Abstract
Much of the present global state of pharmacovigilance has been shaped by major catastrophic events, including tetanus contamination of diphtheria anti-toxin, use of diethylene glycol as a solvent for sulfanilamide, and financially motivated contamination of heparin. Less dramatic issues pose continuing, less tractable problems that are in need of attention; for example, reciprocal notification for drug–drug interactions identified for one of the two drugs; high-risk adverse events that could be readily mitigated by wearable articles that could notify first responders to the patient’s circumstances and needs; single-use syringes for abuse-potential drugs that could eliminate risk to unsuspecting patients of drugs contaminated by infected healthcare personnel who divert drugs for personal use; mandatory lot number reporting in association with adverse event reporting by hospitals that could assist in product complaint evaluation; and addressing the regulatory gap between manufacturing release and administration to patients. A forum for deliberation among stakeholders, as well as strong, focused advocacy, is needed to resolve present and future issues.
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Paul Beninger works part-time as a Senior Medical Advisor in the Department of Global Pharmacovigilance and Epidemiology at Genzyme/Sanofi, and also works part-time as Assistant Professor and Director of the MD/MBA Program at Tufts’ Public Health and Community Medicine, Tufts University School of Medicine. He receives a salary, annual bonus and stock options as part of his compensation from Genzyme/Sanofi, and receives a salary as compensation from Tufts.
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Beninger, P. Pharmacovigilance: Work in Progress. Pharm Med 31, 1–5 (2017). https://doi.org/10.1007/s40290-016-0169-z
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DOI: https://doi.org/10.1007/s40290-016-0169-z