Real-Time Monitoring on Adverse Drug Reactions (ADRs).

Adverse drug reactions (ADRs) pose significant risks to patient safety and present a major challenge in clinical practice and drug development. Real-time monitoring of ADRs has emerged as a crucial strategy to detect, assess, and mitigate the risks associated with medications promptly. By leveraging advanced technologies such as artificial intelligence (AI), machine learning (ML), and digital health tools, healthcare systems can now more effectively monitor ADRs, enhancing both patient safety and the efficiency of drug development processes.

1. Welcome REAL-TIME MONITORING OF ADVERSE DRUG REACTIONS K.Jahnavi B.pharmacy 094/072024 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

2. Introduction defination and importance methods of real-time monitoring tool and resources benefits of real-time monitoring challenges and limitations conclusion 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch INDEX

3. INTRODUCTION Adverse drug reactions (ADRs) are a leading cause of morbidity and mortality worldwide, accounting for significant healthcare costs and patient suffering. Traditional methods of ADR monitoring, relying on spontaneous reporting and periodic safety updates, often lag behind the rapid pace of pharmaceutical innovation and clinical practice. In today's digital era, real-time monitoring of ADRs offers a transformative approach to pharmacovigilance. By harnessing the power of electronic health records, social media, and advanced analytics, we can now detect safety signals faster, respond more swiftly, and protect patients more effectively. This presentation will explore the latest developments and best practices in real-time monitoring of ADRs, highlighting the benefits, challenges, and future directions of this critical field 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

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5. METHODS OF REAL -TIME MONITORING 1. Electronic Health Records (EHRs): Mining EHRs for adverse event data, using natural language processing and machine learning algorithms. 2. Social Media and Online Forums: Monitoring social media platforms, online forums, and patient communities for reports of adverse reactions. 3. Active Surveillance: Proactively monitoring patient populations, such as through patient registries or cohorts, to detect adverse reactions. 4. Machine Learning and AI: Applying machine learning algorithms to large datasets, including EHRs, claims data, and social media, to identify patterns and predict potential safety issues. 5. Spontaneous Reporting: Encouraging healthcare professionals and patients to report adverse reactions through online portals or mobile apps. 6. Distributed Data Networks: Analyzing data from multiple sources, such as EHRs, claims data, and research studies, to identify safety signals. 7. Real-World Evidence (RWE) Platforms: Using RWE platforms to analyze data from various sources, including EHRs, claims data, and wearable devices. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch

6. TOOLS AND RESOURCE DATABASES: FDA adverse event reporting system ( FAERS) EudraVigilance (European Medicines Agency) SOFTWARE: Oracle Argus (Pharmacovigilance software) ArisGlobal LifeSphere(Pharmacovigilance Software) MOBILE APPS: Medwatcher (mobile app for reporting ADRs) AdverseEvent(mobile for reporting ADRs) ONLINE PLATFORMS: MedDRA (Medical Dictionary for Regulatory Activities) WHO-UMC(World health Organization-Uppsala Monitoring centre)

7. BENEFITS OF REAL-TIME MONITORING IMPROVED PATIENT SAFETY: Early detection and response to safety issues reduce harm to patients. ENHANCED SIGNAL DETECTION: Real-time monitoring identifies potential safety signals faster and market accurately. FASTER REGULATORY ACTION: Rapid detection enables quicker regulatory decisions and market actions. BETTER INFORMED HEALTHCARE DECISIONS: Real-time data supports informed treatment chocies and patient counseling . REDUCED HEALTHCARE COSTS: Early intervention minimizes costly hospitalizations and treatments. INCREASED PATIENT ENGAGEMENT: R eal -time monitoring empowers patients to report adverse reactions and take an active role in their care.

8. CHALLENGES AND LIMITATIONS CHALLENGES: Data Quality and Accurancy: ensuring reliable and accurate data from various sources. 2. Data Interation and Interperability: Combining data from disparate systems and formats 3. Real-time Data analytics: processing and analyzing large volumes of data in real-time. 4. Signal Detection and Validation: Distinguishing true safety signals from noise and false postives.

9. CONCLUSION: In conclusion, real-time monitoring of adverse drug reactions is a critical component of modern pharmacovigilance. By leveraging advances in technology, data analytics, and collaboration, we can transform the detection and response to safety signals. While challenges and limitations exist, the benefits of real-time monitoring in improving patient safety, reducing healthcare costs, and enhancing drug development are undeniable. As we move forward, it is essential to: Continue investing in robust real-time monitoring systems Foster global collaboration and harmonization Address emerging challenges and limitations Prioritize patient-centered approaches Embrace innovation and technological advancements Together, we can create a safer, more effective, and more responsive pharmacovigilance system, ultimately protecting patients and improving public health."

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