Adverse Events and Risk Management

A number of variables influence the likelihood of an adverse event being reported. These include the length of time that a product has been marketed, the market share, experience and sophistication of the population using the product, and publicity about adverse events. Currently there is little incentive for health professional reporting of adverse events, which partially imderlies the problem with underreporting. Lack of exposure data and the issue of underreporting preclude estimation of incidence rates. Causality assessment is difficult or impossible because of the quality of the data received and the lack of a comparator (control) group. Finally, comparisons of product safety cannot be directly obtained from adverse event data. 

Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alternative medicine use among adults United States, 2002. Adv Data 2004 343 1-19. 

Hoffman FA. Botanicals as drugs a US perspective. In Lam YW, Huang S-M, Hall SD, eds. Herbal Supplements - Drug Interactions. Taylor Francis, 2006. 

WHO issues guidelines for herbal medicines. Bull World Health Organ 2004 82(3) 238. 

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