Pharmacovigilance: Work in Progress

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• 作者：Paul Beninger
• 刊名：Pharmaceutical Medicine
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：31
• 期：1
• 页码：1-5
• 全文大小：
• 刊物主题：Pharmaceutical Sciences/Technology; Pharmacotherapy; Pharmacology/Toxicology;
• 出版者：Springer International Publishing
• ISSN：1179-1993
• 卷排序：31

文摘

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.