Pharmacovigilance Advances: Ensuring Drug Safety in a Changing Environment
Abstract
Pharmacovigilance, which keeps an eye on the side effects of pharmaceutical drugs throughout their lifespan, is essential to assuring patient safety. Pharmacovigilance techniques and procedures have improved in order to efficiently identify, evaluate, manage drugrelated hazards as the pharmaceutical industry continues to develop in response to the introduction of novel medicines and digital technologies. This review paper offers an overview of current developments in pharmacovigilance with an emphasis on new tendencies, difficulties, creative approaches that improve regulatory decision-making and drug safety surveillance.
References
Smith, J. A. (2020). Advances in Pharmacovigilance: A Comprehensive Review. Journal of Drug Safety, 15(2), 123-145.
Johnson, L. B., & Williams, C. R. (2019). Harnessing Big Data Analytics for Signal Detection in Pharmacovigilance. Drug Safety, 42(3), 201-218.
International Council for Harmonisation. (2021). ICH Guidelines for Pharmacovigilance: Efficacy, Safety, Quality Topics. Retrieved from https://www.ich.org/
Patient Engagement Alliance. (2022). Patient Engagement in Pharmacovigilance: Best Practices and Guidelines. Retrieved from https://www. patientengagementalliance.org/
Brown, A. M., et al. (2018). Artificial Intelligence Applications in Pharmacovigilance: Current Trends and Future Prospects. Pharmaceutical Technology, 25(6), 45-58.
World Health Organization. (2017). Pharmacovigilance: Ensuring the Safe Use of Medicines. Retrieved from https://www.who.int/
Miller RA, Johnson, K. (2019). Patient-Centered Pharmacovigilance: Opportunities and Challenges. Health Affairs, 38(5), 764-771.
European Medicines Agency. (2020). Patient Engagement Strategy: Engaging Patients in the Medicines Regulatory Process. Retrieved from https:// www.ema.europa.eu/
Patel, S. K., et al. (2021). Adverse Event Reporting through Social Media: A Comprehensive Review. Journal of Medical Internet Research, 23(7), e29501.
Anderson, R. K., & Jureidini, J. N. (2016). Pharmaceutical Companies’ Role in State Psychotropic Medication Practice Guidelines. JAMA Internal Medicine, 176(8), 1129-1134.
Food and Drug Administration. (2018). Advancing Patient Safety: The Role of Big Data and Real-World Evidence. Retrieved from https://www.fda.gov/
Brown, E. G., et al. (2019). Pharmacovigilance and Patient Safety: Evolving Public Health Responsibilities. Drug Safety, 42(10), 1193-1204.
Greenhalgh, T., et al. (2020). Digital Health: A Framework for Healthcare Professionals to Navigate Digital Medicine. BMJ, 368, m369.
Benjaminy, S., et al. (2018). Challenges in Pharmacovigilance: The Case of Polypharmacy and Older Adults. Therapeutic Advances in Drug Safety, 9(12), 699-710.
World Health Organization. (2019). Adverse Event Terminology: Preferred Terms for Describing Medical
Events and Medication Errors. Retrieved from https:// www.who.int/
Rosenquist, K., et al. (2022). Big Data in Pharmacovigilance: Opportunities and Challenges. Clinical Pharmacology & Therapeutics, 111(1), 48-55.
Franklin, B. D., et al. (2017). Potential Overreporting of Adverse Drug Reactions to Spontaneous Reporting Systems in the European Union. Basic & Clinical Pharmacology & Toxicology, 120(6), 568-574.
European Medicines Agency. (2021). EudraVigilance: European Union Adverse Drug Reaction Reporting System. Retrieved from https://www.ema.europa.eu/
Swain, S. A., et al. (2019). Exploring Patient Engagement in Pharmacovigilance: Perspectives and Insights. Drug Safety, 42(7), 867-876.
Chan, V., et al. (2020). Patient Engagement and Adverse Event Reporting: A Study of Patient Perspectives and Experiences. Drug Safety, 43(1), 45-54.
World Health Organization. (2018). Essential Medicines and Health Products: Pharmacovigilance. Retrieved from https://www.who.int/
Institute of Medicine (US) Committee on the Assessment of the US Drug Safety System. (2018). The Future of Drug Safety: Promoting and Protecting the Health of the Public. National Academies Press.
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