Abstract
AbstractThe goal of pharmacovigilance (PV) is to prevent adverse events (AEs) associated with drugs and vaccines. Current PV programs are of a reactive nature and rest entirely on data science, i.e., detecting and analyzing AE data from provider/patient reports, health records and even social media. The ensuing preventive actions are too late for people who have experienced AEs and often overly broad, as responses include entire product withdrawals, batch recalls, or contraindications of subpopulations. To prevent AEs in a timely and precise manner, it is necessary to go beyond data science and incorporate measurement science into PV efforts through person-level patient screening and dose-level product surveillance. Measurement-based PV may be called ‘preventive pharmacovigilance’, the goal of which is to identify susceptible individuals and defective doses to prevent AEs. A comprehensive PV program should contain both reactive and preventive components by integrating data science and measurement science.
Funder
U.S. Food and Drug Administration
National Institute for Innovation in Manufacturing Biopharmaceuticals
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology
Reference17 articles.
1. WHO. The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products; 2002. https://www.who.int/publications/i/item/10665-42493. Accessed 9 June 2023
2. US Food and Drug Administration. Postmarketing surveillance programs | Surveillance: post drug-approval activities. Published 2021. https://www.fda.gov/drugs/surveillance/postmarketing-surveillance-programs. Accessed 2 June 2023
3. Gottlieb S. Evaluating Postmarket vaccine safety - time to consolidate this Mission at a single agency. JAMA Heal Forum. 2021;2(4):E211236. https://doi.org/10.1001/jamahealthforum.2021.1236.
4. Kotarek J, Stuart C, De Paoli SH, et al. Subvisible particle content, formulation, and dose of an erythropoietin peptide mimetic product are associated with severe adverse Postmarketing events. J Pharm Sci. 2016;105(3):1023–7. https://doi.org/10.1016/S0022-3549(15)00180-X.
5. European Medicines Agency. Batches of the Insulin Medicine NovoMix 30 FlexPen and Penfill to be recalled, (EMA/ 657469/ 2013). http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/10/WC500153147.pdf. Accessed 3 Apr 2023
Cited by
3 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献