentation method to address the challenge of data scarcity in modeling longitudinal patterns in Electronic Health Records (EHR) of patients using natural language processing (NLP) algorithms. The proposed method generates augmented data by rearranging the orders of medical records within a visit where the order of elements are not obvious, if any. Applying the proposed method to the clopidogrel treatment failure detection task enabled up to 5.3% absolute improvement in terms of ROC-AUC (from 0.908 without augmentation to 0.961 with augmentation) when it was used during the pre-training procedure. It was also shown that the augmentation helped to improve performance during fine-tuning procedures, especially when the amount of labeled training data is limited.

Importance: We introduce a novel Retrieval Augmented Generation (RAG)-Large Language Model (LLM) as a Clinical Decision Support System (CDSS) for safe medication prescription. This model addresses the limitations of traditional rule-based CDSS by providing relevant prescribing error alerts tailored to patient context and institutional guidelines. Objective: The study evaluates the efficacy of an LLM-based CDSS in identifying medication errors across various medical and surgical case vignettes, compared to a human expert panel. It also examines clinician preferences among different CDSS integration modalities: junior pharmacist, LLM-based CDSS alone, and a combination of both. Design, Setting, and Participants: Utilizing a RAG model with GPT-4.0, the study involved 61 prescribing error scenarios within 23 clinical vignettes across 12 specialties. An expert panel assessed these cases using the PCNE classification and NCC MERP index. Three junior pharmacists independently reviewed each vignette under simulated conditions. Main Outcomes and Measures: The study assesses the LLM-based CDSS's accuracy, precision, recall, and F1 scores in identifying Drug-Related Problems (DRPs), compared to junior pharmacists alone or in an assistive mode with the CDSS. Results: The co-pilot mode of RAG-LLM significantly improved DRP identification accuracy by 22% over solo pharmacists. It showed higher recall and F1 scores, indicating better detection of severe DRPs, despite a slight decrease in precision. Accuracy varied across categories when pharmacists had access to RAG-LLM responses. Conclusions: The RAG-LLM based CDSS enhances medication error identification accuracy when used with junior pharmacists, especially in detecting severe DRPs.

Adverse drug reaction (ADR) detection is an essential task in the medical field, as ADRs have a gravely detrimental impact on patients' health and the healthcare system. Due to a large number of people sharing information on social media platforms, an increasing number of efforts focus on social media data to carry out effective ADR detection. Despite having achieved impressive performance, the existing methods of ADR detection still suffer from three main challenges. Firstly, researchers have consistently ignored the interaction between domain keywords and other words in the sentence. Secondly, social media datasets suffer from the challenges of low annotated data. Thirdly, the issue of sample imbalance is commonly observed in social media datasets. To solve these challenges, we propose the Knowledge Enhanced Shallow and Deep Transformer(KESDT) model for ADR detection. Specifically, to cope with the first issue, we incorporate the domain keywords into the Transformer model through a shallow fusion manner, which enables the model to fully exploit the interactive relationships between domain keywords and other words in the sentence. To overcome the low annotated data, we integrate the synonym sets into the Transformer model through a deep fusion manner, which expands the size of the samples. To mitigate the impact of sample imbalance, we replace the standard cross entropy loss function with the focal loss function for effective model training. We conduct extensive experiments on three public datasets including TwiMed, Twitter, and CADEC. The proposed KESDT outperforms state-of-the-art baselines on F1 values, with relative improvements of 4.87%, 47.83%, and 5.73% respectively, which demonstrates the effectiveness of our proposed KESDT.

Adverse drug events (ADEs) are an important aspect of drug safety. Various texts such as biomedical literature, drug reviews, and user posts on social media and medical forums contain a wealth of information about ADEs. Recent studies have applied word embedding and deep learning -based natural language processing to automate ADE detection from text. However, they did not explore incorporating explicit medical knowledge about drugs and adverse reactions or the corresponding feature learning. This paper adopts the heterogenous text graph which describes relationships between documents, words and concepts, augments it with medical knowledge from the Unified Medical Language System, and proposes a concept-aware attention mechanism which learns features differently for the different types of nodes in the graph. We further utilize contextualized embeddings from pretrained language models and convolutional graph neural networks for effective feature representation and relational learning. Experiments on four public datasets show that our model achieves performance competitive to the recent advances and the concept-aware attention consistently outperforms other attention mechanisms.