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.
Published Version
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