title: Improving the drug quality and safety net.
abstract: When large quantities of contaminated, subpotent, or superpotent drugs are introduced into the medical supply pipeline, injury or death of hundreds or thousands of patients can occur. Tracing the origin of substandard and dangerous products and tracking across regions and countries where shipped is quite costly in both money and time. From patients' perspective, timely access to quality product is paramount. Receiving deficient product threatens their survival and creates huge sums of financial cost to both them and the medical system. With the passage of HR 3204 the FDA must now find a way to be proactive in policing the global medical product supply line without restricting market availability. Without a comprehensive, world-focused implementation plan these new regulations will fail to protect the public.
authors.affiliation: University of Missouri-Kansas City School of Pharmacy, Kansas City, MO, USA acarter@mriglobal.org.
authors.forename: Alan
authors.initials: A
authors.lastname: Carter
mesh_terms: D003257:Consumer Product Safety; D058110:Counterfeit Drugs; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000592:standards*; D060735:Pharmacovigilance; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D058110:Counterfeit Drugs; D004364:Pharmaceutical Preparations
keywords: counterfeit; global; legislation; outcomes; pharmacovigilance; substandard