Adverse drug event reporting

Edlavitch SA. Adverse drug event reporting. Arch IntMed 1988 148 1499-503. 

Thomas J. Moore, Michael R. Cohen, and Curt D. Furberg, Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005, Archives of Internal Medicine 167, no. 16, 2007, pp. 1,752-1,759. Also available online. URL http //archinte.ama-assn.org/cgi/content/short/167/16/1752. Downloaded April 14, 2009. 

Bouchy, C. (1990a, November 13). Memo to Leigh Thompson, A. Weinstein, andR. Zerbe, with copies to M. Gerhard, T. Sidney and H. Weber. Re Adverse drug event reporting— Suicide fluoxetine. Retrieved from http //www.breggin.com... 

Is the system vital to the exercise of statutory responsibilities, such as adverse drug event reporting ... 

Finney DJ. The design and logic of a monitor of drug use. J Chronic Dis 1965 18 77-98. Edlavitch SA. Adverse drug event reporting. Arch Intern Med 1988 148 1499-503. 

Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the Food and Drug Administration, 1998-2005. Arch Intern Med 2007 167 1752-1759. 

Submit an occurrence or adverse drug event report per organizational policy. 

K. N. Woodward, Veterinary adverse drug event reporting in the United States, Australia and Canada, in Veterinary Pharmacovigilance. Adverse... 

Form FDA 3500A Mandatory reporting of adverse drug events by manufacturers Mandatory reporting of adverse device events by manufacturers, importers and device user facilities... 

An adverse drug event (ADE) can be defined as An injury related to the use of a drug, although the causality of this relationship may not be proven (Leape 1995). Medications are the most frequent cause of adverse event. In a review it was reported that ADEs are common in most clinical settings included adult inpatients (reported incidences of 6.5%), adult outpatients (27.4%), and a paediatric inpatients (2.3%) (Morimoto et al. 2004). No data on the elderly was reported but it is probably even higher than in adult settings. 

Figueras, A., Tato, F., Fontainas, J. and Gestal-Otero, J.J. (1999). Influence of physician s attitudes on reporting adverse drug events A case-control study. Medical Care 37 809-814. 

Adverse drug events (ADE) FDA Adverse Event Reporting System (AERS) http //www.fda.gov/cder/aers/default.htm Safety reports... 

Sulfasalazine is another DMARD often used in the treatment of RA. It is estimated that 20-30% of RA patients on SSZ report adverse drug reactions. Adverse drug events of SSZ are G1 and hematologic. 

Adverse drug events (ADEs), defined as any injury owing to a medication error, happen often. The Institute of Medicine has reported that at least 1.5 million preventable ADEs occur each year in hospitals and in people s homes. You can reduce your risk of having an ADE by having all your medications reviewed by your doctor or pharmacist. 

Ladewski LA, Belknap SM, Nebeker JR, Sartor O, Lyons EA, Kuzel TC, Tallman MS, Raisch DW, Auerbach AR, Schumock GT, Kwaan HC, Bennett CL. Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002 First results from the research on adverse drug events and reports project. J Clin Oncol 2003 21 3859-3866. 

The report noted that, during this time, the CDER processed and evaluated more than 460,000 reports of adverse drug events, including more than 25,000 submitted directly from individual health-care providers and patients. In addition to this ongoing work, the CDER s new initiatives included ... 

Finally, on a very simple and non-sciendfic basis, I personally wonder whether we are really helping the credibility of an excellent ADE [adverse drug event] system by calling overdose what a physician reports as suicide attempt and by calling depression what a physician is reporting as suicide ideation Of course by the end of the day we will do... 

There is continued focus on adverse drug events and medication errors. Processes must respond to actual or potential adverse drug events and medication errors and properly report them internally and externally (e.g., to the FDA, ISMP, or USP). Other standards address how adverse drug events and medication errors should be addressed to improve systems, support staff education and training, and minimize the risk of medication-related errors and adverse events. 

Health care systems should develop better systems for monitoring and reporting adverse drug events. 

The FDA reports that 319,741 people in the United States were hospitalized as a result of serious adverse drug events in 2008, and of these cases, 15.6% - almost 50,000 - patients died. In fact, from January 2000 to June 2009 the FDA has reported nearly 2 million cases of serious adverse drug events, of which 17 % (336,448) have resulted in death. About 5% of hospital admissions in the United States are estimated to be for the treatment of ADRs. Moreover, as many as one-third of all emergency department and urgent care-center visits are drug related. 

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