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@article{205621,
        author = {Ritesh Kumar},
        title = {POST-MARKETING ADR SURVEILLANCE FOR ORPHAN DRUGS},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {7120-7123},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=205621},
        abstract = {The post-marketing surveillance of Adverse Drug Reactions (ADRs) represents a critical component of pharmacovigilance, ensuring long-term drug safety and efficacy after clinical approval. This challenge becomes significantly compounded in the context of orphan drugs pharmaceutical agents developed specifically to treat, prevent, or diagnose rare medical conditions. Due to the inherently small and geographically dispersed patient populations, pre-marketing clinical trials for orphan drugs are structurally limited by small sample sizes, shorter durations, and a lack of diverse demographic representation. Consequently, many rare, delayed, or long-term systemic toxicities remain undetected until the drug is introduced to the broader market. The primary objective of this study is to evaluate the existing frameworks, methodologies, and operational bottlenecks associated with post-marketing ADR surveillance for orphan drugs. This research highlights the critical role of innovative pharmacovigilance strategies, including global rare disease registries, real-world evidence (RWE) generation, patient-reported outcome (PRO) measures, and advanced data-mining algorithms applied to spontaneous reporting databases (such as FDA FAERS and WHO VigiBase). The findings emphasize that traditional, passive surveillance methods often suffer from severe under-reporting and data fragmentation when applied to rare diseases. The study demonstrates that integrating active surveillance models, fostering international regulatory alignment, and leveraging digital health interventions significantly enhance the early signal detection of hidden ADRs. Ultimately, this paper concludes that robust, specialized post-marketing surveillance is indispensable for optimizing the risk-benefit profile of orphan drugs, thereby safeguarding vulnerable patient populations suffering from rare diseases and guiding informed clinical decision-making.},
        keywords = {Post-Marketing Surveillance, Pharmacovigilance, Orphan Drugs, Adverse Drug Reactions (ADRs), Rare Diseases, Signal Detection.},
        month = {June},
        }