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J Clin Pharmacol. 2002 Aug;42(8):846-66.

Risk assessment in regulatory policy making for human and veterinary public health.

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Center for Veterinary Medicine, US Food and Drug Administration, Rockville, Maryland 20855, USA.


Risk assessment is the method of systematically identifying and assessing factors that influence the probability and consequences of a negative event occurring. One responsibility of veterinary medicine is to protect animal and human health. Food animal production uses antibiotics to enhance production. Regulators evaluate new production technology to ensure animal safety and safe, edible products and to make public policy decisions by assessing risks/benefits. The U.S. Food and Drug Administration, Center for Veterinary Medicine's (CVM's) first risk assessment addressed the potential human health impact of campylobacter effects associated with the use of fluoroquinolines in food-producing animals. CVM used the Monte Carlo method to estimate risk byprobability distributions that reflect the uncertainty and variability in the data used for the assessment. Enterococci faecium is a species more likely to be resistant to antibiotics of last resort. Effective control of multidrug-resistant enterococci will requirea better understanding of the transfer of E. faeciumfrom animals to humans and the interaction between E. faecium, the hospital environment, and humans; prudent antibiotic use; better contact isolation in hospitals; and better surveillance. CVM will model these factors in a second, more complex risk assessment designed to examine the indirect transfer of resistance from animals to humans. Use of risk assessments allows researchers, the industry, regulatory authorities, and educators to make better policy decisions regarding antimicrobial use in food animals and humans and the development of resistance. Today the question of whether the use of antimicrobials for growth enhancement infood animals should or should not be terminated for the benefit of human health remains unresolved.

[Indexed for MEDLINE]

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