Enhancing Drug Safety: Challenges, Solutions, and Recommendations in Post-Marketing Pharmacovigilance

Authors

  • Vani Pathuri Pharmacovigilance Department, Nexpro Technologies Inc, Hillsborough, New Jersey, United States of America. Author

Keywords:

Post-Marketing Pharmacovigilance, Adverse Drug Reaction (ADR) Detection, Real-World Evidence (RWE) in Drug Safety, Drug Safety Surveillance Tools, Regulatory Compliance in Pharmacovigilance

Abstract

Effective post-marketing pharmacovigilance (PV) is necessary to find and lessen these dangers through careful checking, telling about problems, and following rules. Improvements in data study tools, real-world proof, and teamwork ways give fresh chances to make PV work better. This paper examines the challenges of post-marketing PV, explores solutions through advanced tools and regulatory frameworks, and evaluates best practices for optimizing drug safety. We discuss the importance of spontaneous adverse event reporting, the role of real-world evidence in detecting safety signals, and the methodologies used to ensure compliance and efficacy in PV efforts. We propose a strategic approach emphasizing emerging trends, advanced surveillance tools, and collaborative frameworks to address existing gaps and ensure safer drug use in real-world settings.

References

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R. Patel, "Regulatory Gaps in Post-Marketing Surveillance," in Drug Regulation Quarterly, 2019

Tharpe, "Adverse Drug Reaction Reporting," in Journal of Pharmacovigilance, 2018

James et al., "Global Pharmacovigilance Systems," in International Journal of Drug Safety, 2017

Chen et al., "Big Data in Drug Safety," in Data Science Journal, 2016.

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Published

23-08-2024

How to Cite

Vani Pathuri. (2024). Enhancing Drug Safety: Challenges, Solutions, and Recommendations in Post-Marketing Pharmacovigilance. International Journal of Computer Science and Information Technology Research , 5(3), 30-39. https://ijcsitr.com/index.php/home/article/view/IJCSITR_2024_05_03_04