Therapeutic risk management interventions: feasibility and effectiveness

Journal of the American Pharmacists Association : JAPhA
Elizabeth AndrewsSuzanne Cook

Abstract

To review the effectiveness and feasibility of risk management strategies implemented for drugs with significant known risks. Published medical literature and regulatory archives, including proceedings of Food and Drug Administration advisory committee meetings. Iterative searches of the medical literature, the Internet, and Web-based government information sources were conducted throughout 2002-2003. Search terms were related to risk management, drug safety, and the names of specific medications known to be subject to risk management programs. Key studies that illustrated examples of risk management and evaluated risk management programs were selected by the authors. Performed manually by the authors. Much of the information regarding the effectiveness of risk management interventions in reducing risk is anecdotal; little information has been published. Given the demand for evidence-based clinical decision making, pharmaceutical manufacturers and the health care community must understand whether these programs are achieving their ultimate goals of reducing risks to patients, while making needed therapies available. This paucity of evidence points to new opportunities for researchers across disciplines to better understand the ...Continue Reading

References

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Citations

Oct 26, 2011·Statistical Methods in Medical Research·Hassan AssarehKerrie Mengersen
Sep 19, 2006·Pharmacoepidemiology and Drug Safety·Ceri HirstElizabeth Andrews
Nov 18, 2009·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Arjen F J GeertsToine C G Egberts
Jul 29, 2006·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Craig G HartfordPaula Marquez

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