THE ROLE OF PHARMACOVIGILANCE IN ENSURING DRUG SAFETY

Abstract

 Pharmacovigilance has become an essential component of the policy on the state of the population since the increasing pharmaceutical complexity and the development of extensive pharmaceutical use by people. Because adverse drug reactions (ADRs) remain one of the main causes of morbidity and a healthcare burden in most countries, effective post-marketing surveillance provisions are necessary to identify the occurrence of a variety of risks that may accompany the use of medicinal products.The study has a multi-pronged methodology through the spontaneous reporting part, cohort follow-up and case control assessments, which were complemented with the help of advanced statistics and artificial intelligence-backed algorithms. An organized framework to recognize the trends, demographic correlations and measure ADR severity both using traditional approaches and real-world data mix was created.Findings demonstrated that there was a significant growth in the number of ADR reports with time and that the rates of incidences varied between different classes of drugs like antibiotics and antidepressants. The disparity occurred in terms of age and gender and the results varied between mild and severe and a disproportionate risk of certain populations. The AI-assisted systems proved to be more effective than traditional ones in the process of creating a signal or a predictive model in the early discovery of the potential safety issues and allowed finding them quicker. The change of reporting behaviors also differed considerably within the healthcare professionals and patients which denotes using more diverse and accessible pharmacovigilance platforms.To summarize, the research emphasizes the current change of pharmacovigilance role in the contemporary healthcare environment and the necessity to provide international unification of safety requirements. The advancements in technologies provide the unprecedented opportunities to improve ADR monitoring, and the systemic issues like underreporting or inequality of infrastructure should be overcome. To create effective patient protection policies globally, regulatory frameworks have to be toughened, stakeholder agencies have to be encouraged, and intelligent surveillance tools need to be onboarded to help build a responsive, robust pharmacovigilance environment.