Citation:

Vani Pathuri , 2022. "Ethical Considerations in Modern Pharmacovigilance and Signal Detection", ESP Journal of Engineering & Technology Advancements, 2(1): 168-172.

Abstract:

Pharmacovigilance is one of the most significant components of drug safety and a guarantee for public health, particularly after the drug has been marketed. Yet, with the evolution in the surveillance of pharmaceuticals, here lies a litany of ethical challenges regarding privacy, consent, transparency, and patient monitoring. This paper will discuss critical modern ethical issues in pharmacovigilance involving big data, ethics of post-market surveillance, and challenges in signal detection for vulnerable populations, all compounded by new technologies such as AI and social media. Other ethical issues are off-label drug use, reporting and interpretation of adverse events, and transparency in communicating drug safety. Based on our experience, we would like to propose a set of strategies that would guide these ethical challenges, such as improved guidelines on transparency, better frameworks of regulation, and balanced risk management approaches to ensure both drug safety and innovation without sacrificing patients' rights or public trust.

References:

[1] G. G. L. Y. Lee, "Ethical issues in pharmacovigilance: A review," in Journal of Clinical Pharmacology, 2019.

[2] A. Smith et al., "The role of artificial intelligence in drug safety monitoring," in Journal of Pharmacovigilance, 2018.

[3] M. Anderson, J. Johnson, "Ethical implications of off-label drug use and post-market surveillance," in Pharmacology & Therapeutics Journal, 2017.

[4] R. Parker, G. Lee, "Ethical implications of social media in pharmacovigilance," in Pharmaceutical Ethics Review, 2019

Keywords:

Pharmacovigilance, Ethical Challenges, Drug Safety, Signal Detection, Post-Market Surveillance.